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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glatiramer acetate, Quantity: 40 mg/mL

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: mannitol; water for injections

Administration route:

Subcutaneous

Units in package:

12

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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.

Product summary:

Visual Identification: Clear solution in a clear, colourless glass syringe equipped with needle covered by a needle shield, stopper and piston rod.; 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

Authorization status:

Registered

Authorization date:

2020-11-12

Patient Information leaflet

GLATIRA
1
GLATIRA 20 MG/ML, 40 MG/ML
®
_glatiramer acetate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common questions about Glatira
20
mg/mL
and
Glatira
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
GLATIRA
20
MG/ML
AND GLATIRA 40 MG/ML IS
USED FOR
Glatira 20 mg/mL and Glatira 40
mg/mL
is
used
for
the
management of relapsing forms
of Multiple Sclerosis (MS).
Glatira
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 (eg. 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 Glatira works in MS is
unknown,
it
is
thought
that
Glatira works by changing the
immune
processes
that
are
believed to be responsible for the
disease.
Glatira 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
Glatira
generally
find
that
they
will
experience
fewer relapses.
Your
doctor,
however,
may
prescribe
Glatira
for
another
purpose.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY QUESTIONS ABOUT
WHY IT HAS BEEN PRESCRIBED FOR
YOU.
This m

Summary of Product characteristics

Australian Product Information
Glatira PI v 1.1
Page | 1
GLATIRA
SOLUTION FOR INJECTION
_ _
_ (GLATIRAMER ACETATE) _
_ _
PRODUCT INFORMATION
1 NAME OF THE MEDICINE
Glatiramer acetate.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glatira 20mg/1 mL contains 20 mg of glatiramer acetate.
Glatira 40mg/1 mL contains 40 mg of glatiramer acetate.
Glatiramer acetate, the active ingredient in both Glatira
20 mg/1 mL and Glatira 40 mg/1 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
Glatira 20 mg/1 mL is a clear, colourless solution for injection, in a
1 mL pre-filled syringe.
Glatira 40 mg/1 mL is a clear, colourless solution for injection, in a
1 mL pre-filled syringe.
The pH of a 0.5% solution in water is in the range of 5.5 to 7.0 and
an osmolarity of about 265
mOsmol/L and 300 mOsmol/L for the 20mg/mL and 40mg/mL, respectively.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC 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 DOSE AND METHOD OF ADMINISTRATION
The only recommended route of administration of Glatira injection is
by the subcutaneous route.
Glatira should not be administered by the intravenous or intramuscular
routes.
Glatira 20 mg/1 mL: The recommended dosage in adults for subcutaneous
injection of
glatiramer acetate 20 mg /1mL solution for injection is once daily.
Glatira 40 mg/1 mL: The recommended dosage in adults for subcutaneous
injection of
glatiramer acetate 40 mg /1mL solution for injection is three times a
week, and at least 48 hours
apart.
Australian Product Informat