Trofodermin - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Clostebol (Clostebol acetate), Neomycin (Neomycin sulfate)

Trofodermin 5 mg / ml + 5 mg / ml cutaneous spray, suspension

Trofodermin package inserts are available for packs:
  • Trofodermin 5 mg / ml + 5 mg / ml cutaneous spray, suspension
  • Trofodermin 500 mg / 100 g + 500 mg / 100 g cream

Indications Why is Trofodermin used? What is it for?

Talk to your doctor if you don't feel better or if you feel worse after a few days.

Trofodermin contains clostebol acetate and neomycin sulfate.

  • Clostebol acetate belongs to a group of medicines called steroids. Helps heal skin lesions
  • Neomycin sulfate is an antibiotic. It fights skin infections caused by bacteria.

This medicine is used to help heal skin wounds such as:

  • abrasions and erosions of the skin;
  • injuries and wounds, such as varicose ulcers, due to poor blood circulation, pressure sores (due to immobility in the bed) or trauma ulcers;
  • fissures (cuts) on the nipple, which may appear during breastfeeding;
  • anal fissures (small cuts around the anus);
  • burn wounds;
  • infected wounds;
  • wounds that delay scar formation;
  • irritation, redness and sensitization of the skin that appears after radiotherapy (radiodermatitis);
  • dryness, cracking with skin ulceration or peeling.

Contraindications When Trofodermin should not be used

Do not use Trofodermin

  • if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).

Precautions for use What you need to know before taking Trofodermin

Do not use Trofodermin continuously, on large areas of skin and for long periods of time, this is because the neomycin sulphate contained in the medicine can cause kidney or hearing problems.

Shake the container before use, do not spray the suspension on a flame or incandescent body, do not turn the container upside down during dispensing, do not inhale and do not splash the suspension into your eyes.

For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.

Children

Do not use Trofodermin for long periods of time, especially in young children.

Interactions Which drugs or foods can modify the effect of Trofodermin

Other medicines and Trofodermin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Using Trofodermin together with other medicines containing antibiotics may increase the risk of allergy or may make the side effects more serious.

Trofodermin with food, drink and alcohol

There are no known interactions.

Warnings It is important to know that:

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 or pharmacist for advice before using this medicine. Use Trofodermin during pregnancy and breastfeeding only as needed.

Driving and using machines

It doesn't interfere.

Dose, Method and Time of Administration How to use Trofodermin: Posology

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is 1-2 applications per day. Spray the skin suspension on the wound and eventually cover with a sterile gauze (see section 2 "Warnings and precautions").

Use only locally on the skin.

Overdose What to do if you have taken too much Trofodermin

In case of applications for long periods and on large areas of injured skin, undesirable effects may arise due to the passage of the drug into the bloodstream such as increased hair on the skin.

In this case, stop the treatment and contact your doctor or pharmacist.

Side Effects What are the side effects of Trofodermin

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The use, especially if prolonged, of products for (local) skin use can give rise to allergy phenomena. Furthermore, an application for long periods and on large areas of wounded skin can cause an increase in hair on the skin due to "absorption of large quantities of clostebol acetate into your body.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the website: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

The container is a pressurized container. Do not pierce or burn the container, even after use. Protect the container under pressure from sunlight and heat.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP." The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Composition and pharmaceutical form

What Trofodermin contains

In a pressurized container:

  • The active ingredients are clostebol acetate 0.150 g, neomycin sulfate 0.150 g.
  • The other ingredients are: magnesium stearate; liquid paraffin; isobutane at 3.2 bar.

Description of the appearance of Trofodermin and contents of the package

Trofodermin 5 mg / ml + 5 mg / ml cutaneous spray, suspension is presented in a pressurized container containing 30 ml of suspension.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Trofodermin can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER 09 .0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS AND QUALITY CONTROLS

01.0 NAME OF THE MEDICINAL PRODUCT

TROFODERMIN

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Trofodermin 500 mg / 100 g + 500 mg / 100 g cream

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).

Trofodermin 5 mg / ml + 5 mg / ml cutaneous spray, suspension

A 30ml pressurized container contains:

Clostebol acetate 0.150 g;

neomycin sulfate 0.150 g.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Cream.

Skin spray, suspension.

04.0 CLINICAL INFORMATION

04.1 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).


04.2 Posology and method of administration

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 eventually cover the injured part with sterile gauze.

Trofodermin 5 mg / ml + 5 mg / ml cutaneous spray, suspension:

1-2 applications per day; eventually cover the injured part with sterile gauze.


04.3 Contraindications

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


04.4 Special warnings and appropriate precautions for use

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 early childhood.

Trofodermin 5 mg / ml + 5 mg / ml cutaneous spray, suspension

As for the spray it is recommended to shake before use, not to vaporize on a flame or incandescent body, not to overturn during delivery, 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).


04.5 Interactions with other medicinal products and other forms of interaction

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


04.6 Pregnancy and breastfeeding

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


04.7 Effects on ability to drive and use machines

There is no known interference of Trofodermin with the ability to drive or use machines.


04.8 Undesirable 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 of suspected adverse reactions occurring 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. "address: www.agenziafarmaco.gov.it/it/responsabili.


04.9 Overdose

A 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 mentioned above. In this case, treatment must be suspended.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: androgens for topical use.

ATC code: D11AE.

Mechanism of action

Of the two active ingredients of Trofodermin, clostebol acetate, a derivative of testosterone, exerts a trophic-healing effect and determines a net shortening of the repair time of cutaneous and cutaneous-mucous lesions. It owes this effect to the property common to all anabolic steroids of activating the cellular biochemical mechanisms delegated to protein synthesis and that is to the formation of the most important building material on which the granulation and re-epithelialization process ultimately depend. The second component of Trofodermin, neomycin, acts favorably on the same process indirectly, eliminating or preventing the establishment of a local infection, which is notoriously the most important factor in delaying the evolution of wounds towards healing.


05.2 "Pharmacokinetic properties

Absorption

After local application of the labeled steroid on the de-epithelialized skin of volunteers, clostebol acetate showed a very poor systemic absorption (documented by the urinary radioactivity measurement).


05.3 Preclinical safety data

Subacute toxicity tests carried out in rabbits for repeated local application for 15 days at a dose of 1 g / kg excluded changes in body weight, consumption of food and water, diuresis, blood count and azotemia and bilirubinemia. as well as the weight of the internal organs The skin of the treated animals showed locally significantly less alterations than those treated with the excipient alone.

06.0 PHARMACEUTICAL INFORMATION

06.1 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.


06.2 Incompatibility

Not relevant.


06.3 Period of validity

Trofodermin 500 mg / 100 g + 500 mg / 100 g cream

3 years.

Shelf life after first opening: 30 days.

Trofodermin 5 mg / ml + 5 mg / ml cutaneous spray, suspension

3 years.


06.4 Special precautions for storage

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 exceeding 50 ° C.


06.5 Nature of the immediate packaging and contents of the package

Trofodermin 500 mg / 100 g + 500 mg / 100 g cream

30 g aluminum tube.

Not all pack sizes may be marketed.

Trofodermin 5 mg / ml + 5 mg / ml cutaneous spray, suspension

30 ml aluminum pressurized container.


06.6 Instructions for use and handling

No special instructions.

Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.

07.0 MARKETING AUTHORIZATION HOLDER

Pharmaceutical Laboratory S.I.T. S.r.l. - Via Cavour 70 - 27035 Mede (PV).

08.0 MARKETING AUTHORIZATION NUMBER

Trofodermin 500 mg / 100 g + 500 mg / 100 g cream 10 g tube - AIC n. 020942013

Trofodermin 500 mg / 100 g + 500 mg / 100 g cream 30 g tube - AIC n. 020942025

Trofodermin 500 mg / 100 g + 500 mg / 100 g cream tube of 50 g - AIC n. 020942037

Trofodermin 5 mg / ml + 5 mg / ml cutaneous spray, suspension - AIC n. 020942049

pressurized container of 30 ml

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

Date of first authorization: 1 October 1991

Date of most recent renewal: 1 June 2010

10.0 DATE OF REVISION OF THE TEXT

24 December 2014

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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