ELAPRASE Concentrate for solution for infusion Ref.[9221] Active ingredients: Idursulfase

This treatment should be supervised by a physician or other healthcare professional experienced in the management of patients with MPS II disease or other inherited metabolic disorders.

Posology

Elaprase is administered at a dose of 0.5 mg/kg body weight every week by intravenous infusion over a 3 hour period, which may be gradually reduced to 1 hour if no infusion-associated reactions are observed (see section 4.4).

For instructions for use, see section 6.6.

Infusion at home may be considered for patients who have received several months of treatment in the clinic and who are tolerating their infusions well. Home infusions should be performed under the surveillance of a physician or other healthcare professional.

Special populations

Elderly patients

There is no clinical experience in patients over 65 years of age.

Patients with renal or hepatic impairment

There is no clinical experience in patients with renal or hepatic insufficiency. (see section 5.2).

Paediatric population

The dose for children and adolescents is the same as for adults, 0.5 mg/kg body weight weekly.

Method of administration

For instructions on dilution of the medicinal product before administration, see section 6.6.

There is no experience with overdoses of Elaprase.

Shelf life: 3 years.

Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C.

After dilution: From a microbiological safety point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 to 8°C.

Store in a refrigerator (2°C–8°C).

Do not freeze.

For storage conditions after dilution of the medicinal product, see section 6.3.

5 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal and blue flipoff cap. Each vial contains 3 ml of concentrate for solution for infusion.

Pack sizes of 1, 4 and 10 vials. Not all pack sizes may be marketed.

Each vial of Elaprase is intended for single use only and contains 6 mg of idursulfase in 3 ml of solution. Elaprase is for intravenous infusion and must be diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion prior to use. It is recommended to deliver the total volume of infusion using a 0.2 µm in line filter. Elaprase should not be infused with other medicinal products in the infusion tubing.

• The number of vials to be diluted should be determined based on the individual patient’s weight and the recommended dose of 0.5 mg/kg.
• The solution in the vials should not be used if it is discoloured or if particulate matter is present. The solution should not be shaken.
• The calculated volume of Elaprase should be withdrawn from the appropriate number of vials.
• The total volume required of Elaprase should be diluted in 100 ml of 9 mg/ml (0.9%) sodium chloride solution for infusion. Care must be taken to ensure the sterility of the prepared solutions since Elaprase does not contain any preservative or bacteriostatic agent; aseptic technique must be observed. Once diluted, the solution should be mixed gently, but not shaken.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.