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

csl behring gmbh - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 1300 mg in 50 ml - riastap® , fibrinogen concentrate (human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. limitation of use riastap is not indicated for dysfibrinogenemia. riastap is contraindicated in patients with known anaphylactic or severe systemic reactions to human plasma-derived products. risk summary there are no studies of riastap use in pregnant women. animal reproduction studies have not been conducted with riastap. it is not known whether riastap 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 defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of riastap in human milk, its effects on the breastfed infant, or its effects on mi

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.

Israel - English - Ministry of Health

csl behring ltd., israel - human fibrinogen - powder for solution for inj/inf - human fibrinogen 900 - 1300 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.

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

octapharma usa inc - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibryga is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in adults and children with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. fibryga is not indicated for dysfibrinogenemia. fibryga is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis, to fibryga or its components (sodium citrate dihydrate; glycine; l-arginine hydrochloride). risk summary there are no data with fibryga use in pregnant women to determine whether there is a drug-associated risk. animal reproduction studies have not been conducted with fibryga. it is not known whether fibryga can cause fetal harm when administered to a pregnant woman or can affect fertility. 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 is no information regarding the presence of fibryga

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

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 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

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

csl behring australia pty ltd - fibrinogen, quantity: 900 mg - injection, powder for - excipient ingredients: sodium citrate; albumin; arginine hydrochloride; sodium chloride - treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia.

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