Israel - engelsk - 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 - engelsk - Ministry of Health

medici medical ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 0.5 g / 10 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in: primary immunodeficiency syndromes such as:- congenital agammaglobulinaemia and hypogammaglobulinaemia- common variable immunodeficiency- severe combined immunodeficiency- wiskott aldrich syndromemyeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.children with congenital aids and recurrent infections.immunomodulation :idiopathic thrombocytopenic purpura (itp), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.guillain barré syndrome.kawasaki disease.allogeneic bone marrow transplantation

Israel - engelsk - Ministry of Health

kamada ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 5 g / 100 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, and children and adolescents in:- primary immunodeficiency syndromes with impaired antibody production - hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed- hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation- congenital aids with recurrent bacterial infectionsimmunomodulation in adults, and children and adolescents 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

Israel - engelsk - Ministry of Health

padagis israel agencies ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 0.1 g/ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - gamunex is indicated as replacement therapy of primary immunodeficiency (pi) states in which severe impaiment of antibody forming capacity has been shown, such as congential agammaglobulinemia, common variable immunodeficiency, x-limked immunodeficiency with hyper igm, wiskott- aldrich syndrom, and severed combined immunodeficiencies. gamunex is also indicated in idiopathic thrombocytopenia purpura (itp) to raise platelet counts to prevent bleeding or to allow a patient with itp to undergo surgery.treatment of chronic inflammatory demyelinating polyneuropathy (cidp).

Irland - engelsk - HPRA (Health Products Regulatory Authority)

baxalta innovations gmbh - human plasma protein >95% immunoglobulins - solution for injection - 160 gram(s)/litre - immunoglobulins, normal human; immunoglobulins, normal human, for extravascular adm. - immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration - replacement therapy in adults and children in primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency - igg subclass deficiencies with recurrent infections

Israel - hebraisk - Ministry of Health

csl behring ltd., israel - immunoglobulins, normal human - תמיסה להזרקה - 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

Israel - hebraisk - Ministry of Health

padagis israel agencies ltd, israel - immunoglobulins, normal human - תמיסה לאינפוזיה - immunoglobulins, normal human 0.1 g/ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - gamunex is indicated as replacement therapy of primary immunodeficiency (pi) states in which severe impaiment of antibody forming capacity has been shown, such as congential agammaglobulinemia, common variable immunodeficiency, x-limked immunodeficiency with hyper igm, wiskott- aldrich syndrom, and severed combined immunodeficiencies. gamunex is also indicated in idiopathic thrombocytopenia purpura (itp) to raise platelet counts to prevent bleeding or to allow a patient with itp to undergo surgery.treatment of chronic inflammatory demyelinating polyneuropathy (cidp).

Israel - engelsk - Ministry of Health

omrix biopharmaceuticals - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 50 mg/ml mg/ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy * primary immunodeficiency (patients with primary defective antibody synthesis such as agammaglobulinemia or hypogammaglobulinemia) * myeloma or chronic lymphocytic leukemia (cll) with severe secondary hypogammaglobulinemia and recurrent infections. * children with congenital aids and recurrent infections - immunomodulation * idiopathic thrombocytopenic purpura (itp) * guillain barre syndrome * kawasaki disease - allogenic bone marrow transplantation

Israel - engelsk - Ministry of Health

dover medical & scientific equipment ltd, israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 50 mg/ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in: • primary immunodeficiency syndromes such as: - congenital agammaglobulinaemia and hypogammaglobulinaemia - common variable immunodeficiency - severe combined immunodeficiency - wiskott aldrich syndrome. • children with congenital aids and recurrent bacterial infections. immunomodulatory effect: • idiopathic thrombocytopenic purpura (itp) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count. • guillain barre syndrome. • kawasaki disease. allogeneic bone marrow transplantation.• myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Israel - engelsk - Ministry of Health

takeda israel ltd - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 100 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - ivig can be used in all age ranges, unless otherwise specified below.replacement therapy in:primary immunodeficiency syndromes with impaired antibody production.hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed.hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation.children and adolescents (age 0-18) with congenital aids and recurrent bacterial infections.hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (hsct).immunomodulationprimary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count.guillain barré syndrome.kawasaki disease.