Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

torrent pharmaceuticals limited - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole oral tablets are indicated for the treatment of: - schizophrenia  - acute treatment of manic and mixed episodes associated with bipolar i disorder  - adjunctive treatment of major depressive disorder  - irritability associated with autistic disorder  - treatment of tourette's disorder  aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions ( 6.2) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs, including aripiprazole, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see clinical considerations) . overall available data from published epidemiologic studies of pregnant women exposed to aripiprazole have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother associated with untreated schizophrenia, bipolar i disorder, or major depressive disorder, and with exposure to antipsychotics, including aripiprazole, during pregnancy (see clinical considerations) . in animal reproduction studies, oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses 10 and 19 times, respectively, the maximum recommended human dose (mrhd) of 30 mg/day based on mg/m 2 body  surface area, produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. oral and intravenous aripiprazole administration during the pre- and post- natal period in rats at doses 10 times the mrhd based on mg/m 2  body surface area, produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk there is a risk to the mother from untreated schizophrenia or bipolar i disorder, including increased risk of relapse, hospitalization, and suicide. schizophrenia and bipolar i disorder are associated with increased adverse perinatal outcomes, including preterm birth. it is not known if this is a direct result of the illness or other comorbid factors. a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. the women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs (including aripiprazole) during the third trimester of pregnancy. these symptoms have varied in severity. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. monitor neonates for extrapyramidal and/or withdrawal symptoms. data human data published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. a retrospective study from a medicaid database of 9,258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. animal data in animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits. in pregnant rats treated orally with aripiprazole during organogenesis at doses of 3, 10, and 30 mg/kg/day, which are approximately 1, 3 and 10 times the mrhd of 30 mg/day based on mg/m 2  body surface area, a slight prolongation of gestation and delay in fetal development, as evidenced by decreased fetal weight and undescended testes, were observed at 10 times the mrhd. delayed skeletal ossification was observed at 3 and 10 times the mrhd. delivered offspring had increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed at 10 times the mrhd (the other dose groups were not examined for these findings). postnatally, delayed vaginal opening was seen at 3 and 10 times the mrhd. impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) were observed at 10 times the mrhd; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. in pregnant rats injected intravenously with aripiprazole during organogenesis at doses of 3, 9, and 27 mg/kg/day, which are 1, 3, and 9 times the mrhd of 30 mg/day based on mg/m 2  body surface area, decreased fetal weight and delayed skeletal ossification were observed at 9 times the mrhd; this dose also caused maternal toxicity. in pregnant rabbits treated orally with aripiprazole during organogenesis at doses of 10, 30, and 100 mg/kg/day which are 6, 19, and 65 times the mrhd of 30 mg/day based on mg/m 2  body surface area, decreased maternal food consumption, and increased abortions as well as increased fetal mortality were observed at 65 times the mrhd. decreased fetal weight and increased incidence of fused sternebrae were observed at 19 and 65 times the mrhd. in pregnant rabbits injected intravenously with aripiprazole during organogenesis at doses of 3, 10, and 30 mg/kg/day, which are 2, 6, and 19 times the mrhd of 30 mg/day based on mg/m 2  body surface area, decreased fetal weight, increased fetal abnormalities (primarily skeletal), and decreased fetal skeletal ossification were observed at 19 times the mrhd; this dose also caused maternal toxicity. the fetal no-effect dose was 10 mg/kg/day, which is 6 times the mrhd. in rats treated orally with aripiprazole peri- and post-natally from gestation day 17 through postpartum day 21 at doses of 3, 10, and 30 mg/kg/day which are 1, 3, and 10 times the mrhd of 30 mg/day based on mg/m 2  body surface area slight maternal toxicity and slightly prolonged gestation were observed at 10 times the mrhd. an increase in stillbirths and, decreases in pup weight (persisting into adulthood) and survival were also seen at this dose. in rats injected intravenously with aripiprazole from gestation day 6 through lactation day 20 at doses of 3, 8, and 20 mg/kg/day, which are 1, 3, and 6 times the mrhd of 30 mg/day based on mg/m 2  body surface area, increased stillbirths were observed at 3 and 6 times the mrhd; and decreases in early postnatal pup weight and survival were observed at 6 times the mrhd; these doses also caused some maternal toxicity. there were no effects on postnatal behavioral and reproductive development. risk summary limited data from published literature report the presence of aripiprazole in human breast milk, at relative infant doses ranging between 0.7% to 8.3% of the maternal weight-adjusted dosage. there are reports of poor weight gain in breastfed infants exposed to aripiprazole and reports of inadequate milk supply in lactating women taking aripiprazole. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for aripiprazole and any potential adverse effects on the breastfed infant from aripiprazole or from the underlying maternal condition.  safety and effectiveness in pediatric patients with major depressive disorder or agitation associated with schizophrenia or bipolar mania have not been established. the pharmacokinetics of aripiprazole and dehydro-aripiprazole in pediatric patients, 10 to 17 years of age, were similar to those in adults after correcting for the differences in body weight [see clinical pharmacology ( 12.3) ] . schizophrenia safety and effectiveness in pediatric patients with schizophrenia were established in a 6 week, placebo-controlled clinical trial in 202 pediatric patients aged 13 to 17 years [see dosage and administration ( 2.1), adverse reactions ( 6.1) , and clinical studies ( 14.1) ] . although maintenance efficacy in pediatric patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. bipolar i disorder safety and effectiveness in pediatric patients with bipolar mania were established in a 4 week, placebo-controlled clinical trial in 197 pediatric patients aged 10 to 17 years [see dosage and administration ( 2.2), adverse reactions ( 6.1) , and clinical studies ( 14.2)] . although maintenance efficacy in pediatric patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. the efficacy of adjunctive aripiprazole with concomitant lithium or valproate in the treatment of manic or mixed episodes in pediatric patients has not been systematically evaluated. however, such efficacy and lack of pharmacokinetic interaction between aripiprazole and lithium or valproate can be extrapolated from adult data, along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. irritability associated with autistic disorder safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two 8 week, placebo-controlled clinical trials in 212 pediatric patients aged 6 to 17 years [see indications and usage ( 1), dosage and administration ( 2.4), adverse reactions ( 6.1) , and clinical studies ( 14.4)] . a maintenance trial was conducted in pediatric patients (6 to 17 years of age) with irritability associated with autistic disorder. the first phase of this trial was an open-label, flexibly dosed (aripiprazole 2 to 15 mg/day) phase in which patients were stabilized (defined as >25% improvement on the abc-i subscale, and a cgi-i rating of "much improved" or "very much improved") on aripiprazole for 12 consecutive weeks. overall, 85 patients were stabilized and entered the second, 16 week, double-blind phase where they were randomized to either continue aripiprazole treatment or switch to placebo. in this trial, the efficacy of aripiprazole for the maintenance treatment of irritability associated with autistic disorder was not established. tourette's disorder safety and effectiveness of aripiprazole in pediatric patients with tourette's disorder were established in one 8 week (aged 7 to 17 years) and one 10 week trial (aged 6 to 18 years) in 194 pediatric patients [see dosage and administration ( 2.5), adverse reactions ( 6.1), and clinical studies ( 14.5) ]. maintenance efficacy in pediatric patients has not been systematically evaluated. juvenile animal studies aripiprazole in juvenile rats caused mortality, cns clinical signs, impaired memory and learning, and delayed sexual maturation when administered at oral doses of 10, 20, 40 mg/kg/day from weaning (21 days old) through maturity (80 days old). at 40 mg/kg/day, mortality, decreased activity, splayed hind limbs, hunched posture, ataxia, tremors and other cns signs were observed in both genders. in addition, delayed sexual maturation was observed in males. at all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary (atrophy), adrenals (adrenocortical hypertrophy), mammary glands (hyperplasia and increased secretion), and female reproductive organs (vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea) were observed. the changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. a no observed adverse effect level (noael) could not be determined and, at the lowest tested dose of 10 mg/kg/day, there is no safety margin relative to the systemic exposures (auc 0 to 24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2 month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies. aripiprazole in juvenile dogs (2 months old) caused cns clinical signs of tremors, hypoactivity, ataxia, recumbency and limited use of hind limbs when administered orally for 6 months at 3, 10, 30 mg/kg/day. mean body weight and weight gain were decreased up to 18% in females in all drug groups relative to control values. a noael could not be determined and, at the lowest tested dose of 3 mg/kg/day, there is no safety margin relative to the systemic exposures (auc 0 to 24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2 month recovery period. no dosage adjustment is recommended for elderly patients [see boxed warning, warnings and precautions ( 5.1) , and clinical pharmacology ( 12.3) ] . of the 13,543 patients treated with oral aripiprazole in clinical trials, 1,073 (8%) were ≥65 years old and 799 (6%) were ≥75 years old. placebo-controlled studies of oral aripiprazole in schizophrenia, bipolar mania, or major depressive disorder did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. aripiprazole is not approved for the treatment of patients with psychosis associated with alzheimer's disease [see boxed warning and warnings and precautions ( 5.1) ] . dosage adjustment is recommended in known cyp2d6 poor metabolizers due to high aripiprazole concentrations. approximately 8% of caucasians and 3 to 8% of black/african americans cannot metabolize cyp2d6 substrates and are classified as poor metabolizers (pm) [see dosage and administration ( 2.7) and clinical pharmacology ( 12.3) ]. no dosage adjustment for aripiprazole is required on the basis of a patient's hepatic function (mild to severe hepatic impairment, child-pugh score between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 ml/minute) [see clinical pharmacology ( 12.3) ] . no dosage adjustment for aripiprazole is required on the basis of a patient's sex, race, or smoking status [see clinical pharmacology ( 12.3) ] . aripiprazole is not a controlled substance. aripiprazole has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of aripiprazole misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). in physical dependence studies in monkeys, withdrawal symptoms were observed upon abrupt cessation of dosing. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam 10 mg - diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. diazepam tablets are contraindicated in patients with a known hypersensitivity to diazepam and, because of lack of sufficient clinical experience, in pediatric patients under 6 months of age. diazepam tablets are also contraindicated in patients with myasthenia gravis, severe respiratory insufficiency, severe hepatic insufficiency, and sleep apnea syndrome. they may be used in patients with open-angle glaucoma who are receiving appropriate therapy, but is contraindicated in acute narrow-angle glaucoma. diazepam tablets contain diazepam, a schedule iv controlled substance. diazepam tablets are a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings: abuse, misuse, and addiction). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). diazepam tablets may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses), those who have had longer durations of use (see warnings: dependence and withdrawal reactions). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam tablets or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of diazepam tabletsand warnings: dependence and withdrawal reactions). acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines. tolerance to diazepam tablets may develop from continued therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of diazepam tablets may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

salix pharmaceuticals, inc. - methylnaltrexone bromide (unii: rfo6il3d3m) (methylnaltrexone - unii:0rk7m7iabe) - methylnaltrexone bromide 150 mg - relistor tablets and relistor injection are indicated for the treatment of opioid-induced constipation (oic) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. relistor injection is indicated for the treatment of oic in adult patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. relistor is contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation [see warnings and precautions ( 5.1)] . risk summary the limited available data with relistor in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriages. there are clinical considerations when relistor is used by pregnant women [see clinical considerations]. in animal reproduction studies, no effects on embryofetal development were observed with the administration of intravenous methylnaltrexone bromide during organogenesis in rats and rabbits at doses up to 20 times and 26 times, respectively, the subcutaneous maximum recommended human dose (mrhd) of 12 mg relistor injection per day. the intravenous doses in rats and rabbits are about 0.5 times and 0.7 times, respectively, the oral mrhd of 450 mg/day [see data]. advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions the use of relistor during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier. data animal data reproduction studies have been performed with methylnaltrexone bromide administered during the period of organogenesis to rats at intravenous doses up to 25 mg/kg/day (about 20 times the subcutaneous mrhd of 12 mg/day based on body surface area), and did not cause any adverse effects on embryofetal development. in rabbits, intravenous doses of methylnaltrexone bromide up to 16 mg/kg/day (about 26 times the subcutaneous mrhd of 12 mg/day) did not show any embryofetal toxicity. the intravenous doses in rats (25 mg/kg/day) and rabbits (16 mg/kg/day) are about 0.5 and 0.7 times, respectively, the oral mrhd of 450 mg/day based on body surface area. a pre- and postnatal development study in rats showed no evidence of any adverse effect on pre- and postnatal development at subcutaneous doses of methylnaltrexone bromide up to 100 mg/kg/day (about 81 times the subcutaneous mrhd of 12 mg/day; about 2.2 times the oral mrhd of 450 mg/day). risk summary there is no information regarding the presence of methylnaltrexone in human milk, the effects on the breastfed infant, or the effects on milk production. methylnaltrexone is present in rat milk [see data]. because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with relistor. data radioactivity appeared in rat milk within 30 minutes of a single subcutaneous administration of radiolabeled methylnaltrexone bromide and was concentrated up to 24-fold at 8 hours after administration relative to plasma concentrations. safety and effectiveness of relistor tablets and injection have not been established in pediatric patients. juvenile animal studies in juvenile rats administered intravenous methylnaltrexone bromide for 13 weeks, adverse clinical signs such as convulsions, tremors and labored breathing were observed, and the juvenile rats were found to be more sensitive to the adverse effects of methylnaltrexone when compared to adult animals. juvenile dogs administered intravenous methylnaltrexone bromide for 13 weeks had a toxicity profile similar to adult dogs [see nonclinical toxicology ( 13.2)] . of the total number of patients in clinical studies of relistor tablets, a total of 136 patients (10%) were aged 65 years and older, while 23 (2%) were aged 75 and older. in clinical studies of relistor tablets, no overall differences in effectiveness were observed. adverse reactions were similar; however, there was a higher incidence of diarrhea in elderly patients. of the total number of patients in clinical studies of relistor injection, a total of 226 (28%) were aged 65 years and older, while 108 (13%) were aged 75 years and older. in clinical studies of relistor injection, no overall differences in safety or effectiveness were observed between elderly patients and younger patients. based on pharmacokinetic data, and safety and efficacy data from controlled clinical trials, no dosage adjustment based on age is recommended. monitor elderly patients for adverse reactions. in a study of subjects with varying degrees of renal impairment receiving relistor injection subcutaneously, there was a significant increase in the exposure to methylnaltrexone in subjects with moderate and severe renal impairment (creatinine clearance less than 60 ml/minute as estimated by cockcroft-gault) compared to healthy subjects [see clinical pharmacology ( 12.3)] . therefore, a dosage reduction of relistor tablets and relistor injection is recommended in patients with moderate and severe renal impairment [see dosage and administration ( 2.4)] . no dosage adjustment of relistor tablets or relistor injection is needed in patients with mild renal impairment (creatinine clearance greater than 60 ml/minute as estimated by cockcroft-gault). tablets in a study of subjects with varying degrees of hepatic impairment receiving a 450 mg dose of relistor tablets, there was a significant increase in systemic exposure of methylnaltrexone for subjects with moderate (child-pugh class b) and severe (child-pugh class c) hepatic impairment compared to healthy subjects with normal hepatic function [see clinical pharmacology ( 12.3)] . therefore, a dosage reduction of relistor tablets is recommended in patients with moderate or severe hepatic impairment [see dosage and administration ( 2.5)]. no dosage adjustment of relistor tablets is needed in patients with mild hepatic impairment (child-pugh class a). injection in a study of subjects with mild or moderate hepatic impairment, there was no clinically meaningful change in systemic exposure of methylnaltrexone compared to healthy subjects with normal hepatic function [see clinical pharmacology ( 12.3)] . therefore, no dosage adjustment of relistor injection is needed for patients with mild or moderate hepatic impairment [see clinical pharmacology ( 12.3)]. patients with severe hepatic impairment were not studied. in patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions. if considering dosage adjustment, follow the recommendations in table 3 [see dosage and administration ( 2.5)]. instructions for use relistor ® (rel-i-store) (methylnaltrexone bromide) injection, for subcutaneous use pre-filled syringe read this instructions for use before you start using relistor and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. the following instructions explain how to prepare and give an injection of relistor the right way, when using a pre-filled syringe of relistor. important information: - do not use a relistor pre-filled syringe and attached needle more than 1 time, even if there is medicine left in the syringe. see step 4 “dispose of used pre-filled syringes and needles.” - safely throw away relistor pre-filled syringes and attached needle after use. - to avoid needle-stick injuries, do not recap used needles. - avoid touching the trigger fingers of the relistor pre-filled syringe to keep from activating the needle guard (safety device) too soon. the needle guard is activated by pressure from the plunger on the trigger fingers (see figure a). gather the supplies you will need for your injection (see figure a). these include: - 1 relistor pre-filled syringe with attached needle - 1 alcohol swab - 1 cotton ball or gauze - 1 adhesive bandage - a puncture resistant container, such as an fda-cleared sharps disposal container to dispose of used pre-filled syringes and needles. see step 4: “dispose of used pre-filled syringes and needles.” step 1: choose and prepare the injection site - choose an injection site on your stomach-area (abdomen), thighs, or upper arms. see the shaded areas in figures b and c below. do not inject at the exact same spot each time (rotate injection sites). do not inject into areas where the skin is tender, bruised, red or hard. avoid areas with scars or stretch marks. figure b abdomen or thigh – use these sites when injecting yourself or another person. figure c upper arm – use this site only when injecting another person. - clean the injection site with an alcohol swab and let it air dry. do not touch this area again before giving the injection (see figure d). step 2: prepare the pre-filled syringe - choose a flat, clean, well-lit work surface. - wash your hands with soap and water before preparing for the injection. - look at the pre-filled syringe of relistor (see figure e). make sure that the dose prescribed by your healthcare provider matches the dose on the pre-filled syringe label. look at the plunger rod of the syringe. if the dose prescribed by your healthcare provider is 8 mg, the plunger rod will be yellow; if the prescribed dose is 12 mg, the plunger rod of the syringe will be dark blue (see figure e). - the liquid in the pre-filled syringe should be colorless to pale yellow, and should not have any particles in it. do not use the pre-filled syringe if it looks discolored, cloudy, or has any particles. - use one hand to firmly hold the barrel of the pre-filled syringe. use your other hand to pull the needle cap straight off (see figure f). do not touch the needle or allow it to touch anything. step 3: inject relistor - use one hand to pinch the skin around the injection site (see figure g). - use your other hand to hold the pre-filled syringe. insert the full length of the needle into the skin at a 45-degree angle with a quick “dart‑like” motion (see figure h). - let go of the skin and slowly push the plunger in with your thumb until the pre-filled syringe is empty (see figure i). this will release the needle guard (safety device). - continue to hold pressure on the plunger with your thumb and quickly pull the needle out of the skin. be careful to keep the needle at the same angle as it was inserted. remove your thumb from the plunger to allow the protective sleeve to cover the needle (see figure j). there may be a little bleeding at the injection site. - hold a cotton ball or gauze over the injection site (see figure k). do not rub the injection site. apply an adhesive bandage to the injection site if needed. step 4: dispose of used pre-filled syringes and needles - do not reuse the pre-filled syringe and attached needle. - to avoid needle-stick injuries, do not recap used needles. - put your used pre-filled syringes and attached needles in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - if you have any questions, talk to your healthcare provider or pharmacist. - how should i store relistor? - store pre-filled syringes at room temperature between 68° to 77°f (20° to 25°c). - do not freeze relistor. - keep relistor away from light until you are ready to use it. - keep relistor and all medicines, needles and syringes out of the reach of children. for more information, go to www.relistor.com or call 1-800-321-4576. this instructions for use has been approved by the u.s. food and drug administration. distributed by: salix pharmaceuticals, a division of bausch health us, llc bridgewater, nj 08807 usa under license from: progenics pharmaceuticals, inc. tarrytown, ny 10591 usa for injection: u.s. patent numbers: 8,247,425; 8,420,663; 8,552,025; 8,822,490; 9,180,125; 9,492,445; 9,669,096 and 10,376,584 for tablets: u.s. patent numbers: 8,420,663; 8,524,276; 8,956,651; 9,180,125; 9,314,461; 9,492,445; 9,724,343; 10,307,417 and 10,376,505 relistor is a trademark of salix pharmaceuticals, inc. or its affiliates. any other product/brand names are trademarks of the respective owners. © 2020 salix pharmaceuticals, inc. or its affiliates revised: 04/2020 9502505 70014843 instructions for use relistor ® (rel-i-store) (methylnaltrexone bromide) injection, for subcutaneous use vial and syringe with retractable needle in tray read this instructions for use before you start using relistor and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. the following instructions explain how to prepare and give an injection of relistor the right way, when using a relistor tray containing a syringe with a retractable needle. a retractable needle is one that is pulled back so that it is covered after use, to prevent needle-stick injury. important information: - do not use a relistor vial more than 1 time, even if there is medicine left in the vial. - if relistor has been drawn into a syringe and you are unable to use the medicine right away, carefully recap the needle and keep the syringe at room temperature for up to 24 hours. for more information about how to store relistor, see the section called “ how should i store relistor? ” at the end of this instructions for use. - safely throw away relistor vials after use. - do not reuse syringes and needles. see step 5: “dispose of used syringes and needles” for information about how to safely throw away used needles and syringes. - to avoid needle-stick injuries, do not recap used needles. your tray should include (see figure a): - 1 relistor vial - 1 1 ml syringe with retractable needle (vanishpoint) - 2 alcohol swabs - you will also need: - 1 cotton ball or gauze - 1 adhesive bandage - a puncture resistant container, such as an fda-cleared sharps disposal container to dispose of your used syringes and needles. see step 5: “dispose of used syringes and needles.” step 1: choose and prepare the injection site - choose an injection site on your stomach-area (abdomen), thighs, or upper arms. see the shaded areas in figures b and c below. do not inject at the exact same spot each time (rotate injection sites). do not inject into areas where the skin is tender, bruised, red, or hard. avoid areas with scars or stretch marks. - figure b abdomen or thigh – use these sites when injecting yourself or another person. figure c upper arm – use this site only when injecting another person. - clean the injection site with an alcohol swab and let it air dry. do not touch this area again before giving the injection (see figure d). step 2: prepare the injection - choose a flat, clean, well-lit work surface. - wash your hands with soap and water before preparing for the injection. - look at the vial of relistor (see figure e). the liquid in the vial should be colorless to pale yellow, and should not have any particles in it. do not use the vial if it looks discolored, cloudy, or has any particles. step 3: prepare the syringe - remove the cap from the vial containing relistor (see figure f). - wipe the rubber stopper with an alcohol swab (see figure g). - firmly hold the barrel of the syringe with one hand. with your other hand, pull the needle cap straight off (see figure h). do not touch the needle or allow it to touch anything. - carefully pull back on the plunger to the line that matches the dose prescribed by your healthcare provider (see figures i and j). for most people, this will be the 0.4 ml mark which is an 8 mg dose or the 0.6 ml mark which is a 12 mg dose. - use one hand to hold the vial steady. use your other hand to insert the needle straight down into the rubber top of the relistor vial (see figure k). do not insert it at an angle. this may cause the needle to bend or break. you will feel some resistance as the needle passes through the rubber top. - gently push down on the plunger until you feel resistance, and most of the air has gone from the syringe into the vial (see figure l). stop pushing down on the plunger when you feel resistance. if you continue to push down on the plunger when you feel resistance, the needle will pull back (retract) into the syringe barrel. - with the needle still in the vial, turn the vial and syringe upside down. hold the syringe at eye level. make sure the tip of the needle is in the fluid. slowly pull back on the plunger (see figure m) until the top of the plunger lines up with the mark that matches your prescribed dose. for most people, this will be the 0.4 ml mark which is an 8 mg dose or the 0.6 ml mark which is a 12 mg dose. - you may see some fluid or bubbles inside the vial when the syringe is filled. this is normal. - with the needle still in the vial, gently tap the syringe to make any air bubbles rise to the top (see figure n). - gently push the plunger up until all air bubbles are out of the syringe (see figure o). a small air bubble may stay in the syringe. this is okay and it will not affect the dose of medicine in the syringe. - make sure the tip of the needle is in the fluid. slowly pull back the plunger to draw the right amount of liquid back into the syringe (see figure p). - check to be sure that you have the right dose of relistor in the syringe. - slowly withdraw the needle from the vial. do not touch the needle or allow it to touch anything. safely throw away the vial with any unused medicine. step 4: inject relistor - use one hand to pinch the skin around the injection site (see figure q). - use your other hand to hold the syringe. insert the full length of the needle into the skin at a 45-degree angle with a quick “dart-like” motion (see figure r). - let go of the skin and slowly push in on the plunger past the resistance point, until the syringe is empty and you hear a click (see figure s). - the click sound means that the needle (see figure t) has been pulled back (retracted) into the syringe barrel (see figure u). you can now remove the syringe from your skin. - hold a cotton ball or gauze over the injection site (see figure v). do not rub the injection site. apply an adhesive bandage to the injection site if needed. step 5: dispose of used syringes and needles - do not re-use syringes or needles. - to avoid needle-stick injuries, do not recap used needles. - put your used needles and syringes in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - if you have any questions, talk to your healthcare provider or pharmacist. how should i store relistor? - store relistor vials at room temperature between 68° to 77°f (20° to 25°c). - do not freeze relistor. - keep relistor away from light until you are ready to use it. - if relistor has been drawn into a syringe and you are unable to use the medicine right away, keep the syringe at room temperature for up to 24 hours. keep relistor and all medicines, needles and syringes out of the reach of children. for more information, go to www.relistor.com or call 1-800-321-4576. this instructions for use has been approved by the u.s. food and drug administration. distributed by: salix pharmaceuticals, a division of bausch health us, llc bridgewater, nj 08807 usa under license from: progenics pharmaceuticals, inc. tarrytown, ny 10591 usa for injection: u.s. patent numbers: 8,247,425; 8,420,663; 8,552,025; 8,822,490; 9,180,125; 9,492,445; 9,669,096 and 10,376,584 for tablets: u.s. patent numbers: 8,420,663; 8,524,276; 8,956,651; 9,180,125; 9,314,461; 9,492,445; 9,724,343; 10,307,417 and 10,376,505 relistor is a trademark of salix pharmaceuticals, inc. or its affiliates. any other product/brand names are trademarks of the respective owners. © 2020 salix pharmaceuticals, inc. or its affiliates revised: 04/2020 9502505 70014843 instructions for use relistor ® (rel-i-store) (methylnaltrexone bromide) injection, for subcutaneous use vial read this instructions for use before you start using relistor and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. the following instructions explain how to prepare and give an injection of relistor the right way, when using a vial of relistor. important information: - use the syringes and needles prescribed by your healthcare provider. - do not use a relistor vial more than 1 time, even if there is medicine left in the vial. - if relistor has been drawn into a syringe and you are unable to use the medicine right away, carefully recap the needle and keep the syringe at room temperature for up to 24 hours. for more information about how to store relistor, see the section “how should i store relistor ?” at the end of this instructions for use. - safely throw away relistor vials after use. - do not re-use syringes or needles. see step 5 “dispose of used syringes and needles” for information about how to safely throw away used needles and syringes. - to avoid needle-stick injuries, do not recap used needles. gather the supplies you will need for your injection (see figure a.). these include: - 1 relistor vial - 1 1 ml syringe with a 27-gauge, ½ inch needle for subcutaneous use - 2 alcohol swabs - 1 cotton ball or gauze - 1 adhesive bandage - a puncture resistant container, such as an fda-cleared sharps disposal container to dispose of used syringes and needles. see step 5: “dispose of used syringes and needles.” step 1: choose and prepare the injection site - choose an injection site on your stomach-area (abdomen), thighs, or upper arms. see the shaded areas in figures b and c below. do not inject at the exact same spot each time (rotate injection sites). do not inject into areas where the skin is tender, bruised, red or hard. avoid areas with scars or stretch marks. - figure b abdomen or thigh – use these sites when injecting yourself or another person. - figure c upper arm – use this site only when injecting another person. - clean the injection site with an alcohol swab and let it air dry. do not touch this area again before giving the injection (see figure d). step 2: prepare the injection - choose a flat, clean, well-lit work surface. - wash your hands with soap and water before preparing for the injection. - look at the vial of relistor (see figure e). the liquid in the vial should be colorless to pale yellow, and should not have any particles in it. do not use the vial if it looks discolored, cloudy, or has any particles. step 3: prepare the syringe - remove the cap from the relistor vial (see figure f). - wipe the rubber stopper with an alcohol swab (see figure g). - firmly hold the barrel of the syringe with one hand. with your other hand, pull the needle cap straight off (see figure h). do not touch the needle or allow it to touch anything. - carefully pull back on the plunger to the line that matches the dose prescribed by your healthcare provider (see figures i and j). for most people, this will be the 0.4 ml mark which is an 8 mg dose or the 0.6 ml mark which is a 12 mg dose. - use one hand to hold the vial steady. use your other hand to insert the needle straight down into the rubber top of the vial (see figure k). do not insert it at an angle. this may cause the needle to bend or break. you will feel some resistance as the needle passes through the rubber top. - gently push down the plunger until all of the air has gone from the syringe into the vial (see figure l). - with the needle still in the vial, turn the vial and syringe upside down. hold the syringe at eye level. make sure the tip of the needle is in the fluid. slowly pull back on the plunger (see figure m) until the top of the plunger lines up with the mark that matches your prescribed dose. for most people, this will be the 0.4 ml mark which is an 8 mg dose or the 0.6 ml mark which is a 12 mg dose. - you may see some fluid or bubbles inside the vial when the syringe is filled. this is normal. - with the needle still in the vial, gently tap the side of the syringe to make any air bubbles rise to the top (see figure n). - slowly push the plunger up until all air bubbles are out of the syringe (see figure o). a small air bubble may stay in the syringe. this is okay and it will not affect the dose of medicine in the syringe. - make sure the tip of the needle is in the fluid. slowly pull back the plunger to draw the right amount of liquid back into the syringe (see figure p). - check to be sure that you have the right dose of relistor in the syringe. - slowly withdraw the needle from the vial. do not touch the needle or allow it to touch anything. safely throw away the vial with any unused medicine. step 4: inject relistor - use one hand to pinch the skin around the injection site (see figure q). - use your other hand to hold the syringe. insert the full length of the needle into the skin at a 45-degree angle with a quick “dart‑like” motion (see figure r). - let go of the skin and slowly push in on the plunger until the syringe is empty (figure s). - when the syringe is empty, quickly pull the needle out of the skin, being careful to keep it at the same angle as it was inserted. there may be a little bleeding at the injection site. - hold a cotton ball or gauze over the injection site (figure t). do not rub the injection site. apply an adhesive bandage to the injection site if needed. step 5: dispose of used syringes and needles - do not re-use a syringe or needle. - to avoid needle-stick injuries, do not recap a used needle. - put your used needles and syringes in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda’s website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - if you have any questions, talk to your healthcare provider or pharmacist. how should i store relistor? - store relistor vials at room temperature between 68° to 77°f (20° to 25°c). - do not freeze relistor. - keep relistor away from light until you are ready to use it. - if relistor has been drawn into a syringe and you are unable to use the medicine right away, keep the syringe at room temperature for up to 24 hours. keep relistor and all medicines, needles and syringes out of the reach of children. for more information, go to www.relistor.com or call 1-800-321-4576. this instructions for use has been approved by the u.s. food and drug administration. distributed by: salix pharmaceuticals, a division of bausch health us, llc bridgewater, nj 08807 usa under license from: progenics pharmaceuticals, inc. tarrytown, ny 10591 usa for injection: u.s. patent numbers: 8,247,425; 8,420,663; 8,552,025; 8,822,490; 9,180,125; 9,492,445; 9,669,096 and 10,376,584 for tablets: u.s. patent numbers: 8,420,663; 8,524,276; 8,956,651; 9,180,125; 9,314,461; 9,492,445; 9,724,343; 10,307,417 and 10,376,505 relistor is a trademark of salix pharmaceuticals, inc. or its affiliates. any other product/brand names are trademarks of the respective owners. © 2020 salix pharmaceuticals, inc. or its affiliates revised: 04/2020 9502505 70014843

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

stat rx usa llc - atomoxetine hydrochloride (unii: 57wvb6i2w0) (atomoxetine - unii:asw034s0b8) - atomoxetine hydrochloride 10 mg - strattera is indicated for the treatment of attention–deficit/hyperactivity disorder (adhd). the efficacy of strattera capsules was established in seven clinical trials in outpatients with adhd: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see clinical studies (14)]. a diagnosis of adhd (dsm–iv) implies the presence of hyperactive–impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. the symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. the specific etiology of adhd is unknown, and there is no single diagnostic test. adequate diagnosis re

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

ascend laboratories, llc - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 5 mg - finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (bph) in men with an enlarged prostate to:      -     improve symptoms      -    reduce the risk of acute urinary retention      -    reduce the risk of the need for surgery including transurethral resection of the prostate (turp) and prostatectomy. finasteride tablets administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of bph (a confirmed ≥ 4 point increase in american urological association (aua) symptom score). finasteride tablets are not approved for the prevention of prostate cancer.   finasteride tablets are contraindicated in the following: - hypersensitivity to any component of this medication. - pregnancy. finasteride use is contraindicated in females when they are or may potentially be pregnant. because of the ability of type ii 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (dht), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant female who receives finasteride. if this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant female should be apprised of the potential hazard to the male fetus. [see also warnings and precautions (5.3), use in specific populations (8.1), and how supplied/storage and handling (16) .] in female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. risk summary finasteride tablets are contraindicated in pregnant females and not indicated for use in females. based on animal studies and the mechanism of action, finasteride tablets may cause abnormal development of external genitalia in a male fetus if administered to a pregnant female [see warnings and precautions (5.3) and clinical pharmacology (12.1)]. in an embryo-fetal development study in rats, there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring of pregnant rats administered oral finasteride during the period of major organogenesis at doses approximately 0.1 to 86 times the maximum recommended human dose (mrhd) of 5 mg/day (based on auc at animal doses of 0.1 to 100 mg/kg/day). decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development were also observed in male offspring at oral maternal doses approximately 0.03 times the mrhd (based on auc at animal dose of 0.03 mg/kg/day), along with decreased anogenital distance in male offspring at oral maternal doses approximately 0.003 times the mrhd (based on auc at animal dose of 0.003 mg/kg/day). finasteride tablet is a type ii 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (dht), a hormone necessary for normal development of male genitalia. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus. abnormal male genital development is an expected consequence when conversion of testosterone to 5α-dihydrotestosterone (dht) is inhibited by 5α-reductase inhibitors. these outcomes are similar to those reported in male infants with genetic 5α-reductase deficiency. females could be exposed to finasteride through contact with crushed or broken finasteride tablets or semen from a male partner taking finasteride tablets. with regard to finasteride exposure through the skin, finasteride tablets are coated and will prevent skin contact with finasteride during normal handling if the tablets have not been crushed or broken. females who are pregnant or may potentially be pregnant should not handle crushed or broken finasteride tablets because of possible exposure of a male fetus. with regard to potential finasteride exposure through semen, three studies have been conducted that measured finasteride concentrations in semen in men receiving finasteride tablets 5 mg/day. in these studies the highest amount of finasteride in semen was estimated to be 50-to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating dht levels in men [see data and clinical pharmacology (12.3)].  data human data in 2 studies of healthy subjects (n=69) receiving finasteride tablets 5 mg/day for 6 to 24 weeks, finasteride concentrations in semen ranged from undetectable (<0.1 ng/ml) to 10.54 ng/ml. in an earlier study using a less sensitive assay, finasteride concentrations in semen of 16 subjects receiving finasteride tablets 5 mg/day ranged from undetectable (<1.0 ng/ml) to 21 ng/ml. using the highest semen level measured and assuming 100% absorption would be up to 105 ng per day, which is 50-to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating dht levels in men [see clinical pharmacology (12.3)]. animal data in an embryo-fetal development study, pregnant rats received finasteride during the period of major organogenesis (gestation days 6 to 17). at maternal doses of oral finasteride approximately 0.1 to 86 times the maximum recommended human dose (mrhd) of 5 mg/day (based on auc at animal doses of 0.1 to 100 mg/kg/day) there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring. exposure multiples were estimated using data from nonpregnant rats. days 16 to 17 of gestation is a critical period in male fetal rats for differentiation of the external genitalia. at oral maternal doses approximately 0.03 times the mrhd (based on auc at animal dose of 0.03 mg/kg/day), male offspring had decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development. decreased anogenital distance occurred in male offspring of pregnant rats that received approximately 0.003 times the mrhd (based on auc at animal dose of 0.003 mg/kg/day). no abnormalities were observed in female offspring at any maternal dose of finasteride. no developmental abnormalities were observed in the offspring of untreated females mated with finasteride treated male rats that received approximately 61 times the mrhd (based on auc at animal dose of 80 mg/kg/day). slightly decreased fertility was observed in male offspring after administration of about 3 times the mrhd (based on auc at animal dose of 3 mg/kg/day) to female rats during late gestation and lactation. no effects on fertility were seen in female offspring under these conditions. no evidence of male external genital malformations or other abnormalities were observed in rabbit fetuses exposed to finasteride during the period of major organogenesis (gestation days 6 to 18) at maternal oral doses up to 100 mg/kg /day, (finasteride exposure levels were not measured in rabbits). however, this study may not have included the critical period for finasteride effects on development of male external genitalia in the rabbit. the fetal effects of maternal finasteride exposure during the period of embryonic and fetal development were evaluated in the rhesus monkey (gestation days 20 to 100), in a species and development period more predictive of specific effects in humans than the studies in rats and rabbits. intravenous administration of finasteride to pregnant monkeys at doses as high as 800 ng/day (estimated maximal blood concentration of 1.86 ng/ml or about 143 times the highest estimated exposure of pregnant females to finasteride from semen of men taking 5 mg/day) resulted in no abnormalities in male fetuses. in confirmation of the relevance of the rhesus model for human fetal development, oral administration of a dose of finasteride (2 mg/kg/day or approximately 18,000 times the highest estimated blood levels of finasteride from semen of men taking 5 mg/day) to pregnant monkeys resulted in external genital abnormalities in male fetuses. no other abnormalities were observed in male fetuses and no finasteride-related abnormalities were observed in female fetuses at any dose. risk summary finasteride tablets are not indicated for use in females.                       infertility females      finasteride tablets are not indicated for use in females. males      treatment with finasteride tablets for 24 weeks to evaluate semen parameters in healthy male volunteers revealed no clinically meaningful effects on sperm concentration, mobility, morphology, or ph. a 0.6 ml (22.1%) median decrease in ejaculate volume with a concomitant reduction in total sperm per ejaculate was observed. these parameters remained within the normal range and were reversible upon discontinuation of therapy with an average time to return to baseline of 84 weeks [see warnings and precautions (5.5)].      there have been postmarketing reports of male infertility and/or poor seminal quality; normalization or improvement of seminal quality has been reported after discontinuation of finasteride [see adverse reactions (6.2)]. finasteride tablets are not indicated for use in pediatric patients. safety and effectiveness in pediatric patients have not been established. of the total number of subjects included in a long-term efficacy and safety study, 1,480 and 105 subjects were 65 and over and 75 and over, respectively. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. no dosage adjustment is necessary in the elderly [see clinical pharmacology (12.3) and clinical studies (14)] . caution should be exercised in the administration of finasteride tablets in those patients with liver function abnormalities, as finasteride is metabolized extensively in the liver [see clinical pharmacology (12.3) ] .  no dosage adjustment is necessary in patients with renal impairment [see clinical pharmacology (12.3)] .  

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

mas management group, inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 20 mg - omeprazole delayed-release capsules are a proton pump inhibitor (ppi) indicated for the: - treatment of active duodenal ulcer in adults ( 1.1) - eradication of helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2) - treatment of active benign gastric ulcer in adults ( 1.3) - treatment of symptomatic gastroesophageal reflux disease (gerd) in patients 2 years of age and older ( 1.4) - maintenance of healing of ee due to acid-mediated gerd in patients 2 years of age and older ( 1.6) - pathologic hypersecretory conditions in adults ( 1.7) omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with h. p

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - secukinumab (unii: dlg4eml025) (secukinumab - unii:dlg4eml025) - secukinumab 150 mg in 1 ml - cosentyx® is indicated for the treatment of moderate to severe plaque psoriasis (pso) in patients 6 years and older who are candidates for systemic therapy or phototherapy. cosentyx is indicated for the treatment of active psoriatic arthritis (psa) in patients 2 years of age and older. cosentyx is indicated for the treatment of adult patients with active ankylosing spondylitis (as). cosentyx is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation. cosentyx is indicated for the treatment of active enthesitis-related arthritis (era) in pediatric patients 4 years of age and older. cosentyx is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (hs). cosentyx is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in cosentyx. cases of anaphylaxis have been reported during treatment with cosentyx [see warnings and precautions (5.2)] . risk summary limited available human data with cosentyx use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in an embryo-fetal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the maximum recommended human dose (mrhd) (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data an embryo-fetal development study was performed in cynomolgus monkeys with secukinumab. no malformations or embryo-fetal toxicity were observed in fetuses from pregnant monkeys that were administered secukinumab weekly by the subcutaneous route during the period of organogenesis at doses up to 30 times the mrhd (on a mg/kg basis at a maternal dose of 150 mg/kg). a pre- and post-natal development toxicity study was performed in mice with a murine analog of secukinumab. no treatment-related effects on functional, morphological, or immunological development were observed in fetuses from pregnant mice that were administered the murine analog of secukinumab on gestation days 6, 11, and 17 and on postpartum days 4, 10, and 16 at doses up to 150 mg/kg/dose. risk summary it is not known whether secukinumab is excreted in human milk or absorbed systemically after ingestion. there are no data on the effects of cosentyx on the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cosentyx and any potential adverse effects on the breastfed child from cosentyx or from the underlying maternal condition. subcutaneous administration pediatric plaque psoriasis the safety and effectiveness of cosentyx have been established for the treatment of moderate to severe pso in pediatric patients aged 6 years and older who are candidates for systemic therapy or phototherapy [see adverse reactions (6.1) and clinical studies (14.2)] . safety and effectiveness of cosentyx in pediatric patients with pso below the age of 6 years have not been established. juvenile psoriatic arthritis the safety and effectiveness of cosentyx have been established for the treatment of active jpsa in pediatric patients aged 2 years and older who weigh 15 kg or more [see adverse reactions (6.1) and clinical studies (14.6)] . the safety and effectiveness of cosentyx in pediatric patients less than 2 years of age with jpsa or with a body weight less than 15 kg has not been established. enthesitis-related arthritis the safety and effectiveness of cosentyx for the treatment of active era in pediatric patients aged 4 years and older who weigh 15 kg or more has been established [see adverse reactions (6.1) and clinical studies (14.6)] . the safety and effectiveness of cosentyx in pediatric patients below the age of 4 years old or with body weight less than 15 kg have not been established. hidradenitis suppurativa the safety and effectiveness of cosentyx in pediatric patients with hs have not been established. intravenous administration the safety and effectiveness of intravenous cosentyx in pediatric patients have not been established. of the 3,430 pso subjects exposed to subcutaneous cosentyx in clinical trials, a total of 230 (7%) were 65 years of age or older, and 32 (1%) subjects were 75 years of age or older. although no differences in safety or efficacy were observed between subjects 65 years of age or older and younger adult subjects, the number of subjects 65 years of age and older was not sufficient to determine whether they respond differently from younger adult subjects. of the 1,060 subjects with hs exposed to cosentyx in clinical trials, a total of 14 (1.3%) were 65 years of age and older. clinical trials in hs did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects. instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 300 mg/2 ml single-dose prefilled syringe be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the prefilled syringe before you use it for the first time. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx prefilled syringe if either the seal on the outside carton or the seal of the blister are broken. keep the cosentyx prefilled syringe in the sealed carton until you are ready to use it. - do not use the cosentyx prefilled syringe if the syringe has been dropped onto a hard surface or dropped after removing the needle cap. - do not shake the cosentyx prefilled syringe. - the prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. the needle guard will help to prevent needle stick injuries to anyone who handles the prefilled syringe. - do not remove the needle cap until just before you give the injection. - avoid touching the syringe guard wings before use. touching them may cause the syringe guard to be activated too early. - throw away (dispose of) the used cosentyx prefilled syringe right away after use. do not re-use the cosentyx prefilled syringe . see “how should i dispose of the used cosentyx prefilled syringe?” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx prefilled syringe in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx prefilled syringe in the original carton until ready to use to protect from light. - do not freeze the cosentyx prefilled syringe. - throw away (dispose of) any expired or unused cosentyx prefilled syringes. keep cosentyx and all medicines out of the reach of children. cosentyx prefilled syringe parts (see figure a): - areas of your body that you may use as injection sites include: the front of your thighs (see figure c) the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - the front of your thighs (see figure c) - the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) - the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - choose a different site for each injection of cosentyx. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with scars or stretch marks. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. t2023-42 instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 150 mg/ml single-dose prefilled syringe be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the prefilled syringe before you use it for the first time. children should not inject cosentyx themselves using the prefilled syringe. an adult caregiver should prepare and inject cosentyx after receiving proper training in subcutaneous injection technique. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx prefilled syringe if either the seal on the outside carton or the seal of the blister are broken. keep the cosentyx prefilled syringe in the sealed carton until you are ready to use it. - do not use the cosentyx prefilled syringe if the syringe has been dropped onto a hard surface or dropped after removing the needle cap. - do not shake the cosentyx prefilled syringe. - the needle caps of the prefilled syringes contain latex. do not handle the prefilled syringes if you are sensitive to latex. - the prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. the needle guard will help to prevent needle stick injuries to anyone who handles the prefilled syringe. - do not remove the needle cap until just before you give the injection. - avoid touching the syringe guard wings before use. touching them may cause the syringe guard to be activated too early. - throw away (dispose of) the used cosentyx prefilled syringe right away after use. do not re-use the cosentyx prefilled syringe. see “how should i dispose of used cosentyx prefilled syringes?” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx prefilled syringes in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx prefilled syringes in the original carton until ready to use to protect from light. - the cosentyx prefilled syringes may be stored at room temperature, up to 86°f (30°c), for up to 4 days. - write the date the cosentyx prefilled syringes were removed from and returned to the refrigerator in the space provided on the carton. - throw away the cosentyx prefilled syringe if it has been kept outside of the refrigerator over 4 days. - cosentyx prefilled syringe may be returned to the refrigerator only 1 time and must be stored between 36°f to 46°f (2°c to 8°c) until you use it or until it expires. - do not freeze the cosentyx prefilled syringes. - throw away (dispose of) any expired or unused cosentyx prefilled syringes. keep cosentyx and all medicines out of the reach of children. - if your prescribed dose of cosentyx is 150 mg , you must give 1 injection . - if your prescribed dose of cosentyx is 300 mg , you must give 2 injections . - areas of your body that you may use as injection sites include: the front of your thighs (see figure c) the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - the front of your thighs (see figure c) - the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) - the upper outer arms, if a caregiver or healthcare provider is giving you the injection (see figure d) - choose a different site for each injection of cosentyx. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with scars or stretch marks. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. t2023-43 instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 75 mg/0.5 ml single-dose prefilled syringe be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the prefilled syringe before you use it for the first time. children should not inject cosentyx themselves using the prefilled syringe. an adult caregiver should prepare and inject cosentyx after receiving proper training in subcutaneous injection technique. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx prefilled syringe if either the seal on the outside carton or the seal of the blister are broken. keep the cosentyx prefilled syringe in the sealed carton until you are ready to use it. - do not use the cosentyx prefilled syringe if the syringe has been dropped onto a hard surface or dropped after removing the needle cap. - do not shake the cosentyx prefilled syringe. - the needle cap of the prefilled syringe contains latex. do not handle the prefilled syringe if you are sensitive to latex. - the prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. the needle guard will help to prevent needle stick injuries to anyone who handles the prefilled syringe. - do not remove the needle cap until just before you give the injection. - avoid touching the syringe guard wings before use. touching them may cause the syringe guard to be activated too early. - throw away (dispose of) the used cosentyx prefilled syringe right away after use. do not re-use the cosentyx prefilled syringe. see “how should i dispose of the used cosentyx prefilled syringe? ” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx prefilled syringe in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx prefilled syringe in the original carton until ready to use to protect from light. - cosentyx prefilled syringe may be stored at room temperature, up to 86°f (30°c), for up to 4 days. - write the date cosentyx prefilled syringe was removed from and returned to the refrigerator in the space provided on the carton. - throw away cosentyx prefilled syringe if it has been kept outside of the refrigerator over 4 days. - cosentyx prefilled syringe may be returned to the refrigerator only 1 time and must be stored between 36°f to 46°f (2°c to 8°c) until you use it or until it expires. - do not freeze the cosentyx prefilled syringe. - throw away (dispose of) any expired or unused cosentyx prefilled syringe. keep cosentyx and all medicines out of the reach of children. - areas of your body that you may use as injection sites include: the front of your thighs (see figure c) the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) the upper outer arms (see figure d) - the front of your thighs (see figure c) - the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see figure c) - the upper outer arms (see figure d) - choose a different site for each injection of cosentyx. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with scars or stretch marks. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. t2023-44 - do not use the cosentyx unoready pen if the seal on the outer carton is broken. keep the cosentyx unoready pen in the sealed outer carton until you are ready to use it. - do not shake the cosentyx unoready pen. - if you drop your cosentyx unoready pen, do not use it if it looks damaged, or if you dropped it with the cap removed. - the needle is covered by the needle guard and the needle will not be seen. do not touch or push the needle guard because you could get a needle stick. - throw away (dispose of) the used cosentyx unoready pen right away after use. - do not re-use the cosentyx unoready pen. see “step 9. disposing of the used cosentyx unoready pen ” at the end of this instructions for use. - store your carton of cosentyx unoready pen in a refrigerator between 36°f and 46°f (2°c and 8°c). - keep the cosentyx unoready pen in the original carton until ready to use to protect from light. - do not freeze the cosentyx unoready pen. - throw away (dispose of) any expired or unused cosentyx unoready pen. - a new cosentyx unoready pen each cosentyx unoready pen contains 300 mg of cosentyx. check to make sure that you have the correct medicine and dose. - 1 alcohol wipe - 1 cotton ball or gauze - sharps disposal container. see “step 9. disposing of the used cosentyx unoready pen ” at the end of this instructions for use. - look at the expiration date (exp) on your cosentyx unoready pen. do not use the cosentyx unoready pen if the expiration date has passed. - look through the viewing window. the liquid should be clear. its color may vary from colorless to slightly yellow. - do not use if the liquid contains visible particles, is cloudy or is discolored. you may see air bubbles, which is normal. - the recommended site is the front of the thighs. you may also use the lower abdomen, but not the area 2 inches around the navel (belly button) (see figure f) . - choose a different site each time you give an injection. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard or in an area of skin that is affected by psoriasis. avoid areas with scars or stretch marks. - if a caregiver or healthcare provider is giving you your injection, they may also inject into your outer upper arm (see figure g) . - wash your hands well with soap and water. - using a circular motion, clean the injection site with the alcohol wipe (see figure h) . leave it to dry before injecting. - do not touch the cleaned area again before injecting. - only remove the cap when you are ready to use the cosentyx unoready pen. - pull the cap straight off (see figure i) . do not twist the cap. - throw away the cap. do not try to re-attach the cap. - use the cosentyx unoready pen within 5 minutes of removing the cap. - this means the medicine has been delivered. contact your healthcare provider or pharmacist if the green indicator is not visible or does not fill the window. - there may be a small amount of blood at the injection site. you can press a cotton ball or gauze over the injection site and hold it for a few seconds. do not rub the injection site. you may cover the injection site with a small adhesive bandage, if needed. - put your used cosentyx unoready pen in an fda-cleared sharps disposal container right away after use (see figure m) . do not throw away (dispose of) the cosentyx unoready pen in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles, syringes, and cosentyx unoready pens. t2023-45 instructions for use cosentyx® [koe-sen-tix] (secukinumab) injection, for subcutaneous use 150 mg/ml single-dose sensoready® pen be sure that you read, understand, and follow this instructions for use before injecting cosentyx. your healthcare provider should show you how to prepare and inject cosentyx properly using the sensoready pen before you use it for the first time. children should not inject cosentyx themselves using the sensoready pen. an adult caregiver should prepare and inject cosentyx after receiving proper training in subcutaneous injection technique. talk to your healthcare provider if you have any questions. important information you need to know before injecting cosentyx: - do not use the cosentyx sensoready pen if either the seal on the outer carton or the seal on the pen is broken. keep the cosentyx sensoready pen in the sealed outer carton until you are ready to use it. - do not shake the cosentyx sensoready pen. - the caps of the sensoready pens contain latex. do not handle the sensoready pens if you are sensitive to latex. - if you drop your cosentyx sensoready pen, do not use it if the sensoready pen looks damaged, or if you dropped it with the cap removed. - throw away (dispose of) the used cosentyx sensoready pen right away after use. do not re-use the cosentyx sensoready pen. see “how should i dispose of used cosentyx sensoready pens? ” at the end of this instructions for use. how should i store cosentyx? - store your carton of cosentyx sensoready pens in a refrigerator, between 36°f to 46°f (2°c to 8°c). - keep the cosentyx sensoready pens in the original carton until ready to use to protect from light. - the cosentyx sensoready pens may be stored at room temperature, up to 86°f (30°c), for up to 4 days. - write the date the cosentyx sensoready pens were removed from and returned to the refrigerator in the space provided on the carton. - throw away the cosentyx sensoready pen if it has been kept outside of the refrigerator over 4 days. - cosentyx sensoready pen may be returned to the refrigerator only 1 time and must be stored between 36°f to 46°f (2°c to 8°c) until you use it or until it expires. - do not freeze the cosentyx sensoready pens. - throw away (dispose of) any expired or unused cosentyx sensoready pens. keep cosentyx and all medicines out of the reach of children. - if your prescribed dose of cosentyx is 150 mg, you must give 1 injection. - if your prescribed dose of cosentyx is 300 mg, you must give 2 injections. - 1 alcohol wipe - 1 cotton ball or gauze - sharps disposal container. - look through the viewing window. the liquid should be clear. its color may vary from colorless to slightly yellow. do not use if the liquid contains visible particles, is cloudy or is discolored. you may see a small air bubble, which is normal. - look at the expiration date (exp) on your sensoready pen. do not use your cosentyx sensoready pen if the expiration date has passed. - the recommended site is the front of the thighs. you may also use the lower abdomen, but not the area 2 inches around the navel (belly button) (see figure e). - choose a different site each time you give an injection. - do not inject into areas where the skin is tender, bruised, red, scaly, or hard, or in an area of skin that is affected by psoriasis. avoid areas with scars or stretch marks. - if a caregiver or healthcare provider is giving you your injection, they may also inject into your outer upper arm (see figure f) . - wash your hands well with soap and water. - using a circular motion, clean the injection site with the alcohol wipe. leave it to dry before injecting (see figure g). - do not touch the cleaned area again before injecting. - only remove the cap when you are ready to use the cosentyx sensoready pen. - twist off the cap in the direction of the arrow (see figure h). - throw away the cap. do not try to re-attach the cap. - use the cosentyx sensoready pen within 5 minutes of removing the cap. - hold the cosentyx sensoready pen at 90 degrees to the cleaned injection site (see figure i) . - the 1st click indicates that the injection has started. - several seconds later a 2nd click will indicate that the injection is almost finished. - press the cosentyx sensoready pen firmly against the skin to start the injection (see figure j) . - the 1st click indicates the injection has started. - keep holding the cosentyx sensoready pen firmly against the skin. - the green indicator shows the progress of the injection. - listen for the 2nd click. this indicates the injection is almost complete. - check the green indicator fills the window and has stopped moving (see figure k) . - the cosentyx sensoready pen can now be removed. - this means the medicine has been delivered. contact your healthcare provider if the green indicator is not visible. - there may be a small amount of blood at the injection site. you can press a cotton ball or gauze over the injection site and hold it for 10 seconds. do not rub the injection site. you may cover the injection site with a small adhesive bandage, if needed. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. t2023-46

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

proficient rx lp - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 500 mg - ciprofloxacin tablets, usp are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and people population listed below. please see dosage and administration for specific recommendations. urinary tract infections caused by escherichia coli, klebsiella pneumoniae, enterobacter cloacae, serratia marcescens, proteus mirabilis, providencia rettgeri, morganella morganii, citrobacter diversus, citrobacter freundii, pseudomonas aeruginosa, methicillin-susceptible staphylococcus epidermidis, staphylococcus saprophyticus, or enterococcus faecalis. acute uncomplicated cystitis in females caused by escherichia coli or staphylococcus saprophyticus . chronic bacterial prostatitis caused by escherichia coli or proteus mirabilis . lower respiratory tract infections caused by escherichia coli, klebsiella pneumoniae, enterobacter cloacae, proteus mirabilis, pseudomonas aeruginosa, haemophilus influenzae, haemophilus parainfluenzae, or penicillin-su

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

novo nordisk - liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - liraglutide 6 mg in 1 ml - victoza is indicated: infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. limitations of use : victoza should not be used in patients with type 1 diabetes mellitus. victoza contains liraglutide and should not be coadministered with other liraglutide-containing products. victoza is contraindicated in patients with a: risk summary based on animal reproduction studies, there may be risks to the fetus from exposure to victoza during pregnancy. victoza should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy. liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (mrhd) of 1.8 mg/day. in pregnant rab

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

novo nordisk - insulin degludec (unii: 54q18076qb) (insulin degludec - unii:54q18076qb) - insulin degludec 100 u in 1 ml - tresiba is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. limitations of use tresiba is contraindicated: risk summary available data from one unpublished trial and the published literature with tresiba use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in a randomized, parallel-group, open-label actively controlled clinical trial that included 91 pregnant women with type 1 diabetes who were administered tresiba once daily and insulin aspart, beginning in gestational weeks 8 to 13 or prior to conception, no clear evidence of maternal or fetal risk associated with tresiba use was observed (see data ). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations ). rats and rabbits were exposed to insulin degludec in animal reproduction studies during organogenesis. pre-and post-implantation losses and vi