Canada - English - Health Canada

recordati rare diseases canada inc - hemin - powder for solution - 268mg - hemin 268mg

Canada - English - Health Canada

recordati rare diseases canada inc - pasireotide (pasireotide pamoate) - powder for suspension, sustained-release - 10mg - pasireotide (pasireotide pamoate) 10mg - somatostatin agonists

Canada - English - Health Canada

recordati rare diseases canada inc - pasireotide (pasireotide pamoate) - powder for suspension, sustained-release - 30mg - pasireotide (pasireotide pamoate) 30mg - somatostatin agonists

Canada - English - Health Canada

recordati rare diseases canada inc - cysteamine (cysteamine hydrochloride) - solution - 0.37% - cysteamine (cysteamine hydrochloride) 0.37% - eent drugs, miscellaneous

Malta - English - Medicines Authority

casen recordati, s.l. autovia de logrono, km 13,300, 50180 utebo, zaragoza, spain - sodium picosulfate, magnesium oxide, light, citric acid, anhydrous - powder for oral solution - sodium picosulfate 10 mg magnesium oxide, light 3.5 g citric acid anhydrous 10.97 g - drugs for constipation

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

recordati rare diseases, inc. - cysteamine hydrochloride (unii: if1b771svb) (cysteamine - unii:5ux2sd1ke2) - cystadrops is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children 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 240 to 960 times the recommended human ophthalmic dose (based on body surface area) [ see data] . cystadrops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes 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. 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 (240 to 960 times the recommended human ophthalmic dose based on body surface area) and have shown cysteamine bitartrate to be teratogenic. observed teratogenic findings were intrauterine death, cleft palate, kyphosis, heart ventricular septal defects, microcephaly, exencephaly, and growth deficits. risk summary there is no information regarding the presence of cysteamine in human milk, the effects on the breastfed infants, or the effects on milk production. cysteamine administered orally is present in milk of lactating rats. it is not known whether measurable levels of cysteamine would be present in maternal milk following topical ocular administration of cystadrops. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cystadrops and any potential adverse effects on the breastfed child from cystadrops or from the underlying maternal conditions. the safety and effectiveness of cystadrops has been established in pediatric patients. use of cystadrops is supported by adequate and well controlled trials in pediatric patients and additional experience supporting the safety of cystadrops. clinical studies of cystadrops did not include sufficient numbers 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 the elderly and younger patients.  the effect of renal impairment on the pharmacokinetics of cysteamine following ophthalmic administration of cysteamine ophthalmic solution has not been evaluated. clearance of cysteamine from the conjunctival sac of the eye is not dependent on renal function and the total systemic dose is negligible, so impaired renal function is unlikely to affect total body clearance. the total daily ophthalmic dose is less than 4% of the recommended oral daily dose of cysteamine; thus, the systemic exposure following ophthalmic administration is expected to be negligible compared to oral administration.

Canada - English - Health Canada

recordati rare diseases canada inc - chlormethine (chlormethine hydrochloride) - gel - 160mcg - chlormethine (chlormethine hydrochloride) 160mcg

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

recordati rare diseases australia pty ltd - dactinomycin, quantity: 500 microgram - injection, powder for - excipient ingredients: mannitol - wilm's tumour; rhabdomyosarcoma; carcinoma of the testes and uterus. other neoplasms: actinomycin d given iv or by regional perfusion, either alone or with other antineoplastic compounds or with x-ray therapy in the palliative treatment of ewing's sarcoma and sarcoma botryoides; non-metastatic ewing's carcinoma. actinomyin d and radiation therapy; actinomycin d in various types of sarcoma, carcinoma and adenocarcinoma using isolation-perfusion technique. for full list of indications refer to approved pi document.

Ireland - English - HPRA (Health Products Regulatory Authority)

recordati ireland limited - lercanidipine hydrochloride; enalapril maleate - film-coated tablet - 10 mg/10 milligram(s) - ace inhibitors and calcium channel blockers; enalapril and lercanidipine

Ireland - English - HPRA (Health Products Regulatory Authority)

recordati ireland limited - enalapril maleate; lercanidipine hydrochloride - film-coated tablet - 20 mg/10 milligram(s) - ace inhibitors and calcium channel blockers; enalapril and lercanidipine