Sandostatin Ampoules 500mcg/ml

  • Name:

    Sandostatin Ampoules 500mcg/ml

  • Company:
    info
  • Active Ingredients:

    octreotide acetate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/12/19

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Summary of Product Characteristics last updated on medicines.ie: 9/8/2019

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Novartis Ireland Limited

Novartis Ireland Limited

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1 - 0 of 115 items.Total: Infinity pages

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 11 December 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 9 August 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 9 August 2019 SmPC

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 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 22 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 24 July 2018 SmPC

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 22 February 2018 SmPC

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 22 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 21 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 February 2017 PIL

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 SmPC

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 SmPC

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 3 September 2015 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 8 May 2015 PIL

Reasons for updating

  • PIL re-instated

Updated on 22 April 2015 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 28 February 2013 PIL

Reasons for updating

  • PIL re-instated

Updated on 16 August 2010 SmPC

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 8 February 2007 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 1 November 2006 PIL

Reasons for updating

  • New PIL for new product
  • PIL retired pending re-submission