ChloraPrep 2% w/v/70% v/v cutaneous solution

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Disponibil de la:

CareFusion U.K.

Codul ATC:

D08AC52

INN (nume internaţional):

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Forma farmaceutică:

CUTANEOUS SOLUTION

Compoziție:

CHLORHEXIDINE GLUCONATE 20 mg/ml; ISOPROPYL ALCOHOL 70 % (V/V)

Tip de prescriptie medicala:

OTC

Zonă Terapeutică:

ANTISEPTICS AND DISINFECTANTS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2012-12-28

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORAPREP
® 2% W/V / 70% V/V
CUTANEOUS SOLUTION
CHLORHEXIDINE GLUCONATE
ISOPROPYL ALCOHOL
SEPP
® 0.67 ML / FREPP
® 1.5 ML /
1.5 ML / 3 ML / 10.5 ML / 26 ML
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 doctor 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. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What ChloraPrep is and what it is used for
2.
What you need to know before you use ChloraPrep
3.
How to use ChloraPrep
4.
Possible side effects
5.
How to store ChloraPrep
6.
Contents of the pack and other information
1.
WHAT CHLORAPREP IS AND WHAT IT IS USED FOR
ChloraPrep is a cutaneous solution of chlorhexidine gluconate 2% w/v
and isopropyl alcohol 70%
v/v in a plastic applicator with a sponge tip on one end. The
applicator contains a fast acting
antiseptic solution, which is used to disinfect the skin and help
prevent infections before invasive
medical procedures, such as injections, insertion of catheters and
minor or major surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORAPREP
DO NOT USE CHLORAPREP:
-
if you are allergic (hypersensitive) to chlorhexidine gluconate or any
of the other ingredients
of ChloraPrep. (See Section 6).
WARNINGS AND PRECAUTIONS
ChloraPrep is for external use only.
ChloraPrep should not be used:
-
near eyes or delicate linings (mucous membranes), as it may cause
irritation. If it does get into
the eye or the delicate linings to the body passages, it should be
washed quickly with plenty of
water.
-
on open skin wounds.
-
on the part of the ear that is inside the body (middle ear).
-
in direct contact with neural tissue (for example brain and spinal
cord tissue).
Use with care in newborn babies, especially those born prematurely.
ChloraPrep may cause
chemical skin burns.
ChloraPrep

Caracteristicilor produsului

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ChloraPrep

2% w/v / 70% v/v cutaneous solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine gluconate 20 mg/ml
Isopropyl alcohol 0.70 ml/ml
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cutaneous Solution.
Clear Solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The medicinal product is to be used for disinfection of the skin prior
to invasive medical
procedures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use.
ChloraPrep may be used on all age groups and patient populations.
However, ChloraPrep should be
used with care in newborn babies, especially those born prematurely
(see also section 4.4, Special
warnings and precautions for use).
One applicator is used containing 0.67 ml, 1.5 ml, 3 ml, 10.5 ml or 26
ml of the ChloraPrep
alcoholic solution.
The choice of applicator will depend on the invasive procedure being
undertaken and the clinician’s
preference.
Page 2 of 8
APPLICATOR
COVERAGE AREA (CM X
CM)
FOR PROCEDURES SUCH AS:
0.67 ML (SEPP)
5 x 8
-
Routine venipuncture
-
Blood culture collection
-
Peripheral (arterial line) cannulation
-
Simple biopsy
1.5 ML
1.5 ML (FREPP)
10 x 13
-
Routine venipuncture
-
Blood culture collection
-
Peripheral (arterial line) cannulation
-
Simple biopsy
-
Dialysis Fistula/Graft site cleansing
3 ML
15 x 15
-
Midline & Central Venous Catheter
(CVC) insertion and maintenance
-
Peritoneal dialysis site cleansing
10.5 ML
26 ML
25 x 30
50 x 50
-
Minor and major surgical procedures
-
Implantable device placement
-
Prosthetic device placement or removal
-
Midline, Peripheral Intravascular Central
Catheter (PICC) & CVC insertion and
maintenance
-
Cardiac catheterisation and Cardiac Cath
Lab procedures
-
Interventional Radiology procedure
Page 3 of 8
The applicator is removed from the wrapper and held with the sponge
facing downward. The
applicator is squeezed gently to break the ampoule containing the
antiseptic solution, which is
released onto