Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
hepatitis B immunoglobulin, Quantity: 400 IU; human immunoglobulin G, Quantity: 160 mg/mL
CSL Behring Australia Pty Ltd
hepatitis B immunoglobulin,human immunoglobulin G
Injection, solution
Excipient Ingredients: glycine; water for injections; human immunoglobulin A
Intramuscular
400IU X 1
(S4) Prescription Only Medicine
Hepatitis B Immunoglobulin-VF is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis B antibody level is inadequate (<10IU/L). Post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to HBsAg-positive or suspected HBsAg-positive material, for example, by needle stick, oral ingestion or sexual exposure. Hepatitis B Immunoglobulin-VF is also indicated for prophylaxis in infants born to HBsAg-positive mothers.
Visual Identification: Clear to opalescent, colourless, solution; Container Type: Vial; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1998-10-21
Hepatitis B Immunoglobulin-VF AU CMI 10.00 Page 1 of 3 HEPATITIS B IMMUNOGLOBULIN-VF Human Hepatitis B Immunoglobulin, solution for intramuscular injection. CONSUMER MEDICINE INFORMATION_ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Hepatitis B Immunoglobulin-VF. It does not contain complete information about Hepatitis B 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 HEPATITIS B IMMUNOGLOBULIN-VF IS USED FOR Hepatitis B Immunoglobulin-VF is manufactured from human plasma (the liquid component of blood) collected by Australian Red Cross Lifeblood. Hepatitis B Immunoglobulin-VF contains protein substances called antibodies which can prevent infection from developing in a person who has been exposed to the hepatitis B virus. Hepatitis B Immunoglobulin-VF is used to prevent hepatitis B infection in a person who comes into contact with blood or other material suspected of being infected with hepatitis B, for example, by accidental needle stick injury or sexual exposure. It is also given to babies born to mothers with hepatitis B infection. Ask your doctor if you have any questions about why Hepatitis B 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 HEPATITIS B IMMUNOGLOBULIN-VF MAKE SURE YOU TELL YOUR DOCTOR OF ANY REASONS YOU KNOW OF WHY YOU SHOULD NOT BE GIVEN THIS MEDICINE. 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 sw Baca dokumen lengkapnya
Hepatitis B Immunoglobulin-VF AU PI 11.00 Page 1 of 9 AUSTRALIAN PRODUCT INFORMATION HEPATITIS B IMMUNOGLOBULIN-VF (HUMAN HEPATITIS B IMMUNOGLOBULIN) – SOLUTION FOR INTRAMUSCULAR INJECTION 1 NAME OF THE MEDICINE Human Hepatitis B Immunoglobulin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hepatitis B Immunoglobulin-VF is a sterile, preservative-free solution containing 160 mg/mL human plasma protein of which at least 98% is immunoglobulin (mainly IgG), with a hepatitis B antibody titre of not less than 100 IU/mL. Hepatitis B Immunoglobulin-VF contains less than 0.5 mg/mL immunoglobulin A (IgA). The pH value of the ready-to-use solution is 6.6. Hepatitis B Immunoglobulin-VF is manufactured from human plasma collected by Australian Red Cross Lifeblood. Hepatitis B Immunoglobulin-VF contains 22.5 mg/mL glycine. 3 PHARMACEUTICAL FORM Solution for intramuscular injection. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Hepatitis B Immunoglobulin-VF is indicated for post-exposure prophylaxis in persons who did not receive prior vaccination, or whose prior vaccination regimen is incomplete, or when the hepatitis B antibody level is inadequate (<10 IU/L). Post-exposure prophylaxis should be considered following percutaneous or permucosal exposure to HBsAg-positive or suspected HBsAg-positive material, for example, by needle stick, oral ingestion or sexual exposure. Hepatitis B Immunoglobulin-VF is also indicated for prophylaxis in infants born to HBsAg-positive mothers. Hepatitis B Immunoglobulin-VF AU PI 11.00 Page 2 of 9 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE _Prophylaxis with Hepatitis B Immunoglobulin-VF in adults following percutaneous or _ _permucosal exposure to HBsAg-positive or suspected HBsAg-positive material: _ Refer to TABLE 1 . TABLE 1: PROPHYLAXIS WITH HEPATITIS B IMMUNOGLOBULIN-VF IN ADULTS FOLLOWING PERCUTANEOUS OR PERMUCOSAL EXPOSURE TO HBSAG-POSITIVE OR SUSPECTED HBSAG-POSITIVE MATERIAL SOURCE MATERIAL VACCINATION HISTORY NO PRIOR VACCINATION OR INCOMPLETE VACCINATION REGIMEN COMPLETED VACCI Baca dokumen lengkapnya