Thyrogen 0.9 mg powder for solution for injection
*Company:
Sanofi GenzymeStatus:
No Recent UpdateLegal 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 10 May 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Thyrogen (2).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 May 2023
File name
1.3.1 SPC IE MT.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 May 2023
File name
1.3.2.1 Mock-up - Package Leaflet (PIL)- Thyrogen.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 15 November 2021
File name
1.3.2 Mock-up PIL-IE-MT - NI Addition.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).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.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).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).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).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.pdf
Reasons for updating
- XPIL Removed
Updated on 25 March 2020
File name
Throgen PIL-IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 10 March 2020
File name
Throgen PIL-IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 11 October 2019
File name
m1-3-1-clean-SPC.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.pdf
Reasons for updating
- Joint PIL superseded by individual PILs
Updated on 04 July 2019
File name
1.3.1 PIL.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.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.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 07 January 2019
File name
PIL Thyrogen 0.9mg powder.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.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)