PREVASE CHLORHEXIDINE GLUCONATE

This product is applied topically. For single use only.

4). Skin disorders Frequency not known: - Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticarial, skin irritation, and blisters. 4). 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. uk/yellowcard.

Prevase 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.

8). Accidental ingestion:- chlorhexidine is poorly absorbed orally. Treat with gastric lavage using milk, egg white, gelatine or mild soap. Employ supportive measures as appropriate. Accidental intravenous infusion – blood transfusion may be necessary to counteract haemolysis.

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, the 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 of sheets or other material in direct contact with the patient.

Where occlusive dressings are to be applied to areas previously exposed to Prevase, care must be taken to ensure no excess product is present prior to application of the dressing. Prevase 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 measure due to migration of solution beyond the intended surgical preparation area.

Extreme care must be taken during application to ensure that Prevase 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 Prevase comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist’s advice should be sought.

8). Do not use in contact with eyes, brain, meninges, middle ear or external ear with a perforated tympanic membrane. Do not inject. When use is to be followed by diathermy do not allow pooling of the fluid to occur and ensure that the skin and surrounding drapes are dry.

Do not use in body cavities.