Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
lamivudine, Quantity: 150 mg
Alphapharm Pty Ltd
Lamivudine
Tablet, film coated
Excipient Ingredients: magnesium stearate; sodium starch glycollate type A; propylene glycol; microcrystalline cellulose; titanium dioxide; hypromellose
Oral
60
(S4) Prescription Only Medicine
Lamivudine tablets in combination with other antiretroviral agents is indicated for the treatment of HIV infected adults and children.
Visual Identification: A white to off-white film coated, capsule shaped, biconvex tablet debossed with "M105" on one side of the tablet and a scoreline on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2012-02-16
LAMIVUDINE ALPHAPHARM _contains the active ingredient lamivudine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start LAMIVUDINE ALPHAPHARM tablets. This leaflet answers some common questions about LAMIVUDINE ALPHAPHARM tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist (also known as a chemist). All medicines have benefits and risks. Some new risks are found even when a medicine has been used for many years. Your doctor has weighed the risks of you taking LAMIVUDINE ALPHAPHARM tablets against the expected benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE TABLETS. You may need to read it again. WHAT LAMIVUDINE ALPHAPHARM TABLETS ARE USED FOR LAMIVUDINE ALPHAPHARM tablets contain lamivudine which belongs to a group of medicines called antivirals. Lamivudine is used together with other antivirals to slow down the progression of human immunodeficiency virus (HIV) infection, which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (e.g. AIDS-related Complex or ARC). Lamivudine does not cure AIDS or kill the HIV virus, but prevents further damage to the immune system by stopping production of new viruses. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people. You will still be able to pass on the HIV virus by sexual activity or by contamination with infected blood. You should still use proper precautions. While taking LAMIVUDINE ALPHAPHARM tablets and/or any other therapy for HIV disease, you may continue to develop other infections and other complications of HIV infection. You should keep in regular contact with the doctor who is looking after you. LAMIVUDINE ALPHAPHARM tablets are not addictive. Ask your doctor if you have any q Прочитать полный документ
AUSTRALIAN PRODUCT INFORMATION LAMIVUDINE ALPHAPHARM _Lamivudine film-coated tablets _ 1 NAME OF THE MEDICINE Lamivudine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LAMIVUDINE ALPHAPHARM film-coated tablets contain 150 mg or 300 mg lamivudine as the active ingredient. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM LAMIVUDINE ALPHAPHARM 150 mg film-coated tablets: White to off-white film-coated, capsule shaped, biconvex tablet debossed with “M105” on one side of the tablet and a score line on the other side. LAMIVUDINE ALPHAPHARM 300 mg film-coated tablets: White to off-white, film-coated, oval shaped, biconvex tablet debossed with “M300” on one side of the tablet and blank on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lamivudine tablets in combination with other antiretroviral agents is indicated for the treatment of HIV infected adults and children. 4.2 DOSE AND METHOD OF ADMINISTRATION Food reduces the C max and extends the T max but the amount of drug absorbed is not reduced. The clinical significance of this is not known (see SECTION 5.2 PHARMACOKINETIC PROPERTIES ). Clinical studies indicate that lamivudine should be used in combination with other antiretroviral therapies. In controlled trials in adults, lamivudine was used in combination with zidovudine 200 mg tds (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS ). Since accurate dosing cannot be achieved with this formulation, dosing according to weight bands is recommended for scored tablets. This dosing regimen for paediatric patients weighing 14 - 30 kg is based primarily on pharmacokinetic modelling. Therefore monitoring of efficacy and safety is necessary in these patients. More accurate dosing can be achieved with oral solution of lamivudine (see Section 5.2 PHARMACOKINETIC PROPERTIES - PHARMACOKINETICS IN CHILDREN ). To ensure administration of the entire recommended dose, the tablet(s) should be swallowed whole and not divided or crushed. If the patient is unabl Прочитать полный документ