NutropinAq
- Name:
NutropinAq
- Company:
Ipsen Pharmaceuticals Ltd
- 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: 03/03/21
(Click to Download)Click on this link to Download PDF directly
Ipsen Pharmaceuticals Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name Cabometyx Tablets | Active Ingredients Cabozantinib |
| Medicine Name Decapeptyl (triptorelin) 3-month | Active Ingredients triptorelin pamoate |
| Medicine Name Decapeptyl (triptorelin) SR | Active Ingredients triptorelin acetate |
| Medicine Name Decapeptyl 6 Month 22.5mg | Active Ingredients triptorelin pamoate |
| Medicine Name Dysport | Active Ingredients Clostridium botulinum type A toxin-haemagglutinin complex |
| Medicine Name INCRELEX | Active Ingredients Mecasermin |
| Medicine Name Mucodyne 375mg Capsules- Discontinued | Active Ingredients Carbocisteine |
| Medicine Name NutropinAq | Active Ingredients Somatropin |
| Medicine Name Somatuline Autogel 60 mg, 90 mg and 120 mg solution for injection in a pre-filled syringe | Active Ingredients Lanreotide acetate |
| Medicine Name Somatuline LA 30mg | Active Ingredients Lanreotide acetate |
| Medicine Name Xermelo 250 mg film-coated tablets | Active Ingredients Telotristat ethyl |
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 3 March 2021 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PIL
2_What you need to know before you use NutropinAq
The Warnings and Precautions information within section 2 has been updated to include additional information related to symptoms of pancreatitis.
4_Possible side effects
The list of uncommon side effects has been updated to include breast enlargement (gynaecomastia). Gynaecomastis has been removed from the rare side effects list.
Reporting side effects:
The section on reporting side effects has been updated to match the most recent QRD Appendix V template.
Updated on 3 March 2021 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Please see below for details of the changes affecting the PIL:
2. What you need to know before you use NutropinAq
The Warnings and Precautions information within section 2 has been updated to include additional information related to symptoms of pancreatitis.
4. Possible side effects
The list of uncommon side effects has been updated to include breast enlargement (gynaecomastia). Gynaecomastis has been removed from the rare side effects list.
Reporting side effects:
The section on reporting side effects has been updated to match the most recent QRD Appendix V template.
Updated on 3 March 2021 SPC
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
Please see below for details of the changes:
4.4 Special warnings and precautions for use:
A warning on Slipped capital femoral epiphysis has been added to section 4.4 under a separate paragraph.
The paragraph previously named “Pancreatitis in children” has been updated as this warning also applies to adults.
4.8 Undesirable effects
The section on reporting of suspected adverse reactions has been updated to match the most recent QRD Appendix V template.
Updated on 19 February 2020 PIL
Reasons for updating
- Change of distributor details
- Correction of spelling/typing errors
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Update to local representatives, update of reporting details in section 6
Updated on 19 February 2020 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to local representatives on PIL and update of SmPC as per QRD template v10.1
Updated on 10 January 2019 PIL
Reasons for updating
- Change to section 6 - what the product contains
Updated on 14 September 2018 PIL
Reasons for updating
- Change to other sources of information section
- Improved presentation of PIL
Updated on 14 September 2018 SPC
Reasons for updating
- Improved presentation of SPC
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to SmPC in line with QRD version 10-formatting changes only.
Updated on 11 May 2018 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
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 4.2: addition of wording relating to women on oestrogen therapy and growth therapy interactions
Section 4.4: addition of warning relating to women on oestrogen therapy
Section 4.5: addition of wording relating to interaction of oestrogen therapy and growth hormones
Updated on 4 May 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 8 April 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 8 April 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 28 May 2014 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 4 June 2013 SPC
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
Updated on 4 June 2013 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 31 May 2013 PIL
Reasons for updating
- Change to side-effects
Updated on 26 January 2012 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
- 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 6.2 - Incompatibilities
- 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
Updated on 26 January 2012 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 27 May 2010 PIL
Reasons for updating
- Improved electronic presentation
Updated on 28 August 2008 PIL
Reasons for updating
- Change to date of revision
Updated on 27 August 2008 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 18 October 2007 PIL
Reasons for updating
- New PIL for new product