Australija - engleski - Department of Health (Therapeutic Goods Administration)

stallergenes australia pty ltd - immunoglobulin - normal; normal immunoglobulin -

Izrael - engleski - 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

Izrael - engleski - 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

Izrael - engleski - Ministry of Health

csl behring ltd., israel - immunoglobulins, normal human - solution for infusion - immunoglobulins, normal human 100 g/l - immunoglobulins, normal human, for intravascular adm. - immunoglobulins, normal human, for intravascular adm. - replacement therapy in• primary immunodeficiency syndromes (pid) such as: – congenital agammaglobulinaemia and hypogammaglobulinaemia – common variable immunodeficiency – severe combined immunodeficiency – wiskott-aldrich syndrome• myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections• children with congenital aids and recurrent infectionsimmunomodulation• immune thrombocytopenic purpura (itp) in children or adults at high risk of bleeding or prior to surgical interventions to correct the platelet count• guillain-barré syndrome• kawasaki disease• chronic inflammatory demyelinating polyneuropathy (cidp)allogeneic bone marrow transplantation

Izrael - engleski - 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).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; zoster immunoglobulin, quantity: 200 iu - injection, solution - excipient ingredients: water for injections; glycine; human immunoglobulin a - indications as at 8 august 2002 : zoster immunoglobulin is indicated for prophylaxis against varicella in patients who meet all four of the criteria listed below: 1. one of the following underlying illnesses or conditions: a. neoplastic disease (leukaemia or lymphoma); b. congenital or acquired immunodeficiency; c. immunosuppressive therapy with steroids or antimetabolites. 2. one of the following types of exposure to chickenpox or shingles patients: a. household contact; b. playmate contact (>1 hour play indoors); c. hospital contact (in same 2 to 4 bedroom or adjacent beds in a large ward); d. newborn contact (newborn of mother who had onset of chickenpox <5 days before delivery or within 48 hours after delivery); e. premature infant (>= 28 weeks gestation) whose mother lacks a prior history of chickenpox; f. premature infant (< 28 weeks gestation or <= 1000g) regardless of maternal history. 3. negative or unknown history of chickenpox. 4. if zoster immunoglobulin can be administered within 96 hours after exposure. zoster immunoglobulin, normal immunoglobulin (immunoglobulin for intramuscular use) or plasma are of no value in the treatment of established varicella or zoster infection. high levels of circulating antibody do not prevent dissemination of infection. zoster immunoglobulin is not indicated for prophylactic use in immunodeficient children or adults when there is a history of varicella, unless the patient's immunosuppressed status is that which is associated with bone marrow transplantation.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 4 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 4 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 2 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 1 g - injection, solution - excipient ingredients: water for injections; proline; polysorbate 80 - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.