Chloraprep Naranja 20 mg/ml + 0.70 ml/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ChloraPrep Orange

20 mg/ml + 0.70 ml/ml cutaneous solution

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 those given by your doctor or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve.

Contents of the leaflet:

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

2. What you need to know before using ChloraPrep Orange

3. How to use ChloraPrep Orange

4. Possible adverse effects

5. How to store ChloraPrep Orange

6. Contents of the pack and other information

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

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

2. What you need to know before using ChloraPrep Orange

Do not use ChloraPrep Orange:

• If you are allergic (hypersensitive) to chlorhexidine digluconate or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to Orange Yellow S (E110).

Warnings and precautions

ChloraPrep Orange is for external use only.

ChloraPrep Orange 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 entry sites, the affected area should be immediately washed with abundant water.
• On open wounds.
• Inside the ear (middle ear).
• In direct contact with neural tissue (e.g., brain and spinal cord).

ChloraPrep Orange 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.

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

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

ChloraPrep may, in rare cases, 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 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 gently applied to the skin. If the solution is applied too vigorously on fragile or sensitive skin, or after repeated use, erythema, swelling, itching, dry and/or scaly skin, and pain may occur. If any of these reactions appear, discontinue application of ChloraPrep Orange immediately.

Avoid prolonged contact with the skin.

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

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, towels) and an oxidizing agent (oxygen, air, nitrous oxide, etc.).

To reduce the risk of fire:

• Do not use electrosurgical cauterization or other ignition sources until the skin is completely dry.
• Remove any soaked materials, gauze, or gowns before starting the procedure.
• Do not use excessive amounts and avoid accumulation of the 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 this medicine, take special care to ensure 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), combined with the use of an ignition source near an oxidizing agent, place the patient at risk of surgical fire.

Other medicines and ChloraPrep

Inform your doctor or nurse if you have recently received 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 are planning to become pregnant, you may use ChloraPrep Orange, but consult your doctor or nurse before using this medicine.

Driving and using machines

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

3. How to use ChloraPrep Orange

The antiseptic solution in ChloraPrep Orange is contained within the plastic applicator. Your doctor or nurse will select the applicator size based on the area to be treated and the surface area to be covered. Your doctor or nurse will gently rub the sponge onto the skin, covering the area that needs to be prepared. Depending on the medical procedure, one or more applicators may be used.

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

If in doubt, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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 rash; wheezing or difficulty breathing; feeling faint or dizzy; unusual metallic taste in the mouth; collapse. You may be experiencing an allergic reaction.

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

Eye disorders:

Frequency unknown: Eye irritation, pain, hyperemia, corneal injury (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).

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 can 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 Orange

This medicinal product does not require any special storage temperature.

Keep in the original packaging; the applicator 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 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 containers and medicines no longer required. This will help protect the environment.

6. Package contents and additional information

Composition of ChloraPrep Orange

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

The other components are purified water and orange-yellow S (E110).

Appearance of ChloraPrep Orange and pack contents

ChloraPrep Orange is a sterile alcoholic antiseptic 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 antiseptic solution and a latex-free dye film. The 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 in a transparent film.

Pack size:

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

Only certain pack sizes may be commercially available.

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 most recent review of this leaflet: 09/2024

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

This information is intended for healthcare professionals only.

Instructions for use of ChloraPrep Orange applicators:

For cutaneous use. External use only.

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

• 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 antiseptic solution. Perform a gentle back-and-forth motion for 30 seconds.

• The 26 ml applicator includes two swabs for cleaning the umbilicus when necessary.

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

• Allow the treated area to dry naturally.

ChloraPrep Orange may remain on the skin after the procedure.

Maximum coverage areas:

• 3 ml: 15 x 15 cm
• 10.5 ml: 25 x 30 cm
• 26 ml: 50 x 50 cm

Precautions for use:

• Allow ChloraPrep Orange to 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 materials, gauzes, or drapes 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 exposed to ChloraPrep Colorless, special care must be taken to ensure 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 in preterm 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, immediately rinse the affected area thoroughly with water.
• ChloraPrep Orange must not enter 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 or broken or damaged skin.
• ChloraPrep Orange 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 tests). 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 or flaky skin, and localized pain at the application site may occur. If any sign of local skin reaction appears, discontinue use of ChloraPrep Orange immediately.
• 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 occur during anesthesia (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 applicator after use according to established procedures.

Refer to the ChloraPrep Orange Summary of Product Characteristics 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 expiry date stated on the label and carton. The expiry date refers to the last day of that month. This medicinal product requires no special temperature storage conditions. Do not freeze. Store in the original packaging.

Active substances

The active substances in ChloraPrep Orange are chlorhexidine digluconate 20 mg/ml and isopropyl alcohol 0.7 ml/ml. The excipients in ChloraPrep Orange are purified water and orange-yellow S (E110).

Marketing Authorization Holder

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