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

New Zealand - English - Medsafe (Medicines Safety Authority)

aurobindo pharma nz limited - carvedilol 12.5mg - film coated tablet - 12.5 mg - active: carvedilol 12.5mg excipient: colloidal silicon dioxide crospovidone hypromellose lactose monohydrate macrogol 400 magnesium stearate polysorbate 80 povidone purified water   sucrose titanium dioxide - indicated for the management of essential hypertension. it can be used alone or in combination with other antihypertensive agents (e.g. calcium channel blockers, diuretics).

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

caraco pharmaceutical laboratories, ltd. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - tablet - 2.5 mg - amlodipine is indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive agents. amlodipine is indicated for the symptomatic treatment of chronic stable angina. amlodipine may be used alone or in combination with other antianginal agents. amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. amlodipine may be used as monotherapy or in combination with other antianginal drugs. in patients with recently documented cad by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. amlodipine is contraindicated in patients with known sensitivity to amlodipine.

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

caraco pharmaceutical laboratories, ltd. - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - tablet, extended release - 500 mg - metformin hydrochloride tablets, usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: - renal disease or renal dysfunction (e.g., 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 tablets, usp. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. diabetic ketoacidosis should be treated with insulin. metformin 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 als

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

aimmune therapeutics - peanut (unii: qe1qx6b99r) (peanut - unii:qe1qx6b99r) - palforzia is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. palforzia is approved for use in patients with a confirmed diagnosis of peanut allergy. initial dose escalation may be administered to patients aged 4 through 17 years. up-dosing and maintenance may be continued in patients 4 years of age and older [see dosage and administration (2.4)] . palforzia is to be used in conjunction with a peanut-avoidant diet. limitation of use: not indicated for the emergency treatment of allergic reactions, including anaphylaxis. palforzia is contraindicated in patients with the following: - uncontrolled asthma [see warnings and precautions (5.3)] - a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease [see warnings and precautions (5.4 and 5.5)] pregnancy regis

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة دار الدواء للتنمية والأستثمار - dar al dawa development and investment co ltd - hydrochlorothiazide 12.5 mg, valsartan 160 mg, amlodipine 10 mg - 12.5 mg, 160 mg, 10 mg

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة دار الدواء للتنمية والأستثمار - dar al dawa development and investment co ltd - hydrochlorothiazide 12.5 mg, valsartan 160 mg, amlodipine 5 mg - 12.5 mg, 160 mg, 5 mg

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة مستودع الأدوية الأردني - the jordan drugstore co - hydrochlorothiazide 12.5 mg, valsartan 160 mg, amlodipine 10 mg - 12.5 mg, 160 mg, 10 mg

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة مستودع الأدوية الأردني - the jordan drugstore co - hydrochlorothiazide 12.5 mg, valsartan 160 mg, amlodipine 5 mg - 12.5 mg, 160 mg, 5 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

max health limited - dobutamine hydrochloride 14 mg/ml equivalent to dobutamine 12.5 mg/ml, 250 mg dobutamine in 20 ml;   - concentrate for infusion - 12.5 mg/ml - active: dobutamine hydrochloride 14 mg/ml equivalent to dobutamine 12.5 mg/ml, 250 mg dobutamine in 20 ml   excipient: hydrochloric acid sodium metabisulfite water for injection - dobutamine hydrochloride is indicated when inotropic support is necessary for the treatment of patients with hypoperfusion states in whom cardiac output is insufficient to meet circulatory demands. dobutamine hydrochloride is also indicated when inotropic support is required for the treatment of patients in whom abnormally increased ventricular filling pressures introduce the risk of pulmonary congestion and oedema. conditions which may precipitate such situations include the following hypoperfusion states: initially cardiac in origin: a. acute heart failure acute myocardial infarction, cardiogenic shock, following cardiac surgery, medicine-induced depression of cardiac contractility such as that which occurs in excessive ?-adrenergic receptor blockade. b. chronic heart failure acute decompensation of chronic congestive heart failure, temporary inotropic support in advanced chronic congestive heart failure, as an adjunct to therapy with conventional oral inotropic agents, systemic vasodilators, and diuretics. initially noncardiac in origin: acute hypoperfusion states secondary to trauma, surgery, sepsis, or hypovolaemia when mean arterial pressure is above 70-mm hg and pulmonary capillary wedge pressure is 18-mm hg or greater, with inadequate response to volume repletion and increased ventricular filling pressure, low cardiac output secondary to mechanical ventilation with positive end-expiratory pressure (peep). paediatric population: dobutamine is indicated in all paediatric age groups (from neonates to 18 years of age) as inotropic support in low cardiac output hypoperfusion states resulting from decompensated heart failure, following cardiac surgery, cardiomyopathies and in cardiogenic or septic shock. dobutamine stress echocardiography: dobutamine hydrochloride may be used as a substitute for physical exercise in stress testing in the diagnosis of coronary artery disease. precautions apply (refer to data sheet).