Softa-Man CHG Cutaneous Solution

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

Chlorhexidine Gluconate; Ethanol

متاح من:

B.BRAUN MEDICAL INDUSTRIES SDN BHD

INN (الاسم الدولي):

Chlorhexidine Gluconate; Ethanol

الوحدات في الحزمة:

100ml ml; 500ml ml; 1000ml ml

المصنعة من قبل:

B.BRAUN MEDICAL AG

نشرة المعلومات

SOFTA-MAN
® CHG
Consumer Medication Information Leaflet(RiMUP)
WHAT IS IN THIS LEAFLET
1. What Softa-Man® CHG is used for
2. How Softa-Man® CHG works.
3. Before you use Softa-Man® CHG.
4. How to use Softa-Man® CHG.
5. While you are using it.
6. Side effects.
7. Storage and Disposal of Softa-Man® CHG.
8. Product Description.
WHAT SOFTA-MAN® CHG IS USED FOR
Softa-Man® CHG is a cutaneous solution (a solu
-
tion for use on the skin) which is used to disinfect
the skin and help prevent infections before medi-
cal procedures, such as injections, insertion of
catheters and surgery.
HOW SOFTA-MAN® CHG WORKS
Softa-Man® CHG is a combination of 0.5% ch-
lorhexidine gluconate and 80% ethanol, which
provides an immediate kill of microorganisms
like bacteria, fungi and many viruses. The active
ingredient
chlorhexidine
digluconate
provides
persistent antimicrobial properties and prevents
regrowth of microorganisms on the treated skin.
BEFORE YOU USE SOFTA-MAN® CHG
- When you must not use it
- Before you start to use it
DO NOT USE SOFTA-MAN® CHG
- if you are allergic to chlorhexidine gluconate,
ethanol or any of the other ingredients of this
medicine (listed in section 6).
- on babies less than 2 months old. Softa-Man®
CHG can sometimes irritate and pass through a
baby’s skin.
- near eyes or delicate linings, as it may cause
irritation. If it does get into the eye or the deli-
cate
linings
to
the
body
passages
(mucous
membranes), it should be washed quickly with
plenty of water.
- on open skin wounds.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doc-
tor or nurse.
- If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects
not listed in this leaflet.
OTHER MEDICINES AND SOFTA-MAN® CHG
Tell your doctor or nurse if you have recently had
a vaccine or skin test injection (patch test used to
test for alle

خصائص المنتج

Softa-Man® CHG contains chlorhexidine. Chlorhexidine is known to
induce hypersensitivity, including generalized allergic reactions and
anaphylactic shock. The prevalence of chlorhexidine hypersensitivity
is unknown, but available literature suggests this is likely to be
very
rare. Softa-Man® CHG 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 rash, redness, swelling, breathing difficulties,
light headedness, and rapid heart rate develop, immediately stop us-
ing the product. Appropriate therapeutic countermeasures must be
instituted as clinically indicated.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF IN-
TERACTION
Alcohol should not be brought into contact with some vaccines and
skin test injections (patch tests). If in doubt, consult the vaccine
man-
ufacturers’ literature.
FERTILITY, PREGNANCY AND LACTATION
There are no studies with this product in pregnant or lactating wom-
en. However, as percutaneous absorption is negligible, there is no
reason why this product may not be used during pregnancy or by
breast feeding mothers.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No effects are reported.
UNDESIRABLE EFFECTS
Very rarely (<1/10,000) allergic or irritation skin reactions have
been
reported with chlorhexidine and ethanol including: erythema, rash
(e.g. erythematous, papular or maculopapular), pruritus and blisters
or application site vesicles. Other local symptoms have included skin
burning sensation, pain and inflammation. At the first sign of local
skin reaction application of Softa-Man® CHG Cutaneous Solution
should be stopped.
IMMUNE SYSTEM DISORDERS
Frequency not known: Hypersensitivity including anaphylactic shock.
OVERDOSE
There are no reports of this occurring and the nature of the product
makes it unlikely.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Antiseptic and disinfectants
ATC code: D08AC52
Mech