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

ropack inc. - betaine (unii: 3scv180c9w) (betaine - unii:3scv180c9w) - betaine 1 g in 1 g - cystadane ® (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. included within the category of homocystinuria are: - cystathionine beta-synthase (cbs) deficiency - 5,10-methylenetetrahydrofolate reductase (mthfr) deficiency - cobalamin cofactor metabolism (cbl) defect none. pregnancy category c: animal reproduction studies have not been conducted with cystadane. it is also not known whether cystadane can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  cystadane should be given to a pregnant woman only if clearly needed. it is not known whether cystadane is excreted in human milk. use only if clearly needed. the majority of case studies of homocystinuria patients treated with cystadane have been pediatric patients, including patients ranging in age from 24 days to 17 years [see clinical studies ( 14)]. children younger than 3 years of age may benefit from dose titration [see dosag

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

ropack inc. - secnidazole (unii: r3459k699k) (secnidazole - unii:r3459k699k) - secnidazole 2 g in 4.8 g - solosec is indicated for the treatment of bacterial vaginosis in adult women [see use in specific populations ( 8.1) and clinical studies ( 14)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of solosec and other antibacterial drugs, solosec should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. hypersensitivity solosec is contraindicated in patients who have shown hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives. risk summary limited available data with solosec use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. in animal reproducti

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

ropack inc. - ferric pyrophosphate citrate (unii: uby79oco9g) (ferric cation - unii:91o4lml611) - ferric cation 272 mg in 272 mg - triferic is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (hdd-ckd). triferic is not intended for use in patients receiving peritoneal dialysis. triferic has not been studied in patients receiving home hemodialysis. none risk summary there are no data with triferic use in pregnant women to inform a drug-associated risk. no teratogenicity was observed in animal reproduction studies with administration of ferric pyrophosphate citrate to pregnant rats and rabbits during organogenesis at doses 96 and 128 times, respectively, the maximum recommended human dose (mrhd) of 27.2 mg per dialysis [see data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. data animal data in a fertility and early embryonic development study in female rats, the maternally toxic ferric pyrophosphate citra

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

agrofresh australia pty ltd - 1-methylcyclopropene - tablet (inc. pellet, bolus, suppository, capsule) - 1-methylcyclopropene hydrocarbon active 20.0 g/kg - growth regulator - apple | apricot | avocado | banana | broccoli | cabbage | carrot | cucumber | kiwi fruit | lettuce | mango | melon | nectarine | - increase storage life | longer storage life

Singapore - English - HSA (Health Sciences Authority)

nihon kohden singapore pte ltd - neurology - the neuropack s1 emg/ep measuring system (hereafter referred to as the system) measures and averages emg, electric/auditory/visual evoked potential and nerve conduction.

Nigeria - English - NAFDAC (National Agency for Food and Drugs Administration and Control)

chloroquine phosphate 40mg/5ml

Egypt - English - EDA (Egyptian Drug Authority)

european egyptian pharm. ind. - effervescent granules

Egypt - English - EDA (Egyptian Drug Authority)

european egyptian pharm. ind. - effervescent granules

Egypt - English - EDA (Egyptian Drug Authority)

european egyptian pharm. ind. - effervescent granules

Bangladesh - English - DGDA (Directorate General of Drug Administration)

marksman pharmaceutical ltd. - ketorolac tromethamine - tablet - 10 mg