BISEPTINE S topical powder/100ml

Solution for topical application.

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

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

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

For 100 ml.

Excipients:

• Antisepsis of superficial surgical and traumatic wounds.

• Adjunctive treatment of dermatological conditions that are primarily bacterial or likely to become superinfected.

• Antisepsis of the skin of the operative field.

Remark : antiseptic agents are not sterilising: they temporarily reduce the number of microorganisms.

Damaged skin :

As a general rule, 1 application, 2 times per day.

Preparation of healthy skin :

2 successive applications corresponding respectively to the cleansing/debridement phase and the antisepsis phase.

• Known hypersensitivity to one of the constituents (chlorhexidine or quaternary ammonium family).

• 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.

• 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.

For external use.

In the absence of data on cutaneous absorption, the risk of systemic effects cannot be excluded. These are all the more to be feared when the antiseptic is used over a large surface, under an occlusive dressing, on damaged skin, particularly 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 nappies in the diaper 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 within 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 on any other material in direct contact with the patient. When occlusive dressings are used on areas previously exposed to BISEPTINE, 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 skin eruption or severe rash, or clinical signs of shock occur, immediately stop application of BISEPTINE and medical management must be initiated as soon as possible.

BISEPTINE, solution for topical use 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 medicinal products containing chlorhexidine despite 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 BISEPTINE, solution for topical use does not migrate beyond the intended site of application into the eyes. Particular precautions must be taken in anaesthetised patients who are not able to immediately report ocular exposure. If BISEPTINE, solution for topical use comes into contact with the eyes, rinse promptly 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.

• Risk of local allergy, generally manifesting as contact eczema, particularly with use on damaged skin, mucous membranes and ulcers of the lower limbs, with possible worsening of an superinfected lesion.

• Risk of general allergy which may, in very rare cases, progress to anaphylactic shock.

• 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/

ANTISEPTICS AND DISINFECTANTS, ATC code: D08AC02 (D: Dermatologicals).

Broad-spectrum bactericidal, fungicidal antiseptic.

Broad antiseptic activity against Gram-positive and Gram-negative bacteria, as well as against Candida albicans.

The individual efficacy of each active ingredient is potentiated by the presence of the 2 others.

In addition:

Benzalkonium chloride gives the solution slightly detergent properties;

Benzyl alcohol, at the concentration used, exerts a slight local anaesthetic and analgesic activity.

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: No special storage precautions.

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

Marketing authorisation (AMM)

CIP 3400933054212 (Bottle/250ml). CIP 3400933576363 (Bottle/40ml). CIP 3400932913343 (Bottle/500ml). CIP 3400932913282 (Pulv/100ml).

Price:

1,99 euros (Fl/250ml). 2,11 euros (Pulv/100ml).

Social security reimbursement at 30% based on the TFR: 1.99 euros (Fl/250ml), 2.11 euros (Pulv/100ml).
Not reimbursed by social security (Fl/500ml).
Hospital model(s) (Fl/40ml, Fl/500ml).
Collection.