ChloraPrep 2% w/v / 70% v/v impregnated cutaneous swab

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Chlorhexidine digluconate; Isopropyl alcohol

Boleh didapati daripada:

Becton Dickinson France

Kod ATC:

D08AC52

INN (Nama Antarabangsa):

Chlorhexidine digluconate; Isopropyl alcohol

Borang farmaseutikal:

Impregnated cutaneous swab

Kawasan terapeutik:

chlorhexidine, combinations

Status kebenaran:

Marketed

Tarikh kebenaran:

2022-02-25

Risalah maklumat

8.375
2.7813
5.5937
8.5
All Dimensions
shown in inches
Fold
Perforation
CHLORAPREP™ 2% W/V / 70% V/V
IMPREGNATED CUTANEOUS SWAB
CHLORHEXIDINE GLUCONATE /
ISOPROPYL ALCOHOL
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
and isopropyl alcohol presented as a plastic stick with a foam
pad impregnated with a fast-acting antiseptic solution on one
end. The product is used to disinfect the skin and help prevent
infections before invasive medical procedures.
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, especially if
you have a history of possible chlorhexidine-related allergic
reactions (see Section 6).
• in the ear canal as the solution may damage your hearing.
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.
• 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 even to
unconsciousness. Early sy

Ciri produk

Health Products Regulatory Authority
25 February 2022
CRN009S5J
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ChloraPrep 2% w/v / 70% v/v impregnated cutaneous swab
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each swab of 1.75 ml solution contains 35 mg of chlorhexidine
gluconate (20 mg/ml) and 1.23 ml isopropyl alcohol (0.70
ml/ml).
Three swabs containing 5.25 ml of solution contains 105 mg of
chlorhexidine gluconate (20 mg/ml) and 3.7 ml isopropyl
alcohol (0.70 ml/ml).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Impregnated cutaneous swab
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 pouch contains either one (1.75 ml) or three (5.25 ml) swabs.
Method of administration
For cutaneous use.
Health Products Regulatory Authority
25 February 2022
CRN009S5J
Page 2 of 6

Only the inside of the pouch is sterile. In order to preserve the
sterility, the pouch should be opened carefully and
the foam pad should not be allowed to touch any non-sterile surface.

Tear pouch at side notch to reveal swab handle(s). Do not touch the
swab foam pad.

Place foam pad flat side down on the treatment area.

Apply the solution for 30 seconds using a gentle back and forth
motion.

The area covered should be allowed to air dry completely.

For triple swabs, use swabs sequentially for a total of 30 seconds.
Choose the appropriate ChloraPrep presentation based on the invasive
procedure being undertaken and the size of the area to
be prepped to avoid excess of solution and the risk of product
pooling.
Other ChloraPrep applicators may be more suitable depend