Trofodermin 0,5g + 0,5g Pharmaceutical Laboratory Sit 30g

Trofodermin 0.5g + 0.5g Sit Pharmaceutical Laboratory - Cream

Therapeutic indications

Abrasions and erosions; skin ulcerative lesions (varicose ulcers, bedsores, traumatic ulcers); nipple fissures, anal fissures; burns; infected wounds; delays in healing; radiodermatitis; dystrophic conditions of the skin (dryness, fissuring, peeling).

Active principles

100 g contain : Clostebol acetate 500 mg; neomycin sulfate 500 mg. Excipients with known effects: lanolin, nipasept (methyl para-hydroxybenzoate, ethyl para-hydroxybenzoate and propyl para-hydroxybenzoate).

Excipients : Polyethylene glycol stearate; stearic acid; liquid paraffin; lanolin; dimethicone; nipasept (methyl para-hydroxybenzoate, ethyl para-hydroxybenzoate and propyl para-hydroxybenzoate); floranol; purified water.

Contraindications

Hypersensitivity to the active substances or to any of the excipients.

Dosage

Dosage 1–2 applications per day. Spread a thin layer of cream on the injured part and eventually cover the injured part with sterile gauze.

storage

No particular conditions.

Warnings

Continuous use of the 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 the Trofodermin should be avoided; especially in very early childhood.
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): it can cause allergic reactions (even delayed).

Interactions

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

Side effects

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. Furthermore, a prolonged application for several weeks on large areas of injured tissues could give rise to the appearance of systemic effects, such as hypertrichosis due to a massive absorption of clostebol.
Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. 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 case of prolonged applications and on large areas of damaged skin, which could induce secondary effects of the type mentioned above. In this case it will be necessary to suspend the treatment.

Pregnancy and breastfeeding

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

Format

30g tube.