Mometasone Furoate Ointment 1mg/g

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

MOMETASONE FUROATE

Disponible desde:

1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany

Código ATC:

D07AC13

Designación común internacional (DCI):

MOMETASONE FUROATE 0.1 % (W/W)

formulario farmacéutico:

OINTMENT

Composición:

MOMETASONE FUROATE 0.1 % (W/W)

tipo de receta:

POM

Área terapéutica:

CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS

Estado de Autorización:

Withdrawn

Fecha de autorización:

2016-03-07

Ficha técnica

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mometasone Furoate – 1 A Pharma 1mg/g ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 1 mg of mometasone furoate (0.1 % w/w
mometasone furoate).
Excipients with known effect: 20 mg propylene glycol
monopalmitostearate/gram ointment and
traces, up to a maximum of 0.015mg Butylhydroxytoluene (E321)/ gram
ointment.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment
A translucent white soft uniform and smooth ointment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mometasone Furoate – 1 A Pharma is indicated in adults, adolescents
and children aged 2 years
and above for the symptomatic treatment of inflammatory skin
conditions which respond to external
treatment with glucocorticoids, such as atopic dermatitis and
psoriasis (excluding widespread
plaque psoriasis, see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
For application on the skin (cutaneous use).
ADULTS, INCLUDING ELDERLY PATIENTS AND CHILDREN AGED 2 YEARS AND OVER:
A thin film of Mometasone Furoate – 1 A Pharma should be applied to
the affected skin area once
daily.
Strong topical corticosteroids generally should not be applied to the
face without close monitoring
by the physician.
Mometasone Furoate – 1 A Pharma should not be used for long periods
(over 3 weeks) or on large
areas (over 20% of body surface area). In children aged 2 years and
older a maximum of 10% of
body surface area should be treated.
It should not be used occlusively or intertriginously. Treatment
duration is limited to a maximum of
3 weeks.
Page 2 of 7
Use of a weaker corticosteroid is often advisable when there is a
clinical improvement.
Local and systemic toxicity is more common following prolonged
continuous application over large
areas of damaged skin, in flexures and under occlusive dressings (see
section 4.4).
PAEDIATRIC POPULATION
CHILDREN BELOW 2 YEARS:
Mometasone Furoate – 1 A Pharma is a potent group III