DosageDosage 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).
AdministrationChlorhexidine Acetate 0.015% w/v and Cetrimide 0.15% w/v, Irrigation Solution is for general topical use. This solution is used undiluted for topical application only. Not for intravenous or oral route of administration.
Hypersensitivity ReactionsChlorhexidine Acetate and Cetrimide 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 PatientsThe 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 PreparationCaution should be exercised when chlorhexidine is used in preoperative skin preparations for face or head (See Section 4.3 Contraindications).
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 reactionsChemical burns in neonates (See Section 4.4 Special Warnings and Precautions for Use).Very occasionally the following reactions have been noted when chlorhexidine-containing irrigating solutions have been used intravesically, intravaginally or topically on traumatised skin: Hypotension, paraesthesia, dyspnoea, tachycardia, cold sweat, generalised erythema, urticaria and loss of consciousness. Other effects that have been noted include pain, haematuria and/or increased urge to urinate.Idiosyncratic reactions to chlorhexidine acetate have been reported and are well documented.
Reporting of suspected adverse reactionsReporting 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