Firazyr 30 mg solution for injection in pre-filled syringe

  • Name:

    Firazyr 30 mg solution for injection in pre-filled syringe

  • Company:
    info
  • Active Ingredients:

    Icatibant Acetate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/08/19

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Summary of Product Characteristics last updated on medicines.ie: 15/8/2019

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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

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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, 30mg, 40mg, 50mg. 60mg & 70mg Capsules, hard Active Ingredients Lisdexamfetamine dimesylate
Medicine Name Tyvense 20mg, 40mg & 60mg 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 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 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

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 SmPC

Reasons for updating

  • 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 7 (Marketing authorisation holder), has changed from Shire Orphan Therapies GmbH to Shire Pharmaceuticals Ireland Limited

Updated on 22 May 2018 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - 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 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 SmPC

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 6.3 - update to the shelf life from 2 years to 18 months
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 SmPC

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 SmPC

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

Date of renewal added.  Date of revision of text updated

Updated on 21 March 2013 PIL

Reasons for updating

  • Change to date of revision

Updated on 21 November 2012 SmPC

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 SmPC

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 SmPC

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 SmPC

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   'Firazyr is not for self-administration.' has been removed.

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 SmPC

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

4.8 Undesirable effects
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 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