ChloraPrep with Tint 2% w/v / 70% v/v cutaneous solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Chlorhexidine gluconate; ISOPROPYL ALCOHOL
Available from:
Carefusion U.K. 244 Limited
ATC code:
D08AC; D08AC52
INN (International Name):
Chlorhexidine gluconate; ISOPROPYL ALCOHOL
Dosage:
2/70 percent
Pharmaceutical form:
Cutaneous solution
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Biguanides and amidines; chlorhexidine, combinations
Authorization status:
Marketed
Authorization number:
PA1435/001/001
Authorization date:
2010-07-02

PACKAGE LEAFLET

Package leaflet: Information for the user

ChloraPrep with Tint 2% w/v / 70% v/v Cutaneous Solution

Chlorhexidine Gluconate / Isopropyl Alcohol

3 ml / 10.5 ml / 26 ml

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If you get any side effects talk to your doctor or nurse. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet:

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

2. What you need to know before you use ChloraPrep with Tint

3. How to use ChloraPrep with Tint

4. Possible side effects

5. How to store ChloraPrep with Tint

6. Contents of the pack and other information

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

ChloraPrep with Tint is a cutaneous solution of chlorhexidine gluconate 2% w/v and isopropyl alcohol

70% v/v in a plastic applicator with a sponge tip on 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, insertion of catheters and minor or major surgery. ChloraPrep

with Tint contains a tint to colour the skin, which plays no role in the antiseptic properties of the

solution.

2. What you need to know before you use ChloraPrep with Tint

Do not use ChloraPrep with Tint:

- if you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of

ChloraPrep with Tint. (See Section 6).

Warnings and precautions

ChloraPrep with Tint is for external use only.

ChloraPrep with Tint should not be used:

near eyes or delicate linings (mucous membranes), as it may cause irritation. If it does get into

the eye or the delicate linings to the body passages, it should be washed quickly with plenty of

water.

- on open skin wounds.

- on the part of the ear that is inside the body (middle ear).

- in direct contact with neural tissue (for example brain and spinal cord tissue).

ChloraPrep with Tint may in rare cases cause severe allergic reactions, leading to a drop in blood

pressure and even to unconsciousness. Early symptoms of a severe allergic reaction may be skin rash

or asthma. If you notice these symptoms, stop using ChloraPrep with Tint and contact your doctor as

soon as possible (see under section 4: “Possible side effects”).

ChloraPrep with Tint should only be applied to the skin gently. When the solution has been applied in

an over-vigorous manner to very fragile or sensitive skin or after repeated use, rash, inflammation,

itching, dry and/or flaky skin and pain may occur. At the first sign of any of these reactions, application

of ChloraPrep with Tint should be stopped.

Prolonged skin contact should be avoided.

Soaked materials, such as drapes or gowns should be removed before use. The solution should

not be allowed to pool.

The solution is flammable. Do not use ignition sources until the skin is completely dry.

Children

Use with care in newborn babies, especially those born prematurely. ChloraPrep with Tint may

cause chemical skin burns.

Other medicines and ChloraPrep with Tint

Tell your doctor or nurse if you have recently had a vaccine or skin test injection (patch test used to

test for allergies).

Pregnancy, breast-feeding and fertility

There are no studies with ChloraPrep with Tint in pregnant or lactating women.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to chlorhexidine

gluconate is negligible. ChloraPrep with Tint can be used during pregnancy.

Lactation

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-

feeding woman to chlorhexidine gluconate is negligible. ChloraPrep with Tint can be used during

breast-feeding.

Fertility

The effects of chlorhexidine gluconate on human reproduction have not been studied.

Driving and using machines

ChloraPrep with Tint does not affect your driving or ability to use machines.

3. How to use ChloraPrep with Tint

The antiseptic solution within the ChloraPrep with Tint system is kept inside the plastic applicator.

Your doctor or nurse will select the applicator size based on the procedure site and area to be

covered. Your doctor or nurse will rub the sponge gently over your skin, covering the skin area that

needs to be prepared. Depending on your medical procedure, more than one applicator may be used.

ChloraPrep with Tint is only used on the skin and each applicator is only used once.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, ChloraPrep with Tint can cause side effects, although not everybody gets them.

Very rarely (fewer than 1 in 10,000 people), allergic or irritated skin reactions to the ingredients in

ChloraPrep with Tint (chlorhexidine gluconate, isopropyl alcohol and the tint Sunset Yellow E110)

have been reported.

If you experience any of the following reactions stop using ChloraPrep with Tint and get immediate

medical help: swelling of the face, lips, tongue or throat; a red itchy skin rash; wheezing or difficulty

breathing; feeling faint and dizzy; a strange metallic taste in the mouth; collapse. You may be

having an allergic reaction.

If you develop a rash or your skin becomes itchy, red, dry or inflamed where you have used the

product as a skin wash, stop using it and talk to your doctor or pharmacist.

If the side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your

doctor or nurse immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed

in this leaflet. You can also report side effects directly via:

United Kingdom

Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1

6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ie

Malta

ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ChloraPrep with Tint

Flammable. This medicine does not require any special temperature storage conditions.

Store in the original packaging; applicator is sterile unless seal is broken.

Avoid exposure of the container and contents to naked flames during use, storage and disposal. Do not

use this medicine after the expiry date which is stated on the label or carton 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 throw away medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ChloraPrep with Tint contains

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

ml/ml.

The other ingredients are purified water and Sunset Yellow (E110).

What ChloraPrep with Tint looks like and contents of the pack

The 3 ml and 10.5 ml applicators consist of a latex-free round foam sponge attached to a plastic barrel

which holds a glass ampoule containing the antiseptic solution. The 26 ml applicator consists of a latex-

free square foam sponge attached to a plastic barrel which holds two glass ampoules containing the

antiseptic solution. 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

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing

Authorisation

holder

ChloraPrep

with

Tint

CareFusion U.K. 244 Ltd

The Crescent, Jays Close,

Basingstoke, Hampshire RG22 4BS

United Kingdom

+44 (0) 800 0437 546

The Manufacturer of ChloraPrep with Tint is

Insight Health Limited

Unit A Bridgefields,

Welwyn Garden City, Hertfordshire AL7 1RX

United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following

names:

Austria - Chloraprep gefärbt

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

UK - ChloraPrep with Tint

This leaflet was last revised in 10/2018

<-----------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

ChloraPrep with Tint 2% w/v / 70% v/v Cutaneous Solution

Chlorhexidine Gluconate / Isopropyl Alcohol

3 ml / 10.5 ml / 26 ml

Instructions for using ChloraPrep with Tint applicators:

For cutaneous use. For external use only.

Remove the applicator from the wrapper and hold it with the sponge facing downward.

Squeeze the applicator once only:

26 ml squeeze lever on handle

other products, squeeze wings

Do not repeatedly pinch or pump the wings in an attempt to accelerate the saturation of the foam.

Gently press the sponge against the patient’s skin in order to apply the antiseptic solution.

Once the solution is visible on the skin, use gentle back and forth strokes to prep the site for 30

seconds.

The 26 ml applicator includes two swabs. Clean intact umbilicus with enclosed swabs when

applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.)

Allow the covered area to air dry completely.

ChloraPrep with Tint can be left on the skin post procedure.

Maximum coverage areas:

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:

Allow ChloraPrep with Tint to dry completely before starting any medical procedure. Do not use

electrocautery procedures until the skin is completely dry. Do not use excessive quantities and do

not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in

direct contact with the patient.

Use with care in neonates, especially those born before 32 weeks of gestation and within the first 2

weeks of life. ChloraPrep with Tint may cause chemical skin burns.

Do not use near eyes or mucous membranes, as it may cause irritation. If it does get into the eye or

the mucous membranes, it should be washed quickly with plenty of water.

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

ChloraPrep with Tint should not come into contact with neural tissues or the middle ear.

Chlorhexidine is incompatible with soap and other anionic agents.

Alcohol should not be brought into contact with some vaccines and skin test injections (patch tests).

If in doubt, consult the vaccine manufacturer’s literature.

Do not apply the solution in an over vigorous manner to very fragile or sensitive skin. After repeated

use, local skin reaction may occur including: erythema or inflammation, itching, dry and/or flaky

skin and local application site pain. At the first sign of local skin reaction, stop application of

ChloraPrep with Tint.

Special precautions for disposal

The solution is flammable. Do not use while smoking or near any naked flames or strong heat source.

Avoid exposure of the container and contents to naked flames during use, storage and disposal. Discard

the applicator after use as per clinical waste procedures.

Please refer to the Summary of Product Characteristics for ChloraPrep with Tint for further

detailed information.

Storage Procedures

ChloraPrep with Tint is for single use only and is sterile until the packaging is opened. Do not

use ChloraPrep with Tint after the expiry date stated on the label or carton. The expiry date refers to

the last day of

that

month.

This

medicine

does

require

special

temperature

storage

conditions. Store in the original packaging.

Active Substances

The active substances in ChloraPrep with Tint are 2% w/v chlorhexidine gluconate and 70% v/v

isopropyl alcohol. The inactive ingredients in ChloraPrep with Tint are purified water and Sunset

Yellow (E110).

Marketing Authorisation Holder

CareFusion U.K. 244 Ltd

The Crescent, Jays Close,

Basingstoke, Hampshire RG22 4BS

United Kingdom

ChloraPrep is a registered trademark of CareFusion Corporation or one of its subsidiaries.

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03 January 2019

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

ChloraPrep with Tint 2% w/v / 70% v/v cutaneous solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Chlorhexidine gluconate 20mg/ml

Isopropyl alcohol 0.70ml/ml

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Cutaneous Solution.

Orange Solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

The medicinal product is to be used for disinfection of the skin prior to invasive

medical procedures.

4.2 Posology and method of administration

Posology

ChloraPrep with Tint may be used on all age groups and patient populations.

Paediatric population

However, ChloraPrep with Tint should be used with care in newborn babies,

especially those born prematurely (see also section 4.4, Special warnings and

precautions for use).

One applicator is used containing 3 ml, 10.5 ml or 26 ml of the ChloraPrep with Tint

alcoholic solution.

Method of administration

For cutaneous use.

The choice of applicator will depend on the invasive procedure being undertaken

and the clinician’s preference.

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The applicator is removed from the wrapper and held with the sponge facing

downward. The applicator is squeezed gently to break the ampoule containing the

antiseptic solution, which is released onto the sponge in a controlled flow (for the

26 ml applicator the lever is pressed). Pinch wings once only to activate the

applicator and release the antiseptic. Do not repeatedly pinch or pump the wings in

an attempt to accelerate the saturation of the foam. The broken ampoule remains

safely contained within the applicator. The sponge is gently pressed against the

patient’s skin in order to apply the antiseptic solution. Once the solution is visible on

the skin, use gentle back and forth strokes to prep the site for 30 seconds. The 26 ml

applicator includes two swabs. Clean intact umbilicus with enclosed swabs when

applicable. (Moisten swabs by pressing against solution-soaked sponge applicator.)

The area covered should be allowed to air dry completely.

It is recommended that ChloraPrep with Tint remain on the skin post-procedure to

provide continued antimicrobial activity. The tint will slowly fade from the skin. If

removal is necessary, remove with soap and water or alcohol.

4.3 Contraindications

Known hypersensitivity to ChloraPrep with Tint or any of its components, especially

in those with a history of possible chlorhexidine-related allergic reactions (see

sections 4.4 and 4.8).

4.4 Special warnings and precautions for use

The solution is flammable. Do not use electrocautery procedures or other ignition

sources until the skin is completely dry.

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Remove any soaked materials, drapes or gowns before proceeding with the

intervention. Do not use excessive quantities and do not allow the solution to pool in

skin folds or under the patient or drip on sheets or other material in direct contact

with the patient. Where occlusive dressings are to be applied to areas previously

exposed to ChloraPrep with Tint, care must be taken to ensure no excess product is

present prior to application of the dressing.

For external use only on intact skin.

ChloraPrep with Tint contains chlorhexidine. Chlorhexidine is known to induce

hypersensitivity, including generalised allergic reactions and anaphylactic shock. The

prevalence of chlorhexidine hypersensitivity is not known, but available literature

suggests this is likely to be very rare. ChloraPrep with Tint should not be

administered to anyone with a potential history of an allergic reaction to a

chlorhexidine-containing compound (see sections 4.3 and 4.8).

The solution is an irritant to eyes and mucous membranes. It should therefore be

kept away from these areas. If the solution comes in contact with the eyes, they

should be washed promptly and thoroughly with water.

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

addition, direct contact with neural tissue or the middle ear must be avoided.

Prolonged skin contact with alcohol containing solutions should be avoided.

It is important to ensure that the correct method of applications is strictly followed

(see section 4.2 above). When the solution has been applied in an over-vigorous

manner to very fragile or sensitive skin or after repeated use, local skin reaction may

occur including: erythema or inflammation, itching, dry and/or flaky skin and local

application site pain. At the first sign of local skin reaction application of ChloraPrep

with Tint should be stopped.

Paediatric population

The use of chlorhexidine solutions, both alcohol based and aqueous, for skin

antisepsis prior to invasive procedures has been associated with chemical burns in

neonates. Based on available case reports and the published literature, this risk

appears to be higher in preterm infants, especially those born before 32 weeks of

gestation and within the first 2 weeks of life.

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4.5 Interaction with other medicinal products and other forms of interactions

Alcohol should not be brought into contact with some vaccines and skin test

injections (patch tests). If in doubt, consult the vaccine manufacturer’s literature.

4.6 Fertility, pregnancy and lactation

There are no studies with this product in pregnant or lactating women.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to

chlorhexidine gluconate is negligible. ChloraPrep with Tint can be used during

pregnancy.

Breast-feeding

No effects on the breastfed newborn/infant are anticipated since the systemic

exposure of the breast-feeding woman to chlorhexidine gluconate is negligible.

ChloraPrep with Tint can be used during breast-feeding.

Fertility

The effects of chlorhexidine gluconate on human reproduction have not been

studied.

4.7 Effects on ability to drive and use machines

ChloraPrep with Tint has no or negligible influence on the ability to drive and use

machines.

4.8 Undesirable effects

Skin disorders:

Very rarely (<1/10,000) allergic or irritation skin reactions have been reported with

chlorhexidine, isopropyl alcohol and Sunset Yellow (E110) including: erythema, rash

(e.g. erythematous, papular, or maculopapular), pruritus and blisters or application

site vesicles. Other local symptoms have included skin burning sensation, pain and

inflammation.

Frequency not known: dermatitis, eczema, urticaria, chemical burns in neonates.

Immune disorders:

Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3

and 4.4).

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The most commonly reported adverse reactions reported are associated with

application site reactions. These were noted to occur most often within the area of

application of the solution (i.e. at the prep site) and very rarely spread. The adverse

reactions were often self-limiting in nature or resolved following treatment with

topical steroids and / or antihistamines. The most commonly reported reactions were

non-serious in nature and included application site rash, application site erythema,

application site vesicles, application site pain and application site pruritus. Frequency,

type and severity of adverse reactions in children are expected to be the same as in

adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Healthcare professionals are asked to report any suspected adverse

reactions via:

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

4.9 Overdose

There are no reports of overdose with this product.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Chlorhexidine, combinations, ATC code: D08A C52.

Mechanism of Action

Bisbiguanide antiseptics exert their lethal effect upon bacterial cells through

non-specific interaction with acidic phospholipids of the cell membranes.

Chlorhexidine gluconate is a cationic biguanide. Its antimicrobial action is due to the

disruption of the cell membrane and the precipitation of cell contents. It has a

bactericidal or bacteriostatic action against a wide range of gram-positive and

gram-negative bacteria. It is relatively ineffective against mycobacteria. It inhibits

some viruses and is active against some fungi. It is inactive against bacterial spores. It

has a superior residual property in comparison to currently available skin antiseptics.

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Chlorhexidine gluconate has a strong binding property to skin and has a residual

property on the skin that has been documented at 48 hours. Chlorhexidine gluconate

is not neutralised in the presence of organic matter.

Isopropyl alcohol is a rapidly bactericidal and a fast acting broad spectrum antiseptic,

but is not considered persistent. Its mechanism of action appears to be denaturation

of proteins.

Pharmacodynamic effects

ChloraPrep with Tint is a sterile antiseptic solution containing a combination of 2%

Chlorhexidine gluconate in 70% Isopropyl alcohol, which is effective for both rapid

and persistent reduction of bacterial load across various body regions for a broad

spectrum of organisms. Isopropyl alcohol (70%) provides an immediate kill of

transient and resident microorganisms on the stratum corneum and 2%

Chlorhexidine gluconate binds to the superficial cell layers of the epidermis and

provides a residual, or persistent, antimicrobial property that prevents regrowth of

microorganisms.

Clinical efficacy and safety

Clinical studies with 2% Chlorhexidine gluconate in 70% Isopropyl alcohol have

demonstrated that the combination offers equal or similar effectiveness in reducing

skin bacterial load and more sustained antibacterial effects over longer periods after

application, compared to the individual components alone, as well as to other

commonly used antiseptics such as Povidone-iodine.

ChloraPrep with Tint meets the criteria for chemical disinfectants and antiseptic

products as established by European Standards:

EN 1040 - basic bactericidal activity (Phase 1)

EN 1275 - basic yeasticidal activity (Phase 1)

EN 13727 - bactericidal activity (Phase 2/Step 1)

EN 13624 - fungicidal activity (Phase 2/Step 1)

ChloraPrep with Tint meets these EN criteria for bactericidal and fungicidal activity

for the following organisms at contact times ranging from 5 to 15 minutes, with the

exception of Aspergillus brasiliensis. Additional testing of ChloraPrep with Tint at full

concentration against Aspergillus brasiliensis for exposure up to 60 minutes met EN

13624 criteria, as follows:

Table: In vitro microbiocidal effects

Strain

Contact time

Conditions

Result

EN Criteria

Pseudomonas aeruginosa

5 min

100%, 75%,

>5.69 log

reduction

EN 1040

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Staphylococcus aureus

5 min

100%, 75%,

>4.67 log

reduction

EN 1040

Candida albicans

15 min

100%, 75%,

> 4.25

reduction

EN 1275

Enterococcus hirae

5 min

100%, 75%,

50% in

clean

0.3 g/L

bovine

serum

albumin

> 5.71

reduction

EN 13727

Pseudomonas aeruginosa

5 min

100%, 75%,

50% in

clean

0.3 g/L

bovine

serum

albumin

> 5.55

reduction

EN 13727

Staphylococcus aureus

5 min

100%, 75%,

50% in

clean

0.3 g/L

bovine

serum

albumin

> 5.78

reduction

EN 13727

Candida albicans

15 min

100%, 75%,

50% in

clean

0.3 g/L

bovine

serum

albumin

> 4.17

reduction

EN 13624

Aspergillus brasiliensis

60 min

100%

> 4.26

reduction

EN 13624

5.2 Pharmacokinetic properties

Absorption

There is little absorption of isopropyl alcohol or of chlorhexidine gluconate through

intact skin.

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Pharmacokinetic studies have not been conducted with the product.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber that are not already

included elsewhere in the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Purified water

Sunset Yellow (E110)

6.2 Incompatibilities

Chlorhexidine is incompatible with soap, hypochlorite bleach and other anionic

agents. Hypochlorite bleaches may cause brown stains to develop in fabrics, which

have previously been in contact with preparations containing chlorhexidine.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Flammable. This medicinal product does not require any special temperature storage

conditions.

Store in the original packaging; applicator is sterile unless seal is broken.

Avoid exposure of the container and contents to naked flames during use, storage

and disposal.

6.5 Nature and contents of container

The applicators consist of a latex-free sponge attached to a plastic handle/barrel

which holds a latex-free dyed pledget and glass ampoule containing the sterile

antiseptic solution. The 3 ml and 10.5 ml applicators consist of a latex-free round

foam sponge attached to a plastic barrel which holds a glass ampoule containing the

antiseptic solution. The 26 ml applicator consists of a latex-free square foam sponge

attached to a plastic barrel which holds two glass ampoules containing the antiseptic

solution. The sterile applicators are individually packaged in a transparent film.

The medicinal product is available as 3 ml, 10.5 ml and 26 ml fill volumes.

Pack Size:

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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.

6.6 Special precautions for disposal and other handling

This product is for single use only.

Any unused product or waste material should be discarded in accordance with local

requirements. No additional environmental precautions for disposal are necessary.

7 MARKETING AUTHORISATION HOLDER

Carefusion U.K. 244 Limited

The Crescent

Jays Close

Basingstoke

Hampshire

RG22 4BS

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA1435/001/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 2

July 2010

Date of last renewal: 27

November 2014

10 DATE OF REVISION OF THE TEXT

January 2019

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