Ástralía - enska - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - tranexamic acid, quantity: 500 mg - injection, solution - excipient ingredients: water for injections - adults for the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty. paediatrics for the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - tranexamic acid, quantity: 1000 mg - injection, solution - excipient ingredients: water for injections - adults for the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty. paediatrics for the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

luminarie pty ltd - tranexamic acid, quantity: 100 mg/ml - injection, solution - excipient ingredients: water for injections - adults,for the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty.,paediatrics,for the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery.

Ástralía - enska - 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

Bandaríkin - enska - 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.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

bridgewest perth pharma pty ltd - tranexamic acid, quantity: 1000 mg - injection, solution - excipient ingredients: water for injections - intravenous administration,adults,for the reduction of peri- and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty.,paediatrics,for the reduction of peri- and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery.

Ísrael - enska - 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.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - sodium valproate, quantity: 1000 mg - injection, solution - excipient ingredients: dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate dihydrate; phosphoric acid; sodium hydroxide; water for injections - valwok is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - sodium valproate, quantity: 400 mg - injection, solution - excipient ingredients: dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate dihydrate; phosphoric acid; sodium hydroxide; water for injections - valwok is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - sodium valproate, quantity: 1000 mg - injection, solution - excipient ingredients: dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate dihydrate; phosphoric acid; sodium hydroxide; water for injections - sodium valproate wockhardt is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.