* Voltaren (diclofenac sodium) 75 mg/ 3 ml 3 ampoules. Antirheumatic, anti-inflammatory, analgesic. i.m. (intraglut.) / i.v. infusion.
* Composition: Each ampoule contains:
& & Sodium {o- {(2,6-dichlorophenyl) – amino} – phenyl} – acetate ( = diclofenac. natr.) 75 mg, excipients, preservative && solution for injection up to 3 ml.
* Therapeutic Indications:
& & # Intramuscular injection initial treatment of:
& & – Exacerbations of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis,
& & spondylarthritis, painful syndromes of the vertebral coulmn, non-articular rheumatism.
& & – Acute attacks of gout.
& & – Renal colic and biliary colic.
& & – Post-traumatic and postoperative pain, inflammation, and swelling.
& & – Severe migraine attacks.
& & # Intravenous infusion: Treatment or prevention of postoperative pain in a hospital setting.
* Dosage / administration:
& & – Adults: Voltaren ampoules should not be given for more than 2 days; if necessary, treatment can be continued with
& & Voltaren tablets or suppositories.
& & – Intramuscular Injection: The following directions for intramuscular injection must be followed in order to avoid
& & damage to a nerve or other tissue at the injection site. The dosage is generally one 75 mg ampoule daily, given by
& & deep intragluteal injection into the upper outer quadrant. In severe cases (e.g. colic) the daily dose can exceptionally
& & be increased to two injections of 75 mg, separated by an interval of a few hours (one into each buttock).
& & Alternatively, one ampoule of 75 mg can be combined with other dosage forms of Voltaren (tablets, suppositories)
& & up to a maximum daily dosage of 150 mg. In migraine attacks, clinical experience is limited to initial use of 1 ampoule of
& & 75 mg administered as soon as possible, followed by suppositories up to 100 mg on the same day if required.
& & The total dosage should not exceed 175 mg on the first day. No data are available on the use of Voltaren to treat
& & migraine for more than one day. Should it be necessary to continue treatment on the following days, the maximum
& & daily dose is to be limited to 150 mg (given in divided doses in the form of suppositories).
& & – Intravenous infusion: Voltaren must not be given as an intravenous bolus injection. Immediately before starting an I.V.
& & infusion, voltaren must be diluted with saline 0.9% or glucose 5% infusion solution buffered with sodium bicarbonate.
& & Two alternative dosage regimens of voltaren are recommended: For the treatment of moderate to severe postoperative
& & pain, 75 mg should be infused continuously over a period of 30 minutes to 2 hours. If necessary, treatment may be
& & repeated after a few hours, but the dosage should not exceed 150 mg within any period of 24 hours. For the prevention
& & of postoperative pain, a loading dose of 25-50 mg should be infused after surgery over 15 minutes to 1 hour, followed by
& & a continuous infusion of about 5 mg per hour up to a maximum daily dosage of 150 mg.
& & – Children: Voltaren ampoules are contraindicated in children.
* Contraindications:
& & – Gastric or intestinal ulcer or bleeding.
& & – Known hypersensitivity to the active substance, or sodium metabisulphite and other excipients.
& & – Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltaren is also contraindicated in patients in whom attacks
& & of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other drugs with prostaglandin-synthetase
& & inhibiting activity.
& & – Nasal polyps, angioedema, bronchospasm, or asthma.
& & – Moderate to severe impairment of renal function, hypovolaemia, or dehydration.
& & – Patients at high risk for postoperative bleeding or imcomplete haemostasis, haemotopoietic disorders, or cerebrovascular bleeding.
& & – Voltaren must not be used together with high doses of anticoagulants or with other anti-inflammatory agents.
& & – Voltaren ampoules must not be used in children, since there is no experience of such use.
* To be used under medical supervision.
* Protect from light and heat (store below 30 degrees C).
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