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

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

Malta - English - Medicines Authority

octapharma (ip) limited - human von willebrand factor; human coagulation factor viii - powder and solvent for solution for injection - human von willebrand factor 500 iu; human coagulation factor viii 500 iu - antihemorrhagics

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxter sa-nv - human fibrinogen humain 72 mg/ml - 110 mg/ml (component 1); factor xiii 0,6 iu/ml - 10 iu/ml (component 1); aprotinin (component 1); human thrombin 500 iu/ml (component 2); calcium chloride dihydrate - eq. calcium chloride quantum satis (component 2) - solution for sealant - 2 ml - factor xiii; aprotinin; human thrombin 500 iu/ml; calcium chloride dihydrate; human fibrinogen - combinations

Malta - English - Medicines Authority

octapharma (ip) sprl alle de la recherche 65, 1070 (anderlecht), belgium - human von, willebrand factor, human coagulation, factor viii - powder and solvent for solution for injection - human von willebrand factor 500 iu human coagulation factor viii 500 iu - antihemorrhagics

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

Israel - English - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 250 iu - coagulation factor viii - coagulation factor viii - is indicated for the prevention and control of bleeding in patients with moderate or severe factor viii deficiency due to classical hemophilia a .fanhdi is not effective in controlling the bleeding of patients with von willebrond's disease.

Israel - English - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 500 iu - coagulation factor viii - coagulation factor viii - is indicated for the prevention and control of bleeding in patients with moderate or severe factor viii deficiency due to classical hemophilia a . fanhdi is not effective in controlling the bleeding of patients with von willebrond's disease.

Israel - English - Ministry of Health

medici medical ltd, israel - factor viii (human) - powder for solution for injection - factor viii (human) 1000 iu - coagulation factor viii - coagulation factor viii - is indicated for the prevention and control of bleeding in patients with moderate or severe factor viii deficiency due to classical hemophilia a . fanhdi is not effective in controlling the bleeding of patients with von willebrond's disease.

Israel - English - Ministry of Health

csl behring ltd., israel - factor viii (human); von willebrand factor - powder and solvent for solution for injection/infusion - factor viii (human) 500 iu / 10 ml; von willebrand factor 1200 iu / 10 ml - coagulation factor xiii - coagulation factor xiii - congenital and acquired deficiency of blood clotting factor viii: severe or moderate haemophilia, prophylaxis during operation, von willebrands disease.