RinsA CGC 15 (Chlorhexidine Gluconate 0.015% wv and Cetrimide 0.15% wv Irrigation Solution)

Country: Malaysia

Language: English

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

Active ingredient:

CHLORHEXIDINE GLUCONATE; CETRIMIDE

Available from:

AIN MEDICARE SDN. BHD.

INN (International Name):

CHLORHEXIDINE GLUCONATE; CETRIMIDE

Units in package:

30 ml

Manufactured by:

AIN MEDICARE SDN. BHD.

Patient Information leaflet

RINSA CGC 15
Chlorhexidine Gluconate 0.015% w/v and Cetrimide 0.15% w/v Irrigation
Solution
RINSA CGC 50
Chlorhexidine Gluconate 0.05% w/v and Cetrimide 0.5% w/v Irrigation
Solution
Page 1/2
_Consumer Medication Information Leaflet (RiMUP)_
_ _
WHAT IS IN THIS LEAFLET
1.
What
RinsA CGC
is used for
2.
How
RinsA CGC
works
3.
Before you use
RinsA CGC
4.
How to use
RinsA CGC
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
8.
RinsA CGC
9.
Product Description
10.
Manufacturer
and
Product
Registration Holder
11.
Date of Revision
12.
Serial Number
WHAT
RINSA CGC
IS USED FOR
RinsA
CGC
is
an
antiseptic
solution
used for cleansing and irrigating the skin
and wound.
HOW
RINSA CGC
WORKS
RinsA
CGC
is
an
agent
to
kill
microorganism upon contact. It is used
to
prevent
infection
by
destroying
microorganisms
on
skin.
It
works
by
killing the bacteria that cause infection.
BEFORE YOU USE
RINSA CGC
When you must not use it
Do not take
RinsA CGC
if you are
allergic (hypersensitive) to chlorhexidine
gluconate
or
cetrimide
or
any
of
the
ingredients
listed
in
the
Product
Description section.
Before you start to use it
RinsA CGC
is for external use only.
Not for injection.
RinsA CGC
should only be applied to
the skin gently. When the solution has
been applied in an over vigorous
manner
to very fragile or sensitive skin or after
repeated use, rash, inflammation, itching,
dry
and/or
flaky
skin
and
pain
may
occur. At the first sign of any of these
reactions, applications of
RinsA CGC
should be stopped
.
_Pregnancy _
Chlorhexidine has been used by a large
number of pregnant women and women
of childbearing age without any proven
increase
in
the
frequency
of
malformations or other direct or indirect
harmful effects on the fetus having been
observed.
Based on negligible topical absorption
and
a
complete
lack
of
any
unusual
reported
effects
when
used
during
pregnancy,
chlorhexidine
would
not
appear
to
present
a
risk
to
pregnant
women.
No
special
precautions
or
changes
in
methods
of
application
or
use
of
chlorhexidine seem nee

Summary of Product characteristics

USER INFORMATION
READ CAREFULLY
RINSA CGC 15
(Chlorhexidine Gluconate 0.015% w/v and Cetrimide 0.15% w/v Irrigation
Solution)
Sterile Topical Antiseptic Solution
PRODUCT DESCRIPTION:
RinsA CGC 15
is a clear, orange and sterile irrigation solution.
PHARMACODYNAMICS:
CHLORHEXIDINE: Chlorhexidine is an antiseptic and disinfectant which
is effective
against a wide range of vegetative Gram-positive and Gram-negative
organisms, some
viruses and some fungi. It is ineffective against bacterial spores at
room temperature,
and acid-fast bacteria are inhibited but not killed. It is more active
against Gram-positive
than Gram-negative bacteria and some species of Pseudomonas and
Proteus are
relatively less susceptible. Chlorhexidine is most active at a neutral
or slightly acid pH
and its activity may be reduced by blood and other organic matter.
CETRIMIDE: Cetrimide is a quaternary ammonium disinfectant with
properties typical
of cationic surfactants. Solutions of these surfactants have
emulsifying and detergent
properties and bactericidal activity against both Gram-positive and
Gram-negative
organisms but higher concentrations are necessary to kill the latter.
The combined
detergent and antibacterial properties of cetrimide make it useful in
cleansing dirty or
infected wounds. It is however, relatively ineffective against
bacterial spores, acid-fast
bacteria, viruses and fungi.
PHARMACOKINETICS :
Chlorhexidine is poorly absorbed from the gastrointestinal tract and
skin.
INDICATION :
RinsA CGC 15
is for cleansing and irrigating the skin and dirty wounds where an
added surfactant effect is required.
RECOMMENDED DOSAGE :
Rinse the area to be cleaned with water, apply the minimum amount of
RinsA CGC
15
necessary to cover the wound area and wash gently. Rinse again
thoroughly. Apply
to wound as necessary. Discard remaining solution after use.
ROUTE OF ADMINISTRATION :
Topical
CONTRAINDICATIONS :
RinsA CGC 15
should not be used in patients with known hypersensitivity to either
chlorhexidine or cetrimide. It should not be used