TROFODERMIN CR DERM30G 0.5+0.5

TROFODERMIN

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 (para-hydroxybenzoate style, para-hydroxybenzoate etyl and para-hydroxybenzoate propile). Trofodermin 5 mg/ml + 5 mg/ml skin spray, suspension A 30 ml pressure container contains: Clostebol acetate 0.150 g; neomycin sulphate 0.150 g. For the full list of excipients, see paragraph 6.1.

Excellent

Trofodermin 500 mg/100 g + 500 mg/100 g cream Polyethyleneglycol stearate; stearic acid; liquid paraffin; lanolin; dimeticons; nipasept (para-hydroxybenzoate, para-hydroxybenzoate and para-hydroxybenzoate propile); floranol; purified water. Trofodermin 5 mg/ml + 5 mg/ml skin spray, suspension Magnesium stearate; liquid paraffin; isobutane at 3.2 bar.

Therapeutic indications

Abrasions and erosion; skin ulcerative lesions (ulcere da varici, piaghe da decubito, ulcer traumatic); nipple ragadi, anal ragadi; burns; infected wounds; delays in scarring; radiodermites; cutaneous distrophytic states (sweetness, fissure, desquamation).

Contraindications

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

Population

Population Trofodermin 500 mg/100 g + 500 mg/100 g cream: 1–2 applications per day. Spread a thin layer of cream on the smooth part and possibly cover the smooth part with sterile gauze. Trofodermin 5 mg/ml + 5 mg/ml skin spray, suspension:1–2 applications per day; possibly 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 skin spray, suspension Protect against sunlight and not expose at temperatures above 50° C.

Warnings

It is to avoid the continuous use of the Trofodermin. Due to the potential risk of ototoxicity and neomycin nephrotoxicity, prolonged use of the product is not recommended on extensive leased surfaces that allow the absorption of neomycin. Pediatric population It is to avoid the continuous use of the Trofodermin; especially in the early childhood. Trofodermin 5 mg/ml + 5 mg/ml skin spray, suspension As for the spray it is recommended to shake before use, not to vaporize on a flame or on a glowing body, not to flip over during delivery, not to inhale or spray in the eyes. Trofodermin 500 mg/100 g + 500 mg/100 g cream contains: – lanolin: it can cause local skin reactions (e.g. contact dermatitis) – nipasept (para-hydroxybenzoatemethyl, para-hydroxybenzoate etyl and propile para-hydroxybenzoate): it can cause allergic reactions (also delayed).

Interactions

The combined use of Trofodermin with topical preparations containing other aminoglycoside antibiotics can increase the risk of sensitization or exalt any side effects.

Effects

The use, especially if prolonged, of products for topical use can give rise to phenomena of sensitization. Moreover, a prolonged application for several weeks on vast areas of lexious tissues could result in the appearance of systemic effects, such as hypertricosis due to a massive absorption of clostebol. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

A possibility of overdosing can only be contemplated in case of prolonged applications and large areas of lesa skin, which could induce secondary effects of the type mentioned above. In this case the treatment will be suspended.

In pregnancy and during breastfeeding, the drug must be administered only in case of actual need.

Source: Farmadati