COPAXONE Solution for injection Ref.[8738] Active ingredients: Glatiramer

The initiation of Copaxone treatment should be supervised by a neurologist or a physician experienced in the treatment of MS.

Posology

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.

Renal impairment

Copaxone has not been specifically studied in patients with renal impairment (see section 4.4).

Elderly

Copaxone has not been specifically studied in the elderly.

Paediatric population

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 Copaxone 20 mg subcutaneously every day is similar to that seen in adults. There is not enough information available on the use of Copaxone in children below 12 years of age to make any recommendation for its use. Therefore, Copaxone should not be used in this population.

Method of administration

Copaxone 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 CSYNC device is available should the patients want to make their injection with an injection device. The CSYNC device is an autoinjector to be used with Copaxone pre-filled syringes and it has not been tested with other pre-filled syringes. The CSYNC device should be used as recommended in the information provided by the device manufacturer.

Symptoms

A few cases of overdose with Copaxone (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.

Management

In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.

3 years.

Keep the pre-filled syringes in the outer carton, in order to protect from light.

Store in a refrigerator (2°C-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 Copaxone 20 mg/ml 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).

A pre-filled syringe containing Copaxone solution for injection consists of a 1 ml colourless type I glass syringe barrel with staked needle, a polypropylene (optional polystyrene) plunger rod, a rubber plunger stopper and a needle shield.

Each pre-filled syringe is packed separately in a PVC blister pack.

Copaxone is available in packs containing 7, 28 or 30 pre-filled syringes of 1 ml solution for injection or a multipack containing 90 (3 packs of 30) pre-filled syringes of 1 ml solution for injection.

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.