BRABIO

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GLATIRAMER ACETATE

Available from:

Generics (UK) Limited

ATC code:

L03AX13

INN (International Name):

GLATIRAMER ACETATE

Dosage:

40 Mg/Ml

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

glatiramer acetate

Authorization status:

Marketed

Authorization date:

2017-11-24

Patient Information leaflet

Colours
Non-Print
Colours
Date:
Time:
Equate CMYK
with
Dimensions
Main Font
Body Text Size
Min Text Size used
Page Count
No. of colours
Pharma Code
SAP No.
Vendor Job No.
Trackwise Proof No.
Client Market
Keyline/Drawing No
.
Barcode Info
Description
Component Type
Affiliate Item Code
Superceded Affiliate Item Code
TrackWise PR No.
MA No.
Packing Site/Printer
Supplier Code
Sign-offs
Myriad Pro
10.5 pt
10.5 pt
Brabio_40mg_ml_12
Leaflet
1291656
N/A
1291656
PL 04569/1756
PA0405/101/001
Synthon Chile Ltda
(Santiago - CL)
TBC
N/A
N/A
500223
3
Ireland;
United Kingdom
9047_lf_160x560_v1
N/A
22 Sep 17
16:38
1
160 x 560 mm
Black
1 / 2
3D Render ID
N/A
v3/Jul 2017
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRABIO 40 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,
administered 3 times a week, 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 b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brabio 40 mg/ml solution for injection, pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains 40 mg glatiramer acetate*,
equivalent to 36 mg of glatiramer base per pre-filled
syringe.
* Glatiramer acetate is the acetate salt of synthetic polypeptides,
containing four naturally occurring amino acids: L-
glutamic acid, L-alanine, L tyrosine and L-lysine, in molar fraction
ranges of 0.129-0.153, 0.392-0.462, 0.086-0.100
and 0.300-0.374, respectively. The average molecular weight of
glatiramer acetate is in the range of 5,000-9,000
daltons.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection, pre-filled syringe [Solution for injection]
Clear colourless to slightly yellow/brownish solution free from
visible particles.
The solution for injection has a pH of 5.5 - 7.0 and an osmolarity of
about 300 mOsmol/L.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glatiramer acetate is indicated for the treatment of relapsing forms
of multiple sclerosis (MS) (see section 5.1 for
important information on the population for which efficacy has been
established).
Glatiramer acetate is not indicated in primary or secondary
progressive MS.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The recommended dosage in adults is 40 mg of glatiramer acetate (one
pre-filled syringe), administered as a
subcutaneous injection three times a week with at least 48 hours
apart.
At the present time, it is not known for how long the patient should
be treated.
A decision concerning long term treatment should be made on an
individual basis by the treating physician.
_Paediatric population_
Children and adolescents: No clinical trials or pharmacokinetic
studies have been conducted in children or adolescents
for glatiramer acetate. There is not enough information available on
the use of glatiramer acetate 40 mg/ml TIW in
children and adolescents below 18 years of age to make any
recommendatio