Canada - inglese - Health Canada

mint pharmaceuticals inc - icatibant (icatibant acetate) - solution - 10mg - icatibant (icatibant acetate) 10mg

Canada - inglese - Health Canada

accord healthcare inc - icatibant (icatibant acetate) - solution - 30mg - icatibant (icatibant acetate) 30mg

Canada - inglese - Health Canada

juno pharmaceuticals corp. - icatibant (icatibant acetate) - solution - 10mg - icatibant (icatibant acetate) 10mg

Stati Uniti - inglese - NLM (National Library of Medicine)

eugia us llc - icatibant acetate (unii: 325o8467xk) (icatibant - unii:7pg89g35q7) - icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (hae) in adults 18 years of age and older. none. risk summary available data from published literature and the pharmacovigilance database with icatibant use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, icatibant, administered by the subcutaneous route during the period of organogenesis, did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits at doses approximately 0.025 times the maximum recommended human dose (mrhd) and higher. decreased embryofetal survival was observed in rabbits at a subcutaneous dose that was 13 times the mrhd. in a pre- and post-natal development study in rats, delayed parturition was observed at subcutaneous doses 0.5 times the mrhd and higher, which resulted in deaths of dams at doses 2 times the mrhd

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

cipla australia pty ltd - icatibant acetate, quantity: 31.38 mg (equivalent: icatibant, qty 30 mg) - injection, solution - excipient ingredients: sodium chloride; glacial acetic acid; sodium hydroxide; water for injections - cipla icatibant is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older with c1-esterase-inhibitor deficiency.

Israele - inglese - Ministry of Health

teva israel ltd - icatibant as acetate - solution for injection - icatibant as acetate 30 mg / 3 ml - icatibant - icatibant teva is indicated for symptomatic treatment of acute attacks of hereditary angioedima (hae) in adults, adolescents and children aged 2 years and older, with c1-esterase-inhibitor deficiency.

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

juno pharmaceuticals pty ltd - icatibant acetate, quantity: 31.38 mg (equivalent: icatibant, qty 30 mg) - injection, solution - excipient ingredients: glacial acetic acid; sodium chloride; water for injections; sodium hydroxide - fyzant is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older with c1-esterase-inhibitor deficiency.

Stati Uniti - inglese - NLM (National Library of Medicine)

cycle pharmaceuticals ltd-uk - icatibant acetate (unii: 325o8467xk) (icatibant - unii:7pg89g35q7) - sajazir (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (hae) in adults 18 years of age and older. none. risk summary available data from published literature and the pharmacovigilance database with icatibant use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, icatibant, administered by the subcutaneous route during the period of organogenesis, did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits at doses approximately 0.025 times the maximum recommended human dose (mrhd) and higher. decreased embryofetal survival was observed in rabbits at a subcutaneous dose that was 13 times the mrhd. in a pre-and post-natal development study in rats, delayed parturition was observed at subcutaneous doses 0.5 times the mrhd and higher, which resulted in deaths of dams at doses 2 times the mrhd and higher. fetal death and early pup deaths were observed with doses 2 times the mrhd (see data ). 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 in an embryo-fetal development study with rats that received icatibant from gestation days 7 to 18, there was no evidence of any treatment-related structural abnormalities or effects on embryo-fetal survival with maternal doses up to 2.7 times the mrhd (on a mg/m2 basis with maternal subcutaneous doses up to 25 mg/kg/day). in a fertility and early embryonic development study with rats, icatibant increased pre-implantation loss at a dose that was 7 times the mrhd (on an auc basis at a maternal dose of 10 mg/kg/day). in an embryo-fetal development study with rabbits that received icatibant from gestation days 7 to 18, premature birth and abortion rates increased at doses approximately 0.025 times the mrhd and higher (on a mg/m2 basis at maternal subcutaneous doses of 0.1 mg/kg and higher). icatibant treatment resulted in dose-related decreases of total implantations and total number of live fetuses as well as dose-related increases of percent pre-implantation loss at a dose that was 13 times the mrhd (on an auc basis with a maternal subcutaneous dose of 10 mg/kg/day). there was no evidence of any treatment-related structural abnormalities with maternal doses up to 13 times the mrhd (on an auc basis with maternal subcutaneous doses up to 10 mg/kg/day). in a pre- and post-natal development study in the rat, dams received icatibant by the subcutaneous route at doses of 1, 3, and 10 mg/kg/day from gestation day 6 to post-partum (ppd) day 20. delayed parturition was observed at doses 0.5 times the mrhd and higher (on an auc basis with maternal subcutaneous doses of 1 mg/kg/day and higher), which resulted in deaths of dams at doses 2 times the mrhd and higher (on an auc basis with maternal subcutaneous doses of 3 mg/kg/day and higher). fetal death and increased pup deaths through ppd 4 were observed with doses 2 times the mrhd (on an auc with a maternal subcutaneous dose of 3 mg/kg/day and higher). impairment of pup righting reflex and decreased pup hair growth were also observed at 7 times the mrhd (on an auc basis with a maternal dose of 10 mg/kg). icatibant and the m2 metabolite were found in maternal milk following subcutaneous administration of icatibant. the no effect dose for f1 pups was identified at a dose 0.5 times the mrhd (on an auc basis with a maternal subcutaneous dose of 1 mg/kg/day). a no effect dose was not identified for f0 maternal toxicity. risk summary there are no data on the presence of icatibant in human milk, the effects on the breastfed infant, or the effects on milk production. icatibant and the m2 metabolite were found in rat milk following subcutaneous administration of icatibant (see data ). when a drug is present in animal milk, it is likely that the drug will be present in human milk. however, systemic absorption of icatibant in infants is not expected after oral exposure through breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for icatibant and any potential adverse effects on the breastfed child from icatibant or from the underlying maternal condition. data animal data icatibant is excreted into the milk of lactating rats at concentrations that sometimes slightly exceeded those measured in the maternal plasma. safety and effectiveness in pediatric patients below the age of 18 years have not been established. juvenile toxicity data subcutaneous daily administration of icatibant to young rats during the juvenile period of development (postnatal days 22-70) delayed the sexual maturation of male reproductive tissues (atrophy of testes and epididymides) at exposures approximating one-third or greater the mrhd on a mg/m2 basis. impaired fertility and reproductive performance were also observed in male rats at the end of the postnatal treatment period at exposures approximating the mrhd or greater on a mg/m2 basis. no effects were observed in females at exposures approximating 3-fold the mrhd on a mg/m2 basis. the observed tissue findings in males were consistent with those seen in sexually mature rats and dogs and are attributed to antagonism of the bradykinin b2 receptor and subsequent effects on gonadotropins. the observed effects may be a consequence of daily icatibant administration. toxicity to the testis did not occur in dogs treated twice a week for 9 months [see carcinogenesis, mutagenesis, impairment of fertility (13.1)] . clinical studies of icatibant injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. elderly patients are likely to have increased systemic exposure to icatibant injection compared to younger (18-45 years) patients [see clinical pharmacology (12.3)] . since other reported clinical experience has not identified differences in efficacy and safety between elderly and younger patients, no dose adjustment is recommended. icatibant injection was studied in patients with mild to moderate (child pugh scores of 5 to 8) hepatic impairment. no change in systemic exposure is noted in these patient populations. no dose adjustment is required in patients with hepatic impairment [see clinical pharmacology (12.3)] . although a formal renal impairment study has not been conducted, 10 of 37 patients treated with icatibant injection had hepatorenal syndrome with glomerular filtration rate (gfr) below 60 ml/min. icatibant injection is cleared non-renally and hence it is not expected to show any change in systemic exposure in patients with impaired renal function. no dose adjustment is required in patients with renal impairment [see clinical pharmacology (12.3)] .

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

alphapharm pty ltd - icatibant, quantity: 30 mg - injection, solution - excipient ingredients: glacial acetic acid; water for injections; sodium chloride; sodium hydroxide - icatibant mylan is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults with c1-esterase-inhibitor deficiency.

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

takeda new zealand limited - icatibant 10 mg/ml ((as icatibant acetate)) - solution for injection - 10 mg/ml - active: icatibant 10 mg/ml ((as icatibant acetate)) excipient: glacial acetic acid sodium chloride sodium hydroxide water for injection - firazyr is indicated for symptomatic treatment of acute attacks of hereditary angiooedema (hae) in adults (with c1-esterase-inhibitor deficiency).