Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, the Netherlands
Cerezyme 400 Units Powder for concentrate for solution for infusion.
| Pharmaceutical Form |
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Powder for concentrate for solution for infusion. Cerezyme is a white to off-white powder. |
Each vial contains 400 units* of imiglucerase**.
After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (400 U/10 ml).
* An enzyme unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl β-D-glucopyranoside (pNP-Glc) per minute at 37°C.
** Imiglucerase is a modified form of human acid β-glucosidase and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture, with mannose modification for targeting macrophages.
Excipients: For the full list of excipients, see section 6.1.
This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6). After reconstitution, the solution contains 1.24 mmol sodium (400 U/10 mL). To be taken into consideration by patients on a controlled sodium diet.
| Active Ingredient | Description | |
|---|---|---|
| Imiglucerase |
Imiglucerase is a recombinant macrophage targeted acid β-glucosidase that replaces the deficient enzyme activity, hydrolysing glucosylceramide, thus correcting initial pathophysiology and preventing secondary pathology. Imiglucerase has been shown to improve both mental and physical aspects in the quality of life of Gaucher disease. |
| List of Excipients |
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Mannitol |
Cerezyme is supplied in type I borosilicate (clear) glass 20 ml vials. The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap.
To provide sufficient volume to allow accurate dispensing, each vial is formulated to contain an overfill of 0.6 ml.
Pack sizes: 1, 5 or 25 vials per carton.
Not all pack sizes may be marketed.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, the Netherlands
EU/1/97/053/003 Cerezyme 400 Units 1 vial of powder for concentrate for solution for infusion
EU/1/97/053/004 Cerezyme 400 Units 5 vials of powder for concentrate for solution for infusion
EU/1/97/053/005 Cerezyme 400 Units 25 vials of powder for concentrate for solution for infusion
Date of first authorisation: 17 November 1997
Date of latest renewal: 17 September 2007
| Drug | Countries | |
|---|---|---|
| CEREZYME | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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