VeraSeal European Union - English - EMA (European Medicines Agency)

veraseal

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

TachoSil European Union - English - EMA (European Medicines Agency)

tachosil

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).

MONOFIX-VF human coagulation factor IX 1000IU powder for injection vial and 10 mL diluent vial Australia - English - Department of Health (Therapeutic Goods Administration)

monofix-vf human coagulation factor ix 1000iu powder for injection vial and 10 ml diluent vial

csl behring australia pty ltd - factor ix, quantity: 1000 iu - injection, powder for - excipient ingredients: phosphate; plasma proteins; antithrombin iii; heparin sodium; sodium; citrate; chloride - monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

MONOFIX-VF human coagulation factor IX 500IU powder for injection vial and 5mL diluent vial Australia - English - Department of Health (Therapeutic Goods Administration)

monofix-vf human coagulation factor ix 500iu powder for injection vial and 5ml diluent vial

csl behring australia pty ltd - factor ix, quantity: 500 iu - injection, powder for - excipient ingredients: citrate; heparin sodium; antithrombin iii; sodium; chloride; plasma proteins; phosphate - monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

TISSEEL VH S/D fibrin sealant syringe Australia - English - Department of Health (Therapeutic Goods Administration)

tisseel vh s/d fibrin sealant syringe

baxter healthcare pty ltd - calcium chloride dihydrate, quantity: 36 micromole/ml; human thrombin, quantity: 400 iu/ml - solution - excipient ingredients: albumin; sodium chloride; water for injections - tissel is indicated: - as adjunct to haemostasis during surgical procedures, when control of bleeding by conventional surgical techniques is ineffective or impractical; and - as a sealant as an adjunct for closure of colostomies. - as a sealant and/or adhesive for use in autologous chrondrocyte implantation (aci) or matrix-induced autologous chondrocyte implantation (maci) procedures. - for mesh fixation in non-iatrogenic abdominal wall hernia repair, as an alternative to sutures, staples or tacks.

TRETTEN (coagulation factor xiii a-subunit- recombinant kit United States - English - NLM (National Library of Medicine)

tretten (coagulation factor xiii a-subunit- recombinant kit

novo nordisk - catridecacog (unii: nu23q531g1) (catridecacog - unii:nu23q531g1) - factor xiii concentrate (human) 2500 [iu] in 3 ml - tretten, coagulation factor xiii a-subunit (recombinant), is indicated for routine prophylaxis for bleeding in patients with congenital factor xiii a-subunit deficiency. tretten is not for use in patients with congenital factor xiii b‑subunit deficiency tretten is contraindicated in patients who have known hypersensitivity to the active substance or to any of the excipients [see description (11)]. risk summary there are no adequate and well-controlled studies using tretten in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with tretten. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. miscarriage is a known complication of congenital fxiii deficiency. pooling data from 39 publications, the miscarriage rate was 66% in 63 patients with 192 pregnancies (70% in 179 pregnancies in fxiii a-subunit deficiency women). miscar

EVITHROM- human thrombin liquid United States - English - NLM (National Library of Medicine)

evithrom- human thrombin liquid

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

VeraSeal solutions for sealant 2 mL (Human fibrinogen 80 mg/mL syringe 1 mL / Human thrombin 500 IU/mL syringe 1 mL) Australia - English - Department of Health (Therapeutic Goods Administration)

veraseal solutions for sealant 2 ml (human fibrinogen 80 mg/ml syringe 1 ml / human thrombin 500 iu/ml syringe 1 ml)

grifols australia pty ltd - human thrombin, quantity: 500 iu/ml - application - excipient ingredients: - veraseal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.

VeraSeal solutions for sealant 10 mL (Human fibrinogen 80 mg/mL syringe 5 ml / Human thrombin 500 IU/mL syringe 5 ml) Australia - English - Department of Health (Therapeutic Goods Administration)

veraseal solutions for sealant 10 ml (human fibrinogen 80 mg/ml syringe 5 ml / human thrombin 500 iu/ml syringe 5 ml)

grifols australia pty ltd - human thrombin, quantity: 500 iu/ml - application - excipient ingredients: - veraseal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.

VeraSeal solutions for sealant 4 mL (Human fibrinogen 80 mg/mL syringe 2 ml / Human thrombin 500 IU/mL syringe 2 ml) Australia - English - Department of Health (Therapeutic Goods Administration)

veraseal solutions for sealant 4 ml (human fibrinogen 80 mg/ml syringe 2 ml / human thrombin 500 iu/ml syringe 2 ml)

grifols australia pty ltd - human thrombin, quantity: 500 iu/ml - application - excipient ingredients: - veraseal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.