SoluPrep with tint 2%w/v/70%v/v cutaneous solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
ISOPROPYL ALCOHOL; Chlorhexidine gluconate
Available from:
3M Deutschland GmbH
ATC code:
D08AC; D08AC52
INN (International Name):
ISOPROPYL ALCOHOL; Chlorhexidine gluconate
Dosage:
20 milligram(s)/millilitre
Pharmaceutical form:
Cutaneous solution
Therapeutic area:
Biguanides and amidines; chlorhexidine, combinations
Authorization number:
PA1762/002/002
Authorization date:
2019-08-13

Package Leaflet: Information for the patient

<Invented name> 2% w/v / 70% v/v cutaneous solution

<Invented name> with tint 2% w/v / 70% v/v cutaneous solution

Chlorhexidine Gluconate / Isopropyl Alcohol

Colourless solution: 10.5 mL in applicator

Green tinted solution: 10.5 mL/26 mL in applicator

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

What <Invented name> is and what it is used for

What you need to know before <Invented name> is used

How <Invented name> is used

Possible side effects

How to store <Invented name>

Contents of the pack and other information

1.

What <Invented name> is and what it is used for

<Invented name> is a sterile antiseptic solution of chlorhexidine gluconate 20mg/mL and

isopropyl alcohol 0.70mL/mL in an applicator with a sponge tip on one end. The applicator

contains a fast acting antiseptic solution, which is used

in subjects aged 1 year and above

disinfect the skin before invasive medical procedures (such as insertion of catheters, minor and

major surgery) to help reduce bacteria that potentially can cause skin infection.

<Invented name> tinted solution contains a tint to colour the skin,

it plays no role in the

antiseptic properties of the solution.

2.

What you need to know before <Invented name> is used

<Invented name> must not be used:

if you are allergic to chlorhexidine gluconate, isopropyl alcohol or any of the other

ingredients of this medicine (listed in section 6).

Warnings and precautions

<Invented name> is for external use only on intact skin.

The solution is flammable. Do not use electrocautery procedures (i.e. surgical procedures

where a surgeon or doctor used electricity to heat tissue to prevent or stop bleeding or remove

abnormal tissue growth) or other ignition sources until the skin is completely dry.

<Invented name> should not be used:

Near eyes, in the ears (including the middle ear, part of the ear that is inside the body) or

on delicate linings (mucous membranes), as the solution may cause serious or permanent

injury if it comes into contact with these areas. If it does get in contact with these areas, it

should be washed quickly with plenty of cold water and a doctor should be contacted;

on open skin wounds or broken or damaged skin;

as general skin cleanser;

for lumbar puncture (the procedure of taking fluid from the spine in the lower back

through a hollow needle) or in contact with neural tissue (for example brain and spinal

cord tissue);

Avoid prolonged skin contact. If signs of local skin reaction appear, the use of <invented name>

should be stopped.

Children

<Invented name> may be used in all age groups and patient populations. However, <invented

name> is not recommended in children less than 1 year old. <Invented name> may cause

irritation or chemical skin burns in newborn babies, especially those born prematurely.

Other medicines and <Invented name>

Tell your doctor or nurse if you are using, have recently used or might use any other

medicines.

Pregnancy and breast-feeding

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

Pregnancy

<Invented name> may be used during pregnancy.

Breast-feeding

<Invented name> may be used during breast-feeding.

Driving and using machines

<Invented name> does not affect your driving or ability to use machines.

3.

How <Invented name> is used

The antiseptic solution is in the applicator. The 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

solution over your skin, covering the skin area that needs to be prepared.

<Invented name> is only used on the skin and each applicator is only used once.

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

Possible side effects

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

If you experience any of the following reactions tell your health care provider and get medical

help immediately as you may be having an allergic reaction:

swelling of the face, lips, tongue or throat

a red itchy skin rash

wheezing or difficulty breathing

feeling faint or dizzy

The frequency of allergic reactions are not known.

Other side effects that may occur:

Common (may affect up to 1 in 10 people)

Reactions at the application site:

rash, reddening of the skin, small fluid-filled bumps, pain

and itching at the application site;

Very rare (may affect up to 1 in 10,000 people)

allergic or irritation skin reactions including rash, reddening of the skin, itching and

application site blisters;

local symptoms such as skin burning sensation, pain and inflammation;

Frequency unknown

dermatitis (skin becomes red, swollen and sore), eczema (patches of rough, dry inflamed

skin), urticaria (hives), chemical burns in neonates.

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 the national reporting

system listed in Appendix V.*

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

medicine.

5.

How to store <Invented name>

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Do not refrigerate or frezze.

Flammable. Keep away from fire and naked flame duiring use, storage and disposal. Store in

the original package.

Do not use this medicine after the expiry date which is stated on the pouch and applicator

label.

<Invented name> is for single use only and is sterile until the packaging is opened. Do not use

the medicine if the package has been damaged.

Do not throw away any medicines via wastewater or household waste. These measures will

help protect the environment.

6.

Contents of the pack and other information

What <Invented name> contains

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

ml/ml

The other ingredients are:

Tributyl acetylcitrate, Poly(isooctyl acrylate-

co

-methyl methacrylate-

co

vinylpyrrolidone), Purified water, Trisodium Hydroxyethyl Ethylenediamine Triacetic

Acid (HEDTA).

The other ingredients are:

Tributyl acetylcitrate, Poly(isooctyl acrylate-

co

-methyl methacrylate-

co

vinylpyrrolidone), Purified water, E102 Tartrazine, E133 Brilliant Blue, Trisodium

Hydroxyethyl Ethylenediamine Triacetic Acid (HEDTA).

What <Invented name> looks like and contents of the pack

<Invented name> is a colourless solution. <Invented name> is a green tinted solution.

It is

provided in an applicator which consists of foam sponge attached to a plastic barrel which

holds a glass ampoule containing the sterile antiseptic cutaneous solution. The container

closure system is not made with natural rubber latex. Two cotton-tipped swabs are provided

with each 26-mL pack. The applicators are sterile and individually packaged.

10.5 mL green tinted solution:

50 applicators

10.5 mL colourless solution: 50 applicators

26 mL green tinted solution:

20 applicators

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

[To be completed nationally]

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

following names:

Austria:

Soluprep steril

Belgium:

Chlorhexidine gluconate / isopropyl alcohol 3M Deutschland GmbH

France:

Digluconate de chlorhexidine / alcool isopropylique 3M Deutschland GmbH

Germany:

Soluprep steril

Ireland:

Soluprep

Netherlands: Soluprep

Norway:

Chlorhexidine gluconate / isopropyl alcohol 3M

Sweden:

Soluprep

Soluprep

This leaflet was last revised in:

MM/YYYY

The following information is intended for healthcare professionals only:

<Invented name> 2% w/v / 70% v/v cutaneous solution

<Invented name> with tint 2% w/v / 70% v/v cutaneous solution

Chlorhexidine Gluconate / Isopropyl Alcohol

Instructions for using <Invented name> applicators:

For cutaneous use. For external and single use only.

The volume of solution (i.e. applicator size) will dependent upon type of invasive medical

procedure.

As this product does not have presentations of smaller volumes, prescribers should use

alternate products for disinfection of skin prior to simple invasive procedures that require

small volume.

Solution Volume (mL)

Applicator

Maximum Coverage Area (cm x cm)

10.5

Tint

34 cm x 34 cm (1156 cm

10.5

Colourless

Tint

50 cm x 50 cm (2500 cm

Precautions for Use:

<Invented name> may be used in all age groups and patient populations. However,

<invented name> is not recommended in children less than 1 year old. <Invented name>

may cause chemical skin burns in newborn babies, especially those born prematurely.

Avoid getting solution into hair. Wet hair is flammable. Hair may take up to 1 hour to dry.

Keep out of eyes, ears and mouth. The solution may cause serious or permanent injury if it

comes into contact with these areas. If contact occurs, rinse immediately and thoroughly

with cold water and contact a doctor.

Chlorhexidine is incompatible with soap and other anionic agents.

Prolonged skin contact with alcohol containing solutions should be avoided. At the first sign of

local skin reaction the use of <invented name> should be discontinued

While waiting for solution to completely dry:

Do not drape or use ignition source (e.g., electrocautery, laser).

When prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart

until completely dry. Otherwise, skin may adhere to itself.

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.

Remove wet materials from prep area. Replace if necessary.

After solution is completely dry:

To reduce risk of fire, begin draping and/or using cautery only after solution is completely

dry and all wet materials are removed.

If incise drapes are used, apply directly to dry prep.

Apply dressing following standard practices.

It is recommended that the antiseptic remain on the skin after the procedure for continued

protection. The antiseptic will gradually wear away. If early removal is desired, use alcohol.

Place alcohol soaked gauze for approximately 40 seconds on the prepped area. Lightly rub

gauze over area to remove the antiseptic.

Other information for product with green tint:

The green tint will slowly fade from the skin. Alcohol may be used to remove the green

tint if desired. Place alcohol soaked gauze for approximately 40 seconds on the prepped

area. Lightly rub gauze over area to remove the green tint.

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Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

SoluPrep with tint 2%w/v/70%v/v cutaneous solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml solution contains 20 mg chlorhexidine digluconate and 0.70 mL isopropyl alcohol.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cutaneous solution.

Green tinted solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

The medicinal product is to be used in subjects aged 1 year and above for disinfection of the skin prior to invasive medical

procedures to help reduce bacteria that can potentially cause skin infection.

4.2 Posology and method of administration

Posology

For cutaneous use.

SoluPrep may be used in all age groups and patient populations. However, SoluPrep is not recommended in the paediatric

population less than 1 year old (see Section 4.4 Special warnings and precautions for use).

Two sized single use applicators are available:

- 10.5 mL green tinted or colourless solution

- 26 mL green tinted solution

The choice of applicator size will depend on the type of invasive medical procedure being performed and the preference of the

clinician.

As this product does not have presentations of smaller volumes, prescribers should use alternate products for disinfection of

skin prior to simple invasive procedures that require small volume.

Solution Volume (mL)

Maximum Coverage Area (cm x cm)

To be used for:

10.5

(colourless)

34 cm x 34 cm

(1156 cm

Head, neck and small prep areas

- Minor and Major

surgical procedures

- Implantable device

placement

- Prosthetic device

placement or removal

- Midline, peripheral

intravascular central

catheter (PICC), central

venous catheter (CVC)

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insertion and

maintenance

- Cardiac

catheterization and

Cardiac Cath Lab

procedure

- Interventional

Radiology procedures

10.5

(green tinted)

34 cm x 34 cm

(1156 cm

Head, neck and small prep areas

26

(green tinted only)

50 cm x 50 cm

(2500 cm

Large prep areas below the neck

Method of administration

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Avoid getting solution into hair. Wet hair is flammable. Hair may take up to 1 hour to dry.

It is recommended that the antiseptic solution remain on the skin after the procedure for continued protection. The antiseptic

will gradually wear away. If early removal is desired, use alcohol. Place alcohol soaked gauze for approximately 40 seconds on

the prepped area. Lightly rub gauze over area to remove the green tint.

4.3 Contraindications

Known hypersensitivity to chlorhexidine, isopropyl alcohol or any other ingredients listed in section 6.1, 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

For external use only on intact skin.

The solution is flammable. Do not use electrocautery procedures or other ignition sources until the skin is completely dry.

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 SoluPrep, care must be taken to ensure no

excess product is present prior to application of the dressing.

To reduce risk of fire, apply the solution carefully:

- Avoid getting solution into hair. Wet hair is flammable. Hair may take up to 1 hour to dry.

- When prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry.

- Begin draping and/or using electrocautery only after solution is completely dry (minimum of 3 minutes on hairless skin; up to

1 hour in hair) and all wet materials are removed.

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SoluPrep contains chlorhexidine. Rare but serious allergic reactions have been reported with products containing chlorhexidine.

SoluPrep should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing

compound (see Section 4.3 and 4.8)

Keep out of eyes, ears and mouth. The solution may cause serious or permanent injury if it comes into contact with these areas.

If contact occurs, rinse immediately and thoroughly with cold water and contact a doctor.

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. As the

development of the epidermal barrier is a continuous process beyond the first months of life, SoluPrep is not recommended in

the age group less than 1 year old.

Do not use for lumbar puncture or in contact with the meninges. In addition, direct contact with neural tissue or the middle ear

must be avoided.

Do not use on open skin wounds, broken or damaged skin or as a general skin cleaner.

Prolonged skin contact with alcohol containing solutions should be avoided. At the first sign of local skin reaction the use of

SoluPrep should be discontinued.

The product is for single use only. It is important to ensure that the correct method of application is followed (see section 4.2).

Discard the applicator after a single use along with any portion of the solution not required to cover the treatment area.

4.5 Interaction with other medicinal products and other forms of interactions

The product is applied topically and the expected systemic activity is very low. No studies were performed to investigate its

pharmacologic effects when used concomitantly with other medications.

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 and isopropyl alcohol is

negligible. SoluPrep may 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 and isopropyl alcohol is negligible. SoluPrep may be used during breast-feeding.

Fertility

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

No effects on fertility are anticipated since systemic exposure to isopropyl alcohol is negligible.

4.7 Effects on ability to drive and use machines

SoluPrep has no influence on the ability to drive or use machines.

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4.8 Undesirable effects

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Skin disorders:

Very rare (<1/10,000) allergic or irritation skin reactions have been reported with chlorhexidine, isopropyl alcohol 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 unknown: dermatitis, eczema, urticaria, chemical burns in neonates.

Immune disorders:

Frequency unknown: 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 that this is

likely to be rare in the perioperative setting (see Section 4.3 and 4.4).

Common: 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

This product is indicated for use as a preoperative surgical skin preparation and will be administered in a controlled

environment by qualified personnel. In addition, the product is administered to a localised body region and is not absorbed

through the skin in any significant amounts. Therefore, the potential for an overdose with this product is low.

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

on the skin. 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.

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SoluPrep is a sterile antiseptic solution containing active ingredients of 2% CHG and 70% IPA with an acrylate co‑polymer, that

is effective for both rapidand 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 persistent

antimicrobial property that prevents regrowth of microorganisms.

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.

In vitro studies

SoluPrep 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)

SoluPrep meets these EN criteria for bactericidal and fungicidal activity for the following organisms at 5 minutes and 15

minutes contact time (Table 1).

Table 1: In vitro EN 1040 and EN 1275 microbiocidal effects

Strain

Contact Time

Conditions

Log Reduction

EN Criteria

Pseudomonas aeruginosa

5 min

100%, 75%

>5.08

EN 1040

Staphylococcus aureus

5 min

100%, 75%

>5.08

EN 1040

Aspergillus brasiliensis

15 min

100%, 75%

>4.22

EN 1275

Candida

Albicans

15 min

100%, 75%

>4.08

EN 1275

An in vitro time-kill study was conducted using both the tinted and colourless SoluPrep solutions (at full strength and at 50%

strength) to determine how rapidly and effectively the test products killed a variety of organisms. A total of 48 repository

isolates and 144 clinical isolates were evaluated. Both the colourless and tinted formulations demonstrated >5 log10

reductions at both the 3-minute and 5‑minute time points for all microorganisms tested.

Another in vitro time-kill study was conducted using both the tinted and colourless solutions to determine how rapidly and

effectively the test products killed a variety of organisms in the presence of a serum challenge. Six challenge microorganisms

were evaluated. Both the colourless and tinted formulations demonstrated >5 log

reductions at both the 3-minute and

5-minute time points for all microorganisms tested.

Anin vitro antimicrobial resistance study was conducted to detect the potential for development of resistance to the test

product (tinted SoluPrep) by the sequential passage of 42 clinically relevant microorganisms through increasing concentrations

of the antimicrobial included in the culture media. The maximum inhibitory concentration (MIC) did not increase for any of the

strains evaluated for emergence of resistance; therefore, tinted SoluPrep was not considered to have the potential for the

development of resistance. An evaluation of the potential for antibiotic cross-resistance was done by comparing the MIC of

several antibiotics before and after extended exposure to sub-lethal levels of each antiseptic. There was no indication of a

change in MIC related to cross-resistance observed for any of the organism/antibiotic combinations tested.

Paediatric population

The European Medicines Agency granted a product-specific waiver for all subsets of the paediatric population on the grounds

that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for paediatric

patients. (see section 4.2 and 4.4 for information on use in infants).

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5.2 Pharmacokinetic properties

There is little absorption of isopropyl alcohol or of chlorhexidine gluconate through intact skin..Chlorhexidine gluconate was

below the limit of detection (<1 ng/ml) in all subjects in a clinical study designed to evaluate pharmacokinetics following

dermal exposure to a maximum amount of product (4 X 26 ml applicators) applied to intact skin.

5.3 Preclinical safety data

Chlorhexidine gluconate and isopropyl alcohol both have long histories of safe and effective use as patient preoperative skin

preparation active ingredients and a large literature database on the safety and efficacy of these two active ingredients exists.

The SoluPrep product was evaluated in a Primary Skin Irritation Study in Rabbits, a Murine Local Lymph Node Assay in Mice, a

Repeated Dose Dermal Toxicity Study in Rabbits, and a Primary Irritancy and Phototoxicity in Hairless Mice. These studies

demonstrated that there was little or no skin irritation/sensitization and with no systemic toxicity observed.

Adverse effects associated with chlorhexidine gluconate and isopropyl alcohol in non-clinical studies described in the literature

were observed at systemic exposures considered sufficiently in excess of the maximum human exposure achieved by topical

use, indicating little relevance to clinical use of SoluPrep.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Green tinted Solution:

Tributyl acetylcitrate

Poly(isooctyl acrylate-co-methyl methacrylate-co-N-vinylpyrrolidinone)

Purified water

E102 Tartrazine

E133 Brilliant Blue

Trisodium Hydroxyethyl Ethylenediamine Triacetic Acid (HEDTA)

6.2 Incompatibilities

Chlorhexidine is incompatible with soap and other anionic agents.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

Flammable. Keep away from fire or naked flame during use, storage and disposal.

Store in the original package. Applicator is sterile unless the seal is broken.

6.5 Nature and contents of container

SoluPrep is provided in an applicator that consists of foam sponge attached to a plastic barrel which holds a glass ampoule

containing the sterile antiseptic cutaneous solution. The container closure system is not made with natural rubber latex. Two

cotton-tipped swabs are provided with each 26-mL pack. The applicators are sterile and individually packaged. It is available as

tint solution and colourless solution:

10.5 mL green tinted solution: 50 applicators

26 mL green tinted solution: 20 applicators

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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 medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

3M Deutschland GmbH

Carl-Schurz-Straße 1

41453 Neuss

Germany

8 MARKETING AUTHORISATION NUMBER

PA1762/002/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 13

August 2019

10 DATE OF REVISION OF THE TEXT

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