Skip to Content

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

Active substance(s): GLATIRAMER ACETATE

View full screen / Print PDF » Download PDF ⇩
Transcript
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

1. What Brabio is and what it is
used for
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.

· 
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.
If you wish to use the Brabio injection
device to make your injection, please 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).
· 
If you are pregnant.
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
Do not use Brabio if you are pregnant.
You should use effective birth-control (e.g.
the 'pill' or condoms) to avoid pregnancy
during the treatment with Brabio.
In case you would like to breast-feed while
using Brabio, please discuss this first with
your doctor.
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 before taking this
medicine.
Driving and using machines
Brabio is not known to influence the ability
to drive or operate machinery.

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 prefilled 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 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.


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), nonspecific 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),
inflammmation 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:
Synthon BV
Microweg 22, 6545 CM Nijmegen,
The Netherlands
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 03/2016

822685

Expand view ⇕

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.

Hide