ChloraPrep 2% w/v/ 70% v/v Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlorhexidine gluconate; ISOPROPYL ALCOHOL

Available from:

Carefusion U.K. 244 Limited

ATC code:

D08AC; D08AC52

INN (International Name):

Chlorhexidine gluconate; ISOPROPYL ALCOHOL

Dosage:

2.0/70 percent

Pharmaceutical form:

Cutaneous solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Biguanides and amidines; chlorhexidine, combinations

Authorization status:

Marketed

Authorization date:

2012-12-14

Patient Information leaflet

1
PACKAGE LEAFLET
2 PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORAPREP 2% W/V / 70% V/V CUTANEOUS SOLUTION
CHLORHEXIDINE GLUCONATE / ISOPROPYL ALCOHOL
SEPP 0.67 ML / 1 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).
ChloraPrep may in rare cases cause severe allergic reactions, leading
to a drop in blood pressure and

Summary of Product characteristics

Health Products Regulatory Authority
03 January 2019
CRN008P36
Page 1 of 11
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
Posology
ChloraPrep may be used on all age groups and patient populations.
_Paediatric population_
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 ml, 1.5 ml, 3 ml, 10.5 ml
or 26 ml of the
ChloraPrep alcoholic solution.
Method of administration
For cutaneous use.
The choice of applicator will depend on the invasive procedure being
undertaken
and the clinician’s preference.
Health Products Regulatory Authority
03 January 2019
CRN008P36
Page 2 of 11
Health Products Regulatory Authority
03 January 2019
CRN008P36
Page 3 of 11
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 the sponge in a controlled
flow (for the
0.67 ml the barrel is squeezed; for the 26 ml applicator the lever is
pressed). Pinch
wings ONCE ONLY to activate the applicator and release the antiseptic.
Do not
repeatedly pinch or pump the wings in an attempt to accelerate the
saturation of the
foam. The broken ampoule remains safely contained within the
applicator. The
sponge is gently pressed against the patient’s skin in order to
apply the antiseptic
solution. Once the solution is visible on the skin, use gentle back
and forth strokes to
prep the site for