Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
PERMETHRIN
GLAXO SMITH KLINE (ISRAEL) LTD
P03AC04
CREAM
PERMETHRIN 5 %W/W
DERMAL
Required
GLAXOSMITHKLINE TRADING SERVICES LIMITED
PERMETHRIN
PERMETHRIN
Is indicated for the treatment of scabies.
2023-03-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed according to a physician's prescription only Lyclear Dermal Cream The tube contains Permethrin 5% w/w. For the list of the inactive and allergenic ingredients in the medicine, see section 2 – “Important information about some of the ingredients in the medicine” and section 6 – “Additional information”. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. The medicine is not intended for babies under the age of 2 months old. 1. WHAT IS THE MEDICINE INTENDED FOR? Lyclear Dermal Cream is used to treat scabies. Therapeutic group: Lyclear Dermal Cream belongs to a group of medicines called pyrethroids, which are anti-parasitic agents. 2. BEFORE USING THE MEDICINE Do not use the medicine if: • you are sensitive (allergic) to permethrin, other pyrethrins, to any of the additional ingredients contained in the medicine (listed in section 6) or to chrysanthemums. Special warnings regarding use of the medicine Before using Lyclear Dermal Cream, tell your physician if: • You are treating infants, see below in the section “Children up to 23 months of age”. • You are known to be allergic to chrysanthemums or other plants from the compositae family, you should only use Lyclear Dermal Cream after talking to your physician. • Lyclear Dermal Cream is intended for cutaneous use only. Do not swallow this medicine. • Avoid contact with the eyes or mucous membranes (inside the nose or throat, genital region) or open wounds. In the event of eye contact, rinse immediately with water or saline (salt solution 0.9%, if readily available). • People routinely involved in treating others may wish to wear gl Olvassa el a teljes dokumentumot
LYCLEAR DERMAL CREAM 1. NAME OF THE MEDICINAL PRODUCT Lyclear Dermal Cream 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Permethrin 5% w/w (equivalent to 50 mg/g) Excipients with known effect: Contains formaldehyde solution 0.278% w/w and butylated hydroxytoluene (E321) 0.02 %w/w For the full list of excipients, see section 6.1. 2. PHARMACEUTICAL FORM Cream A white to off-white cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lyclear Dermal Cream is indicated for the treatment of scabies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lyclear Dermal Cream is suitable for use by adults and children of 2 months of age and above. Lyclear Dermal Cream is also suitable for use by the elderly. Keep this medicine out of sight and reach of children. Lyclear Dermal Cream should be applied to clean, dry, cool skin. If the patient has taken a warm bath prior to treatment the skin should be allowed to cool before the cream is applied. Lyclear Dermal Cream is a vanishing cream and when rubbed gently into the skin it will disappear. Therefore, there is no need to continue to apply cream to the skin until it remains detectable on the surface. Older children should be supervised by an adult when applying the cream to ensure that a thorough treatment is administered. Posology For adults and children over 12 years of age, up to one 30g tube may be used as a single application. A few adults may need to use more than one tube to ensure total body coverage, but not more than two tubes (60g in total) should be used for a single application. For children 12 years and under, the following table indicates the approximate amount of cream to be used as a single application. These drug recommendations are only approximate and are intended to serve as a guide. (Recommendations are based on the use of a 30g tube). Children aged: 2 months to 1 year up to ⅛ of a tube 1-5 years up to ¼ of a tube 6-12 years up to ½ of a tube The safety and efficacy of Lyclear in children under 2 months of age have not been established. No data are available Olvassa el a teljes dokumentumot