CHLORHEXIDINE/BENZALKONIUM/BENZYL ALCOHOL BIOGARAN 0,25 g/0,025 g/4 ml for 100 ml topical application powder bottle/100ml

Solution for topical application.

Chlorhexidine digluconate ........................................................................................................0,25 g

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

Benzyl alcohol .............................................................................................................................4 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.

Dosage

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

Hypersensitivity to the active substances or to the quaternary ammonium family or to any of the excipients listed in section Composition.

This product must not be brought into contact with the brain and meninges, the eye, nor enter the auditory canal in the event of tympanic membrane perforation.

This product must not be used on mucous membranes, in particular genital mucosa (risk of erosive balanitis or vaginitis).

This product must not be used for disinfection of medical and surgical equipment.

For external use.

CHLORHEXIDINE/ BENZALKONIUM/BENZYL ALCOHOL BIOGARAN 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 medicines 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 CHLORHEXIDINE/ BENZALKONIUM/BENZYL ALCOHOL BIOGARAN 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 CHLORHEXIDINE/ BENZALKONIUM/BENZYL ALCOHOL BIOGARAN comes into contact with the eyes, rinse promptly and thoroughly with water. Advice should be sought from an ophthalmologist.

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, on the patient, on sheets or on any other equipment in direct contact with the patient. When occlusive dressings are used on areas previously exposed to CHLORHEXIDINE/ BENZALKONIUM/ALCOHOL BENZYLIC BIOGARAN, 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 reported with antiseptics containing chlorhexidine. If difficulty breathing, rapidly progressing urticarial skin eruption or severe rash, or clinical signs of shock occur, immediately stop application of CHLORHEXIDINE/BENZALKONIUM/ALCOHOL BENZYLIC BIOGARAN and medical treatment must be initiated as quickly as possible.

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 ulcerations of the lower limbs, with possible worsening of a superinfected lesion.

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

Chemical burns in newborns (frequency unknown).

Eye disorder:

Frequency undetermined: corneal erosion, epithelial lesion/corneal lesion, significant permanent visual impairment*.

* Cases of severe corneal erosion and significant permanent visual impairment due to unintentional ocular exposure have been reported after marketing, 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 should report any suspected adverse reaction via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/ .

Pharmacotherapeutic class: ANTISEPTICS AND DISINFECTANTS, - ATC code: D08AC02.

(D: Dermatology).

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.

For the 250 ml bottle: 3 years.

For the 100 ml spray bottle: 2 years

For the 250 ml bottle:

This medicine does not require any particular storage precautions.

For the 100 ml spray bottle:

Store at a temperature not exceeding 25°C.

No special requirements.

Marketing authorisation (AMM)

CIP 3400930016237 (opaque bottle/250ml). CIP 3400930133415 (Fl pulv/100ml).

Price:

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

Remb Séc soc at 30% based on the TFR: 1.99 euros (Fl opaq/250ml).
Remb Séc soc at 30% based on the TFR: 2.11 euros (Fl pulv/100ml) in the indications:

• Indication(s) listed in the MA at the date of publication of this order (Fl pulv/100ml)

Collection.