Sandostatin 500 microgram/1ml, solution for injection/infusion

*
Pharmacy Only: Prescription
  • Company:

    Novartis Ireland Limited
  • 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 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

In Section 4.8 information on how to report a side effect has been added.

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