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

bayer australia ltd - interferon beta-1b, quantity: 0.25 mg/ml - injection, powder for - excipient ingredients: albumin; mannitol - betaferon is indicated for the treatment of: - ambulatory patients with relapsing-remitting multiple sclerosis (ms) characterised by at least two attacks of neurologic dysfunction over a two year period followed by complete or incomplete recovery. - betaferon is also indicated for the reduction of frequency and severity of clinical relapses, and for the slowing of progression of disease in patients with secondary progressive multiple sclerosis. - the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - interferon beta-1b 0.25mg (20% excess in quantity filled) - injection with diluent - 8 miu - active: interferon beta-1b 0.25mg (20% excess in quantity filled) excipient: albumin hydrochloric acid mannitol sodium hydroxide hydrochloric acid sodium chloride water for injection - betaferon is indicated for: · the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded, · the treatment of ambulatory patients, with relapsing-remitting multiple sclerosis characterised by at least two attacks of neurological dysfunction over a two year period followed by complete or incomplete recovery. · the reduction of frequency and severity of clinical relapses and for slowing the progression of disease in patients with secondary progressive multiple sclerosis

Israel - English - Ministry of Health

sanofi israel ltd - iron as iron iii sodium ferric glugonate compl. - solution for injection/ concentrate for solution for infusion - iron as iron iii sodium ferric glugonate compl. 62.5 mg / 5 ml - various combinations - various combinations - ferrlecit is indicated in adults and children 6 years and above.severe iron deficiency states only when oral administration has been found impossible; in cases of gastrointestinal malabsorption which rules out oral iron therapy; patients treated by dialysis getting erythropoietin.

European Union - English - EMA (European Medicines Agency)

bayer ag  - interferon beta-1b - multiple sclerosis - immunostimulants, - betaferon is indicated for the treatment ofpatients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years;patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.

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

ropack inc. - ferric pyrophosphate citrate (unii: uby79oco9g) (ferric cation - unii:91o4lml611) - ferric cation 272 mg in 272 mg - triferic is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (hdd-ckd). triferic is not intended for use in patients receiving peritoneal dialysis. triferic has not been studied in patients receiving home hemodialysis. none risk summary there are no data with triferic use in pregnant women to inform a drug-associated risk. no teratogenicity was observed in animal reproduction studies with administration of ferric pyrophosphate citrate to pregnant rats and rabbits during organogenesis at doses 96 and 128 times, respectively, the maximum recommended human dose (mrhd) of 27.2 mg per dialysis [see data]. 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 a fertility and early embryonic development study in female rats, the maternally toxic ferric pyrophosphate citra

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

rockwell medical, inc - ferric pyrophosphate citrate (unii: uby79oco9g) (ferric cation - unii:91o4lml611) - ferric cation 5.44 mg in 1 ml - triferic is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (hdd-ckd). triferic is not intended for use in patients receiving peritoneal dialysis. triferic has not been studied in patients receiving home hemodialysis. none risk summary there are no data with triferic use in pregnant women to inform a drug-associated risk. no teratogenicity was observed in animal reproduction studies with administration of ferric pyrophosphate citrate to pregnant rats and rabbits during organogenesis at doses 96 and 128 times, respectively, the maximum recommended human dose (mrhd) of 27.2 mg per dialysis [see data]. 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 a fertility and early embryonic development study in female rats, the maternally toxic ferric py

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

rockwell medical, inc - ferric pyrophosphate citrate (unii: uby79oco9g) (ferric cation - unii:91o4lml611) - triferic is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (hdd-ckd). triferic is not intended for use in patients receiving peritoneal dialysis. triferic has not been studied in patients receiving home hemodialysis. none risk summary there are no data on triferic use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in pregnant rats and rabbits, ferric pyrophosphate citrate caused adverse developmental outcomes at maternally toxic dose levels that were higher than the maximum theoretical amount of iron transferred to patients from triferic. use triferic 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 of birth defect, loss, or other adverse outcomes. in the us. general populati

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

pharmacosmos a/s - ferric derisomaltose (unii: ahu547pi9h) (ferric derisomaltose - unii:ahu547pi9h) - monoferric is indicated for the treatment of iron deficiency anemia (ida) in adult patients: - who have intolerance to oral iron or have had unsatisfactory response to oral iron - who have non-hemodialysis dependent chronic kidney disease (ndd-ckd) monoferric is contraindicated in patients with a history of serious hypersensitivity to monoferric or any of its components [see warnings and precautions (5.1), description (11)] . reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. risk summary there are no available data on monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. however, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to ass

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

rockwell medical inc. - ferric pyrophosphate citrate (unii: uby79oco9g) (ferric cation - unii:91o4lml611) - triferic avnu is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (hdd-ckd). limitations of use - triferic avnu is not intended for use in patients receiving peritoneal dialysis. - triferic avnu  has not been studied in patients receiving home hemodialysis. none risk summary there are no available data on triferic avnu usein pregnant women to inform a drug-associated risk of major birth defects,  miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, intravenous administration of ferric pyrophosphate citrate to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes at maternally toxic dose levels that were higher than the maximum theoretical amount of iron transferred to patients from triferic avnu (see data) .  the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregna

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

pharmacosmos therapeutics inc. - ferric derisomaltose (unii: ahu547pi9h) (ferric derisomaltose - unii:ahu547pi9h) - monoferric is indicated for the treatment of iron deficiency anemia (ida) in adult patients: - who have intolerance to oral iron or have had unsatisfactory response to oral iron - who have non-hemodialysis dependent chronic kidney disease (ndd-ckd) monoferric is contraindicated in patients with a history of serious hypersensitivity to monoferric or any of its components (see warnings and precautions (5.1), description (11)) . reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. risk summary there are no available data on monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. however, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects ( see data) . there are risks to the mother and fetus associated with untreated iron deficiency anemia (ida) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions ( see clinical considerations) . iron complexes have been reported to be teratogenic and embryocidal in non-iron depleted pregnant animals. the findings in animals may be due to iron overload and may not be applicable to patients with iron deficiency. animal reproduction studies of ferric derisomaltose administered to rats and rabbits during the period of organogenesis caused adverse developmental outcomes including structural abnormalities and embryo-fetal mortality at doses approximately 0.09 and 0.4 times the maximum recommended human dose (mrhd) of 1000 mg, respectively, based on body surface area ( see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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. clinical considerations disease-associated maternal and/or embryo/fetal risk untreated iron deficiency anemia (ida) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. adverse pregnancy outcomes associated with ida includes increased risk for preterm delivery and low birth weight. fetal/neonatal adverse reactions severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as monoferric) which may cause fetal bradycardia, especially during the second and third trimester. data animal data iron complexes have been reported to be teratogenic and embryocidal in non-anemic pregnant animals at single doses above 125 mg iron/kg body weight. the highest recommended dose in human clinical use is 20 mg iron/kg body weight. in a combined fertility and embryo-fetal development study in rats, ferric derisomaltose was administered intravenously to female rats 14 days prior to cohabitation and through gestation day (gd) 17 at doses of 3, 11, and 32 mg fe/kg/day. the doses of 11 and 32 mg fe/kg/day (approximately 0.1 and 0.3 times the mrhd of 1000 mg, based on body surface area (bsa)) resulted in an increase in the incidence of skeletal developmental delays. ferric derisomaltose was administered intravenously to pregnant rabbits during organogenesis, from gd7 to gd20, at doses of 11, 25 and 43 mg fe/kg/day. the dose of 43 mg fe/kg/day (approximately 0.8 times the mrhd of 1000 mg, based on bsa) resulted in increased maternal mortality, abortion, and premature delivery, and increased postimplantation loss. adverse developmental findings at this dose included fetal mortality, reduced fetal weights, and fetal developmental variations and malformations (including domed head, cleft palate, microglossia, hydrocephaly, small brain). fetal malformations and reduced fetal weights were also noted in the 25 mg fe/kg/day group (approximately 0.5 times the mrhd based on bsa). risk summary the available data on the use of monoferric in lactating women demonstrate that iron is present in breast milk. however, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for monoferric in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. clinical considerations monitor breastfed children for gastrointestinal toxicity (constipation, diarrhea). safety and effectiveness have not been established in pediatric patients. of the 3934 patients in clinical studies of monoferric, 29% were 65 years and over, while 13% were 75 years and over. no overall differences in safety or effectiveness were observed between these patients and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.