PEVARYL Topical cream (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Pevaryl 1% Topical Cream.
Qualitative and quantitative composition
Econazole nitrate 1.0% w/w. Each gram of cream contains 10 mg econazole nitrate. Excipients: each gram of cream contains 2 mg benzoic acid and 52 micrograms butylhydroxyanisole For a full list of excipients, ...
Pharmaceutical form
Cream.
Therapeutic indications
For the treatment of cutaneous candidiasis, dermatophytosis and pityriasis versicolor.
Posology and method of administration
For cutaneous administration. Dosage The dosage regimen is the same for all patients. Apply twice daily to the affected part and rub into the skin gently with the finger. The usual treatment duration is ...
Contraindications
Pevaryl Topical Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.
Special warnings and precautions for use
For external use only. Care should be taken not to get Pevaryl Topical Cream in the eyes or mouth. If the product is accidently applied to the eyes the patient should wash with clean water or saline and ...
Interaction with other medicinal products and other forms of interaction
Econazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on ...
Fertility, pregnancy and lactation
Pregnancy Systemic absorption of econazole is low (< 10%) after topical application to the intact skin in humans. There are no adequate and well-controlled studies on adverse effects from the use of Pevaryl ...
Effects on ability to drive and use machines
None known.
Undesirable effects
The safety of econazole nitrate cream (1%) and econazole nitrate emulsion (1%) was evaluated in 470 subjects who participated in 12 clinical trials and received at least one administration of either formulation. ...
Overdose
Pevaryl Topical Cream is for cutaneous application only. In the event of accidental ingestion, treat symptomatically. If large amounts have been taken by mouth or swallowed, use appropriate supportive ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antifungals For Topical Use, Imidazole and triazole derivatives, econazole ATC code: D01AC03 Econazole nitrate is a broad spectrum antimycotic with activity against dermatophytes, ...
Pharmacokinetic properties
Econazole nitrate is only slightly absorbed from the skin. No active drug has been detected in the serum. Radio labelling shows that less than 0.1% of an oral dose is absorbed. Peak serum levels are achieved ...
Preclinical safety data
Low neonatal survival and fetal toxicity was associated only with maternal toxicity. In animal studies, econazole nitrate has shown no teratogenic effects but was foetotoxic in rodents at maternal subcutaneous ...
List of excipients
Macrogols (PEG-6 and PEG-32) / glycol stearate Oleoyl macrogolglycerides Liquid paraffin Butylhydroxyanisole (E320) Benzoic acid (E210) Flower Perfume 4074 Purified water
Incompatibilities
None stated.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Resin lined, aluminium tubes containing 15 g or 30 g of cream.
Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Marketing authorization number(s)
PL 00242/0259
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 March 1995 Renewal of authorisation: 18 March 2009
Date of revision of the text
9 August 2019
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