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)

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

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.

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

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

csl behring 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 - zemaira is an alpha1 -proteinase inhibitor (a1 -pi) indicated for chronic augmentation and maintenance therapy in adults with a1 -pi deficiency and clinical evidence of emphysema. zemaira increases antigenic and functional (anti-neutrophil elastase capacity [anec]) serum levels and lung epithelial lining fluid (elf) levels of a1 -pi. clinical data demonstrating the long-term effects of chronic augmentation therapy of individuals with zemaira are not available. the effect of augmentation therapy with zemaira or any a1 -pi product on pulmonary exacerbations and on the progression of emphysema in a1 -pi deficiency has not been demonstrated in randomized, controlled clinical studies. zemaira is not indicated as therapy for lung disease patients in whom severe a1 -pi deficiency has not been established. - zemaira is contraindicated in patients with a history of anaphylaxis or severe systemic reactions to zemaira or a1 -pi protein. - zemaira is contraindicated in immunoglobulin a (iga)-deficient patients with antibodies against iga, due to the risk of severe hypersensitivity [see warnings and precautions (5.2)] . risk summary no animal reproduction studies have been conducted with zemaira and its safety for use in human pregnancy has not been established in controlled clinical trials. since alpha1 -proteinase inhibitor is an endogenous human protein, it is considered unlikely that zemaira will cause harm to the fetus when given at recommended doses. however, zemaira should be given with caution to pregnant women. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the excretion of zemaira in human milk, the effect on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zemaira and any potential adverse effects on the breastfed infant from zemaira or from the underlying maternal condition. safety and effectiveness in the pediatric population have not been established. the safety and efficacy of zemaira in the geriatric population have not been established due to an insufficient number of subjects.

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 1 g in 50 ml - glassia is an alpha1 -proteinase inhibitor (human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of alpha1 -pi, also known as alpha1 -antitrypsin (aat) deficiency. limitations of use : - the effect of augmentation therapy with glassia or any alpha1 -pi product 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 and maintenance therapy of individuals with glassia are not available. - glassia is not indicated as therapy for lung disease in patients in whom severe alpha1 -pi deficiency has not been established. glassia is contraindicated in: - immunoglobulin a (iga) deficient patients with antibodies against iga. - individuals with a history of anaphylaxis or other severe systemic reaction to alpha1 -pi products. risk summar

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

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 1000 mg - solution - excipient ingredients: monobasic sodium phosphate; alanine; water for injections - prolastin? c liquid is an alpha-1-proteinase inhibitor indicated to increase serum alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha-1-antitrypsin and with clinically significant emphysema (fev1 <80%).,the data for clinical efficacy of prolastin? c liquid 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)

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 4000 mg - liquid, multipurpose - excipient ingredients: monobasic sodium phosphate monohydrate; alanine; water for injections - prolastin? c liquid is an alpha-1-proteinase inhibitor indicated to increase serum alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha-1- antitrypsin and with clinically significant emphysema (fev1 <80%).,the data for clinical efficacy of prolastin? c liquid 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)

grifols australia pty ltd - alpha-1-proteinase inhibitor, quantity: 500 mg - liquid, multipurpose - excipient ingredients: monobasic sodium phosphate monohydrate; alanine; water for injections - prolastin? c liquid is an alpha-1-proteinase inhibitor indicated to increase serum alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha-1- antitrypsin and with clinically significant emphysema (fev1 <80%).,the data for clinical efficacy of prolastin? c liquid 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.

Canada - English - Health Canada

grifols therapeutics llc - alpha1-proteinase inhibitor (human) - powder for solution - 500mg - alpha1-proteinase inhibitor (human) 500mg - enzymes