Firazyr 30 mg solution for injection in pre-filled syringe
- Name:
Firazyr 30 mg solution for injection in pre-filled syringe
- Company:
Shire Pharmaceuticals Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/10/20
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Shire Pharmaceuticals Ireland Limited
Company Products
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 29 October 2020
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use: Sodium content added
4.5 Interaction with other medicinal products and other forms of interaction: Paediatric population updated
4.8 Undesirable effects: Reporting of suspected adverse reactions details updated
6.3 Shelf life amended to 2 years
10 Date of revision of the text amended to 19 October 2020
Updated on 29 October 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 16 August 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 15 August 2019
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Section 6.3 Increase in shelf life from 18 months to 24 months and section 7 inclusion of post code in MAH address
Updated on 10 September 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 10 September 2018
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
In section 7 (Marketing authorisation holder), has changed from Shire Orphan Therapies GmbH to Shire Pharmaceuticals Ireland Limited
Updated on 22 May 2018
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 18 May 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 30 October 2017 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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
Firazyr is now indicated for the treatment of adolescents, and children aged 2 years and older (in addition to adults). The SPC has additional information related to this change included in sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2, 5.3, 6.6, and 10.
Updated on 30 October 2017
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 30 October 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 30 October 2017 PIL
Reasons for updating
- 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 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 7 April 2017 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 10 - consequent change to the update of the date of revision of the text
Updated on 5 June 2015 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 2 April 2014 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
Statement for reporting of suspected adverse reactions added.
5.1 Pharmacodynamic properties
Time to onset of symptom relief updated with larger numbers of patients and attacks.
Total number of phase III patients with attacks affecting the larynx updated.
Updated on 27 March 2014 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 22 March 2013 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- 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
Updated on 21 March 2013 PIL
Reasons for updating
- Change to date of revision
Updated on 21 November 2012 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.6 Fertility, pregnancy and lactation
Data about effect on reproductive hormones and sperm from study in healthy men and women added.
5.3 Preclinical safety data
Data from juvenile toxicity study in rats added in.
Updated on 13 November 2012 PIL
Reasons for updating
- Change to date of revision
Updated on 31 August 2012 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
Some wording changes + updated
5.1 Pharmacodynamic properties
Data from a third randomized, placebo-controlled, parallel-group study (FAST-3) added.
Updated on 30 August 2012 PIL
Reasons for updating
- Change to side-effects
Updated on 27 June 2012 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- 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
In section 4.6 - "In both rats and dogs, repeated use of icatibant resulted in effects on reproductive organs." has been added
In section 5.3 - data from longer term animal studies has been added
In section 7 - Marketing authorisation holder has been changed to "Shire Orphan Therapies GmbH, Friedrichstrasse 149, D-10117, Berlin, Germany
Updated on 21 June 2012 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 28 July 2011 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.2 the following has been added:
"Firazyr may be self-administered or administered by a caregiver only after training in subcutaneous injection technique by a healthcare professional.
The decision on initiating self-administration of Firazyr should only be taken by a physician experienced in the diagnosis and treatment of hereditary angioedema (see section 4.4). "
In section 4.4 the following has been added:
"Self-administration
For patients who never received Firazyr previously, the first treatment should be given in a medical institution or under the guidance of a physician.
In case of insufficient relief or recurrence of symptoms after self-treatment, it is recommended that the patient should seek medical advice and that subsequent doses are given in a medical institution (see section 4.2).
Patients experiencing a laryngeal attack should always seek medical advice and be observed in a medical institution also after having taken the injection at home."
Updated on 11 July 2011 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Change to warnings or special precautions for use
Updated on 16 August 2010 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- 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
Number of sujects/patients with effects updated.
Adverse reactions table amended
5.1 Pharmacodynamic properties
Controlled Clinical study data amended.
Number of patients in study amended.
6.5 Nature and content of container
Amended to:
3 ml of solution in a 3 ml pre‑filled syringe (type I glass) with plunger stopper (bromobutyl coated with fluorocarbon polymer). A hypodermic needle (25 G; 16 mm) is included in the pack.
Pack size of one pre‑filled syringe with one needle or a multipack containing three pre‑filled syringes with three needles.
Not all pack sizes may be marketed.
8 Marketing Authorisation Number(s)
Added : EU/1/08/461/002
10 Date of Revision of the text
Date amended to 07/2010
Updated on 13 August 2010 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 22 June 2010 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)