국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
lamivudine, Quantity: 10 mg/mL
ViiV Healthcare Pty Ltd
Oral Liquid, solution
Excipient Ingredients: citric acid; sodium hydroxide; propyl hydroxybenzoate; purified water; hydrochloric acid; sodium citrate dihydrate; methyl hydroxybenzoate; propylene glycol; sucrose; Flavour
Oral
240mL
(S4) Prescription Only Medicine
3TC (lamivudine) in combination with other antiretroviral agents is indicated for the treatment of HIV infected adults and children.
Visual Identification: Clear, colourless to pale yellow solution, with the odour of fruit.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1998-06-09
3TC ORAL SOLUTION _lamivudine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you start 3TC oral solution. This leaflet answers some common questions about 3TC oral solution. It does not contain all of 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. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the risks of you taking 3TC against the expected benefits it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE ORAL SOLUTION. You may need to read it again. WHAT 3TC ORAL SOLUTION IS USED FOR 3TC oral solution contains lamivudine which belongs to a group of medicines called antivirals. 3TC 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 (eg AIDS-related Complex or ARC). 3TC 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 3TC 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. 3TC oral solution is not addictive. Your doctor may have prescribed 3TC oral solution for another reason. Ask your doctor if you have any questions about why 3TC oral solution have been prescribed for you. BEFORE Y 전체 문서 읽기
1 AUSTRALIAN PRODUCT INFORMATION 3TC (LAMIVUDINE) FILM-COATED TABLETS AND ORAL SOLUTION 1 NAME OF THE MEDICINE Lamivudine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lamivudine is a white to off-white crystalline solid which is highly soluble in water. 3TC Tablets contain 150 mg or 300 mg lamivudine. 3TC Oral Solution contains 10 mg/mL lamivudine. 3TC Oral Solution also contains 20% (w/v) sucrose, methyl hydroxybenzoate (218) and propyl hydroxybenzoate (216). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM TABLETS 3TC 150 mg tablets are available as both scored and unscored tablets. 3TC 150 mg unscored tablets are white, film-coated, diamond-shaped tablets, engraved 'GX CJ7' on the upper tablet face. Each tablet contains 150 mg of lamivudine. 3TC 150 mg scored tablets are white, film-coated, diamond-shaped tablets, engraved 'GX CJ7' on both tablet faces. Each tablet contains 150 mg of lamivudine. 3TC 300 mg tablets are grey, film-coated, diamond-shaped, engraved ‘GX EJ7’ on the upper tablet face. Each tablet contains 300 mg of lamivudine. ORAL SOLUTION Strawberry/banana flavoured. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 3TC (lamivudine) 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). 2 Clinical studies indicate that 3TC should be used in combination with other antiretroviral therapies. In controlled trials in adults, 3TC 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 modelli 전체 문서 읽기