Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
human immunoglobulin G, Quantity: 100 mg/mL
Octapharma Australia Pty Ltd
human immunoglobulin G
Injection
Excipient Ingredients: maltose; octoxinol 10; tributyl phosphate; water for injections; human immunoglobulin A
Intravenous
100 mL in 100mL bottle
(S4) Prescription Only Medicine
Replacement therapy in: Primary immunodeficiency syndromes: congenital agammaglobulinaemia and hypogammaglobulinaemia; common variable immunodeficiency; severe combined immunodeficiencies; Wiskott Aldrich syndrome; Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. Children with congenital Acquired Immune Deficiency Syndrome (AIDS) who have repeated bacterial infections; Immunomodulation: Idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct platelet count. Guillain Barre syndrome. Kawasaki disease. Allogeneic bone marrow transplantation.
Visual Identification: Clear or slightly opalescent solution.; Container Type: Bottle; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Restricted flow insert
Licence status A
2009-11-30
_ _ 1/ 7 OCTAGAM ® 10% CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING OCTAGAM ® 10%? Octagam ® 10% contains the active ingredient human normal immunoglobulin. Octagam ® 10% is used in patients who do not have enough antibodies (proteins that help the body fight infection) in their blood. For more information, see section 1. Why am I using octagam ® 10%? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE OCTAGAM ® 10%? Do not use if you have ever had an allergic reaction to any human normal immunoglobulin or to any ingredients listed at the end of the CMI. Do not use if you have antibodies to human immunoglobulin A in your blood – this may occur if you have human immunoglobulin A deficiency. There are a number of circumstance in which people may need to use caution when using this medicine. It is important to understand if these apply to you before taking octagam ® 10% (see Section 2. What should I know before I use octagam ® 10%? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with OCTAGAM ® 10% and effect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE OCTAGAM® 10%? Your doctor will administer octagam ® 10% as a slow injection (infusion) into a vein. For more information, see Section 4. How do I use octagam ® 10%? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING OCTAGAM® 10%? THINGS YOU SHOULD DO Tell your doctor if you become pregnant Tell your doctor if you are to have any blood glucose tests Tell your doctor if you are to receive a vaccine Remind your doctor/pharmacist that you are on octagam ® 10%? before starting any new medicines For more information, see Section 5. What should I know while using octagam® 10%? in the full CMI. 6. ARE THERE ANY SIDE EFFECTS? All medicines can have side effects allthough not everybo Прочитайте повний документ
_ _ _ _ _1/14 _ AUSTRALIAN PRODUCT INFORMATION - OCTAGAM ® 10% (HUMAN NORMAL IMMUNOGLOBULIN, 100 MG/ML, SOLUTION FOR INTRAVENOUS INFUSION) 1. NAME OF THE MEDICINE Human Normal Immunoglobulin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Octagam ® 10% contains 100 mg/mL of human normal immunoglobulin with a purity of at least 95% immunoglobulin G (IgG), and a broad spectrum of antibodies against infectious agents. It is composed of the following distribution of IgG subclasses (approx. values): IgG 1 60% IgG 2 32% IgG 3 7% IgG 4 1% Octagam ® 10% contains ≤ 3% polymers. Monomer and dimer content is ≥ 90%. The human immunoglobulin A (IgA) content is ≤ 0.4 mg/mL. Octagam 10% is contraindicated in patients with IgA deficiency (for further details, refer to section 4.3 Contraindications). Octagam ® 10% contains all the IgG activities, which are present in the normal population. It is prepared from pooled plasma from more than 3,500 donors. For a full list of excipients, see section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Solution for intravenous infusion. The solution is clear or slightly opalescent. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replacement therapy in: • Primary immunodeficiency syndromes: − congenital agammaglobulinaemia and hypogammaglobulinaemia − common variable immunodeficiency − severe combined immunodeficiencies − Wiskott Aldrich syndrome • Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. _ _ _ _ _2/14 _ • Children with congenital Acquired Immune Deficiency Syndrome (AIDS) who have repeated bacterial infections. Immunomodulation • Idiopathic thrombocytopenic purpura, in adults or children with a high risk of bleeding or prior to surgery to correct the platelet count. • Guillain Barré syndrome • Kawasaki disease Allogeneic bone marrow transplantation 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE The dose and dosage regimen is dependent on the indication. In replacement therapy the dosage may need Прочитайте повний документ