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

mylan pharmaceuticals inc. - cysteamine bitartrate (unii: qo84gz3tst) (cysteamine - unii:5ux2sd1ke2) - cysteamine 50 mg - cystagon® is indicated for the management of nephropathic cystinosis in children and adults. cystagon® is contraindicated in patients who have developed hypersensitivity to it or to cysteamine or penicillamine. cystagon® has not been associated with abuse potential, psychological or physical dependence in humans.

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

raptor therapeutics inc. - cysteamine bitartrate (unii: qo84gz3tst) (cysteamine - unii:5ux2sd1ke2) - cysteamine 25 mg

Philippines - English - FDA (Food And Drug Administration)

ambica international corporation; distributor: team excel distribution inc. - regular insulin human (rdna origin) - solution for injection (sc) - 100 iu/ml

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

leadiant biosciences, inc. - cysteamine hydrochloride (unii: if1b771svb) (cysteamine - unii:5ux2sd1ke2) - cysteamine hydrochloride 6.5 mg in 1 ml - cystaran is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. none. risk summary there are no adequate and well controlled studies of ophthalmic cysteamine in pregnant women to inform any drug associated risks. oral administration of cysteamine to pregnant rats throughout the period of organogenesis was teratogenic at doses 86 to 345 times the recommended human ophthalmic dose (based on body surface area) [see data] . cystaran should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. data animal data teratology studies have been performed in rats at oral doses in the range of 37.5 mg/kg/day to 150 mg/kg/day (86 to 345 times the recommended human ophthalmic dose based on a body surface area) and have revealed cysteamine bitartrate to be teratogenic. observed teratogenic findings were intrauterine death, cleft palate, kyphosis, heart ventricular septal defects, microcephaly, exe

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

horizon therapeutics usa, inc. - cysteamine bitartrate (unii: qo84gz3tst) (cysteamine - unii:5ux2sd1ke2) - cysteamine 25 mg - procysbi is indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older. the use of procysbi is contraindicated in patients with a serious hypersensitivity reaction, including anaphylaxis, to penicillamine or cysteamine. risk summary there are no available data on procysbi use in pregnant women to inform any drug-associated risks for birth defects or miscarriage [see data] . cysteamine (administered as cysteamine bitartrate) was teratogenic and fetotoxic in rats at doses less than the recommended human maintenance dose. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. advise pregnant women of the potential risk to a fetus. data animal data embryo-fetal development studies were conducted in rats using oral administration of cysteamine

Philippines - English - FDA (Food And Drug Administration)

ambica international corporation; distributor: team excel distibution inc. - isophane insulin human (rdna origin) - suspension for injection (sc) - 100 iu/ml

Philippines - English - FDA (Food And Drug Administration)

team excel distribution inc.; distributor: team excel distribution inc. - isophane insulin human, recombinant dna - sterile suspension for injection ( sc ) - 100 units/ml

Philippines - English - FDA (Food And Drug Administration)

team excel distribution inc.; distributor: team excel distribution inc. - neutral insulin human , isophane insulin human, recombinant dna - sterile suspension for injection ( sc ) - 100 units/ml ( 30% as neutral insulin human/ 70% as isophane insulin human )

Philippines - English - FDA (Food And Drug Administration)

team excel distribution inc.; distributor: team excel distribution inc. - regular insulin human, recombinant dna - sterile suspension for injection ( sc ) - 100 units/ml

Philippines - English - FDA (Food And Drug Administration)

team excel distribution inc - carvedilol - tablet, film coated - 6.25mg