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

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

glatiramer acetate, Quantity: 40 mg

Saatavilla:

Teva Pharma Australia Pty Ltd

INN (Kansainvälinen yleisnimi):

Glatiramer acetate

Lääkemuoto:

Injection, solution

Koostumus:

Excipient Ingredients: mannitol; water for injections

Antoreitti:

Subcutaneous

Kpl paketissa:

12 single pre-filled syringes

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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.

Tuoteyhteenveto:

Visual Identification: A clear, colourless solution for injection, essentially free of visible particles.; Container Type: Syringe; 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

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2015-02-25

Pakkausseloste

COPAXONE
® 40 MG/ML
_glatiramer acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Copaxone 40 mg/
mL. 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 40
MG/ML IS USED FOR
Copaxone 40 mg/mL is used for the
management of relapsing forms of
Multiple Sclerosis (MS).
Copaxone 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
40mg/mL generally find that they
will experience fewer relapses.
Your doctor, however, may prescribe
Copaxone for another purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available with
a doctor’s prescription.
BE

Valmisteyhteenveto

Teva Pharma Australia Pty Limited Version 4.0 1
AUSTRALIAN PI – COPAXONE
® (GLATIRAMER ACETATE) SOLUTION
FOR INJECTION
1
NAME OF THE MEDICINE
Glatiramer acetate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Copaxone 20 mg/mL contains 20 mg of glatiramer acetate.
Copaxone 40 mg/mL contains 40 mg of glatiramer acetate.
Glatiramer acetate, the active ingredient in both Copaxone 20 mg/mL
and Copaxone 40 mg/mL, 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 is a clear, colourless solution for injection, in a
pre-filled syringe.
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.
COPAXONE 20 MG/ML
The recommended dosage in adults is a once daily subcutaneous
injection of 1 mL Copaxone 20 mg.
This corresponds to one Copaxone 20 mg/mL pre-filled syringe.
COPAXONE 40 MG/ML
The recommended dosage in adults is 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.
Teva Pharma Australia Pty Limited Version 4.0 2
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 loca