Trofodermin Cutaneous Spray 5% + 5% Healing 30ml

NAME
TROFODERMIN

PHARMACOTHERAPEUTIC CATEGORY
Dermatological preparations.

ACTIVE PRINCIPLES
Clostebol acetate 500 mg; neomycin sulfate 500 mg.

EXCIPIENTS
Cream 500 mg / 100 g + 500 mg / 100 g: polyethylene glycol stearate; stearic acid; liquid paraffin; lanolin; dimethicone; nipasept (methyl para-hydroxybenzoate, ethyl para-hydroxybenzoate and propyl para-hydroxybenzoate); floranol; purified water. Skin spray, suspension 5 mg / ml + 5 mg / ml: magnesium stearate; liquid paraffin; isobutane at 3.2 bar.

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).

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the excipients.

DOSAGE
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 eventually cover the injured part with sterile gauze. Skin spray, suspension 5 mg / ml + 5 mg / ml: 1-2 applications per day; eventually cover the injured part with sterile gauze.

STORAGE
Skin spray, suspension 5 mg / ml + 5 mg / ml: protect from sunlight and do not expose to temperatures above 50 degrees C.

WARNINGS
Continued use of the drug should be avoided. Due to the potential risk of ototoxicity and nephrotoxicity of neomycin, prolonged use of the product on large damaged surfaces that may allow the absorption of neomycin is not recommended. Pediatric population: continuous use of the product should be avoided; especially in very early childhood. Skin spray, suspension 5 mg / ml + 5 mg / ml: as regards the spray it is recommended to shake before use, not to spray on a flame or on an incandescent body, not to overturn during delivery, not to inhale it 'spray in the eye. The cream contains lanolin; nipasept (methyl para-hydroxybenzoate, ethyl para-hydroxybenzoate and propyl para-hydroxybenzoate).

INTERACTIONS
The combined use of the drug with topical preparations containing other aminoglycoside antibiotics can '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. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
During pregnancy and breastfeeding, the drug should be administered only in case of real need.