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

takeda pharmaceuticals australia pty ltd - protein c, quantity: 1000 iu - injection, intravenous infusion - excipient ingredients: water for injections - ceprotin is indicated in purpura fulminas and coumarin induced skin necrosis in patients with severe congenital protein c deficiency. since safety and efficacy data are not available in conditions other than severe congenital deficiency, use should be limited to these conditions.

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

takeda pharmaceuticals australia pty ltd - protein c, quantity: 500 iu - injection, diluent for - excipient ingredients: water for injections - ceprotin is indicated in purpura fulminas and coumarin induced skin necrosis in patients with severe congenital protein c deficiency. since safety and efficacy data are not available in conditions other than severe congenital deficiency, use should be limited to these conditions.

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

takeda pharmaceuticals america, inc. - protein c (unii: 3z6s89txpw) (protein c - unii:3z6s89txpw) - protein c 500 [iu] in 5 ml - ceprotin, protein c concentrate (human), is an anticoagulant indicated for neonates, pediatric and adult patients with severe congenital protein c deficiency for the prevention and treatment of venous thrombosis and purpura fulminans. none. risk summary there are no data with ceprotin use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with ceprotin. it is also not known whether ceprotin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ceprotin has not been studied for use during labor and delivery. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively, regardless of drug exposure. risk summary there is no information regarding the presence of ceprotin in human milk, the effect on the breastfed infant, or the effects on milk production. ceprotin has not been studied for use in nursing mothers

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.

Malta - English - Medicines Authority

sanquin plesmanlaan 125, 1066 cx amsterdam, netherlands - human plasma, protein - solution for infusion - human plasma protein 40 g/l - blood substitutes and perfusion solutions

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

sanofi pasteur inc. - tuberculin purified protein derivative (unii: i7l8fkn87j) (tuberculin purified protein derivative - unii:i7l8fkn87j) - tuberculin purified protein derivative 5 [iu] in 0.1 ml - tubersol tuberculin purified protein derivative (mantoux), is indicated to aid diagnosis of tuberculosis infection (tb) in persons at increased risk of developing active disease. the centers for disease control and prevention (cdc) have published guidelines regarding populations that would benefit from tuberculin skin testing (tst). current recommendations can be accessed at: http://www.cdc.gov/tb/publications/factsheets/testing.htm. previous bcg vaccination is not a contraindication to tuberculin testing. the skin-test results of bcg vaccinated persons can be used to support or exclude the diagnosis of tb infection. however, an fda-approved interferon gamma release assay is preferred over tuberculin skin test for persons 5 years of age and older who were previously vaccinated with bcg. (8) allergy to any component of tubersol or an anaphylactic or other allergic reaction to a previous test of tuberculin ppd is a contraindication to the use of tubersol. (see description and how supplied.) tubersol should not be administered to: - persons who have had a severe reaction (e.g., necrosis, blistering, anaphylactic shock, or ulcerations) to a previous tst, - persons with documented active tuberculosis or a clear history of treatment for tb infection or disease, (9) - persons with extensive burns or eczema.

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

physicians total care, inc. - tuberculin purified protein derivative (unii: i7l8fkn87j) (tuberculin purified protein derivative - unii:i7l8fkn87j) - tuberculin purified protein derivative 5 [iu] in 0.1 ml - tubersol, tuberculin purified protein derivative (mantoux), is indicated to aid diagnosis of tuberculosis infection (tb) in persons at increased risk of developing active disease. the centers for disease control and prevention (cdc) have published guidelines regarding populations that would benefit from tuberculin skin testing (tst). current recommendations can be accessed at: http://www.cdc.gov/tb/publications/factsheets/testing.htm. previous bcg vaccination is not a contraindication to tuberculin testing. the skin-test results of bcg vaccinated persons can be used to support or exclude the diagnosis of tb infection. however, an fda-approved interferon gamma release assay is preferred over tuberculin skin test for persons 5 years of age and older who were previously vaccinated with bcg. (9) allergy to any component of tubersol or an anaphylactic or other allergic reaction to a previous test of tuberculin ppd is a contraindication to the use of tubersol. (see description and how supplied) tubersol should not

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

baxalta us inc - protein c (unii: 3z6s89txpw) (protein c - unii:3z6s89txpw) - protein c 100 [iu] in 1 ml