Chloraprep

Package leaflet: Information for the user

ChloraPrep 2% w/v / 70% v/v

skin solution
chlorhexidine gluconate / isopropyl alcohol
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you to.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What ChloraPrep is and what it is used for
2. What you need to know before using ChloraPrep
3. How to use ChloraPrep
4. Possible side effects
5. How to store ChloraPrep
6. Contents of the pack and other information

1. What ChloraPrep is and what it is used for

ChloraPrep is a cutaneous solution of chlorhexidine gluconate and isopropyl alcohol in a plastic applicator with a sponge tip at one end. The applicator contains a fast-acting antiseptic solution, which is used to disinfect the skin and help prevent infections prior to invasive medical procedures such as injections, catheter insertion, and minor or major surgical procedures.

2. What you need to know before using ChloraPrep

Do not use ChloraPrep

• if you are allergic (hypersensitive) to chlorhexidine gluconate or to any of the other ingredients of ChloraPrep, especially if you have a history of possible allergic reactions related to chlorhexidine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using ChloraPrep.
ChloraPrep is a medicine for external use only.
ChloraPrep must not be used in the following cases:

• near delicate membranes (mucous membranes): it may cause irritation. In case of contact with delicate membranes, rinse immediately with plenty of water.
• on open skin wounds and on non-intact or damaged skin.
• inside the ear (middle ear).
• in direct contact with neural tissue (e.g. brain and spinal cord tissue).

ChloraPrep must 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 thoroughly with water. In case of eye irritation, redness or pain, or visual disturbance, seek medical advice immediately.
Serious cases of permanent corneal injury (damage to the surface of the eye) have been reported following accidental contact of similar products with the eye during surgical procedures in patients under general anaesthesia (deep sleep induced). Such injuries may require corneal transplantation.
Rarely, ChloraPrep may cause severe allergic reactions leading to a drop in blood pressure and even loss of consciousness. Early signs of an allergic reaction may include 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 should be applied gently to the skin only. When the solution is applied too vigorously on very thin or sensitive skin, or with repeated use, erythema, inflammation, itching, dryness and/or scaling of the skin and pain may occur. At the first signs of such reactions, discontinue application of ChloraPrep immediately.
Avoid prolonged contact with the skin.
Impregnated materials, such as drapes or gowns, must be removed before use. Avoid pooling of the solution.
The solution is flammable. Do not use sources of ignition, open flames or intense heat near the treated area until the skin is completely dry.

Children
Use with caution in newborns, particularly in those born prematurely. ChloraPrep may cause chemical burns on the skin.

Other medicines and ChloraPrep
Inform your doctor, pharmacist or nurse if you have recently received vaccinations or skin tests (patch tests for allergies).

Pregnancy, breastfeeding and fertility
No studies have been conducted with ChloraPrep in pregnant or breastfeeding women.

Pregnancy
No effects during pregnancy are expected, since systemic exposure to chlorhexidine gluconate is negligible. ChloraPrep may be used during pregnancy.

Breastfeeding
No effects on breastfed infants are expected, since systemic exposure to chlorhexidine gluconate in breastfeeding women is negligible. ChloraPrep may be used during breastfeeding.

Fertility
No studies have been conducted on the effects of chlorhexidine gluconate on human reproduction.

Driving and using machines
ChloraPrep does not affect the ability to drive or use machinery.

3. How to use ChloraPrep

The antiseptic solution in ChloraPrep is contained in the plastic applicator. Your doctor,
pharmacist, or nurse will select the appropriate applicator size depending on the procedure site and
the skin area to be covered. The doctor, pharmacist, or nurse will gently apply the sponge
onto the skin, covering the area that needs to be prepared. Depending on the medical procedure,
more than one applicator may be required.
ChloraPrep is for use only on intact skin, and each applicator is for single use only.
If you have any doubts about how to use ChloraPrep, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

If you experience any of the following adverse reactions, stop using ChloraPrep and seek immediate medical assistance: swelling of the face, lips, tongue or throat; a skin rash with redness and itching; wheezing or difficulty breathing; feeling faint or dizzy; a metallic taste in the mouth; collapse. You may be experiencing an allergic reaction.

If you develop a skin rash or itching, pain, redness, blistering, dryness or inflammation of the skin where you applied the product for skin cleansing, stop using ChloraPrep immediately and speak to your doctor, pharmacist or nurse.

Very rarely (incidence less than 1 in 10,000 people), cases of allergic reactions or skin irritation due to components of ChloraPrep (chlorhexidine gluconate and isopropyl alcohol) have been reported.

Other possible side effects, whose frequency is unknown, include: eye irritation, pain, chemical burns, corneal trauma (injury to the surface of the eye), and permanent eye damage, including permanent vision impairment (following accidental eye exposure during head, face and neck surgery) in patients under general anaesthesia (induced deep sleep), and skin burns in newborns/infants.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ChloraPrep

Keep this medicinal product out of the sight and reach of children.
This medicinal product does not require any special storage temperature.
Store in the original packaging; the applicator is sterile until the seal is intact.
Flammable. Avoid exposing the container and its contents to open flames during use,
storage, or disposal. Do not use this medicinal product after the expiry date stated on
the carton (EXP) or on the label (EXP). The expiry date refers to the last day of that
month.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ChloraPrep contains

• The active substances are chlorhexidine gluconate and isopropyl alcohol. 1 ml of solution contains 20 mg of chlorhexidine gluconate (20 mg/ml) and 0.70 ml of isopropyl alcohol (0.70 ml/ml).
  1 applicator with 1 ml of solution contains 20 mg of chlorhexidine gluconate (20 mg/ml) and 0.70 ml of isopropyl alcohol (0.70 ml/ml).
  1 applicator with 1.5 ml of solution contains 30 mg of chlorhexidine gluconate (20 mg/ml) and 1.05 ml of isopropyl alcohol (0.70 ml/ml).
  1 applicator with 3 ml of solution contains 60 mg of chlorhexidine gluconate (20 mg/ml) and 2.10 ml of isopropyl alcohol (0.70 ml/ml).
  1 applicator with 10.5 ml of solution contains 210 mg of chlorhexidine gluconate (20 mg/ml) and 7.35 ml of isopropyl alcohol (0.70 ml/ml).
  1 applicator with 26 ml of solution contains 520 mg of chlorhexidine gluconate (20 mg/ml) and 18.20 ml of isopropyl alcohol (0.70 ml/ml).
• The other component is purified water.

Description of the appearance of ChloraPrep and package contents
The 1.5 ml Frepp applicator consists of a latex-free rectangular sponge connected to a plastic handle that holds a glass ampoule containing the antiseptic solution.
The 1 ml, 1.5 ml, 3 ml, and 10.5 ml applicators consist of a latex-free round sponge connected to a plastic handle that holds a glass ampoule containing the antiseptic solution.
The 26 ml applicator consists of a latex-free square sponge connected to a plastic handle that holds two glass ampoules containing the antiseptic solution.
The sterile applicators are individually packaged in a peelable film.
The packaging consists of a lid sealed to a polymer film, creating a kind of "pouch" enclosing the applicator.

Pack sizes:
Multiple packs containing 60 applicators, each containing 1 ml of cutaneous solution.
Multiple packs containing 20 applicators, each containing 1.5 ml of cutaneous solution (Frepp).
1 applicator containing 1.5 ml of cutaneous solution.
Multiple packs containing 25 applicators, each containing 1.5 ml of cutaneous solution.
1 applicator containing 3 ml of cutaneous solution.
Multiple packs containing 25 applicators, each containing 3 ml of cutaneous solution.
1 applicator containing 10.5 ml of cutaneous solution.
Multiple packs containing 25 applicators, each containing 10.5 ml of cutaneous solution.
1 applicator containing 26 ml of cutaneous solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Becton Dickinson France S.A.S.
11 Rue Aristide Bergès
38800 Le Pont de Claix
France

Contact for reporting adverse events or for customer medical inquiries: +39

Manufacturer responsible for batch release
INSIGHT HEALTH LIMITED
UNIT A BRIDGEFIELDS,
WELWYN GARDEN CITY, HERTFORDSHIRE AL7 1RX
UNITED KINGDOM

BD INFECTION PREVENTION BV
EREMBODEGEM-DORP 86
9320 EREMBODEGEM
BELGIUM

This medicinal product is authorized in the European Economic Area and the United Kingdom under the following names:
Austria – ChloraPrep 20 mg/ml + 0.7 ml/ml Lösung zur Anwendung auf der Haut
Belgium – ChloraPrep à 2 % p/v / 70 % v/v solution pour application cutanée
Finland – ChloraPrep 20 mg/ml / 0.70 ml/ml liuos iholle
France – CHLORAPREP, solution pour application cutanée
Germany – ChloraPrep 2 % w/v / 70 % v/v Lösung zur Anwendung auf der Haut
Ireland – ChloraPrep 2% w/v / 70% v/v cutaneous solution
Italy – ChloraPrep 2% p/v / 70% v/v soluzione cutanea
Luxembourg – ChloraPrep à 2 % p/v / 70 % v/v solution pour application cutanée
Malta – ChloraPrep 2% w/v / 70% v/v cutaneous solution
Netherlands – ChloraPrep 2% w/v / 70% v/v oplossing voor cutaan gebruik
Norway – Chloraprep 20 mg/ml + 0.70 ml/ml liniment, oppløsning
Portugal – Chloraprep 20 mg/ml + 550 mg/ml solução cutânea
Sweden – Chloraprep 20 mg/ml + 0.70 ml/ml kutan lösning
United Kingdom – ChloraPrep 2% w/v / 70% v/v cutaneous solution

<---------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for physicians or healthcare professionals.
ChloraPrep 2% p/v / 70% v/v cutaneous solution
chlorhexidine gluconate / isopropyl alcohol

Instructions for the use of ChloraPrep applicators:

For topical use. For external use only.

• Remove the applicator from the wrapper and hold it with the sponge facing downwards.
• Press the applicator only once:
  • 26 ml: press the lever on the handle
  • For other products, press the wings
• Do not press or squeeze the wings repeatedly in an attempt to speed up sponge saturation.
• Gently press the sponge onto the patient's skin to apply the antiseptic solution. When the solution is visible on the skin, prepare the site by gently rubbing the sponge back and forth on the skin for 30 seconds.
• The 26 ml applicator contains two sponges.
• Allow the treated area to dry completely by air.

ChloraPrep may be left on the skin even after the procedure.
Maximum coverage area:

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

Precautions for use:

• Wait for ChloraPrep to dry completely before starting any medical procedure. Do not use sources of combustion, open flames, or intense heat near the treated area until the skin is completely dry. Do not use excessive amounts of ChloraPrep and avoid allowing the solution to accumulate in skin folds or under the patient’s body, or dripping onto sheets or other materials in direct contact with the patient.
• Use with caution in neonates, particularly those born before 32 weeks of gestation and during the first two weeks of life. ChloraPrep may cause chemical burns to the skin.
• Do not use near mucous membranes: it may cause irritation, pain, and chemical burns. In case of contact with mucous membranes, rinse immediately with abundant water.
• ChloraPrep must not come into contact with the eyes due to the risk of visual impairment. If contact occurs, immediately and thoroughly rinse with water. It is advisable to consult an ophthalmologist.
• Do not use on open wounds or damaged skin.
• ChloraPrep must not come into contact with neural tissue or the middle ear.
• Chlorhexidine is incompatible with soap and other anionic agents.
• Avoid contact of alcohol with certain vaccines and skin test injections (patch tests for allergies). In case of doubt, consult the manufacturer's literature for the vaccine.
• Do not apply the solution too vigorously on very thin or sensitive skin. With repeated use, local skin reactions may occur, including erythema or inflammation, pruritus, dryness and/or scaliness of the skin, and local pain at the application site. At the first signs of local skin reaction, discontinue ChloraPrep application immediately.
• Do not use in patients with known hypersensitivity to the active substances or to any of the excipients, particularly in those with a history of possible allergic reactions related to chlorhexidine. Chlorhexidine-based products 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), a chlorhexidine-related allergic reaction should be considered.
• Particular caution is required to avoid exposing the patient to any other product containing chlorhexidine during the course of treatment.

Special disposal precautions
ChloraPrep is a single-use product.
The solution is flammable. Avoid exposing the container and its contents to open flames during use, storage, or disposal. Dispose of the applicator after use according to clinical waste procedures.
For more detailed information, refer to the ChloraPrep product characteristics summary.
Storage instructions
ChloraPrep is a single-use, sterile product until the package is opened. Do not use ChloraPrep after the expiry date stated on the label or packaging. The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage temperature. Store in the original packaging.
Active substances
The active substances in ChloraPrep are: 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol.
The inactive ingredient in ChloraPrep is purified water.
Marketing Authorization Holder
Becton Dickinson France S.A.S.
11 Rue Aristide Bergès
38800 Le Pont de Claix
France

Package leaflet: Information for the user

ChloraPrep 2% w/v / 70% v/v medicated skin swab

chlorhexidine gluconate / isopropyl alcohol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has instructed you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What ChloraPrep is and what it is used for
2. What you need to know before using ChloraPrep
3. How to use ChloraPrep
4. Possible side effects
5. How to store ChloraPrep
6. Contents of the pack and other information

2. What ChloraPrep is and what it is used for

ChloraPrep is a topical solution containing chlorhexidine gluconate and isopropyl alcohol, provided in the form of a plastic applicator stick with a foam pad impregnated with a fast-acting antiseptic solution at one end. The product is used to disinfect the skin and help prevent infections prior to invasive medical procedures.

3. What you need to know before using ChloraPrep

Do not use ChloraPrep

• if you are allergic (hypersensitive) to chlorhexidine gluconate or to any of the other ingredients of ChloraPrep, especially if you have a history of possible allergic reactions related to chlorhexidine (listed in section 6).
• in the ear canal, as the solution may damage hearing.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ChloraPrep.
ChloraPrep is for external use only.
ChloraPrep must not be used in the following cases:

• near delicate membranes (mucous membranes): it may cause irritation. In case of contact with delicate membranes, rinse immediately with abundant water.
• on open skin wounds and non-intact or damaged skin.
• in direct contact with nervous tissue (e.g. brain and spinal cord tissue).

ChloraPrep must not come into contact with the eyes due to the risk of visual damage. If contact occurs, immediately and thoroughly rinse with water. If eye irritation, redness, pain, or visual disturbance occurs, seek medical advice immediately.
Serious cases of permanent corneal injury (damage to the surface of the eye) have been reported following accidental contact of similar products with the eye during surgical procedures in patients under general anesthesia (induced deep sleep). Such injuries may require corneal transplantation.
Rarely, ChloraPrep may cause severe allergic reactions leading to a drop in blood pressure and even loss of consciousness. Early signs of an 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 should be applied gently only to the skin. When the solution is applied too vigorously on very thin or sensitive skin, or with repeated use, erythema, inflammation, itching, dryness and/or scaling of the skin, and pain may occur. At the first signs of such reactions, immediately discontinue application of ChloraPrep.
Avoid prolonged contact with the skin.
Impregnated materials, such as drapes or gowns, should be removed before use. Avoid pooling of the solution.
The solution is flammable. Do not use sources of ignition, open flames, or intense heat near the treated area until the skin is completely dry.

Children
Use with caution in newborns, particularly in premature infants. ChloraPrep may cause chemical burns on the skin.

Other medicines and ChloraPrep
Inform your doctor, pharmacist, or nurse about any recent vaccinations or skin tests (patch tests for allergies).

Pregnancy, breastfeeding and fertility
No studies have been conducted with ChloraPrep in pregnant or breastfeeding women.

Pregnancy
No systemic effects are expected during pregnancy, since systemic exposure to chlorhexidine gluconate is negligible. ChloraPrep may be used during pregnancy.

Breastfeeding
No effects are expected in breastfed infants, since systemic exposure to chlorhexidine gluconate in breastfeeding women is negligible. ChloraPrep may be used during breastfeeding.

Fertility
No studies have been conducted on the effects of chlorhexidine gluconate on human reproduction.

Driving and using machines
ChloraPrep does not affect the ability to drive or operate machinery.

3. How to use ChloraPrep

The antiseptic solution is stored inside an aluminium pouch which also contains the swabs.
Your doctor, pharmacist or nurse will select the appropriate pouch size and the number of ChloraPrep swabs
required, depending on the procedure site and the skin area to be covered. The doctor, pharmacist or
nurse will gently rub the foam swab onto the skin, treating the area of skin that needs to be prepared. Depending on the medical procedure, more than one sachet may be used.
Other ChloraPrep applicators might be more suitable, depending on the medical procedure to be performed.
ChloraPrep is used only on intact skin and each swab is for single use only.
If you have any doubts about the use of ChloraPrep, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following adverse reactions, stop using ChloraPrep: swelling of the face,
lips, tongue or throat; a skin rash with redness and itching; wheezing or difficulty breathing; feeling faint or dizzy; a metallic taste in the mouth; collapse.
You may be having an allergic reaction.
If you develop a rash or itching, pain, redness, blistering, dryness or inflammation of the skin where you applied the product, stop using ChloraPrep immediately and speak to your doctor, pharmacist or nurse.
Very rarely (incidence less than 1 in 10,000 people), cases of allergic reactions or skin irritation due to components of ChloraPrep (chlorhexidine gluconate and isopropyl alcohol) have been reported.
Other possible side effects, the frequency of which is unknown, include: eye irritation, pain, chemical burns, corneal trauma (injury to the surface of the eye), and permanent eye damage, including permanent visual impairment (after accidental exposure of the eyes during surgical procedures on the head, face and neck) in patients under general anaesthesia (induced deep sleep), and skin burns in neonates/infants.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store ChloraPrep

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Store in the original packaging. ChloraPrep is sterile as long as the seal remains intact.
Flammable. Avoid exposing the container and its contents to open flames during use, storage, or disposal.
Do not use this medicine after the expiry date stated on the carton (SCAD) or label (EXP).
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ChloraPrep contains

• The active substances are chlorhexidine gluconate and isopropyl alcohol. Each single-dose sachet containing 1.75 ml of solution contains 35 mg of chlorhexidine gluconate (20 mg/ml) and 1.23 ml of isopropyl alcohol (0.70 ml/ml). Each sachet containing three swabs with 5.25 ml of solution contains 105 mg of chlorhexidine gluconate (20 mg/ml) and 3.7 ml of isopropyl alcohol (0.70 ml/ml).
• The other ingredient is purified water.

Description of the appearance of ChloraPrep and contents of the pack
ChloraPrep swabs consist of a plastic handle attached to a foam tip saturated with solution,
sealed in a plastic film sachet containing the antiseptic solution. A sachet may contain one or three swabs.
Pack sizes:
1.75 ml (single swab): pack of 48 units (total 48 swabs)
5.25 ml (three swabs): pack of 40 units, each containing 3 swabs (total 120 swabs)
Not all pack sizes may be marketed.
Marketing Authorization Holder
Becton Dickinson France S.A.S.
11 Rue Aristide Bergès
38800 Le Pont de Claix
France
Contact for adverse event reporting or customer medical inquiries: +39
Responsible manufacturer for batch release
Bd infection prevention bv
Erembodegem-dorp 86
9320 Erembodegem
Belgium
This medicinal product is authorized in the European Economic Area (EEA) Member States and the United Kingdom
under the following names:
Finland – ChloraPrep 20 mg/ml + 0.70 ml/ml kyllästetty lääketuppo iholle
France – CHLORAPREP tampon cutané imprégné en applicateur
Germany – ChloraPrep 2 % w/v / 70 % v/v Imprägnierter Tupfer zur Anwendung auf der Haut
Ireland – ChloraPrep 2% w/v / 70% v/v impregnated cutaneous swab
Italy – ChloraPrep 2% p/v / 70% v/v tampone cutaneo medicato
Norway – Chloraprep 20 mg/ml + 0.70 ml/ml impregnert vattpinne til bruk på hud
Sweden – Chloraprep 20 mg/ml + 0.70 ml/ml impregnerad kutan svabb
United Kingdom (Northern Ireland) – ChloraPrep 2% w/v / 70% v/v impregnated cutaneous swab
<--------------------------------------------------------------------------------------------------------------------->
The following information is intended for healthcare professionals only.
ChloraPrep 2% p/v / 70% v/v cutaneous swab impregnated with medicinal product
chlorhexidine gluconate / isopropyl alcohol

Instructions for the use of ChloraPrep:

For cutaneous use. For external use only.
Select the appropriate ChloraPrep presentation according to the invasive procedure being performed and the size
of the area to be covered, in order to avoid administering an excessive amount of solution and the risk of
product accumulation. Other ChloraPrep applicators may be more suitable depending on the medical procedure being performed.

• Only the inside of the pouch is sterile. To preserve sterility, open the pouch carefully and do not allow the foam swab to touch any non-sterile surface.
• Tear the pouch at the side notch to expose the swab handle. Do not touch the foam swab.
• Place the pad with the flat side down onto the patient's skin treatment area.
• Apply the solution for 30 seconds using a gentle back-and-forth motion.
• Allow the treated area to dry completely by air.
• For three swabs, use the swabs sequentially for a total of 30 seconds. ChloraPrep solution may be left on the skin even after the procedure.

Maximum coverage area:

• Single swab (1.75 ml): 6 cm x 7 cm
• Three swabs (5.25 ml): 10 cm x 16 cm

Precautions for use:

• Wait for the ChloraPrep solution to dry completely on the skin before initiating any medical procedure. Do not use sources of combustion, open flames, or intense heat near the treated area until the skin is completely dry.
• Do not use excessive amounts of ChloraPrep and avoid accumulation of the solution in skin folds, under the patient’s body, or dripping onto sheets or other materials in direct contact with the patient.
• Use with caution in neonates, particularly those born before 32 weeks of gestation and during the first 2 weeks of life. ChloraPrep may cause chemical skin burns.
• Do not use near mucous membranes: it may cause irritation, pain, and chemical burns. In case of contact with mucous membranes, rinse immediately with abundant water.
• ChloraPrep must not come into contact with the eyes due to the risk of visual damage. If contact occurs, immediately and thoroughly rinse with water. It is advisable to consult an ophthalmologist.
• Do not use on open skin wounds or on damaged or injured skin.
• ChloraPrep must not come into contact with nervous tissue. To prevent exposure of the middle ear to ChloraPrep through tympanic membrane perforation, the use of ChloraPrep in the ear canal is contraindicated.
• Chlorhexidine is incompatible with soap and other anionic agents.
• Avoid contact of alcohol with certain vaccines and skin test injections (patch tests for allergies). In case of doubt, consult the manufacturer's literature for the vaccine.
• Do not apply the solution too vigorously on very thin or sensitive skin. With repeated use, local skin reactions may occur, including erythema or inflammation, itching, dryness and/or scaliness of the skin, and local pain at the application site. At the first signs of local skin reaction, discontinue ChloraPrep application immediately.
• Do not use in patients with known hypersensitivity to the active substances or to any of the excipients, particularly in those with a history of possible allergic reactions related to chlorhexidine. Chlorhexidine-containing products 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.
• Particular caution is required to avoid patient exposure to any other product containing chlorhexidine during the treatment period.

Special disposal precautions
ChloraPrep is a single-use product.
The solution is flammable. Avoid exposing the container and its contents to open flames
during use, storage, or disposal. Dispose of the swab after use according to clinical waste procedures.
For more detailed information, refer to the ChloraPrep product summary of characteristics.

Storage instructions
ChloraPrep is a single-use, sterile product until the package is opened. Do not use
ChloraPrep after the expiry date stated on the label or packaging. The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage temperature. Store in the original packaging.

Active substances
The active substances in ChloraPrep are: 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol. The inactive ingredient in ChloraPrep is purified water.

Marketing Authorization Holder
Becton Dickinson France S.A.S.
11 Rue Aristide Bergès
38800 Le Pont de Claix
France

Package leaflet: Information for the user

ChloraPrep with Dye 2% w/v / 70% v/v Skin Solution

chlorhexidine gluconate / isopropyl alcohol
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has instructed you. – Keep this leaflet. You may need to read it again.

• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What ChloraPrep with Dye is and what it is used for
2. What you need to know before using ChloraPrep with Dye
3. How to use ChloraPrep with Dye
4. Possible side effects
5. How to store ChloraPrep with Dye
6. Contents of the pack and other information

1. What ChloraPrep with Dye is and what it is used for

ChloraPrep with Dye is a cutaneous solution of chlorhexidine gluconate and isopropyl alcohol in a plastic applicator with a sponge tip at one end. The applicator contains a fast-acting antiseptic solution used to disinfect the skin and help prevent infections before invasive medical procedures such as injections, catheter insertion, and minor or major surgical interventions. ChloraPrep with Dye contains a skin dye, which however does not impair the antiseptic properties of the solution.

2. What you need to know before using ChloraPrep with Dye

Do not use ChloraPrep with Dye

• if you are allergic (hypersensitive) to chlorhexidine gluconate or to any of the other ingredients of ChloraPrep with Dye, especially if you have a history of possible allergic reactions related to chlorhexidine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ChloraPrep with Dye.
ChloraPrep with Dye is for external use only.
ChloraPrep with Dye must not be used in the following cases:

• near delicate membranes (mucous membranes): it may cause irritation. If contact occurs with delicate membranes, rinse immediately with plenty of water.
• on open skin wounds or on non-intact or damaged skin.
• inside the ear (middle ear).
• in direct contact with neural tissue (e.g. brain and spinal cord tissue).

ChloraPrep with Dye must not come into contact with the eyes due to the risk of visual damage.
If contact occurs with the eyes, immediately and thoroughly rinse with water. If eye irritation, redness, pain, or visual disturbances occur, consult a doctor immediately.
Following accidental contact of similar products with the eye during surgical procedures in patients under general anaesthesia (induced deep sleep), serious cases of permanent corneal injury (damage to the surface of the eye) have been reported. Such injuries may require corneal transplantation.
Rarely, ChloraPrep with Dye may cause severe allergic reactions leading to a drop in blood pressure and even loss of consciousness. Early symptoms of an allergic reaction may include skin rash or asthma. If you notice these symptoms, discontinue use of ChloraPrep with Dye and contact your doctor as soon as possible (see section 4 “Undesirable effects”).
ChloraPrep with Dye should be applied gently and only to the skin. When the solution is applied too vigorously on very thin or sensitive skin, or with repeated use, erythema, inflammation, itching, dryness and/or scaliness of the skin, and pain may occur. At the first signs of such reactions, immediately discontinue application of ChloraPrep with Dye.
Avoid prolonged skin contact.
Materials soaked with the solution, such as drapes or gowns, must be removed before use. Avoid pooling of the solution.
The solution is flammable. Do not use sources of ignition, open flames, or intense heat near the treated area until the skin is completely dry.

Children
Use with caution in neonates, particularly in premature infants. ChloraPrep with Dye may cause chemical burns on the skin.

Other medicines and ChloraPrep with Dye
Inform your doctor, pharmacist, or nurse about any recent vaccinations or skin tests (patch tests for allergies).

Pregnancy, breastfeeding, and fertility
No studies have been conducted with ChloraPrep with Dye in pregnant or breastfeeding women.

Pregnancy
No effects during pregnancy are expected, since systemic exposure to chlorhexidine gluconate is negligible. ChloraPrep with Dye may be used during pregnancy.

Breastfeeding
No effects on breastfed newborns/infants are expected, since systemic exposure to chlorhexidine gluconate in breastfeeding women is negligible. ChloraPrep with Dye may be used during breastfeeding.

Fertility
No studies have been conducted on the effects of chlorhexidine gluconate on human reproduction.

Driving and using machines
ChloraPrep with Dye does not affect the ability to drive or operate machinery.

3. How to use ChloraPrep with Dye

The antiseptic solution of ChloraPrep with Dye is contained in the plastic applicator. Your doctor,
pharmacist, or nurse will select the appropriate applicator size based on the procedure site and the area of
skin to be covered. The doctor, pharmacist, or nurse will gently apply the sponge to the skin,
covering the area of skin that needs to be prepared. Depending on the medical procedure to be performed,
it may be necessary to use more than one applicator.
ChloraPrep with Dye is for use only on intact skin, and each applicator is for single use only.
If you have any doubts about the use of ChloraPrep with Dye, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following adverse reactions, stop using ChloraPrep with Dye and seek immediate medical assistance: swelling of the face, lips, tongue or throat; a rash with redness and itching; wheezing or difficulty breathing; feeling faint or dizzy; a metallic taste in the mouth; collapse. You may be having an allergic reaction.
If you develop a rash or itching, pain, redness, blistering, dryness or inflammation of the skin where you applied the product for skin cleansing, stop using ChloraPrep with Dye immediately and speak to your doctor, pharmacist or nurse.
Very rarely (incidence less than 1 in 10,000 people), cases of allergic reactions or skin irritation to the components of ChloraPrep with Dye (chlorhexidine gluconate, isopropyl alcohol and sunset yellow dye E110) have been reported.
Other possible side effects, whose frequency is unknown, include: eye irritation, pain, chemical burns, corneal trauma (injury to the surface of the eye), and permanent eye damage, including permanent impairment of vision (after accidental exposure to the eyes during head, face and neck surgery) in patients under general anaesthesia (induced deep sleep), and skin burns in newborns/infants.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via [appropriate reporting system]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ChloraPrep with Dye

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage temperature.
Store in the original packaging; the applicator is sterile until the seal is broken.
Flammable. Avoid exposing the container and its contents to open flames during use, storage, and disposal.
Do not use this medicine after the expiry date stated on the carton (EXP) or label (EXP). The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What ChloraPrep with Tint Contains

• The active substances are chlorhexidine gluconate and isopropyl alcohol. 1 ml of solution contains 20 mg of chlorhexidine gluconate (20 mg/ml) and 0.70 ml of isopropyl alcohol (0.70 ml/ml).
  One 3 ml applicator contains 60 mg of chlorhexidine gluconate (20 mg/ml) and 2.10 ml of isopropyl alcohol (0.70 ml/ml).
  One 10.5 ml applicator contains 210 mg of chlorhexidine gluconate (20 mg/ml) and 7.35 ml of isopropyl alcohol (0.70 ml/ml).
  One 26 ml applicator contains 520 mg of chlorhexidine gluconate (20 mg/ml) and 18.20 ml of isopropyl alcohol (0.70 ml/ml).
• The other components are purified water and sunset yellow (E110).

Description of the Appearance of ChloraPrep with Tint and Contents of the Package
The 3 ml and 10.5 ml applicators consist of a round, latex-free sponge attached to a plastic handle that holds a glass ampoule containing the antiseptic solution. The 26 ml applicator consists of a square, latex-free sponge connected to a plastic handle that holds two glass ampoules containing the antiseptic solution. The sterile applicators are individually packaged in a peelable foil.
The packaging consists of a cover material sealed to a polymer film, creating a kind of "pouch" surrounding the applicator.

Pack Sizes:
1 applicator containing 3 ml of cutaneous solution.
Multiple packs containing 25 applicators, each containing 3 ml of cutaneous solution.
1 applicator containing 10.5 ml of cutaneous solution.
Multiple packs containing 25 applicators, each containing 10.5 ml of cutaneous solution.
1 applicator containing 26 ml of cutaneous solution.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Becton Dickinson France S.A.S.
11 Rue Aristide Bergès
38800 Le Pont de Claix
France
Contact for adverse event reporting or customer medical inquiries: +39

Responsible Manufacturer for Batch Release
INSIGHT HEALTH LIMITED
UNIT A BRIDGEFIELDS,
WELWYN GARDEN CITY, HERTFORDSHIRE AL7 1RX
UNITED KINGDOM

BD INFECTION PREVENTION BV
EREMBODEGEM-DORP 86
9320 EREMBODEGEM
BELGIUM

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom under the following names:
Austria – ChloraPrep gefärbt 20 mg/ml + 0.7 ml/ml Lösung zur Anwendung auf der Haut
Belgium – ChloraPrep coloré à 2 % p/v / 70 % v/v solution pour application cutanée
Finland – ChloraPrep värillinen 20 mg/ml / 0.70 ml/ml liuos iholle
France – CHLORAPREP COLORE, solution pour application cutanée
Germany – ChloraPrep gefärbt 2% w/v / 70% v/v Lösung zur Anwendung auf der Haut
Ireland – ChloraPrep with Tint 2% w/v / 70% v/v cutaneous solution
Italy – ChloraPrep con Colorante 2% p/v / 70% v/v soluzione cutanea
Luxembourg – Chloraprep coloré à 2 % p/v / 70 % v/v solution pour application cutanée
Malta – ChloraPrep with Tint 2% w/v / 70% v/v cutaneous solution
Netherlands – Getinte ChloraPrep 2% w/v / 70% v/v oplossing voor cutaan gebruik
Norway – Chloraprep med farge 20 mg/ml + 0.70 ml/ml liniment, oppløsning
Portugal – Chloraprep laranja 20 mg/ml (2% p/v) + 550 mg/ml (70% v/v) solução cutânea
Sweden – Chloraprep färgad 20 mg/ml + 0.70 ml/ml kutan lösning
United Kingdom – ChloraPrep with Tint 2% w/v / 70% v/v cutaneous solution

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The following information is intended exclusively for physicians or healthcare professionals.

ChloraPrep with Tint 2% p/v / 70% v/v cutaneous solution
chlorhexidine gluconate / isopropyl alcohol

Instructions for Use of ChloraPrep with Tint Applicators:
For cutaneous use. For external use only.

• Remove the applicator from its pouch and hold it with the sponge facing downward.
• Press the applicator once only:
  • For 26 ml: press the lever on the handle
  • For other products: press the wings
• Do not press or squeeze the wings repeatedly in an attempt to speed up sponge saturation.
• Gently press the sponge onto the patient's skin to apply the antiseptic solution. When solution becomes visible on the skin, prepare the site by gently moving the sponge back and forth over the skin for 30 seconds.
• The 26 ml applicator includes two sponges.
• Allow the treated area to dry completely by air.

ChloraPrep with Tint may be left on the skin even after the procedure.

Maximum Coverage Area:

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

Precautions for Use:

• Wait until ChloraPrep with Tint has completely dried before initiating any medical procedure. Do not use sources of ignition, open flames, or intense heat near the treated area until the skin is completely dry. Avoid excessive use of ChloraPrep with Tint and prevent pooling of the solution in skin folds, under the patient’s body, or dripping onto sheets or other materials in direct contact with the patient.
• Use with caution in neonates, especially those born before 32 weeks of gestation and during the first two weeks of life. ChloraPrep with Tint may cause chemical skin burns.
• Do not use near mucous membranes: it may cause irritation, pain, and chemical burns. In case of contact with mucous membranes, rinse immediately with abundant water.
• ChloraPrep with Tint 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. Consultation with an ophthalmologist is recommended.
• Do not use on open wounds or damaged skin.
• ChloraPrep with Tint must not come into contact with neural tissue or the middle ear.
• Chlorhexidine is incompatible with soap and other anionic agents.
• Avoid contact of alcohol with certain vaccines and skin test injections (patch tests for allergies). In case of doubt, consult the vaccine manufacturer’s literature.
• Do not apply the solution too vigorously on very thin or sensitive skin. With repeated use, local skin reactions may occur, including erythema or inflammation, itching, dryness and/or scaling of the skin, and local pain at the application site. At the first signs of a local skin reaction, discontinue use of ChloraPrep with Tint immediately.
• Do not use in patients with known hypersensitivity to the active substances or to any of the excipients, particularly those with a history of possible allergic reactions related to chlorhexidine. Chlorhexidine-containing products 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.
• Particular caution is required to avoid patient exposure to any other product containing chlorhexidine during the treatment cycle.

Special Disposal Precautions
ChloraPrep with Tint is a single-use product.
The solution is flammable. Avoid exposing the container and its contents to open flames during use, storage, or disposal. Dispose of the applicator after use according to clinical waste procedures.
For more detailed information, refer to the Summary of Product Characteristics for ChloraPrep with Tint.

Storage Instructions
ChloraPrep with Tint is a single-use, sterile product until the package is opened. Do not use ChloraPrep with Tint after the expiry date stated on the label or packaging. The expiry date refers to the last day of that month. This medicinal product does not require any special temperature storage conditions. Store in the original packaging.

Active Substances
The active substances in ChloraPrep with Tint are: 2% chlorhexidine gluconate and 70% v/v isopropyl alcohol.
The excipients in ChloraPrep with Tint are purified water and sunset yellow (E110).

Marketing Authorization Holder
Becton Dickinson France S.A.S.
11 Rue Aristide Bergès
38800 Le Pont de Claix
France