ETOFLAM Gel (2015)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Etoflam 5% w/w Gel.
Qualitative and quantitative composition
The gel contains 5% w/w etofenamate. For a full list of excipients, see section 6.1.
Pharmaceutical form
Gel. A nearly transparent yellowish gel.
Therapeutic indications
For the treatment of inflammatory disorders of the musculo-skeletal system.
Posology and method of administration
Recommended dosage Adults (including the elderly) Etoflam 5% w/w gel is applied topically. A 5-10cm strip of gel (according to the area affected) should be rubbed in gently. This may be repeated up to ...
Contraindications
Etoflam 5% w/w gel contains alcohol and should not be applied to broken skin. Use with occlusive dressings. Use in patients hypersensitive to any of the ingredients or to non-steroidal anti-inflammatory ...
Special warnings and precautions for use
Etoflam 5% w/w gel contains alcohol and therefore contact with the eyes or the mucous membranes should be avoided. Hands should be thoroughly washed after use of this product. This product should not be ...
Interaction with other medicinal products and other forms of interaction
None known.
Fertility, pregnancy and lactation
Etoflam 5% w/w gel is not recommended for use during pregnancy and lactation. Etofenamate and some of its metabolites have been shown to cross the placenta in rats (oral and cutaneous) and rabbits (cutaneous). ...
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
The following undesirable effects have been reported through post-marketing use. Undesirable effects listed in the table are grouped by MedDRA System Organ Classes and are ranked under heading of frequency, ...
Overdose
In view of the topical route of administration overdosage is not considered a practical possibility.
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-inflammatory/analgesic for the treatment of inflammatory musculoskeletal system disorder Mechanism of action Interactions with the arachidonic acid cascade (inhibition of ...
Pharmacokinetic properties
In human studies plasma levels after a single topical application of gel were found to be low. Levels were similar in patients with impaired kidney function. Levels are broadly independent of kidney function. ...
Preclinical safety data
Animal studies have shown no evidence of an embryotoxic or carcinogenic effect. In vitro and in vivo studies of the induction of gene and chromosome mutations were negative. A mutagenic effect appears ...
List of excipients
Fatty alcohol polyglycol ether Isopropyl alcohol Macrogol 400 Carbomer Sodium hydroxide Purified water
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Collapsible aluminium tube with an internal coating with polyethylene screw cap. Tubes contain either 20g or 100g of gel product. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, Co. Meath
Marketing authorization number(s)
PA1113/002/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 04 April 1990 Date of last renewal: 04 February 2010
Date of revision of the text
November 2015
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