Valtrex

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Valaciclovir hydrochloride 278mg equivalent to valaciclovir 250 mg;  ; Valaciclovir hydrochloride 278mg equivalent to valaciclovir 250 mg

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Valaciclovir hydrochloride 278 mg (equivalent to valaciclovir 250 mg)

Dosage:

250 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Valaciclovir hydrochloride 278mg equivalent to valaciclovir 250 mg   Excipient: Carnauba wax Colloidal silicon dioxide Crospovidone Edible ink blue brilliant 5312 Magnesium stearate Microcrystalline cellulose Opadry white OY-S-28861 Povidone Purified water   Active: Valaciclovir hydrochloride 278mg equivalent to valaciclovir 250 mg Excipient: Carnauba wax Colloidal silicon dioxide Crospovidone Magnesium stearate Microcrystalline cellulose Opadry white OY-S-28861 Povidone Purified water  

Units in package:

Blister pack, HSV Suppression pack, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Divi's Laboratories Limited

Therapeutic indications:

VALTREX is indicated for the treatment of herpes zoster (shingles) and the reduction of zoster - associated pain, which includes acute and post herpetic neuralgia, when given to immunocompetent patients in infection of less than 72 hours duration.

Product summary:

Package - Contents - Shelf Life: Blister pack, HSV Suppression pack - 60 tablets - 24 months from date of manufacture stored at or below 30°C

Authorization date:

1997-06-30

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
VALTREX 500 mg film coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains valaciclovir hydrochloride equivalent to 500 mg
valaciclovir
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTCIAL FORM
Film coated tablets.
White, biconvex, elongated, film coated tablets with a white to
off-white core,
unscored and engraved ‘GX CF1’ on one side.
4. CLINCAL PARTICULARS
_ _
4.1 THERAPEUTIC INDICATIONS
VALTREX is indicated for the treatment of herpes zoster (shingles) and
the
reduction of zoster - associated pain, which includes acute and post
herpetic
neuralgia, when given to immunocompetent patients in infection of less
than
72 hours duration.
VALTREX is indicated for the treatment of herpes simplex infections of
the
skin and mucous membranes including initial and recurrent genital
herpes in
immunocompetent patients.
VALTREX can prevent lesion development when taken at the first signs
and
symptoms of a herpes simplex virus (HSV) recurrence.
VALTREX is indicated for the prevention (suppression) of recurrent
herpes
simplex infections of the skin and mucous membranes, including genital
herpes in immunocompetent and immunocompromised patients.
VALTREX is indicated for the prophylaxis of cytomegalovirus (CMV)
infection
and disease, following organ transplantation. CMV prophylaxis with
VALTREX
reduces acute graft rejection (renal transplant patients),
opportunistic
infections and other herpes virus infections (herpes simplex virus
(HSV),
varicella zoster virus (VZV)).
4.2 DOSE AND METHOD OF ADMINISTRATION_ _
DOSE
Treatment of varicella zoster virus infections
Herpes zoster (shingles) including ophthalmic zoster
2
The dosage in adults is 1000 mg of VALTREX to be taken 3 times daily
for 7
days.
Treatment of herpes simplex infections
The dosage in adults is 500 mg of VALTREX to be taken twice daily.
For recurrent episodes, treatment should be for 5 days. For initial
episodes,
which can be more severe, treatment may have to be ext