DESOWEN Desonide 0.5mg/g ointment tube

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

desonide, Quantity: 0.5 mg/g

Dostupné z:

Galderma Australia Pty Ltd

INN (Medzinárodný Name):

Desonide

Forma lieku:

Ointment

Zloženie:

Excipient Ingredients: liquid paraffin; polyethylene

Spôsob podávania:

Topical

Počet v balení:

30G, 25G, 60G, 50G

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Desowen Ointment 0.05% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses for adults and children aged 2 years and older.

Prehľad produktov:

Visual Identification: Smooth, soft, translucent, grease-like ointment; Container Type: Tube; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

1998-12-21

Súhrn charakteristických

Desowen PI 1
AUSTRALIAN PRODUCT INFORMATION
DESOWEN
_Desonide 0.05% _
1
NAME OF THE MEDICINE
Desonide
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of DESOWEN lotion, ointment and cream contains 0.5 mg of
desonide.
Desonide is a nonfluorinated corticosteroid. Desonide is a white
powder or crystal. Practically insoluble
in water; sparingly soluble in alcohol and in acetone; soluble in
chloroform.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
DESOWEN Lotion: contains: hydroxybenzoates
DESOWEN Cream: contains sorbates
3 PHARMACEUTICAL FORM
DESOWEN lotion is a white to off-white, soft, smooth lotion.
DESOWEN ointment is a smooth, soft, translucent, grease-like ointment.
DESOWEN cream is a white, shiny, semi-solid emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desowen Cream 0.05%, Lotion 0.05% and Ointment 0.05% is indicated for
the relief of inflammatory
and pruritic manifestations of corticosteroid responsive dermatoses
for adults and children aged
2 years and older.
4.2 DOSE AND METHOD OF ADMINISTRATION
Desowen (desonide) Cream 0.05%, Lotion 0.05% or Ointment 0.05% should
be applied as a thin film
to the affected areas two to three times daily depending on the
severity of the condition. Shake lotion
well before using.
Occlusive dressing may be used for the management of psoriasis or
recalcitrant conditions. If an
infection develops the use of occlusive dressings should be
discontinued and appropriate antimicrobial
therapy instituted.
Periods of continuous treatment should not exceed 8 weeks in adults or
children.
An increase in the number of daily applications may exacerbate the
adverse effects without enhancing
the therapeutic effects.
Treatment of large skin areas requires monitoring of the number of
tubes used.
4.3 CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a
history of hypersensitivity to any of
the components of the preparations.
DESOWEN preparations are also contraindicated in most viral infections
of the skin (vaccinia, herpes