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CHLORAPREP 2% W/V / 70% V/V CUTANEOUS SOLUTION

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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

Perforation

ChloraPrep 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 ChloraPrep should be stopped.
Prolonged skin contact should be avoided.
Soaked materials, such as drapes or gowns should be removed
before use. The solution should not be allowed to pool.
The solution is flammable. Do not use ignition sources until
the skin is completely dry.
Other medicines and ChloraPrep
Tell your doctor or nurse if you have recently had a vaccine or
skin test injection (patch test used to test for allergies).
Pregnancy, breast-feeding and fertility
There are no studies with ChloraPrep in pregnant or
lactating women.

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 may in rare cases cause severe allergic
reactions, leading to a drop in blood pressure and even
to unconsciousness. Early symptoms of a severe allergic
reaction may be skin rash or asthma. If you notice these
symptoms, stop using ChloraPrep and contact your doctor
as soon as possible (see under section 4: “Possible side
effects”).

Pregnancy
No effects during pregnancy are anticipated, since
systemic exposure to chlorhexidine gluconate is negligible.
ChloraPrep can be used during pregnancy.
Lactation
No effects on the breastfed newborn/infant are anticipated
since the systemic exposure of the breast-feeding woman
to chlorhexidine gluconate is negligible. ChloraPrep can be
used during breast-feeding.
Fertility
The effects of chlorhexidine gluconate on human
reproduction have not been studied.
Driving and using machines
ChloraPrep does not affect your driving or ability
to use machines.
3. How to use ChloraPrep
The antiseptic solution within the ChloraPrep system is
kept inside the plastic applicator. Your doctor or nurse
will select the applicator size based on the procedure site
and area to be covered. Your doctor or nurse will rub
the sponge gently over your skin, covering the skin area
that needs to be prepared. Depending on your medical
procedure, more than one applicator may be used.

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
The following information is intended for medical
or healthcare professionals only:
Instructions for using ChloraPrep® applicators:
For cutaneous use. For external use only.
- Remove the applicator from the wrapper and hold it
with the sponge facing downward.
- Squeeze the applicator once only:
   - 0.67 ml (Sepp) squeeze barrel
   - 26 ml squeeze lever on handle
   - other products, squeeze wings
- Do not repeatedly pinch or pump the wings in an
attempt to accelerate the saturation of the foam.
- Gently press the sponge 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 30 seconds.
- The 26 ml applicator includes two swabs. Clean intact
umbilicus with enclosed swabs when applicable.
(Moisten swabs by pressing against solution-soaked
sponge applicator.)
- Allow the covered area to air dry completely.
ChloraPrep can be left on the skin post procedure.
Maximum coverage areas:
- Sepp (0.67 ml)
5 cm x 8 cm
- Frepp (1.5 ml)
10 cm x 13 cm
- 1.5 ml
10 cm x 13 cm
- 3 ml
15 cm x 15 cm
- 10.5 ml
25 cm x 30 cm
- 26 ml
50 cm x 50 cm

Very rarely (fewer than 1 in 10,000 people), allergic or
irritated skin reactions to the ingredients in ChloraPrep
(chlorhexidine gluconate and isopropyl alcohol) have been
reported.

Precautions for Use:
- Allow ChloraPrep to dry completely before starting
any medical procedure. Do not use electrocautery
procedures until the skin is completely dry. Do not use
excessive quantities and do not allow the solution to
pool in skin folds or under the patient or drip on sheets
or other material in direct contact with the patient.
- Use with care in neonates, especially those born before
32 weeks of gestation and within the first 2 weeks of
life. ChloraPrep may cause chemical skin burns.
- Do not use near eyes or mucous membranes, as it may
cause irritation. If it does get into the eye or the mucous
membranes, it should be washed quickly with plenty of
water.
- Do not use on open skin wounds, broken or damaged
skin.
- ChloraPrep should not come into contact with neural
tissues or the middle ear.
- Chlorhexidine is incompatible with soap and other
anionic agents.

See other side for further instructions.

See other side for further instructions.

ChloraPrep is only used on the skin and each applicator is
only used once.
If you have any further questions on the use of this
product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, ChloraPrep can cause side effects,
although not everybody gets them.

El Paso Documentation Use Only

Date:

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Perforation

- Alcohol should not be brought into contact with some
vaccines and skin test injections (patch tests). If in
doubt, consult the vaccine manufacturer’s literature.
- Do not apply the solution in an over vigorous manner
to very fragile or sensitive skin. After repeated use,
local skin reaction may occur including; erythema or
inflammation, itching, dry and/or flaky skin and local
application site pain. At the first sign of local skin
reaction, stop application of ChloraPrep.
Special precautions for disposal
The solution is flammable. Do not use while smoking
or near any naked flames or strong heat source. Avoid
exposure of the container and contents to naked flames
during use, storage and disposal. Discard the applicator
after use as per clinical waste procedures.

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If you experience any of the following reactions stop using
ChloraPrep and get immediate medical help: swelling
of the face, lips, tongue or throat; a red itchy skin rash;
wheezing or difficulty breathing; feeling faint and dizzy; a
strange metallic taste in the mouth; collapse. You may be
having an allergic reaction.
If you develop a rash or your skin becomes itchy, red, dry or
inflamed where you have used the product as a skin wash,
stop using it and talk to your doctor or pharmacist.
If the side effect gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
nurse immediately.

Please refer to the Summary of Product Characteristics for
ChloraPrep for further detailed information.
Storage Procedures
ChloraPrep is for single use only and is sterile until the
packaging is opened. Do not use ChloraPrep after the expiry
date stated on the label or carton. The expiry date refers to
the last day of that month. Do not store above 25ºC. Avoid
freezing. Store in the original packaging.
Active Substances
The active substances in ChloraPrep are 2% w/v
chlorhexidine gluconate and 70% v/v isopropyl alcohol.
The inactive ingredient in ChloraPrep is purified water.
Marketing Authorisation Holder
CareFusion U.K. 244 Ltd.
The Crescent, Jays Close,
Basingstoke, Hampshire RG22 4BS
United Kingdom

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via:
United Kingdom
Yellow Card Scheme, Website:
www.mhra.gov.uk/yellowcard

200 applicators
20 applicators
25 applicators
25 applicators
1 applicator or 25 applicators
1 applicator

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder of ChloraPrep® is
CareFusion U.K. 244 Ltd.
The Crescent, Jays Close,
Basingstoke, Hampshire RG22 4BS
United Kingdom
+44(0)-800-0437-546

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store ChloraPrep
Flammable. Do not store above 25ºC.
Store in the original packaging; applicator is sterile unless
seal is broken.
Avoid exposure of the container and contents to naked flames
during use, storage and disposal. Do not use this medicine
after the expiry date which is stated on the label or carton
after EXP. The expiry date refers to the last day of that month.
Keep out of the reach and sight of children.
Do not throw away medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What ChloraPrep contains
The active substances are chlorhexidine gluconate
20 mg/ml and isopropyl alcohol 0.70 ml/ml. The other
ingredient is purified water.
What ChloraPrep looks like and contents
of the pack
The Sepp 0.67 ml applicator consists of a latex-free
foam tip attached to a plastic barrel which holds a glass

El Paso Documentation Use Only

Pack Size:
0.67 ml Sepp:
1.5 ml Frepp:
1.5 ml:
3 ml:
10.5 ml:
26 ml:

Not all pack sizes may be marketed

Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

ChloraPrep®, Sepp® and Frepp® are registered trademarks of
CareFusion Corporation or one of its subsidiaries.

ampoule containing the antiseptic solution. The Frepp
1.5 ml applicator consists of a latex-free rectangular
foam sponge attached to a plastic barrel which holds a
glass ampoule containing the antiseptic solution. The 1.5
ml, 3 ml and 10.5 ml applicators consist of a latex-free
round foam sponge attached to a plastic barrel which
holds a glass ampoule containing the antiseptic solution.
The 26 ml applicator consists of a latex-free square foam
sponge attached to a plastic barrel which holds two glass
ampoules containing the antiseptic solution. The sterile
applicators are individually packaged in a transparent film.

Date:

The Manufacturer of ChloraPrep® is
Insight Health Limited
Unit A Bridgefields,
Welwyn Garden City, Hertfordshire AL7 1RX
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria - ChloraPrep
Belgium - ChloraPrep
Finland - ChloraPrep
France - ChloraPrep
Germany - ChloraPrep
Ireland - ChloraPrep
Italy - ChloraPrep
Luxembourg - ChloraPrep
Malta - ChloraPrep
Netherlands - ChloraPrep
Norway - Chloraprep
Portugal - Chloraprep
Sweden - Chloraprep
UK - ChloraPrep
This leaflet was last revised in 02/2015.
ChloraPrep®, Sepp® and Frepp® are registered trademarks of
CareFusion Corporation or one of its subsidiaries.
License Numbers:
UK: PL 31760/0004
IE: PA 1435/1/2
MT: MA 700/002011
Artwork 6-775000UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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