Insuman Comb 25 100 IU/ml suspension for injection in a cartridge

Product Information *

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 10 September 2020

File name

1.3.1 SPC Comb 25 Cartridge - clean_1599735662.pdf

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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 10 September 2020

File name

1.3.1 PIL Comb 25 Cartridge - clean_1599735546.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 07 May 2019

File name

NEW PIL Insuman Comb25 Cartridge 544584 v2 - cropped_1557217605.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Updated on 26 April 2019

File name

SPC-Comb25-Ireland-Remove Optipen-SA924-33_1556271374.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

To delete reference to the re-usable insulin pen injector OptiPen used for the administration of Insuman 3 ml cartridges as it is no longer produced

4.4     Special warnings and precautions for use

Insuman Comb 25 100 IU/ml in a cartridge

Pens to be used with Insuman Comb 25 100 IU/ml in cartridges

Insuman Comb 25 100 IU/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used.

The Insuman Comb 25 cartridges should only be used with the following pens:

- JuniorSTAR which delivers Insuman Comb 25 in 0.5 unit dose increments

- OptiPen, ClikSTAR, Tactipen, Autopen 24, AllStar and AllStar PRO which all deliver Insuman Comb 25 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.

Not all of these pens may be marketed in your country (see section 4.2 and 6.6).

 

6.6     Special precautions for disposal and other handling

Insuman Comb 25 100 IU/ml in a cartridge

Insulin pen

Insuman Comb 25 100 IU/ml in cartridges is only suitable for subcutaneous injections from a reusable pen. If administration by syringe is necessary, a vial should be used.

The Insuman Comb 25 cartridges are to be used only in conjunction with the pens: OptiPen, ClikSTAR, Autopen 24, Tactipen, AllStar, AllStar PRO or JuniorSTAR (see section 4.2 and 4.4). Not all of these pens may be marketed in your country.

Updated on 29 May 2018

File name

Insuman Comb 25 100 IU-ml cartridge and vial SPC.docx

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)

Updated on 29 May 2018

File name

Insuman Comb 25 Cartridge PIL.pdf

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 04 August 2017

File name

PIL_13659_385.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 August 2017

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses

Updated on 27 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 27 July 2017

Reasons for updating

  • 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

Group Type IB variation:
IA - B.IV.1.a.1 - To add AllStar PRO reusable pen to the list of pens to be used with the cartridge presentations: the leaflet and carton of the cartridges pack for Insuman Basal, Comb15, Comb25, Infusat and Rapid are updated. The cartons of all the Insumans are also updated to remove ‘Medicinal product subject to medical prescription’ as the ‘POM’ pictogramme applies instead.
IA - B.II.e.5.b - To delete the following presentations for Insuman:
- the 3 mL pre‐filled pen OptiSet of Insuman Rapid, Basal, Comb15, Comb 25, and Comb 50 - solution or suspension for injection 100 IU/mL (EU/1/97/030/065 - 084 and EU/1/97/030/100 - 109)
‐ the 3 mL pre‐filled pen OptiSet of Insuman Comb 30 - suspension for injection 100 IU/mL (EU/1/97/030/178 - 183)
‐ the 3 mL glass cartridge for OptiClik with Insuman Rapid, Basal, Comb15, Comb 25, and Comb 50 - solution or suspension for injection 100 IU/mL (EU/1/97/030/110 - 139)
- the 3 mL glass cartridge for OptiClik with Insuman Comb 30 -suspension for injection 100 IU/mL (EU/1/97/030/184 - 189)
Note: the SPCs for vial, cartridge and pre-filled pens have been combined
IB - C.I.7.a - To delete Insuman Comb 15, suspension for injection 40 IU/mL, in 10 ml vial (EU/1/97/030/041 - 42)
The company took the opportunity to make editorial changes to ET, DE, FI, HU, PL and SL.

Updated on 24 January 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 20 December 2013

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 6.6 - Special precautions for disposal and other handling
  • 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

Sections 4.4 and 6.6 updated to include the new pen names 'AllStar' and 'JuniorStar'
Section 4.8 updated with the new PV Legislation wording on adverse effect reporting

Updated on 16 December 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision

Updated on 14 September 2012

Reasons for updating

  • Correction of spelling/typing errors
  • Change to marketing authorisation holder

Updated on 20 August 2012

Reasons for updating

  • 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

Section 10 updated with the last revision of text (Insuman Basal Vial SmPC updated)

Updated on 11 June 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - 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 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • 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 updated in line with new QRD template version 8.0 including corrections of translation inconsistencies, typos & mistakes.

Updated on 03 May 2011

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 03 March 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Changes: Update Section 2 of the PiL: New warning RE: Pioglitazone

Update Product Information in order to add information related to the risk of medication errors

Updated on 03 February 2010

Reasons for updating

  • Improved electronic presentation

Updated on 02 December 2009

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Section on transferring to Insuman rapid moved from section 4.2 to 4.4.

Updated on 04 September 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 07 July 2008

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

change to the following sections:
 
2
4.2
4.4
4.5
6.3
6.6
10

Updated on 04 September 2006

Reasons for updating

  • New SPC for medicines.ie

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