Nchi: Armenia
Lugha: Kiingereza
Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diclofenac (diclofenac sodium)
Delpharm Huningue S.A.S.
M01AB05
diclofenac (diclofenac sodium)
50mg
suppositories
(10/2x5/) in blister
Prescription
Registered
2017-04-03
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Voltaren ® Suppositories 25 mg Voltaren ® Suppositories 50 mg Voltaren ® Suppositories 100 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac sodium). Each suppository contains 25 mg, 50 mg or 100 mg diclofenac sodium Ph.Eur. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORMS Suppositories. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults and Elderly_ : Relief of all grades of pain and inflammation in a wide range of conditions, including: (i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout; (ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis; (iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery. _Children (aged 1-14 years) _ (i) Juvenile chronic arthritis (only for suppositories 25 mg) _Children (aged 6 years and above) _ (ii) As monotherapy or as adjunct therapy with morphine or other opiates (due to its opiate- sparing effect) for the relief of acute post-operative pain. In keeping with standard therapeutic principles, the underlying disease should be treated with specific therapy as appropriate. Fever alone is not an indication. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The suppositories should be inserted well into the rectum.It is recommended to insert the suppositories after passing stools. Not to be taken by mouth, as per rectal administration only. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration 2 necessary to control symptoms (see section 4.4 Special warnings and precautions for use). ADULTS: 100-150 mg daily, in divided doses. Usually 75-100 mg/day with moderate symptoms and long-term therapy. The recommended maximum daily dose o Soma hati kamili