Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium chloride
Sodium phosphate monobasic, monohydrate
Sodium phosphate dibasic, heptahydrate
Polysorbate 20
Water for injections

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
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.

6.4   Special precautions for storage

Store in a refrigerator (2°C – 8°C).
Do not freeze.
For storage conditions after dilution of the medicinal product, see section 6.3.
6.5   Nature and contents of container

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

Pack size of 1 vial.

6.6   Special precautions for disposal and other handling

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-     The calculated volume of Elaprase should be withdrawn from the appropriate number of vials.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.