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

csl behring australia pty ltd - tetanus immunoglobulin, quantity: 250 iu; human immunoglobulin g, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine; human immunoglobulin a - tetanus immunoglobulin is indicated for the passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus or whose immunisation history is doubtful. it should also be given to the fully immunised patient with a tetanus-prone wound if more than 10 years have elapsed since the last dose of toxoid. in all the above instances, active immunisation with tetanus toxoid, adsorbed or adt vaccine should be commenced at the same time [in accordance with details specified in table 1 (guide to tetanus prophylaxis in wound management) in indication section of the approved product information provided as attachment 1]. although tetanus immunoglobulin and vaccine should be given at the same time, they should be administered in opposite limbs, using separate syringes.

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

csl behring australia pty ltd - human immunoglobulin g, quantity: 160 mg/ml; hepatitis b immunoglobulin, quantity: 100 iu - injection, solution - excipient ingredients: glycine; water for injections; human immunoglobulin a - indications as at 8 august 2002 : hepatitis b immunoglobulin is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive material or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin is also indicated for prophylaxis in infants born to hbsag-positive mothers. hepatitis b immunoglobulin-vf is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis b antibody level is inadequate (<10iu/l). post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to hbsag-positive or suspected hbsag-positive material, for example, by needle stick, oral ingestion or sexual exposure. hepatitis b immunoglobulin-vf is also indicated for prophylaxis in infants born to hbsag-positive mothers.

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

csl behring australia pty ltd - human immunoglobulin g, quantity: 50 mg/ml; cytomegalovirus immunoglobulin, quantity: 1500000 u - injection, intravenous infusion - excipient ingredients: water for injections; human immunoglobulin a; maltose - cmv immunoglobulin-vf is indicated for the prevention of cmv infection following bone marrow and renal transplants. specifically, the product is indicated when the recipient is seronegative for cmv and receives a graft from a cmv positive donor. cmv immunoglobulin-vf may also be a helpful adjunct to therapy in patients with established cmv infection, e.g. cmv pneumonitis.

Izrael - engleski - 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.

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

csl behring australia pty ltd - tetanus immunoglobulin, quantity: 4000 iu; human immunoglobulin g, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: maltose; water for injections; human immunoglobulin a - tetanus immunoglobulin-vf (for intravenous use) is used in the management of clinical tetanus.

Malta - engleski - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - immunoglobulin antihepatitis - solution for injection - immunoglobulin antihepatitis b 100 iu/ml - immune sera and immunoglobulins

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

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

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

csl behring australia pty ltd - human immunoglobulin g, quantity: 1.6 g - injection, solution - excipient ingredients: glycine; human immunoglobulin a - evogam is indicated in adults and children for replacement therapy in: * primary immunodeficiency disease (pid) and * symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

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

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

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

csl behring australia pty ltd - human immunoglobulin g, quantity: 20 g - injection, solution - excipient ingredients: human immunoglobulin a; glycine - intragam 10 is indicated for replacement igg therapy in: - primary immunodeficiency disease (pid) - myeloma and chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections - congenital or acquired immune deficiency syndrome with recurrent infections. intragam 10 is indicated for immunomodulatory therapy in: - immune thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count - allogeneic bone marrow transplantation - kawasaki disease - guillain-barr? syndrome (gbs) - chronic inflammatory demyelinating polyneuropathy (cidp) - multifocal motor neuropathy (mmn) - myasthenia gravis (mg) in acute exacerbation (myasthenic crisis) or prior to surgery and/or thymectomy; as maintenance therapy for moderate to severe mg when other treatments have been ineffective or caused intolerable side effects - short-term therapy for severely affected nonparaneoplastic lambert-eaton myasthenic syndrome (lems) patients - treatment of significant functional impairment in patients who have a verified diagnosis of stiff person syndrome.