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

kamada ltd, israel - human hepatitis b immunoglobulin - solution for infusion - human hepatitis b immunoglobulin 50 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - prophylaxis against hepatitis b in adults and children over 2 years of age who have not been vaccinated against hepatitis b (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis b by accidental contact with hepatitis b virus containing material following: - percutaneous exposure (e.g. accidental needle stick). - direct mucous membrane contact. when the administration of an intramuscular hepatitis b immunoglobulin is not possible. the immunoglobulin should be administered in association with hepatitis b vaccine. prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis b virus. immunoprophylaxis of hepatitis b in the newborn of a hepatitis b virus carrier mother.

Israel - English - Ministry of Health

kamada ltd, israel - human normal immunoglobulin - solution for infusion - human normal immunoglobulin 50 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, and children and adolescents (0-18 years) in:- primary immunodeficiency syndromes (pid) with impaired antibody production- secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of <4 g/l* psaf= failure to mount at least a 2-fold rise in igg antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccinesimmunomodulation in adults, and children and adolescents (0-18 years) in:- primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count- guillain barré syndrome- kawasaki disease (in conjunction with acetylsalicylic acid)- chronic inflammatory demyelinating polyradiculoneuropathy (cidp)- multifocal motor neuropathy (mmn)

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - albumin (human serum) (venous) - injection - 5.00% - albumin (human serum) (venous) 5%

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - albumin (human serum) (venous) - infusion, solution - 0.2 g/ml - albumin (human serum) (venous) 0.2 g/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - plasma protein containing at least 95% human albumin - solution for infusion - 50 gram(s)/litre - blood substitutes and plasma protein fractions; albumin - plasma substitutes and plasma protein fractions - restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - plasma protein containing at least 95% human albumin - solution for infusion - 200 gram(s)/litre - blood substitutes and plasma protein fractions; albumin - plasma substitutes and plasma protein fractions - restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate

Malta - English - Medicines Authority

baxter healthcare limited - albumin, human 50 g/l - solution for infusion

Malta - English - Medicines Authority

baxter healthcare limited - albumin, human 200 g/l - solution for infusion

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

csl behring australia pty ltd - human immunoglobulin g, quantity: 40 g - injection, intravenous infusion - excipient ingredients: proline - privigen is an immune globulin intravenous (human), 10% liquid indicated for the treatment of the following conditions. 1.1 primary humoral immunodeficiency privigen indicated as replacement therapy for primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (cvid), x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. 1.2 chronic immune thrombocytopenic purpura privigen is indicated for the treatment of patients with chronic immune thrombocytopenic purpura (itp) to raise platelet counts. 1.3 chronic inflammatory demyelinating polyneuropathy privigen is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (cidp) to improve neuromuscular disability and impairment. limitation of use: privigen maintenance therapy in cidp has not been studied for periods longer than 6 months. after responding during an initial treatment period, not all patients require indefinite maintenance therapy with privigen in order to remain free of cidp symptoms. individualize the duration of any treatment beyond 6 months based upon the patient?s response and demonstrated need for continued therapy.