Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
Primecrown 2010 Limited
D11AX18
DICLOFENAC SODIUM
3 percent weight/weight
Gel
Product subject to prescription which may be renewed (B)
diclofenac
Authorised
2011-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solaraze 3% gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains 30 mg diclofenac sodium (3% w/w). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel _Product imported from the United Kingdom:_ A clear, transparent, colourless or pale yellow gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of actinic keratoses 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _USE IN ADULTS_: Solaraze is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 grams (the size of a pea) of the gel is used on a 5 cm x 5 cm lesion site. The usual duration of therapy is from 60 to 90 days. Maximum efficacy has been observed with treatment duration towards the upper end of this range. Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy. A maximum of 8 grams daily should not be exceeded. Long term efficacy has not been established. _USE IN THE ELDERLY:_ The usual adult dose may be used. _USE IN CHILDREN:_ Dosage recommendations and indications for the use of Solaraze have not been established for use in children. 4.3 CONTRAINDICATIONS Solaraze is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, macrogol monomethyl ether 350 and/ or sodium hyaluronate. Because of cross-reactions, the gel should not be used by patients who have experienced hypersensitivity reactions such as symptoms of asthma, allergic rhinitis or urticaria, to acetylsalicylic acid or other non-steroidal anti-inflammatory agents. The use of Solaraze is contraindicated during the last trimester of pregnancy_ (see Section 4.6)._ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The likelihood of systemic side effects occurring following the topical application of Solaraze is very small compared to the frequency of side effects with oral diclofenac, owing to Baca dokumen lengkapnya