Valtrex

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Valaciclovir hydrochloride 556mg equivalent to valaciclovir 500 mg;  ; Valaciclovir hydrochloride 556mg equivalent to valaciclovir 500 mg

Inapatikana kutoka:

GlaxoSmithKline NZ Limited

INN (Jina la Kimataifa):

Valaciclovir hydrochloride 556 mg (equivalent to valaciclovir 500 mg)

Kipimo:

500 mg

Dawa fomu:

Film coated tablet

Tungo:

Active: Valaciclovir hydrochloride 556mg equivalent to valaciclovir 500 mg   Excipient: Carnauba wax Colloidal silicon dioxide Crospovidone Edible ink blue brilliant 5312 Magnesium stearate Microcrystalline cellulose Opadry white YS1-18043 Povidone Purified water   Active: Valaciclovir hydrochloride 556mg equivalent to valaciclovir 500 mg Excipient: Carnauba wax Colloidal silicon dioxide Crospovidone Magnesium stearate Microcrystalline cellulose Opadry white YS1-18043 Povidone Purified water  

Vitengo katika mfuko:

Blister pack, HSV treatment pack, 10 tablets

Darasa:

Prescription

Dawa ya aina:

Prescription

Viwandani na:

Divi's Laboratories Limited

Matibabu dalili:

· 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.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Blister pack, HSV treatment pack - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, HSV suppression treatment pack - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Shingles treatment pack - 42 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, polypropylene - 20 tablets - 24 months from date of manufacture stored at or below 30°C

Idhini ya tarehe:

1994-06-30

Taarifa za kipeperushi

VALTREX tablets
1
VALTREX TABLETS
_valaciclovir 500 mg _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using VALTREX
tablets.
This leaflet answers some common
questions about VALTREX tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking VALTREX
tablets against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VALTREX
TABLETS ARE USED FOR
VALTREX tablets belong to a group
of medicines called antivirals. It
works by killing or stopping the
growth of viruses called herpes
simplex (HSV), varicella zoster
(VZV) and cytomegolovirus (CMV).
VALTREX tablets can be used to:
•
treat shingles (herpes zoster)
•
treat HSV infections of the skin
and genital herpes. It is also used
to help prevent these infections
from returning
•
treat shingles affecting the eye
region (ophthalmic zoster)
•
prevent infection with CMV after
organ transplants.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU TAKE
VALTREX TABLETS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VALTREX TABLETS IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
valaciclovir or aciclovir
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT, TRYING TO BECOME
PREGNANT OR BREASTFEEDING,

Tabia za bidhaa

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