This information is intended for use by health professionals

1. Name of the medicinal product

Chlorhexidine Acetate BP 0.02% w/v for Irrigation.

2. Qualitative and quantitative composition

2.1. Active Ingredients

Chlorhexidine Acetate BP

2.2. Quantitative Composition

Chlorhexidine Acetate 0. 198g/1000ml

3. Pharmaceutical form

Sterile, non-pyrogenic irrigating solution for administration to human beings.

4. Clinical particulars
4.1 Therapeutic indications

Chlorhexidine Acetate BP is a disinfectant which is effective against a wide range of vegetative gram-positive and gram-negative bacteria.

4.2 Posology and method of administration

Dosage

Dosage and duration of administration are to be individualized and depend upon the indication for use, the patient's age, weight, clinical condition, and concomitant treatment, and on patient's clinical response to treatment (See Section 4.4 Chemical Burns in Neonates and Preoperative Skin Preparation).

Administration

Chlorhexidine Acetate BP 0.02% w/v for Irrigation is recommended for general topical use when antibacterial irrigation is indicated, including wound and burn irrigation and for the disinfection of respirators.

Not for intravenous or oral route of administration or for use in body cavities (please see section 4.4).

4.3 Contraindications

In patients with a known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8)."

Do not use in the eye, auditory canal (especially in perforated eardrums), or near meninges, brain or spinal cord (See Section 4.4 Special Warnings and Precautions for Use).

4.4 Special warnings and precautions for use

This solution is not to be taken orally.

This solution is not for intravenous administration. Accidental ingestion should be treated with a stomach lavage consisting of milk, egg white, gelatine or mild soap.

Idiosyncratic reactions to Chlorhexidine Acetate BP have been reported. Not for use in body cavities

Hypersensitivity Reactions

Chlorhexidine Acetate contains chlorhexidine, which is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock, which can be fatal. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. This product 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).

If any signs or symptoms of a suspected hypersensitivity reaction develop, immediately stop use. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Chemical Burns in Neonates and Pediatric Patients

The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with skin reactions such as chemical burns in neonates. 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.

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 chlorhexidine, care must be taken to ensure no excess product is present prior to application of the dressing.

Preoperative Skin Preparation

Caution should be exercised when chlorhexidine is used in preoperative skin preparations for face or head (See Section 4.3 Contraindications).

4.5 Interaction with other medicinal products and other forms of interaction

The activity of chlorhexidine is reduced or neutralized by an alkaline pH, the presence of organic matter, anionic detergents, and tannins.

4.6 Pregnancy and lactation

Physicians should carefully consider the potential risks and benefit for each specific patient before prescribing chlorhexidine.

Chlorhexidine has been used in pregnant women and no harmful effects have been reported.

There are no adequate data to support the use of chlorhexidine in lactating women.

4.7 Effects on ability to drive and use machines

Chlorhexidine acetate has no influence on the ability to drive and use machines.

4.8 Undesirable effects

Immune system disorders (frequency not known:

Hypersensitivity reactions including anaphylactic shock and anaphylactoid reactions (see sections 4.3 and 4,4) manifested by cardiac arrest, circulatory collapse, hypotension, bronchospasm, tachycardia, rash, erythema and urticaria

Skin and subcutaneous tissue disorders (frequency not known):

Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.

Other Adverse Reactions

The adverse events reported and/or observed with other chlorhexidine products include:

Fatal anaphylactic reactions

Chemical burns in neonates (See Section 4.4 Special Warnings and Precautions for Use)

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 the Yellow Card Scheme.

Website: www.mhra.gov.uk/yellowcard

4.9 Overdose

Overdose of chlorhexidine may constitute a medical emergency. In case of accidental ingestion or overdose, seek immediate medical attention.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Not applicable.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6. Pharmaceutical particulars
6.1 List of excipients

Water for Injections EP To 1000ml

Acetic Acid (pH adjustment) QS

6.2 Incompatibilities

Additives may be incompatible with chlorhexidine.

Chlorhexidine must not be mixed with soaps or other anionic materials.

6.3 Shelf life

The shelf life is 24 months providing the unit has not been opened.

6.4 Special precautions for storage

Storage temperature should not exceed 25°C.

Protect from direct sunlight.

6.5 Nature and contents of container

100ml, 120ml, 250ml, 500ml and 1000ml pour bottles and form-fill-seal containers.

6.6 Special precautions for disposal and other handling

Product should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit. Do not use unless the solution is clear and the seal is intact.

7. Marketing authorisation holder

Baxter Healthcare Limited.,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

8. Marketing authorisation number(s)

PL 0116/0140

9. Date of first authorisation/renewal of the authorisation

09.11.1984 / 29.02.1996

10. Date of revision of the text

Sept 2016