COPEMYLTRI 40 mg /Ml Инъекционный Раствор

Содержание инструкции

1. What Copemyltri is and what it is used for
2. What you need to know before you use Copemyltri
3. How to use Copemyltri
4. Possible side effects
5. How to store Copemyltri
6. Package contents and other information

Copemyltri 40 mg/ml injectable solution in pre-filled syringe
glatiramer acetate

Read this leaflet carefully before you usethis medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Copemyltri is and what it is used for
• 2. What you need to know before you use Copemyltri
• 3. How to use Copemyltri
• 4. Possible side effects
• 5. How to store Copemyltri
• 6. Contents of the pack and other information

1. What Copemyltri is and what it is used for

Copemyltri is a medicine, administered 3 times a week, that changes the way your body's immune system works (it is classified as an immunomodulatory agent). It is believed that the symptoms of multiple sclerosis (MS) are caused by a defect in the body's immune system. This produces outbreaks of inflammation in the brain and spinal cord.
Copemyltri is used to reduce the number of times you suffer from MS attacks (relapses).
No benefit has been demonstrated in the case where you have a form of MS that does not present, or hardly presents, relapses. Copemyltri may not have any effect on the duration of an MS attack or on the intensity of pain during an attack.

2. What you need to know before you use Copemyltri

Do not use Copemyltri

• if you are allergic to glatiramer acetate or any of the otheringredientsof this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Copemyltri

• if you have any problems with your kidneys or heartas you may need regular tests and check-ups.

Children
Copemyltri should not be used in children under 18 years of age.

Elderly
Copemyltri has not been specifically studied in the elderly. Ask your doctor for advice.

Other medicines and Copemyltri
Tell your doctor or pharmacistif you are taking, have recently taken or might
take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice and an assessment of treatment with
Copemyltri during pregnancy and/or breastfeeding.

Driving and using machines
The effect of Copemyltri on the ability to drive and use machines is unknown.

3. How to use Copemyltri

Use this medicine following the doctor's instructions exactly. If you have any doubts
consult your doctor or pharmacist.
The dose in adults is one pre-filled syringe (40 mg of glatiramer acetate), administered under the
skin (subcutaneously) three times a week, at intervals of at least 48 hours, for example on Monday,
Wednesday and Friday. It is recommended to administer the medicine on the same
days each week.
It is very important to inject Copemyltri correctly:

• Only into the tissue under the skin (subcutaneous tissue) (see “Instructions for Use” below).
• At the dose indicated by the doctor. Take only the dose prescribed by the doctor.
• Never use the same syringe more than once. Unused product or waste material must be disposed of.
• Do not mix or administer the contents of Copemyltri pre-filled syringes with any other product.
• Do not use the solution if it contains particles. Use a new syringe.

The first time you use Copemyltri you will be given complete instructions and will be assisted by
a doctor or nurse. They will be with you while you give yourself the injection
and for the next 30 minutes, to make sure you have no problems.

Instructions for Use
Read these instructions carefully before using Copemyltri.
Before the injection, make sure you have everything you need:

• A blister pack with a pre-filled syringe of Copemyltri
• A container for disposing of needles and syringes.
• For each injection, take only one blister pack with a pre-filled syringe from the package. Store all remaining syringes in the box.
• If the syringe has been stored in the refrigerator, take the blister pack containing the syringe out for at least 20 minutes before giving yourself the injection to warm it to room temperature.

Wash your hands carefully with water and soap.
If you wish to use the Copemyltri injection device to give the injection, refer to the
instructions for use provided with the Copemyltri injection device.
Choose the injection site using the diagrams in Figure 1.
There are seven possible injection areas on your body: arms, thighs, hips and
abdomen (stomach). Within each injection area there are several injection sites. Choose a different
injection site each day. This will reduce the likelihood of any irritation or pain
at the injection site. Rotate the injection sites within the same area. Do not use the
same site every time.
Note:do not inject into an area that is sore or discolored or into areas where you feel lumps
or nodules.
It is recommended to keep a schedule with the planned rotation of injection sites and
to note it in a diary. There are some areas of the body where it may be difficult
to give yourself an injection (such as the back of the arm). If you want to
use these areas, you may need help.

Figure 1
How to give yourself the injection

• Remove the syringe from its protective blister pack by removing the paper label.
• Remove the cap from the needle.
• Gently pinch the skin with the thumb and index finger of your free hand (Figure 2).
• Push the needle into the skin as shown in Figure 3.
• Inject the medicine by pushing the plunger down smoothly until the syringe is empty.
• Withdraw the syringe and needle straight out.
• Dispose of the syringe in a secure disposal container. Do not put the syringe in household waste, but carefully place it in a puncture-proof container as recommended by your doctor or nurse.

Figure 2 Figure 3
If you think that the effect of Copemyltri is too strong or too weak, consult your
doctor.

If you use more Copemyltri than you should
Tell your doctor immediately.

If you forget to use Copemyltri
Take it as soon as you remember or have the opportunity to use it ,then skip the next day.
Do not take a double dose to make up for a missed dose. If possible, return to your
normal dosing schedule the following week.

If you stop using Copemyltri
Do not stop using Copemyltri 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 everyone will experience them.

Allergic reactions (hypersensitivity)
You may develop an allergic reaction to this medicine, but this is not common.

Stop using Copemyltri and contactyour doctor immediately or go to the
nearest hospital emergency roomif you notice any of these
side effects:

• skin rash (red spots or hives)
• swelling of the eyelids, face or lips
• sudden shortness of breath (difficulty breathing)
• convulsions (seizures)
• fainting.

Other reactions following injection (immediate post-injection reaction)
Some people may experience one or more of the following symptoms within minutes
after the injection of glatiramer acetate. These usually do not cause problems and generally
disappear within half an hour.
However, if the following symptoms last more than 30 minutes, contactyour doctor
immediately or go to the nearest hospital emergency room:

• flushing (redness) of the chest or face (vasodilation)
• shortness of breath (dyspnea)
• chest pain
• pounding and rapid heartbeat (palpitations, tachycardia).

In general, the side effects reported by patients who used glatiramer acetate
40 mg/ml three times a week have also been reported by patients who used
glatiramer acetate 20 mg/ml. (see the following list).
The following side effects have been reported with glatiramer acetate:
Very common (may affect more than 1 in 10 people):

• infections, flu
• anxiety, depression
• headache
• nausea
• skin rashes
• joint or back pain
• feeling weak, skin reactions at the injection site, including redness, pain, blistering, itching, swelling of tissues, inflammation and hypersensitivity (these reactions at the injection site are not uncommon and usually decrease over time), nonspecific pain.

Common (may affect up to 1 in 10 people):

• respiratory tract infections, stomach flu, herpes, ear inflammation, runny nose, dental abscess, vaginal yeast infection
• non-cancerous skin growth (non-malignant skin neoplasm), tissue growth (neoplasm)
• swollen lymph nodes
• allergic reactions
• loss of appetite, weight gain
• nervousness
• altered taste, increased muscle stiffness, migraine, speech disorder, fainting, tremor
• double vision, eye disorders
• ear disorders
• cough, hay fever
• anal or rectal disorders, constipation, tooth decay, indigestion, difficulty swallowing, fecal incontinence, vomiting
• abnormal liver function tests
• bruising, excessive sweating, itching, skin changes, hives
• neck pain
• urgent need to empty the bladder, frequent urination, inability to empty the bladder properly
• chills, facial swelling, loss of tissue under the skin at the injection site, local reactions, peripheral edema caused by fluid accumulation, fever.

Uncommon (may affect up to 1 in 100 people):

• Abscess, skin and soft tissue inflammation, boils, Herpes

Shingles, kidney inflammation

• skin tumor
• increased white blood cell count, decreased white blood cell count, enlarged spleen, decreased platelet count, change in white blood cell shape
• enlarged thyroid, hyperactive thyroid
• low alcohol tolerance, gout, increased blood fat levels, increased blood sodium levels, decreased serum ferritin
• abnormal dreams, confusion, euphoric mood, seeing, hearing, smelling, tasting or perceiving things that are not there (hallucinations), aggressiveness, strangely elevated mood, personality disorders, attempted suicide
• numbness and pain in the hand (carpal tunnel syndrome), mental disorders, seizures, difficulty writing and reading, muscle disorders, difficulty moving, involuntary muscle contractions, nerve inflammation, abnormal neuro-muscular connection leading to abnormal muscle function, rapid involuntary eye movements, paralysis, foot drop (peroneal nerve paralysis), state of unconsciousness (stupor), blurred vision
• cataract, corneal eye injury, dry eye, eye bleeding, drooping upper eyelid, pupil dilation, weakening of the optic nerve leading to vision problems
• extrasystoles, slow heartbeat, episodic fast heartbeat
• varicose veins
• periodic cessation of breathing, nosebleeds, abnormally fast or deep breathing (hyperventilation), sensation of throat tightening, lung problems, inability to breathe due to throat narrowing (feeling of suffocation)
• intestinal inflammation, colon polyps, bowel inflammation, belching, esophageal ulcer, gum inflammation, rectal bleeding, enlarged salivary glands
• gallstones, enlarged liver
• skin and soft tissue swelling, contact dermatitis, red and painful skin nodules, skin nodules
• swelling, inflammation and pain in the joints (arthritis or osteoarthritis), inflammation and pain of the fluid cushion lining the joints (present in some joints), flank pain, decreased muscle mass
• blood in the urine, kidney stones, urinary tract disorders, altered urine
• abortion
• breast swelling, difficulty getting an erection, downward or outward displacement of pelvic organs (pelvic prolapse), prolonged erection, prostate disorders, abnormal Pap test (abnormal cervical smear), testicular disorders, vaginal bleeding, vaginal disorders
• cysts, hangover-like effects, low body temperature (hypothermia), nonspecific inflammation, tissue destruction at the injection site, mucosal problems
• disorders after vaccination.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system at “ www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa ”.
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Copemyltri

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C).
The pre-filled syringes of Copemyltri can be kept out of the refrigerator at a
temperature between 15°C and 22°C for one month. This can be done only once. After one
month, the pre-filled syringes of Copemyltri that have not been used and are still in their
original packaging must be placed in the refrigerator.
Do not freeze.
Keep the pre-filled syringes in the outer packaging to protect the medicine from
light.
Do not use this medicine after the expiry date which is stated on the label and
on the carton (Exp.). The expiry date refers to the last day of that month.
Discard any syringe that contains particles.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package contents and other information

What Copemyltri contains

• The active ingredient is glatiramer acetate. 1 ml of injection solution (the content of a pre-filled syringe) contains 40 mg of glatiramer acetate.
• The excipients are mannitol and water for injectable preparations.

Description of the appearance of Copemyltri and contents of thepack
Copemyltri injectable solution in a pre-filled syringe is a sterile, clear solution, from
colorless to slightly yellowish/brownish, free from visible particles.
Throw away the syringe if it contains particles and start again. Use a new syringe.
3 pre-filled syringes,
12 pre-filled syringes
36 (3x12) pre-filled syringes.
Not all pack sizes may be marketed.

Marketing authorisation holderand manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan (Italy)

Manufacturer
Synthon Hispania, S.L.C/ Castelló no1, Pol. Las Salinas, Sant Boi de Llobregat Barcelona 08830
Spain.
Synthon BV Microweg 22 Nijmegen 6545 CM Netherlands

This medicinal product is authorised in the Member States of the European Economic Area
with the designation.
Belgium: Glatiramyl 40 mg/ml, solution for injection in a pre-filled syringe
Denmark: Copemyl
Finland: Glatimyl 40 mg/ml injection solution, solution, pre-filled syringe
France: Glatiramer Mylan 40 mg/ml, solution injectable en seringue préremplie
Germany: CLIFT 40 mg/ml Injection solution in a pre-filled syringe
Greece: Glatiramer / Mylan 40 mg/ml solution for injection, pre-filled syringe
England: Brabio 40 mg/ml solution for injection, pre-filled syringe
Ireland: Brabio 40 mg/ml solution for injection, pre-filled syringe
Italy: COPEMYLTRI
Norway: Copemyl 40 mg/ml injection fluid, solution in pre-filled syringe
Netherlands: Glatirameeracetaat Mylan 40 mg/ml, solution for injection in a pre-filled syringe
Spain: Glatiramero Mylan 40 mg/ml solución inyectable en jeringa precargada
Sweden: Glatimyl 40 mg/ml injection fluid, solution, pre-filled syringe