COPAXONE 20 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GLATIRAMER ACETATE

Available from:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC code:

L03AX13

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

GLATIRAMER ACETATE 20 MG/DOSE

Administration route:

S.C

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

GLATIRAMER ACETATE

Therapeutic area:

GLATIRAMER ACETATE

Therapeutic indications:

For reducing the frequency of relapses in pateints with relapsing-remitting multiple sclerosis. Copaxone is indicated for the treatment of patients who have experienced a well defined first clinical episode and are determined to be at high risk of developing clinically definite multiple sclerosis (CDMS). These patients should have MRI findings which are compatible with the diagnosis of multiple sclerosis.

Authorization date:

2013-03-31

Patient Information leaflet

Patient leaflet in accordance with the Pharmacists’ Regulations
(Preparations) – 1986
This medicine is dispensed with a doctor’s prescription only
COPAXONE
®
20 mg/ml
Solution in pre-filled syringe
For subcutaneous injection only
Composition
Each Copaxone 20 mg/ml syringe (1 ml) contains:
glatiramer acetate 20 mg
For information on inactive ingredients, see section 6 “Additional
information”.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor
or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their medical condition is
similar to yours.
This medicine is intended for subcutaneous injection only.
This medicine is not intended for use in children or adolescents below
18 years of age.
1. What is this medicine intended for?
Copaxone 20 mg/ml modifies the way in which your body’s immune
system works. The symptoms
of multiple sclerosis are thought to be caused by a defect in the
body’s immune system. This
produces areas of inflammation in the brain and spinal cord.
Copaxone 20 mg/ml is indicated for reducing the frequency of relapses
in patients with relapsing-
remitting multiple sclerosis.
Copaxone 20 mg/ml is indicated for the treatment of patients after a
first clinical episode that
indicates a high risk of developing multiple sclerosis.
Therapeutic group:
Immune system stimulant.
2. Before using this medicine
Do not use this medicine if:
•
you are sensitive (allergic) to the active ingredient (glatiramer
acetate) or to any of the
additional ingredients contained in the medicine (see section 6 –
“Additional information” in
this leaflet).
Special warnings about using this medicine
Before starting treatment, inform the doctor or pharmacist if:
•
you suffer from kidney or heart problems, since regular testing and
monitoring may be
necessary.
•
you suffer from or

Summary of Product characteristics

COPAXONE 20mg/ml_solution for injection RC SmpC 062023 Notification
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
COPAXONE
®
20mg/ml solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pre-filled syringe (1 ml) of solution for injection contains 20 mg
glatiramer acetate*,
equivalent to 18 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
characterized including in terms
of amino acid sequence, although the final glatiramer acetate
composition is not entirely random.
For 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 265 mOsmol/L.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
Copaxone is indicated for reducing the frequency of relapses in
patients with relapsing-remitting
multiple sclerosis.
Copaxone is indicated for the treatment of patients who have
experienced a well-defined first
clinical episode and are determined to be at high risk of developing
clinically definite multiple
sclerosis (CDMS). These patients should have MRI findings which are
compatible with the
diagnosis of multiple sclerosis.
COPAXONE 20mg/ml_solution for injection RC SmpC 062023 Notification
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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 20 mg of glatiramer acetate (one
pre-filled syringe),
administered as a subcutaneous injecti