Bandaríkin - enska - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - first aid antibiotic first aid to help prevent infection in

Bandaríkin - enska - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - rosuvastatin calcium (unii: 83mvu38m7q) (rosuvastatin - unii:413kh5zj73) - crestor is indicated: crestor is contraindicated in the following conditions: risk summary discontinue crestor when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. crestor decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, crestor may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology (12.1)] . in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. published data from prospective and retrospective observational cohort studies with crestor use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see data) . in animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (mrhd) of 40 mg/day, based on auc and body surface area (mg/m2), respectively (see data) . 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. data human data a medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. the relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. there were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. in the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. animal data in female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the mrhd dose of 40 mg/day based on auc). in pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the mrhd of 40 mg/day based body surface area). in pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the mrhd of 40 mg/day based on body surface area). rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. in rabbits, fetal tissue distribution was 25% of maternal plasma concentration after a single oral gavage dose of 1 mg/kg on gestation day 18. risk summary limited data from case reports in published literature indicate that crestor is present in human milk. there is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. statins, including crestor, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with crestor [see use in specific populations (8.1) and clinical pharmacology (12.1)] . the safety and effectiveness of crestor as an adjunct to diet to reduce ldl-c have been established in pediatric patients 8 years of age and older with hefh. use of crestor for this indication is based on one 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with hefh and one 2‑year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with hefh [see clinical studies (14)] . in the 1-year trial with a 12-week controlled phase, there was no detectable effect of crestor on growth, weight, bmi (body mass index), or sexual maturation in patients aged 10 to 17 years. the safety and effectiveness of crestor as an adjunct to other ldl-c-lowering therapies to reduce ldl-c have been established pediatric patients 7 years of age and older with hofh. use of crestor for this indication is based on a randomized, placebo-controlled, cross-over study in 14 pediatric patients 7 years of age and older with hofh [see clinical studies (14)] . the safety and effectiveness of crestor have not been established in pediatric patients younger than 8 years of age with hefh, younger than 7 years of age with hofh, or in pediatric patients with other types of hyperlipidemia (other than hefh or hofh). of the total number of crestor-treated patients in clinical studies, 3159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects. advanced age (≥65 years) is a risk factor for crestor-associated myopathy and rhabdomyolysis. dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. monitor geriatric patients receiving crestor for the increased risk of myopathy [see warnings and precautions (5.1)] . rosuvastatin exposure is not influenced by mild to moderate renal impairment (clcr ≥30 ml/min/1.73 m2 ). exposure to rosuvastatin is increased to a clinically significant extent in patients with severe renal impairment (clcr <30 ml/min/1.73 m2 ) who are not receiving hemodialysis [see clinical pharmacology (12.3)] . renal impairment is a risk factor for myopathy and rhabdomyolysis. monitor all patients with renal impairment for development of myopathy. in patients with severe renal impairment not on hemodialysis, the recommended starting dosage is 5 mg daily and should not exceed 10 mg daily [see dosage and administration (2.5) and warnings and precautions (5.1)] . crestor is contraindicated in patients with acute liver failure or decompensated cirrhosis. chronic alcohol liver disease is known to increase rosuvastatin exposure. patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury [see contraindications (4), warning and precautions (5.3) and clinical pharmacology (12.3)] . pharmacokinetic studies have demonstrated an approximate 2‑fold increase in median exposure to rosuvastatin in asian subjects when compared with white controls. adjust the crestor dosage in asian patients [see dosage and administration (2.4) and clinical pharmacology (12.3)] .

Malasía - enska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

hl pharmaceuticals sdn. bhd. - thiamine hydrochloride; potassium citrate monohydrate; biotin; d-calcium pantothenate; ascorbic acid (vitamin c); niacinamide; niacin; pyridoxine hydrochloride; pyridoxal 5-phosphate monohydrate; riboflavin 5-phosphate sodium; riboflavin; zinc oxide; methylcobalamin; folic acid -

Bandaríkin - enska - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - first aid antibiotic first aid to help prevent infection in minor:

Bandaríkin - enska - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - seizure disorders: clonazepam tablets are useful alone or as an adjunct in the treatment of the lennox- gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. some loss of effect may occur during the course of clonazepam treatment (see precautions: loss of effect ). panic disorder: clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-v. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of clonazepam tablets was established in two 6- to 9-week trials  in panic disorder patients whose diagnoses corresponded to the dsm-lilr category of panic disorder (see error! hyperlink reference not valid. error! hyperlink reference not valid. ). panic disorder (dsm-v) is characterized by recurrent unexpected panic attacks, i.e., a discrete  period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness  or tingling  sensations); (13) chills or hot flushes. the effectiveness of clonazepam tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. the physician who elects to use clonazepam tablets for extended periods should periodically reevaluate the long- term usefulness of the drug for the individual patient (see dosage and administration). clonazepam tablets are contraindicated in patients with the following conditions: controlled substance class: clonazepam tablets contain clonazepam, a schedule iv controlled substance. abuse: clonazepam tablet is 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  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) . dependence: physical dependence clonazepam 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) and 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 clonazepam tablets or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of clonazepam tablets and warnings: dependence and withdrawal reactions ). acute withdrawal signs and symptoms 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 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. tolerance tolerance to clonazepam 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 clonazepam tablets may  develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines. following the short-term treatment of patients with panic disorder in studies 1 and 2 (see error! hyperlink reference not valid. error! hyperlink reference not valid. ) , patients were gradually withdrawn during a 7-week downward- titration (discontinuance) period. overall, the discontinuance period was associated with good tolerability and a very modest clinical deterioration, without evidence of a significant rebound phenomenon. however, there are not sufficient data from adequate and well-controlled long-term clonazepam studies in patients with panic disorder to accurately estimate the risks of withdrawal symptoms and dependence that may be associated with such use. what is the most important information i should know about clonazepam tablets? do not drive or operate heavy machinery until you know how taking clonazepam tablets with opioids affects you. call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: how can i watch for early symptoms of suicidal thoughts and actions? call your healthcare provider between visits as needed, especially if you are worried about symptoms. suicidal thoughts or actions can be caused by things other than medicines. if you have suicidal thoughts or actions, your healthcare provider may check for other causes. do not stop clonazepam tablets without first talking to a healthcare provider. what are clonazepam tablets? clonazepam tablet is a federally controlled substance (c-iv) because it  contains clonazepam that can be  abused or lead to  dependence. keep clonazepam tablets in a safe place to prevent misuse and  abuse. selling  or giving  away clonazepam tablets may harm others, and is against the law. tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. it is not known if clonazepam tablets are safe or effective in treating panic disorder in children younger than 18 years old. who should not take clonazepam tablets? do not take clonazepam tablets if you: ask your healthcare provider if you are not sure if you have any of the problems listed above. before you take clonazepam tablets, tell your healthcare provider if you: tell your healthcare provider right away if you become pregnant while taking clonazepam tablets. you and your healthcare provider will decide if you should take clonazepam tablets while you are pregnant. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. taking clonazepam tablets with certain other medicines can cause side effects or affect how well clonazepam tablets or the other medicines work. do not start or stop other medicines without talking to your healthcare provider. how should i take clonazepam tablets? what should i avoid while taking clonazepam tablets? what are the possible side effects of clonazepam tablets? see “what is the most important information i should know about clonazepam tablets?” clonazepam tablets can also make your seizures happen more often or make them worse. call your healthcare provider right away if your seizures get worse while taking clonazepam tablets. the most common side effects of clonazepam tablets include: these are not all the possible  side  effects of  clonazepam tablets.  call  your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088 or contact advagen pharma ltd, at 866-488-0312. how should i store clonazepam tablets? general information about the safe and effective use of clonazepam tablets. medicines are sometimes prescribed for purposes other than those listed in a medication guide. do not use clonazepam tablets for a condition for which it was not prescribed. do not give clonazepam tablets to other people, even if they have the same  symptoms  that you have. it may harm them. you can ask your pharmacist or healthcare provider for information about clonazepam tablets that is written for health professionals. for more information, contact advagen pharma ltd, at 866-488-0312. what are the ingredients in clonazepam tablets? active ingredient: clonazepam inactive ingredients: this medication guide has been approved by the u.s. food and drug administration. manufactured by: rubicon research private limited ambernath, dist: thane, 421506 india distributed by: advagen pharma ltd 666 plainsboro road suite 605 plainsboro, nj  08536, us revision: 04/22 repackaged by: preferred pharmaceuticals inc.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - rosuvastatin calcium, quantity: 10.4 mg - tablet, film coated - excipient ingredients: magnesium oxide; microcrystalline cellulose; magnesium stearate; lactose monohydrate; crospovidone; purified water; titanium dioxide; hypromellose; triacetin; iron oxide red - crestabs should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events crestabs is indicated for prevention of major cardiovascular events in men ?50 years old and women ?60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). crestabs is indicated to: ? reduce the risk of nonfatal myocardial infarction ? reduce the risk of nonfatal stroke ? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia crestabs is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with crestabs, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - rosuvastatin calcium, quantity: 20.8 mg - tablet, film coated - excipient ingredients: magnesium stearate; microcrystalline cellulose; magnesium oxide; lactose monohydrate; crospovidone; purified water; titanium dioxide; hypromellose; triacetin; iron oxide red - crestabs should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events crestabs is indicated for prevention of major cardiovascular events in men ?50 years old and women ?60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). crestabs is indicated to: ? reduce the risk of nonfatal myocardial infarction ? reduce the risk of nonfatal stroke ? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia crestabs is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with crestabs, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - rosuvastatin calcium, quantity: 20.8 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; crospovidone; purified water; magnesium oxide; titanium dioxide; hypromellose; triacetin; iron oxide red - crestabs should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events crestabs is indicated for prevention of major cardiovascular events in men ?50 years old and women ?60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). crestabs is indicated to: ? reduce the risk of nonfatal myocardial infarction ? reduce the risk of nonfatal stroke ? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia crestabs is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with crestabs, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - rosuvastatin calcium, quantity: 41.6 mg - tablet, film coated - excipient ingredients: purified water; magnesium stearate; microcrystalline cellulose; magnesium oxide; lactose monohydrate; crospovidone; titanium dioxide; hypromellose; triacetin; iron oxide red - crestabs should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events crestabs is indicated for prevention of major cardiovascular events in men ?50 years old and women ?60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). crestabs is indicated to: ? reduce the risk of nonfatal myocardial infarction ? reduce the risk of nonfatal stroke ? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia crestabs is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with crestabs, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - rosuvastatin calcium, quantity: 10.4 mg - tablet, film coated - excipient ingredients: purified water; crospovidone; magnesium stearate; magnesium oxide; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red - crestabs should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events crestabs is indicated for prevention of major cardiovascular events in men ?50 years old and women ?60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). crestabs is indicated to: ? reduce the risk of nonfatal myocardial infarction ? reduce the risk of nonfatal stroke ? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia crestabs is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia). prior to initiating therapy with crestabs, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.