Soluprep 2% w/v / 70% v/v cutaneous solution – patient leaflet, side effects, dosage

1. What SoluPrep is and what it is used for

SoluPrep 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 to 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.

2. What you need to know before SoluPrep is used

SoluPrep 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

SoluPrep 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. SoluPrep 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 SoluPrep should be stopped.

Children

SoluPrep may be used in all age groups and patient populations. However, SoluPrep is not recommended in children less than 1 year old. SoluPrep may cause irritation or chemical skin burns in newborn babies, especially those born prematurely.

Other medicines and SoluPrep

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

SoluPrep may be used during pregnancy.

Breast-feeding

SoluPrep may be used during breast-feeding.

Driving and using machines

SoluPrep does not affect your driving or ability to use machines.

3. How SoluPrep 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.

SoluPrep 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.

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 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

5. How to store SoluPrep

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

Do not store above 30°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.

SoluPrep 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 SoluPrep 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-N-vinylpyrrolidone), Purified water, Trisodium Hydroxyethyl Ethylenediamine Triacetic Acid (HEDTA).

• The other ingredients are:

What SoluPrep looks like and contents of the pack

SoluPrep is a colourless solution. SoluPrep 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

KCI Medical Limited

Building 47 Charnwood Campus

10 Bakewell Road

Loughborough

England

LE11 5RB

Manufacturer

3M Health Care Limited

Derby Road

Loughborough

UK

LE11 5SF

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

UK: SoluPrep

This leaflet was last revised in:

May 2024

The following information is intended for healthcare professionals only:

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

Chlorhexidine Gluconate / Isopropyl Alcohol

Instructions for using SoluPrep 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.

Precautions for Use:

• SoluPrep may be used in all age groups and patient populations. However, SoluPrep is not recommended in children less than 1 year old. SoluPrep 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 SoluPrep 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.