União Europeia - inglês - EMA (European Medicines Agency)

instituto grifols, s.a. - human fibrinogen, human thrombin - hemostasis, surgical - antihemorrhagics - supportive treatment in adults where standard surgical techniques are insufficient:for improvement of haemostasisas suture support in vascular surgery

União Europeia - inglês - EMA (European Medicines Agency)

mallinckrodt pharmaceuticals ireland limited - human fibrinogen, human thrombin - hemostasis, surgical - antihemorrhagics - supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis.raplixa must be used in combination with an approved gelatin sponge.raplixa is indicated in adults over 18 years of age.

União Europeia - inglês - EMA (European Medicines Agency)

corza medical gmbh - human fibrinogen, human thrombin - hemostasis, surgical - antihemorrhagics - tachosil is indicated in adults and children from 1 month of age for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. tachosil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.1).

União Europeia - inglês - myHealthbox

takeda austria gmbh - human fibrinogen / human thrombin - sealant matrix - 5.5 mg human fibrinogen and 2.0 iu human thrombin per cm² - hemostasis, surgical - local haemostatics - indicated in adults for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, and for suture support in vascular surgery where standard techniques are insufficient

Estados Unidos - inglês - NLM (National Library of Medicine)

baxalta us inc. - human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g), fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - human thrombin 2.0 [usp'u] - tachosil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. limitations for use do not use tachosil for: pregnancy category c animal reproduction studies have not been conducted with tachosil. there are no adequate and well-controlled studies in pregnant women. it is also not known whether tachosil can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. tachosil should be administered to pregnant women only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when tachosil is administered to nursing mothers. the use of tachosil has been studied in patients aged one month to 16 years; use in children under the age of one month may be

Estados Unidos - inglês - NLM (National Library of Medicine)

baxter healthcare corporation - human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g), fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - human thrombin 2.0 [usp'u] - tachosil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. limitations for use do not use tachosil for: risk summary a review of available data suggests that major birth defects occur in 2-4% of the u.s. general population and that miscarriage occurs in 15-20% of clinically recognized pregnancies, regardless of drug exposure. animal reproduction studies have not been conducted with tachosil. there are no adequate and well-controlled studies in pregnant women. it is also not known whether tachosil can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. tachosil should be administered to pregnant women only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, ca

Estados Unidos - inglês - NLM (National Library of Medicine)

grifols usa, llc - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - vistaseal is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. vistaseal is effective in heparinized patients. - do not inject directly into the circulatory system. [see warnings and precautions (5.1)] - do not use for the treatment of severe or brisk arterial bleeding. in these situations, blood flow will wash away vistaseal and prevent hemostasis. - do not use vistaseal in patients known to have anaphylactic or severe systemic hypersensitivity reactions to the administration of human blood products. [see warnings and precautions (5.2)] - do not use vistaseal for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved. [see dosage and administration (2.3)] risk summary there are no available data with vistaseal use in pregnant women. animal reproduction studies have not been perfo

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - human thrombin, quantity: 800 iu - solution - excipient ingredients: water for injections; mannitol; sodium acetate; albumin; calcium chloride dihydrate; tributyl phosphate; octoxinol 9 - as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. as suture support for haemostasis in large vessel vascular surgery. for suture line sealing in dura mater closure.

Estados Unidos - inglês - NLM (National Library of Medicine)

baxter healthcare corporation - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 90 mg in 1 ml

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - human thrombin, quantity: 4000 iu - solution - excipient ingredients: mannitol; calcium chloride dihydrate; water for injections; sodium acetate; albumin; tributyl phosphate; octoxinol 9 - ? as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. ? as suture support for haemostasis in large vessel vascular surgery. ? for suture line sealing in dura mater closure.