ELOMET Cream (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
ELOMET Cream 0.1%.
2. Qualitative and quantitative composition
Each gram of Mometasone furoate cream 0.1% contains 1 mg mometasone furoate in a cream base of hexylene glycol, hydrogenated soybean lecithin, titanium dioxide, aluminum starch octenylsuccinate, white ...
3. Pharmaceutical form
Cream.
4.1. Therapeutic indications
ELOMET Cream 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. The lotion formulation may be applied to scalp lesions.
4.2. Posology and method of administration
A thin film of ELOMET Cream 0.1% should be applied to the affected skin areas once daily until the lesion heals or for a duration of three weeks, whichever is sooner.
4.3. Contraindications
ELOMET Cream 0.1% is contraindicated in patients who are sensitive to mometasone furoate, to other corticosteroids or to any component of these preparations.
4.4. Special warnings and precautions for use
If irritation or sensitization develops with the use of ELOMET Cream treatment should be discontinued and appropriate therapy instituted. In the presence of an infection, use of an appropriate antifungal ...
4.5. Interaction with other medicinal products and other forms of interaction
No known data.
4.6. Pregnancy and lactation
Since safe use of ELOMET Cream in pregnant women has not been established, topical corticosteroids should be used during pregnancy only if the potential benefit justifies potential risk to the fetus. Drugs ...
4.8. Undesirable effects
Local adverse reactions reported very rarely with ELOMET Cream 0.1% include paresthesia, pruritus and signs of skin atrophy. The following local adverse reactions have been reported infrequently with the ...
4.9. Overdose
Symptoms Excessive, prolonged use of topical corticosteroids can suppress pituitary- adrenal function resulting in secondary adrenal insufficiency. Treatment Appropriate symptomatic treatment is indicated. ...
5.1. Pharmacodynamic properties
Mometasone furoate, a synthetic corticosteroid, exhibits anti-inflammatory, antipruritic and vasoconstrictive properties. The pharmacologic profile of mometasone furoate was determined by standard laboratory ...
5.2. Pharmacokinetic properties
The percutaneous absorption and excretion of 3H-mometasone furoate cream and/or ointment was evaluated in rats, rabbits and dogs with doses ranging from 5.2 to 22 μg/cm<sup>2</sup>. Additionally, the tissue ...
6.2. Incompatibilities
No known data.
6.4. Special precautions for storage
Store below 30°C. Shelf-life information can be found on the outer carton of the product. Keep medicines out of reach of children. Further information can be obtained from the doctor or the pharmacist. ...
6.5. Nature and contents of container
Tubes of 5g, 15g and 50g. Not all presentations may be available locally.
7. Marketing authorization holder
Product Registrant: Organon Singapore Pte. Ltd., 150 Beach Road, #36-01/08 Gateway West, Singapore 189720 Zuellig Pharma (B) Sdn Bhd, Unit 5, 1st floor, Spg 607, Jalan Gadong, Kg Beribi, BSB, BE1118, Brunei ...
10. Date of revision of the text
June 2022
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