Thyrogen 0.9 mg powder for solution for injection *
Pharmacy Only: Prescription

  • Company:

    Sanofi Genzyme
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 15 November 2021

File name

1.3.2 Mock-up PIL-IE-MT - NI Addition_1636977449.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • 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 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 11 November 2021

File name

1.3.2 Mock-up Carton-IE-MT- NI Addition (1)_1636644322.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • 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 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 May 2021

File name

1.3.1 SPC IE MT_1621328082.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 12 February 2021

File name

T PIL-IE-MT (3)_1613130111.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 02 December 2020

File name

1.3.1 SPC (3)_1606902727.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 02 December 2020

File name

1.3.1 PIL (9)_1606902686.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer

Updated on 06 July 2020

File name

Throgen PIL-IE_1585126467.pdf

Reasons for updating

  • XPIL Removed

Updated on 25 March 2020

File name

Throgen PIL-IE_1585126467.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 10 March 2020

File name

Throgen PIL-IE_1583829583.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 11 October 2019

File name

m1-3-1-clean-SPC_1570800181.pdf

Reasons for updating

  • 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

 Section 4.8

Enlargement of residual thyroid tissue or metastases can occur following treatment with Thyrogen. This may lead to acute symptoms, which depend on the anatomical location of the tissue. For example, hemiplegia, hemiparesis or loss of vision have occurred in patients with CNS metastases. Laryngeal oedema, respiratory distress requiring tracheotomy, and pain at the site of metastasis have also been reported after Thyrogen administration. It is recommended that pre-treatment with corticosteroids be considered for patients in whom local tumour expansion may compromise vital anatomic structures.

 

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

 

4.9     Overdose

Updated on 11 October 2019

File name

1.3.2 Mock-up PIL-IE-MT-splitting joint packs-BREXIT_1570788978.pdf

Reasons for updating

  • Joint PIL superseded by individual PILs

Updated on 04 July 2019

File name

1.3.1 PIL_1562233914.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 04 July 2019

File name

Thyrogen 0.9 mg powder for solution for injection_1562234206.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Update of sections 4.4 and 5.1 of the SmPC with long term follow-up results from studies HiLo and ESTIMABL1. Additionally, the sodium content provision wording in the Package Leaflet is aligned to the Annex to the European Commission guideline on "Excipients in the labelling and package leaflet of medicinal products for human use" (SANTE-2017-11668).

Updated on 14 January 2019

File name

PIL thyrogen 0.9mg_1547470503.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 07 January 2019

File name

PIL Thyrogen 0.9mg powder_1546865807.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 07 January 2019

File name

SPC Thyrogen 0.9mg powder_1546866321.pdf

Reasons for updating

  • Change to section 4.9 - Overdose
  • 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

4.9     Overdose

 

Data on exposure above the recommended dose is limited to clinical studies and a special treatment program.  Three patients in clinical trials and one patient in the special treatment program experienced symptoms after receiving Thyrogen doses higher than those recommended. Two patients had nausea after 2.7 mg IM dose, and in one of these patients nausea was also accompanied by weakness, dizziness and headache.  The third patient experienced nausea, vomiting and hot flushes after 3.6 mg IM dose.  In the special treatment program, a 77 year-old patient with metastatic thyroid cancer who had not been thyroidectomised received 4 doses of Thyrogen 0.9 mg over 6 days, developed atrial fibrillation, cardiac decompensation and terminal myocardial infarction 2 days later. 

 

One additional patient enrolled in a clinical trial experienced symptoms after receiving Thyrogen intravenously.  This patient received 0.3 mg of Thyrogen as a single intravenous (IV) bolus and, 15 minutes later experienced severe nausea, vomiting, diaphoresis, hypotension and tachycardia.

 

A suggested treatment in case of overdose would be the reestablishment of fluid balance and administration of an antiemetic may also be considered.

 

Updated on 17 July 2018

File name

Thyrogen 0.9mg powder for solution for infusion PIL.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 01 March 2018

File name

PIL_14676_208.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 March 2018

Reasons for updating

  • Improved presentation of PIL

Updated on 05 February 2018

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 30 June 2016

Reasons for updating

  • New SPC for new product

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

Updated on 30 June 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

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: To amend the frequencies of paraesthesia and diarrhoea (from common to uncommon adverse reactions) and to add influenza, ageusia, dysgeusia and neck pain as uncommon adverse reactions.

Section 4.2, 4.4, 4.7, 4.8, 5.1, 6.2, 6.4, 6.5 and 6.6: Minor editorial updates to reflect the preferred terms according to the most recent MedDRA version (SmPC template).

Updated on 30 June 2016

Reasons for updating

  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 07 October 2014

Reasons for updating

  • Change to further information section

Updated on 08 March 2013

Reasons for updating

  • Change to date of revision

Updated on 07 March 2013

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Free text change information supplied by the pharmaceutical company

In section 4.1 - Therapeutic indications, the remnant ablation indication has been updated to include a range of 30-100 mCi radioiodine as opposed to the fixed dose of 100 mCi as follows: 

"Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer"

Updated on 29 May 2012

Reasons for updating

  • Removal/change of distributor

Updated on 21 September 2011

Reasons for updating

  • Change to date of revision

Updated on 20 September 2011

Reasons for updating

  • 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


Statement added:“Very rare cases of stroke have been reported from world-wide post marketing experience in female patients. The relationship to Thyrogen administration is unknown”.

Updated on 31 August 2010

Reasons for updating

  • Change to further information section

Updated on 29 April 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 28 April 2010

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