Mircera solution for injection 75 mcg syringe tube 0.3 ml No. 1

Mircera injection solution is used in the treatment of symptomatic anemia associated with chronic kidney disease.

Composition

Active ingredient: methoxy polyethylene glycol-epoetin beta;

1 pre-filled syringe with 0.3 ml solution for injection contains 50 mcg or 75 mcg methoxy polyethylene glycol-epoetin beta;

Excipients: L-methionine; sodium sulfate anhydrous; sodium dihydrogen phosphate monohydrate; mannitol (E 421); poloxamer 188; diluted hydrochloric acid or sodium hydroxide solution (qs to pH 6.2); water for injections.

Contraindication

Method of application

Treatment with Mircera should be supervised by a physician experienced in the treatment of patients with renal insufficiency.

Mircera can be administered subcutaneously or intravenously. Mircera is administered subcutaneously in the abdomen, upper arm, or thigh. These sites are equally suitable for subcutaneous administration.

Application features

Pregnant women

Mircera should be used with caution in pregnant women.

Children

Treatment with Mircera is not recommended for children (under 18 years of age) due to the lack of data on the efficacy and safety of the drug.

Drivers

The drug has no or negligible influence on the ability to drive and use machines.

Overdose

Mircera has a wide therapeutic range. When initiating therapy, individual response to therapy should be taken into account. Overdose may lead to an increase in the pharmacodynamic effect, i.e. excessive erythropoiesis. In case of excessive increase in hemoglobin levels, Mircera treatment should be temporarily discontinued. Phlebotomy may be recommended if clinically indicated.

Side effects

When using Mircera, adverse reactions may occur in approximately 6% of patients. The most common adverse reaction was arterial hypertension (common adverse reaction).

Interaction

In the absence of compatibility studies, Mircera should not be mixed with other drugs.

Storage conditions

Store in the original packaging to protect from light at a temperature of 2°C to 8°C, out of the reach of children. Do not freeze.

The product can be removed from the refrigerator and stored at room temperature (not above 30°C) for a single use. The product should be used within this period, which should not exceed 1 month.

Shelf life - 3 years.