Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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1. NAME OF THE MEDICINAL PRODUCT
Copaxone 20 mg/ml Solution for Injection, Pre-filled Syringe
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains 20 mg glatiramer acetate*, equivalent to 18 mg of glatiramer base per pre-filled syringe
* Glatiramer acetate is the acetate salt of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine and L-lysine, in molar fraction ranges of 0.129-0.153, 0.392-0.462, 0.086-0.100 and 0.300-0.374, respectively. The average molecular weight of glatiramer acetate is in the range of 5,000-9,000 daltons.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for Injection, Pre-filled Syringe
Clear solution free of visible particles
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Copaxone is indicated for the treatment of patients who have experienced a well- defined first clinical episode and are determined to be at high risk of developing clinically definite multiple sclerosis (CDMS) (see Section 5.1).
Copaxone is indicated for the reduction in frequency of relapses in ambulatory patients, (i.e. who can walk unaided) with relapsing, remitting multiple sclerosis (MS). In clinical trials this was characterised by at least two attacks of neurological dysfunction over the preceding two-year period (see Section 5.1).
Copaxone is not indicated in primary or secondary progressive MS.
4.2 Posology and method of administration
The recommended dosage in adults is 20 mg of glatiramer acetate (one pre-filled syringe), administered as a subcutaneous injection once daily.
At the present time, it is not known for how long the patient should be treated.
A decision concerning long term treatment should be made on an individual basis by the treating physician.
Paediatric Use: Children and adolescents: No prospective, randomized, controlled clinical trials or pharmacokinetic studies have been conducted in children or adolescents. However, limited published data suggest that the safety profile in adolescents from 12 to 18 years of age receiving Copaxone 20 mg subcutaneously every day is similar to that seen in adults. There is not enough information availab
