XEMACORT Cream (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Xemacort 20 mg/g + 1 mg/g cream.
2. Qualitative and quantitative composition
1 g cream contains 20 mg fusidic acid and 1 mg betamethasone corresponding to 1,214 mg betamethasone valerate. <u>Excipients with known effect:</u> Contains cetostearyl alcohol 72 mg/g and chlorocresol ...
3. Pharmaceutical form
Cream. White to off white, smooth, homogeneous cream.
4.1. Therapeutic indications
Xemacort 20 mg/g + 1 mg/g cream is indicated for the treatment of eczematous dermatoses in adults and children over 1 year of age, including atopic eczema, discoid eczema, stasis eczema, contact eczema ...
4.2. Posology and method of administration
Posology A single treatment course should not normally exceed 2 weeks. Method of administration For cutaneous use. A small quantity should be applied to the affected area twice daily until a satisfactory ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Due to the content of corticosteroid preparations, fusidic acid/betamethasone cream is contraindicated in the ...
4.4. Special warnings and precautions for use
Systemic absorption Long-term continuous topical therapy should be avoided, particularly in infants and children. Depending on the application site, possible systemic absorption of betamethasone valerate ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy Fusidic acid No effects during pregnancy are anticipated, since systemic exposure to fusidic acid is negligible Studies in animals have not shown teratogenic effects with fusidic acid. Limited ...
4.7. Effects on ability to drive and use machines
Xemacort 20 mg/g + 1 mg/g cream has no or negligible influence on the ability to drive or to use machines.
4.8. Undesirable effects
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting. The most frequently reported adverse reaction during treatment ...
4.9. Overdose
For topically applied fusidic acid, no information concerning potential symptoms and signs due to overdose administration is available. Cushings syndrome and adrenocortical insufficiency may develop following ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Corticosteroids, potent, combinations with antibiotic <b>ATC code:</b> D07CC01 Xemacort 20 mg/g + 1 mg/g cream combines the well-known anti-inflammatory and antipruritic ...
5.2. Pharmacokinetic properties
There are no data which define the pharmacokinetics of fusidic acid/betamethasone cream, following topical administration in man. However, <em>in vitro</em> studies show that fusidic acid can penetrate ...
5.3. Preclinical safety data
Studies of corticosteroids in animals have shown reproductive toxicity (e.g. cleft palate, skeletal malformations, low birth weight).
6.1. List of excipients
Macrogol cetostearyl ether Cetostearyl alcohol Chlorocresol Liquid paraffin Sodium dihydrogen phosphate dihydrate White soft paraffin All-rac-α-tocopherol Purified water Sodium hydroxide
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
<u>Unopened container:</u> 36 months. <u>After first opening:</u> 6 months.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
Aluminium tubes with a white conical polyethylene cap of 5 gram, 15 gram, 30 gram, and 60 grams. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Generics [UK] Limited t/a Mylan, Station Close, Potters, Bar, Hertfordshire EN6, 1TL, United Kingdom
8. Marketing authorization number(s)
PL 04569/1625
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 23 March 2015 Date of latest renewal: 24 March 2020
10. Date of revision of the text
September 2021
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