ONYTEC Medicated nail lacquer (2018)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Onytec 80mg/g medicated nail lacquer.

2. Qualitative and quantitative composition

One gram of medicated nail lacquer contains 80 mg of ciclopirox. Excipient with known effect: 10 mg cetostearyl alcohol / g solution. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Medicated nail lacquer. Clear, colourless to slightly yellowish solution.

4.1. Therapeutic indications

Mild to moderate fungal infections of the nails caused by dermatophytes, yeasts and moulds, without nail matrix/lunula involvement. Onytec 80 mg/g medicated nail lacquer is indicated in adults.

4.2. Posology and method of administration

Posology Paediatric population The safety and efficacy of Onytec in children and adolescents below 18 years of age have not yet been established. No data are available. Method of administration Cutaneous ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children and adolescents below 18 years of age due to insufficient experience in this age group.

4.4. Special warnings and precautions for use

Mild to moderate onychomycosis is defined as fungal infection affecting up to 75% of the nail surface, involvement of up to 5 nails, without involvement of nail matrix/lunula. In case of severe onychomycosis ...

4.5. Interaction with other medicinal products and other forms of interaction

No drug interaction studies have been performed. However, after application as recommended, the systemic bioavailability of ciclopirox is below 2%, an amount which is considered as negligible, thus no ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no clinical data on exposed pregnant women for ciclopirox. Animal studies have shown no direct or indirect harmful effect on pregnancy, embryonic development, development of the foetus ...

4.7. Effects on ability to drive and use machines

Onytec has no influence on the ability to drive and use machines.

4.8. Undesirable effects

For the frequency of occurrence of undersirable effects, the following phrases are used: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very ...

4.9. Overdose

Onytec is for topical use. No overdose has been reported with the use of this product. In the event of accidental oral ingestion, an appropriate method of gastric emptying may be used.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for dermatological use; Other antifungals for topical use ATC code: D01AE14 Onytec nail lacquer is an original, patented formulation of ciclopirox based ...

5.2. Pharmacokinetic properties

Onytec nail lacquer has demonstrated good penetration properties through keratin. By achieving fungicidal concentrations at the site of infection, the active substance leads to irreversible binding to ...

5.3. Preclinical safety data

Preclinical data up to a daily oral dose of 10 mg ciclopirox/kg revealed no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity and carcinogenic potential. In ...

6.1. List of excipients

Ethyl acetate Ethanol (96%) Cetostearyl alcohol Hydroxypropyl-chitosan Purified water

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years. After first opening the bottle: 6 months.

6.4. Special precautions for storage

Keep the bottle in the outer carton, in order to protect from light. Do not refrigerate or freeze. After first opening the container: Keep the bottle tightly closed to avoid evaporation of the content. ...

6.5. Nature and contents of container

Clear glass bottles with polypropylene screw caps which are fitted with a brush. Pack sizes: 3.3 ml, 6.6 ml. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Polichem S.A., 50, Val Fleuri, L-1526 Luxembourg, Luxembourg

8. Marketing authorization number(s)

PA1005/002/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 28th September 2012 Date of latest renewal: 14th March 2017

10. Date of revision of the text

June 2018

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