Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
normal immunoglobulin, Quantity: 2 g
CSL Behring Australia Pty Ltd
normal immunoglobulin
Injection, solution
Excipient Ingredients: polysorbate 80; proline; water for injections
Subcutaneous
10 mL
(S4) Prescription Only Medicine
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.
Visual Identification: Clear and pale-yellow or light-brown solution; during storage it may show formation of slight turbidity or a small amount of particulate matter; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-05-08
Hizentra AU CMI 7.00 Page 1 of 7 HIZENTRA ® Human Normal Immunoglobulin 20% (20 g per 100 mL), solution for subcutaneous administration. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Hizentra ® . It does not contain all the available information. If you require further information about this medicine or your treatment, have any questions, or are not sure about something in this leaflet, consult your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the benefits that Hizentra ® will have for you against the possible risks. 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. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. 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 HIZENTRA ® IS USED FOR Your medicine is Hizentra ® , a solution for subcutaneous infusion. Hizentra ® contains human immunoglobulins. Immunoglobulins are also called antibodies and are a type of protein found in the blood. Immunoglobulins are produced by your body’s immune system to fight infections caused by bacteria and viruses. If you do not have enough antibodies you may not be able to fight off diseases. Your doctor may give you Hizentra ® either for: • the replacement of antibodies because your antibody levels are low (referred to as immunodeficiency), or • a condition where there is an imbalance in your immune system requiring treatment with immunoglobulins (referred to as immunomodulation). Your doctor may have prescribed Hizentra ® for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU ARE GIVEN HIZENTRA ® WHEN YOU MUST NOT HAVE IT DO NOT HAVE HIZENTRA ® _ _IF YOU HAVE: • a history of allergy to human immunoglob Citiți documentul complet
Hizentra AU PI 12.00 Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION HIZENTRA ® (NORMAL IMMUNOGLOBULIN (HUMAN)) 1 NAME OF THE MEDICINE Normal immunoglobulin (Human) 20% (20 g/100 mL), subcutaneous injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hizentra ® is a 20% solution containing 20 g/100 mL of total human plasma protein with a purity of at least 98% immunoglobulin G (IgG). More than 90% of the IgG consists of monomers and dimers, aggregates (≤2%–typically below 0.1%). The distribution of the IgG subclasses is similar to that of normal human plasma (approximate values: 69% IgG 1 , 26% IgG 2 , 3% IgG 3 , 2% IgG 4 ). The maximum IgA content is 0.05 mg/mL (normally below 0.005 mg/mL). The product contains 250 mmol/L of proline as a stabiliser which is a physiological non-essential amino acid. The product also contains trace amounts of Polysorbate 80 and sodium. Hizentra ® contains no carbohydrate stabiliser (e.g. sucrose, maltose) and no preservative. 3 PHARMACEUTICAL FORM Hizentra ® is a sterile, clear and colourless or pale-yellow or light-brown solution of human normal immunoglobulin for subcutaneous injection. Hizentra ® has a nominal osmolality of 380 mOsm/kg and is approximately isotonic. The pH value of the ready-to-use solution is 4.8. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 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. Hizentra AU PI 12.00 Page 2 of 20 4.2 D OSE AND METHOD OF ADMINISTRATION Hizentra ® should only be administered SUBCUTANEOUSLY . DOSAGE The dose and dose regimen are dependent on the indication. _REPLACEMENT THERAPY (PID AND SYMPTOMATIC HYPOGAMMAGLOBULINAEMIA) _ The dose may need to be individualised for each patient dependent on the clinical response and serum IgG trough levels. The following Citiți documentul complet