Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - encephalitis, tick borne, inactivated, whole virus - suspension for injection - encephalitis, tick borne, inactivated, whole virus 2.4 mcg / 0.5 ml - encephalitis, tick borne, inactivated, whole virus - ticovac 0.5 ml is indicated for the active (prophylactic) immunization of adolescents from 16 years of age and adults against tick-borne encephalitis (tbe).

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - encephalitis, tick borne, inactivated, whole virus - suspension for injection - encephalitis, tick borne, inactivated, whole virus 1.2 mcg / 0.25 ml - encephalitis, tick borne, inactivated, whole virus - ticovac junior 0.25 ml is indicated for the active (prophylactic) immunization of children aged from 1 year to 15 years against tick-borne encephalitis (tbe).

Singapore - English - HSA (Health Sciences Authority)

livanova singapore pte ltd - cardiovascular - the stöckert s5 system (abbreviation: s5 system) is a modular perfusion system which can be assembled and configured for different applications at any time. the s5 system controls and monitors extracorporeal blood circulation during a cardiopulmonary perfusion.

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - fremanezumab, quantity: 225 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; histidine; polysorbate 80; disodium edetate; sucrose; water for injections - ajovy is indicated for the preventive treatment of migraine in adults.

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - fremanezumab, quantity: 225 mg - injection, solution - excipient ingredients: histidine; disodium edetate; histidine hydrochloride monohydrate; polysorbate 80; sucrose; water for injections - ajovy is indicated for the preventive treatment of migraine in adults.

European Union - English - EMA (European Medicines Agency)

teva gmbh - fremanezumab - migraine disorders - calcitonin gene-related peptide (cgrp) antagonists - ajovy is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

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

teva pharmaceuticals usa, inc. - fremanezumab (unii: pf8k38cg54) (fremanezumab - unii:pf8k38cg54) - ajovy is indicated for the preventive treatment of migraine in adults. ajovy is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ajovy during pregnancy. healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-927-2605 or visiting www.tevamigrainepregnancyregistry.com.  risk summary there are no adequate data on the developmental risk associated with the use of ajovy in pregnant women. ajovy has a long half-life [see clinical pharmacology (12.3)] . this should be taken into consideration for women who are pregnant or plan to become pregnant while using ajovy. administration of fremanezumab-vfrm to rats and rabbits during the period of organogenesis or to rats throu

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

pfizer laboratories div pfizer inc - tick-borne encephalitis purified antigen (formaldehyde inactivated) (unii: 42xd79uqq6) (tick-borne encephalitis purified antigen (formaldehyde inactivated) - unii:42xd79uqq6) - ticovac™ is indicated for active immunization to prevent tick-borne encephalitis (tbe). ticovac is approved for use in individuals 1 year of age and older. severe allergic reaction (e.g. anaphylaxis) to any component of ticovac [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. there are no adequate and well-controlled studies of ticovac in pregnant women. available human data are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy. developmental and reproductive toxicity studies in animals have not been conducted with ticovac. risk summary human data are not available to assess the impact of ticovac on milk production, its presence in breast milk, or its effects on the breastfed. the developmental and health benefits of breastfee

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

physicians total care, inc. - glyburide (unii: sx6k58tvwc) (glyburide - unii:sx6k58tvwc), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - glyburide 2.5 mg - glucovance (glyburide and metformin hcl) tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glucovance is contraindicated in patients with: - renal disease or renal dysfunction (eg, as suggested by serum creatinine levels ≥1.5 mg/dl [males], ≥1.4 mg/dl [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see warnings and precautions ). - known hypersensitivity to metformin hydrochloride or glyburide. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. glucovance should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (see also precautions .)

Singapore - English - HSA (Health Sciences Authority)

livanova singapore pte ltd - cardiovascular - indicated for speed-controlled pumping of blood through cardio-pulmonary bypass circuit for durations of 6 hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the c5 system.