Vivere Cream 5 % ww

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ACYCLOVIR

Boleh didapati daripada:

SPG PHARMA (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

ACYCLOVIR

Unit dalam pakej:

5 gm

Dikeluarkan oleh:

SIAM BHEASACH CO LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
VIVERE CREAM 5% W/W
Acyclovir (5% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Vivere Cream is used for
2.
How Vivere Cream works
3.
Before you use Vivere Cream
4.
How to use Vivere Cream
5.
While you are using Vivere
Cream
6.
Side Effects
7.
Storage and Disposal of Vivere
Cream
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial number
WHAT VIVERE CREAM IS USED FOR
Vivere Cream is used to treat cold
sores and genital infections caused
by the herpes simplex virus.
HOW VIVERE CREAM WORKS
Vivere Cream contains a medicine
called acyclovir. It belongs to a
group of medicines called
antivirals.
Vivere Cream works by killing or
stopping the growth of viruses that
cause cold sores or genital herpes.
BEFORE YOU USE VIVERE CREAM
_- When you must not use it _
Do not use Vivere Cream if:
_ _
▪
you are allergic to acyclovir,
valacyclovir or any other
ingredients listed at the end of
this leaflet
-
_Before you start to use it_
Tell your doctor or pharmacist if:
▪
you have a condition where your
immune system works less well,
and your body is less able to
fight infections (e.g. if you have
human immunodeficiency virus
(HIV) or AIDS or if you have
had a bone marrow transplant)
_Pregnancy and breast-feeding _
Ask your doctor or pharmacist
before using any medicine.
_- Taking other medicines _
Please tell your doctor or
pharmacist if you are taking or
have recently taken any other
medicines. This includes traditional
products or medicines bought
without a prescription.
HOW TO USE VIVERE CREAM
_- How much to use_
Always use Vivere Cream exactly
as your doctor has told you. Check
with your doctor or pharmacist if
you are not sure.
_Adults and children_
▪
Apply a thin layer of cream to
the affected area five times a day
▪
You should space each
application of Vivere Cream by
four hours. Suggested times are:
7am, 11am, 3pm, 7pm and 11pm
▪
If your cold sore has not healed
after 4 days, or your genital
herpes sore has not healed aft

Ciri produk

Vivere Cream 5% w/w should be
applied to the lesions or impending
lesions as soon as possible,
preferably during the earliest stages
(prodrome or erythema). Treatment
can also be started during the later
(papule or blister) stages.
Treatment should be continued for
at least 4 days for herpes labialis
and for 5 days for genital herpes.
If healing has not occurred treatment
may be continued for up to 10 days.
ROUTE OF ADMINISTRATION:
Topical
CONTRAINDICATION(S):
Contraindicated in patients known
to be hypersensitive to acyclovir,
valacyclovir or any of the excipients
of Vivere Cream 5% w/w.
WARNINGS AND PRECAUTIONS:
For External Use Only.
Vivere Cream 5% w/w is not
recommended for application to
mucous membranes, such as in
the mouth, eye or vagina, as it
may be irritant. Particular care
should be taken to avoid accidental
introduction into the eye.
In severely immune-compromised
patients (e.g. AIDS patients or bone
marrow transplant recipients) oral
acyclovir dosing should be
considered. Such patients should
be encouraged to consult a
physician concerning the treatment
of any infection.
INTERACTIONS WITH
OTHER MEDICAMENTS:
No clinically significant interactions
have been identified.
NAME AND STRENGTH OF
ACTIVE SUBSTANCE:
Acyclovir 5% w/w.
PRODUCT DESCRIPTION:
A smooth odourless white cream.
PHARMACODYNAMICS:
Acyclovir is an antiviral agent
which is highly active in vitro
against herpes simplex virus (HSV)
types I and II and varicella zoster
virus. Toxicity to mammalian host
cells is low.
Acyclovir is phosphorylated after
entry into herpes infected cells to
the active compound acyclovir
triphosphate. The first step in this
process is dependent on the
presence of the HSV-coded
thymidine kinase. Acyclovir
triphosphate acts as an inhibitor
of and substrate for, the herpes-
specified DNA polymerase,
preventing further viral DNA
synthesis without affecting normal
cellular processes.
PHARMACOKINETICS:
Only minimal systemic absorption
of acyclovir following repeated
topical administration of
Vivere Cream 5% w/w.
INDICATIO