Australija - engleski - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 1000 mg - diluent, not applicable - excipient ingredients: - prolastin-c is an alpha-1-proteinase inhibitor (human, alpha1-pi) indicated to increase serum alpha1-pi levels in adults with congenital deficiency of alpha-1 antitrypsin and with clinically significant emphysema (fev1 less than 80%). the data for clinical efficacy of prolastin-c is derived from changes in the biomarkers alpha-1 anti-protease level and ct lung density. efficacy on fev1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials. clinical trials have only included patients who were not smoking.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 500 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

shire pharmaceuticals ltd - c1-esterase inhibitor - powder and solvent for solution for injection - 500unit

Australija - engleski - Department of Health (Therapeutic Goods Administration)

viropharma pty ltd - c1 esterase inhibitor -

Europska Unija - engleski - EMA (European Medicines Agency)

pharming group n.v. - recombinant human c1-inhibitor - angioedemas, hereditary - drugs used in hereditary angioedema, other hematological agents - ruconest is indicated for treatment of acute angioedema attacks in adults with hereditary angioedema (hae) due to c1-esterase-inhibitor deficiency.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

grifols usa, llc - .alpha.1-proteinase inhibitor human (unii: f43i396ois) (.alpha.1-proteinase inhibitor human - unii:f43i396ois) - .alpha.1-proteinase inhibitor human 1000 mg in 20 ml - prolastin-c is an alpha1 -proteinase inhibitor (human) (alpha1 -pi) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1 -pi (alpha1 -antitrypsin deficiency). prolastin-c increases antigenic and functional (anti-neutrophil elastase capacity, anec) serum levels and antigenic lung epithelial lining fluid levels of alpha1 -pi. limitations of use - the effect of augmentation therapy with any alpha1 -pi, including prolastin-c, on pulmonary exacerbations and on the progression of emphysema in alpha1 -pi deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. - clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with prolastin-c are not available. - prolastin-c is not indicated as therapy for lung disease in patients in whom severe alpha1 -pi deficiency has not been established. prolastin-c is contraindicated in: - iga deficient patients w

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - .alpha.1-proteinase inhibitor human (unii: f43i396ois) (.alpha.1-proteinase inhibitor human - unii:f43i396ois) - .alpha.1-proteinase inhibitor human 16 mg in 1 ml - aralast np is an alpha1 -proteinase inhibitor (alpha1 -pi) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of alpha1 -pi (alpha1 -antitrypsin deficiency). aralast np increases antigenic and functional (anti-neutrophil elastase capacity, anec) serum levels and antigenic lung epithelial lining fluid levels of alpha1 -pi. the effect of augmentation therapy with any alpha1 -pi, including aralast np, on pulmonary exacerbations and on the progression of emphysema in alpha1 -antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy with aralast np or aralast are not available. aralast np is not indicated as therapy for lung disease in patients in whom severe congenital alpha1 -pi deficiency has not been established. aralast np is contraindicated in immunoglobulin a (iga) deficient patients with antib

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - anti-inhibitor coagulant complex (unii: cs849dun3m) (anti-inhibitor coagulant complex - unii:cs849dun3m) - anti-inhibitor coagulant complex 500 [usp'u] in 20 ml - feiba is an anti-inhibitor coagulant complex indicated for use in hemophilia a and b patients with inhibitors for: - control and prevention of bleeding episodes - perioperative management - routine prophylaxis to prevent or reduce the frequency of bleeding episodes. feiba is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor viii or coagulation factor ix. - known anaphylactic or severe hypersensitivity reactions to feiba or any of its components, including factors of the kinin generating system. - disseminated intravascular coagulation (dic). - acute thrombosis or embolism (including myocardial infarction). risk summary there are no data with feiba use in pregnant women to inform a drug-associated risk. there are no adequate and well-controlled studies in pregnant women. animal reproduction studies have not been conducted with feiba. it is also not known whether feiba can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. in the u.s. general population, the estimated background risk for major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there is no information available on the effect of feiba on labor and delivery. risk summary there is no information regarding the presence of feiba in human milk, the effect on 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 feiba and any potential adverse effects on the breastfed child from feiba or from the underlying condition. safety and efficacy of feiba have been evaluated in nine pediatric subjects treated in the routine prophylaxis trial including 4 subjects ≥7 to <12 years of age and 5 subjects ≥12 to <16 years of age. the dosing for all pediatric subjects was based on body weight. a total of 576 infusions were given for the treatment of 223 bleeding episodes (504 infusions for joint bleeding episodes, 72 infusions for muscle and soft tissue bleeding episodes). in 223 (100%) of the episodes, hemostasis was achieved with one or more infusions. hemostatic efficacy was rated as excellent or good in a majority (96.9%) of the bleeding episodes in both regimens at 24 hours post infusion. the median annualized bleeding episode rate (abr) for children ≥7 to <12 years of age was 7.7 bleeds per patient per year, as compared to 39 for subjects treated with on-demand therapy [see clinical studies (14)] . the safety and efficacy of feiba has not been evaluated in neonates. the safety and efficacy of feiba has not been evaluated in subjects ≥65 years of age.