Chloraprep 2% W/V & 70% V/V Cutaneous Solution
Fold Perforation
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 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").
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.
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 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.
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.
See other side for further instructions.
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) Frepp (1.5 ml)
1.5 ml 3 ml
10.5 ml 26 ml
5 cm x 8 cm 10 cm x 13 cm 10 cm x 13 cm 15 cm x 15 cm 25 cm x 30 cm 50 cm x 50 cm
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.
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- 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.
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 25°C. 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
ChloraPrep®, Sepp® and Frepp® are registered trademarks of CareFusion Corporation or one of its subsidiaries.
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.
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
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
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
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 25°C.
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.
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.
Pack Size: 0.67 ml Sepp:
1.5 ml Frepp:
1.5 ml:
3 ml:
10.5 ml:
26 ml:
200 applicators 20 applicators 25 applicators 25 applicators
1 applicator or 25 applicators 1 applicator
Not all pack sizes may be marketed
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
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.
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
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 700/00201 1
Artwork 6-775000UK KXXXX
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