Australia - English - 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.

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.

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

takeda pharmaceuticals australia pty ltd - c1 esterase inhibitor, quantity: 500 u - injection, solution - excipient ingredients: water for injections - treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with c1 inhibitor deficiency. routine prevention of angioedema attacks in adults and adolescents with frequent attacks of hereditary angioedema (hae), who are intolerant to or insufficiently protected by oral therapy.

United States - English - 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

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

csl behring gmbh - human c1-esterase inhibitor (unii: 6kic4bb60g) (human c1-esterase inhibitor - unii:6kic4bb60g) - human c1-esterase inhibitor 2000 [iu] in 4 ml - haegarda is a plasma-derived concentrate of c1 esterase inhibitor (human) (c1-inh) indicated for routine prophylaxis to prevent hereditary angioedema (hae) attacks in patients 6 years of age and older. haegarda is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to c1-inh preparations or its excipients [see description (11)]. risk summary there are no prospective clinical data from haegarda use in pregnant women. c1-inh is a normal component of human plasma. animal developmental or reproduction toxicity studies have not been conducted with haegarda. in the u.s. general population, the estimated background risk of major birth defects occurs in 2-4% of the general population and miscarriage occurs in 15-20% of clinically recognized pregnancies. data in a retrospective case collection study, 22 pregnant women with type i hae and ranging in age from 20 to 38 years received c1-inh doses of 500 or 1000 iu per i.v. administration for the treatmen

United States - English - 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

United States - English - 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

United States - English - 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 liquid 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). limitations of use - the effect of augmentation therapy with any alpha1 -pi, including prolastin-c liquid, 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 liquid are not available. - prolastin-c liquid is not indicated as therapy for lung disease in patients in whom severe alpha1 -pi deficiency has not been established. prolastin-c liquid is contraindicated in: - iga deficient patients with antibodies against iga, due to the risk of severe hypersensitivity. - patients with a history of anaphylaxis or other sever