Humalog 200 Units/ml KwikPen, solution for injection in pre-filled pen

  • Name:

    Humalog 200 Units/ml KwikPen, solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    Insulin lispro

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/07/18

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Summary of Product Characteristics last updated on medicines.ie: 29/8/2018

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Eli Lilly and Company (Ireland) Limited

Eli Lilly and Company (Ireland) Limited

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Medicine Name ABASAGLAR 100 units/mL solution for injection in pre-filled pen Active Ingredients Insulin glargine
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Medicine Name Alimta Active Ingredients Pemetrexed disodium
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Medicine Name Cialis 2.5mg Tablets Active Ingredients Tadalafil
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Medicine Name Cymbalta Active Ingredients duloxetine hydrochloride
Medicine Name Cyramza 10 mg/ml concentrate for solution for infusion Active Ingredients Ramucirumab
Medicine Name Forsteo Active Ingredients Teriparatide
Medicine Name Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen Active Ingredients Insulin lispro
Medicine Name Humalog 100 units/ml Kwikpen soluton for injection Active Ingredients Insulin lispro
Medicine Name Humalog 100 units/ml, solution for injection in cartridge (3ml) (insulin lispro) Active Ingredients Insulin lispro
Medicine Name Humalog 100 units/ml, solution for injection in vial Active Ingredients Insulin lispro
Medicine Name Humalog 200 Units/ml KwikPen, solution for injection in pre-filled pen Active Ingredients Insulin lispro
Medicine Name Humalog Mix25 100 units/ml Kwikpen suspension for injection Active Ingredients Insulin lispro
Medicine Name Humalog Mix25 100 units/ml suspension for injection in cartridge Active Ingredients Insulin lispro
Medicine Name Humalog Mix50 100 units/ml Kwikpen suspension for injection Active Ingredients Insulin lispro
Medicine Name Humalog Mix50 100 units/ml suspension for injection in cartridge Active Ingredients Insulin lispro
Medicine Name Humulin I (Isophane), 100IU/ml suspension for injection in cartridge Active Ingredients Insulin human
Medicine Name Humulin I (Isophane), 100IU/ml suspension for injection in vial Active Ingredients Human Insulin
Medicine Name Humulin I KwikPen 100 IU/ml suspension for injection Active Ingredients Human Insulin
Medicine Name Humulin M3 (Mixture 3), 100IU/ml suspension for injection in cartridge Active Ingredients Insulin human
Medicine Name Humulin M3 (Mixture 3), 100IU/ml suspension for injection in vial Active Ingredients Insulin human
1 - 0 of 41 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 31 August 2018 Ed-HCP

Reasons for updating

  • Replace document

Updated on 29 August 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

A major change resulting in the consolidation of the 10 individual SmPCs (1 per Humalog presentation) into 4 combined SmPCs, divided as follows:

  • 100 u/ml cartridge, vial, KwikPen, Junior KwikPen
  • Mix25 100 u/ml cartridge, vial, KwikPen
  • Mix50 100 u/ml cartridge, KwikPen
  • 200 u/ml KwikPen

New information for the Humalog 200 units/ml KwikPen SmPC:

Minor changes in formatting & text through SmPC.

Updated on 5 July 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 23 April 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 23 February 2018 SmPC

Reasons for updating

  • 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

6.         Pharmaceutical Particulars

 

 

6.5    Nature and contents of container

 

Type I glass cartridges, sealed with chlorobutyl halobutyl disc seals and plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges which contain 600 units insulin lispro (200 units/ml), are sealed in a disposable pen injector, called the “KwikPen”. Needles are not included.

 

1 pre-filled pen of 3 ml

2 pre-filled pens of 3 ml

5 pre-filled pens of 3 ml

Multipacks containing 10 (2 packs of 5) pre-filled pen of 3 ml

 

Not all packs may be marketed.

 

 

10. DATE OF REVISION OF THE TEXT

 

01 February 2018

Updated on 23 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 2 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 November 2017 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 31 October 2017 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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

Changes

 

Added (underline) deleted (strikethrough)

 

1.         NAME OF THE MEDICINAL PRODUCT

 

Humalog 200 units/ml KwikPen, solution for injection in a pre-filled pen

 

2.             Qualitative and Quantitative Composition

 

One ml contains 100 units (equivalent to 3.5mg) insulin lispro (recombinant DNA origin produced in E.coli). Each container includes 3ml equivalent to 300 units insulin lispro.

 

Each KwikPen delivers 1-60 units in steps of 1 unit.

 

For a full list of excipients, see section 6.1.

 

 

3.             Pharmaceutical Form

 

Solution for injection. KwikPen.

 

Clear, colourless, aqueous solution.

 

 

4.2       Posology and method of administration

Humalog 100 units/ml KwikPen, Humalog 200 units/ml KwikPen and Humalog 100 units/ml Junior KwikPen

Humalog 100 units/ml KwikPen and Humalog 200 units/ml KwikPen

Humalog KwikPen is available in two strengths. For both, the needed dose is dialled in units. Both pre-filled pens, tThe Humalog 100 units/ml KwikPen and the Humalog 200 units/ml KwikPen deliver 1 – 60 units in steps of 1 unit in a single injection. The Humalog 100 units/ml Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units in a single injection. The number of insulin units is shown in the dose window of the pen regardless of strength and no dose conversion should be done when transferring a patient to a new strength or to a pen with a different dose step.

 

 

4.4       Special warnings and precautions for use

Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who are blind or have poor vision must be instructed to always get help/assistance from another person who has good vision and is trained in using the insulin device.

 

 

4.8          Undesirable effects

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, website: www.hpra.ie, e-mail: medsafety@hpra.ie, or United Kingdom: Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

 

10. DATE OF REVISION OF THE TEXT

 

19th October 2017

 

 

                                                                                                                                                                                HLG67M

Updated on 5 December 2016 PIL

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 1 December 2016 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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

(New text bold. Text struck-through removed)

 

 

Changes

5.1       Pharmacodynamic properties

 

Figure 2:   the abbreviated term for units, ‘U’, is replaced with the full spelling (i.e.- ‘units/ml’). 

 

 

10.       DATE OF REVISION OF THE TEXT

 

01 January 2016   10 November 2016

Updated on 30 August 2016 SmPC

Reasons for updating

  • New SPC for new product

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 25 August 2016 PIL

Reasons for updating

  • New PIL for new product