Copaxone 20 mg Solution

    Copaxone 20 mg Solution

    S4


    1. WHAT COPAXONE 20 MG/ML IS AND WHAT IT IS USED FOR:

    • To reduce the number of times you suffer attacks (relapses) of multiple sclerosis (MS). It has not been demonstrated to help if you have any form of MS which does not have relapses, or hardly any relapses.

    • In patients who have experienced symptoms for the first time, and where the patient is at a high risk of developing multiple sclerosis. (This will be determined by your doctor). Your doctor will also rule out any other reasons which could explain these symptoms before you are treated.

    2. WHAT YOU NEED TO KNOW BEFORE YOU USE COPAXONE 20 MG/ML:

    COPAXONE 20 mg/ml should not be administered to you:

    • If you are hypersensitive (allergic) to glatiramer acetate or any of the other ingredients of COPAXONE 20 mg/ml (listed in section 6 ).

    Warnings and precautions:

    Take special care with COPAXONE 20 mg/ml and tell your doctor if any of the following apply to you:

    • if you have any kidney or heart problems as you may need to have regular tests and check-ups.

    • if you have or have had any liver problems (including those due to alcohol consumption).

    Elderly: COPAXONE 20 mg/ml has not been studied in the elderly. Please ask your doctor or healthcare professional for advice.

    Children and adolescents: The use of COPAXONE 20 mg/ml is not recommended in children and adolescents under 18 years of age.

    Other medicines and COPAXONE 20 mg/ml:

    Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines).

    Pregnancy and breastfeeding:

    If you are pregnant or breastfeeding, think you may be pregnant or planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine.

    3. HOW TO USE COPAXONE 20 MG/ML:

    Do not share medicines prescribed for you with any other person. Always use COPAXONE 20 mg/ml exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

    • The recommended daily dose in adults and adolescents aged 18 years and over is one pre-filled syringe (20 mg glatiramer acetate), injected subcutaneously (under the skin).

    • Never use the same syringe more than once. Any unused medicine must be discarded.

    • Do not mix the contents of the COPAXONE 20 mg/ml pre-filled syringe with any other product.

    • If the solution in the pre-filled syringe contains particles or is cloudy, do not use it. Use a new syringe.

    • The first time you use COPAXONE 20 mg/ml, you will be given full instructions and will be supervised by a doctor or healthcare professional. They will be with you while you give yourself the injection, and for 30 minutes afterwards to make sure you do not have any problems.

    • Before using COPAXONE 20 mg/ml, you should decide where to inject yourself. Choose the injection site within the areas on your body by using the diagrams below (see Figure 1). There are seven possible areas on your body for injection.

    • If you have the impression that COPAXONE 20 mg/ml is too strong or too weak for you, talk to your doctor or healthcare professional.

    • Do not change the dose or dosing routine without speaking to your doctor.

    • A different site of injection should be chosen every day, to reduce the chance of any irritation or pain at the injection site. Please refer to Figure 1 below.

    4. POSSIBLE SIDE EFFECTS:

    COPAXONE 20 mg/ml can have side effects. Not all side effects reported for COPAXONE 20 mg/ml are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving COPAXONE 20 mg/ml, please consult your healthcare provider for advice.

    If any of the following happens, stop using COPAXONE 20 mg/ml and tell your doctor immediately or go to the casualty department at your nearest hospital:

    • swelling of the hands, feet, ankles, face, lips, eyelids and mouth or throat, which may cause difficulty in swallowing or breathing

    • rash (red spots or nettle rash) or itching

    • sudden wheeziness

    • convulsions (fits)

    • fainting.

    These are all very serious side effects. If you have them, you may have had a serious allergic reaction to COPAXONE 20 mg/ml. You may need urgent medical attention or hospitalisation.

    Also tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following symptoms that last longer than 30 minutes:

    • flushing (reddening) of the chest or face (vasodilatation)

    • a feeling of tightness in the chest

    • shortness of breath

    • rapid heart beat (palpitations).

    These are all serious side effects. You may need urgent medical attention.

    5. HOW TO STORE COPAXONE 20 MG/ML:

    STORE ALL MEDICINES OUT OF THE REACH OF CHILDREN.

    Store at 2 °C - 8 °C (in a refrigerator). DO NOT FREEZE COPAXONE 20 mg/ml. Store in the original outer carton until required for use, in order to protect from light. If you cannot store COPAXONE 20 mg/ml in a refrigerator you can store the pre-filled syringes at room temperature for up to one month.

    Do not use COPAXONE 20 mg/ml after the expiry date stated on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

    Important Disclaimer

    The Copaxone 20 mg Solution professional information leaflet below is the property of Teva Pharmaceuticals and is provided on Somayeza exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Somayeza serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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