MONOVO Cream (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Monovo 1mg/g Cream.
2. Qualitative and quantitative composition
One gram of cream contains 1 mg of mometasone furoate (0.1% mometasone furoate). <u>Excipients with known effect:</u> 72.00 mg of cetostearyl alcohol (type A), emulsifying; 10.00 mg of cetyl alcohol and ...
3. Pharmaceutical form
Cream. A white cream.
4.1. Therapeutic indications
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 ...
4.2. Posology and method of administration
Adults, including elderly patients adolescents and children aged 2 years and older A thin film of Monovo should be applied to the affected skin area once daily. Strong topical corticosteroids generally ...
4.3. Contraindications
Monovo is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1 facial rosacea acne vulgaris perioral dermatitis perianal and genital ...
4.4. Special warnings and precautions for use
Any contact with the eyes, and use on the eyelids should be avoided. Monovo should not be applied to broken skin and mucous membranes. Caution should be observed in patients who are hypersensitive to any ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Fertility No effects known. Pregnancy Corticosteroids cross the placenta. There is very limited data on the use of topical mometasone during pregnancy. After systemic use of high dose corticosteroids, ...
4.7. Effects on ability to drive and use machines
Monovo has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Adverse reactions are listed in Table 1 according to MedDRA system organ class and in decreasing frequency defined as follows: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), ...
4.9. Overdose
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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Corticosteroids, Dermatological preparations; Corticosteriods, potent (Group III) <b>ATC Code:</b> D07AC13 Monovo is a potent glucocorticoid, group III. The active substance, ...
5.2. Pharmacokinetic properties
Results from percutaneous absorption studies have indicated that systemic absorption following topical application of mometasone furoate cream 0.1% is minimal. The results show that about 0.4% of the active ...
5.3. Preclinical safety data
Acute Toxicity Type of Animal Type of Application LD<sub>50</sub> (mg/kg) Mouse subcutaneous 200–2000 Rat s ubcutaneous 200 Dog subcutaneous >200 Mouse oral >2000 Rat oral >2000 Chronic Toxicity ...
6.1. List of excipients
Purified water White soft paraffin (contains butylated hydroxytoluene (E321) as antioxidant) Liquid paraffin 2-Methylpentane-2,4-diol Emulsifying cetostearyl alcohol (type A, contains disodium/potassium ...
6.2. Incompatibilities
When treating the genital or anal area with Monovo, the ingredients white soft paraffin and liquid paraffin can lead to a reduction in the functional capability of latex products (e.g. condoms, diaphragms) ...
6.3. Shelf life
2 years Shelf-life after first opening: 6 months.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
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 ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
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
8. Marketing authorization number(s)
PA 1548/002/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 18th November 2011 Date of last renewal: 10th March 2016
10. Date of revision of the text
July 2017
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