* 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). * Produced by: NOVARTIS PHARMA SAE Cairo, under license from: Novartis Pharma AG, Basle, Switzerland.