Stany Zjednoczone - angielski - 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.

Stany Zjednoczone - angielski - 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

Stany Zjednoczone - angielski - 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

Irlandia - angielski - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human fibrinogen; aprotinin; human factor xiii; human thrombin; calcium chloride - solution for sealant - . - local hemostatics; tissue adhesives

Irlandia - angielski - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - human fibrinogen; aprotinin; human factor xiii; human thrombin; calcium chloride - solution for sealant - . - local hemostatics; tissue adhesives

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

ksj pharmatech - human thrombin, quantity: 2 iu/cm2; fibrinogen, quantity: 5.5 mg/cm2 - sponge, medicated - excipient ingredients: sodium chloride; riboflavin; collagen; sodium citrate dihydrate; arginine hydrochloride; albumin - ? tachosil? is indicated as an adjunct to haemostasis during surgery when control of bleeding by standard surgical techniques is ineffective or impractical.

Malta - angielski - Malta Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - calcium chloride, aprotinin, fibrinogen, human, thrombin - solution for sealant - calcium chloride 40 µmole/ml aprotinin 3000 kiu/ml fibrinogen, human 91 mg/ml thrombin, human 500 iu/mg - antihemorrhagics

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

baxter healthcare corporation - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 90 mg in 1 ml - hemostasis: tisseel is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. tisseel is effective in heparinized patients. sealing: 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, can result in life-threatening thromboembolic events, and can increase the likelihood and severity of acute hypersensitivity reactions in susceptible patients ( see warnings and precautions (5.3 ) and adverse reactions (6.2) ). do not use tisseel in individuals with a known hypersensitivity to aproti

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

profibrix bv - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - fibrinogen human 79 mg in 1 g

Irlandia - angielski - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human fibrinogen; human thrombin; calcium chloride; aprotinin - solution for sealant - 4 ml - local hemostatics; tissue adhesives