CHLORAPREP 2% W/V/70% V/V Roztwór do stosowania na skórę

Treść ulotki

1. ChloraPrep 2% p/v / 70% v/v
   1. What is CholaPrep and what is it 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. Package Contents and Other Information
2. ChloraPrep with Dye 2% w/v /70% v/v
   1. What is ChloraPrep with Dye and what is it 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. Package Contents and Other Information

ChloraPrep 2% p/v / 70% v/v

cutaneous solution
Chlorhexidine gluconate, Isopropyl alcohol
Sepp0.67 ml / 1 ml / Frepp1.5 ml /
1.5 ml / 3 ml / 10.5 ml / 26 ml
Read this leaflet carefully before using this medicine as it contains important
information for you.

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

Contents of this leaflet:

• 1. What ChloraPrepis and what it is used for
• 2. What you need to know before you use 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 is CholaPrep and what is it used for

ChloraPrep is a cutaneous solution of chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v 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 before invasive medical procedures such as injections, catheter insertion and minor or major surgical
interventions.

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
ChloraPrep is a medicine for external use only.
ChloraPrep must not be used in the following cases:

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

In rare cases, ChloraPrep may cause serious allergic reactions, leading to a drop in blood
pressure and even loss of consciousness. The first symptoms of an 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 should only be applied to the skin, gently. If the solution is applied too vigorously to very thin or sensitive skin, or in case of repeated use, erythema,
inflammation, itching, dryness and/or scaling of the skin and pain may occur. At the first signs of the aforementioned
reactions, immediately stop applying ChloraPrep.
Avoid prolonged contact with the skin.
Impregnated materials, such as drapes or gowns, must be removed before use. Avoid pooling of solution.
The solution is flammable. Do not use ignition sources before the skin is completely dry.

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

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

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

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

Breastfeeding
No effects are expected on breastfed newborns/infants, as systemic exposure
to chlorhexidine gluconate by the breastfeeding woman 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 operating machinery
ChloraPrep does not affect the ability to drive or operate machinery.

3. How to use ChloraPrep

The ChloraPrep antiseptic solution is contained in the plastic applicator. The doctor or nurse
will choose the applicator size most suitable based on the surgical site and the area to be covered. The
doctor 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, more than one
applicator may be necessary.
ChloraPrep must be used exclusively on the skin and each applicator is for single use.
If you have any doubts about the use of ChloraPrep, please consult your doctor 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 attention: swelling of the face, lips, tongue or throat; a skin
rash with redness and itching; wheezing or difficulty breathing; feeling faint and
dizzy; a strange metallic taste in your mouth; collapse. You may be having an allergic
reaction.
If you develop a skin rash or itching, pain, redness, blisters, dryness or inflammation of the
skin where you have used the product for skin cleansing, stop using
ChloraPrep immediately and talk to your doctor or pharmacist.
Very rarely (incidence less than 1 in 10,000 people) cases of allergic reactions or
reactions of irritated skin to the components of ChloraPrep (chlorhexidine gluconate and isopropyl alcohol) have been reported.
Other possible side effects, whose frequency is not known are: eye irritation, pain, impaired vision, chemical burns, eye injury, skin burns in newborns/infants.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ChloraPrep

Flammable. This medicine does not require any particular storage temperature.
Store in the original package. The applicator is sterile unless the seal is damaged.
Avoid exposing the container and its contents to open flames during use, storage and
disposal. Do not use this medicine after the expiry date which is reported on the label or on the
box after EXP. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children .
Do not dispose of any medicine in the drain or with household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help to protect the environment.

6. Package Contents and Other Information

What ChloraPrep Contains

• The active ingredients are chlorhexidine gluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml.
• The other component is purified water.

Description of the Appearance of ChloraPrep and Package Contents
The 0.67 ml Sepp applicator consists of a latex-free sponge tip connected to a plastic shaft that holds a glass vial containing the antiseptic solution. The 1.5 ml Frepp applicator consists of a rectangular latex-free sponge connected to a plastic shaft that holds a glass vial containing the antiseptic solution. The 1 ml, 1.5 ml, 3 ml and 10.5 ml applicators consist of a round latex-free sponge connected to a plastic shaft that holds a glass vial containing the antiseptic solution. The 26 ml applicator consists of a square latex-free sponge connected to a plastic shaft that holds two glass vials containing the antiseptic solution.
The sterile applicators are individually packaged in a transparent film.
Package format:
0.67 ml Sepp: 200 applicators
1 ml: 60 applicators
1.5 ml Frepp: 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
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Becton Dickinson France S.A.S.
11 Rue Aristide Bergès
38800 Le Pont de Claix
France
800 977 507

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

BECTON DICKINSON B.V.
LANGE DREEF 11
4131 NJ TE VIANEN UT
NETHERLANDS

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria - ChloraPrep
Belgium - ChloraPrep
Finland - ChloraPrep
France - ChloraPrep
Germany - ChloraPrep
Ireland - ChloraPrep
Italy - ChloraPrep
Luxembourg - ChloraPrep
Malta - ChloraPrep
Netherlands - ChloraPrep
Norway - Chloraprep
Portugal - Chloraprep
Sweden – Chloraprep
United Kingdom - ChloraPrep
<---------------------------------------------------------------------------------------------------------
---------------
The following information is intended only for physicians or healthcare professionals.

ChloraPrep 2% w/v / 70% v/v
cutaneous solution
Chlorhexidine gluconate, Isopropyl alcohol
Sepp 0.67 ml / 1 ml / Frepp 1.5 ml /
1.5 ml / 3 ml / 10.5 ml / 26 ml
Instructions for Use of ChloraPrep Applicators:
For cutaneous use. For external use only.

• Remove the applicator from the wrapper and hold it with the sponge facing downwards.
• Press the applicator only once:
• 0.67 ml (Sepp): press in the center of the applicator
• 26 ml: press the lever on the handle
• For other products, press on the tabs
• Do not repeatedly press or squeeze the tabs 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 moving the sponge gently back and forth over the skin for 30 seconds.
• The 26 ml applicator includes two pads. Clean the intact umbilicus with the pads provided, if necessary (moisten the pads by pressing them onto the applicator sponge, saturated with solution).
• Allow the treated area to air dry completely.

ChloraPrep can be left on the skin even after surgery.
Maximum coverage area:

• Sepp (0.67 ml) 5 cm x 8 cm
• 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 electrocautery procedures before the skin is completely dry. Do not use excessive amounts of the product and avoid allowing the solution to accumulate in skin folds or under the patient's body or drip onto the sheets or other material in direct contact with the patient.
• Use with caution in newborns, especially those born before 32 weeks of gestation and in the first 2 weeks of life. ChloraPrep can cause chemical burns to the skin.
• Do not use near the eyes or mucous membranes: it may cause irritation, eye irritation, pain, impaired vision, chemical burns and eye trauma. If contact with eyes or mucous membranes occurs, rinse immediately with plenty of water.
• Do not use on open wounds or broken 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 some vaccines and skin injection tests (allergy patch tests). If in doubt, consult the vaccine manufacturer's literature.
• Do not apply the solution too vigorously to very thin or sensitive skin. With repeated use, local skin reactions including erythema or inflammation, itching, dryness and/or scaling of the skin and local pain at the application site may occur. At the first signs of a local skin reaction, immediately stop applying ChloraPrep.
• Do not use in patients with known hypersensitivity to ChloraPrep solution or to any of its components, especially those with a history of possible allergic reactions to chlorhexidine. Chlorhexidine-based products 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), an allergic reaction related to chlorhexidine should be considered.
• Particular caution is required to avoid exposing the patient to any other product containing chlorhexidine during the treatment cycle.

Special Precautions for Disposal
The solution is flammable. Do not smoke during use, do not expose to 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 clinical waste procedures.
For more detailed information, refer to the ChloraPrep product characteristics summary.

Storage Conditions
ChloraPrep is a single-use product, sterile 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 particular storage temperature. Store in the original packaging.

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

Marketing Authorisation Holder
Becton Dickinson France S.A.S.
11 Rue Aristide Bergès
38800 Le Pont de Claix
France
800 977 507

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

Cutaneous solution
chlorhexidine gluconate, isopropyl alcohol
3 ml / 10.5 ml / 26 ml
Read this leaflet carefully before using this medicine as it contains important
information for you.

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

Contents of this leaflet:

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

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

ChloraPrep with Dye is a cutaneous solution of chlorhexidine gluconate 2% w/v and isopropyl alcohol 70%
v/v in a plastic applicator which has a sponge tip at one end. The applicator contains a
fast-acting antiseptic solution that is used to disinfect the skin and help prevent infections
before invasive medical procedures such as injections, catheter insertion and minor or
major surgical operations. ChloraPrep with Dye contains a coloring substance for the skin, which however does not affect
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 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
ChloraPrep with Dye is a medicine for external use only.
ChloraPrep with Dye should not be used in the following cases:

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

In rare cases, ChloraPrep with Dye may cause severe allergic reactions, leading to a drop in
blood pressure and even loss of consciousness. The first symptoms of an allergic reaction may be rash
or asthma. If you notice these symptoms, stop using ChloraPrep with Dye and contact your doctor
as soon as possible (see section 4 “Undesirable effects”).
ChloraPrep with Dye should only be applied to the skin, gently. If the solution is
applied too vigorously to very thin or sensitive skin, or in case of repeated use, redness, inflammation, itching, dryness and/or scaling of the skin and pain may occur. At the first signs of
the aforementioned reactions, immediately stop applying ChloraPrep with Dye.
Avoid prolonged contact with the skin.
Impregnated materials, such as sheets or gowns, must be removed before use. Avoid pooling of solution.
The solution is flammable. Do not use ignition sources before the skin is completely dry.

Children
Use with caution in newborns, especially premature babies. ChloraPrep with Dye may
cause chemical burns on the skin.

Other medicines and ChloraPrep with Dye
Tell your doctor or nurse about any recent vaccinations or skin injection 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 are expected during pregnancy, as systemic exposure to chlorhexidine
gluconate is negligible. ChloraPrep with Dye may be used during pregnancy.

Breastfeeding
No effects are expected on breastfed newborns/infants, as systemic exposure to
chlorhexidine gluconate by the breastfeeding woman 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 operating machinery
ChloraPrep with Dye does not affect the ability to drive or operate machinery.

3. How to use ChloraPrep with Dye

The ChloraPrep with Dye antiseptic solution is contained in the plastic applicator. The doctor or
nurse will choose the applicator size most suitable based on the surgical site and the area to be
covered. The doctor 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 must be used exclusively on the skin and each applicator is for single use.
If you have any doubts about the use of ChloraPrep with Dye, please contact your doctor or pharmacist.

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 with Colorant and
seek immediate medical attention: swelling of the face, lips, tongue or throat; a skin rash with redness and
itching; wheezing or difficulty breathing; feeling faint and dizzy; a strange metallic taste in your mouth;
collapse. You may be having an allergic reaction.
If you develop a rash or itching, pain, redness, blisters, dryness or inflammation of the skin where you have
used the product for skin cleansing, stop using ChloraPrep with Colorant immediately and talk to your
doctor or pharmacist.
Very rarely (incidence less than 1 in 10,000 people) cases of allergic reactions or skin irritation reactions
to the components of ChloraPrep with Colorant (chlorhexidine gluconate, isopropyl alcohol and the yellow
sunset E110 dye) have been reported.
Other possible side effects, whose frequency is not known are: eye irritation, pain, impaired vision, chemical
burns, eye injury, skin burns in newborns/infants.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or nurse. You can also report
side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ChloraPrep with Dye

Flammable.This medicine does not require any particular storage temperature.
Store in the original packaging; the applicator is sterile unless the seal is damaged.
Avoid exposing the container and its contents to open flames during use, storage and
disposal. Do not use this medicine after the expiry date which is reported on the label or the box
after EXP. The expiry date refers to the last day of that month.
Keep this medicine out of the sight and reach of children.
Do not dispose of any medicine in 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 Colorant Contains

• The active ingredients are chlorhexidine gluconate 20 mg/ml and isopropyl alcohol 0.70 ml/ml.
• The other ingredients are purified water and sunset yellow (E110).

Description of the appearance of ChloraPrep with Colorant and package contents
The 3 ml and 10.5 ml applicators consist of a latex-free, round-shaped sponge connected to a plastic stem
that holds a glass vial containing the antiseptic solution. The 26 ml applicator consists
of a latex-free, square-shaped sponge connected to a plastic stem that holds two glass vials
containing the antiseptic solution. The sterile applicators are individually packaged in a transparent
film.
Package format:
3 ml: 1 applicator or 25 applicators
10.5 ml: 1 applicator or 25 applicators
26 ml: 1 applicator
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Becton Dickinson France S.A.S.
11 Rue Aristide Bergès
38800 Le Pont de Claix
France
800 977 507

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

BECTON DICKINSON B.V.
LANGE DREEF 11
4131 NJ TE VIANEN UT
NETHERLANDS

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria – ChloraPrep coloured
Belgium – Getinte ChloraPrep, ChloraPrep coloré, ChloraPrep gefärbt
Finland – ChloraPrep värillinen
France – ChloraPrep coloré
Germany – ChloraPrep gefärbt
Ireland – ChloraPrep with Tint
Italy – ChloraPrep con Colorante
Luxembourg – Chloraprep coloré
Malta – ChloraPrep with Tint
Netherlands – Getinte ChloraPrep
Norway – Chloraprep med farge
Portugal – Chloraprep laranja
Sweden – Chloraprep färgad
United Kingdom – ChloraPrep with Tint
<-----------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for physicians or healthcare professionals.

ChloraPrep with Colorant 2% w/v /70% v/v
Cutaneous Solution
chlorhexidine gluconate, isopropyl alcohol
3 ml / 10.5 ml / 26 ml
Instructions for use of the ChloraPrep with Colorant applicators:
For cutaneous use. For external use only.

• Remove the applicator from the overpack and hold it with the sponge facing down.
• Press the applicator once: or 26 ml: press the lever on the handle or other products: press the tabs.
• Do not repeatedly press or squeeze the tabs in an attempt to accelerate 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 moving the sponge gently back and forth over the skin for 30 seconds.
• The 26 ml applicator includes two pads. Clean the intact umbilicus with the pads provided, if necessary (moisten the pads by pressing them onto the applicator sponge, saturated with solution).
• Allow the treated area to air dry completely.

ChloraPrep with Colorant may be left on the skin even after surgery.
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 for ChloraPrep with Colorant to dry completely before starting any medical procedure. Do not use electrocautery procedures before the skin is completely dry. Do not use excessive amounts of the product and avoid allowing the solution to accumulate in skin folds or under the patient's body or drip onto sheets or other material in direct contact with the patient.
• Use with caution in newborns, especially those born before 32 weeks of gestation and in the first 2 weeks of life. ChloraPrep with Colorant may cause chemical burns to the skin.
• Do not use near the eyes or mucous membranes: it may cause irritation, eye irritation, pain, impaired vision, chemical burns and eye trauma. If contact occurs with the eyes or mucous membranes, rinse immediately with plenty of water.
• Do not use on open wounds or broken skin.
• ChloraPrep with Colorant 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 some vaccines and skin prick tests (allergy patch tests). If in doubt, consult the vaccine manufacturer's literature.
• Do not apply the solution too vigorously to very thin or sensitive skin. With repeated use, local skin reactions including erythema or inflammation, itching, dryness and/or scaling of the skin and local pain at the application site may occur. If symptoms of a local skin reaction occur, discontinue use of ChloraPrep with Colorant immediately.
• Do not use in patients with known hypersensitivity to ChloraPrep solution or to any of its components, especially those with a history of possible allergic reactions to chlorhexidine. Chlorhexidine-based products 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), an allergic reaction related to chlorhexidine should be considered.
• Particular caution is required to avoid exposing the patient to any other product containing chlorhexidine during the treatment cycle.

Special precautions for disposal
The solution is flammable. Do not smoke during use, do not expose to 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 clinical waste procedures.
For more detailed information, refer to the summary of product characteristics of ChloraPrep
with Colorant.

Storage conditions
ChloraPrep with Colorant is a single-use product, sterile until the package is opened. Do not
use ChloraPrep with Colorant 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 particular temperature
of storage. Store in the original packaging.

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

Marketing Authorisation Holder
Becton Dickinson France S.A.S.
11 Rue Aristide Bergès
38800 Le Pont de Claix
France
800 977 507