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

clinigen limited - amifostine (unii: m487qf2f4v) (amifostine anhydrous - unii:ila426l95o) - ethyol (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see clinical studies (14.1)] . ethyol is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands [see clinical studies (14.2)] . limitation of use do not use ethyol in other settings where chemotherapy can produce a significant survival benefit or cure [see warnings and precautions (5.1)] , or in patients receiving definitive radiotherapy [see warnings and precautions (5.2)] , except in the context of a clinical study. ethyol is contraindicated in patients with known hypersensitivity to aminothiol compounds. when ethyol is used in combination with cisplatin, refer to the cisplatin full prescribing information for pregnancy information. based on findings in animals, ethyol can cause fetal harm when administered to a pregnant woman. there are no available data on ethyol use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, intravenous administration of ethyol to pregnant rabbits during organogenesis was embryotoxic at doses approximately sixty percent of the recommended dose in humans based on body surface area (see data) . advise pregnant women and females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the estimated background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies in the u.s. general population. ethyol has been shown to be embryotoxic in rabbits at intravenous doses of 50 mg/kg, approximately sixty percent of the recommended dose in humans on a body surface area basis. when ethyol is used in combination with cisplatin, refer to the cisplatin full prescribing information for lactation information. there are no data on the presence of amifostine or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with ethyol. when ethyol is used in combination with cisplatin, refer to the cisplatin full prescribing information for contraception and infertility information. verify pregnancy status in females of reproductive potential prior to initiating ethyol. males based on findings from animal studies, ethyol may impair fertility in males of reproductive potential [see nonclinical toxicology (13.1)]. the safety and effectiveness in pediatric patients have not been established. the clinical studies did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in elderly patients.

Ireland - English - HPRA (Health Products Regulatory Authority)

clinigen healthcare b.v. - glycopyrronium bromide - oral solution - 160 microgram(s)/millilitre - glycopyrronium bromide

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

clinigen healthcare ltd - interferon gamma-1b (recombinant human) - solution for injection - 200microgram/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

clinigen healthcare ltd - aldesleukin - powder for solution for injection - 18mega unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

clinigen healthcare ltd - carmustine - prolonged-release intralesional implant - 7.7mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

clinigen healthcare ltd - telavancin hydrochloride - powder for solution for infusion - 250mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

clinigen healthcare ltd - telavancin hydrochloride - powder for solution for infusion - 750mg

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

clinigen healthcare b.v. - foscarnet trisodium hexahydrate 6 g/250 ml - solution for infusion - 24 mg/ml - foscarnet trisodium hexahydrate 24 mg/ml - foscarnet

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

clinigen healthcare b.v. - melatonin 1 mg/ml - oral solution - melatonin

Kenya - English - Pharmacy and Poisons Board

clinigen kenya (plc) ltd western heights, karuna road 10th floor, - mesalamine - prolonged-release tablet - each enteric coated prolonged release tablet… - mesalazine