COPAXONE 20 mg . ml. 1 ml. 28 . filled syringes
COPAXONE 20 mg . / ml. 1 ml. 28 . filled syringes
WHAT Copaxone 20 mg / ml INJECTION AND WHAT IT IS USED
Copaxone 20 mg / ml solution for injection is a product that changes the way your immune system works ( classed as an immunomodulatory drug) . It is believed that the symptoms of multiple sclerosis (MS ) is caused by a defect in the immune defense system . This causes an inflammatory plaques in the brain and spinal cord . Copaxone 20 mg / ml solution for injection is used to reduce the number of relapses of MS ( relapse ) . It is not proven that it helps if you have a form of MS that does not occur with recurrence ( relapse ) or have single attacks. Copaxone 20 mg / ml solution for injection may not have any effect on the duration of relapses of MS or on the severity of the attack .
It is used to treat patients who can not move on their own.
Copaxone 20 mg / ml injection solution can also be used in patients who had received the first clinical symptoms suggestive of a high risk of developing MS . Your doctor will determine whether there are other reasons that could explain these symptoms before starting treatment.
2 . Prior to administering Copaxone 20 mg / ml INJECTION
Do not apply Copaxone 20 mg / ml solution for injection :
If you are allergic (hypersensitive) to the active substance glatiramerov acetate or any of the excipients of Copaxone 20 mg / ml solution for injection
If you are pregnant .
Take special care with Copaxone 20 mg / ml
Ask your doctor for advice if you have any kidney problems or heart problems, as you may need regular tests and checks.
Children: Copaxone 20 mg / ml solution for injection should not be used in children under 12 years of age.
Elderly : Copaxone 20 mg / ml solution for injection has not been specifically studied in the elderly . Please ask your doctor for advice.
Using other medicines
Please tell your doctor or pharmacist if you are taking now or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and lactation
Ask your doctor or pharmacist for advice before taking any medicine. Do not use Copaxone 20 mg / ml solution for injection if you are pregnant . Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
Need to use effective methods of birth control during treatment with Copaxone 20 mg / ml solution for injection .
If you wish to breast-feed while taking this medicine , consult your doctor.
Driving and using machines
It is not known Copaxone 20 mg / ml solution for injection can affect the ability to drive and use machines.
3 . How to use Copaxone 20 mg / ml INJECTION
Always use Copaxone 20 mg / ml solution for injection exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
The daily dose in adults and adolescents over 12 years of age 1 pre-filled syringe ( 20 mg glatiramerov acetate) administered under the skin ( subcutaneously).
It is very important Copaxone 20 mg / ml solution for injection to be injected properly:
In the subcutaneous tissue just under the skin ( see " Instructions for Use " below ) ;
In the dose prescribed by your doctor. Use only the dose recommended by your doctor ;
Never use a syringe more than once. Any unused product or waste it must be destroyed ;
Contents of the syringe Copaxone 20 mg / ml solution for injection should not be mixed or administered with any other medicinal product ;
Do not use Copaxone 20 mg / ml solution for injection , if the solution contains particles . Use a different syringe.
When used for the first time Copaxone 20 mg / ml solution for injection should give you full instructions and you should be seen by a doctor or nurse. They will be with you while you inject yourself , and then half an hour just to be sure that you will not have any problems.
Instructions for use
Read these instructions carefully before using Copaxone 20 mg / ml solution for injection , prefilled syringe.
Before you inject , make sure that you have everything you need :
One blister with a pre-filled syringe Copaxone 20 mg / ml solution for injection .
Waste disposal of used needles and syringes.
For each injection take only one blister Copaxone 20 mg / ml solution for injection , prefilled syringe entire contents. Keep all unused syringes left in the box.
If the syringe was stored under refrigeration, allow the blister with the syringe inside at room temperature for at least 20 minutes prior to injection to ensure that the solution is warmed to room temperature.
Wash hands thoroughly with soap and water.
Select the injection site.
There are seven possible areas on your body where you inject : arms, thighs, buttocks and abdomen. Within each site of injection has several injection sites. Choose a different location for the injection every day. This will reduce the possibilities of any inflammation or pain at the injection site . Rotate injection sites within an injection area . Do not use the exact same spot every time!
Caution : do not use any area that is painful or discolored or where you feel hard knots or lumps .
Recommended to have a planned rotation of injection sites and keep a note of this journal . There are some places on your body , which can be difficult to inject themselves ( like the back of your arm) and you can get help.
Area 1: , stomach area, do not use the circle covering about 5 cm around the navel ;
Area 2 : Right thigh front , about 5 inches above the knee and 5 cm below the groin ;
Area 3 : Left thigh front , about 5 inches above the knee and 5 cm below the groin ;
Area 4 : Left hand (left arm ) rear upper flesh ;
Area 5 : Right hand (right arm ) rear upper flesh ;
Area 6 : Left hip , flesh on the upper flank , always under ( below) from the cross ;
Region 7 : Right hip ; flesh of the upper hip , always under ( below) from the cross.
How to apply:
Remove the syringe from its protective blister pack by peeling back paper label ;
Remove the protective cap from the needle ;
Gently pinch the skin between the thumb and forefinger of the free hand ;
Insert the needle into the skin ;
Inject evenly by pushing the plunger all the way down until the syringe is empty ;
Pull the syringe and needle straight out ;
Discard the needle and syringe in a safety container for disposal. Do not put used syringes into a municipal waste and dispose of them carefully in a puncture-resistant container , as recommended by your doctor or nurse.
If you have the impression that the effect of Copaxone 20 mg / ml solution for injection is too strong or too weak for you, please tell your doctor.
If you use more Copaxone 20 mg / ml solution for injection than you should, tell your doctor immediately.
If you forget to use Copaxone 20 mg / ml solution for injection , insert injection as soon as you remember, but never take a double dose to make up for a missed dose. Put your next dose 24 hours later.
If you stop using Copaxone 20 mg / ml solution for injection
Do not stop the use of Copaxone 20 mg / ml solution for injection without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
As with all medications , Copaxone 20 mg / ml injection solution can cause side effects, although not everyone gets them.
Allergic reactions ( hypersensitivity)
Rarely develop serious allergic reaction to this medicine.
Stop using Copaxone 20 mg / ml solution for injection and immediately call your doctor or go to the nearest emergency center if you notice any of the manifestations of these side effects:
Rash ( red spots or rash hives) ;
Swelling of eyelids, face or lips ;
Sudden wheezing and wheeze ;
Convulsions ( seizures) ;
Other reactions after administration ( immediate post- injection reactions)
Some people may, within a few minutes after the injection of Copaxone 20 mg / ml solution for injection to obtain one or more times following symptoms. They usually do not cause any problems and disappear within half an hour.
However, if these symptoms continue for more than 30 minutes , immediately call your doctor or go to the nearest emergency room .
Appearance of redness on the chest or face ;
A feeling of tightness in the chest ;
shortness of breath ;
Heartbeat ( palpitations) .
When administering Copaxone have been reported following side effects:
Very common (more than 1 in 10 patients):
Skin reactions at the application site . These include flushing, pain , forming circles , itching, swelling of the tissues inflammation and hypersensitivity reaction at the site of administration. These injection site reactions are uncommon and normally decrease over time.
Additionally included are other very common side effects:
Gastrointestinal disorders : nausea ;
General disorders : weakness, chest pain, nonspecific pain;
Infections: infections , flu ;
Disorders of the musculoskeletal system : pain in the joints or back ;
Nervous system disorders : headache ;
Psychiatric disorders: anxiety, depression ;
Skin : skin rash.
Common ( affects less than 1 in 10 but more than 1 in 100 patients):
Blood : enlarged lymph nodes;
Cardiac disorders: fast heartbeat , fast and feels heartbeat ( palpitations ) ;
Ear : hearing problems .
Eye disorders : impaired vision , double vision ;
Gastrointestinal disorders: constipation, tooth sensitivity , indigestion , difficulty swallowing, incontinence of bowel contents, vomiting ;
General: chills, local reactions , fluid retention , swollen ankles , face edema , fever , loss of subcutaneous tissue at the injection site ;
Immune system disorders : allergic reactions;
Infections: respiratory system , stomach, ear , runny nose , sore throat, tooth abscess, vaginal discharge ;
Liver disorders : abnormal liver function tests ;
Metabolic disorders : weight gain , loss of appetite ;
Musculoskeletal disorders: neck pain ;
Neoplasms benign, malignant : expansion of the skin and tissue ;
Nervous system disorders : taste perversion , altered tone of the arteries and muscles , migraine, speech disorders , seizures , tremors ;
Psychiatric disorders: anxiety ;
Renal impairment : inability to empty the bladder, urgent urination , frequent urination ;
Respiratory disorders: cough, hay fever ;
Skin disorders : bruising, excessive sweating , itching , hives and other skin problems.
Uncommon ( affects less than 1 in 100 patients but more than 1 in 1000 patients):
Blood : change in the number or form of white blood cells, low platelet count , enlarged spleen ;
Cardiac disorders: extrasystoles , slow or fast heartbeat ;
Endocrine disorders: full or an overactive thyroid ;
Eye disorders : cataract, scratches on the eyeball , dry eyes, eye hemorrhage , droopy eyelid , dilated pupils, altered vision or blindness ;
Gastrointestinal Disorders: inflammatory bowel disease, colonic polyps , ulcers in the intestines , gingivitis , bleeding from the rectum , large salivary glands ;
General: cysts hangover feeling lower than normal body temperature ( hypothermia ) , non-specific inflammation , tissue destruction at the site of injection, the problems with the mucous membranes ;
Infections: abscesses , boils , skin infections or kidney shingles ;
Injury or poisoning : fatigue after vaccination ;
Hepatic impairment : cholelithiasis , enlarged liver ;
Metabolic disorders , low alcohol tolerance , gout, increased levels of fat in the blood ( hyperlipidemia ), changes in some blood parameters ( increased sodium , decreased firitin ) ;
Musculoskeletal : swollen joints ( arthritis or osteoarthritis ) , decreased muscle mass;
Neoplasms, benign or malignant : skin cancer
Nervous System: tingling and pain in the arms , psychiatric disorders , seizures (convulsions ) , impaired ability to speak and write , muscle spasms , abnormal muscle tone , inflammation of the peripheral nerves , muscle weakness , paralysis, eye problems , "falling foot " state of unconsciousness ( stupor ) , spots in the visual field ;
Conditions associated with pregnancy : abortion;
Psychiatric disorders: abnormal dreams , confusion, unusual happy state or increased activity , seeing or hearing things , aggression, personality changes , suicide attempts ;
Renal impairment : blood in the urine or other urination problems , kidney stones ;
Reproductive system : swelling of the mammary glands , increased erection difficulty getting an erection , prolapse, vaginal problems , prostate or testicular cancer , vaginal bleeding , abnormal Pap smear ;
Respiratory disorders : lung problems , a feeling of tightness in the throat , inability to breath , unusually fast or deep breathing ( hyperventilation ) , bleeding from the nose ;
Skin disorders : edema capillaries rash after contact , skin lumps , painful red nodules on the skin ;
Vascular disorders: varicose veins.
Rare (between 1 and 10 in every 10,000 patients) and very rare (less than 1 in 10,000 patients):
Severe allergic reactions.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5 . HOW TO STORE Copaxone 20 mg / ml INJECTION
Keep out of the reach of children. Store in a refrigerator (2 ° C to 8 ° C).
Packages of Copaxone 20 mg / ml solution for injection pre -filled syringe can be stored outside the refrigerator, at room temperature for no longer than 1 month. After the two month period , Copaxone 20 mg / ml solution for injection pre -filled syringes that have not been used and are stored in the original container is to be stored in a refrigerator ( at 2 ° C to 8 ° C ) .
Do not freeze .
Store in the original package to protect from light.
Do not use Copaxone 20 mg / ml solution for injection after the expiry date stated on the
carton. The expiry date refers to the last day of that month.
Throw away any syringe containing particles.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . ADDITIONAL INFORMATION
What does Copaxone 20 mg / ml solution for injection
The active substance is glatiramerov acetate . 1 ml of solution for injection ( content of one pre-filled syringe) contains 20 mg glatiramerov acetate .
The other ingredients are mannitol, water for injections.
Looks like Copaxone 20 mg / ml solution for injection and contents of the pack
Copaxone 20 mg / ml solution for injection is a sterile clear solution without particles . The package contains 7 or 28 pre-filled syringes , each containing 1 ml Copaxone .
Not all pack sizes may be marketed.
If the solution contains particles discard it and start again . Use a different syringe.
Manufacturer of this product is:
Teva Pharmaceuticals Europe BV, Netherlands