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

recordati rare diseases, inc. - clorazepate dipotassium (unii: 63fn7g03xy) (clorazepic acid - unii:d51wo0g0l4) - clorazepate dipotassium 7.5 mg - tranxene is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. tranxene tablets are indicated as adjunctive therapy in the management of partial seizures. the effectiveness of tranxene tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. long-term studies in epileptic patients, however, have shown continued therapeutic activity. the physician should reassess periodically the usefulness of the drug for the individual patient. tranxene tablets are indicated for the symptomatic relief of acute alcohol withdrawal. tranxene tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.

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

recordati rare diseases, inc. - ethotoin (unii: 46qg38nc4u) (ethotoin - unii:46qg38nc4u) - ethotoin 250 mg - peganone (ethotoin tablets, usp) is indicated for the control of tonic-clonic (grand mal) and complex partial (psychomotor) seizures. peganone (ethotoin tablets, usp) is contraindicated in patients with hepatic abnormalities or hematologic disorders.

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

recordati rare diseases, inc. - methamphetamine hydrochloride (unii: 997f43z9cv) (methamphetamine - unii:44ral3456c) - methamphetamine hydrochloride 5 mg - attention deficit disorder with hyperactivity: desoxyn tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children over 6 years of age with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. in patients known to be hypersensitive to amphetamine, or other components of desoxyn. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine p

Australia - English - Department of Health (Therapeutic Goods Administration)

recordati rare diseases australia pty ltd - dinutuximab beta, quantity: 4.5 mg/ml - solution - excipient ingredients: polysorbate 20; hydrochloric acid; sucrose; water for injections; histidine - qarziba is indicated for the treatment of high-risk neuroblastoma in patients who have previously received induction chemotherapy and achieved at least a partial response.

European Union - English - EMA (European Medicines Agency)

recordati rare diseases - carglumic acid - amino acid metabolism, inborn errors; propionic acidemia - other alimentary tract and metabolism products, - carbaglu is indicated in treatment of:hyperammonaemia due to n-acetylglutamate-synthase primary deficiency;hyperammonaemia due to isovaleric acidaemia;hyperammonaemia due to methymalonic acidaemia;hyperammonaemia due to propionic acidaemia.

European Union - English - EMA (European Medicines Agency)

recordati rare diseases - betaine anhydrous - homocystinuria - other alimentary tract and metabolism products, - adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (cbs);5,10-methylene-tetrahydrofolate reductase (mthfr);cobalamin cofactor metabolism (cbl).cystadane should be used as supplement to other therapies such as vitamin b6 (pyridoxine), vitamin b12 (cobalamin), folate and a specific diet.

European Union - English - EMA (European Medicines Agency)

recordati rare diseases - mercaptamine hydrochloride - cystinosis - ophthalmologicals - cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.

European Union - English - EMA (European Medicines Agency)

recordati rare diseases - zinc - hepatolenticular degeneration - other alimentary tract and metabolism products, - treatment of wilson's disease.

European Union - English - EMA (European Medicines Agency)

recordati rare diseases - mercaptamine bitartrate - cystinosis - other alimentary tract and metabolism products, - cystagon is indicated for the treatment of proven nephropathic cystinosis. cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.

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

recordati rare diseases, inc. - pasireotide (unii: 98h1t17066) (pasireotide - unii:98h1t17066) - signifor is indicated for the treatment of adult patients with cushing's disease for whom pituitary surgery is not an option or has not been curative. none. risk summary the limited data with signifor in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in embryo-fetal development studies in rabbits, findings indicating developmental delay were observed with subcutaneous administration of pasireotide during organogenesis at doses less than the exposure in humans at the highest recommended dose; maternal toxicity was not observed at this dose (see data) . the estimated 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%-4% and 15%-20%, respectively. data animal data in embryo-fetal development studies in rats given 1, 5, and 10 mg/kg/day subcutaneously throughout org