Chlorhexidine Acetate BP 0.05% w/v for Irrigation

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

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 0.05% w/v for Irrigation is recommended for general topical use when antibacterial irrigation is indicated, including wound and burn irrigation. Not for intravenous or oral route of administration.4.3 Contraindications In patients with a known hypersensitivity to the product 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 product should only be used in specialist units familiar with the appropriate selection of patients. 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. **Hypersensitivity Reactions** Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been reported with chlorhexidine. Fatal anaphylactic reactions have been reported with other products containing chlorhexidine (See Section 4.8 Adverse Reactions). 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** 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). Chlorhexidine 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 chlorhexidine does not migrate beyond its intended application site into the eyes. Particular care should be taken in anesthetized patients, who are unable to immediately report ocular exposure. If chlorhexidine comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist's advice should be sought. **Use in Pediatric Patients** The use of chlorhexidine solutions has been associated with skin reactions such as chemical burns in neonates (See Section 4.4 Warnings – Chemical Burns in Neonates).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 There is no information of the effects of chlorhexidine on the ability to operate an automobile or other heavy machinery.4.8 Undesirable effects **Immune system disorders:** Hypersensitivity reactions including anaphylactic/anaphylactoid reactions manifested by cardiac arrest, shock, circulatory collapse, hypotension, bronchospasm, tachycardia, rash, erythema and urticaria **Skin and subcutaneous tissue disorders:** Rash **Other adverse reactions (Class 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) Eye Disorder: Frequency not known: Corneal erosion, corneal epithelium defect/ injury corneal, 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 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/yellowcard4.9 Overdose Overdose of chlorhexidine may constitute a medical emergency. In case of accidental overdose seek immediate medical attention.

5.1 Pharmacodynamic properties Not applicable.5.2 Pharmacokinetic properties Not applicable.5.3 Preclinical safety data Not applicable.

6.1 List of excipients Water for Injections EP To 1000ml Acetic Acid (pH adjustment) QS6.2 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 solution from direct sunlight.6.5 Nature and contents of container 100ml, 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.