Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
abacavir sulfate, Quantity: 702 mg (Equivalent: abacavir, Qty 600 mg); lamivudine, Quantity: 300 mg
ViiV Healthcare Pty Ltd
Tablet, film coated
Excipient Ingredients: sodium starch glycollate; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; sunset yellow FCF; polysorbate 80; macrogol 400
Oral
30 tablets
(S4) Prescription Only Medicine
KIVEXA tablets are a combination of two nucleoside analogues (abacavir and lamivudine). KIVEXA is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age.
Visual Identification: Orange, film-coated, modified capsule shaped tablets, debossed with GS FC2 on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2005-03-24
KIVEXA KIVEXA CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. Important safety information on KIVEXA hypersensitivity reaction is provided in the full CMI. Read before using this medicine. 1. WHY AM I USING KIVEXA? KIVEXA contains the active ingredients abacavir and lamivudine. KIVEXA is used together with other antiretrovirals to slow down the progression of human immunodeficiency virus (HIV) infection, which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (eg AIDS-related Complex or ARC). For more information, see Section 1. Why am I using KIVEXA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE KIVEXA? Do not use if you have ever had an allergic reaction to abacavir or lamivudine or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use KIVEXA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with KIVEXA and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE KIVEXA? • The normal dose for adults and adolescents is one tablet, once a day. • KIVEXA tablets should be swallowed whole with water. • KIVEXA tablets do not have to be taken with food. More instructions can be found in Section 4. How do I use KIVEXA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING KIVEXA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using KIVEXA. • If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. • For as long as you're taking KIVEXA, your doctor will arrange regular blood tests to check for side effects. • Keep in contact with your Citiți documentul complet
1 AUSTRALIAN PRODUCT INFORMATION KIVEXA (ABACAVIR AND LAMIVUDINE) FILM-COATED TABLETS ABACAVIR, A COMPONENT OF KIVEXA TABLETS, IS ASSOCIATED WITH HYPERSENSITIVITY REACTIONS, WHICH CAN BE LIFE-THREATENING, AND IN RARE CASES FATAL. KIVEXA TABLETS, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (TRIUMEQ, TRIZIVIR AND ZIAGEN), MUST NEVER BE RESTARTED FOLLOWING A HYPERSENSITIVITY REACTION (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE AND SECTION 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)). 1 NAME OF THE MEDICINE Abacavir (as sulfate) and lamivudine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION KIVEXA is supplied as film-coated tablets each containing 600 mg of abacavir as abacavir sulfate and 300 mg lamivudine. Abacavir sulfate is a white to off-white crystalline powder with a solubility of approximately 77 mg/mL in water at 25°C. Lamivudine is a white to off-white crystalline solid which is highly soluble in water. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Orange, film-coated, modified capsule shaped tablets, debossed with GS FC2 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS KIVEXA tablets are a combination of two nucleoside analogues (abacavir and lamivudine). KIVEXA is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age. 4.2 DOSE AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. KIVEXA tablets should not be administered to adults or adolescents who weigh less than 40 kg because it is a fixed-dose tablet that cannot be dose reduced. KIVEXA tablets can be taken with or without food. KIVEXA tablets should not be prescribed for patients requiring dosage adjustments, such as those with creatinine clearance < 30 mL/min. Separate preparations of abacavir (ZIAGEN) or 2 lamivudine (3TC) should be administered in cases where discontinuation or dose adjustment is indicate Citiți documentul complet