Krajina: Arménsko
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
hydrocortisone (hydrocortisone 17-butyrate)
Temmler Italia S.r.L.
D07AB02
hydrocortisone (hydrocortisone 17-butyrate)
1mg/g
ointment for topical use
aluminium tube 30g
OTC
Registered
2017-06-08
LOCOID ® (hydrocortisone-17-butyrate) CTD Module 1 Cream, ointment and cutaneous solution Section 1.3: Product Information SmPC NL – Locoid range MA transfer – 21-Jun-2016 1 of 5 1. NAME OF THE MEDICINAL PRODUCT Locoid ointment, ointment 1 mg/g Locoid Lipocream, cream 1 mg/g Locoid cream, cream 1 mg/g Locoid scalp lotion, lotion 1 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Locoid ointment, Locoid Lipocream and Locoid cream contain 1 mg/g and Locoid scalp lotion contains 1 mg/ml hydrocortisone-17-butyrate. The Locoid ointment is hydrophobic (greasy); Locoid Lipocream and Locoid cream contain buffered oil- in-water emulsions (Locoid Lipocream has more fat, Locoid cream has more water). Locoid scalp lotion is a buffered, somewhat viscous solution based on isopropanol-water. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Locoid ointment is an ointment, Locoid Lipocream and Locoid are creams and Locoid scalp lotion is a solution for cutaneous use. Locoid ointment, Locoid Lipocream and Locoid cream are all white. Locoid scalp lotion is clear and colourless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTICAL INDICATIONS Superficial, corticosteroid-sensitive skin conditions that are not caused by micro-organisms and that are expected to respond insufficiently to will respond to mildly active products. Aftercare or maintenance treatment of dermatoses that were suppressed before with a stronger product. 4.2 DOSAGE AND METHOD OF ADMINISTRATION Apply a bit of Locoid to the skin 1-3 times a day. After improvement of the condition, application once daily or 2 to 3 times per week is usually sufficient. In general, do not use more than 30-60 g per week. Apply Locoid in a thin layer equally on the affected skin areas. To improve the penetration in the skin, a mild massage may be performed carefully. Occlusion may be necessary to achieve better therapeutic results. 4.3 CONTRAINDICATIONS Skin conditions caused by: - bacterial infections (e.g. pyodermias, luetic and tuberculous processes) - viral inf Prečítajte si celý dokument