Apidra 100 Units/ml solution for injection in a vial

  • Name:

    Apidra 100 Units/ml solution for injection in a vial

  • Company:
    info
  • Active Ingredients:

    Insulin Glulisine

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/09/19

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Summary of Product Characteristics last updated on medicines.ie: 20/2/2019

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Medicine Name Apidra 100 Units/ml solution for injection in a vial Active Ingredients Insulin Glulisine
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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 September 2019 PIL

Reasons for updating

  • Joint PIL superseded by individual PILs

Free text change information supplied by the pharmaceutical company

Replace UK/Ireland PIL with Ireland only PIL

Updated on 1 April 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 20 February 2019 SmPC

Reasons for updating

  • 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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Apidra 100 Units/ml solution for injection in a cartridge

Pens to be used with Apidra 100 units/ml solution for injection in a cartridge

Apidra 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used.

The Apidra cartridges should only be used with the following pens:

  • JuniorSTAR which delivers Apidra in 0.5 unit dose increments
  • OptiPen, ClikSTAR, Tactipen, Autopen 24, AllStar and AllStar PRO which all deliver Apidra in 1 unit dose increments.
    These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens (see section 4.2 and 6.6).
    Not all of these pens may be marketed in your country.

 

 

 

4.5     Interaction with other medicinal products and other forms of interaction

 

Studies on pharmacokinetic interactions have not been performed. Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur.

A number of substances affect glucose metabolism and may require dose adjustment of insulin glulisine and particularly close monitoring.

Substances that may enhance the blood‑glucose‑lowering activity and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), pentoxifylline, propoxyphene, salicylates and sulfphonamide antibiotics.

 

 

 

Updated on 16 October 2018 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 11 October 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 29 May 2018 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 17 May 2018 SmPC

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 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.2, 4.4 and 6.6 and Package Leaflet sections 2 and 3 to implement the recommendation of potential increased risk of medication errors associated with withdrawing insulin from pre-filled pens and cartridges. The labelling has been updated accordingly. Also the  has updated pictures to reflect the revised packaging materials for Apidra SoloStar.
In addition the MAH has update the contact details for the local representatives in Germany

Updated on 26 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 26 June 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update SPC to add CE marked reusable pen AllStar PRO

Updated on 23 March 2017 SmPC

Reasons for updating

  • Addition of joint SPC covering all presentations

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 24 January 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 24 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 October 2014 PIL

Reasons for updating

  • Change to further information section

Updated on 1 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 24 April 2013 PIL

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 16 August 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 3 May 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 4 November 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 24 February 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 22 September 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 4 March 2008 PIL

Reasons for updating

  • New PIL for medicines.ie