Paul Reading Maurice Curtis, Andrew Naylor, Richard Faull ... - ACNR

COPAXONE ® (glatiramer acetate)PRE-FILLED SYRINGEPRESCRIBING INFORMATIONPresentation - Glatiramer acetate 20mgsolution for injection in 1ml Pre-filled Syringe.Indication - Reduction of frequency ofrelapses in relapsing-remitting multiplesclerosis in ambulatory patients who have hadat least two relapses in the preceding twoyears before initiation of therapy. Dosage andadministration - 20mg of glatiramer acetate(one pre-filled syringe) administered subcutaneouslyonce daily. Children (1%: Nausea,anxiety, rash, sweating, chills, face oedema,syncope, vomiting, lymphadenopathy, oedema,nervousness, tremor, herpes simplex, skinbenign neoplasm, eye disorder, vaginalmoniliasis. Rarely: Anaphylactoid reactions,convulsions, shifts in white blood cell counts,elevated liver enzymes (with no evidence ofclinical significance) and skin necrosis atinjection sites. Please refer to the SPC for afull list of adverse events. Overdose - Monitor,treat symptomatically. PharmaceuticalPrecautions - Store Copaxone in refrigerator(2ºC to 8ºC). If the pre-filled syringes cannotbe stored in a refrigerator, they can be storedat room temperature (15ºC to 25ºC) once forup to one month. Legal Category - POM.Package Quantity and Basic NHS Cost - 28pre-filled syringes of Copaxone: £545.59.Product Licence Number - 10921/0023.Further Information - Further medicalinformation available on request from TevaPharmaceuticals Limited, The Gate House,Gatehouse Way, Aylesbury, Bucks, HP19 8DBDate of Preparation - September 2007.Your decisiontodaycan make a differencetomorrowInformation about adverse eventreporting can be found atwww.yellowcard.gov.uk.Adverse events should also be reported toTeva Pharmaceuticals Ltd ontelephone number: 01296 719768.Reference: Ford C. et al. Multiple Sclerosis 2006; 12: 309-320.(glatiramer acetate)Long-term activeDate of preparation: October 2007Code: C0807/428a