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

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

corza medical gmbh - human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g), fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - 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)

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.

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 90 [iu] in 1 ml - tisseel is a fibrin sealant indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of blunt or penetrating splenic injuries when control of bleeding by conventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical. tisseel is a hemostatic agent that may be used in fully heparinized patients undergoing cardiopulmonary bypass. tisseel is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies. do not inject tisseel directly into the circulatory system or into highly vascularized tissue. intravascular application of tisseel can lead to intravascular coagulation, may result in life-threatening thromboembolic events, and may increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients (see warnings and precautions, use in cardiopulmonary surgery (5.3

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

Kenya - English - Pharmacy and Poisons Board

human bioplazma llc h-2100 godollo transics milhaly ut 80hungary - human albumin - solution for infusion - 20%human albumin - blood substitutes and plasma protein fractions

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

ethicon, inc - human thrombin (unii: 6k15abl77g) (human thrombin - unii:6k15abl77g) - human thrombin 2000 [iu] in 2 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 an anaphylactic or severe systemic reaction to evithrom® or to human blood products. - do not use for the treatment of severe or brisk arterial bleeding. risk summary there are no 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. evithrom® should be given to a pregnant woman only if clearly needed. in the u.s. general population, the estimated background

Malta - English - Medicines Authority

biotest pharma gmbh landsteinerstrasse 5, 63303 dreieich, germany - human plasma, protein - solution for infusion - human plasma protein 200 g/l - blood substitutes and perfusion solutions