Israel - English - Ministry of Health

csl behring ltd., israel - human-rabies immunoglobulin - solution for injection - human-rabies immunoglobulin 150 iu/ml - rabies immunoglobulin - rabies immunoglobulin - prophylaxis of rabies.

Singapore - English - HSA (Health Sciences Authority)

csl behring pte. ltd. - human albumin - infusion, solution - 200g/l - human albumin 200g/l

Israel - English - Ministry of Health

csl behring ltd., israel - human fibrinogen - powder for solution for inj/inf - human fibrinogen 900 - 1300 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.

Israel - English - 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.

Israel - English - Ministry of Health

csl behring ltd., israel - coagulation factor ii (human); coagulation factor ix (human- rfixfc); coagulation factor vii (human); coagulation factor x (human); protein c; protein s antigen - powder and solvent for solution for injection - coagulation factor ii (human) 200 - 480 iu; coagulation factor vii (human) 100 - 250 iu; coagulation factor ix (human- rfixfc) 200 - 310 iu; coagulation factor x (human) 220 - 600 iu; protein c 150 - 450 iu; protein s antigen 120 - 380 iu - coagulation factor ix, ii, vii and x in combination - coagulation factor ix, ii, vii and x in combination - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

Israel - English - Ministry of Health

csl behring ltd., israel - immunoglobulins, normal human - solution for injection - immunoglobulins, normal human 160 mg/ml - immunoglobulins, normal human, for extravascular adm. - immunoglobulins, normal human, for extravascular adm. - substitution in - primary antibody deficiency syndromes resulting from defective antibody synthesis. - protracted transitory hypogammaglobulinaemia especially in premature infants .prophylaxis of hepatitis a- before exposure- within 2 weeks after exposure בקשה לתוספת התוויה 28/4/2019indications for subcutaneous administration (scig)replacement therapy in adults, children and adolescents (0-18 years) in: • primary immunodeficiency syndromes with impaired antibody production (see section 4.4).• hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (cll), in whom prophylactic antibiotics have failed or are contra-indicated.• hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (mm) patients • hypogammaglobulinaemia in patients pre- and post- allogeneic haematopoietic stem cell transplantation (hsct)indications for intramuscular administration (imig)hepatitis a prophylaxisin adults and children and adolescents (0-18 years)• pre-exposure prophylaxis, preferably in combination with vaccination, in unvaccinated individuals travelling in less than 2 weeks to areas of hepatitis a risk.• post-exposure prophylaxis in unvaccinated individuals within 2 weeks of hepatitis a virus (hav) exposure.consideration should also be given to other official guidance on the appropriate use in hepatitis a prophylaxis. for long term hepatitis a prophylaxis, vaccination is recommended. הערה: הבקשה הינה בהתאם לנוהל ema (25.2.15)- guideline on core smpc for human normal immunoglobulin for subcutaneous and intramuscular administration

Israel - English - Ministry of Health

csl behring ltd., israel - coagulation factor ii (human); coagulation factor ix (human- rfixfc); coagulation factor vii (human); coagulation factor x (human); protein c; protein s antigen - powder and solvent for solution for injection - coagulation factor ii (human) 400 - 960 iu; coagulation factor vii (human) 200 - 500 iu; coagulation factor ix (human- rfixfc) 400 - 620 iu; coagulation factor x (human) 440 - 1200 iu; protein c 300 - 900 iu; protein s antigen 240 - 760 iu - coagulation factor ix, ii, vii and x in combination - treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin k antagonists, or in case of overdose of vitamin k antagonists, when rapid correction of the deficiency is required.

Israel - English - Ministry of Health

csl behring ltd., israel - factor viii (human); von willebrand factor - powder and solvent for solution for injection/infusion - factor viii (human) 1000 iu / 15 ml; von willebrand factor 2400 iu / 15 ml - coagulation factor viii - coagulation factor viii - congenital and acquired deficiency of blood clotting factor viii: severe or moderate haemophilia,prophylaxis during operation, von willebrands disease.

Israel - English - Ministry of Health

csl behring ltd., israel - factor viii (human); von willebrand factor - powder and solvent for solution for injection/infusion - factor viii (human) 250 iu / 5 ml; von willebrand factor 600 iu / 5 ml - coagulation factor viii - coagulation factor viii - congenital and acquired deficiency of blood clotting factor viii: severe or moderate haemophilia, prophylaxis during operation, von willebrand's disease.

Israel - English - Ministry of Health

csl behring ltd., israel - factor viii (human); von willebrand factor - powder and solvent for solution for injection/infusion - factor viii (human) 500 iu / 10 ml; von willebrand factor 1200 iu / 10 ml - coagulation factor xiii - coagulation factor xiii - congenital and acquired deficiency of blood clotting factor viii: severe or moderate haemophilia, prophylaxis during operation, von willebrands disease.