New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - ezetimibe 10mg; simvastatin 10mg;   - tablet - 10mg/10mg - active: ezetimibe 10mg simvastatin 10mg   excipient: ascorbic acid butylated hydroxyanisole citric acid monohydrate croscarmellose sodium hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose sodium laurilsulfate - primary hypercholesterolaemia zimybe is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), triglycerides (tg), and non high-density lipoprotein cholesterol (non-hdl-c), and to increase high-density lipoprotein cholesterol (hdl-c) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia in patients not adequately treated on a statin alone. homozygous familial hypercholesterolaemia (hofh) zimybe is indicated for the reduction of elevated total-c and ldl-c levels in adult and adolescent (10 to 17 years of age) patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

United States - English - NLM (National Library of Medicine)

precision nuclear llc - ammonia n-13 (unii: 9oqo0e343z) (ammonia n-13 - unii:9oqo0e343z) - ammonia n-13 260 mci in 1 ml - ammonia n 13 injection usp is indicated for diagnostic positron emission tomography (pet) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. none pregnancy category c animal reproduction studies have not been conducted with ammonia n 13 injection. it is also not known whether ammonia n 13 injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ammonia n 13 injection should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk and because of the potential for radiation exposure to nursing infants from ammonia n 13 injection, use alternative infant nutrition sources (e.g., stored breast milk or infant formula) for 2 hours (> 10 half-lives of radioactive decay for n 13 isotope) after administration of the drug or avoid use of the drug, taking

United States - English - NLM (National Library of Medicine)

novavax, inc. - sars-cov-2 spike glycoprotein vaccine antigen nvx-cov2373 (unii: uk9ak2in1p) (sars-cov-2 spike glycoprotein vaccine antigen nvx-cov2373 - unii:uk9ak2in1p) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) for the emergency use of novavax covid-19 vaccine, adjuvanted (2023-2024 formula) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 12 years of age and older. novavax covid-19 vaccine, adjuvanted is not licensed for any use. justification for emergency use of vaccines during the covid-19 pandemic there is currently an outbreak of covid-19 caused by sars-cov-2. the secretary of the department of health and human services (hhs) has: - determined that there is a public health emergency, or a significant potential for a public health emergency related to covid-19.4 - declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the covid-19 pandemic.5 an eua is an fda authorization for the emergency use of an unapproved product or unapproved use of an approved

United States - English - NLM (National Library of Medicine)

seqirus inc. - influenza a virus a/washington/19/2020 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: 3yn85tu9mj) (influenza a virus a/washington/19/2020 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:32ss7wu2j7), influenza a virus a/tasmania/503/2020 (h3n2) antigen (mdck cell derived, propiolactone inactivated) (unii: 6er9j3gb63) (influenza a virus a/tasmania/503/2020 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:bun3xfj2b3), - flucelvax quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. flucelvax quadrivalent is approved for use in persons 6 months of age and older. [see clinical studies (14)] do not administer flucelvax quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine [see description (11)] . risk summary all pregnancies have a 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. there are insufficient data for flucelvax quadrivalent in pregnant women to inform vaccine-associated risks in pregnancy. there were no developmental toxicity studies of flucelvax quadrivalent performed in animals. a developmental toxicity study has been performed in female r

United States - English - NLM (National Library of Medicine)

seqirus inc. - influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: b8p3xn76w4) (influenza a virus a/georgia/12/2022 cvr-167 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:n8jks3vk2a), influenza a virus a/darwin/11/2021 (h3n2) antigen (mdck cell derived, propiolactone inactivated) (unii: pv9k2r8hrm) (influenza a virus a/darwin/11/2021 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:c6pm4nxj3 - flucelvax quadrivalent is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. flucelvax quadrivalent is approved for use in persons 6 months of age and older. [see clinical studies (14)] do not administer flucelvax quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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 collected in a prospective pregnancy exposure registry from 665 women vaccinated with flucelvax quadrivalent showed no evidence of a vaccine-associated increase in the risk of major birth defects and miscarriages when flucelvax quadrivalent is administered during any trime

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

alphamed drug store saudi arabia - 10's (0.5 ml x 10 single dose ampoules) - injection - 10 lf/0.5 ml - immunologicals , vaccines-vaccines , antisera

United States - English - NLM (National Library of Medicine)

seqirus inc. - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) antigen (propiolactone inactivated) (unii: v8pc20ubcn) (influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:wlsrj8jc6s) - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) antigen (propiolactone inactivated) 15 ug in 0.5 ml

United States - English - NLM (National Library of Medicine)

seqirus, inc. - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) antigen (mdck cell derived, propiolactone inactivated) (unii: qwjhw3wexs) (influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated) - unii:55qh9pjkdv) - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) antigen (mdck cell derived, propiolactone inactivated) 15 ug in 0.5 ml

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution, 0.15% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years). brimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past. pregnancy category b: teratogenicity studies have been performed in animals. brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. the highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5.0 mg/kg/day) achieved auc exposure values 360- and 20-fold higher, or 260- and 15-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate ophthalmic solution 0.15%,1 drop in both eyes three

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals limited - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte) - brimonidine tartrate ophthalmic solution, 0.15% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension. brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years). brimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past. pregnancy category b: teratogenicity studies have been performed in animals. brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. the highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5.0 mg/kg/day) achieved auc exposure values 360- and 20-fold higher, or 260- and 15-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate ophthalmic solution 0.15%,1 drop in both eyes three