CHLORAPREP INCOLORO 20 mg/mL + 0.70 mL/mL impregnated cutaneous stick

2. What you need to know before you start using ChloraPrep Colorless

Do not use ChloraPrep Colorless:

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

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

Warnings and precautions

ChloraPrep Colorless is for external use only.

ChloraPrep should not be used:

• Near sensitive areas (mucous membranes), as it may cause irritation, pain, and chemical burns. In case of contact with mucous membranes, the affected area should be washed immediately with plenty of water.
• On open wounds.
• On the inner part of the ear (middle ear).
• In direct contact with neural tissue (e.g., brain and spinal cord)

ChloraPrep should not come into contact with the eyes due to the risk of visual impairment. If it comes into contact with the eyes, wash immediately and abundantly with water. In case of irritation, redness, or pain in the eyes, or visual disturbances, consult a doctor immediately.

Severe cases of persistent corneal injury (injury to the surface of the eye) that may require a corneal transplant have been reported when similar products have accidentally come into contact with the eyes during surgical interventions, in patients under general anesthesia (deep sleep induced without pain).

This medicine may, in rare cases, cause severe allergic reactions, leading to a decrease in blood pressure and even loss of consciousness. The first symptoms of a severe allergic reaction may be skin rash or asthma. If you notice these symptoms, stop using this medicine 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 to fragile or sensitive skin, or after repeated use, erythema, inflammation, itching, dry skin, and/or peeling and pain may occur. At the first sign of any of these reactions, administration of this medicine should be stopped.

Avoid prolonged contact with the skin.

The solution is flammable. Cases of fire in the operating room have been reported, resulting in severe burns to the patient. 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 using an ignition source (electrosurgical units, lasers, fiber optic light sources, high-speed drills/burs...) in combination with a combustion source (such as cloths, towels...) and an oxidizing agent (oxygen, air, nitrous oxide...).

To reduce the risk of fire:

• Do not use electrocautery procedures or other ignition sources until the skin is completely dry.
• Remove any soaked material, gauze, or gowns before starting the intervention.
• Do not use excessive amounts and avoid accumulating the solution in skin folds, under the patient, or soaking sheets or other materials in direct contact with the patient.
• When applying an occlusive dressing to areas previously exposed to this medicine, special care should be taken to ensure that there is no excess product 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) and the use of an ignition source near an oxidizing agent put the patient at risk of suffering a surgical fire.

Children

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

Other medicines and ChloraPrep

Tell your doctor or nurse if you have recently been given a vaccine or an injection for a skin test (epicutaneous tests for detecting allergies).

Pregnancy, breastfeeding, and fertility

There are no studies on the administration of Chloraprep in pregnant or breastfeeding women. No systemic effect is expected due to the negligible absorption of chlorhexidine. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you can use this medicine, consult your doctor or nurse before using this medicine.

Driving and using machines

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

3. How to use ChloraPrep Colorless

The recommended dosage varies depending on the location of the procedure and the area to be covered. The doctor or nursing staff will select the most suitable size of ChloraPrep Colorless.

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

Route and method of administration

ChloraPrep is for use on the skin only and each swab is for single use.

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

In case of doubt, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

Other adverse reactions related to this medicine are:

Ocular disorders:

Unknown frequency: Eye irritation, pain, hyperemia, corneal injury (injury to the surface of the eye), and permanent eye injury, including permanent visual impairment (after accidental eye exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (deep sleep induced without pain).

Use in children

ChloraPrep should be used with caution in neonates, especially those born before 32 weeks of gestation, and during the first 2 weeks of life, as it may cause chemical burns to the skin.

Reporting of side effects:

If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ChloraPrep Colorless

This medicine does not require special storage conditions.

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

Flammable. Avoid exposure of 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 expiration date stated on the label after CAD. The expiration date is 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 the package and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of ChloraPrep Colorless

The active ingredients 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 ingredients are: purified water.

Appearance of the product and package contents

ChloraPrep Colorless is presented in the form of a plastic stick with a foam pad attached, hermetically sealed in an aluminum foil bag containing the antiseptic solution.

A bag may contain one or three impregnated skin swabs.

Package size:

1.75 ml (one skin swab): Box of 48 bags (48 swabs)

5.25 ml (three skin swabs): Box of 40 bags (120 swabs)

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 the last revision of this leaflet: 09/2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended only for healthcare professionals.

Instructions for use of ChloraPrep Colorless applicators:

For skin use. For external use only. Choose the appropriate presentation of ChloraPrep based on the invasive medical procedure being performed and the size of the area to be prepared to avoid excess solution and the risk of product accumulation.

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

• The interior of the bag is sterile. To preserve sterility, the bag should be opened carefully and the foam pad should not be touched to any non-sterile surface.
• Tear the bag at the lateral notch to show the sticks of the swabs. Do not touch the foam pad of the applicator.
• Place the foam pad with the flat side down on the treatment area.
• Apply the solution for 30 seconds with a gentle back-and-forth motion.
• Let the covered area dry completely in the air.
• In the case of the triple package, use the swabs sequentially for a total of 30 seconds.

ChloraPrep can 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:

• Let ChloraPrep dry completely on the skin before starting any medical procedure. Do not use while smoking or near open flames or strong heat sources.
• To reduce the risk of fire:
  • Do not use electrocautery procedures or other ignition sources until the skin is completely dry.
  • Remove any soaked material, gauze, or gowns before starting the intervention.
  • Do not use excessive amounts and avoid accumulating the solution in skin folds, under the patient, or soaking sheets or other materials in direct contact with the patient.
  • When applying an occlusive dressing to areas previously exposed to ChloraPrep Colorless, special care should be taken to ensure that there is no excess product before applying the dressing.
  • Procedures performed on the head, neck, and upper chest (above T5) and the use of an ignition source near an oxidizing agent put the patient at risk of suffering a 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, the affected area should be washed immediately with plenty of water.
• ChloraPrep Colorless should not come into contact with the eyes due to the risk of visual impairment. If it comes into contact with the eyes, wash immediately and abundantly with water. Consult an ophthalmologist.
• Do not use on open wounds or broken skin.
• ChloraPrep should not come into contact with neural tissue or the middle ear.
• Chlorhexidine is incompatible with soap and other anionic agents.
• Alcohol should not come into contact with certain vaccines and injections for skin tests (epicutaneous tests). In case of doubt, consult the manufacturer's information for the vaccine.
• Do not apply the solution too vigorously to fragile or sensitive skin. After repeated use, a local skin reaction with erythema or inflammation, itching, dry skin, and/or peeling and pain may occur. At the first sign of a local skin reaction, administration of ChloraPrep should be stopped.
• Do not use in patients with known hypersensitivity to the ChloraPrep solution or any of its components, especially in those with a history of possible allergic reactions related to chlorhexidine. Products containing chlorhexidine are known causes of anaphylactic reactions during anesthesia. If symptoms of an anaphylactic reaction are detected during anesthesia (e.g., sudden drop in blood pressure, urticaria, angioedema), a chlorhexidine-related allergic reaction should be considered.

Special precautions should be taken to avoid exposing the patient 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 heat sources. Avoid exposure of the container and its contents to open flames during use, storage, and disposal. Dispose of the swab after use according to established procedures.

Consult the technical data sheet of ChloraPrep for more detailed information.

Storage instructions

ChloraPrep is for single use and is sterile if the package is intact. Do not use ChloraPrep after the expiration date indicated on the label and the box. The expiration date refers to the last day of that month. This medicine does not require special storage conditions.Do not freeze.

Active ingredients

The active ingredients of ChloraPrep Colorless are chlorhexidine digluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml. The excipient of ChloraPrep is purified water.

Marketing authorization holder

Becton Dickinson France

11 Rue Aristide Bergès

38800 Le Pont de Claix

France