Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
normal immunoglobulin, Quantity: 60 mg/mL
CSL Behring Australia Pty Ltd
normal immunoglobulin
Injection, solution
Excipient Ingredients: maltose; water for injections; human immunoglobulin A
Intravenous
10mL x 1
(S4) Prescription Only Medicine
Intragam P is indicated in replacement Immunoglobulin G (IgG) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. INDICATIONS AS AT 21 JULY 2000: Replacement IgG therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. Immunomodulatory therapy in: idiopathic thrombocytopenic purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogenic bone marrow transplantation; Kawasaki disease. INDICATIONS AS AT 25 FEBRUARY 2003: For replacement immunoglobulin G (IgG) therapy in: Primary immunodeficiency; Myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and; Congenital acquired immune deficiency syndrome with recurrent infections. For immunomodulatory therapy in: Idiopathic thrombocytopenic purpura (ITP) in adults or children at high risk of bleeding or prior to surgery to correct platelet count; Allogeneic bone marrow transplantation; Kawasaki disease, and; Guillain-Barre Syndrome (GBS).
Visual Identification: A clear colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
1999-05-28
Intragam P AU CMI 15.00 Page 1 of 4 INTRAGAM ® P Human Normal Immunoglobulin, solution for intravenous infusion. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Intragam ® P. It does not contain complete information about Intragam ® P. It does not take the place of talking to your doctor. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE,_ _ASK YOUR DOCTOR. FOLLOW YOUR DOCTOR’S ADVICE EVEN IF IT IS DIFFERENT FROM WHAT THIS LEAFLET SAYS. PLEASE READ THIS LEAFLET CAREFULLY AND KEEP IT FOR FUTURE REFERENCE. The information in this leaflet is subject to change. Please check with your doctor whether there is any new information about this medicine that you should know since you were last treated. WHAT INTRAGAM ® P IS USED FOR Intragam ® P is manufactured from human plasma (the liquid component of blood) _ _ collected by the Australian Red Cross Blood Service. Intragam ® P is used for patients who need replacement of antibodies which form part of our immune system and can provide protection against some infections. Intragam ® P is also used in diseases when the immune system is overactive, these are called autoimmune disorders. Ask your doctor if you have any questions about why Intragam ® P has been prescribed for you. Your doctor will have assessed the risks and benefits for you associated with the use of this medicine. _ _ BEFORE YOU ARE GIVEN INTRAGAM ® P INTRAGAM ® P MUST NOT BE USED IF YOU HAVE A HISTORY OF ALLERGY TO HUMAN IMMUNOGLOBULIN PRODUCTS. TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, OR IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO AN INJECTION. TELL YOUR DOCTOR ALSO IF YOU: • have previously been advised that you have Immunoglobulin A (IgA) deficiency • have previously been advised that you have kidney disease • have a history of heart, or blood vessel disease, or blood clots, have thick blood, have been immobile for some time. Also tell the doctor what medicine you are using as some medicines, such as those that Läs hela dokumentet
Intragam P AU PI 15.00 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION INTRAGAM ® P (HUMAN NORMAL IMMUNOGLOBULIN) 1 NAME OF THE MEDICINE Human Normal Immunoglobulin 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Intragam ® P is a sterile, preservative free solution for intravenous infusion containing 6 g of human protein and 10 g of maltose in each 100 mL. The solution has a pH of 4.25. Isotonicity is achieved by the addition of maltose. At least 98% of the protein has the electrophoretic mobility of immunoglobulin G (IgG). At least 90% of the protein is IgG monomer and dimer. Based on three preclinical and four clinical batches, the distribution of IgG subclasses present in Intragam ® P is, on the average, 61% IgG 1 , 36% IgG 2 , 3% IgG 3 and 1% IgG 4 . Intragam ® P contains only trace amounts of IgA (nominally <0.025 mg/mL). Intragam ® P is manufactured from human plasma collected by the Australian Red Cross Blood Service. Excipient of known effect: maltose. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Intragam ® P is indicated for replacement IgG therapy in: • Primary Immunodeficiency Diseases (PID) • Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. Intragam ® P is indicated for immunomodulatory therapy in: • Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count • Kawasaki disease • Guillain-Barré Syndrome (GBS). Comprehensive evidence-based guidelines describing appropriate clinical use of intravenous immunoglobulin in ITP have been published and should be followed wherever possible to avoid the inappropriate utilisation of this blood product 1, 2 . Intragam P AU PI 15.00 Page 2 of 13 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE _REPLACEMENT THERAPY _ The optimal dose and frequency of administration of Intragam ® P must be determined for each patient _._ Freedom from recurrent bacterial infections is usually achieved with a serum IgG level above Läs hela dokumentet