Cinryze 500 IU powder and solvent for solution for injection
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal 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
File name
Irish Patient Diary Artwork.pdf
Reasons for updating
- Replace File
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Irish Paediatric (Patient) (IU).pdf
Reasons for updating
- Replace File
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Irish Paediatric (HCP) (IU).pdf
Reasons for updating
- Replace File
File name
Irish Patient Diary Artwork.pdf
Reasons for updating
- Replace File
File name
Irish Paediatric (Patient) (IU).pdf
Reasons for updating
- Replace File
File name
Irish Paediatric (HCP) (IU).pdf
Reasons for updating
- Replace File
Updated on 14 October 2022
File name
IE NI - SPC - active substance -clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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 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)
Free text change information supplied by the pharmaceutical company
Active substance name updated from ‘C1 inhibitor (human)’ to ‘Human C1-esterase inhibitor’
Updated on 14 October 2022
File name
IE NI -PIL -active substance and local rep - clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 07 October 2022
File name
Cinryze SmPC IE and NI - 17 May 2022.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 24 May 2022
File name
Cinryze SmPC IE and NI - 17 May 2022.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 24 May 2022
File name
Cinryze PIL IE and NI - May 2022.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
File name
Patient Guide_06102021.pdf
Reasons for updating
- Replace File
File name
Patient Diary_06102021.pdf
Reasons for updating
- Replace File
File name
HCP Guide_06102021.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Contact information update
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Cinryze Patient Diary_04-07-2017.pdf
Reasons for updating
- Add New Doc
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Cinryze Patient Guide_04-07-2017.pdf
Reasons for updating
- Add New Doc
File name
Cinryze_HCP Guide_15-05-2017.pdf
Reasons for updating
- Add New Doc
Updated on 15 February 2021
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IRE-Cinryze-PIL-TIAIN-085-Clean-01FEB2021.doc.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 04 January 2021
File name
IRE-Cinryze-SPC-TIB-081-Clean-13Oct2020.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.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.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.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.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.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
File name
PIL_16513_985.pdf
Reasons for updating
- New PIL for new product
Updated on 03 April 2018
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
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
File name
PIL_16513_757.pdf
Reasons for updating
- New PIL for new product
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 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 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 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
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
Updated on 09 November 2015
Reasons for updating
- New PIL for medicines.ie