STERETS UNISEPT Cutaneous solution Ref.[49658] Active ingredients: Chlorhexidine

Sterets Unisept 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. Sterets Unisept 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 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.

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

1. When used in aseptic procedures, the outside of the sachet should be disinfected before opening.
2. Any surplus should be discarded immediately after use.
3. For external use only. NOT for injection.
4. Do not use within body cavities.
5. Contact with the eyes should be avoided.

Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with Sterets Unisept solution.

Sterets Unisept is incompatible with anionic agents.

Although there are no adverse reports for this product in pregnant and lactating mothers, as with all medicines, care should be exercised when administering the product to pregnant or lactating women.

None known.

Very Common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very rare (<1/10,000); not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.

Immune system disorders

Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).

Injury, poisoning and procedural complications

Frequency not known: Chemical burns in neonates

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: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2. Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie.

Sterets Unisept is incompatible with anionic agents.