ELIDEL Cream (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Elidel 10mg/g cream.
Qualitative and quantitative composition
1 g of cream contains 10 mg of pimecrolimus. Excipients with known effect: 10 mg benzyl alcohol, 40 mg cetyl alcohol, 40 mg stearyl alcohol, and 50 mg propylene glycol (E 1520) in 1 g of cream. For a full ...
Pharmaceutical form
Cream. Whitish and homogeneous.
Therapeutic indications
Treatment of patients aged 2 years and over with mild or moderate atopic dermatitis where treatment with topical corticosteroids is either inadvisable or not possible. This may include: Intolerance to ...
Posology and method of administration
Elidel should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. Elidel can be used in the short term for the treatment of the signs and symptoms of atopic ...
Contraindications
Hypersensitivity to pimecrolimus, other macrolactams or to any of the excipients (see section 6.1).
Special warnings and precautions for use
Elidel cream should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that causes immunosuppression. Long-term effect on the local skin immune response and ...
Interaction with other medicinal products and other forms of interaction
Potential interactions between Elidel and other medicinal products have not been systematically evaluated. Pimecrolimus is exclusively metabolised by CYP 450 3A4. Based on its minimal extent of absorption, ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of Elidel in pregnant women. Animal studies using dermal application do not indicate direct or indirect harmful effects with respect to embryonal/fetal ...
Effects on ability to drive and use machines
Elidel has no known effect on the ability to drive and use machines.
Undesirable effects
The most common adverse events were application site reactions which were reported by approximately 19% of the patients treated with Elidel and 16% of patients in the control groups. These reactions generally ...
Overdose
There has been no experience of overdose with Elidel.
Pharmacodynamic properties
Pharmacotherapeutic group: Other dermatological preparations. Agents for dermatitis, excluding corticosteroids. ATC code: D11AH02 Mechanism of action Pimecrolimus is a lipophilic anti-inflammatory ascomycin ...
Pharmacokinetic properties
Data in animals The bioavailability of pimecrolimus in mini-pigs following a single dermal dose (applied for 22h under semi-occlusion) was 0.03%. The amount of active substance-related material in the ...
Preclinical safety data
Conventional studies of repeated dose toxicity, reproductive toxicity and carcinogenicity using oral administration produced effects at exposures sufficiently in excess of those in man to be of negligible ...
List of excipients
Medium chain triglycerides Oleyl alcohol Propylene glycol (E1520) Stearyl alcohol Cetyl alcohol Mono-and di-glycerides Sodium cetostearyl sulphate Benzyl alcohol Citric acid anhydrous Sodium hydroxide ...
Incompatibilities
Not applicable.
Shelf life
2 years. After first opening the container: 12 months.
Special precautions for storage
Do not store above 25°C. Do not freeze.
Nature and contents of container
Aluminium tube with a phenol-epoxy protective inner lacquer and polypropylene screw cap. Tubes of 5, 15, 30, 60 and 100 grams. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Emollients can be applied together with Elidel (see section 4.2). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Mylan Products Ltd., Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0163
Date of first authorization / renewal of the authorization
1 August 2013
Date of revision of the text
June 2019
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