Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
betamethasone (betamethasone dipropionate), salicylic acid
Schering-Plough Labo N.V.
D07XC01
betamethasone (betamethasone dipropionate), salicylic acid
0,5mg/g+ 30mg/g
ointment
30g aluminium tube
Prescription
Registered
2021-06-16
2 1. NAME OF THE MEDICINAL PRODUCT DIPROSALIC ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _GENERAL CHARACTERISTIC: _ _MAIN PHYSICAL/CHEMICAL PROPERTIES_: soft, homogeneous, white ointment without foreign inclusions. _COMPOSITION: _1 g of ointment contains betamethasone 0.5 mg (as dipropionate) and salicylic acid 30 mg; _EXCIPIENTS_: liquid paraffin, white soft paraffin. 3. PHARMACEUTICAL FORM Ointment. PHARMACOTHERAPEUTIC GROUP. Dermatological corticosteroids. Highly active corticosteroids in combination with other agents. ATC code: D07X C01. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS To relieve inflammations in the uninfected subacute and chronic hyperkeratotic and dry dermatoses that are normally responsive to corticosteroid therapy: psoriasis, chronic atopic dermatitis, neurodermatitis (lichen simplex chronicus), lichen planus, eczema (including nummular eczema, grocers itch, eczematoid dermatitis), dyshidrosis (dropsy), seborrheic dermatitis of the scalp, ichthyosis vulgaris and other ichthyotic conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and children_: a thin film should be applied to cover the affected area twice daily – in the morning and in the evening. For some patients adequate maintenance therapy may be achieved with less frequent application. Duration of therapy varies depending upon the severity and state of the disease. _Maximum daily dose_: the dose should be adjusted to have daily control of symptoms. 4.3 CONTRAINDICATIONS - Hypersensitivity to any of components of the preparation. - Bacterial and viral infections of skin (herpes, varicella, herpes zoster, molluscum contagiosum) or fungal infection; tuberculosis, syphilis, skin post-vaccinal reactions. - Acne vulgaris, acne, rosacea, perioral dermatitis. Avoid contact with wounds, ulcers or mucosa. Do not use Diprosalic in ophthalmology; do not use under occlusive dressing. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If irritation or sensitization develops with the use of the drug, treatment should be discontinued. Đọc toàn bộ tài liệu