Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
BENZYL BENZOATE
May & Baker Limited
25 %w/v
Cutaneous Emulsion
1983-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ascabiol Emulsion 25 % w/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzyl Benzoate 25 % w/v. For excipients, see 6.1. 3 PHARMACEUTICAL FORM A cutaneous emulsion A homogeneous white emulsion with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of scabies and pediculosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION SCABIES: After total bathing ‘Ascabiol’ emulsion should be applied to the whole body except the head and face. A second application may be repeated within 5 days or alternatively it may be applied on three occasions at 12 hourly intervals. PEDICULOSIS: The affected region should be coated with ‘Ascabiol’ emulsion followed by a wash 24 hours later. This may be repeated two or three times in severe cases. For use in children the emulsion should be diluted with an equal volume of water. For infants the proportion of emulsion to water should be 1:3. 4.3 CONTRAINDICATIONS Use in patients with a known hypersensitivity to benzyl benzoate. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Benzyl benzoate must not be allowed to come into contact with the eyes. ‘Ascabiol’ causes little skin irritation, but may cause a transient burning sensation. This is usually mild, but can occasionally be severe in sensitive individuals. In the event of a severe skin reaction the preparation should be washed off using soap and water. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION If this preparation is accidentally taken by mouth, treatment should consist of gastric lavage or the administration of an emetic. An anticonvulsant should be given as necessary, otherwise treatment is symptomatic. IRISH MEDICINES BOARD __________________________________ Διαβάστε το πλήρες έγγραφο