Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd - human thrombin, quantity: 1600 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.

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human fibrinogen; human factor xiii; aprotinin; human thrombin; calcium chloride - powder and solvent for sealant - . - local hemostatics; tissue adhesives

Estats Units - anglès - NLM (National Library of Medicine)

ethicon, inc. - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k), human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g) - fibrinogen human 8.6 mg in 1 cm2 - evarrest® is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. limitations for use: - cannot safely or effectively be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding. - not for use in children under one month of age - laparoscopic and other minimally invasive surgeries where manual compression would be difficult to achieve. do not use evarrest® for - bleeding from large defects in visible arteries or veins where the injured vascular wall requires conventional surgical repair and maintenance of vessel patency or where there would be persistent exposure of evarrest to blood flow and/or pressure during absorption of the product. - intravascular application. this can result in life-threatening thromboembolic events. - individuals know

Unió Europea - anglès - EMA (European Medicines Agency)

omrix biopharmaceuticals n. v. - human fibrinogen, human thrombin - hemostasis - local hemostatics - supportive treatment in adult surgery where standard surgical techniques are insufficient (see section 5.1):- for improvement of haemostasis.

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - human fibrinogen; human factor xiii; aprotinin; human thrombin; calcium chloride - powder and solvent for sealant - . - local hemostatics; tissue adhesives

Malta - anglès - Malta Medicines Authority

baxter healthcare limited - calcium chloride; aprotinin; fibrinogen, human; thrombin, human - solution for sealant - calcium chloride 40 µmole/ml; aprotinin 3000 kiu/ml; fibrinogen, human 91 mg/ml; thrombin, human 500 iu/mg - antihemorrhagics

Estats Units - anglès - NLM (National Library of Medicine)

ethicon inc - human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g) - human thrombin 1000 [iu] in 1 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 anaphylactic or severe systemic reaction to human blood products. - do not use for the treatment of severe or brisk arterial bleeding. risk summary there are no clinical 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. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4

Estats Units - anglès - NLM (National Library of Medicine)

baxalta us inc. - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 90 mg in 1 ml - tisseel is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. tisseel is effective in heparinized patients. tisseel is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies. do not inject tisseel directly into the circulatory system or into highly vascularized tissue. intravascular application of tisseel can lead to intravascular coagulation, can result in life-threatening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients (see warnings and precautions(5.3) and adverse reactions (6.2)).   do not use tisseel in individuals with a known hypersensitivity to aprotinin  (see warnings and pre

Estats Units - anglès - NLM (National Library of Medicine)

baxalta us inc. - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 90 mg in 1 ml - tisseel is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. tisseel is effective in heparinized patients. tisseel is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies. do not inject tisseel directly into the circulatory system or into highly vascularized tissue. intravascular application of tisseel can lead to intravascular coagulation, can result in life-threatening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients (see warnings and precautions(5.3) and adverse reactions (6.2)).   do not use tisseel in individuals with a known hypersensitivity to aprotinin  (see warnings and pre

Unió Europea - anglès - EMA (European Medicines Agency)

omrix biopharmaceuticals n. v. - human fibrinogen, human thrombin - hemostasis, surgical - antihemorrhagics - evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis.evicel is also indicated as suture support for haemostasis in vascular surgery.