Master Aid disinfectant 1g/100ml skin solution 250ml

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Cleaning and disinfection of damaged skin: superficial wounds, first degree burns and bedsores with involvement limited to the epidermis

ACTIVE INGREDIENTS

100 ml contain: Active ingredient: chlorhexidine digluconate 1 g. For the full list of excipients, see section 6.1.

EXCIPIENTS

Citrus essence, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Dosage: Apply an amount of solution appropriate to the extent of the lesion on the affected part 2-3 times a day. Do not exceed the recommended doses. Pediatric population: The safety and efficacy of MASTER AID Disinfectant in children have not yet been established (see section 4.4).

CONSERVATION

Keep container tightly closed. Store in the original package in order to protect the medicine from light. Store in a cool place.

WARNINGS

The product is for external use only; the use, especially if prolonged, of products for topical use can give rise to sensitization phenomena, in which case interrupt the treatment and institute suitable therapy. Do not use for prolonged treatments; after a short period of treatment without appreciable results, clinical evaluation is necessary. Avoid contact with eyes. The product must not be placed in contact with the brain, meninges and middle ear, nor penetrate into the ear canal in case of eardrum perforation. Do not expose the treated part to direct sunlight after applying the product. Accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal, consequences. Remove all soaked materials including surgical drapes or gowns. Use only the necessary quantity of product and prevent the solution from accumulating in the skin folds or under the patient's body or dripping onto sheets or other material in direct contact with the patient. Where it is necessary to apply occlusive dressings to areas previously exposed to MASTER AID Disinfectant, care must be taken to ensure that no excess product is present prior to application of the dressing. Pediatric population: The use of chlorhexidine solutions, either alcoholic or aqueous, for skin antisepsis prior to invasive procedures has been associated with chemical burns in newborns. Based on available reports and published literature, this risk appears to be higher in preterm infants, particularly those born before 32 weeks of gestation and in the first 2 weeks of life. Important information about some excipients: MASTER-AID Disinfectant contains citrus aroma which in turn contains citral, citronellol, coumarin, farfalle, geraniol, limonene, linalool. Citral, citronellol, coumarin, farfalle, geraniol, limonene, linalool can cause allergic reactions.

INTERACTIONS

Avoid the simultaneous use of other antiseptics and detergents. Pediatric population: Interaction studies have only been carried out in adults.

SIDE EFFECTS

In some cases, intolerance (burning or irritation) may occur, however without consequences and which does not require modification of the treatment. Some rare cases of idiosyncrasy have been reported with respect to chlorhexidine. The patient is invited to inform his doctor or pharmacist of the appearance of undesirable effects not described. Pediatric population: Chemical burns in newborns (frequency not known). Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system of the Italian Medicines Agency at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Under normal conditions of use, no symptoms of overdose are known. Chlorhexidine is poorly absorbed from the gastrointestinal tract and skin.

PREGNANCY AND BREASTFEEDING

The exclusively topical skin use and the very low dermal absorption do not affect use during pregnancy and breastfeeding.

EFFECTS ON DRIVING ABILITY

MASTER AID Disinfectant does not alter the ability to drive or use machinery.