USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. limitations of use: pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. deferiprone tablets are contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)] . risk summary: in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mortality and alterations to growth (see data ). the limited available data from deferiprone use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. based on evidence and developmental toxicity in animal studies, deferiprone tablets can cause fetal harm when administered to a pregnant woman. advise pregnant women and females of reproductive potential of the potential risk to a 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 of miscarriage is 2-4% and 15-20%, respectively. data: human data: post-marketing data available from 39 pregnancies of deferiprone-treated patients and 10 pregnancies of partners of deferiprone-treated patients are as follows: of the 39 pregnancies in deferiprone-treated patients, 23 resulted in healthy newborns, 6 ended in spontaneous abortion, 9 had unknown outcomes, and 1 infant was born with anal atresia, nephroptosis, ventricular septal defect, hemivertebra and urethral fistula. of the 10 pregnancies in partners of deferiprone-treated patients, 5 resulted in healthy newborns, 1 resulted in a healthy newborn with slight hypospadias, 1 was electively terminated, 1 resulted in the intrauterine death of twins, and 2 had unknown outcomes. animal data: during organogenesis, pregnant rats and rabbits received deferiprone at oral doses of 0, 30, 80 or 200 mg/kg/day, and 0, 10, 50, or 150 mg/kg/day, respectively. the daily dose was administered as two equal divided doses approximately 7 hours apart. doses of 200 mg/kg/day in rats and 150 mg/kg/day in rabbits, approximately 33% and 49% of the mrhd, respectively, resulted in increased post-implantation loss and reduced fetal weights in the presence of maternal toxicity (reduced maternal body weight and body weight gain in both rats and rabbits; abnormal large placenta at low incidence in rats). the 200 mg/kg/day dose in rats resulted in external, visceral and skeletal fetal malformations, such as cranial malformations, cleft palate, limb malrotation, anal atresia, internal hydrocephaly, anophthalmia, and fused bones. the dose of 150 mg/kg/day in rabbits resulted in external fetal malformations (partially opened eyes) and minor blood vessel and skeletal variations. in rats, malformations including micrognathia and persistent ductus arteriosus could be observed in the absence of maternal toxicity at doses equal to or greater than 30 and 80 mg/kg/day, approximately 5% and 13% of the mhrd, respectively. risk summary: there is no information regarding the presence of deferiprone in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, including the potential for tumorigenicity shown for deferiprone in animal studies, advise patients that breastfeeding is not recommended during treatment with deferiprone tablets, and for at least 2 weeks after the last dose. pregnancy testing: pregnancy testing is recommended for females of reproductive potential prior to initiating deferiprone tablets. contraception: females: deferiprone tablets can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise female patients of reproductive potential to use effective contraception during treatment with deferiprone tablets and for at least 6 months after the last dose. males: based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with deferiprone tablets and for at least 3 months after the last dose [see nonclinical toxicology (13.1)] . safety and effectiveness of deferiprone tablets have not been established in pediatric patients with chronic iron overload due to blood transfusions who are less than 8 years of age. pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information . clinical studies of deferiprone 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.

USA - engelsk - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. limitations of use - safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with diamond blackfan anemia. pediatric use information is approved for chiesi usa, inc.'s ferriprox ® (deferiprone) tablets. however, due to chiesi usa, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. deferiprone is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)]. risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mortality and alterations to growth (see data) . the limited available data from deferiprone use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. based on evidence and developmental toxicity in animal studies, deferiprone can cause fetal harm when administered to a pregnant woman. advise pregnant women and females of reproductive potential of the potential risk to a 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 of miscarriage is 2 to 4% and 15 to 20%, respectively. data human data post-marketing data available from 39 pregnancies of deferiprone-treated patients and 10 pregnancies of partners of deferiprone-treated patients are as follows: of the 39 pregnancies in deferiprone-treated patients, 23 resulted in healthy newborns, 6 ended in spontaneous abortion, 9 had unknown outcomes, and 1 infant was born with anal atresia, nephroptosis, ventricular septal defect, hemivertebra and urethral fistula. of the 10 pregnancies in partners of deferiprone-treated patients, 5 resulted in healthy newborns, 1 resulted in a healthy newborn with slight hypospadias, 1 was electively terminated, 1 resulted in the intrauterine death of twins, and 2 had unknown outcomes. animal data during organogenesis, pregnant rats and rabbits received deferiprone at oral doses of 0, 30, 80 or 200 mg/kg/day, and 0, 10, 50, or 150 mg/kg/day, respectively. the daily dose was administered as two equal divided doses approximately 7 hours apart. doses of 200 mg/kg/day in rats and 150 mg/kg/day in rabbits, approximately 33% and 49% of the mrhd, respectively, resulted in increased post-implantation loss and reduced fetal weights in the presence of maternal toxicity (reduced maternal body weight and body weight gain in both rats and rabbits; abnormal large placenta at low incidence in rats). the 200 mg/kg/day dose in rats resulted in external, visceral and skeletal fetal malformations such as cranial malformations, cleft palate, limb malrotation, anal atresia, internal hydrocephaly, anophthalmia and fused bones. the dose of 150 mg/kg/day in rabbits resulted in external fetal malformations (partially opened eyes) and minor blood vessel and skeletal variations. in rats, malformations including micrognathia and persistent ductus arteriosus could be observed in the absence of maternal toxicity at doses equal to or greater than 30 and 80 mg/kg/day, approximately 5% and 13% of the mhrd, respectively. risk summary there is no information regarding the presence of deferiprone in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, including the potential for tumorigenicity shown for deferiprone in animal studies, advise patients that breastfeeding is not recommended during treatment with deferiprone, and for at least 2 weeks after the last dose. pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiating deferiprone. contraception females deferiprone can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise female patients of reproductive potential to use effective contraception during treatment with deferiprone and for at least 6 months after the last dose. males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with deferiprone and for at least 3 months after the last dose [see nonclinical toxicology (13.1)] . safety and effectiveness of deferiprone tablets have not been established in pediatric patients with chronic iron overload due to blood transfusions who are less than 8 years of age. pediatric use information is approved for chiesi usa, inc.'s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of deferiprone 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.

Den europeiske union - italiensk - EMA (European Medicines Agency)

lipomed gmbh - deferiprone - iron overload; beta-thalassemia - tutti gli altri prodotti terapeutici - deferiprone lipomed in monoterapia è indicato per il trattamento del sovraccarico di ferro nei pazienti con talassemia major, mentre la terapia di chelazione è controindicata o inadeguata. deferiprone lipomed in combinazione con un altro chelante è indicato nei pazienti con talassemia major, quando la monoterapia con qualsiasi agente chelante del ferro è inefficace, o quando la prevenzione o il trattamento di conseguenze pericolose per la vita del sovraccarico di ferro giustifica rapida o per la cpu correzione.

Den europeiske union - fransk - EMA (European Medicines Agency)

lipomed gmbh - deferiprone - iron overload; beta-thalassemia - tous les autres produits thérapeutiques - deferiprone lipomed en monothérapie est indiqué pour le traitement de la surcharge en fer chez les patients atteints de thalassémie majeure lorsque le courant de la thérapie de chélation est contre-indiqué ou inadéquate. deferiprone lipomed en combinaison avec un autre chélateur est indiqué chez les patients atteints de thalassémie majeure lorsque la monothérapie avec tout chélateur de fer est inefficace, ou lorsque la prévention ou le traitement de la vie en danger les conséquences de la surcharge en fer justifie rapide ou intensive correction.

USA - engelsk - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. limitations of use: pediatric use information is approved for chiesi usa, inc.’s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. deferiprone tablets are contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulation. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)] . risk summary: in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mor

Den europeiske union - maltesisk - EMA (European Medicines Agency)

lipomed gmbh - deferiprone - iron overload; beta-thalassemia - il-prodotti terapewtiċi l-oħra kollha - deferiprone lipomed monoterapija hija indikata għat-trattament tal-eċċess tal-ħadid fil-pazjenti b'talassemija maġġuri meta attwali terapija ta ' kelazzjoni b'hija kontra-indikata jew inadegwata. deferiprone lipomed flimkien ma ieħor tal-kelant pero 'huwa indikat fil-pazjenti b'talassemija maġġuri meta kull monoterapija ma ''kelaturi tal-ħadid hija ineffettiv, jew meta l-prevenzjoni jew it-trattament ta' periklu għall-ħajja-konsegwenzi ta ' tagħbija żejda tal-ħadid jiġġustifika mgħaġġel jew intensiv korrezzjoni.

Den europeiske union - engelsk - EMA (European Medicines Agency)

lipomed gmbh - deferiprone - iron overload; beta-thalassemia - all other therapeutic products - deferiprone lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.deferiprone lipomed in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction.

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

arrow generiques - défériprone 500 mg - comprimé - 500 mg - pour un comprimé > défériprone 500 mg - tous autres médicaments - classe pharmacothérapeutique : tous autres médicaments, agents chélateurs du fer - code atc : v03ac02.deferiprone arrow 500 mg, comprimé pelliculé sécable con t i en t l a sub st a nce ac t i v e déf é r i pr on e.deferiprone arrow 500 mg, comprimé pelliculé sécable es t un chélateur du fer, un type de m édi c am ent qu i pe r m et de suppr i m er l e f e r en e xcè s d ans l e co r ps.deferiprone arrow 500 mg, comprimé pelliculé sécable es t u t i l i sé po ur t r ai t er l a s ur c har g e en f e r prov oquée par des t r an sf u si o ns sang ui nes f r éque nt e s chez l es pat i en t s pr é sen t an t une t h al ass ém i e m aj eu r e l o r sque l e t r ai t em ent ch él at eu r en c our s est cont r e- i ndi qué ou i nada pt é.

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

arrow generiques - défériprone 1000 mg - comprimé - 1000 mg - pour un comprimé > défériprone 1000 mg - tous autres médicaments - classe pharmacothérapeutique : tous autres médicaments, agents chélateurs du fer - code atc : v03ac02.deferiprone arrow 1000 mg, comprimé pelliculé sécable con t i en t l a sub st a nce ac t i v e déf é r i pr on e.deferiprone arrow 1000 mg, comprimé pelliculé sécable es t un chélateur du fer, un type de m édi c am ent qu i pe r m et de suppr i m er l e f e r en e xcè s d ans l e co r ps.deferiprone arrow 1000 mg, comprimé pelliculé sécable es t u t i l i sé po ur t r ai t er l a s ur c har g e en f e r prov oquée par des t r an sf u si o ns sang ui nes f r éque nt e s chez l es pat i en t s pr é sen t en t une t h al ass ém i e m aj eu r e l o r sque l e t r ai t em ent ch él at eu r en c our s est cont r e- i ndi qué ou i nada pt é.

Den europeiske union - slovakisk - EMA (European Medicines Agency)

lipomed gmbh - deferiprone - iron overload; beta-thalassemia - všetky ostatné terapeutické produkty - deferiprone lipomed monotherapy je indikovaný na liečbu preťaženia železom u pacientov s thalassaemia hlavných keď aktuálny chelatačné terapia je kontraindikovaný alebo je nedostatočné. deferiprone lipomed v kombinácii s inou chelator je indikovaný u pacientov s thalassaemia hlavných keď monotherapy s akýmkoľvek železa chelator je neúčinné, alebo keď prevenciu alebo liečbu život ohrozujúcich dôsledky preťaženia železom ospravedlňuje rýchle alebo intenzívnej korekcie.