Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
tetanus immunoglobulin, Quantity: 4000 IU; human immunoglobulin G, Quantity: 50 mg/mL
CSL Behring Australia Pty Ltd
human immunoglobulin G,tetanus immunoglobulin
Injection, intravenous infusion
Excipient Ingredients: maltose; water for injections; human immunoglobulin A
Intravenous
4000IU X 1
(S4) Prescription Only Medicine
Tetanus Immunoglobulin-VF (For Intravenous Use) is used in the management of clinical tetanus.
Visual Identification: Slightly viscous solution - clear and colourless; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1991-11-04
Tetanus Immunoglobulin-VF (For Intravenous Use) AU CMI 15.00 Page 1 of 4 TETANUS IMMUNOGLOBULIN-VF_ _(FOR INTRAVENOUS USE) Human Tetanus Immunoglobulin, solution for intravenous infusion. CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tetanus Immunoglobulin-VF (For Intravenous Use). It does not contain complete information about Tetanus Immunoglobulin-VF (For Intravenous Use). 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 TETANUS IMMUNOGLOBULIN-VF (FOR INTRAVENOUS USE) IS USED FOR Tetanus Immunoglobulin-VF (For Intravenous Use) 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 antibodies against the poison produced by bacteria which cause tetanus. This medicine is used for the treatment of tetanus infection. Ask your doctor if you have any questions about why Tetanus Immunoglobulin-VF (For Intravenous Use) has been prescribed for you. Your doctor will have assessed the risks and benefits for you associated with the use of this product. BEFORE YOU ARE GIVEN TETANUS IMMUNOGLOBULIN-VF (FOR INTRAVENOUS USE) TELL YOUR DOCTOR IF YOU HAVE, OR HAVE HAD, AN ALLERGY TO HUMAN IMMUNOGLOBULIN PRODUCTS OR TO MALTOSE. SOME OF THE SYMPTOMS OF AN ALLERGIC REACTION MAY INCLUDE RASH, ITCHINESS, SWELLING OF THE LIPS AND TONGUE, SHORTNESS OF BREATH. TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES OR IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO AN INJECTION. TELL YOUR DOCTOR ALSO IF YOU: • have previously been advised t Read the complete document
Tetanus Immunoglobulin-VF (IV) AU PI 16.00 Page 1 of 10 AUSTRALIAN PRODUCT INFORMATION TETANUS IMMUNOGLOBULIN-VF (FOR INTRAVENOUS USE) (HUMAN TETANUS IMMUNOGLOBULIN) – SOLUTION FOR INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Human Tetanus Immunoglobulin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tetanus Immunoglobulin-VF (For Intravenous Use) 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 tetanus antitoxin activity of 4000 IU per vial. 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 ). Tetanus Immunoglobulin-VF (For Intravenous Use) contains less than 0.5 mg/mL immunoglobulin A (IgA). The pH value of the ready-to-use solution is 4.25. Tetanus Immunoglobulin-VF (For Intravenous Use) 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 Tetanus Immunoglobulin-VF (For Intravenous Use) is used in the management of clinical tetanus. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE The recommended dose of Tetanus Immunoglobulin-VF (For Intravenous Use) for the treatment of tetanus is 4000 IU. After administration of this dose (4000 IU), it has been Tetanus Immunoglobulin-VF (IV) AU PI 16.00 Page 2 of 10 shown that circulating antibody levels are maintained above the minimum protective titre for at least 6 weeks. The dose, therefore, need not be repeated. ADMINISTRATION If the product appears to be turbid by transmitted light or contains any sediment it must not be used, and the vial should be returned to Australian Red Cross Lifeblood. THE PRODUCT DOES NOT CONTAIN AN ANTIMICROBIAL PRESERVATIVE. IT MUST, THEREFORE, BE USED IMMEDIATELY AFTER OPENING THE VIAL. ANY UNUSED PORTION MUST BE Read the complete document