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BRABIO 20MG/ML SOLUTION FOR INJECTION PRE-FILLED SYRINGE

Active substance(s): GLATIRAMER ACETATE / GLATIRAMER ACETATE / GLATIRAMER ACETATE

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Package leaflet: Information for the user

Brabio 20 mg/ml
solution for injection,
pre-filled syringe
(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 Brabio is and what it is used for
2. What you need to know before you
use Brabio
3. How to use Brabio
4. Possible side effects
5. How to store Brabio
6. Contents of the pack and other
information

• do not mix or co-administer the
content of Brabio pre-filled syringes
with any product
• if the solution contains particles, do
not use it. Use a new syringe.
The first time you use Brabio 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 Brabio.
Before the injection, make sure you have
everything you need:
• one blister with one Brabio 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.

1. What Brabio is and what it is If you wish to use the Brabio injection
used for
device to make your injection, please
Brabio is a medicinal product which
modifies the way in which your body's
immune system works (it is classed as
an immunomodulating agent). The
symptoms of multiple sclerosis (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.
Brabio 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.
Brabio 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.
Brabio 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.

refer to the instructions for use provided
with the Brabio injection device.
Choose the injection site, using the
diagrams in Figure 1.
There are seven possible areas on your
body for injection: arms, thighs, hips and
stomach (belly). 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 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 arm). If you want to use these, you
may require assistance.

2. What you need to know before
you use Brabio
Do not use Brabio:
• 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 Brabio:
• if you have any kidney or heart
problems as you may need to have
regular tests and check-ups.
Children
Brabio is not to be used in children
below the age of 12 years.
Elderly
Brabio has not been specifically studied
in the elderly. Please ask your doctor for
advice.
Other medicines and Brabio
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 or pharmacist for advice
and consideration regarding Brabio
treatment during pregnancy and/or
lactation.
Driving and using machines
Brabio is not known to influence the
ability to drive or operate machinery.

Figure 1
How to inject:
• remove the syringe from its protective
blister by peeling back the paper label
• remove the shield from the needle
• gently pinch up the skin with the
thumb and forefinger of the free hand
(Figure 2)
• push the needle into the skin as
shown in Figure 3
• 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

3. How to use Brabio
Always use this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.
The 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 Brabio
properly:
• into the tissue under the skin
(subcutaneous tissue) only (see
"Instructions for Use" below)
• at the dose instructed by your doctor.
Take only the dose prescribed by your
doctor
• never use the same syringe more than
once. Any unused product or waste
must be discarded

Figure 2

Figure 3

If you have the impression that the effect
of Brabio is too strong or too weak, talk
to your doctor.
If you use more Brabio than you
should
Talk to your doctor immediately.
If you forget to use Brabio
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 Brabio
Do not stop using Brabio 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 Brabio 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
Brabio. 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)
• chestpain
• pounding and rapid heartbeat
(palpitations, tachycardia).
The following side effects have been
reported with Brabio:
Very common side effects (may affect
more than 1 in 10 people):
Infections, 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 skin, pain, 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 side effects (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, 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 injection site, local reaction,
peripheral swelling due to build-up of
fluid, fever
Uncommon side effects (may effect up
to 1 in 100 people):
Abscess, inflammation of skin and the
soft tissue underneath, boils, shingles,
inflammation of 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 •
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, abnormal
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,
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 heart beats, slow heart

beats, episodic fast heart beats • varicose
vein • periodic stops in breathing, nose
bleeding, abnormally fast or deep
breathing (hyperventilation), tight
feeling in the throat, lung disorder,
inability to breath 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 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 via the Yellow Card Scheme, at
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety
of this medicine.

5. How to store Brabio
Keep this medicine out of the sight and
reach of children.
Store in a refrigerator (2°C - 8°C).
Brabio 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
Brabio 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.
Do not use this medicine after the expiry
date which is stated on the label and
carton after ‘EXP’. The first two digits
indicate the month and the last four
digits indicate the year. The expiry date
refers to the last day of that month.
Dispose of any syringes that contain
particles.
Do not throw away any medicine
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 Brabio contains
• The active substance is glatiramer
acetate. 1 ml solution for injection
(the contents of one pre-filled syringe)
contains 20 mg glatiramer acetate.
• The other excipients are mannitol and
water for injections.
What Brabio looks like and contents
of the pack
Brabio solution for injection in pre-filled
syringe is a sterile, clear colourless to
slightly yellow/brownish solution.
If the solution contains particles, throw it
away and start again. Use a new syringe.
7 pre-filled syringes
28 pre-filled syringes
30 pre-filled syringes
90 (3x30) pre-filled syringes
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Mylan,
Potters Bar,
Hertfordshire,
EN6 1TL,
UK.
Manufacturer(s):
Synthon Hispania SL
Castelló 1, Poligono Las Salinas,
08830 Sant Boi de Llobregat, Spain
Synthon BV
Microweg 22, 6545 CM Nijmegen,
The Netherlands
This leaflet was last revised in 07/2017
1218676

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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