Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Glatiramer acetate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) (see Section 5.1 for important information on the population for which efficacy has been established).
Glatiramer acetate is not indicated in primary or secondary progressive MS.
The initiation of glatiramer acetate treatment should be supervised by a neurologist or a physician experienced in the treatment of MS.
The recommended dosage in adults is 20 mg of glatiramer acetate (one pre-filled syringe), administered as a subcutaneous injection once daily.
At the present time, it is not known for how long the patient should be treated.
A decision concerning long term treatment should be made on an individual basis by the treating physician.
The safety and efficacy of glatiramer acetate in children and adolescents has not been established.
However, limited published data suggest that the safety profile in adolescents from 12 to 18 years of age receiving glatiramer acetate 20mg subcutaneously every day is similar to that seen in adults.
There is not enough information available on the use of glatiramer acetate in children below 12 years of age to make any recommendation for its use. Therefore, glatiramer acetate should not be used in this population.
Glatiramer acetate has not been specifically studied in the elderly.
Glatiramer acetate has not been specifically studied in patients with renal impairment (see section 4.4).
Glatiramer acetate is for subcutaneous use.
Patients should be instructed in self-injection techniques and should be supervised by a health-care professional the first time they self-inject and for 30 minutes after.
A different site should be chosen for every injection, so this will reduce the chances of any irritation or pain at the site of the injection. Sites for self-injection include the abdomen, arms, hips and thighs.
The MyJECT device is available should the patients want to make their injection with an injection device. The MyJECT device is an autoinjector to be used with Brabio 20 mg/mL Solution for Injection pre-filled syringes and it has not been tested with other pre-filled syringes. The MyJECT device should be used as recommended in the information provided by the device manufacturer.
A few cases of overdose with glatiramer acetate (up to 300 mg glatiramer acetate) have been reported. These cases were not associated with any adverse reactions other than those mentioned in section 4.8.
In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.
3 years.
Store in the original package in order to protect from light.
Store in a refrigerator (2°C to 8°C).
Do not freeze.
If the pre-filled syringes cannot be stored in a refrigerator, they can be stored between 15°C and 25°C, once, for up to one month.
After this one month period, if the glatiramer acetate pre-filled syringes have not been used and are still in their original packaging, they must be returned to storage in a refrigerator (2°C to 8°C).
The container closure system consists of a single use glass syringe barrel with an integrated needle. A rubber stopper (bromobutyl, type 1) is fitted in the barrel for closure and acts as a piston during injection. A driving rod is screwed in the rubber stopper. The needle is covered with a needle shield.
The volume of solution in the syringe is 1.0 ml.
7 pre-filled syringes
28 pre-filled syringes
30 pre-filled syringes
90 (3x30) pre-filled syringes
Not all pack sizes may be marketed.
For single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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