DESOWEN Desonide 0.5mg/g cream tube

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

desonide, Quantity: 0.5 mg/g

Доступно од:

Galderma Australia Pty Ltd

INN (Међународно име):

Desonide

Фармацеутски облик:

Cream

Састав:

Excipient Ingredients: emulsifying wax; propylene glycol; stearic acid; isopropyl palmitate; synthetic beeswax; polysorbate 60; sorbic acid; potassium sorbate; propyl gallate; sodium hydroxide; citric acid; purified water

Пут администрације:

Topical

Јединице у пакету:

60G, 50G, 30G, 25G

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Desowen Cream 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.

Резиме производа:

Visual Identification: White, shiny, semi-solid emulsion; Container Type: Tube; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Licence status A

Датум одобрења:

1998-12-21

Карактеристике производа

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