Canada - English - Health Canada

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

Canada - English - Health Canada

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

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

recordati rare diseases, inc. - hemin (unii: 743lrp9s7n) (hemin - unii:743lrp9s7n) - hemin 7 mg in 1 ml - panhematin (hemin for injection) is indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women. manifestations such as pain, hypertension, tachycardia, abnormal mental status and mild to progressive neurologic signs may be controlled in selected patients with this disorder. similar findings have been reported in other patients with acute intermittent porphyria, porphyria variegata and hereditary coproporphyria. panhematin is not indicated in porphyria cutanea tarda. panhematin is contraindicated in patients with known hypersensitivity to this drug.

Canada - English - Health Canada

recordati rare diseases canada inc - dactinomycin - powder for solution - 0.5mg - dactinomycin 0.5mg - antineoplastic agents

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

recordati rare diseases inc. - ibuprofen lysine (unii: n01orx9d6s) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 10 mg in 1 ml - neoprofen is indicated to close a clinically significant patent ductus arteriosus (pda) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. the clinical trial was conducted among infants with an asymptomatic pda. however, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant pda. neoprofen is contraindicated in: - preterm infants with proven or suspected infection that is untreated; - preterm infants with congenital heart disease in whom patency of the pda is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of fallot, severe coarctation of the aorta); - preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; - preterm infant

Canada - English - Health Canada

recordati rare diseases canada inc - betaine - powder for solution - 1g - betaine 1g - other miscellaneous therapeutic agents

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

recordati rare diseases australia pty ltd - carglumic acid, quantity: 200 mg - tablet, dispersible - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; hypromellose; sodium stearylfumarate - carbaglu is indicated in treatment of,? hyperammonaemia due to n-acetylglutamate synthase primary deficiency,? hyperammonaemia due to organic acidaemias such as:,-hyperammonaemia due to isovaleric acidaemia -hyperammonaemia due to methylmalonic acidaemia -hyperammonaemia due to propionic acidaemia

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

recordati rare diseases, inc. - hemin (unii: 743lrp9s7n) (hemin - unii:743lrp9s7n) - hemin 7 mg in 1 ml - panhematin is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be inadequate. limitations of use - before administering panhematin, consider an appropriate period of carbohydrate loading (i.e., 400 g glucose/day for 1 to 2 days) [see dosage and administration ( 2.1)] . - attacks of porphyria may progress to a point where irreversible neuronal damage has occurred. panhematin therapy is intended to prevent an attack from reaching the critical stage of neuronal degeneration. panhematin is not effective in repairing neuronal damage. panhematin is contraindicated in patients with known hypersensitivity to this drug. risk summary about 50% of the women with acute intermittent porphyria experience an acute attack of porphyria in pregnancy and/or the puerperium. it is most severe in early pregnancy and the puerperium, and can result in fatal outcome. although anecdotal evidence suggests safe use of hematin during pregnancy, the available human data is not sufficient to establish the presence or absence of drug-associated risk. animal reproduction studies have not been conducted with hematin. it is also not known whether hematin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. panhematin should be given to a pregnant woman only if clearly needed. avoid administering hematin in severe pre-eclampsia because of a theoretical risk of potentiation of the coagulation disorder [see warnings and precautions ( 5.3)] . 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. risk summary it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for panhematin and any potential adverse effects on the breastfed child from panhematin or from the underlying maternal condition. safety and effectiveness in pediatric patients under 16 years of age have not been established. clinical data for subjects aged 65 and over was not sufficient to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in response between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

recordati rare diseases, inc. - dactinomycin (unii: 1cc1jfe158) (dactinomycin - unii:1cc1jfe158) - dactinomycin 0.5 mg in 1 ml - cosmegen is indicated for the treatment of adult and pediatric patients with wilms tumor, as part of a multi-phase, combination chemotherapy regimen. cosmegen is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen. cosmegen is indicated for the treatment of adult and pediatric patients with ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen. cosmegen is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen. cosmegen is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen. cosmegen is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion. none. risk summary based on findings from animal studies and its mechanism of action, cosmegen can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1)] . in animal reproduction studies, administration of dactinomycin to pregnant animals during the period of organogenesis was teratogenic, resulting in malformations at doses lower than the recommended human dose (see data) . advise pregnant women of the potential risk to a fetus [see use in special populations ( 8.3)] . 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 dactinomycin was teratogenic in animals. administration of dactinomycin to pregnant rats, rabbits, and hamsters during the period of organogenesis, increased the incidence of fetal malformations and caused embryotoxicity at doses (based on body surface area) as low as 0.2 times the clinical dose of 1250 mcg/m 2 . risk summary there are no data on the presence of dactinomycin or its metabolites in human milk or their effects on the breastfed infant or on milk production. because of the potential for serious adverse reactions in breastfed infants from cosmegen, advise women not to breastfeed during treatment with cosmegen and, based on limited published data regarding the dactinomycin half-life, for 14 days after the final dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating cosmegen [see use in specific population ( 8.1)]. contraception cosmegen can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1)] . females advise females of reproductive potential to use effective contraception during treatment with cosmegen and for at least 6 months after the final dose. males because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with cosmegen and for 3 months after the final dose [ see nonclinical toxicology ( 13.1)] . the safety and effectiveness of dactinomycin have been established in pediatric patients with wilms tumor, rhabdomyosarcoma, ewing sarcoma, and metastatic nonseminomatous testicular cancer . the safety and effectiveness of dactinomycin have been established in post-menarchal pediatric patients with gestational trophoblastic neoplasia. the safety and effectiveness of cosmegen have not been established in pediatric patients undergoing regional perfusion for locally recurrent or locoregional solid malignancies. clinical studies of cosmegen did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

recordati rare diseases australia pty ltd - 45156 - medicine administration kit, percutaneous, medicated, single-use - medicine administration kit for signifor lar for single use only