País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
SODIUM AUROTHIOMALATE
May & Baker Limited
SODIUM AUROTHIOMALATE
20 mg/0.5 Millilitre
Solution for Injection
Withdrawn
2007-10-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Myocrisin Injection 20 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Aurothiomalate 20 mg in 0.5 ml. For excipients see 6.1. 3 PHARMACEUTICAL FORM Solution for Injection A pale yellow aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in the management of active progressive rheumatoid arthritis, including progressive juvenile rheumatoid arthritis especially if polyarticular or sero-positive. In some cases of chronic discoid lupus erythematosus unresponsive to anti-malarials a response may be obtained with this drug. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Myocrisin should be administered only by deep intramuscular injection followed by gentle massage of the area. The patient should remain under supervision for a period of 30 minutes after drug administration. Adults (including elderly): An initial dose of 10mg should be given the first week followed by weekly doses of 50mg until signs of remission occur. At this point, 50mg doses should be given until full remission occurs. With full remission, the interval between injections should be increased progressively to three, four and then (after 18 months to 2 years), to six weeks. If after reaching a total dose of 1 gram (excluding the test dose), no major improvement has occurred and the patient has not shown any signs of gold toxicity, six 100mg injections may be administered at weekly intervals. If no signs of remission occur after this time, other forms of treatment are to be considered. Children: Therapy should be initiated with low doses with gradual increments to the following maxima: Dosage should be continued for a 6 months. If no improvement has occurred, therapy should be stopped. If improvement has occur Leia o documento completo