Χώρα: Σιγκαπούρη
Γλώσσα: Αγγλικά
Πηγή: HSA (Health Sciences Authority)
DICLOFENAC SODIUM
NOVARTIS (SINGAPORE) PTE LTD
M01AB05
75 mg/3 ml
INJECTION
INTRAMUSCULAR
Prescription Only
NOVARTIS PHARMA AG
1991-04-08
VOLTAREN Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative and related substance. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Solution for injection. ACTIVE SUBSTANCE The active substance is sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= diclofenac sodium). One Voltaren ® ampoule of 3 mL contains 75 mg of diclofenac sodium. ACTIVE MOIETY Diclofenac EXCIPIENTS Mannitol; sodium metabisulphite (E223); benzyl alcohol; propylene glycol; water for injection; sodium hydroxide; nitrogen, pure. Pharmaceutical formulations may vary between countries. INDICATIONS INTRAMUSCULAR INJECTION Treatment of: Exacerbations of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism. Acute attacks of gout. Renal colic and biliary colic. Post-traumatic and post-operative pain, inflammation and swelling. Severe migraine attacks. INTRAVENOUS INFUSION Treatment or prevention of post-operative pain in a hospital setting. Novartis Page 2 Country-specific Package Leaflet (Singapore) 03 Sep 2013 Voltaren solution for injection DOSAGE AND ADMINISTRATION DOSAGE As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section WARNINGS AND PRECAUTIONS). ADULTS Voltaren solution for injection should not be given for more than 2 days; if necessary, treatment can be continued with Voltaren tablets or suppositories. SPECIAL POPULATIONS PEDIATRICS Because of their dosage Διαβάστε το πλήρες έγγραφο