Tanzania - English - Tanzania Medicinces & Medical Devices Authority

hainan hualon pharmaceutical co. ltd., china - aztreonam - powder for solution for injection - 0.5 g

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

hainan poly pharm. co., ltd. - levoleucovorin calcium (unii: 778xl6vbs8) (levoleucovorin - unii:990s25980y) - levoleucovorin injection is indicated for: - rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. - diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. - the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. limitations of use: levoleucovorin injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin b 12 , because of the risk of progression of neurologic manifestations despite hematologic remission. levoleucovorin is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid or folinic acid [see adverse reactions ( 6.2)] . risk summary there are limited data with levoleucovorin use in pregnant women. animal reproduction studies have not been conducted with levoleucovorin. levoleucovorin is admin

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

hainan shuangcheng pharmaceuticals co., ltd. - bivalirudin (unii: tn9bex005g) (bivalirudin - unii:tn9bex005g) - bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. bivalirudin is contraindicated in patients with: - active major bleeding; - hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see adverse reactions (6.3)] . risk summary there are no data available on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (mrhd) of 15 mg/kg/day based on body surface area (bsa) during organogenesis, respectively, revealed no evidence of fetal harm. 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 indic

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

hainan shuangcheng pharmaceuticals co., ltd. - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide is contraindicated in patients with: - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke - current o

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

fuda pharmaceutical co. limited (tanzania), tanzania - omeprazole - powder and solvent for solution for injection - 40 mg

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

hainan poly pharm. co., ltd. - voriconazole (unii: jfu09i87tr) (voriconazole - unii:jfu09i87tr) - voriconazole is indicated for use in patients 12 years of age and older in the treatment of the following fungal infections: in clinical trials, the majority of isolates recovered were aspergillus fumigatus . there was a small number of cases of culture-proven disease due to species of aspergillus other than a. fumigatus [ see clinical studies (14.1) and clinical pharmacology (12.4) ]. [ see clinical studies (14.2) and clinical pharmacology (12.4) ] [ see clinical studies (14.3) and clinical pharmacology (12.4) ] [ see clinical studies (14.4) and clinical pharmacology (12.4) ] specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). therapy may be instituted before the results of the cultures and other laboratory studies are known. however, once these results become available, antifungal therapy should be adjusted accordingly. - voriconazole is contraindicated in patients with k

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

hainan poly pharm. co., ltd. - dobutamine hydrochloride (unii: 0wr771djxv) (dobutamine - unii:3s12j47372) - dobutamine injection, usp is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-amp-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. in controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-amp-dependent inotropes were consistently associated with increased risk of hospitalization and death. patients with nyha class iv symptoms appeared to be at particular risk. dobutamine

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

medispec (m) sdn.bhd - desloratadine -

Israel - English - Ministry of Health

a.l. medi-market ltd. - bivalirudin as trifluoroacetate - powder for concentrate for solution for injection / infusion - bivalirudin as trifluoroacetate 250 mg/vial - bivalirudin - bivalirudin medi-market 250 mg is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (pci) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.

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

trans arabia drug store llc china - 10 glass vials (5ml) - infusion - 100mg/ml - central nervous system-antiepileptics