Cinryze 500 IU powder and solvent for solution for injection

  • Name:

    Cinryze 500 IU powder and solvent for solution for injection

  • Company:
    info
  • Active Ingredients:

    C1 inhibitor (human)

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/07/19

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Summary of Product Characteristics last updated on medicines.ie: 16/7/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Shire Pharmaceuticals Ireland Limited

Shire Pharmaceuticals Ireland Limited

Address: Shire Pharmaceuticals Ireland Limited, Block 2, Miesian Plaza, 50-58 Baggot St, Dublin 2, Ireland

Medical Information E-mail: medinfoEMEA@shire.com

Customer Care direct line: 01800837470

Company Products

Medicine NameActive Ingredients
Medicine Name Buccolam 2.5mg, 5mg, 7.5mg and 10mg oromucosal solution Active Ingredients Midazolam Hydrochloride
Medicine Name Cinryze 500 IU powder and solvent for solution for injection Active Ingredients C1 inhibitor (human)
Medicine Name Equasym XL 10, 20 & 30mg Modified Release Capsules Active Ingredients Methylphenidate Hydrochloride
Medicine Name Firazyr 30 mg solution for injection in pre-filled syringe Active Ingredients Icatibant Acetate
Medicine Name Foznol 250mg, 500mg, 750mg & 1000mg Chewable Tablets Active Ingredients Lanthanum Carbonate Hydrate
Medicine Name Intuniv 1mg, 2mg, 3mg, 4mg prolonged-release tablets Active Ingredients Guanfacine hydrochloride
Medicine Name Mezavant XL Active Ingredients Mesalazine
Medicine Name Reminyl Oral Solution Active Ingredients Galantamine Hydrobromide
Medicine Name Reminyl XL 8mg, 16mg and 24 mg prolonged release capsules Active Ingredients Galantamine Hydrobromide
Medicine Name Resolor 1 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Resolor 2 mg film-coated tablets Active Ingredients Prucalopride Succinate
Medicine Name Tyvense 20mg, 40mg & 60mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Tyvense 30mg, 50mg & 70mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Xagrid 0.5mg hard capsule Active Ingredients Anagrelide hydrochloride
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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.

Updated on 16 July 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 16 July 2019 SmPC

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 3 April 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 April 2018 PIL

Reasons for updating

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

Updated on 29 September 2017 SmPC

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 PIL

Reasons for updating

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

Updated on 29 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 29 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 June 2017 SmPC

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 PIL

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 PIL

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 SmPC

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 PIL

Reasons for updating

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

Updated on 9 November 2015 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 November 2015 SmPC

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