European Union - English - EMA (European Medicines Agency)

leadiant gmbh - chenodeoxycholic acid - xanthomatosis, cerebrotendinous; metabolism, inborn errors - bile and liver therapy - chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (ctx)) in infants, children and adolescents aged 1 month to 18 years and adults.

Israel - English - Ministry of Health

mbi pharma ltd., israel - chenodeoxycholic acid - hard capsule - chenodeoxycholic acid 250 mg - chenodeoxycholic acid - the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (ctx)) in infants, children and adolescents aged 1 month to 18 years and adults.

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

leadiant biosciences, inc. - pegademase bovine (unii: hw3h7d91f6) (pegademase bovine - unii:hw3h7d91f6) - pegademase bovine 250 [iu] in 1 ml - adagen® (pegademase bovine) injection is indicated for enzyme replacement therapy for adenosine deaminase (ada) deficiency in patients with severe combined immunodeficiency disease (scid) who are not suitable candidates for – or who have failed – bone marrow transplantation. adagen® (pegademase bovine) injection is recommended for use in infants from birth or in children of any age at the time of diagnosis. adagen® (pegademase bovine) injection is not intended as a replacement for hla identical bone marrow transplant therapy. adagen® (pegademase bovine) injection is also not intended to replace continued close medical supervision and the initiation of appropriate diagnostic tests and therapy (e.g., antibiotics, nutrition, oxygen, gammaglobulin) as indicated for intercurrent illnesses. there is no evidence to support the safety and efficacy of adagen® (pegademase bovine) injection as preparatory or support therapy for bone marrow transplantation. since adagen® (pegademase bovine) injection is admin

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

leadiant biosciences, inc. - levocarnitine (unii: 0g389fzz9m) (levocarnitine - unii:0g389fzz9m) - levocarnitine 1 g in 10 ml - carnitor ® (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. in the reported cases, the clinical presentation consisted of recurrent episodes of reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. associated symptoms included hypotonia, muscle weakness and failure to thrive. a diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see clinical pharmacology ). in some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient. carnitor ® (levocarnitine) is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency. none

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

leadiant biosciences, inc. - levocarnitine (unii: 0g389fzz9m) (levocarnitine - unii:0g389fzz9m) - levocarnitine 1 g in 10 ml - carnitor ® (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. in the reported cases, the clinical presentation consisted of recurrent episodes of reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. associated symptoms included hypotonia, muscle weakness and failure to thrive. a diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see clinical pharmacology ). in some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient. carnitor ® (levocarnitine) is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency. none

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

leadiant biosciences, inc. - levocarnitine (unii: 0g389fzz9m) (levocarnitine - unii:0g389fzz9m) - levocarnitine 330 mg - carnitor® (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. in the reported cases, the clinical presentation consisted of recurrent episodes of reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. associated symptoms included hypotonia, muscle weakness and failure to thrive. a diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see clinical pharmacology ). in some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient. carnitor® (levocarnitine) is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency. none known.

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

leadiant biosciences, inc. - levocarnitine (unii: 0g389fzz9m) (levocarnitine - unii:0g389fzz9m) - levocarnitine 1 g in 5 ml - for the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. for the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. none known.

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

leadiant biosciences, inc. - amphotericin b (unii: 7xu7a7droe) (amphotericin b - unii:7xu7a7droe), dimyristoylphosphatidylcholine, dl- (unii: u86zgc74v5) (dimyristoylphosphatidylcholine, dl- - unii:u86zgc74v5), dimyristoylphosphatidylglycerol, dl- (unii: bi71wt9p3r) (dimyristoylphosphatidylglycerol, dl- - unii:bi71wt9p3r) - amphotericin b 5 mg in 1 ml - abelcet ® is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin b therapy. this is based on open-label treatment of patients judged by their physicians to be intolerant to or failing conventional amphotericin b therapy (see description of clinical studies). description of clinical studies fungal infections data from 473 patients were pooled from three open-label studies in which abelcet ® was provided for the treatment of patients with invasive fungal infections who were judged by their physicians to be refractory to or intolerant of conventional amphotericin b, or who had preexisting nephrotoxicity. results of these studies demonstrated effectiveness of abelcet ® in the treatment of invasive fungal infections as a second line therapy. patients were defined by their individual physician as being refractory to or failing conventional amphotericin b therapy based on overall clinical judgement after receiving a minimu

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)

leadiant biosciences, inc. - procarbazine hydrochloride (unii: xh0nph5zx8) (procarbazine - unii:35s93y190k) - procarbazine 50 mg - matulane is indicated for use in combination with other anticancer drugs for the treatment of stage iii and iv hodgkin's disease. matulane is used as part of the mopp (nitrogen mustard, vincristine, procarbazine, prednisone) regimen. matulane is contraindicated in patients with known hypersensitivity to the drug or inadequate marrow reserve as demonstrated by bone marrow aspiration. due consideration of this possible state should be given to each patient who has leukopenia, thrombocytopenia or anemia.