Ülke: Ermenistan
Dil: İngilizce
Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diclofenac (diclofenac sodium)
Medical Horizon Ltd
M01AB05
diclofenac (diclofenac sodium)
100mg
suppositories rectal
(10/2x5/)
Prescription
Registered
2019-06-11
PRODUCT – DICLON 12.5 MG, 25 MG, 50 MG, 100 MG RECTAL SUPPOSITORIES Page 1 of 16 SUMMARY PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Diclon 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Diclofenac sodium 12.5 mg, 25 mg, 50 mg, 100 mg For excipients, see 6.1 3. PHARMACEUTICAL FORM Rectal 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: 1. Arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and acute gout. 2. Acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis. 3. Other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery. Children (aged 1-12 years): Juvenile chronic arthritis (12.5 mg and 25 mg suppositories only). Children (aged 6 years and above): 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 (12.5 mg and 25 mg suppositories only). Diclon 50 mg and 100 mg suppositories are not indicated for use in children. PRODUCT – DICLON 12.5 MG, 25 MG, 50 MG, 100 MG RECTAL SUPPOSITORIES Page 2 of 16 4.2 Posology and method of administration Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Not to be taken by mouth, as per rectal administration only. The suppositories should be inserted well into the rectum. It is recommended to insert the suppositories after passing stools. Adults: 75-150 mg daily, in divided doses (25mg, 50mg and 100mg suppositories only). The recommended maximum daily dose of Diclon is 150 mg. The total daily dose should generally be divided into 2 to 3 doses. To suppress nocturnal pain and morning stiffness, treatment with Diclofenac Tablets during the day can be supplemented by the ad Belgenin tamamını okuyun