Mometasone multichem

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Mometasone furoate 1 mg/g (Manufacturing formula includes includes 2 % overage (1.02 mg/g)); Mometasone furoate 1 mg/g (Manufacturing formula includes includes 2 % overage (1.02 mg/g))

Disponible desde:

Multichem NZ Limited

Designación común internacional (DCI):

Mometasone furoate 1 mg/g (Manufacturing formula includes includes 2 % overage (1.02 mg/g))

Dosis:

0.1% w/w

formulario farmacéutico:

Topical ointment

Composición:

Active: Mometasone furoate 1 mg/g (Manufacturing formula includes includes 2 % overage (1.02 mg/g)) Excipient: Hexylene glycol Macrogol stearate 1500 Polysorbate 80 White beeswax White soft paraffin Active: Mometasone furoate 1 mg/g (Manufacturing formula includes includes 2 % overage (1.02 mg/g)) Excipient: Hexylene glycol Macrogol stearate 1500 Polysorbate 80 White beeswax White soft paraffin

Unidades en paquete:

Tube, aluminium, with PP cap, 10 g

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

Cipla Ltd

indicaciones terapéuticas:

For the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, such as psoriasis and atopic dermatitis.

Resumen del producto:

Package - Contents - Shelf Life: Tube, aluminium, with PP cap - 10 g - 30 months from date of manufacture stored at or below 25°C. Unopened - Tube, aluminium, with PP cap - 15 g - 30 months from date of manufacture stored at or below 25°C. Unopened - Tube, aluminium, with PP cap - 45 g - 30 months from date of manufacture stored at or below 25°C. Unopened

Fecha de autorización:

2004-08-20

Ficha técnica

NEW ZEALAND DATA SHEET
Mometasone multichem
1. PRODUCT NAME
Mometasone multichem cream, 0.1% w/w
Mometasone multichem ointment, 0.1% w/w
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 1mg of mometasone furoate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Mometasone multichem cream is a soft white smooth cream.
Mometasone multichem ointment is a soft smooth ointment.
4. CLINICAL PARTICULARS
4.1
Therapeutic indications
Mometasone multichem cream and ointment are indicated for the relief
of inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses, such
as psoriasis and atopic
dermatitis.
4.2
Dose and method of administration
A thin film of Mometasone multichem cream or ointment should be
applied to the affected skin
areas once daily. Mometasone multichem cream is suitable for moist
lesions; the ointment should
be used for dry, scaling and fissured lesions.
4.3
Contraindications
Mometasone multichem cream and ointment are contraindicated in
patients who are hypersensitive
to mometasone furoate or to other corticosteroids. Like other topical
corticosteroids, Mometasone
multichem cream and ointment is contraindicated in most viral
infections of the skin, tuberculosis,
acne rosacea, perioral dermatitis, fungal skin infections and
ulcerative conditions.
4.4
Special warnings and precautions for use
If irritation or sensitisation develops with the use of Mometasone
multichem cream or ointment,
treatment should be discontinued and appropriate therapy instituted.
In the presence of an infection, use of an appropriate antifungal or
antibacterial agent should be
instituted. If a favourable response does not occur promptly,
Mometasone multichem cream or
ointment should be discontinued until the infection is controlled
adequately.
Babies and children up to four years should not be treated with
topical steroids for longer than three
weeks. In infants the napkin may act as an occlusive dressing and
increase absorption. Adrenal
suppression is more likely to occur