Label: information for the user

ChloraPrep Orange

20 mg/ml + 0.70 ml/ml skin solution

Digluconate of chlorhexidine / Isopropyl alcohol

Read this label carefully before starting to use thismedicine, because it contains important informationfor you

Follow exactly the administration instructions of the medicine contained in this label or those indicated by your doctor or nurse.

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• Ifyou experience adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.
• You should consult a doctor if it worsens or does not improve.

6. Contents of the container and additional information

ChloraPrep Orange is a skin solution of chlorhexidine gluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml, which is used to disinfectthe skin before performing invasive medical procedures, such as injections, insertion of intravascular catheters, minor and major surgery.

Do not use ChloraPrep Orange:

• If you are allergic (hypersensitive) to chlorhexidine digluconate or to any of the other components of this medicinal product (listed in section 6).
• If you are allergic (hypersensitive) to Yellow B (E110)

Warnings and precautions

ChloraPrep Orange is for external use only.

ChloraPrep Orange 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 of the body's entryways, 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., the brain and spinal cord).

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

Severe cases of persistent corneal injury (injury to the surface of the eye) have been reported, which may require a corneal transplant when similar products have accidentally come into contact with the eyes during surgical procedures, in patients under general anesthesia (deep, painless sleep).

Use with caution in newborns, especially in premature babies. ChloraPrep can cause chemical burns on 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 Orange should only be applied to the skin gently. If the solution is applied too vigorously to fragile or sensitive skin, or after repeated use, it may cause erythema, inflammation, itching, dry skin, and/or peeling, and pain. Stop administering ChloraPrep Orange at the first sign of any of these reactions.

Avoid prolonged contact with the skin.

The solution is flammable.Cases of fires in the operating room have been reported, resulting in severe burns to the patient.

The risk of fire is high when using a heat source (electrosurgical units, lasers, fiber optic light sources, high-speed drills/burs...) in combination with a combustible source (cloths, towels...) and an oxidizer (oxygen, air, nitrous oxide...).

To reduce the risk of fire:

• Do not use electrocautery procedures or other heat sources until the skin is completely dry.
• Remove any soaked material, gauze, or gowns before starting the procedure.
• Do not use excessive amounts and avoid allowing the solution to accumulate in skin folds, under the patient, or soak bedclothes or other material in direct contact with the patient.
• When applying occlusive dressings to areas previously exposed to this medication, be especially careful not to have excess product before placing the dressing.
• Reduce oxygen supply or any other oxidizer to the minimum necessary.Procedures performed in the head, neck, and upper chest (above T5) and the use of a heat source near an oxidizer put the patient at risk of suffering a surgical fire.

Other medicinal products and ChloraPrep

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, you may use ChloraPrep Orange. Consult your doctor or nurse before using this medicinal product.

Driving and operating machinery

ChloraPrep Orange does not affect your ability to drive or operate machinery.

The antiseptic solution of ChloraPrep Orange is found 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 several applicators may be used.

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

If in doubt, ask your doctor or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very rarely (less than 1 in 10,000 people) allergic reactions or skin irritation caused by the components of ChloraPrep Orange (chlorhexidine digluconate, isopropyl alcohol, and the yellow-orange dye E110) have been reported.

Stop using ChloraPrep and seek immediate medical attention if you experience any of the following reactions: swelling of the face, lips, tongue, or throat; red, itchy skin rash; wheezing or difficulty breathing; feeling of faintness 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 cleansing, stop using it and consult your doctor or pharmacist.

Eye Disorders:

Unknown frequency: Eye irritation, pain, hyperemia, corneal injury (injury to the eye surface) and permanent eye injury, including permanent visual impairment (following accidental eye exposure during surgical interventions on the head, face, and neck) in patients under general anesthesia (deep, painless sleep).

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not require any special storage temperature.

Store 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 medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe label after CAD.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medicines. By doing so, you will help protect the environment.

Composition of ChloraPrep Orange

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

The other components are purified water, and yellow B (E110).

Appearance of ChloraPrep Orange and packaging contents

ChloraPrep Orange is a sterile alcoholic antiseptic solution containing chlorhexidine digluconate and isopropyl alcohol in an applicator. The applicator consists of a non-latex sponge attached to a plastic handle/cylinder containing a glass vial with the antiseptic solution and a non-latex colorant film. The 3 ml and 10.5 ml applicators contain a single vial in the plastic handle. The 26 ml applicator contains two 13 ml vials. The sterile applicators are individually packaged in a transparent film.

Package size:

• 3 ml:1 applicator or 25 applicators
• 10.5 ml:1 applicator or 25 applicators
• 26 ml:1 applicator or 25 applicators

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Becton Dickinson France

11 Rue Aristide Bergès

38800 Le Pont de Claix

France

Manufacturer responsible:

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)

Last review date of this leaflet:09/2024

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/

This information is intended solely for healthcare professionals.

Instructions for use of ChloraPrep Orange applicators:

For cutaneous use. Only for external use.

- Remove the applicator from the packaging and hold it with the sponge facing downwards.

- Press the applicator once:

- Gently press the sponge against the patient's skin to apply the antiseptic solution. A smooth forward and backward motion should be made for 30 seconds.

-The 26 ml applicator includes two swabs for cleaning the navel when necessary.

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

- Allow the treated area to dry naturally.

ChloraPrepOrangemay be left on the skin after the procedure.

Maximum coverage areas:

- 3 ml15 x 15 cm

- 10.5 ml25 x 30 cm

- 26 ml50 x 50 cm

Precautions for use:

-Allow ChloraPrepOrangeto dry completely before starting any medical procedure.

- To reduce the risk of fire:

•Do not use electrocautery or other ignition sources until the skin is completely dry.

•Remove any soaked material, gauze, or scrubs before starting the procedure.

•Do not use excessive amounts and avoid allowing the solution to accumulate in skin folds, under the patient, or to soak bedding or other materials in direct contact with the patient.

•When applying occlusive dressings to areas previously exposed to ChloraPrep Incoloro, take special care to ensure 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 oxidizer put the patient at risk of surgical fire.

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

- Do not use near mucous membranes, as it may cause irritation, pain, and chemical burns. In case of contact with mucous membranes, wash the affected area immediately with plenty of water.

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

- Do not use on open skin wounds or on damaged or broken skin.

-ChloraPrepOrangeshould 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 injection tests (epicutaneous test). In case of doubt, consult the manufacturer's information on the vaccine.

- Do not apply the solution too vigorously on fragile or sensitive skin. After repeated use, it may cause local skin reactions with erythema or inflammation, itching, dry skin, and/or peeling, and localized pain in the administration area. Stop administration of ChloraPrep Orange at the first sign of local skin reaction.

- 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 anaphylactic symptoms are detected during anesthesia (e.g., sudden drop in blood pressure, urticaria, angioedema), consider the reaction related to chlorhexidine.

- Take special precautions to avoid exposure of the patient to any other product containing chlorhexidine during treatment.

Special precautions for disposal

The solution is flammable. Do not use while smoking or near open flames or strong heat sources.Avoid exposing 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 Orange for more detailed information.

Storage instructions

ChloraPrep Orange is for single use and is sterile if the packaging is intact. Do not use ChloraPrep Orange 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 any special storage temperature.Do not freeze. Store in the original packaging.

Active principles

The active principles of ChloraPrepOrangeare chlorhexidine digluconate 20 mg/ml and isopropyl alcohol 0.7 ml/ml. The excipients of ChloraPrep Orange are purified water, and yellow B (E110).

Marketing authorization holder

Becton Dickinson France

11 Rue Aristide Bergès

38800 Le Pont de Claix

France