VALACICLOVIR

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

VALACICLOVIR HYDROCHLORIDE MONOHYDRATE

Fáanlegur frá:

Accord Healthcare Limited

ATC númer:

J05AB11

INN (Alþjóðlegt nafn):

VALACICLOVIR HYDROCHLORIDE MONOHYDRATE

Skammtar:

500 Milligram

Lyfjaform:

Film Coated Tablet

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

valaciclovir

Leyfisstaða:

Marketed

Leyfisdagur:

2009-05-28

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valaciclovir 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg valaciclovir (as valaciclovir
hydrochloride monohydrate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oval, white, biconvex, film-coated tablets, 17.6 x 8.8 mm with VC2 on
one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Varicella zoster virus (VZV) infections – herpes zoster_
Valaciclovir is indicated for the treatment of herpes zoster
(shingles) and ophthalmic zoster in immunocompetent adults
(see sections 4.4).
Valaciclovir is indicated for the treatment of herpes zoster in adult
patients with mild or moderate immunosuppression
(see section 4.4).
_Herpes simplex virus (HSV) infections_
Valaciclovir is indicated
-
for the treatment and suppression of HSV infections of the skin and
mucous membranes including
-
treatment of first-episode of genital herpes in immunocompetent adults
and adolescents and in
immunocompromised adults
-
treatment of recurrences of genital herpes in immunocompetent adults
and adolescents, and in
immunocompromised adults
-
suppression of recurrent genital herpes in immunocompetent adults and
adolescents and in
immunocompromised adults
-
treatment and suppression of recurrent ocular HSV infections (see
section 4.4).
Clinical studies have not been conducted in HSV-infected patients
immunocompromised for other causes than HIV-
infection (see section 5.1).
_Cytomegalovirus (CMV) infections_:
Valaciclovir is indicated for the prophylaxis of CMV infection and
disease following solid organ transplantation in
adults and adolescents (see section 4.4)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Varicella zoster virus (VZV) infections – herpes zoster and
ophthalmic zoster_
Patients should be advised to start treatment as soon as possible
after a diagnosis of herpes zoster.
There are no data on treatment started more than 72 hours after onset
of the zoste