Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
human immunoglobulin G, Quantity: 50 mg/mL; cytomegalovirus immunoglobulin, Quantity: 1500000 U
CSL Behring Australia Pty Ltd
cytomegalovirus immunoglobulin,human immunoglobulin G
Injection, intravenous infusion
Excipient Ingredients: water for injections; human immunoglobulin A; maltose
Intravenous
potency fill
(S4) Prescription Only Medicine
CMV Immunoglobulin-VF is indicated for the prevention of CMV infection following bone marrow and renal transplants. Specifically, the product is indicated when the recipient is seronegative for CMV and receives a graft from a CMV positive donor. CMV Immunoglobulin-VF may also be a helpful adjunct to therapy in patients with established CMV infection, e.g. CMV pneumonitis.
Visual Identification: Clear, colourless, slightly viscous solution; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1991-11-04
CMV Immunoglobulin-VF AU CMI 16.00 Page 1 of 4 CMV IMMUNOGLOBULIN-VF Human Cytomegalovirus Immunoglobulin, solution for intravenous infusion. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CMV Immunoglobulin-VF. The letters CMV stand for cytomegalovirus, a type of virus. It does not contain complete information about CMV Immunoglobulin-VF. 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 CMV IMMUNOGLOBULIN-VF IS USED FOR CMV Immunoglobulin-VF is manufactured from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood. Donations are selected on the basis that they contain high levels of specific antibody to the cytomegalovirus. CMV Immunoglobulin-VF contains protein substances called antibodies, which can provide protection against cytomegalovirus infection. CMV Immunoglobulin-VF is used to prevent cytomegalovirus infection in specific transplant patients. It may also help in the treatment of cytomegalovirus infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY CMV IMMUNOGLOBULIN-VF HAS BEEN PRESCRIBED FOR YOU. Your doctor will have assessed the risks and benefits associated with the use of this medicine for you. BEFORE YOU ARE GIVEN CMV IMMUNOGLOBULIN-VF MAKE SURE YOU TELL YOUR DOCTOR OF ANY REASONS YOU KNOW OF WHY YOU SHOULD NOT BE GIVEN THIS MEDICINE. INFORM YOUR DOCTOR OF YOUR BLOOD GROUP, IF KNOWN. YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE: • a history of allergy to human immunoglobulin products (allergic reactions may include skin rash, face swelling, wheezing or breathing difficulties) or previ Read the complete document
CMV Immunoglobulin-VF AU PI 18.00 Page 1 of 11 AUSTRALIAN PRODUCT INFORMATION CMV IMMUNOGLOBULIN-VF (HUMAN CYTOMEGALOVIRUS IMMUNOGLOBULIN) – SOLUTION FOR INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Human Cytomegalovirus Immunoglobulin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CMV Immunoglobulin-VF is a sterile, preservative free solution containing 50–70 mg/mL human plasma protein of which at least 98% is immunoglobulin (mainly IgG), with a cytomegalovirus (CMV) immunoglobulin activity of 1.5 million units per vial. The content of CMV immunoglobulin is defined in terms of EIA (enzyme immunoassay) units. One unit is equivalent to the specified volume of a standard CMV Immunoglobulin. The distribution of the IgG subclasses closely resembles that found in normal human plasma (approximate mean ranges: 52.5–64.9% IgG 1 , 29.0–42.2% IgG 2 , 3.1–6.8% IgG 3 , 0.4– 1.2% IgG 4 ). CMV Immunoglobulin-VF contains less than 0.5 mg/mL immunoglobulin A (IgA). The pH value of the ready-to-use solution is 4.25. CMV Immunoglobulin-VF is manufactured from human plasma collected by Australian Red Cross Lifeblood. Isotonicity is achieved by the addition of 292 mmol/L maltose. 3 PHARMACEUTICAL FORM Solution for intravenous infusion. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS CMV Immunoglobulin-VF is indicated for the prevention of CMV infection following bone marrow and renal transplants. Specifically, the product is indicated when the recipient is seronegative for CMV and receives a graft from a CMV positive donor. CMV Immunoglobulin-VF may also be a helpful adjunct to therapy in patients with established CMV infection, e.g. CMV pneumonitis. CMV Immunoglobulin-VF AU PI 18.00 Page 2 of 11 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE Because there is currently no international standard for CMV Immunoglobulin-VF, recommended dosage remains empirical. For prophylactic use it is recommended that patients receive 25,000 units/kg on days -4, -2, on the day of transplantation (intra-operatively) and then weekly for a fu Read the complete document