COPAXONE PEN glatiramer acetate 40 mg/1 mL solution for injection prefilled pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glatiramer acetate, Quantity: 40 mg

Available from:

Teva Pharma Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: mannitol; water for injections

Administration route:

Subcutaneous

Units in package:

36 pre-filled pens (multi pack 3 x 12), 12 single pre-filled pens, 3 pre-filled pens

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Copaxone is indicated for the: 1- Reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis. 2-Treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent MRI lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

Product summary:

Visual Identification: A clear, colourless solution for injection, essentially free of visible particles.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-04-17

Patient Information leaflet

COPAXONE PEN
®
_40 MG/ML_
_glatiramer acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Copaxone Pen 40
mg/mL.
Copaxone Pen is a single use, fixed
dose device that contains a pre-filled
syringe of Copaxone 40 mg/mL. This
device will assist in the
administration of Copaxone.
It does not contain all the available
information. It does not take the
place of talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT COPAXONE PEN
40MG/ML IS USED FOR
Copaxone Pen 40 mg/mL is used for
the management of relapsing forms
of Multiple Sclerosis (MS).
Copaxone Pen may also be used in
patients who, for the first time, have
experienced symptoms and have
MRI changes that indicate a high risk
for development of MS. Your doctor
will rule out any other reasons which
could explain these symptoms before
you are treated.
The cause of MS is not yet known.
MS affects the brain and spinal cord.
In MS, the body’s immune system
reacts against its own myelin (the
‘insulation’ surrounding nerve
fibres). In relapsing forms of MS,
people can have ‘exacerbations’ from
time to time (e.g. blurred vision,
weakness in the legs or arms, or loss
of control of bowel or bladder
function). These are followed by
periods of recovery.
Although the exact mechanism of
how Copaxone works in MS is
unknown, it is thought that Copaxone
works by changing the immune
processes that are believed to be
responsible for the disease.
Copaxone has been shown to be
effective in reducing the number of
relapses in patients with relapsing
remitting MS. Although it is not a
cure, patients treated with Copaxone
generally find that they will
experience fewer relapses.
Your doctor, however, may prescribe
Copaxone Pen 40mg/

Summary of Product characteristics

Teva Pharma Australia Pty Limited Version 3.0 1
AUSTRALIAN PI – COPAXONE PEN
® (GLATIRAMER ACETATE) SOLUTION
FOR INJECTION IN A PRE-FILLED PEN
1
NAME OF THE MEDICINE
Glatiramer acetate.
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 pen.
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 with
an average molar fraction 0.141,
0.427, 0.095 and 0.338, respectively.
For the full list of excipients, see Section 6.1 “List of
excipients”.
3
PHARMACEUTICAL FORM
COPAXONE PEN® contains Copaxone as a clear, colourless solution for
injection, in a pre-filled pen.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Reduction of the frequency of relapses in patients with Relapsing
Remitting Multiple Sclerosis.
Treatment of patients with a single clinical event suggestive of
multiple sclerosis and at least two
clinically silent MRI lesions characteristic of multiple sclerosis, if
alternative diagnoses have been
excluded.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The only recommended route of administration of Copaxone injection is
by the subcutaneous route.
Copaxone should not be administered by the intravenous or
intramuscular routes.
The recommended dosage in adults is 40mg of Copaxone (one pre-filled
pen), administered as one
subcutaneous injection of 1 mL Copaxone 40 mg administered three times
a week and at least 48
hours apart. This corresponds to one Copaxone 40 mg/mL pre-filled
syringe per administration.
METHOD OF ADMINISTRATION
Sites for self-injection include arms, abdomen, hips and thighs. A
different site for injection should be
used each day in order to reduce the likelihood of local irritation or
pain as a result of the injection.
Patients should be instructed in self-injection techniques to assure
the safe administration of
Copaxone when using the pre-filled pen (see package inse