Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
DICLOFENAC RESINATE EQV DICLOFENAC SODIUM
NOVARTIS (SINGAPORE) PTE LTD
M01AB05
15 mg/ml
SOLUTION
ORAL
Prescription Only
Delpharm Huningue S.A.S.
1994-01-24
CATAFLAM Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative and related substance. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Oral drops suspension. ACTIVE SUBSTANCE The active substance is [o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate resinate (= diclofenac resinate). One hundred millilitres of Cataflam ® suspension (oral drops) contain diclofenac resinate equivalent to 1.5 g diclofenac sodium (0.5 mg per drop or 15 mg per mL). ACTIVE MOIETY Diclofenac EXCIPIENTS Castor oil, hydrogenated; paraffin liquid; saccharin sodium; copolymer of acrylic and methacrylic acid with divinylbenzene and ethylvinylbenzene (Zerolite 236 SRC 48), washed; tutti-frutti flavour. Pharmaceutical formulations may vary between countries. INDICATIONS Treatment of: Juvenile rheumatoid arthritis, Post-traumatic and post-operative pain, inflammation, and swelling, e.g. following dental or orthopedic surgery, As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication. Novartis Page 2 Country Specific Package Leaflet (Singapore) 10 Feb 2012 Cataflam oral drops suspension DOSAGE AND ADMINISTRATION DOSAGE As a general recommendation, the dose should be individually adjusted and the lowest effective dose given for the shortest possible duration. The oral drops should be swallowed. ADULTS Specific pharmaceutical forms (e.g. tablets, suppositories, solution for injection) are available for use in adults. The initial daily dose is 100 to 150 mg. In milder cases, 75 to 100 mg daily is usually sufficient. The total daily dose should generally be divided into 2 to 3 separa Baca dokumen lengkap