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

baxter healthcare pty ltd - human thrombin, quantity: 3.2 iu/ml; calcium chloride dihydrate, quantity: 36 micromole/ml - solution - excipient ingredients: sodium chloride; albumin; water for injections - artiss is indicated to adhere autologous skin grafts in burn patients. artiss is indicated to adhere tissue flaps during rhytidectomy (face-lift). artiss is not indicated for haemostasis

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - aprotinin 2250 kiu/ml - 3750 kiu/ml; factor xiii 1.2 iu/ml - 10 iu/ml (in total protein solution); fibrinogen 72 mg/ml - 110 mg/ml (in total protein solution); calcium chloride dihydrate 0.036 mmol/ml - 0.044 mmol/ml; thrombin 400 iu/ml - 625 iu/ml - topical solution - active: aprotinin 2250 kiu/ml - 3750 kiu/ml factor xiii 1.2 iu/ml - 10 iu/ml (in total protein solution) fibrinogen 72 mg/ml - 110 mg/ml (in total protein solution) excipient: albumin histidine as l-histidine nicotinamide polysorbate 80 sodium citrate water for injection active: calcium chloride dihydrate 0.036 mmol/ml - 0.044 mmol/ml thrombin 400 iu/ml - 625 iu/ml excipient: albumin sodium chloride water for injection - as adjunct to haemostasis during surgical procedures, when control of bleeding by conventional surgical techniques is ineffective or impractical

New Zealand - English - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - aprotinin 2250 kiu/ml - 3750 kiu/ml; factor xiii 1.2 iu/ml - 10 iu/ml; fibrinogen 72 mg/ml - 110 mg/ml; calcium chloride dihydrate 0.036 mmol/ml - 0.044 mmol/ml; thrombin 3.2 iu/ml - 5 iu/ml - topical solution - 4 iu - active: aprotinin 2250 kiu/ml - 3750 kiu/ml factor xiii 1.2 iu/ml - 10 iu/ml fibrinogen 72 mg/ml - 110 mg/ml excipient: albumin histidine nicotinamide polysorbate 80 sodium citrate dihydrate water for injection active: calcium chloride dihydrate 0.036 mmol/ml - 0.044 mmol/ml thrombin 3.2 iu/ml - 5 iu/ml excipient: albumin sodium chloride water for injection - artiss is indicated for use in adhering autologous skin grafts in burn patients. artiss is not indicated for haemostasis.

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - aprotinin - solution for injection - aprotinin 500,000/50 kiu/ml - antihemorrhagics

Malta - English - Medicines Authority

miller and miller chemicals unit 3, burnside industrial est, 49-53 roebuck road hainault, essex ig63ug, united kingdom - aprotinin - solution for injection - aprotinin 10,000 kiu/ml - antihemorrhagics

Malta - English - Medicines Authority

cherubino limited delf building, sliema road, gzira, gzr 1637, malta - aprotinin - solution for injection - aprotinin 100000 kiu/ml - antihemorrhagics

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

nordic pharma ltd - aprotinin - solution for infusion - 10000kallikrein inactivator unit/1ml

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 - 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. 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 aprotinin  (see warnings and pre

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 - 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. 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 aprotinin  (see warnings and pre