Saizen 5.83 mg/ml solution for injection
*Company:
MerckStatus:
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 11 January 2024
File name
IE PIL Saizen 5.83 mgml - QRD- TW4234358.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
QRD changes (minor editorial & grammatical changes). TW4234358
Updated on 11 January 2024
File name
IE SPC Saizen 5.83-mg-QRD- TW4234358.pdf
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 4.6 - Pregnancy and lactation
- 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
QRD changes (addition of traceability statement and minor editorial changes). TW4234358
Updated on 16 June 2023
File name
Saizen 5.83mg SPC - shelflife - June 2023 - TW3952201 v15.pdf
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
To extend the shelf-life from 18 months to 2years – see SPC section 6.3
Our reference: TW 3952201
Updated on 21 January 2022
File name
IE PIL Saizen 5.83 mgml - IA coolclick deletion - TW3167578 - Jan 2022 - CLEAN.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Removal of the cool click wording
Our Reference: TW3167578
Updated on 21 January 2022
File name
Saizen Solution 5.83mg and 8mg IE TW3167578 combined current v14.0.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.4 - Special precautions for storage
- 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
Removal of the cool click wording
Our Reference: TW3167578
Updated on 27 August 2019
File name
MC-5873-2019 (6 PIL).pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 21 August 2019
File name
Saizen Solution 5.83mg and 8mg IE TW1997614 combined current v13.0.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
- 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 01 November 2018
File name
5.83 pil (IE-MA Transfer).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 01 November 2018
File name
Saizen_Solution_5.83mg_and_8mg_IE_TW1735731_combined_current_v12.0.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 01 August 2018
File name
Saizen_Solution_5.83mg_and_8mg_IE_TW1712520_combined_current_v11.0.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 17 July 2018
File name
Saizen 5.83mg PIL - CCDS 4.0 TW1663989.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 17 July 2018
File name
Saizen_Solution_5.83mg_and_8mg_IE_TW1663989_combined_current_v10.0.docx
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 4.5 - 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 November 2017
File name
PIL_15344_809.pdf
Reasons for updating
- New PIL for new product
Updated on 24 November 2017
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 14 September 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 September 2017
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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 14 September 2017
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 24 May 2017
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- 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 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
TW1173469
There are extensive editorial changes throughout the SPC due to CCDS v3.0 updates, and
- Addition of the adverse reactions “Gynaecomastia” and “Carpal tunnel syndrome”.
- Addition of the interactions of somatropin with glucocorticoids and oestrogens.
- Addition of information on patients with renal or hepatic impairment.
Updated on 23 May 2017
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
Updated on 19 August 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- 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 19 August 2016
Reasons for updating
- Change to side-effects
Updated on 06 June 2016
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
Pregnancy
No clinical data on exposed pregnancies are available. From the reproductive studies performed in animals with somatropin containing products, there is no evidence of an increased risk of adverse reactions for the embryo or foetus (see section 5.3). However, somatropin containing products are not recommended during pregnancy and in woman of childbearing potential not using contraception.
Breastfeeding
There have been no clinical studies conducted with somatropin in breast-feeding women. It is not known whether somatropin is excreted in human milk. Therefore caution should be exercised when somatropin is administered to breast-feeding women.
Fertility
Non-clinical toxicity studies showed that recombinant human growth hormone did not induce adverse effects on male and female fertility (see section 5.3).
5.3 Preclinical safety data
The local tolerability of Saizen solutions containing 0.3% metacresol when injected in animals was considered good and found suitable for SC or IM administration.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Formal carcinogenicity bioassays were not performed. This is justified, given the proteinous nature of the drug substance and the negative outcome of the genotoxicity testing. The potential effects of r‑hGH on the growth of pre-existing tumours have been evaluated through in vitro and in vivo experiments which have shown that r‑hGH is not expected to cause or stimulate tumours in patients. Reproductive toxicology studies do not indicate harm to the foetus, or impaired fertility, despite administration of doses sufficiently high to produce some pharmacological effects on growth.
Updated on 27 April 2015
Reasons for updating
- Change to storage instructions
Updated on 15 April 2015
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
6.3 Shelf life
18 months
Chemical, physical and microbiological in-use stability has been demonstrated for a total of 28 days at 2°C to 8°C, of which up to 7 consecutive days can be at or below 25°C.
Other in-use storage times and conditions are the responsibility of the user.
6.4 Special precautions for storage
Store the unused Saizen cartridge in a refrigerator (2°C‑8°C). Do not freeze. Store in the original package to protect from light.
After first injection, the Saizen cartridge or the easypod auto-injector containing the Saizen cartridge has to be stored in a refrigerator (2°C‑8°C) for a maximum of 28 days, of which up to 7 consecutive days can be outside of a refrigerator at or below 25°C (see section 6.3). When stored outside of the refrigerator for up to 7 consecutive days, the Saizen cartridge must be returned to the refrigerator and used within 28 days after first injection.
When using the easypod auto-injector, the cartridge is kept in the device. The cool.click needle-free auto-injector should be stored outside of a refrigerator always separately from the Saizen cartridge. Protect the used cartridge from light.
Updated on 14 April 2015
Reasons for updating
- Change to storage instructions
Updated on 18 March 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 15 November 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
4.4 Special warnings and precautions for use
............
In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm. Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms.
.............
Pancreatitis
Although rare, pancreatitis should be considered in somatropin-treated patients especially children who develop abdominal pain.
4.8 Undesirable effects..........
Pancreatitis has been reported in post-marketing studies during growth hormone therapy.
10. Date of the revision of the text
11/2013
Updated on 18 April 2013
Reasons for updating
- Change to date of revision
Updated on 18 July 2012
Reasons for updating
- Change of contraindications
Updated on 08 May 2012
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- 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
Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting GH therapy. Treatment should be discontinued if there is evidence of tumour growth.
Section 4.4 Special warnings and precautions for use
The maximum recommended daily dose should not be exceeded (see section 4.2).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Section6.5 Nature and contents of container (correction of a typo)
The container is a colourless type I glass cartridge with closure consisting of a bromobutyl rubber plunger stopper and an aluminium crimp cap with a bromobutyl rubber single inlay.
Updated on 17 April 2012
Reasons for updating
- New PIL for medicines.ie
Updated on 10 February 2012
Reasons for updating
- SPC re-instated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Product has now been launched so SPC has been re-instated
Updated on 08 March 2011
Reasons for updating
- New SPC for new product
- SPC retired pending re-submission
Legal category:Product subject to medical prescription which may not be renewed (A)