Cinryze 500 IU powder and solvent for solution for injection *

  • Company:

    Takeda Products Ireland Ltd
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

EDM Updated on 13 October 2021

File name

Patient Diary_06102021_1634131680.pdf

Reasons for updating

  • Replace File

EDM Updated on 13 October 2021

File name

HCP Guide_06102021_1634131680.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Contact information update

EDM Updated on 13 October 2021

File name

Patient Guide_06102021_1634131680.pdf

Reasons for updating

  • Replace File

EDM Updated on 19 April 2021

File name

Cinryze Patient Diary_04-07-2017_1618845905.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 19 April 2021

File name

Cinryze Patient Guide_04-07-2017_1618845904.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 19 April 2021

File name

Cinryze_HCP Guide_15-05-2017_1618845804.pdf

Reasons for updating

  • Add New Doc

Updated on 15 February 2021

File name

IRE-Cinryze-PIL-TIAIN-085-Clean-01FEB2021.doc_1613400146.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 04 January 2021

File name

IRE-Cinryze-SPC-TIB-081-Clean-13Oct2020_1609780403.pdf

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 20 October 2020

File name

IRE-Cinryze-PIL-TIB-081-Clean-Oct2020_1603236291.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to improve clarity and readability

Free text change information supplied by the pharmaceutical company

Warnings and precautions

It is strongly recommended that every time you receive a dose of Cinryze the name and batch number of the product are recorded by your nurse or doctor in order to maintain a record for the batches used. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded by your nurse or doctor.

Cinryze contains sodium

Each vial of Cinryze contains approximately 11.5 mg of sodium. This should be taken into account by people on a controlled sodium diet.This medicine contains 11.5 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 0.5% of the recommended maximum daily dietary intake of sodium for an adult.

4. Possible side effects

Reporting side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Website: www.hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland:

HPRA Pharmacovigilance

Website: www.hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

 

Revision date: 03/2020 10/2020

Updated on 20 October 2020

File name

IRE-Cinryze-SPC-TIB-081-Clean-13Oct2020_1603235803.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Section 4.4.

addition of:U     Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

UTransmissible agents, the following text was removed:

It is strongly recommended that every time Cinryze is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

 

Sodium:

This medicinal product contains 11.5 mg sodium per vial, equivalent to 0.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.Each vial of Cinryze contains approximately 11.5 mg of sodium. To be taken into consideration by patients on a controlled sodium diet.

Section 4.8 UReporting of suspected adverse reactions:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

10.     DATE OF REVISION OF THE TEX

06/2019 13 October 2020

Updated on 02 April 2020

File name

UK-IE-Cinryze-PIL-TIAIN-076-Mar 2020-Clean_1585832334.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 16 July 2019

File name

UK_IE-Cinryze-PIL-TII-Jul19-Clean_1563287062.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 16 July 2019

File name

UK_IE-Cinryze-SmPC-TII-Jul19-Clean_JD_1563287630.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.8 (Undesirable Effects) - revision of the introductory paragraphs 'summary of safety profile' and 'tabulated list of adverse reactions' and changes made to adverse reaction (AR) frequencies for the following ARs: Hypersensitivity, dizziness, nausea, headache, vomiting, erythema, pyrexia, pruritus, injection site rash/erythema and infusion site pain.

Updated on 03 April 2018

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 03 April 2018

File name

PIL_16513_985.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 September 2017

File name

PIL_16513_757.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 September 2017

Reasons for updating

  • New SPC for new product

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

Updated on 29 September 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Replacement of Unit (U) by International Unit (IU) in the product information. This change has been made to the name of the product, and throughout the SPC whenever the dose is mentioned.

Also, addition of the following wording in section 4.4 (Special Warnings and Precautions for Use) of the SPC:

o    (Þ) [Historically assigned potency values were relative to an in-house reference  standard whereby 1 Unit (U) is equal to the mean quantity of C1 inhibitor present in 1 ml of normal human plasma.]  An international reference standard (IU) has now been implemented where IU is also defined as the amount of C1 inhibitor present in 1 ml of normal human plasma.

o    The date of revision of the text has been updated

Updated on 29 September 2017

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 6 - date of revision

Updated on 28 June 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 28 June 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 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

The age range for the licensed indications of Cinryze have been updated to include children 2 years and above for the treatment and pre-procedure prevention of angioedema attacks in those with hereditary angioedema (HAE) and for children 6 years and above for the routine prevention of angioedema attacks in those with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.

This is in addition to adults and adolescents (aged 12 to 17).

As a consequence, sections 4.1, 4.2, 4.8, 5.1, 5.2, 6.5, 6.6 and 10 have been updated.
 
There is also an additional syringe  being included in the pack, as well as a venipuncture set and protective mat, which are contained within a larger carton than before.

 

Updated on 23 June 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Retired from medicines.ie

Updated on 23 June 2016

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Changes following MA renewal May 2016

Updated on 22 June 2016

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects

Updated on 09 November 2015

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 09 November 2015

Reasons for updating

  • New PIL for medicines.ie