BISEPTINESPRAID S cutaneous spray Bottle powder/50ml

Chlorhexidine digluconate....................................................................................................................0,250 g

Benzalkonium chloride.........................................................................................................................0,025 g

Benzyl alcohol..................................................................................................................................... 4,000 ml

For 100 ml of solution.

Antisepsis of superficial wounds.

• Cutaneous application.

• 1 to 2 applications per day. It is not necessary to rinse after application.

• Known hypersensitivity to one of the constituents, notably to chlorhexidine (or its chemical class) or to benzalkonium chloride (of the quaternary ammonium family).

• This product must not be used on mucous membranes, particularly genital ones (risk of balanitis or erosive vaginitis).

• This product must not be used for disinfecting medical-surgical equipment.

• This product must not be brought into contact with the brain and meninges, the eye, nor enter the ear canal in case of tympanic perforation.

For external use.

In the absence of data on cutaneous absorption, the risk of systemic effects cannot be ruled out. These are all the more to be feared when the antiseptic is used over a large surface area, under an occlusive dressing, on damaged skin, notably burned skin, a mucous membrane, or the skin of a premature infant or infant (due to the surface area/weight ratio and the occlusive effect of diapers in the napkin area).

Once an antiseptic preparation is opened, microbial contamination is possible.

Cases of burns have been reported when using electrosurgical units after application of alcohol-based antiseptics, linked to the presence of residual product. It is therefore advisable to ensure, after preparing the operative field, that the product is completely dry and that no residual quantities of product that could have run, particularly into skin folds or onto the table drape, remain.

The use of chlorhexidine solutions, alcoholic or aqueous, for skin antisepsis before an invasive procedure has been associated with chemical burns in newborns.

Based on reported cases and published literature, this risk appears to be higher in premature children, particularly those born before 32 weeks of gestation and in the first 2 weeks of life.

Remove all soaked materials, gowns or surgical drapes before proceeding with the procedure. Do not use excessive quantities and do not leave the solution in skin folds or on the patient, or on sheets or any other material in direct contact with the patient. When occlusive dressings are used on areas previously exposed to BISEPTINESPRAID, all precautions must be taken to ensure there is no excess product before applying the dressing.

Rare cases of severe hypersensitivity reactions progressing to anaphylactic shock have been described with antiseptics containing chlorhexidine. If respiratory difficulties, rapidly progressing urticarial-type skin eruption or severe rash, or clinical signs of shock occur, immediately stop application of BISEPTINESPRAID and medical management must be initiated as quickly as possible.

BISEPTINESPRAID, solution for cutaneous application must not come into contact with the eye. Serious cases of persistent corneal damage, which may require corneal transplantation, have been reported following accidental ocular exposure to chlorhexidine-containing medicines despite taking eye protection measures, due to migration of the solution beyond the intended surgical preparation area. During application, extreme caution should be exercised to ensure that BISEPTINESPRAID, solution for cutaneous application does not migrate beyond the intended application site into the eyes. Particular precautions must be taken in anaesthetised patients who are unable to immediately report ocular exposure. If BISEPTINESPRAID, solution for cutaneous application comes into contact with the eyes, rinse quickly and thoroughly with water. Advice should be sought from an ophthalmologist.

Given possible interactions, simultaneous or successive use of antiseptics or soap should be avoided, except with other cationic compounds.

Use with caution in pregnant or breastfeeding women, due to a lack of usable data.

• Possibility of allergic contact eczema.

• A few rare cases of idiosyncrasy (in particular anaphylactic shock) have been observed with chlorhexidine.

• Chemical burns in newborns (frequency unknown).

• Eye disorder:

• Frequency not determined: corneal erosion, epithelial injury/corneal injury, significant permanent visual impairment*.

* Cases of severe corneal erosion and significant permanent visual impairment due to unintentional ocular exposure have been reported after marketing authorisation, which in some patients led to the need for corneal transplantation (see section Warnings and precautions).

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

In case of massive oral ingestion, perform gastric lavage. The acute toxicity per os of chlorhexidine is low (digestive absorption is almost negligible).

Contact a poison control centre.

Pharmacotherapeutic class: ANTISEPTIC (D. Dermatology)

Combination of three active ingredients, possessing bactericidal activity against Gram-positive and Gram-negative germs, as well as fungicidal activity against Candida albicans:

• Chlorhexidine (broad-spectrum bactericidal antiseptic of the biguanide family),

• Benzalkonium chloride (antiseptic of the quaternary ammonium family),

• Benzyl alcohol.

Chlorhexidine and benzalkonium chloride must not be combined with soaps and anionic compounds.

• 3 years for polyethylene bottles.

• 2 years for polyethylene spray bottles.

• For polyethylene bottles: Store at a temperature not exceeding 30°C.

• For polyethylene spray bottles: Store at a temperature not exceeding 25°C.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.