ChloraPrep Swabstick

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

Posology

ChloraPrep may be used in all age groups and patient populations (see section on paediatric population, below).

Paediatric population

ChloraPrep should be used with care in newborn babies, especially those born prematurely (see also section 4.4, Special warnings and precautions for use).

Method of administration

For cutaneous use.

One pouch contains either one swab (1.75 mL) or three swabs (5.25 mL).

The choice of pouch will depend on the invasive procedure being undertaken and the clinician's preference.

• Only the inside of the pouch is sterile. In order to preserve sterility, the pouch should be opened carefully and the foam pad should not be allowed to touch any non-sterile surface.

• Tear the pouch at its side notch to reveal the swab handle(s). Do not touch the swab foam pad.

• Place the foam pad flat-side down on the treatment area of the patient's skin.

• Apply the solution for 30 seconds using a gentle back and forth motion.

• The area covered should be allowed to air dry completely.

• For triple swabs, use the swabs sequentially for a total of 30 seconds.

Choose the appropriate ChloraPrep presentation based on the invasive procedure being undertaken and the size of the area to be prepared in order to avoid administering excess solution and the risk of product pooling (see section 4.4).

Other ChloraPrep applicators may be more suitable depending on the medical procedure being undertaken.

It is recommended that ChloraPrep solution remains on the skin post-procedure to provide continued antimicrobial activity. If removal is necessary, remove with soap and water or alcohol.

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).

Use in the ear canal due to the risk of ototoxicity (see section 4.4).

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 of ChloraPrep 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, 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 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 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 mucous membranes. It should therefore be kept away from these areas.

ChloraPrep must not come into contact with the eye. Serious cases of persistent corneal injury, potentially requiring corneal transplant, were reported following accidental ocular exposure to chlorhexidine containing medicinal products despite taking eye protective measures due to migration of solution beyond the intended surgical preparation area. Extreme care must be taken during application to ensure that ChloraPrep does not migrate beyond its intended application site into the eyes. Particular care should be taken in anaesthetised patients, who are unable to immediately report ocular exposure. If ChloraPrep comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist's advice should be sought.

Do not use on open skin wounds. Do not use on broken or damaged skin. In addition, direct contact with neural tissue must be avoided. When the middle ear is exposed to chlorhexidine there is a risk of ototoxicity. To prevent exposure of the middle ear to ChlorPrep via a perforation of the eardrum, the use of ChloraPrep in the ear canal is contraindicated (see section 4.3).

It is important to ensure that the correct method of application is strictly followed (see section 4.2 above).

Prolonged skin contact with alcohol containing solutions should be avoided.

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 should be stopped.

Anaphylactic reactions during anaesthesia

Chlorhexidine-containing products are known causes of anaphylactic reactions during anaesthesia.

The symptoms of anaphylactic reactions might be masked in an anesthetised patient e.g. a significant portion of skin may be covered or patient unable to communicate early symptoms. If symptoms of an anaphylactic reaction are detected during anaesthesia (e.g. abrupt fall in blood pressure, hives, angioedema), chlorhexidine-related allergic reaction should be considered.

When chlorhexidine-related allergic reaction during anaesthesia is suspected, other products containing chlorhexidine used during anaesthesia (e.g. IV lines) should be removed. Special precaution should be taken to avoid patient exposure to any other product containing chlorhexidine during the course of the treatment.

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.

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.

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 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 can be used during breast-feeding.

Fertility

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

ChloraPrep has no or negligible influence on the ability to drive and use machines.

Skin and subcutaneous tissue disorders:

Very rarely (<1/10,000) allergic or irritation skin reactions have been reported with chlorhexidine and 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 not known (cannot be estimated from the available data): dermatitis, eczema, urticaria, chemical burns in neonates.

Immune system disorders:

Frequency not known (cannot be estimated from the available data): Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).

The most commonly reported adverse reactions 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 skin preparation 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.

Cases of anaphylactic reactions have been reported during anaesthesia.

Eye disorders:

Frequency not known (cannot be estimated from the available data): Eye irritation, pain, hyperaemia, corneal erosion, epithelium defect/corneal injury, significant permanent visual impairment*.

*Cases of severe corneal erosion and permanent significant visual impairment due to inadvertent ocular exposure have been reported post-marketing, leading to some patients requiring corneal transplant (see section 4.4).

Description of selected adverse reactions

There have been isolated spontaneous reports of generalised allergic reactions potentially associated with ChloraPrep solution that have been reported during anaesthesia. In some cases, the patient may have had a pre-existing sensitivity to chlorhexidine (see Section 4.4).

This product may cause a severe allergic reaction. Symptoms may include wheezing/difficulty breathing, shock, facial swelling, hives, or rash. Use of ChloraPrep is contra-indicated where patients have shown previous hypersensitivity to chlorhexidine or isopropyl alcohol (see Section 4.3).

In case of hypersensitivity or allergic reaction, stop the product application immediately.

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 Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

There are no reports of overdose with this product.

Pharmacotherapeutic group: antiseptics and disinfectants. 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. 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 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 solution 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 solution 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 at full concentration against Aspergillus brasiliensis for exposure up to 60 minutes met EN 13624 criteria, as follows:

Table: In vitro microbiocidal effects

Absorption

There is little absorption of isopropyl alcohol or of chlorhexidine gluconate through intact skin. Pharmacokinetic studies have not been conducted with the product.

There are no preclinical data of relevance to the prescriber that are not already included elsewhere in the Summary of Product Characteristics.

Purified water

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.

3 years

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

Store in the original package; ChloraPrep is sterile unless the seal is broken.

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

The drug product is a sterile swab (i.e. polypropylene stick(s) with a polyester polyurethane foam-tipped pad) impregnated with a chlorhexidine and isopropyl alcohol solution and hermetically sealed in a single-use pouch with a film/foil lamination and a polypropylene or polypropylene/ethylene copolymer inner-liner.

A pouch can contain either one or three swab(s).

Pack Sizes:

1.75 mL (Single swab): Carton of 48 pouches (total: 48 swabs)

5.25 mL (Triple swab): Carton of 40 pouches each containing 3 swabs (total: 120 swabs)

Not all pack sizes may be marketed.

This product is for single use only.

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