Country: Israel
Language: English
Source: Ministry of Health
GLATIRAMER ACETATE
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
L03AX13
SOLUTION FOR INJECTION
GLATIRAMER ACETATE 20 MG/DOSE
S.C
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
GLATIRAMER ACETATE
GLATIRAMER ACETATE
For reducing the frequency of relapses in pateints with relapsing-remitting multiple sclerosis. 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). These patients should have MRI findings which are compatible with the diagnosis of multiple sclerosis.
2013-03-31
Patient leaflet in accordance with the Pharmacists’ Regulations (Preparations) – 1986 This medicine is dispensed with a doctor’s prescription only COPAXONE ® 20 mg/ml Solution in pre-filled syringe For subcutaneous injection only Composition Each Copaxone 20 mg/ml syringe (1 ml) contains: glatiramer acetate 20 mg For information on inactive ingredients, see section 6 “Additional information”. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. This medicine is intended for subcutaneous injection only. This medicine is not intended for use in children or adolescents below 18 years of age. 1. What is this medicine intended for? Copaxone 20 mg/ml modifies the way in which your body’s immune system works. The symptoms of multiple sclerosis are thought to be caused by a defect in the body’s immune system. This produces areas of inflammation in the brain and spinal cord. Copaxone 20 mg/ml is indicated for reducing the frequency of relapses in patients with relapsing- remitting multiple sclerosis. Copaxone 20 mg/ml is indicated for the treatment of patients after a first clinical episode that indicates a high risk of developing multiple sclerosis. Therapeutic group: Immune system stimulant. 2. Before using this medicine Do not use this medicine if: • you are sensitive (allergic) to the active ingredient (glatiramer acetate) or to any of the additional ingredients contained in the medicine (see section 6 – “Additional information” in this leaflet). Special warnings about using this medicine Before starting treatment, inform the doctor or pharmacist if: • you suffer from kidney or heart problems, since regular testing and monitoring may be necessary. • you suffer from or Read the complete document
COPAXONE 20mg/ml_solution for injection RC SmpC 062023 Notification Clean SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT COPAXONE ® 20mg/ml solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pre-filled syringe (1 ml) of solution for injection contains 20 mg glatiramer acetate*, equivalent to 18 mg of glatiramer * . 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. Due to its compositional complexity, no specific polypeptide can be fully characterized including in terms of amino acid sequence, although the final glatiramer acetate composition is not entirely random. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe Clear solution free of visible particles The solution for injection has a pH of 5.5 - 7.0 and an osmolarity of about 265 mOsmol/L. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications Copaxone is indicated for reducing the frequency of relapses in patients with relapsing-remitting multiple sclerosis. 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). These patients should have MRI findings which are compatible with the diagnosis of multiple sclerosis. COPAXONE 20mg/ml_solution for injection RC SmpC 062023 Notification Clean 4.2. Posology and method of administration The initiation of Copaxone treatment should be supervised by a neurologist or a physician experienced in the treatment of MS. Posology The recommended dosage in adults is 20 mg of glatiramer acetate (one pre-filled syringe), administered as a subcutaneous injecti Read the complete document