Brabio 40 mg/ml solution for injection in pre-filled syringe

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Glatiramer acetate

Inapatikana kutoka:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC kanuni:

L03AX; L03AX13

INN (Jina la Kimataifa):

Glatiramer acetate

Kipimo:

40 milligram(s)/millilitre

Dawa fomu:

Solution for injection in pre-filled syringe

Eneo la matibabu:

Other immunostimulants; glatiramer acetate

Idhini hali ya:

Marketed

Idhini ya tarehe:

2017-11-24

Taarifa za kipeperushi

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRABIO 40 MG/ML SOLUTION FOR INJECTION IN 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 medicine used for the treatment of relapsing forms of
multiple sclerosis (MS). It modifies the way in
which your body's immune system works and 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.
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.
•
if you have or have had any
LIVE

Tabia za bidhaa

Health Products Regulatory Authority
22 August 2022
CRN00CQZ4
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brabio 40 mg/ml solution for injection in 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.
Due to its compositional complexity, no specific polypeptide can be
fully characterised, including in terms of amino acid
sequence, although the final glatiramer acetate composition is not
entirely random.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
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
The initiation of glatiramer acetate treatment should be supervised by
a neurologist or a physician experienced in the
treatment of MS.
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
ind