Unimed’s ChlorSept 2% with IPA Antiseptic Solution

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

Chlorhexidine Gluconate 20% Solution; Isopropyl Alcohol

متاح من:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (الاسم الدولي):

Chlorhexidine Gluconate 20% Solution; Isopropyl Alcohol

الوحدات في الحزمة:

250 ml; 60 ml; 500 ml; 500 ml

المصنعة من قبل:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

نشرة المعلومات

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
UNIMED`S CHLORSEPT 2% WITH IPA ANTISEPTIC
SOLUTION
10% v/v of Chlorhexidine gluconate 20% solution equivalent to
chlorhexidine gluconate (2.0% w/v), Isopropyl
Alcohol (70.0% v/v)
1
WHAT IS IN THIS LEAFLET
1.
What Unimed’s ChlorSept 2% is
used for
2.
How Unimed’s ChlorSept 2%works
3.
Before you use Unimed’s
ChlorSept 2%
4.
How to use Unimed’s ChlorSept
2%
5.
While you are using Unimed’s
ChlorSept 2%
6.
Side effects
7.
Storage and disposal
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT UNIMED’S CHLORSEPT 2% IS USED
FOR
Unimed’s
ChlorSept
2%
is
used
for
antiseptic purpose on the skin prior to
invasive medical procedure.
HOW UNIMED’S CHLORSEPT 2% WORKS
Unimed’s
ChlorSept
2%
contains
Chlorhexidine
gluconate
as
its
active
ingredient.
It
has
antiseptic
and
disinfectant properties.
Unimed’s
ChlorSept
2%
also
has
Isopropyl alcohol as its active ingredient,
which
has
bactericidal
and
antiseptic
properties.
BEFORE YOU USE UNIMED’S CHLORSEPT
2%
_-When you must not use it _
Tell your doctor before using Unimed’s
ChlorSept 2% if you

Have Chlorhexidine-related allergic
reactions.

Have
known
hypersensitivity
to
Unimed ChlorSept 2%’s with IPA
Antiseptic
Solution
or
any
of
its
components.
_-Pregnancy and breastfeeding _
No
effects
during
pregnancy
and
lactation are anticipated.
_-Taking other medicines _
Inform your doctor or pharmacist before
taking these medicines, including any
that you get without a prescription from
your pharmacy, supermarket or health
food shop.
Some
medicines
and
Unimed’s
ChlorSept 2% may interfere with each
other.
They
may
be
affected
by
Unimed’s ChlorSept 2% or may affect
how well it works.

Incompatible
with
soaps
or
other
anionic agents.

Suspending agents such as alginates
and tragacanth, insoluble powders such
as kaolin, and insoluble compounds of
calcium, magnesium, and zinc.

should not be brought into contact with
some vaccines and skin test injections

خصائص المنتج

UNIMED’S CHLORSEPT 2%WITH IPA ANTISEPTIC SOLUTION
COMPOSITION AND STRENGTH OF ACTIVE INGREDIENTS:
10% v/v of Chlorhexidine gluconate 20% solution equivalent to
chlorhexidine gluconate……2.0% w/v
Isopropyl alcohol
…………………………………………………………………………...….
70% v/v
PRODUCT DESCRIPTION
A clear, pink color solution
PHARMACODYNAMICS
Chlorhexidine gluconate is a type of chemical agent used to destroy or
inhibit the growth of pathogenic
micro-organisms in the non-sporing or vegetative state. Disinfectants
not necessarily kill all micro-
organisms but may reduce to the level of limiting or preventing
infection. The combination with alcohols
may have a synergistic effect and the antimicrobial efficacy of
chlorhexidine is much lower and slower
with possibility of occurrence in bacterial resistance. Disinfection
of catheter insertion sites with aqueous
chlorhexidine
2%
has been
reported
to
be
associated
with
fewer
local
and
systemic
infections.
Chlorhexidine is a bisbiguanide antiseptic and disinfectant that is
bactericidal or bacteriostatic with a wide
range of Gram-positive and Gram-negative bacteria. It is more
effective against Gram-positive than
Gram-negative bacteria, and some species of Pseudomonas and Proteus
have low susceptibility. It is
relatively ineffective against mycobacteria. Chlorhexidine inhibits
some viruses and is active against
some fungi. It is inactive against bacterial spores at room
temperature. Chlorhexidine is most active at a
neutral or slightly acid pH.
Isopropyl alcohol is a bactericidal agent that acts by the
denaturation of proteins. It is a rapidly bactericidal
and a fast-acting broad-spectrum antiseptic, but is not considered
persistent. At concentrations of 70%
v/v, it is a much effective antibacterial preservative than ethanol
(95%). The bactericidal effect of aqueous
solutions increases steadily as the concentration approaches 100% v/v.
However, isopropyl alcohol is
ineffective against bacterial spores.
PHARMACOKINETICS
Chlorhexidine