Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
normal immunoglobulin, Quantity: 10 mg/mL
Grifols Australia Pty Ltd
normal immunoglobulin
Injection
Excipient Ingredients: water for injections; glycine
Intravenous, Subcutaneous
1 x 100mL vial
(S4) Prescription Only Medicine
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.
Visual Identification: Clear liquid, colourless to pale yellow.; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2006-05-05
GAMUNEX ® 1 CONSUMER MEDICINE INFORMATION GAMUNEX ® Normal Immunoglobulin (Human), 10% for Intravenous or Subcutaneous Administration WHAT IS IN THIS LEAFLET This leaflet answers some common questions about GAMUNEX ® . It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you receiving GAMUNEX ® against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT GAMUNEX ® IS USED FOR GAMUNEX ® is used to replace antibodies (used to fight infections) in people with conditions that impair the body’s ability to make antibodies. These conditions include: Primary Immunodeficiency Diseases. Symptomatic Hypogammaglobulinaemia secondary to underlying disease or treatment. GAMUNEX ® is also used to modulate the immune system in people whose immune systems are not working well. These conditions include Idiopathic Thrombocytopaenic Purpura (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count. People with ITP have antibodies that do not work properly and may need treatment with GAMUNEX ® to raise blood platelet counts to prevent bleeding or prior to undergoing surgery. Guillain Barré Syndrome (GBS). Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Kawasaki disease. This medicine belongs to a group of medicines called immunoglobulins. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. GAMUNEX ® 2 BEFORE YOU RECEIVE GAMUNEX ® _WHEN YOU MUST NOT RECEIVE IT_ YOU SHOULD NOT RECEIVE GAMUNEX ® IF: you have an allergy to immunoglobulin or any of the ingredients listed at the end of this leaflet. you have severe immunoglobulin A (IgA) deficiency (which may also cause a severe a Izlasiet visu dokumentu
1 AUSTRALIAN PRODUCT INFORMATION GAMUNEX ® (NORMAL IMMUNOGLOBULIN (HUMAN), 10%, INTRAVENOUS SOLUTION VIAL) 1 NAME OF THE MEDICINE Normal immunoglobulin (Human), 10%, for Intravenous or Subcutaneous Administration 2 QUALITATIVE AND QUANTITATIVE COMPOSITION GAMUNEX ® Normal immunoglobulin (Human), 10%, Solution for Intravenous or Subcutaneous Administration. One mL contains: Normal immunoglobulin (Human) ...............................................................................100 mg (purity of at least 98% IgG) Each vial of 10 mL contains: 1 g of human normal immunoglobulin Each vial of 25 mL contains: 2.5 g of human normal immunoglobulin Each vial of 50 mL contains: 5 g of human normal immunoglobulin Each vial of 100 mL contains: 10 g of human normal immunoglobulin Each vial of 200 mL contains: 20 g of human normal immunoglobulin Each vial of 400 mL contains: 40 g of human normal immunoglobulin Distribution of the IgG subclasses (average values): IgG 1 .................... 62.8% IgG 2 .................... 29.7% IgG 3 ...................... 4.8% IgG 4 ...................... 2.7% The maximum IgA content is 84 micrograms/mL. Produced from plasma of human donors. For a full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Dosage form: Injection The solution is clear to opalescent, colourless to pale yellow. 2 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 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 Barré Syndrome (GBS). - Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). - Kawasaki disease. 4.2 D OSE AND METHOD OF ADMINISTRATION GAMUNEX ® is recommended for administration by intravenous infusion for all indications. GAMUNEX ® can also be administered by subcutaneous infusion for replacement therapy i Izlasiet visu dokumentu