Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
MALATHION
SSL International plc
0.5 %w/v
Cutaneous Solution
2010-01-08
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prioderm Lotion 0.5% w/v Cutaneous Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The lotion contains 0.5% w/v Malathion. _For excipients, see 6.1._ 3 PHARMACEUTICAL FORM Cutaneous Solution. A clear colourless lotion with a characteristic alcoholic and citrus odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of infestation of hair by pediculosis capitis (head lice). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Topical Adults, the Elderly and children aged 6 months and above Rub the lotion gently into the scalp until all hair and scalp is thoroughly moistened. Allow hair to dry naturally in a well ventilated room. Do not use hair dryer or other artificial heat. Live lice with be eradicated after a minimum treatment period of two hours. However, the lotion should be left on the head for a further period of 8-10 hours to ensure that all lice eggs are totally eradicated. Shampoo in normal manner. Rise and comb the hair while wet to remove dead lice. In the event of early re-infestation, Prioderm Lotion may be applied again provided 7 days have elapsed since the first application. Residual protective effect is variable and of short duration and should not be relief upon. 4.3 CONTRAINDICATIONS ○ Known hypersensitivity to active constituents. ○ Not to be used on infants less than six months old except under medical advice. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. The eyes should be well protected during the application and washing of hair. 2. Persons applying this product should wear rubber gloves so that their continued direct contact is avoided. 3. All members of the household should be treated, preferably simultaneously. 4. The source o Przeczytaj cały dokument