Sandostatin 500 microgram/1ml, solution for injection/infusion
*Company:
Novartis Ireland LimitedStatus:
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 05 January 2024
File name
Sandostatin AMPs_REGPIL_PF23-0171_clean Jan 2024.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 05 January 2024
File name
Sandostatin 500mcg-ml Amps_REG SPC_PF23-0171_clean_Jan 2024.pdf
Reasons for updating
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 November 2021
File name
Sandostatin 500mcg-ml Amps REG SPC PF 21-0207 clean November 2021.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 10 November 2021
File name
Sandostatin AMPs REGPIL PF 21-0207 clean November 2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 17 August 2021
File name
Sandostatin AMPs REGPIL PF 21-0100 clean August 2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - overdose, missed or forgotten doses
Updated on 17 August 2021
File name
Sandostatin 500mcg-ml Amps REGSPC PF 21-0100 clean August 2021.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 July 2021
File name
Sandostatin Amps REG PIL PF21-0106 July 2021 clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 07 July 2021
File name
Sandostatin 500mcg-ml Amps PROSPC PF21-0071 July 2021 clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- 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
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 07 July 2021
File name
Sandostatin Amps REGPIL PF21-0071 July 2021 clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 18 May 2021
File name
Sandostatin AMPs REGPIL PF 20-0111 DE5095II38 - PI - solution (002) Feb 2021 Clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 01 April 2021
File name
Sandostatin 500mcg-ml Amps REGSPC PF 20-0111 clean March 2021.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 February 2021
File name
Sandostatin Amps REGPIL PF20-0099 Jan 2021 clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
Updated on 05 February 2021
File name
Sandostatin 500mcg-ml Amps REGSPC PF20-0099 Jan 2021 clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 11 December 2019
File name
PIL_Sandostatin_July 2019_clean_.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 09 August 2019
File name
PIL_Sandostatin_July 2019_clean_.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 09 August 2019
File name
SANDOSTATIN 500 mcg-ml ampoules REGSPC July 2019 clean PF 19-0021.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 March 2019
File name
Sandostatin Amps 2220907_IE_p2_LFT_X-4 RA approved 19.03.2019_IPHA.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 22 January 2019
File name
Sandostatin AMPS 2214822_IE_p3_LFT_X-4 RA approved 31.08.2018 TBI by 06.01.2019 IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 24 July 2018
File name
SANDOSTATIN 500 mcg-ml ampoules REGSPC_July 2018_clean.pdf
Reasons for updating
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 April 2018
File name
Sandostatin Amps 2209872_IE_p1_LFT_X-4 RA approved 28.03.2018 IPHA TBI by 17.08.2018.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 22 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 February 2018
Reasons for updating
- 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 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.2 Posology and method of administration
Assessment of IGF-1 has been added under Acromegaly
In Section 4.4 Special warnings and precautions for use
Information on Gallbladder and related events has been updated
In Section 4.8 Undesirable effects
thyroid dysfunction has been renamed as thyroid disorder
Blood and lymphatic system disorders –Thrombocytopenia has been added as an Adverse drug reactions derived from spontaneous reports
Information has been added on Gallbladder and related reactions, Hypersensitivity and anaphylactic reactions, Cardiac disorders and Thrombocytopenia
Typographical changes have been made to sections 4.2, 4.3.
Updated on 21 February 2017
File name
PIL_11600_26.pdf
Reasons for updating
- New PIL for new product
Updated on 21 February 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
Updated on 21 September 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- 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
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Updated description
3. PHARMACEUTICAL form
Updated description
4.2 Posology and method of administration
Method of administration
Sandostatin may be administered directly by subcutaneous (s.c.) injection or by intravenous (i.v.) infusion after dilution. For further instructions on handling and instructions for dilution of the medicinal product, refer to section 6.6.
4.4 Special warnings and precautions for use
Sodium content
Sandostatin contains less than 1 mmol (23 mg) sodium per dose, i.e is essentially “sodium-free”.
5.1 Pharmacodynamic properties
Updated info
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6
6.3 Shelf life
Updated with sentence added: Diluted solutions should be used immediately after preparation.
6.4 Special precautions for storage
Updated
6.5 Nature and contents of container
Change in description
6.6 Special precautions for disposal and other handling
Updated information
Updated on 25 November 2015
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)
Free text change information supplied by the pharmaceutical company
Updated on 03 September 2015
Reasons for updating
- Change due to harmonisation of PIL
Updated on 08 May 2015
Reasons for updating
- PIL re-instated
Updated on 22 April 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to how the medicine works
- Change to further information section
- Improved electronic presentation
Updated on 20 March 2015
Reasons for updating
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Referral approval-update to Sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3
Updated on 23 April 2014
Reasons for updating
- Change to warnings or special precautions for use
Updated on 28 February 2013
Reasons for updating
- PIL re-instated
Updated on 16 August 2010
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 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 4.1 has been updated to include 2 new additional indocations:
Prevention of complications following pancreatic surgery .
Emergency management to stop bleeding and to protect from re-bleeding owing to gastro-esophageal varices in patients with cirrhosis. Sandostatin is to be used in association with specific treatment such as endoscopic sclerotherapy
Updated on 08 February 2007
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 November 2006
Reasons for updating
- New PIL for new product
- PIL retired pending re-submission