Chloraprep Incoloro 20 mg/ml + 0.70 ml/ml swabstick for cutaneous use

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ChloraPrep Colorless 20 mg/ml + 0.70 ml/ml impregnated skin swab

chlorhexidine digluconate / isopropyl alcohol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What ChloraPrep Colorless is and what it is used for
2. What you need to know before using ChloraPrep Colorless
3. How to use ChloraPrep Colorless
4. Possible adverse effects
5. How to store ChloraPrep Colorless
6. Contents of the pack and other information

1. What ChloraPrep Colorless is and what it is used for

ChloraPrep belongs to the therapeutic group of antiseptics and disinfectants. It is available as one or three single-use skin applicators impregnated with a fast-acting solution containing the antiseptics chlorhexidine digluconate and isopropyl alcohol. The primary packaging consists of a hermetically sealed aluminum foil pouch.

It is used to disinfect the skin and help prevent infections prior to invasive medical procedures such as injections, insertion of intravascular catheters, and minor or major surgery.

2. What you need to know before using ChloraPrep Clear

Do not use ChloraPrep Clear:

If you are allergic (hypersensitive) to chlorhexidine digluconate or to any of the other ingredients of this medicine (listed in section 6).

For disinfection of the ear canal, as it may cause hearing problems.

Warnings and precautions

ChloraPrep Clear is for external use only.

ChloraPrep must not be used:

• Near sensitive areas (mucous membranes), as it may cause irritation, pain, and chemical burns. In case of contact with mucous membranes at body orifices, immediately rinse the affected area thoroughly with plenty of water.
• On open wounds.
• Inside the ear (middle ear).
• In direct contact with neural tissue (e.g., brain and spinal cord).

ChloraPrep must not come into contact with the eyes due to the risk of visual injury. If contact occurs, immediately and thoroughly rinse the eyes with water. If eye irritation, redness, pain, or visual disturbances occur, consult a doctor immediately.

Serious, persistent corneal injury (damage to the surface of the eye) has been reported, which in some cases required corneal transplantation, when similar products accidentally came into contact with the eyes during surgical procedures in patients under general anesthesia (induced painless deep sleep).

This medicine may rarely cause severe allergic reactions, leading to a drop in blood pressure and even loss of consciousness. Early signs of a severe allergic reaction may include skin rash or asthma. If you experience these symptoms, stop using this medicine immediately and contact your doctor as soon as possible (see section 4: "Possible side effects").

This medicine should only be applied gently to the skin. If the solution is applied too vigorously on fragile or sensitive skin, or with repeated use, erythema, inflammation, itching, dryness and/or peeling, and pain may occur. If any of these reactions appear, discontinue use immediately.

Avoid prolonged contact with the skin.

The solution is flammable. Cases of operating room fires resulting in severe patient burns have been reported. Do not use with electrocautery procedures or other ignition sources, such as cigarettes, open flames, or strong heat sources, until the skin is completely dry.

The risk of fire is high when an ignition source (electrosurgical units, lasers, fiber-optic light sources, high-speed drills/burs) is used in combination with a combustible material (such as drapes or towels) and an oxidizing agent (oxygen, air, nitrous oxide, etc.).

To reduce the risk of fire:

• Do not use electrocautery procedures or other ignition sources until the skin is completely dry.
• Remove any soaked materials, gauze, or surgical gowns before starting the procedure.
• Do not use excessive amounts and avoid pooling of the solution in skin folds, under the patient, or soaking of sheets and other materials in direct contact with the patient.
• When applying an occlusive dressing to areas previously treated with this medicine, ensure that no excess product remains before applying the dressing.
• Reduce the supply of oxygen or any other oxidizing agent to the minimum necessary. Procedures performed on the head, neck, and upper chest (above T5), especially when combined with an ignition source near an oxidizing agent, place the patient at risk of surgical fire.

Children

Use with caution in neonates, especially premature infants. ChloraPrep may cause chemical burns on the skin.

Other medicines and ChloraPrep

Inform your doctor or nurse if you have recently received a vaccine or a skin test injection (epicutaneous tests for detecting allergies).

Pregnancy, breastfeeding, and fertility

There are no studies on the use of Chloraprep in pregnant or breastfeeding women. Systemic effects are not expected due to the negligible absorption of chlorhexidine. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or nurse before using this medicine.

Driving and use of machines

ChloraPrep does not affect the ability to drive or operate machinery.

3. How to use ChloraPrep Clear

The recommended dosage varies depending on the procedure site and the area to be covered. The physician or nursing staff will select the most appropriate ChloraPrep Clear package size.

Other ChloraPrep applicators may be more suitable depending on the medical procedure.

Route and method of administration

ChloraPrep is for topical use only, and each swab is for single use only.

The physician or nursing staff will gently rub the foam pad onto the skin, covering the cutaneous area that needs to be prepared. More than one swab may be used depending on your medical procedure.

If in doubt, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Allergic reactions or skin irritation caused by the components of this medicine (chlorhexidine digluconate, isopropyl alcohol) have been reported very rarely (less than 1 in 10,000 people).

Stop using this medicine if you experience any of the following symptoms: swelling of the face, lips, tongue or throat; red, itchy rash; wheezing or difficulty breathing; feeling faint or dizzy; a strange metallic taste in the mouth; collapse. You may be having an allergic reaction.

If you develop a rash or if your skin becomes red, itchy, dry or inflamed in the area where you applied the skin wash product, stop using it and consult your doctor or pharmacist.

Other adverse reactions associated with this medicine are:

Eye disorders:

Frequency unknown: Eye irritation, pain, hyperaemia, corneal lesion (damage to the surface of the eye), and permanent eye injury, including permanent visual impairment (following accidental eye exposure during surgical procedures on the head, face, and neck) in patients under general anaesthesia (induced painless deep sleep).

Use in children

ChloraPrep should be used with caution in neonates, especially in premature infants born before 32 weeks of gestation, and during the first two weeks of life, as it may cause chemical burns to the skin.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ChloraPrep Colorless

This medicinal product does not require special storage conditions.

Keep in the original container. ChloraPrep Colorless is sterile if the container is intact.

Flammable. Avoid exposing the bottle and its contents to open flames during use, storage, and disposal of the product.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of ChloraPrep Clear

The active substances are chlorhexidine digluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml.

Each impregnated swab contains 35 mg of chlorhexidine digluconate and 1.23 ml of isopropyl alcohol.

Three impregnated swabs contain 105 mg of chlorhexidine digluconate and 3.68 ml of isopropyl alcohol.

The other component is: purified water.

Appearance of the product and contents of the pack

ChloraPrep Clear is supplied as a plastic rod with an attached foam pad saturated with antiseptic solution, hermetically sealed in an aluminium foil pouch containing the antiseptic solution.

A pouch may contain one or three impregnated skin swabs.

Pack sizes:

1.75 ml (one impregnated skin swab): Pack of 48 pouches (48 swabs)
5.25 ml (three impregnated skin swabs): Pack of 40 pouches (120 swabs)

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Becton Dickinson France
11 Rue Aristide Bergès
38800 Le Pont de Claix
France
900 938 914

Manufacturer:

BD Infection Prevention B.V.
Erembodegem-Dorp 86
Erembodegem 9320
Belgium

Local representative:

Becton Dickinson, S.A.
Camino de Valdeoliva, s/n
28750 – San Agustín del Guadalix (Madrid)

Date of most recent review of this leaflet: 09/2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only.

Instructions for use of ChloraPrep Clear applicators:

For cutaneous use. For external use only. Select the appropriate ChloraPrep presentation according to the invasive medical procedure being performed and the size of the area to be prepared, in order to avoid excess solution and the risk of product accumulation.

Other ChloraPrep applicators may be more suitable depending on the medical procedure.

• Only the inside of the pouch is sterile. To maintain sterility, open the pouch carefully and do not allow the foam pad to touch any non-sterile surface.
• Tear the pouch at the side notch to expose the swab rods. Do not touch the foam pad of the applicator.
• Place the foam pad flat-side down onto the treatment area.
• Apply the solution for 30 seconds using a gentle back-and-forth motion.
• Allow the treated area to dry completely by air.
• For the triple-pack, use the swabs sequentially for a total of 30 seconds.

ChloraPrep may be left on the skin after the procedure.

Maximum coverage areas:

• One swab (1.75 ml): 6 cm x 7 cm
• Three swabs (5.25 ml): 10 cm x 16 cm

Precautions for use:

• Allow ChloraPrep to dry completely on the skin before starting any medical procedure. Do not use while smoking or near open flames or strong sources of heat.
• To reduce the risk of fire:
  • Do not use electrocautery or other ignition sources until the skin is completely dry.
  • Remove any soaked materials, gauzes, or drapes before starting the procedure.
  • Do not use excessive amounts and avoid pooling of solution in skin folds, under the patient, or soaking into sheets or other materials in direct contact with the patient.
  • When applying an occlusive dressing to areas previously exposed to ChloraPrep Clear, ensure that no excess product remains before applying the dressing.
  • Procedures performed on the head, neck, and upper chest (above T5), combined with the use of an ignition source near an oxidizing agent, place the patient at risk of surgical fire.
• Use with caution in neonates, especially those born before 32 weeks of gestation and during the first 2 weeks of life. ChloraPrep may cause chemical burns to the skin.
• Do not use near mucous membranes, as it may cause irritation, pain, and chemical burns. In case of contact with mucous membranes, immediately rinse the affected area thoroughly with water.
• ChloraPrep Clear must not come into contact with the eyes due to the risk of visual injury. If contact occurs, immediately and thoroughly rinse eyes with water. Consult an ophthalmologist.
• Do not use on open wounds, broken or damaged skin.
• ChloraPrep must not come into contact with neural tissue or the middle ear.
• Chlorhexidine is incompatible with soap and other anionic agents.
• Alcohol must not come into contact with certain vaccines and skin test injections (epicutaneous testing). In case of doubt, consult the vaccine manufacturer's information.
• Do not apply the solution too vigorously on fragile or sensitive skin. With repeated use, local skin reactions such as erythema or inflammation, itching, dry and/or flaky skin, and localized pain at the application site may occur. At the first sign of a local skin reaction, discontinue use of ChloraPrep.
• Do not use in patients with known hypersensitivity to ChloraPrep solution or any of its components, especially those with a history of possible allergic reactions related to chlorhexidine. Products containing chlorhexidine are known causes of anaphylactic reactions during anaesthesia. If symptoms of an anaphylactic reaction occur during anaesthesia (e.g., sudden drop in blood pressure, urticaria, angioedema), a chlorhexidine-related allergic reaction should be considered.

• Special precautions must be taken to avoid patient exposure to any other product containing chlorhexidine during the course of treatment.

Special precautions for disposal

The solution is flammable. Do not use while smoking or near open flames or strong sources of heat. Avoid exposing the container and its contents to open flames during use, storage, and disposal. Dispose of the swab after use according to established procedures.

Refer to the ChloraPrep Summary of Product Characteristics for more detailed information.

Storage instructions

ChloraPrep is for single use only and is sterile if the packaging is intact. Do not use ChloraPrep after the expiry date stated on the label and carton. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Do not freeze.

Active substances

The active substances in ChloraPrep Clear are chlorhexidine digluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml. The excipient in ChloraPrep is purified water.

Marketing Authorisation Holder

Becton Dickinson France
11 Rue Aristide Bergès
38800 Le Pont de Claix
France