Unimed's ChlorSept 5% Antiseptic Solution

Country: Malaysia

Language: English

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

Active ingredient:

Chlorhexidine Gluconate 20% Solution

Available from:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (International Name):

Chlorhexidine Gluconate 20% Solution

Units in package:

120 ml; 1000 ml

Manufactured by:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
UNIMED`S CHLORSEPT 5% ANTISEPTIC SOLUTION
25.0% v/v of Chlorhexidine gluconate 20% solution equivalent to
chlorhexidine gluconate……….5% w/v
1
WHAT IS IN THIS LEAFLET
1.
What UNIMED’S CHLORSEPT
5% is used for
2.
How UNIMED’S CHLORSEPT
5% works
3.
Before you use UNIMED’S
CHLORSEPT 5%
4.
How to use UNIMED’S
CHLORSEPT 5%
5.
While you are using UNIMED’S
CHLORSEPT 5%
6.
Side effects
7.
Storage and disposal
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT UNIMED’S CHLORSEPT 5%
IS USED FOR
UNIMED’S CHLORSEPT 5% is used
for preoperative skin disinfection and for
wounds or burns.
HOW UNIMED’S CHLORSEPT 5%
WORKS
UNIMED’S CHLORSEPT 5% contains
Chlorhexidine
gluconate
as
its
active
ingredient. It has antiseptic properties
which
kills
bacteria
and
inhibit
the
bacterial growth.
BEFORE
YOU
USE
UNIMED’S
CHLORSEPT 5%
_-When you must not use it _
Tell
your
doctor
before
using
UNIMED’S CHLORSEPT 5% if you

have hypersensitivity (itching, skin
rash,
redness,
swelling,
breathing
difficulties, light headedness, rapid
heart rate development)

anaphylactic shock.

Allergic reaction to Chlorhexidine.
_-Pregnancy and breastfeeding _
No
effects
during
pregnancy
and
lactation are anticipated, since systemic
exposure to chlorhexidine gluconate is
negligible
_._
_-Taking other medicines _
Inform your doctor or pharmacist before
taking this medicines, including any that
you get without a prescription from your
pharmacy, supermarket or health food
shop.
Some
medicines
and
UNIMED’S
CHLORSEPT
5%
may
interfere
with
each other. They may be affected by
UNIMED’S CHLORSEPT 5% or may
affect how well it works.

Incompatible
with
soaps
or
other
anionic agents.
HOW TO USE UNIMED’S CHLORSEPT
5%
_-How much to use _
Always use UNIMED’S CHLORSEPT
5%
exactly
as
your
doctor
has
prescribed. You should check with your
doctor or pharmacist if in doubt.
The usual dose:

_Pre-Operative Skin Disinfection: _
To be
used di

Summary of Product characteristics

UNIMED’S CHLORSEPT 5% ANTISEPTIC SOLUTION
NAME AND STRENGTH OF ACTIVE SUBSTANCE:
25.0%
v/v
of
Chlorhexidine
gluconate
20%
solution
equivalent
to
chlorhexidine
gluconate…..5% w/v
DESCRIPTION:
PRODUCT DESCRIPTION
A clear reddish pink solution with lavender fragrance
PHARMACODYNAMICS
Chlorhexidine is a bisbiguanide antiseptic that is bactericidal (kills
bacteria) or bacteriostatic
(inhibits bacterial growth) against a wide range of Gram-positive and
Gram-negative bacteria.
Chlorhexidine kills bacteria by binding cationic molecule to
negatively charged bacterial cell
walls and microbial complexes leading to precipitation of cytoplasmic
contents of bacterial cell
wall which results in cell death. At lower concentration, it acts as a
bacteriostatic by alteration
of bacterial cell osmotic equilibrium and leakage of potassium and
phosphorus.
PHARMACOKINETICS
Chlorhexidine is poorly absorbed from the skin.
_ _
_ _
INDICATIONS
Unimed’s ChlorSept 5% Antiseptic Solution used for preoperative skin
disinfection and for
wounds or burns.
_ _
_ _
RECOMMENDED DOSE
_Pre-Operative Skin Disinfection:_
To be used diluted with 1: 10 in 70% alcohol for preoperative
skin disinfection
_ _
_General cleansing for wounds or burns: _
To be used with 1: 100 in 70% alcohol for wounds or
burns.
_ _
_ _
ROUTE OF ADMINISTRATION
For topical use only.
CONTRAINDICATIONS
Hypersensitivity including anaphylactic shock.
WARNING AND PRECAUTIONS
For external use only
Keep this medicine out of the reach of children.
Unimed’s ChlorSept 5% Antiseptic Solution contains chlorhexidine.
Chlorhexidine is known to induce hypersensitivity, including
generalised allergic reactions and
anaphylactic
shock.
The
prevalence
of
chlorhexidine
hypersensitivity
is
unknown,
but
available literature suggests this is likely to be very rare.
Unimed’s ChlorSept 5% Antiseptic Solution should not be administered
to anyone with a
possible history of an allergic reaction to chlorhexidine. If any
signs or symptoms of a
suspected hypersensitivity reaction such as itching, skin