Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
HYDROCORTISONE ACETATE
KARO PHARMA AB
D07AA; D07AA02
HYDROCORTISONE ACETATE
Cream
Corticosteroids, weak (group I); hydrocortisone
Marketed
1996-09-24
Health Products Regulatory Authority 30 September 2022 CRN00CVFH Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT HC45 Hydrocortisone Acetate Cream (Hydrocortisone Acetate 1% w/w) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrocortisone acetate 1% w/w. Excipients: Cetostearyl alcohol 7.2% w/w For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. White, odourless or almost odourless cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Allergic contact dermatitis Irritant contact dermatitis Insect bite reactions Mild to moderate eczema 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN OVER 10 YEARS: Once or twice a day, for a maximum of 7 days. Medical advice should be sought if the condition does not improve. ELDERLY POPULATION Dosage adjustments are not considered necessary in the elderly. PAEDIATRIC POPULATION Dosage recommendations as above for children over 10 years of age. The product should not be used in children under 10 years of age unless recommended by a health care professional. METHOD OF ADMINISTRATION For topical administration. Apply sparingly to a small area. Massage gently into the skin. 4.3 CONTRAINDICATIONS Hypersensitivity to hydrocortisone acetate or to any of the excipients listed in section 6.1 Do not use on the eyes or face (for example, in rosacea or perioral dermatoses) the ano-genital area or on broken or infected skin, (including impetigo, cold sores, acne or athlete’s foot or infected bites or stings). Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin. Not for use with an occlusive dressing or on large areas of the body. Health Products Regulatory Authority 30 September 2022 CRN00CVFH Page 2 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The product should not be used during pregnancy or breast-feeding unless recommended by a health care professional (see section 4.6). Prolonged use of the product is not recommended (see section 4.2) as continuous application without int Կարդացեք ամբողջական փաստաթուղթը