What Elaprase contains
The active substance is idursulfase, which is a form of the human enzyme iduronate-2-sulfatase. Idursulfase is produced in a human cell line by genetic engineering technology.
Each vial of Elaprase contains 6 mg of idursulfase. Each ml contains 2 mg of idursulfase.
The other ingredients are Polysorbate 20
Sodium chloride
Sodium phosphate dibasic, heptahydrate
Sodium phosphate monobasic, monohydrate
Water for injections
What Elaprase looks like and contents of the pack
Elaprase is a concentrate for solution for infusion. It is supplied in a glass vial as a clear to slightly opalescent, colourless solution.
Each vial contains 3 ml of concentratefor solution for infusion.
Elaprase is supplied in pack sizes of 1, 4 and 10 vials per carton
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Shire Human Genetic Therapies AB, Svärdvägen 11D, 182 33 Danderyd, Sweden
Manufacturer
Shire Human Genetic Therapies AB, Åldermansgatan 13, 227 64 Lund, Sweden
This leaflet was last approved
This medicine has been authorised under ?exceptional circumstances?.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
More detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu. There are also links to other web sites about rare disease and treatments. ---------------------------------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only:
Instructions for use, handling and disposal
1. Calculate the total dose to be administered and number of Elaprase vials needed.
2. Dilute the total volume of Elaprase concentrate for solution for infusion required in 100 ml of 9 mg/ml sodium chloride solution for infusion (0.9%w/v). 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.
3. The solution should be inspected visually for particulate matter and discolouration prior to administration. Do not shake.
4. It is recommended that administration is started as soon as possible. The chemical and physical stability of the diluted solution has been demonstrated for 8 hours at 25°C.
5. Do not infuse Elaprase concomitantly in the same intravenous line with other agents.
6. For single use only. Any unused product or waste material should be disposed of in accordance with local requirements.