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

ethicon inc - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 85 mg in 1 ml - 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)

ethicon inc - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 85 mg in 1 ml - 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

Israel - English - Ministry of Health

csl behring ltd., israel - human fibrinogen - powder for solution for inj/inf - human fibrinogen 1800 - 2600 mg / 1 vials - fibrinogen, human - fibrinogen, human - haemocomplettan p 1g/2g, fibrinogen concentrate (human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.haemocomplettan p 1g/2g is not indicated for dysfibrinogenemia.

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

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)

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).

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.

United States - English - 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

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

baxalta us inc. - 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 indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age. artiss is not indicated for hemostasis. do not inject artiss directly into blood vessels. intravascular application of artiss may result in life-threatening thromboembolic events. do not use artiss in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substances or excipients (see warnings/precautions, hypersensitivity/allergic/anaphylactic reactions (5.1) and adverse reactions, overall adverse reactions (6.1)). pregnancy category c animal reproduction studies have not been conducted with artiss. 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 (f

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

baxalta us inc. - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 90 mg in 1 ml - artiss is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age. artiss is indicated to adhere tissue flaps during facial rhytidectomy surgery (face-lift). artiss is not indicated as an adjunct to hemostasis. do not inject artiss directly into blood vessels. intravascular application of artiss may result in life-threatening thromboembolic events. do not use artiss in individuals with a known hypersensitivity to aprotinin and/or hypersensitivity to any of the active substances or excipients (see warnings/precautions, hypersensitivity/allergic/anaphylactic reactions (5.1) and adverse reactions (6)). pregnancy category c animal reproduction studies have not been conducted with artiss. 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 inact