Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: glycine; water for injections - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: water for injections; glycine - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: glycine; water for injections - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 3.2 g - injection, solution - excipient ingredients: human immunoglobulin a; glycine; water for injections - evogam is indicated in adults and children for replacement therapy in: primary immunodeficiency disease (pid) and symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 0.8 g - injection, solution - excipient ingredients: glycine; human immunoglobulin a; water for injections - evogam is indicated in adults and children for replacement therapy in: primary immunodeficiency disease (pid) and symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

Европска Унија - Енглески - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuscular blockade - all other therapeutic products - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults.for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Европска Унија - Енглески - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - sugammadex sodium - neuromuscular blockade - all other therapeutic products - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Европска Унија - Енглески - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - sugammadex sodium - neuromuscular blockade - all other therapeutic products - reversal of neuromuscular blockade induced by rocuronium or vecuronium.for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Европска Унија - Енглески - EMA (European Medicines Agency)

extrovis eu ltd. - sugammadex sodium - neuromuscular blockade - all other therapeutic products - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Израел - Енглески - 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