METVIX Cream (2019)
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Περιεχόμενα
Name of the medicinal product
Metvix 160 mg/g cream.
Qualitative and quantitative composition
Metvix contains 160 mg/g of methyl aminolevulinate (as hydrochloride) equivalent to 16.0% of methyl aminolevulinate (as hydrochloride). Excipients with known effect: Metvix contains cetostearyl alcohol ...
Pharmaceutical form
Cream. The colour is cream to pale yellow.
Therapeutic indications
Treatment of thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp when other therapies are considered less appropriate. Only for treatment of superficial and/or nodular ...
Posology and method of administration
Posology Adults (including the older people) AK, BCC and Bowens disease using red light For treatment of actinic keratoses (AK) one session of photodynamic therapy should be administered. Treated lesions ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including arachis oil or peanut or soya. Morpheaform basal cell carcinoma. Porphyria.
Special warnings and precautions for use
The usage of Metvix requires a specific knowledge in photodynamic therapy as it may necessitate the use of a red light lamp. Accordingly, it should be administered in the presence of a physician, a nurse ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of methyl aminolevulinate in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Metvix is not recommended ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Metvix with red light in AK, BCC and Bowens disease a) Summary of the safety profile: approximately 60% of patients experience reactions localised to the treatment site that are attributable to toxic effects ...
Overdose
The severity of local phototoxic reactions such as erythema, pain and burning sensation may increase in case of prolonged application time and/or very high red light intensity.
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agent ATC code: L01XD03 Mechanism of action Metvix with red light in AK, BCC and Bowens disease After topical application of methyl aminolevulinate, porphyrins ...
Pharmacokinetic properties
In vitro dermal absorption of radiolabelled methyl aminolevulinate applied to human skin has been studied. After 24 hours the mean cumulative absorption through human skin was 0.26% of the administered ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. When methyl aminolevulinate was administered by IV at ...
List of excipients
Self-emulsifying glyceryl monostearate Cetostearyl alcohol Poloxyl 40 stearate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Disodium edetate Glycerol White soft paraffin Cholesterol ...
Incompatibilities
Not applicable.
Shelf life
Shelf life Unopened: 15 months. 28 days after first opening of the container.
Special precautions for storage
Store in a refrigerator (2°C–8°C).
Nature and contents of container
Aluminium tube with internal protective lacquer and a latex seal. Screw cap of HDPE. Metvix cream is supplied in a tube containing 1g or 2 g cream. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, United Kingdom
Marketing authorization number(s)
PL 10590/0048
Date of first authorization / renewal of the authorization
20/07/2006
Date of revision of the text
05/10/2019
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