Land: Armenië
Taal: Engels
Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diclofenac (diclofenac sodium)
Novartis Pharma Stein AG
diclofenac (diclofenac sodium)
75mg/3ml
solution for injection
Prescription
SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Voltaren® solution for injections 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate) (diclofenac sodium). Each 3ml ampoule contains 75mg diclofenac sodium Ph.Eur. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORMS Solution for injection in ampoules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Ampoules for im use_: The ampoules are effective in acute forms of pain, including renal colic, exacerbations of osteo- and rheumatoid arthritis, acute back pain, acute gout, acute trauma and fractures, and post-operative pain. _Ampoules used in intravenous infusion_: For treatment or prevention of post-operative pain in the hospital setting. 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 (see section 4.4 Special warnings and precautions for use). ADULTS Voltaren ® ampoules (given im or iv) should not be given for more than two days; if necessary, treatment can be continued with Voltaren ® tablets or suppositories. Intramuscular injection: The following directions for intramuscular injection must be adhered to in order to avoid damage to a nerve or other tissue at the injection site. One ampoule once (or in severe cases twice) daily intramuscularly by deep intragluteal injection into the upper outer quadrant. If two injections daily are required it is advised that the alternative buttock be used for the second injection. Alternatively, one ampoule of 75mg can be combined with other dosage forms of Voltaren ® (tablets or suppositories) up to the maximum daily dosage of 150mg. Renal colic: One 75mg ampoule intramuscularly. A further ampoule may be administered after 30 minutes if necessary. The recommended maximum daily dose of Voltaren ® is 150mg. _Intravenous Infusion_: Immediately before initiating an intravenous infusion, Lees het volledige document