Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
normal immunoglobulin, Quantity: 3.2 g
CSL Behring Australia Pty Ltd
normal immunoglobulin
Injection, solution
Excipient Ingredients: human immunoglobulin A; glycine; water for injections
Subcutaneous
20mL x 1
(S4) Prescription Only Medicine
Evogam is indicated in adults and children for replacement therapy in: Primary Immunodeficiency Disease (PID) and Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.
Visual Identification: The solution is clear and pale-yellow to light-brown. If Evogam appears to be turbid or to contain sediment it must not be used.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2012-03-30
Evogam AU CMI 10.00 Page 1 of 6 EVOGAM ® Normal Immunoglobulin (Human) 16%, solution for subcutaneous administration. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Evogam ® . 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. All medicines have benefits and risks. Your doctor has weighed the benefits that Evogam ® 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. WHAT EVOGAM ® IS USED FOR Your medicine is Evogam ® , a solution for subcutaneous infusion. Evogam ® contains human immunoglobulins and is manufactured from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood. 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. Evogam ® can be used as antibody replacement therapy, to correct this lack of antibodies. Your doctor may have prescribed Evogam ® for another reason. Ask your doctor if you have any questions about why it has been prescribed for you. BEFORE YOU RECEIVE EVOGAM ® WHEN YOU MUST NOT HAVE IT DO NOT HAVE EVOGAM ® IF YOU ARE ALLERGIC TO: • human immunoglobulin products • glycine. IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN THIS MEDICINE TALK TO YOUR DOCTOR. BEFORE YOU ARE GIVEN IT TELL YOUR DOCTOR IF YOU: • are pregnant or breast-feeding • have had any vaccination within the last two weeks • are allergic to any medicine or food • have IgA deficiency • have a history of heart, or blood v Прочитайте повний документ
Evogam AU PI 10.00 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION EVOGAM ® (NORMAL IMMUNOGLOBULIN (HUMAN)) – SOLUTION FOR SUBCUTANEOUS INFUSION 1 NAME OF THE MEDICINE Normal Immunoglobulin (Human) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Evogam ® is a sterile preservative-free solution containing 16 g/100 mL of total human plasma protein of which at least 98% is immunoglobulin G (IgG). At least 85% consists of monomers and dimers (typically >90%) and <10% of the IgG are aggregates. The distribution of the IgG subclasses closely resembles that found in normal human plasma (approximate ranges for Evogam ® : 47.8–58.1% IgG 1 , 38.8–49.3% IgG 2 , 0.9–1.4% IgG 3 , 1.4– 2.1% IgG 4 ). Evogam ® contains only trace amounts of IgA, typically <0.025 mg/mL. The pH value of the ready-to-use solution is 5.5. Evogam ® is manufactured from human plasma collected by Australian Red Cross Lifeblood. Evogam ® contains 2.25 g of glycine per 100 mL as a stabiliser. 3 PHARMACEUTICAL FORM Solution for subcutaneous administration. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Evogam ® is indicated in adults and children for replacement therapy in: • Primary Immunodeficiency Diseases (PID) and • symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. 4.2 D OSE AND METHOD OF ADMINISTRATION Evogam ® must be administered SUBCUTANEOUSLY . Treatment should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency. Evogam AU PI 10.00 Page 2 of 13 DOSAGE The dose and dosage interval must be individualised for each patient based on their measured IgG trough levels and ongoing clinical response. The following dose regimens are given as a guideline. A weekly dose in the range 0.05–0.15 g/kg body weight is recommended (this corresponds to a total monthly dose of Evogam ® in the range of 0.2–0.6 g/kg body weight). As the dose is given by body weight and adjusted to clinical outcome, the dose in the paediatric population is not considered to Прочитайте повний документ