Copaxone 40 solution for injection 40 mg/ml syringe 1 ml No. 12

Copaxone 40 is indicated for the treatment of relapsing forms of multiple sclerosis.

Copaxone 40 is not prescribed for primary or secondary progressive multiple sclerosis.

Composition

Active ingredient: glatiramer acetate;

1 ml of solution for injection contains 40 mg of glatiramer acetate;

Excipients: mannitol (E 421), water for injections.

Contraindication

Hypersensitivity to the components of the drug.

Method of application

For adults, the recommended dose is 40 mg glatiramer acetate (one pre-filled syringe) administered subcutaneously 3 times per week. The interval between injections should be at least 48 hours. It is recommended to use the drug on the same days each week.

The duration of treatment with Copaxone 40 is currently not established.

The decision on the duration of treatment is made by the doctor individually for each case.

Application features

Pregnant women

As a precautionary measure, it is advisable to avoid the use of the drug during pregnancy, except in cases where the benefit of use for the mother outweighs the risk of possible effects on the fetus.

Children

Copaxone 40 should not be used in this age group.

Overdose

Several cases of overdose with Copaxone (using 300 mg of glatiramer acetate) have been reported.

Side effects

The injection site reactions most commonly observed with Copaxone 20 mg/ml compared to placebo included erythema, pain, mass, pruritus, swelling, inflammation and hypersensitivity.

Interaction

An increased incidence of injection site reactions has been observed with Copaxone 40. An increased incidence of local reactions has been reported in patients receiving corticosteroid therapy.

Storage conditions

Store in the original package in order to protect from light at 2°C - 8°C (in a refrigerator). Do not freeze.

Keep out of reach of children.

If it is not possible to store the filled syringes in the refrigerator, they can be stored at a temperature of 15 °C - 25 °C for no more than 1 month.

If, after this one-month period, the pre-filled syringes with Copaxone 40 solution have not been used and are in the original packaging, they must be stored in a refrigerator at 2°C - 8°C.

Shelf life - 2 years.