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Cerezyme 400 U Powder for concentrate for solution for infusion

*
Pharmacy Only: Prescription

  • Company:

    Sanofi Genzyme

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Imiglucerase

    *Additional information is available within the SPC or upon request to the company

Updated on 12 May 2023

File name

1.3.2 Mock-up PIL-IE-MT-XI (3).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 09 May 2023

File name

1.3.1 PIL Text IE-MT-XI.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer

Updated on 09 May 2023

File name

1.3.1 SPC IE-UKNI (17).pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 12 January 2023

File name

1.3.2 Mock-up PIL-IE-MT-XI.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 12 January 2023

File name

1.3.2 Mock-up PIL-IE-MT-XI.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 23 November 2022

File name

1.3.1 SPC IE-UKNI (14).pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 08 September 2022

File name

1.3.1 SPC IE-UKNI (6).pdf

Reasons for updating

  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 10 March 2022

File name

1.3.1 SPC IE-UKNI.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 10 March 2022

File name

1.3.1 PIL text IE-UKNI.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 29 November 2021

File name

1.3.1 PIL text IE-UKNI.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 03 February 2021

File name

1.3.1 SPC IE (2).pdf

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 01 February 2021

File name

1.3.2 Mock-up PIL-IE-MT (2).pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 06 July 2020

File name

1.3.2 Mock-up PIL-IE-MT.pdf

Reasons for updating

  • XPIL Removed

Updated on 19 February 2020

File name

1.3.2 Mock-up PIL-IE-MT.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 24 December 2019

File name

Cerezyme 400U PIL.pdf

Reasons for updating

  • Change to section 6 - manufacturer

EDM Updated on 11 October 2019

File name

UK_IE_Patient Manual_CERZ-UK-10_10-2254a(1)a(1)_FINAL.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 11 October 2019

File name

UK_IE_HCP Manual_CERZ-UK-10_10-2255a(1)a(1)_FINAL.pdf

Reasons for updating

  • Add New Doc

Updated on 16 September 2019

File name

PIL (IE).pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 February 2019

File name

PIL mock up Cerezyme.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - marketing authorisation holder

Updated on 07 January 2019

File name

Cerezyme PIL.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - marketing authorisation holder

Updated on 07 January 2019

File name

SPC cerezyme 200 and 400 units .pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Updated on 21 December 2018

File name

PIL Cerezyme 400 units powder for concentrate for solution for infusion .pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents

Updated on 19 December 2018

File name

SPC Cerezyme 200 and 400 units powder for concentrate for solution for infusion .pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Updated on 27 April 2018

File name

Cerezyme 400 U Powder for concentrate for solution for infusion PIL.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 23 March 2018

File name

PIL_14647_319.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 March 2018

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 17 August 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 17 August 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to improve clarity and readability

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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).

Updated on 17 August 2016

Reasons for updating

  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 07 October 2014

Reasons for updating

  • Change to further information section

Updated on 30 August 2012

Reasons for updating

  • Removal/change of distributor

Updated on 02 June 2011

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 01 November 2010

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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.

Updated on 01 November 2010

Reasons for updating

  • Change to date of revision
  • Change to further information section

Updated on 09 September 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 08 September 2010

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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.

Updated on 16 April 2010

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 16 April 2010

Reasons for updating

  • New PIL for medicines.ie