Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
glatiramer acetate, Quantity: 40 mg
Teva Pharma Australia Pty Ltd
Glatiramer acetate
Injection, solution
Excipient Ingredients: mannitol; water for injections
Subcutaneous
12 single pre-filled syringes
(S4) Prescription Only Medicine
Copaxone is indicated for the: 1- Reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis. 2-Treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent MRI lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.
Visual Identification: A clear, colourless solution for injection, essentially free of visible particles.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-02-25
COPAXONE ® 40 MG/ML _glatiramer acetate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Copaxone 40 mg/ mL. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT COPAXONE 40 MG/ML IS USED FOR Copaxone 40 mg/mL is used for the management of relapsing forms of Multiple Sclerosis (MS). Copaxone may also be used in patients who, for the first time, have experienced symptoms and have MRI changes that indicate a high risk for development of MS. Your doctor will rule out any other reasons which could explain these symptoms before you are treated. The cause of MS is not yet known. MS affects the brain and spinal cord. In MS, the body’s immune system reacts against its own myelin (the ‘insulation’ surrounding nerve fibres). In relapsing forms of MS, people can have ‘exacerbations’ from time to time (e.g. blurred vision, weakness in the legs or arms, or loss of control of bowel or bladder function). These are followed by periods of recovery. Although the exact mechanism of how Copaxone works in MS is unknown, it is thought that Copaxone works by changing the immune processes that are believed to be responsible for the disease. Copaxone has been shown to be effective in reducing the number of relapses in patients with relapsing remitting MS. Although it is not a cure, patients treated with Copaxone 40mg/mL generally find that they will experience fewer relapses. Your doctor, however, may prescribe Copaxone for another purpose. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor’s prescription. BE Preberite celoten dokument
Teva Pharma Australia Pty Limited Version 4.0 1 AUSTRALIAN PI – COPAXONE ® (GLATIRAMER ACETATE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Glatiramer acetate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Copaxone 20 mg/mL contains 20 mg of glatiramer acetate. Copaxone 40 mg/mL contains 40 mg of glatiramer acetate. Glatiramer acetate, the active ingredient in both Copaxone 20 mg/mL and Copaxone 40 mg/mL, is the acetate salt of synthetic polypeptides, containing four naturally occurring amino acids: L- glutamic acid, L-alanine, L-tyrosine and L-lysine with an average molar fraction 0.141, 0.427, 0.095 and 0.338, respectively. For the full list of excipients, see Section 6.1 “List of excipients”. 3 PHARMACEUTICAL FORM Copaxone is a clear, colourless solution for injection, in a pre-filled syringe. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis. Treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent MRI lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded. 4.2 D OSE AND METHOD OF ADMINISTRATION The only recommended route of administration of Copaxone injection is by the subcutaneous route. Copaxone should not be administered by the intravenous or intramuscular routes. COPAXONE 20 MG/ML The recommended dosage in adults is a once daily subcutaneous injection of 1 mL Copaxone 20 mg. This corresponds to one Copaxone 20 mg/mL pre-filled syringe. COPAXONE 40 MG/ML The recommended dosage in adults is one subcutaneous injection of 1 mL Copaxone 40 mg administered three times a week and at least 48 hours apart. This corresponds to one Copaxone 40 mg/mL pre-filled syringe per administration. Teva Pharma Australia Pty Limited Version 4.0 2 METHOD OF ADMINISTRATION Sites for self-injection include arms, abdomen, hips and thighs. A different site for injection should be used each day in order to reduce the likelihood of loca Preberite celoten dokument