Copaxone 40mg/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:

TEVA GmbH

ATC kanuni:

L03AX; L03AX13

INN (Jina la Kimataifa):

Glatiramer acetate

Kipimo:

40 milligram(s)/millilitre

Dawa fomu:

Solution for injection in pre-filled syringe

Dawa ya aina:

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

Eneo la matibabu:

Other immunostimulants; glatiramer acetate

Idhini hali ya:

Marketed

Idhini ya tarehe:

2015-01-09

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
COPAXONE 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 Copaxone is and what it is used for
2.
What you need to know before you use Copaxone
3.
How to use Copaxone
4.
Possible side effects
5.
How to store Copaxone
6.
Contents of the pack and other information
1.
WHAT COPAXONE IS AND WHAT IT IS USED FOR
Copaxone 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 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.
Copaxone 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.
Copaxone 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 COPAXONE
DO NOT USE COPAXONE
•
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 Copaxone, if you have
any kidney or heart problems as
you may need to have regular tests and check-ups.
Talk to your doctor or pharmacist before using Copax

Tabia za bidhaa

Health Products Regulatory Authority
05 April 2022
CRN00CQ6F
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Copaxone 40mg/ml solution for injection in pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pre-filled syringe (1 ml) of solution for injection contains 40 mg
glatiramer acetate*, equivalent to 36 mg of glatiramer.
* 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 in pre-filled syringe.
Clear solution free of 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
Copaxone 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). Copaxone
is not indicated in primary or secondary progressive MS.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The initiation of Copaxone 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
individual basis by the treating physician.
_Renal impair