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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ChloraPrep Colorless 20 mg/ml + 0.70 ml/ml cutaneous solution

Chlorhexidine digluconate / Isopropyl alcohol

Read the entire leaflet carefully before starting to use 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 more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve.

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 Colorless 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 Colorless

Do not use ChloraPrep Colorless:

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

Warnings and precautions

ChloraPrep Colorless is for external use only.

ChloraPrep Colorless 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, 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 Colorless 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. In case of eye irritation, redness, pain, or visual disturbances, consult a doctor immediately.

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

Use with caution in neonates, especially premature infants. ChloraPrep may cause chemical burns on 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 Colorless 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, inflammation, itching, dry and/or flaking skin, and pain may occur. If any of these reactions appear, discontinue the use of ChloraPrep Colorless immediately.

Avoid prolonged contact with the skin.

The solution is flammable.

Cases of surgical 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/burrs) is used in combination with a fuel source (such as drapes, towels) and an oxidizer (oxygen, air, nitrous oxide).

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 surgical 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 oxidizer 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 oxidizer, 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 Colorless, but consult your doctor or nurse before using this medicine.

Driving and using machines

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

3. How to use ChloraPrep Colorless

The ChloraPrep Colorless antiseptic solution is contained within the plastic applicator. Your doctor or nurse will select the applicator size according to the area to be treated and the surface 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 topical use on the skin only, and each applicator is for single use only.

If you have any doubts, ask your doctor or nurse.

4. Possible adverse effects

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

Eye disorders:

Frequency unknown: Eye irritation, pain, hyperemia, 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 anesthesia (induced painless deep sleep).

If you develop a rash or 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.

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 Colorless

This medicine 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 you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ChloraPrep Clear

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

The other component is: purified water.

Appearance of ChloraPrep Clear and contents of the pack

ChloraPrep Clear 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. 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. Sterile applicators are individually packaged in a transparent film.

Pack sizes:

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

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

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 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 Clear applicators:

For cutaneous use. For external use only.

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

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

• Allow the treated area to dry naturally.

ChloraPrep Clear may 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:

• Allow ChloraPrep Clear to dry completely before starting any medical procedure.
• 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, gauzes, or drapes before starting the procedure.
  • Do not use excessive amounts and avoid accumulation of solution in skin folds, under the patient, or soaking bed linens or other materials in direct contact with the patient.
  • When applying an occlusive dressing to areas previously exposed to ChloraPrep Clear, special care must be taken to ensure there is no excess product 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 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, immediately rinse the affected area thoroughly with abundant 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 or broken or damaged skin.
• ChloraPrep Clear 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 and/or flaky skin, and localized pain at the application site may occur. If any sign of local skin reaction appears, discontinue use of ChloraPrep Clear 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 anaesthesia. If symptoms of an anaphylactic reaction occur during anaesthesia (e.g., sudden drop in blood pressure, urticaria, angioedema), chlorhexidine-related allergic reaction should be considered.

-Special precautions must 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 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 Clear Summary of Product Characteristics for more detailed information.

Storage instructions

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

Active substances

The active substances in ChloraPrep Clear are chlorhexidine digluconate 20 mg/ml and isopropyl alcohol 0.7 ml/ml. The excipient in ChloraPrep Clear is purified water.

Marketing Authorisation Holder

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