6.3     Shelf life

Unopened vials:

Cerezyme 200 Units powder for concentrate for solution for infusion

2 years

Cerezyme 400 Units powder for concentrate for solution for infusion

3 years

Diluted solution:

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

7.       MARKETING AUTHORISATION HOLDER

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

1.       NAME OF THE MEDICINAL PRODUCT

Cerezyme 200 Units Powder for concentrate for solution for infusion

Cerezyme 400 Units Powder for concentrate for solution for infusion

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

Cerezyme 200 Units powder for concentrate for solution for infusion

Cerezyme 400 Units powder for concentrate for solution for infusion

Cerezyme 200 Units powder for concentrate for solution for infusion

Cerezyme 400 Units powder for concentrate for solution for infusion

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

.3       Shelf life

Unopened vials:

Cerezyme 200 Units powder for concentrate for solution for infusion

2 years

Cerezyme 400 Units powder for concentrate for solution for infusion

2 3 years

.5       Nature and contents of container

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.

Cerezyme 200 Units powder for concentrate for solution for infusion

Cerezyme 400 Units powder for concentrate for solution for infusion

Use Aseptic Technique

Reconstitution

Cerezyme 200 Units powder for concentrate for solution for infusion

Reconstitute each vial with 5.1 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution. The reconstituted volume is 5.3 ml. The pH of the reconstituted solution is approximately 6.1.

Cerezyme 400 Units powder for concentrate for solution for infusion

Dilution

Cerezyme 200 Units powder for concentrate for solution for infusion

Cerezyme 400 Units powder for concentrate for solution for infusion

Section 4.8: Tabulated list of adverse reactions updated to a table that is more readable and reporting of side effects advisory to national competent authorities included.

Sections 2, 4.2, 4.3, 4.4, 4.6, 4.8, 5.1, 6.2, 6.4, 6.5, 6.6, and 8: Minor editorial updates to reflect the preferred terms according to the most recent MedDRA version (SmPC template).

Changes to sections:

6.6 Special precautions for disposal and other handling

Addition to sentence – “It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles. This will not lead to any loss of imiglucerase activity” this has been added under the ‘Dilution’ section and at the beginning of paragraph 2

10 Date of Revision of the Text

Change of date.

Changes to sections:

4.2 Posology and method of administration

Deletion of “for Adults, Children & Elderly from header of “Posology”

Addition of “Paediatric population” – “No dose adjustment is necessary for the paediatric population”.

Addition of header “Method of Administration” plus addition of second paragraph under this header with the process for home infusion.

Addition of next paragraph – “For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6”

4.8 Undesirable effects

Change in table: "Respiratory symptoms" becomes “Dyspnoea, coughing”.  Addition to “Immune system disorders” section.  Addition of “*”,s

Change to paragraph under the table indicating the use of the “*”,s and the removal of the effects listed in the table above, a basic re-wording of the paragraph, also the removal of the first sentence regarding the undesirable effects on a small number of patients.

6.4 Special precautions for storage.

Addition to sentence – “For storage conditions of the diluted medicinal product, see section 6.3”

10 Date of Revision of the Text

Change of date.