Trofodermin 5% + 5% 30 ml cutaneous spray solution

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

INDICATIONS

Abrasions and erosions; ulcerative skin lesions (variceal ulcers, bedsores, traumatic ulcers); nipple fissures, anal fissures; burns; infected wounds; healing delays; radiodermatitis; dystrophic skin conditions (dryness, cracking, flaking).

ACTIVE INGREDIENTS

Trofodermin 500 mg/100 g + 500 mg/100 g cream 100 g contain: Clostebol acetate 500 mg; neomycin sulphate 500 mg. Excipients with known effects: lanolin, nipasept (methyl para-hydroxybenzoate, ethyl para-hydroxybenzoate and propyl para-hydroxybenzoate). Trofodermin 5 mg/ml + 5 mg/ml cutaneous spray, suspension One 30 ml pressurized container contains: Clostebol acetate 0.150 g; neomycin sulphate 0.150 g. For the full list of excipients, see section 6.1.

EXCIPIENTS

Trofodermin 500 mg/100 g + 500 mg/100 g cream Polyethylene glycol stearate; stearic acid; liquid paraffin; lanolin; dimethicone; nipasept (methyl para-hydroxybenzoate, ethyl para-hydroxybenzoate and propyl para-hydroxybenzoate); floranol; purified water. Trofodermin 5 mg/ml + 5 mg/ml cutaneous spray, suspension Magnesium stearate; liquid paraffin; isobutane at 3.2 bar.

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

Dosage Trofodermin 500 mg/100 g + 500 mg/100 g cream: 1–2 applications per day. Spread a thin layer of cream on the injured part and possibly cover the injured part with sterile gauze. Trofodermin 5 mg/ml + 5 mg/ml cutaneous spray, suspension:1–2 applications per day; If necessary, cover the injured part with sterile gauze.

CONSERVATION

Trofodermin 500 mg/100 g + 500 mg/100 g cream For storage conditions after first opening, see paragraph 6.3. Trofodermin 5 mg/ml + 5 mg/ml cutaneous spray, suspension Protect from sunlight and do not expose to temperatures above 50° C.

WARNINGS

Continuous use of Trofodermin should be avoided. Due to the potential risk of ototoxicity and nephrotoxicity of neomycin, prolonged use of the product on large damaged surfaces that could allow the absorption of neomycin is not recommended. Pediatric population Continuous use of Trofodermin should be avoided; especially in early childhood. Trofodermin 5 mg/ml + 5 mg/ml cutaneous spray, suspension As regards the spray, it is recommended to shake before use, not to spray on a flame or incandescent body, not to turn upside down during dispensing, not to inhale or spray into the eyes. Trofodermin 500 mg/100 g + 500 mg/100 g cream contains: – lanolin: can cause local skin reactions (e.g. contact dermatitis) – nipasept (methyl para-hydroxybenzoate, ethyl para-hydroxybenzoate and propyl para-hydroxybenzoate): can cause allergic reactions (even delayed).

INTERACTIONS

The combined use of Trofodermin with topical preparations containing other aminoglycoside antibiotics may increase the risk of sensitization or enhance any secondary effects.

SIDE EFFECTS

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. Furthermore, prolonged application for several weeks on large areas of damaged tissue could give rise to the appearance of systemic effects, such as hypertrichosis due to massive absorption of clostebol. 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 reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

The possibility of overdose can only be contemplated in the case of prolonged applications and on large areas of damaged skin, which could induce secondary effects of the type indicated above. In this case the treatment will need to be suspended.

PREGNANCY AND BREASTFEEDING

During pregnancy and breastfeeding, the drug should only be administered if clearly needed.

EFFECTS ON DRIVING ABILITY

Trofodermin is not known to interfere with the ability to drive or use machinery.