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

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

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.

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

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.