Glatirameeracetaat Zentiva 40 mg/ml, oplossing voor injectie in een voorgevulde spuit

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

GLATIRAMEERACETAAT 40 mg/ml SAMENSTELLING overeenkomend met ; GLATIRAMEER 36 mg/ml

Beschikbaar vanaf:

Alvogen IPCo S.ar.l 5, rue Heienhaff 1736 SENNINGERBERG (LUXEMBURG)

ATC-code:

L03AX13

INN (Algemene Internationale Benaming):

GLATIRAMEERACETAAT 40 mg/ml SAMENSTELLING overeenkomend met ; GLATIRAMEER 36 mg/ml

farmaceutische vorm:

Oplossing voor injectie

Samenstelling:

MANNITOL (D-) (E 421) ; WATER VOOR INJECTIE,

Toedieningsweg:

Subcutaan gebruik

Therapeutisch gebied:

Glatiramer Acetate

Product samenvatting:

Hulpstoffen: MANNITOL (D-) (E 421); WATER VOOR INJECTIE;

Autorisatie datum:

2017-11-02

Bijsluiter

Glatiramer NL/H/3778/001
06/2022 orig.
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLATIRAMEERACETAAT ZENTIVA 40 MG/ML, OPLOSSING VOOR INJECTIE IN EEN
VOORGEVULDE SPUIT
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 Glatirameeracetaat Zentiva is and what it is used for
2.
What you need to know before you use Glatirameeracetaat Zentiva
3.
How to use Glatirameeracetaat Zentiva
4.
Possible side effects
5.
How to store Glatirameeracetaat Zentiva
6.
Contents of the pack and other information
1.
WHAT GLATIRAMEERACETAAT ZENTIVA IS AND WHAT IT IS USED FOR
Glatirameeracetaat Zentiva 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.
Glatirameeracetaat Zentiva 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. Glatirameeracetaat Zentiva 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 GLATIRAMEERACETAAT ZENTIVA
DO NOT USE GLATIRAMEERACETAAT ZENTIVA
-
If you are
ALLERGIC TO GLATIRAMER ACETATE OR ANY OF THE OTHER INGREDIENTS
of this medicine (listed in
section 6).

Productkenmerken

Glatiramer NL/H/3778/001
06/2022 orig.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Glatirameeracetaat Zentiva 40 mg/ml, oplossing voor injectie in een
voorgevulde spuit
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 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