TRAXAM Cutaneous foam (2016)
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Περιεχόμενα
1. Name of the medicinal product
Traxam 3.17% w/w Cutaneous Foam. Felbinac 3.17% w/w Cutaneous Foam.
2. Qualitative and quantitative composition
<u>Active Ingredient:</u> Felbinac (Biphenylacetic Acid) 3.17% w/w. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Cutaneous foam (foam). This medicine is quick-break foam dispensed from cans which contain a concentrate of 3.17% felbinac in ethanol/aqueous vehicle with butane propellant.
4.1. Therapeutic indications
This medicine is a topical anti-inflammatory and analgesic. It is indicated for the relief of rheumatic pain, pain of non-serious arthritic conditions and soft tissue injury such as sprains, strains and ...
4.2. Posology and method of administration
Posology Prescription Only Medicine Adult population The foam should be dispensed onto the hand and rubbed lightly into the affected area(s). This medicine is formulated to break down into a clear liquid ...
4.3. Contraindications
Prescription Only Medicine Hypersensitivity to the ingredients in this product. Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory ...
4.4. Special warnings and precautions for use
It should only be used on non-diseased skin. Use of this medicine should be limited to intact skin. Contact with mucous membranes and the eyes should be avoided. Patients should avoid actuation of the ...
4.5. Interaction with other medicinal products and other forms of interaction
Felbinac is highly protein bound. However, serum levels following topical application are extremely low and therefore clinical drug interactions are unlikely.
4.6. Pregnancy and lactation
Since the safety of felbinac in human pregnancy has not been established, it is not recommended for use in these circumstances. As with other non-steroidal anti-inflammatory agents which inhibit prostaglandin ...
4.7. Effects on ability to drive and use machines
None.
4.8. Undesirable effects
A low incidence of mild local irritation, erythema, dermatitis, pruritis and paraesthesia which recovers spontaneously upon cessation of treatment may be expected with this medicine. Systemic side effects ...
4.9. Overdose
It is unlikely that this medicine could cause adverse systemic effects even if accidental ingestion should occur. Consult a doctor if ingestion is suspected.
5.1. Pharmacodynamic properties
Felbinac is an anti-inflammatory/analgesic agent which has been developed into a topical gel for local treatment of pain and inflammation associated with conditions of the musculo-skeletal system.
5.2. Pharmacokinetic properties
This medicine administered in a pharmacokinetic study achieves similar low circulating levels of felbinac to this medicine.
5.3. Preclinical safety data
Testing of biphenylacetic acid includes single and repeat dose studies, foetal toxicity and fertility studies, mutagenic and carcinogenic potential studies which show an acceptable toxicity profile for ...
6.1. List of excipients
Ethanolamine USNF Ethanol 96% BP Purified water BP Polawax A31 Softigen 767 Butane 40
6.2. Incompatibilities
None.
6.3. Shelf life
12 months.
6.4. Special precautions for storage
This medicine is packed in a Pressurised container. Protect the canister from sunlight and do not expose to temperature above 50°C. Extremes of temperature can occur in motor cars. Do not pierce or burn ...
6.5. Nature and contents of container
Aluminium monobloc can with white enamel body, double grinded microflex internal lacquer and colourless overlacquer. Cans are fitted with a valve made of aluminium microflex and diptube and shave foam ...
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London, EC4N 7BL, UK
8. Marketing authorization number(s)
PL 12762/0086
9. Date of first authorization / renewal of the authorization
09/04/1992 / 17/03/2003
10. Date of revision of the text
09/05/2016
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