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

proficient rx lp - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole tablets are indicated for the treatment of: additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole tablets are 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-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs, including arip

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

major pharmaceuticals - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by escherichia coli, klebsiella pneumoniae, enterobacter cloacae, proteus mirabilis, proteus vulgaris, providencia stuartii, morganella morganii, citrobacter freundii, pseudomonas aeruginosa, methicillin‑ susceptible staphylococcus aureus, methicillin-susceptible staphylococcus epidermidis, or streptococcus pyogenes. ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae, serratia marcescens, or pseudomonas aeruginosa. ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by escherichia coli, pseudomonas aeruginosa, proteus mirabilis, klebsiella pneumoniae, or bacteroides fragilis. ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by escherichia coli ( enterotoxigenic isol

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

major pharmaceuticals - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam is 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 may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is 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 may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam 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

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

amgen, inc - tezepelumab (unii: rj1iw3b4qx) (tezepelumab - unii:rj1iw3b4qx) - tezspire is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. limitations of use: tezspire is not indicated for the relief of acute bronchospasm or status asthmaticus. tezspire is contraindicated in patients who have known hypersensitivity to tezepelumab-ekko or any of its excipients [see warnings and precautions (5.1)] . risk summary there are no available data on tezspire use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. in an enhanced pre- and post-natal development (eppnd) study conducted in cynomolgus monkeys, placental transport of tezepelumab-ekko was observed but there was no evidence of fetal harm following intravenous administration of tezepelumab-ekko throughout pregnancy at doses that produced maternal exposures up to 168 times the exposure at the maximum recommended human dose (mrhd) of 210 mg administered subcutaneously (see data) . the estimated background risk of major birth defects and miscarriages 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: in women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. the level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. data animal data in the eppnd study, pregnant cynomolgus monkeys received tezepelumab-ekko from gd20 to gd22 (dependent on pregnancy determination), at the beginning of organogenesis, and once every 7 days until the end of gestation at doses that produced exposures up to 168 times that achieved with the mrhd (on an auc basis with maternal intravenous doses up to 300 mg/kg/week). there were no tezepelumab-ekko related adverse effects on maternal health, pregnancy outcome, embryo-fetal development, or neonatal growth and development up to 6.5 months of age. tezepelumab-ekko crossed the placenta in cynomolgus monkeys and tezepelumab-ekko serum concentrations were 0.5- to 6.7-fold higher in infants relative to maternal animals. risk summary there is no information regarding the presence of tezepelumab-ekko in human milk, its effects on the breastfed infant, or its effects on milk production. however, tezepelumab-ekko is a human monoclonal antibody immunoglobulin g2λ (igg2λ), and immunoglobulin g (igg) is present in human milk in small amounts. tezepelumab‑ekko was present in the milk of cynomolgus monkeys postpartum following dosing during pregnancy (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tezspire and any potential adverse effects on the breastfed infant from tezspire or from the underlying maternal condition. data animal data in a prenatal and postnatal development study in cynomolgus monkeys, tezepelumab-ekko concentrations in milk were up to 0.5% of the maternal serum concentrations after intravenous administration of tezepelumab-ekko up to 300 mg/kg/week (168 times the exposures based on auc achieved at mrhd). the concentration of tezepelumab-ekko in animal milk does not necessarily predict the concentration of drug in human milk. the safety and effectiveness of tezspire for the add-on maintenance treatment of severe asthma have been established in pediatric patients aged 12 years and older [see adverse reactions (6.1) and clinical studies (14)] . use of tezspire for this indication is supported by evidence from a total of 82 pediatric patients aged 12 to 17 years enrolled in navigator and received treatment with tezspire 210 mg subcutaneously every 4 weeks (n=41) or placebo (n=41). compared with placebo, improvements in annualized asthma exacerbation (rate ratio 0.70; 95% ci 0.34, 1.46) and fev1 (ls mean change versus placebo 0.17 l; 95% ci -0.01, 0.35) were observed in pediatric patients treated with tezspire. the safety profile and pharmacodynamic responses in pediatric patients were generally similar to the overall study population. the safety and effectiveness in patients younger than 12 years of age have not been established. of the 665 patients with asthma treated with tezspire in clinical trials (pathway and navigator) for severe asthma, 119 patients (18%) were 65 years or older. no overall differences in safety or effectiveness of tezspire have been observed between patients 65 years of age and older and younger patients [see adverse reactions (6.1) and clinical studies (14)] .

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

leo pharma inc. - tralokinumab (unii: gk1lyb375a) (tralokinumab - unii:gk1lyb375a) - adbry is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. adbry can be used with or without topical corticosteroids. adbry is contraindicated in patients who have known hypersensitivity to tralokinumab-ldrm or any excipients in adbry [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adbry during pregnancy. healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/. risk summary there are limited data from the use of adbry in pregnant women to inform a drug-associated risk of adverse developmental outcomes. human igg antibodies are known to cross the placental barrier; therefore, adbry may be transmitted from the mother to the developing fetus. in an enhanced pre-and post-natal developmental study, no adverse developmental effects were observed in offspring born to pregnant monkeys after intravenous administration of tralokinumab-ldrm during organogenesis through parturition at doses up to 10 times the maximum recommended human dose (mrhd). the 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. data animal data in a pre- and post-natal development study, intravenous doses up to 100 mg/kg tralokinumab-ldrm were administered to pregnant cynomolgus monkeys once every week from gestation day 20 to parturition. no maternal or developmental toxicity was observed at doses up to 100 mg/kg/week (10 times the mrhd on a mg/kg basis of 10 mg/kg/week). in an enhanced pre- and post-natal development study, intravenous doses up to 100 mg/kg tralokinumab-ldrm (10 times the mrhd on a mg/kg basis of 10 mg/kg/week) were administered to pregnant cynomolgus monkeys once every week from the beginning of organogenesis to parturition. no treatment-related adverse effects on embryofetal toxicity or malformations, or on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age. risk summary there are no data on the presence of tralokinumab-ldrm in human milk, the effects on the breastfed infant, or the effects on milk production. maternal igg is present in breast milk. the effects of local gastrointestinal exposure and limited systemic exposure to adbry on the breastfed infant are unknown. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for adbry and any potential adverse effects on the breastfed child from adbry or from the underlying maternal condition. the safety and effectiveness of adbry have been established for the treatment of moderate-to-severe atopic dermatitis in pediatric patients 12 to 17 years of age whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable . use of adbry in this age group is supported by a multicenter, randomized, double-blind, placebo-controlled study (ecztra 6) in 289 pediatric subjects 12 to 17 years of age with moderate-to-severe atopic dermatitis. the safety and effectiveness were consistent between pediatric subjects 12 to 17 years of age and adult subjects [see adverse reactions (6.1) and clinical studies (14)] . safety and effectiveness of adbry have not been established in pediatric patients younger than 12 years of age. of the 1605 subjects exposed to adbry in 5 atopic dermatitis trials in the initial treatment period of up to 16 weeks, 77 subjects were 65 years or older. clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects [see clinical pharmacology (12.3)]. adbry® [ad'-bree] (tralokinumab-ldrm) injection, for subcutaneous use this instructions for use contains information on how to inject adbry. read this instructions for use before you start using the adbry prefilled syringe 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. keep this instructions for use and refer to it as needed. each single-dose prefilled syringe contains 150 mg of adbry. the adbry prefilled syringes are for one time use only. important information you need to know before injecting adbry: - your healthcare provider should show you or your caregiver how to prepare and inject a dose of adbry using the prefilled syringe before you inject adbry for the first time. talk to your healthcare provider if you have any questions about how to inject adbry the right way. - adbry is given as an injection under the skin (subcutaneous injection). - do not inject yourself or someone else until you have been shown how to inject adbry the right way. - in children 12 years of age and older, it is recommended that adbry be given by or under supervision of an adult. - talk to your healthcare provider about your prescribed dose before injecting adbry. - rotate the injection site each time you give an injection. - the adbry prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. - do not remove the needle cover until just before you give the injection. - do not share or reuse your adbry prefilled syringe. - do not inject through clothes. - store adbry prefilled syringes in a refrigerator between 36°f to 46°f (2°c to 8°c). - store adbry prefilled syringes in the original carton to protect from light until you are ready to use them. - adbry can be stored in the original carton at room temperature up to 86°f (30°c) for up to 14 days. - if left out of the refrigerator for more than 14 days, throw away (dispose of) the adbry prefilled syringes. - do not freeze adbry prefilled syringes. do not use if they have been frozen. - do not shake the adbry prefilled syringes. - do not heat the adbry prefilled syringes. - do not put the adbry prefilled syringes into direct sunlight. - keep adbry prefilled syringes and all medicines out of the reach of children. adbry prefilled syringe parts (see figure a): figure a step 1: setting up adbry injection figure b 1a: gather the supplies needed for your injection. for each adbry dose you will need (see figure b): - a clean, flat, well-lit work surface, like a table - prescribed number of adbry prefilled syringe(s) - an alcohol swab (not included in the carton) - clean cotton balls or gauze pads (not included in the carton) - a puncture-resistant sharps disposal container (not included in the carton). see step 5 "disposing of adbry" at the end of this instructions for use. figure c 1b: take the adbry prefilled syringe carton out of the refrigerator - check the expiration date (exp) on the carton (see figure c). do not use if the expiration date on the carton has passed. - when using the first prefilled syringe, check to make sure the seal on the adbry carton is intact. - do not use the adbry prefilled syringes if the seal on the carton is broken. figure d 1c: determine how many adbry prefilled syringes you need for your dose if you have been prescribed a 300 mg dose, you will need 2 syringes. if you have been prescribed a 150 mg dose, you will only need 1 syringe and the remaining syringe should be returned to the refrigerator in its carton. - remove the adbry prefilled syringe(s) by grasping the body (not the plunger rod) of the adbry prefilled syringe (see figure d ). - do not touch the needle guard clips to keep from activating the safety device (needle guard) too soon. - do not remove the needle cover on the prefilled syringe until you have reached step 3 and are ready to inject. figure e 1d: let the adbry prefilled syringe(s) warm up to room temperature (see figure e) place the adbry prefilled syringe(s) on the flat surface and wait 30 minutes before you inject adbry to let the prefilled syringe(s) warm up to room temperature 68°f to 86°f (20°c to 30°c). this will help to reduce discomfort. - do not microwave the prefilled syringes, run hot water over them, or leave them in direct sunlight. - do not shake the syringes. - do not remove the needle cover on the prefilled syringes until you have reached step 3 and are ready to inject. - do not put the syringes back in the refrigerator after they have reached room temperature. figure f 1e: inspect the adbry prefilled syringe(s) (see figure f) - make sure adbry appears on the label. - check the expiration date printed on the syringe. - check the medicine through the viewing window. the medicine inside should be clear to slightly pearly and colorless to pale yellow. - do not use the adbry prefilled syringe, throw away and get a new one if: the expiration date printed on the syringe has passed the medicine is cloudy, discolored, or has particles in it looks damaged or has been dropped - the expiration date printed on the syringe has passed - the medicine is cloudy, discolored, or has particles in it - looks damaged or has been dropped - you may see small air bubbles in the liquid. this is normal. you do not need to do anything about it. step 2: choosing and preparing injection area figure g 2a: choose the area for your injection (see figure g) - you may inject into your thighs or your stomach area (abdomen), but not within 2 inches (5 cm) of your belly button (navel). - the upper arm can also be used if a caregiver gives the injection. - inject your dose into a different body area each time you inject adbry. - if you need more than 1 injection for your dose, inject into the same body area, but at least 1 inch (3 cm) apart from each other. - do not inject where the skin is tender, damaged, bruised or scarred. figure h 2b: wash your hands and prepare your skin - wash your hands with soap and water. - clean the injection area with an alcohol swab using a circular motion (see figure h ). let the area dry completely. do not blow or touch the cleaned area before injecting. - let the area dry completely. - do not blow or touch the cleaned area before injecting. step 3: injecting adbry figure i 3a: pull off the adbry needle cover hold the adbry prefilled syringe body with one hand, pull the needle cover straight off with your other hand (see figure i ) and throw it away in the sharps container. - do not try to recap the adbry prefilled syringe. - do not hold the plunger rod or plunger head while removing the needle cover. - you may see a drop of liquid at the end of the needle. this is normal. - do not touch the needle, or let it touch any surface. if either of these occur, throw away the syringe and get a new one. figure j 3b: insert the needle with one hand, gently pinch and hold a fold of skin where you cleaned the injection area. with the other hand, insert the needle completely at about a 45-degree angle into your skin (see figure j ). figure k 3c: inject the medicine use your thumb to firmly push down the plunger head all the way down (see figure k ). all the medicine is injected when you cannot push the plunger head any further. figure l 3d: release and remove lift your thumb off the plunger head. the needle will automatically move back inside the syringe body and lock into place (see figure l ). - place a dry cotton ball or gauze pad over the injection site for a few seconds. do not rub the injection site. if needed, cover the injection site with a small bandage. - there may be a small amount of blood or liquid where you injected. this is normal. throw away the used adbry prefilled syringe in the sharps disposal container. see step 5 "disposing of adbry". step 4: repeating for multiple injections figure m if you need to give multiple injections for your prescribed dose, repeat step 3. the other injection(s) should be given into the same body area, but at least 1 inch (3 cm) away from each other. step 5: disposing of adbry syringe(s) figure n - put the used adbry prefilled syringe(s) in an fda-cleared sharps disposal container right away after use (see figure n ). do not throw away the adbry prefilled syringe(s) 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 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 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 recycle your used sharps disposal container. for more information go to www.adbry.com or call 1-844-692-3279. if you still have questions, call your healthcare provider. manufactured by: leo pharma a/s industriparken 55, dk-2750 ballerup, denmark distributed by: leo pharma inc., madison, nj 07940, usa u.s. license no. 2169 adbry® is a registered trademark of leo pharma a/s. © 2023 leo pharma inc. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised 12/2023

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

n.v. perricone llc - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) -

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

n.v. perricone llc - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) -

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

n.v. perricone llc - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) -

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

n.v. perricone llc - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) -

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

n.v. perricone llc - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) -