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COPAXONE ® (glatiramer acetate)
PRE-FILLED SYRINGE PRESCRIBING
INFORMATION
Presentation – Glatiramer acetate 20mg
solution for injection in 1ml Pre-filled
Syringe. Indication – Reduction of frequency
of relapses in relapsing-remitting multiple
sclerosis in ambulatory patients who have
had at least two relapses in the preceding two
years before initiation of therapy. Dosage and
administration – 20mg of glatiramer acetate
(one pre-filled syringe) administered subcutaneously
once daily. Children (1%:
Nausea, anxiety, rash, sweating, chills,
face oedema, syncope, vomiting,
lymphadenopathy, oedema, nervousness,
tremor, herpes simplex, skin benign neoplasm,
eye disorder, vaginal moniliasis. Rarely:
Anaphylactoid reactions, convulsions, shifts
in white blood cell counts, elevated liver
enzymes (with no evidence of clinical
significance) and skin necrosis at injection
sites. Please refer to the SPC for a full list
of adverse events. Overdose – Monitor,
treat symptomatically. Pharmaceutical
Precautions - Store Copaxone in refrigerator
(2°C to 8°C). If the pre-filled syringes cannot
be stored in a refrigerator, they can be stored
at room temperature (15°C to 25°C) once for
up to one month. Legal Category – POM.
Package Quantity and Basic NHS Cost – 28
pre-filled syringes of Copaxone: £545.59.
Product Licence Number – 10921/0023.
Further Information – Further medical
information available on request from Teva
Pharmaceuticals Limited, The Gate House,
Gatehouse Way, Aylesbury, Bucks, HP19 8DB.
Date of Preparation – May 2008.
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Adverse events should be reported.
Reporting forms and information can be
found at www.yellowcard.gov.uk.
Adverse events should also be reported to
Teva Pharmaceuticals Ltd on
telephone number: 01296 719768.
Reference: Ford C. et al. Multiple Sclerosis 2006; 12: 309-320.
Date of preparation: June 2008 Code: C0807/428e
Long-term active