TROSYL Nail solution (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
1. Name of the medicinal product
Trosyl 283 mg/ml Nail Solution.
2. Qualitative and quantitative composition
Tioconazole 283 mg/ml. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Cutaneous solution. A clear pale yellow solution for topical application.
4.1. Therapeutic indications
Tioconazole is a broad spectrum imidazole antifungal agent. Trosyl Nail Solution is indicated for the topical treatment of nail infections due to susceptible fungi (dermatophytes and yeasts) and bacteria. ...
4.2. Posology and method of administration
<b>Route of administration:</b> Topical. <u>Adults:</u> The solution should be applied to the affected nails and immediately surrounding skin every twelve hours using the applicator brush supplied. The ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Trosyl Nail Solution is contraindicated in individuals who have been shown to be hypersensitive to imidazole ...
4.4. Special warnings and precautions for use
Trosyl Nail Solution is not for ophthalmic use.
4.5. Interaction with other medicinal products and other forms of interaction
None known.
4.6. Pregnancy and lactation
Pregnancy In animal studies tioconazole was not teratogenic. At high doses it increased the incidence of renal abnormalities in rat embryos, but this effect was minor and transient and was not evident ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Trosyl Nail Solution is well tolerated following local application. Symptoms of local irritation have been reported by some patients, but are usually seen during the first week of treatment and are transient ...
4.9. Overdose
No cases of overdosage with Trosyl Nail Solution have been reported. Overdosage by topical application of tioconazole is unlikely because of negligible systemic absorption. In the event of excessive oral ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Imidazole and triazole derivatives <b>ATC Code:</b> D01AC07 Tioconazole is an imidazole which is active against commonly occurring dermatophyte and yeast-like fungal species. ...
5.2. Pharmacokinetic properties
Absorption Absorption is rapid and extensive on oral administration to rats, monkeys and man, the major metabolite being a glucuronide conjugate of tioconazole. Tissue uptake in rat and monkey was highest ...
5.3. Preclinical safety data
None relevant to the prescriber.
6.1. List of excipients
Undecylenic acid Ethyl acetate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 25°C. Avoid flame and heat. Do not refrigerate. Replace cap securely after use.
6.5. Nature and contents of container
Trosyl Nail Solution is contained in an amber glass bottle with a HDPE screw cap fitted with an LDPE brush system and polyamide brush bristle applicator containing 12 ml.
6.6. Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PA0822/197/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 06 February 1985 Date of last renewal: 06 February 2010
10. Date of revision of the text
July 2018
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