AstraZeneca Pharmaceuticals LP - search results

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

quetiapine fumarate- quetiapine fumarate tablet, film coated

major pharmaceuticals - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine in schizophrenia was established in three 6 week trials in adults. the effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see clinical studies (14.1)]. pediatric use information in patients (13 to 17 years of age) with schizophrenia is approved for astrazeneca pharmaceuticals lp’s quetiapine fumarate drug product labeling. however, due to astrazeneca pharmaceuticals lp’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients. quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, [see clinical studies (14.2) ]. quetiapine fum

ইস্রায়েল - ইংরেজি - Ministry of Health

kombiglyze xr 5 mg1000 mg

astrazeneca (israel) ltd - metformin hydrochloride; saxagliptin - film coated tablets - extended release - saxagliptin 5 mg; metformin hydrochloride 1000 mg - metformin - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.

ইস্রায়েল - ইংরেজি - Ministry of Health

kombiglyze xr 2.5 mg1000 mg

astrazeneca (israel) ltd - metformin hydrochloride; saxagliptin - film coated tablets - extended release - saxagliptin 2.5 mg; metformin hydrochloride 1000 mg - metformin - kombiglyze xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

saphnelo- anifrolumab injection, solution

astrazeneca pharmaceuticals lp - anifrolumab (unii: 38rl9ae51q) (anifrolumab - unii:38rl9ae51q) - saphnelo (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (sle), who are receiving standard therapy [see clinical studies (14)] . limitations of use the efficacy of saphnelo has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. use of saphnelo is not recommended in these situations. saphnelo is contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia [see warnings and precautions (5.2)] . pregnancy exposure registry a pregnancy exposure registry monitors pregnancy outcomes in women exposed to saphnelo during pregnancy. for more information about the registry or to report a pregnancy while on saphnelo, contact astrazeneca at 1‑877‑693‑9268. risk summary the limited human data with saphnelo use in pregnant women are insufficient to inform on drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcome. monoclonal igg antibodies are known to be actively transported across the placenta as pregnancy progresses; therefore, anifrolumab-fnia exposure to the fetus may be greater during the third trimester of pregnancy. in an enhanced pre- and post-natal development study with pregnant cynomolgus monkeys that received intravenous administration of anifrolumab-fnia, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28‑times the exposure at the maximum recommended human dose (mrhd) on an area under curve (auc) basis (see data) . all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 disease-associated maternal and/or embryo/fetal risk : pregnant women with sle are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia. passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block. data animal data : in an enhanced pre- and post-natal development study, pregnant cynomolgus monkeys received anifrolumab-fnia at intravenous doses of 30 or 60 mg/kg once every 2 weeks from confirmation of pregnancy at gestation day 20, throughout the gestation period, and continuing until 1‑month post-partum (approximately lactation day 28). there was no evidence of anifrolumab-fnia related maternal toxicity, embryo-fetal toxicity, or post-natal developmental effects. no anifrolumab-fnia related effect on t-cell-dependent antibody response in the infants was noted up to day 180 after birth. the no observed adverse effect level (noael) for maternal and developmental toxicity was identified as 60 mg/kg (approximately 28‑times the mrhd on an auc basis). in the infants, mean serum concentrations of anifrolumab‑fnia on day 30 after birth increased with dose and were approximately 4.2% to 9.7% of the respective maternal concentrations. the anifrolumab-fnia concentrations in the infant serum were up to approximately 22‑times the concentrations in the maternal milk, suggesting that anifrolumab-fnia had transferred via the placenta. risk summary no data are available regarding the presence of saphnelo in human milk, the effects on the breastfed child, or the effects on milk production. anifrolumab-fnia was detected in the milk of female cynomolgus monkeys administered anifrolumab-fnia. due to species-species differences in lactation physiology, animal data may not reliably predict drug levels in humans. maternal igg is known to be present in human milk. if anifrolumab-fnia is transferred into human milk, the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to anifrolumab-fnia are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for anifrolumab-fnia and any potential adverse effects on the breast-fed child from anifrolumab-fnia or from the underlying maternal condition. the safety and efficacy of saphnelo in pediatric patients less than 18 years of age have not been established. of the 664 patients with sle exposed to anifrolumab-fnia in clinical trials, 3% (n=20) were 65 and over. the number of patients aged 65 years of age and older was not sufficient to determine whether they respond differently from younger adult patients.

ইউরোপীয় ইউনিয়ন - ইংরেজি - EMA (European Medicines Agency)

pandemic influenza vaccine h5n1 astrazeneca (previously pandemic influenza vaccine h5n1 medimmune)

astrazeneca ab - reassortant influenza virus (live attenuated) of the following strain: a/vietnam/1203/2004 (h5n1) strain - influenza, human - vaccines - prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.pandemic influenza vaccine h5n1 astrazeneca should be used in accordance with official guidance