Canada - engelsk - Health Canada

baxter ag - antithrombin iii (human); water - powder for solution - 1650unit; 30ml - antithrombin iii (human) 1650unit; water 30ml - direct thrombin inhibitors

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

vantive pty ltd - icodextrin, quantity: 75 g/l; sodium chloride, quantity: 5.4 g/l; sodium lactate, quantity: 4.5 g/l; calcium chloride dihydrate, quantity: 257 mg/l; magnesium chloride hexahydrate, quantity: 51 mg/l - solution, dialysis - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - indicated as "an alternative osmotic agent in dialysis solution for the long dwell exchange in patients treated with peritoneal dialysis."

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

vantive pty ltd - icodextrin, quantity: 75 g/l; sodium chloride, quantity: 5.4 g/l; sodium lactate, quantity: 4.5 g/l; calcium chloride dihydrate, quantity: 257 mg/l; magnesium chloride hexahydrate, quantity: 51 mg/l - solution, dialysis - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - indicated as "an alternative osmotic agent in dialysis solution for the long dwell exchange in patients treated with peritoneal dialysis."

Malta - engelsk - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - antithrombin iii - powder and solvent for solution for infusion or injection - antithrombin iii 50 iu - antithrombotic agents

Malta - engelsk - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - antithrombin iii - powder and solvent for solution for infusion or injection - antithrombin iii 50 iu/ml - antithrombotic agents

Singapore - engelsk - HSA (Health Sciences Authority)

baxter healthcare (asia) pte ltd - aprotinin (synthetic) (for sealer protein solution); calcium chloride (for thrombin solution); fibrinogen (clottable protein) (for sealer protein solution); thrombin (for thrombin solution) - solution - aprotinin (synthetic) (for sealer protein solution) 2250-3750 kiu/ml; calcium chloride (for thrombin solution) 36-44 umol/ml; fibrinogen (clottable protein) (for sealer protein solution) 72-110 mg/ml; thrombin (for thrombin solution) 400-625 iu/ml

USA - engelsk - NLM (National Library of Medicine)

baxalta us inc. - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 90 mg in 1 ml - artiss is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age. artiss is indicated to adhere tissue flaps during facial rhytidectomy surgery (face-lift). artiss is not indicated as an adjunct to hemostasis. do not inject artiss directly into blood vessels. intravascular application of artiss may result in life-threatening thromboembolic events. do not use artiss in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substances or excipients (see warnings/precautions, hypersensitivity/allergic/anaphylactic reactions (5.1) and adverse reactions (6)). pregnancy category c animal reproduction studies have not been conducted with artiss. it is also not known whether artiss can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. some viruses, such as parvovirus b19, are particularly difficult to remove or inact

USA - engelsk - NLM (National Library of Medicine)

baxalta us inc. - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 90 mg in 1 ml - artiss is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age. artiss is not indicated for hemostasis. do not inject artiss directly into blood vessels. intravascular application of artiss may result in life-threatening thromboembolic events. do not use artiss in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substances or excipients (see warnings/precautions, hypersensitivity/allergic/anaphylactic reactions (5.1) and adverse reactions, overall adverse reactions (6.1)). pregnancy category c animal reproduction studies have not been conducted with artiss. it is also not known whether artiss can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. some viruses, such as parvovirus b19, are particularly difficult to remove or inactivate at this time. parvovirus b19 most seriously affects pregnant women (f

USA - engelsk - NLM (National Library of Medicine)

ethicon, inc - human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g) - human thrombin 2000 [iu] in 2 ml - evithrom® thrombin, topical (human), is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. evithrom® thrombin, topical (human), may be used in conjunction with an absorbable gelatin sponge, usp. - do not use in individuals known to have an anaphylactic or severe systemic reaction to evithrom® or to human blood products. - do not use for the treatment of severe or brisk arterial bleeding. risk summary there are no data with evithrom® use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with evithrom® . it is not known whether evithrom® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. evithrom® should be given to a pregnant woman only if clearly needed. in the u.s. general population, the estimated background

Israel - engelsk - Ministry of Health

baxter healthcare distribution ltd., israel - calcium chloride dihydrate; glucose monohydrate (as anhydrous); lactic acid as sodium; magnesium chloride hexahydrate; sodium bicarbonate; sodium chloride - solution for peritoneal dialysis - sodium chloride 5.38 g/l; magnesium chloride hexahydrate 0.051 g/l; calcium chloride dihydrate 0.184 g/l; sodium bicarbonate 2.10 g/l; glucose monohydrate (as anhydrous) 38.6 g/l; lactic acid as sodium 1.68 g/l - calcium chloride - calcium chloride - physioneal is indicated whenever peritoneal dialysis is employed including:acute and chronic renal failure; severe water retention; severe electrolyte imbalance; drug intoxication with dialysable substances when a more adequate therapeutic alternative is not available. bicarbonate/lactate based physioneal peritoneal dialysis solutions with a physiological ph are particularly indicated in patients in whom solutions based on lactate buffer only with a low ph cause abdominal inflow pain or discomfort.