Source: Health Products Regulatory Authority (IE) Revision Year: 2017 Publisher: Almirall Hermal GmbH, Scholtzstraße 3, D-21465 Reinbek, Germany Phone: +49 40 727 04 0 Fax: +49 40 72 704 329 E-mail: info@almirall.de
Monovo is indicated 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). Monovo should be used to treat skin complaints where a topical mometasone preparation is indicated.
A thin film of Monovo 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.
Monovo 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 the body surface area should be treated. It should not be used occlusively or intertriginously. Treatment duration is limited to a maximum of 3 weeks.
Use of a weaker corticosteroid is often advisable when there is a clinical improvement.
Monovo is a potent group III glucocorticoid. It is not recommended for use in children below 2 years due to insufficient data on safety.
For application on the skin (cutaneous use).
Excessive long-term use of external corticosteroids may suppress HPA axis function and give rise to secondary adrenocortical insufficiency. If suppression of the HPA axis has been reported, it should be endeavoured, with the usual caution being exercised in these situations, to reduce the frequency of applications or to try to withdraw the drug.
2 years
Shelf-life after first opening: 6 months.
Do not store above 25°C.
The cream is filled in PE/aluminium laminate tubes fitted with a white polypropylene screw cap in a cardboard carton.
Carton of 1 tube.
Tubes with 10g, 15g, 20g, 25g, 30g, 35g, 50g, 60g, 70g, 90g and 100g of cream.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
