Apidra 100 Units/ml solution for injection in a vial
- Name:
Apidra 100 Units/ml solution for injection in a vial
- Company:
SANOFI
- Active Ingredients:
- 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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SANOFI
Company Products
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- Joint PIL superseded by individual PILs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
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
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