Glatiramer Acetate 20mg/ml, Solution for Injection, Pre-Filled Syringe
Package leaflet: Information for the user
glatiramer acetate
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Glatiramer Acetate is and what it is used for
2. What you need to know before you use Glatiramer Acetate
3. How to use Glatiramer Acetate
4. Possible side effects
5. How to store Glatiramer Acetate
6. Contents of the pack and other information
1. What Glatiramer Acetate is and what it is used for
Glatiramer Acetate is a medicine used for the treatment of relapsing forms of multiple sclerosis (MS). It modifies the way in which your body’s immune system works and it is classed as an immunomodulating agent. The symptoms of MS are thought to be caused by a defect in the body’s immune system. This produces patches of inflammation in the brain and spinal cord.
Glatiramer Acetate is used to reduce the number of times you suffer attacks of MS (relapses). It has not been demonstrated to help if you have any form of MS which does not have relapses or hardly any relapses. Glatiramer Acetate may not have any effect on the length of time an MS attack lasts, or how badly you suffer during an attack.
It is used to treat patients who are able to walk without help.
Glatiramer Acetate may also be used in patients who have experienced symptoms for the first time which indicate a high risk of developing MS. Your doctor will rule out any other reasons which could explain these symptoms before you are treated.
2.What you need to know before you use Glatiramer Acetate
Do not use Glatiramer Acetate:
- if you are allergic to glatiramer acetate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Glatiramer Acetate if you have any kidney or heart problems as you may need to have regular tests and check-ups.
Children
Glatiramer Acetate is not to be used in children below the age of 12 years.
Elderly
Glatiramer Acetate has not been specifically studied in the elderly. Please ask your doctor for advice.
Other medicines and Glatiramer Acetate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice and consideration regarding Glatiramer Acetate treatment during pregnancy and/or lactation.
Driving and using machines
Glatiramer Acetate is not known to influence the ability to drive or operate machinery.
3. How to use Glatiramer Acetate
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended daily dose in adults and adolescents aged 12 years and over is one pre-filled syringe (20 mg of glatiramer acetate), administered under the skin (subcutaneously).
It is very important to inject Glatiramer Acetate properly:
- Into the tissue under the skin (subcutaneous use) only (see “Instructions for use”).
- At the dose instructed by your doctor. Use only the dose prescribed by your doctor.
- Never use the same syringe more than once. Any unused product or waste must be discarded.
- Do not mix or co-administer the content of Glatiramer Acetate pre-filled syringes with any product.
- If the solution contains particles, do not use it. Use a new syringe.
The first time you use Glatiramer Acetate you will be given full instructions and will be supervised by a doctor or nurse. They will be with you while you give yourself the injection and for half an hour afterwards, just to make sure you do not have any problems.
Instructions for use
Read these instructions carefully before using Glatiramer Acetate.
Before the injection, make sure you have everything you need:
- One blister with one Glatiramer Acetate pre-filled syringe
- Disposal unit for used needles and syringes.
- For each injection, take only one blister with one pre-filled syringe from the package. Keep all remaining syringes in the box.
- If your syringe has been stored in the refrigerator, take the blister containing the syringe out at least 20 minutes before you will inject the medicine so that it warms up to room temperature.
Wash your hands thoroughly with soap and water.
If you wish to use an injection device to make your injection, the CSYNC device can be used with Glatiramer Acetate. The CSYNC device is only approved to be used with Glatiramer Acetate and has not been tested with other products. Please refer to the instructions for use provided together with the CSYNC injection device.
Choose the injection site, within the areas, using the diagrams. There are seven possible areas on your body for injection:
- Area 1: Stomach area (abdomen) around the belly button. Avoid 5 cm around the belly button,
- Area 2 and 3: Thighs (above your knees),
- Area 4, 5, 6 and 7: Back of the upper arms, and upper hips (below your waist).
Within each injection area, there are several injection sites. Choose a different site for the injection every day. This will reduce the likeliness of any irritation or pain at the site of the injection. Rotate injection areas and also rotate the injection sites within an area. Do not use the same site each time.
Please note: do not inject in any area that is painful or discoloured or where you feel firm knots or lumps. You should consider having a planned schedule for rotating injection sites and making a note of it in a diary. There are some sites on your body that may be difficult for self-injection (like the back of your arms). If you want to use these, you may require assistance.
How to inject:
- Remove the syringe from its protective blister by peeling back the blister lid.
- Remove the shield from the needle, do not remove the shield with your mouth or teeth.
- Gently pinch up the skin with the thumb and forefinger of the freehand (Figure 1).
- Push the needle into the skin as shown in Figure 2.
- Inject the medicine by steadily pushing the plunger all the way down until the syringe is empty.
- Pull the syringe and needle straight out.
- Discard the syringe in a safe disposal container. Do not put used syringes into the household waste but dispose of them carefully in a puncture-proof container as recommended by your doctor or nurse.
If you have the impression that the effect of Glatiramer Acetate is too strong or too weak, talk to your doctor.
If you use more Glatiramer Acetate than you should
Talk to your doctor immediately.
If you forget to use Glatiramer Acetate
Use it as soon as you remember but do not use a double dose to make up for forgotten individual doses. Use the next dose 24 hours later.
If you stop using Glatiramer Acetate
Do not stop using Glatiramer Acetate without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions (hypersensitivity)
You may rarely develop a serious allergic reaction to this medicine.
Stop using Glatiramer Acetate and contact your doctor immediately or go to the casualty department at your nearest hospital, if you notice any sign of these side effects:
- rash (red spots or nettle rash)
- swelling of the eyelids, face or lips
- sudden shortness of breath
- convulsions (fits)
- fainting
Other reactions following injection (immediate post-injection reaction)
It’s uncommon but some people may get one or more of the following symptoms within minutes after injecting Glatiramer Acetate. They normally do not cause any problems and usually disappear within half an hour.
However, if the following symptoms last longer than 30 minutes, contact your doctor immediately or go to the casualty department at your nearest hospital:
- flushing (reddening) of the chest or face (vasodilatation)
- shortness of breath (dyspnoea)
- chest pain
- pounding and rapid heartbeat (palpitations, tachycardia)
The following side effects have been reported with Glatiramer Acetate:
Very common: may affect more than 1 in 10 people
- infection, flu
- anxiety, depression
- headache
- feeling sick
- skin rash
- pain in the joints or back
- feeling weak, skin reactions at the injection site including reddening of the skin, pain, the formation of wheals, itching, tissue swelling, inflammation and hypersensitivity (these injection site reactions are not unusual and normally decrease over time), non-specific pain
Common: may affect up to 1 in 10 people
- inflammation of the respiratory tract, gastric flu, cold sore, inflammation of the ears, runny nose, tooth abscess, vaginal thrush
- non-malignant skin growth (non-malignant neoplasm of skin), tissue growth (neoplasm)
- lymph node swelling
- allergic reactions
- loss of appetite, weight gain
- nervousness
- altered taste increased tightness of muscle tone, migraine, speech disorder, fainting, tremor
- double vision, an eye disorder
- ear disorder
- cough, hay fever
- disorder of anus or rectum, constipation, tooth decay, indigestion, difficulty in swallowing, bowel incontinence, vomiting
- abnormal liver function test
- bruising, excessive sweating, itching, skin disorder, nettle rash
- neck pain
- urge to empty your bladder, frequent urination, inability to empty your bladder appropriately
- chill, face swelling, wasting of tissue under the skin at the injection site, local reaction, peripheral swelling due to build-up of fluid, fever
Uncommon: may affect up to 1 in 100 people
- abscess, inflammation of the skin and the soft tissue underneath, boils, shingles, inflammation of the kidney
- skin cancer
- increased white blood cell count, reduced white blood cell count, spleen enlargement, low blood platelet count, change in form of white blood cells
- an enlarged thyroid, overactive thyroid
- low alcohol tolerance, gout, increase in blood fat levels, increase in blood sodium, decrease in serum ferritin
- abnormal dreams, confusion, euphoric mood, seeing, hearing, smelling, tasting or feeling something that is not there (hallucinations), aggression, abnormally elevated mood, personality disorder, suicide attempt
- hand numbness and pain (carpal tunnel syndrome), mental disorder, fits (convulsion), problems with handwriting and reading, muscle disorders, problems with movement, muscle spasm, nerve inflammation, and an abnormal nerve-muscle link leading to abnormal muscle function, involuntary rapid movement of the eyeballs, paralysis, foot drop (peroneal nerve palsy), unconscious state (stupor), visual blind spots
- cataract, eye lesion in the cornea, dry eye, eye bleeding, droopy upper eyelid, pupil widening, wasting of the optic nerve leading to visual problems
- extra heartbeats, slow heartbeats, episodic fast heartbeats
- varicose vein
- periodic stops in breathing, nose bleeding, abnormally fast or deep breathing (hyperventilation), tight feeling in the throat, lung disorder, inability to breathe due to throat tightness (choking sensation)
- bowel inflammation, polyps in the colon, intestine inflammation, burping, ulcer in the gullet, inflammation of the gums, rectal bleeding, enlarged salivary glands
- gallstones, liver enlargement
- swelling of the skin and soft tissues, skin contact rash, painful red skin lumps, skin lumps
- swelling, inflammation and pain of joints (arthritis or osteoarthritis), inflammation and pain of fluid-sacs lining the joint (exist in some of the joints), flank pain, decrease in the mass of muscles
- blood in the urine, kidney stones, urinary tract disorder, urine abnormality
- abortion
- breast swelling, difficulties getting an erection, fall down or slip out of the place of pelvic organs (pelvic prolapse), sustained erections, disorders of the prostate, abnormal PAP smear test (Smear Cervix Abnormal), testes disorder, vaginal bleeding, vaginal disorder
- cyst, hangover, low body temperature (hypothermia), non-specific inflammation, destruction of tissue at the injection site, problems with mucous membranes
- disorders after vaccination
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Glatiramer Acetate
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton (EXP). The expiry date refers to the last day of that month.
Store in a refrigerator (2?C – 8?C).
Glatiramer Acetate pre-filled syringes can be kept for up to one month outside the refrigerator between 15?C and 25?C. You can do this only once. After one month any Glatiramer Acetate pre-filled syringes that have not been used and are still in their original packaging must be returned to the refrigerator.
Do not freeze.
Keep the pre-filled syringes in the outer carton in order to protect from light.
Dispose of any syringes that contain particles.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Glatiramer Acetate contains
- The active substance is glatiramer acetate. 1 ml solution for injection (the contents of one pre-filled syringe) contains 20 mg glatiramer acetate, equivalent to 18 mg of glatiramer.
- The other ingredients are mannitol and water for injections.
What Glatiramer Acetate looks like and contents of the pack
Glatiramer Acetate Solution for injection in a pre-filled syringe is a clear solution, free of visible particles.
Each pre-filled syringe is packed separately in a PVC blister pack.
Glatiramer Acetate is available in packs containing 7, 28 or 20 pre-filled syringes of 1 ml solution for injection or in a multipack, of 90 pre-filled syringes comprising 3 cartons, each containing 30 pre-filled syringes of 1 ml of solution for injection.
Not all pack sizes may be marketed.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)