Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
valaciclovir, Quantity: 500 mg
Sun Pharma ANZ Pty Ltd
Valaciclovir
Tablet, film coated
Excipient Ingredients: povidone; magnesium stearate; indigo carmine aluminium lake; crospovidone; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 6000; macrogol 400
Oral
100 tablets per pack, 30 tablets per pack, 42 tablets per pack, 10 tablets per pack
(S4) Prescription Only Medicine
For the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. Treatment of ophthalmic zoster. Treatment of clinical episodes of genital herpes simplex infections. For the prevention of recurrent genital herpes in immunocompromised patients with creatinine clearance of > 15 ml/min. For the reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with valaciclovir, it is recommended that patients use safer sex practices (see PRECAUTIONS). For prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.
Visual Identification: Blue, capsule shaped, biconvex, film coated, tablets, debossed with 'V' AND '5' on either side of breakline on one side, notched on either side along with the breakline and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-07-09
Valaciclovir RBX CMI V4 June 2019 Page 1 of 11 VALACICLOVIR RBX _VALACICLOVIR TABLETS_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VALACICLOVIR RBX (valaciclovir). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from https://www.ebs.tga.gov.au/ and may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking VALACICLOVIR RBX against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with this medicine. You may need to read it again. WHAT VALACICLOVIR RBX TABLET IS USED FOR VALACICLOVIR RBX tablets contain valaciclovir (as hydrochloride). VALACICLOVIR RBX tablets belong to a group of medicines called anti-virals. VALACICLOVIR RBX tablets are used for one or more of the following in adults: _TREATMENT OF HERPES ZOSTER (SHINGLES): _Valaciclovir_ _works by stopping the multiplication of the virus which causes shingles. It can reduce the length and severity of an outbreak of shingles and the duration of pain associated with shingles. It is important the treatment is started within the first three days of the shingles attack. Valaciclovir RBX CMI V4 June 2019 Page 2 of 11 _TREATMENT OF OPHTHALMIC ZOSTER (SHINGLES AFFECTING THE EYE _ _REGION)_ _TREATMENT OF GENITAL HERPES INFECTION:_ Valaciclovir works by stopping the multiplication of the virus which causes herpes. It can reduce the length and severity of an outbreak of herpes, the duration of pain and shorten the time to healing of crusts associated with herpes. They do not eliminate the herpes virus from the body. The herpes virus is also known a Đọc toàn bộ tài liệu
Valaciclovir RBX PI V5 June 2019 1 AUSTRALIAN PRODUCT INFORMATION VALACICLOVIR RBX VALACICLOVIR 1 NAME OF THE MEDICINE Valaciclovir 2 QUALITATIVE AND QUANTITATIVE COMPOSITION VALACICLOVIR RBX film-coated tablet contains 500 mg valaciclovir (as hydrochloride). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablet. Blue coloured, capsule shaped, biconvex, film coated tablets, debossed with ‘V’ and ‘5’ on either side of the breakline on one side, notched on either side along with the breakline and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC PARTICULARS VALACICLOVIR RBX is indicated: • For the treatment of herpes zoster (shingles) in adult patients who commence therapy within 72 hours of the onset of rash. • For the treatment of ophthalmic zoster. • For the treatment of clinical episodes of genital herpes simplex infections. • For the prevention of recurrent genital herpes in immunocompromised patients with creatinine clearance of >15 mL/min. • For reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with VALACICLOVIR RBX (valaciclovir), it is recommended that patients use safer sex practices. (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). • For prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE IN ADULTS For treatment of herpes zoster, 1000 mg of valaciclovir (2 tablets of VALACICLOVIR RBX) three times a day for seven days. Valaciclovir RBX PI V5 June 2019 2 For treatment of first clinical presentation of genital herpes, 500 mg of valaciclovir (1 tablet of VALACICLOVIR RBX) twice a day for 5 to 10 days. For recurrent episodes of genital herpes, 500 mg of valaciclovir (1 tablet of VALACICLOVIR RBX) twice daily for 5 days. Dosing should begin as early as possible. For recurrent episodes of genital herpes, this should ideally be duri Đọc toàn bộ tài liệu