STERAX CUTANEOUS EMULSION 0.05% W/W 0.05 %w/w Cutaneous Emulsion

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

DESONIDE

Boleh didapati daripada:

Galderma (UK) Ltd

INN (Nama Antarabangsa):

DESONIDE

Dos:

0.05 %w/w

Borang farmaseutikal:

Cutaneous Emulsion

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2008-03-31

Ciri produk

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sterax Cutaneous Emulsion 0.05% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Desonide 0.05% w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cutaneous emulsion
White to off-white soft, smooth emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the cutaneous treatment of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses suc
as psoriasis, eczema, and other mainly inflammatory dermatoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For external use only.
Tip the bottle gently to place a quantity of cutaneous emulsion on the fingertips sufficient to cover the area to be
treated. Wash hands thoroughly and replace the cap tightly after use.
Adults, children and the elderly:
To be applied once or twice a day depending on the severity of the condition.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the components of the formulation.
Ulcerated lesions.
Acne and rosacea.
Conditions for which cutaneous corticosteroid therapy is contra-indicated, notably skin infections of bacterial, viral, fun
and parasitic origin, even when these include an inflammatory response.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Several preclinical studies were performed to establish the safety of cutaneous application of desonide. From these
studies and based on the general knowledge of the adverse reactions associated with the use of topical corticosteroids,
particularly their potential systemic action on the hormonal system, it is recommended that the application of Sterax on
large areas or under occlusive dressings should be limited.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/07/2006_
_CRN 202600