Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

biotest pharma gmbh - human plasma protein >95% immunoglobulins glucose sodium chloride water for injections - solution for infusion - 50 mg/ml

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

biotest pharma gmbh - human plasma protein >95% immunoglobulins glucose sodium chloride water for injections - solution for infusion - 50 mg/ml

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

biotest pharma gmbh - human plasma protein >95% immunoglobulins glucose sodium chloride water for injections - solution for infusion - 1000/20 mg/ml

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

biotest pharma gmbh - human plasma protein >95% immunoglobulins glucose sodium chloride water for injections - solution for infusion - 2500/50 mg/ml

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

octapharma usa inc - plasma protein fraction (human) (unii: 6d53g0fd0z) (plasma protein fraction (human) - unii:6d53g0fd0z) - plasma protein fraction (human) 11.5 g in 200 ml - octaplas is a solvent / detergent (s/d) treated, pooled human plasma indicated for: - replacement of multiple coagulation factors in patients with acquired deficiencies - due to liver disease - undergoing cardiac surgery and liver transplantation - plasma exchange in patients with thrombotic thrombocytopenic purpura (ttp) do not use octaplas in patients with: - iga deficiency - severe deficiency of protein s - history of hypersensitivity to fresh frozen plasma (ffp) or to plasma-derived products including any plasma protein - history of hypersensitivity reaction to octaplas risk summary animal reproduction studies have not been conducted with octaplas. it is not known whether octaplas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. octaplas should be given to a pregnant woman only if clearly needed. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

octapharma usa inc - plasma protein fraction (human) (unii: 6d53g0fd0z) (plasma protein fraction (human) - unii:6d53g0fd0z) - plasma protein fraction (human) 11.5 g in 200 ml - octaplas is a solvent / detergent (s/d) treated, pooled human plasma indicated for: - replacement of multiple coagulation factors in patients with acquired deficiencies - due to liver disease - undergoing cardiac surgery and liver transplantation - plasma exchange in patients with thrombotic thrombocytopenic purpura (ttp) do not use octaplas in patients with: - iga deficiency - severe deficiency of protein s - history of hypersensitivity to fresh frozen plasma (ffp) or to plasma-derived products including any plasma protein - history of hypersensitivity reaction to octaplas risk summary animal reproduction studies have not been conducted with octaplas. it is not known whether octaplas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. octaplas should be given to a pregnant woman only if clearly needed. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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 [ 4 ]. risk summary efficacy and safety of octaplas in lactating women is unknown. octaplas was evaluated in 91 pediatric patients (age range 0-20 years) in two post-marketing requirement studies. patients were dosed based on body weight and doses were adjusted as needed. there were no hyperfibrinolytic or treatment-related thromboembolic events reported by investigators. please refer to section 14 for information on clinical studies in the pediatric population. clinical studies of octaplas did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

octapharma usa inc - plasma protein fraction (human) (unii: 6d53g0fd0z) (plasma protein fraction (human) - unii:6d53g0fd0z) - plasma protein fraction (human) 11.5 g in 200 ml - octaplas is a solvent / detergent (s/d) treated, pooled human plasma indicated for: - replacement of multiple coagulation factors in patients with acquired deficiencies - due to liver disease - undergoing cardiac surgery and liver transplantation - plasma exchange in patients with thrombotic thrombocytopenic purpura (ttp) do not use octaplas in patients with: - iga deficiency - severe deficiency of protein s - history of hypersensitivity to fresh frozen plasma (ffp) or to plasma-derived products including any plasma protein - history of hypersensitivity reaction to octaplas risk summary animal reproduction studies have not been conducted with octaplas. it is not known whether octaplas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. octaplas should be given to a pregnant woman only if clearly needed. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

octapharma usa inc - plasma protein fraction (human) (unii: 6d53g0fd0z) (plasma protein fraction (human) - unii:6d53g0fd0z) - plasma protein fraction (human) 11.5 g in 200 ml - octaplas is a solvent / detergent (s/d) treated, pooled human plasma indicated for: - replacement of multiple coagulation factors in patients with acquired deficiencies - due to liver disease - undergoing cardiac surgery and liver transplantation - plasma exchange in patients with thrombotic thrombocytopenic purpura (ttp) do not use octaplas in patients with: - iga deficiency - severe deficiency of protein s - history of hypersensitivity to fresh frozen plasma (ffp) or to plasma-derived products including any plasma protein - history of hypersensitivity reaction to octaplas risk summary animal reproduction studies have not been conducted with octaplas. it is not known whether octaplas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. octaplas should be given to a pregnant woman only if clearly needed. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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 [ 4 ]. risk summary efficacy and safety of octaplas in lactating women is unknown. octaplas was evaluated in 91 pediatric patients (age range 0-20 years) in two post-marketing requirement studies. patients were dosed based on body weight and doses were adjusted as needed. there were no hyperfibrinolytic or treatment-related thromboembolic events reported by investigators. please refer to section 14 for information on clinical studies in the pediatric population. clinical studies of octaplas did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Ավստրալիա - անգլերեն - 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.

Ավստրալիա - անգլերեն - 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 - 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.