Israel - English - Ministry of Health

cts ltd - human fibrinogen; thrombin - sealant matrix - thrombin 2 iu/cm2; human fibrinogen 5.5 mg/cm2 - human fibrinogen - human fibrinogen - tachosil is indicated for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for sutute support in vascular surgery where standard techniques are insufficient.

European Union - English - EMA (European Medicines Agency)

csl behring gmbh - human coagulation factor viii, human von willebrand factor - hemophilia a; von willebrand diseases - blood coagulation factors, von willebrand factor and coagulation factor viii in combination, antihemorrhagics - von willebrand disease (vwd)prophylaxis and treatment of haemorrhage or surgical bleeding in patients with vwd, when desmopressin (ddavp) treatment alone is ineffective or contraindicated.haemophilia a (congenital factor-viii deficiency)prophylaxis and treatment of bleeding in patients with haemophilia a.

European Union - English - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - antithrombin alfa - antithrombin iii deficiency - antithrombotic agents - atryn is indicated for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. atryn is normally given in association with heparin or low molecular weight heparin.

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

csl behring australia pty ltd - water for injections, quantity: 40 ml - injection, solution - excipient ingredients: - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

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

csl behring australia pty ltd - water for injections, quantity: 20 ml - injection, solution - excipient ingredients: - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

Malta - English - Medicines Authority

baxter healthcare limited - antithrombin iii 50 iu/ml - powder and solvent for solution for infusion or injection

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

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.

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

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

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

ethicon inc - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - evicel® fibrin sealant (human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. do not use evicel®: - directly into the circulatory system. intravascular application of evicel® may result in life-threatening thromboembolic events [see warnings and precautions, (5.1) and adverse reactions, (6.2)]. - in individuals known to have anaphylactic or severe systemic reaction to human blood products [see adverse reactions (6.2)]. - for brisk arterial bleeding. - for spraying in endoscopic or laparoscopic procedures in those instances where the minimum recommended distance from the applicator tip to the target site cannot be ensured. [see dosage and administration (2.3)]. risk summary there are no data with evicel® use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with evicel® . it is not known whether

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

baxter healthcare corporation - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k), human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g) - fibrinogen human 90 mg in 1 ml - artiss is a fibrin sealant indicated to: artiss is not indicated as an adjunct to hemostasis. do not inject directly into the circulatory system or into highly vascularized tissue. intravascular application can result in life-threatening thromboembolic events and can increase the likelihood and severity of acute hypersensitivity reaction in susceptible patients. do not use in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substances or excipients of artiss including proteins such as fibrinogen, thrombin, and human albumin [see warnings and precautions (5.1) and adverse reactions (6) ]. do not spray where the minimum recommended distance from the applicator tip to the target site cannot be assured. risk summary there are no available data on artiss use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. animal reproduction studies have not been conducted. it is also not known whether artiss can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. some viruses, such as parvovirus b19, are particularly difficult to remove or inactivate at this time. parvovirus b19 most seriously affects pregnant women (fetal infection). the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background 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 2-4% and 15-20%, respectively. risk summary there are no direct or controlled studies of artiss in lactating women. it is not known whether this drug is excreted in human milk, there is no information regarding the effects on the breastfed infant, and the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for artiss and any potential adverse effects on the breastfed child from artiss or from underlying maternal condition. in two clinical trials utilizing artiss to adhere autologous skin grafts to surgically prepared wound beds resulting from burns, the efficacy and safety in 38 pediatric subjects (27 subjects ages 1-10 years and 11 subjects ages 11-16 years) were not different from an adult population. thirteen subjects aged 65 and older (65-71 years of age) have been treated with artiss in facial rhytidectomy clinical trials. separate evaluations of these subjects were not performed. no specific clinical data have been generated for the geriatric population.