Sandostatin LAR 10mg

  • Name:

    Sandostatin LAR 10mg

  • 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: 22/03/19

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Summary of Product Characteristics last updated on medicines.ie: 24/7/2018

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Novartis Ireland Limited

Novartis Ireland Limited

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Medicine Name Azarga 10mg/ml + 5mg/ml eye drops, suspension Active Ingredients Brinzolamide, Timolol Maleate
Medicine Name Azopt 10mg/ml eye drops suspension Active Ingredients Brinzolamide
Medicine Name Cataflam 50 mg Coated Tablets Active Ingredients Diclofenac Potassium
Medicine Name Certican Tablets Active Ingredients Everolimus
Medicine Name CILOXAN 3 mg/ml ear drops, solution Active Ingredients Ciprofloxacin hydrochloride
Medicine Name Co-Diovan 160 mg/12.5 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 160mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 320mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Co-Diovan 80mg/12.5mg film-coated tablets Active Ingredients Hydrochlorothiazide, Valsartan
Medicine Name Cosentyx 150 mg solution for injection in pre-filled pen Active Ingredients secukinumab
Medicine Name Desferal 500mg Vials Active Ingredients Desferrioxamine Mesylate
Medicine Name Diovan 160 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 320mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 3mg/ml Oral Solution Active Ingredients Valsartan
Medicine Name Diovan 40 mg film-coated tablets Active Ingredients Valsartan
Medicine Name Diovan 80 mg film-coated tablets Active Ingredients Valsartan
Medicine Name DuoTrav Eye Drops Solution Active Ingredients Timolol Maleate, Travoprost
Medicine Name Entresto 24mg/26mg, 49mg/51mg and 97mg/103mg film-coated tablets Active Ingredients Sacubitril, Valsartan
Medicine Name Estradot Transdermal Patches Active Ingredients Estradiol Hemihydrate
Medicine Name Eucreas 50mg / 850mg and 50mg / 1000mg film-coated tablets Active Ingredients Metformin Hydrochloride, Vildagliptin
1 - 0 of 116 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 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

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 26 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 26 February 2018 SmPC

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

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

Free text change information supplied by the pharmaceutical company

In Section 4.4 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 28 October 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 October 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use

Updated on 30 September 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • 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

 

Typographical change

4.4 Special warnings and precautions for use

Info provided on Sodium content

6.1 List of excipients

Typographical change

6.2 Incompatibilities

Section updated

6.3 Shelf life

Section updated

6.4 Special precautions for storage

Updated

6.5 Nature and contents of container

Updated

6.6 Special precautions for disposal and other handling

Updated

Updated on 7 January 2016 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 (undesirable effects), information on the reporting of side effects has been added.

Updated on 23 April 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

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
  • Change to section 6.1 - List of excipients
  • 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

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, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6

Updated on 23 April 2014 PIL

Reasons for updating

  • Change to packaging
  • Change to, or new use for medicine

Updated on 29 November 2013 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • 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

In Section 3 Pharmaceutical form, description of Powder and Solvent has changed.

 

In Section 4.2 Posology and method of administration, diagrams have been moved to section 6.6 of SmPC and replaced with new diluent diagrams

 

In Section 6.1 List of Excipients, Poloxamer 188 has been added as an excipient

 

In Section 6.4 Special precautions for storage, typographical changes have been made

 

In Section 6.5 Nature and Contents of Container, Section has been updated to reflect new diluent

 

In Section 6.6 Instructions for Use/Handling, Section has been changed to reflect new diluent

Updated on 27 June 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 29 May 2013 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

In Section 4.1. Therapeutic Indications, new promid indication has been added

In Section 4.2 Posology and method of administration, information has been updated in line with new indication

In Section 5.1. Pharmacodynamic Properties, information has been updated in line with new indication

Updated on 28 February 2013 PIL

Reasons for updating

  • PIL re-instated

Updated on 29 August 2006 PIL

Reasons for updating

  • Change to date of revision
  • PIL retired pending re-submission

Updated on 17 May 2005 PIL

Reasons for updating

  • Change to dosage and administration
  • Change to packaging

Updated on 25 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie