Trofodermin 5% + 5% 30 ml cutaneous spray solution

Trofodermin 5% + 5% 30 ml cutaneous spray solution is a dermatological spray for topical use, formulated to promote healing and disinfection of the skin in the case of skin lesions of various kinds. Its composition is based on two active ingredients: clostebol acetate and neomycin sulphate , which act in synergy to offer an effective healing and antibacterial action. The product is particularly indicated for the treatment of abrasions , erosions , skin ulcers (such as varicose ulcers , bedsores , traumatic ulcers ), nipple fissures and anal fissures , burns , infected wounds , delayed healing , radiodermatitis and skin dystrophic conditions such as dryness, fissures and flaking.

Thanks to the presence of clostebol acetate , Trofodermin skin spray stimulates tissue regeneration, accelerating the wound healing process. Neomycin sulphate , on the other hand, has a broad-spectrum antibacterial action, protecting the skin from infections and bacterial contamination. The 30 ml skin spray formulation allows for practical, hygienic and uniform application even on hard-to-reach areas, without the need to directly touch the injured area.

Trofodermin 5% + 5% cutaneous spray solution is ideal for those who need rapid and targeted treatment of wounds , ensuring effective disinfection and promoting healing even in the presence of ulcerative lesions or infected wounds . Its combined action makes it a valuable ally in the management of traumatic ulcers , bedsores , burns and fissures , ensuring optimal protection of the skin and a rapid recovery of its integrity.

ACTIVE INGREDIENTS

Active ingredients contained in Trofodermin 5% + 5% 30 ml cutaneous spray solution - What is the active ingredient of Trofodermin 5% + 5% 30 ml cutaneous spray solution?

Trofodermin 500 mg/100 g + 500 mg/100 g cream 100 g contain: Clostebol acetate 500 mg; neomycin sulphate 500 mg. Excipients with known effect: lanolin, nipasept (methyl parahydroxybenzoate, ethyl parahydroxybenzoate and propyl parahydroxybenzoate). 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

Composition of Trofodermin 5% + 5% 30 ml cutaneous spray solution - What does Trofodermin 5% + 5% 30 ml cutaneous spray solution contain?

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

DIRECTIONS

Therapeutic indications Trofodermin 5 % + 5 % 30 ml cutaneous spray solution - Why is Trofodermin 5 % + 5 % 30 ml cutaneous spray solution used? What is it used for?

Abrasions and erosions; skin ulcerative lesions (varicose ulcers, bedsores, traumatic ulcers); nipple fissures, anal fissures; burns; infected wounds; delayed healing; radiodermatitis; skin dystrophic conditions (dryness, fissures, desquamation).

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Trofodermin 5% + 5% 30 ml cutaneous spray solution - When should Trofodermin 5% + 5% 30 ml cutaneous spray solution not be used?

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

DOSAGE

Quantity and method of taking Trofodermin 5% + 5% 30 ml cutaneous spray solution - How is Trofodermin 5% + 5% 30 ml cutaneous spray solution taken?

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

CONSERVATION

Storage Trofodermin 5% + 5% 30 ml cutaneous spray solution - How is Trofodermin 5% + 5% 30 ml cutaneous spray solution stored?

Trofodermin 500 mg/100 g + 500 mg/100 g cream For storage conditions after first opening, see section 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

Warnings Trofodermin 5% + 5% 30 ml cutaneous spray solution - It is important to know that Trofodermin 5% + 5% 30 ml cutaneous spray solution:

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 may allow absorption of neomycin is not recommended. Paediatric 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 invert during dispensing, not to inhale or spray in the eyes. Trofodermin 500 mg/100 g + 500 mg/100 g cream contains: – lanolin: may cause local skin reactions (e.g. contact dermatitis) – nipasept (methyl parahydroxybenzoate, ethyl parahydroxybenzoate and propyl parahydroxybenzoate): may cause allergic reactions (even delayed).

INTERACTIONS

Interactions Trofodermin 5 % + 5 % 30 ml cutaneous spray solution - Which medicines or foods can modify the effect of Trofodermin 5 % + 5 % 30 ml cutaneous spray solution?

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

Like all medicines, Trofodermin 5 % + 5 % 30 ml cutaneous spray solution can cause side effects - What are the side effects of Trofodermin 5 % + 5 % 30 ml cutaneous spray solution?

The use, especially if prolonged, of products for topical use may 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 medicinal product is important, as it allows continuous monitoring of the benefit/risk balance 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

Overdose Trofodermin 5% + 5% 30 ml cutaneous spray solution - What are the risks of Trofodermin 5% + 5% 30 ml cutaneous spray solution in case of overdose?

An overdose can be considered only in case of prolonged applications and on large areas of damaged skin, which could induce side effects of the type reported above. In this case it will be necessary to suspend the treatment.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Trofodermin 5% + 5% 30 ml cutaneous spray solution.

During pregnancy and breastfeeding, the drug should be administered only if strictly necessary.

DRIVING AND USE OF MACHINERY

Taking Trofodermin 5% + 5% 30 ml cutaneous spray solution before driving or using machines - Does Trofodermin 5% + 5% 30 ml cutaneous spray solution affect driving or using machines?

Trofodermin has no known effect on the ability to drive or use machinery.