United States - English - 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

United States - English - 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

European Union - English - 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

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

ksj pharmatech - human thrombin, quantity: 2 iu/cm2; fibrinogen, quantity: 5.5 mg/cm2 - sponge, medicated - excipient ingredients: sodium chloride; riboflavin; collagen; sodium citrate dihydrate; arginine hydrochloride; albumin - ? tachosil? is indicated as an adjunct to haemostasis during surgery when control of bleeding by standard surgical techniques is ineffective or impractical.

United States - English - 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

United States - English - 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

European Union - English - 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.

European Union - English - 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

European Union - English - 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).

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

pfizer laboratories div pfizer inc - thrombin (unii: 25ade2236l) (thrombin - unii:25ade2236l) - thrombin 5000 [iu] in 5 ml - thrombin-jmi is topical bovine thrombin indicated to aid 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. in various types of surgeries, solutions of thrombin-jmi may be used in conjunction with an absorbable gelatin sponge, usp for hemostasis.       risk summary animal reproduction studies have not been conducted with thrombin-jmi. it is also not known whether thrombin-jmi can cause fetal harm when administered to a pregnant woman. thrombin-jmi should be given to a pregnant woman only if clearly needed. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4