GLATIRAMER ACETATE-TEVA 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

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:

Glatiramer acetate 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:

Registered

Valtuutus päivämäärä:

2021-09-14

Pakkausseloste

GLATIRAMER ACETATE-TEVA 40 MG/ML
PRE-FILLED SYRINGE
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING GLATIRAMER ACETATE-TEVA?
GLATIRAMER ACETATE-TEVA contains the active ingredient glatiramer
acetate. GLATIRAMER ACETATE-TEVA is used for the
management of relapsing forms of Multiple Sclerosis (MS).
For more information, see Section 1. Why am I using GLATIRAMER
ACETATE-TEVA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GLATIRAMER ACETATE-TEVA?
Do not use if you have ever had an allergic reaction to glatiramer
acetate or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
GLATIRAMER ACETATE-TEVA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with GLATIRAMER ACETATE-TEVA and affect
how it works.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE GLATIRAMER ACETATE-TEVA?
•
The recommended dose of GLATIRAMER ACETATE-TEVA is one 40 mg/mL
pre-filled syringe (1mL) injected three times a
week and at least 48 hours apart.
•
GLATIRAMER ACETATE-TEVA 40 mg/mL is given by an injection into the
fatty layer under the skin (subcutaneous injection).
More instructions can be found in Section 4. How do I use GLATIRAMER
ACETATE-TEVA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GLATIRAMER ACETATE-TEVA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
GLATIRAMER ACETATE-TEVA.
THINGS YOU
SHOULD NOT DO
•
Do not use more than the recommended dose unless your doctor tells you
to.
LOOKING AFTER
YOUR MEDICINE
•
Keep GLATIRAM

Valmisteyhteenveto

Teva Pharma Australia Pty Limited Version 1.0 1
AUSTRALIAN PI – GLATIRAMER ACETATE-TEVA (GLATIRAMER
ACETATE) SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
1
NAME OF THE MEDICINE
Glatiramer acetate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
GLATIRAMER ACETATE-TEVA 20 mg/mL contains 20 mg of glatiramer acetate.
GLATIRAMER ACETATE-TEVA 40 mg/mL contains 40 mg of glatiramer acetate.
Glatiramer acetate, the active ingredient in both GLATIRAMER
ACETATE-TEVA 20 mg/mL and
GLATIRAMER ACETATE-TEVA 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
GLATIRAMER ACETATE-TEVA 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 GLATIRAMER
ACETATE-TEVA injection is by the
subcutaneous route. GLATIRAMER ACETATE-TEVA should not be administered
by the intravenous or
intramuscular routes.
GLATIRAMER ACETATE-TEVA 20 MG/ML
The recommended dosage in adults is a once daily subcutaneous
injection of 1 mL GLATIRAMER
ACETATE-TEVA 20 mg. This corresponds to one GLATIRAMER ACETATE-TEVA 20
mg/mL pre-filled
syringe.
GLATIRAMER ACETATE-TEVA 40 MG/ML
The recommended dosage in adults is one subcutaneous injection of 1 mL
GLATIRAMER ACETATE-
TEVA 40 mg administered three times a week and at least 48 hours
apart. This corresponds to one
GLATIRAMER ACETATE-TEVA 40 mg/mL pre-filled syringe per
administration.
Tev