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.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

cheminova australia pty limited - metsulfuron-methyl - water dispersible granule - metsulfuron-methyl urea-sulfonyl active 600.0 g/kg - herbicide - barley - fallow/pre-plant | barley - post crop & weed emergence | cereal rye - fallow/pre-plant | cereal rye - post crop & weed - african turnip weed | alligator weed | amsinckia,yellow burrweed or burr grass | annual clovers | apple box | australian or native blackthorn | ball mustard | bellyache bush | bitou bush or boneseed | black bindweed | blackberry - rubus spp. | blakely's red gum or gum | bracken | bridal creeper | broadleaf dock | calomba daisy | cape tulip | capeweed | charlock | chickweed | chicory | climbing buckwheat - seedling | crofton weed | cutleaf mignonette | darling pea | deadnettle | denseflower fumitory | dock | dwarf amaranth or boggabri weed | erodium, crowfoot or storksbill | fennel | furze or gorse | golden dodder - cuscuta australis | great mullein | hare's-ear or treacle mustard | harrisia cactus | hawthorn | indian hedge mustard | inkweed | japanese sunflower | kangaroo thorn | lantana - lantana camara | lincoln weed, sand rocket or mustard | mallee catchfly | medic | messmate stringybark | mimosa pigra | mistflower or creeping crofton weed | narrowleaf peppermint | new zealand spinach | noogoora burr | oni

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.

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

recordati rare diseases, inc. - hemin (unii: 743lrp9s7n) (hemin - unii:743lrp9s7n) - hemin 7 mg in 1 ml - panhematin (hemin for injection) is indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women. manifestations such as pain, hypertension, tachycardia, abnormal mental status and mild to progressive neurologic signs may be controlled in selected patients with this disorder. similar findings have been reported in other patients with acute intermittent porphyria, porphyria variegata and hereditary coproporphyria. panhematin is not indicated in porphyria cutanea tarda. panhematin is contraindicated in patients with known hypersensitivity to this drug.

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

recordati rare diseases, inc. - hemin (unii: 743lrp9s7n) (hemin - unii:743lrp9s7n) - hemin 7 mg in 1 ml - panhematin is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be inadequate. limitations of use - before administering panhematin, consider an appropriate period of carbohydrate loading (i.e., 400 g glucose/day for 1 to 2 days) [see dosage and administration ( 2.1)] . - attacks of porphyria may progress to a point where irreversible neuronal damage has occurred. panhematin therapy is intended to prevent an attack from reaching the critical stage of neuronal degeneration. panhematin is not effective in repairing neuronal damage. panhematin is contraindicated in patients with known hypersensitivity to this drug. risk summary about 50% of the women with acute intermittent porphyria experience an acute attack of porphyria in pregnancy and/or the puerperium. it is most severe in early pregnancy and the puerperium, and can result in fatal outcome. although anecdotal evidence suggests safe use of hematin during pregnancy, the available human data is not sufficient to establish the presence or absence of drug-associated risk. animal reproduction studies have not been conducted with hematin. it is also not known whether hematin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. panhematin should be given to a pregnant woman only if clearly needed. avoid administering hematin in severe pre-eclampsia because of a theoretical risk of potentiation of the coagulation disorder [see warnings and precautions ( 5.3)] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for panhematin and any potential adverse effects on the breastfed child from panhematin or from the underlying maternal condition. safety and effectiveness in pediatric patients under 16 years of age have not been established. clinical data for subjects aged 65 and over was not sufficient to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in response between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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