Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
valaciclovir hydrochloride, Quantity: 556 mg (Equivalent: valaciclovir, Qty 500 mg)
Arrotex Pharmaceuticals Pty Ltd
valaciclovir hydrochloride
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica; Carnauba Wax; Colour
Oral
100 tablets
(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. For the treatment of ophthalmic zoster. For the treatment of herpes labialis (cold sores). For the treatment of clinical episodes of genital herpes simplex infections. For the prevention of recurrent genital herpes. Reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with Zelitrex, it is recommended that patients use safer sex practices. (See PRECAUTIONS). Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease.
Visual Identification: White, film coated tablet, white to off-white core, biconvex, elongated, unscored engraved with "500" on one side and plain on the other; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2012-08-30
1 AUSTRALIAN PRODUCT INFORMATION – ZELITREX (VALACICLOVIR AS HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Valaciclovir as hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ZELITREX tablets 500mg contain 500mg of valaciclovir as hydrochloride. 3 PHARMACEUTICAL FORM ZELITREX tablets 500mg: White, film coated tablet, white to off-white core, biconvex, elongated, unscored engraved with “500” on one side and plain on the other. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 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 recurrent herpes labialis (cold sores) For the treatment of clinical episodes of genital herpes simplex infections. For the prevention of recurrent genital herpes. Reduction of transmission of genital herpes in patients suffering from recurrent genital herpes. In addition to therapy with ZELITREX, it is recommended that patients use safer sex practices. (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Prophylaxis of cytomegalovirus (CMV) infection and disease following solid organ transplantation in patients at risk of CMV disease. 2 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE IN ADULTS FOR THE TREATMENT OF HERPES ZOSTER (SHINGLES) For treatment of herpes zoster, 1000 mg of ZELITREX three times a day for seven days. FOR THE TREATMENT OF HERPES LABIALIS (COLD SORES) The recommended dosage of ZELITREX for the treatment of cold sores is 2000 mg twice daily for 1 day with the second dose taken about 12 hours (no sooner than 6 hours) after the first dose. Therapy should be initiated at the earliest symptom of a cold sore (e.g. tingling, itching, or burning) GENITAL HERPES _For the treatment of genital herpes _ For treatment of first clinical presentation of genital herpes, 500 mg of ZELITREX twice a day for 5 to 10 days. For recurrent episodes of genital herpes, 500 mg twice Baca dokumen lengkap