CHLORAPREP INCOLORO 20 mg/mL + 0.70 mL/mL CUTANEOUS SOLUTION

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).

Warnings and Precautions

ChloraPrep Colorless is for external use only.

ChloraPrep Colorless 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 rinsed 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 Colorless should not come into contact with the eyes due to the risk of visual damage. If it comes into contact with the eyes, rinse 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).

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

ChloraPrep 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 ChloraPrep and contact your doctor as soon as possible (see section 4: "Possible side effects").

ChloraPrep Colorless should only be applied gently to the skin. If the solution is applied too vigorously to fragile or sensitive skin, or after repeated use, it may cause redness, inflammation, itching, dry skin, and/or flaking and pain. If you notice any of these reactions, stop using ChloraPrep Colorless.

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.

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 electrocauterization procedures or other ignition sources until the skin is completely dry.
• Remove any damp material, gauzes, 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, take special care 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 surgical fire.

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 to detect allergies).

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you can use ChloraPrep Colorless, but consult your doctor or nurse before using this medicine.

Driving and Using Machines

ChloraPrep Colorless does not affect your ability to drive or use machines.

3. How to Use ChloraPrep Colorless

The antisepsis solution of ChloraPrep Colorless is inside the plastic applicator. Your doctor or nurse will select the size of the applicator based on the area to be treated and the area to be covered. Your doctor or nurse will gently rub the sponge over the skin, covering the area that needs to be prepared. Depending on the medical procedure, one or more applicators may be used.

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

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 ChloraPrep Colorless (chlorhexidine digluconate, isopropyl alcohol) have been reported.

Stop using ChloraPrep and seek medical attention immediately if you experience any of the following reactions: 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.

Eye Disorders:

Frequency not known: 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).

If you develop a skin rash or your skin becomes red with itching, dryness, or inflammation in the area where you used the product for skin washing, stop using it and consult your doctor or pharmacist.

Reporting of Side Effects:

If you experience any side effects, consult your doctor or nurse, even if it is a possible side effect 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 any special storage temperature.

Keep in the original packaging; the applicator is sterile if the packaging 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 expiry date stated on the label after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of ChloraPrep Colorless

The active ingredients are chlorhexidine digluconate 20 mg/ml and isopropyl alcohol 0.7 ml/ml.

The other ingredients are: purified water.

Appearance of ChloraPrep Colorless and Contents of the Pack

ChloraPrep Colorless is a sterile alcoholic antisepsis solution containing chlorhexidine digluconate and isopropyl alcohol in an applicator. The applicator consists of a latex-free sponge attached to a plastic handle/cylinder containing a glass ampoule with the antisepsis solution. The 1 ml, Frepp 1.5 ml, 1.5 ml, 3 ml, and 10.5 ml applicators contain a single ampoule in the plastic handle. The 26 ml applicator contains two 13 ml ampoules. The sterile applicators are individually packaged with a transparent film.

Pack size:

1 ml: 60 applicators

Frepp 1.5 ml: 20 applicators

1.5 ml: 1 applicator or 25 applicators

3 ml: 1 applicator or 25 applicators

10.5 ml: 1 applicator or 25 applicators

26 ml: 1 applicator or 25 applicators

Not all pack 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

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 Last Revision of this Leaflet: 09/2024

Detailed information on 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 cutaneous use. For external use only.

• Remove the applicator from the wrapper and hold it with the sponge facing down.
• Squeeze the applicator once:
• 26 ml: squeeze the lever
• Other products: squeeze the wings
• Gently press the sponge against the patient's skin to apply the antisepsis solution. A smooth back-and-forth motion should be performed for 30 seconds.
• The 26 ml applicator includes two swabs for cleaning the navel when necessary.

(moisten the swabs by pressing against the sponge of the applicator soaked in the solution).

• Let the covered area dry naturally.

ChloraPrep Colorless can be left on the skin after the procedure.

Maximum coverage areas:

• 1 ml 8 x 10 cm
• Frepp (1.5 ml) 10 x 13 cm
• 1.5 ml 10 x 13 cm
• 3 ml 15 x 15 cm
• 10.5 ml 25 x 30 cm
• 26 ml 50 x 50 cm

Precautions for Use:

• Let ChloraPrep Colorless dry completely before starting any medical procedure.
• To reduce the risk of fire:
• Do not use electrocauterization procedures or other ignition sources until the skin is completely dry.
• Remove any damp material, gauzes, 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, take special care 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 surgical fire.

Use with caution in neonates, especially in premature infants. 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, rinse the affected area immediately with plenty of water.

ChloraPrep Colorless should not come into contact with the eyes due to the risk of visual damage. If it comes into contact with the eyes, rinse immediately and abundantly with water. Consult an ophthalmologist.

Do not use on open wounds or broken skin.

ChloraPrep Colorless 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 may occur with redness or inflammation, itching, dry skin, and/or flaking and localized pain in the administration area. If you notice any signs of a local skin reaction, stop using ChloraPrep Colorless.

Do not use in patients with known hypersensitivity to 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), consider a chlorhexidine-related allergic reaction.

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 applicator after use according to established procedures.

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

Storage Instructions

ChloraPrep Colorless is for single use and is sterile if the packaging is intact. Do not use ChloraPrep Colorless after the expiry date stated on the label and the box. The expiry date refers to the last day of that month. This medicine does not require any special storage temperature.Do not freeze. Keep in the original packaging.

Active Ingredients

The active ingredients of ChloraPrep Colorless are chlorhexidine digluconate 20 mg/ml and isopropyl alcohol 0.7 ml/ml. The excipient of ChloraPrep Colorless is purified water.

Marketing Authorization Holder

Becton Dickinson France

11 Rue Aristide Bergès

38800 Le Pont de Claix

France