Humalog Mix50 100 units/ml Kwikpen suspension for injection

*
Pharmacy Only: Prescription
  • Company:

    Eli Lilly and Company (Ireland) Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 20 January 2023

File name

HUMALOG MIX50 100 units-ml cartridge_KP SmPC SEP20 HLG83M_UK-IE.pdf

Reasons for updating

  • Document format updated

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

Updated on 27 September 2021

File name

Humalog_Mix50_Kwikpen_PIL_HLG094_Sep21_NI-IE.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Changes

Added (underline) deleted (strikethrough)

 

4. Possible side effects

Reporting of Side effects

United Kingdom (Northern Ireland): Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

 

6. Contents of the pack and other information

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Ireland and United Kingdom (Northern Ireland)

Eli Lilly and Company (Ireland) Limited

Tel: + 353-(0) 1 661 4377

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

 

This leaflet was revised in September 2020 September 2021

Updated on 24 September 2020

File name

Humalog_Mix50_Kwikpen_PIL_UK-IE_SEP20.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Changes

Added (underline) deleted (strikethrough)

 

2.         What you need to know before you use Humalog  

Warnings and precautions

…..

Skin changes at the injection site

The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (See How to use Humalog Mix50 KwikPen). Contact your doctor if you are currently injecting into a lumpy area before you start injecting a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

 

 4.         Possible side effects

…..

Lipodystrophy (thickening or pitting of the skin) is uncommon (³ 1/1,000 to <1/100). If you notice your skin thickening or pitting at the injection site, tell your doctor. If you inject insulin too often at the same place, the fatty tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes.

 

6.             Contents of the pack and other information

…..

This leaflet was last revised in September 2020.

Updated on 16 September 2020

File name

HUMALOG MIX50 100 units-ml cartridge_KP SmPC SEP20 HLG83M_UK-IE.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 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)

4.       CLINICAL PARTICULARS

4.2   Posology and method of administration

……….

Method of administration

………

Use of injection sites should be rotated so that the same site is not used more than approximately once a month, in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8).

………

4.4   Special warnings and precautions for use

………

Injection technique

Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.

……….

4.8   Undesirable effects

………

Tabulated list of adverse reactions

The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by system organ class and in order of decreasing incidence (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000); not known (cannot be estimated form the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

 

MedDRA system organ classes

Very common

Common

Uncommon

Rare

Very rare

Not known

Immune system disorders

 

Local allergy

 

X

 

 

 

 

Systemic allergy

 

 

 

X

 

 

Skin and subcutaneous tissue disorders

 

Lipodystrophy

 

 

X

 

 

 

Cutaneous amyloidosis

 

 

 

 

 

X

 

Description of selected adverse reactions

………

Skin and subcutaneous tissue disorders

Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see section 4.4).

Lipodystrophy

Lipodystrophy at the injection site is uncommon.

 

10.          DATE OF REVISION OF THE TEXT

 

23 July 2020 03 September 2020

 

 

                                                                                                     HGL81M, HGL82M, HGL83M, HLG84

EDM Updated on 03 September 2020

File name

Humalog-100unitsml-KwikPen_UK-IE_IFU_Aug20.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Updated images for steps 10 & 11.

Amendment to storage temperature (In-use pen).

Date of revision updated.

Updated on 02 September 2020

File name

Humalog_Mix50_Kwikpen_PIL_UK-IE_Aug20.pdf

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 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Minor amendments to wording & formatting have been made throughout sections of the PIL.

Updated on 21 August 2020

File name

HUMALOG MIX50 100 units-ml cartridge_KP SmPC AUG20 HLG79M_UK-IE.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Changes 

Minor formatting changes have been made throughout SmPC.  No new text/concepts with exception of below:

 Added (underline) deleted (strikethrough)

 10.          DATE OF REVISION OF THE TEXT

 13 January 2019 23 July 2020

HLG79M

Updated on 21 August 2020

File name

HUMALOG MIX50 100 units-ml cartridge_KP SmPC AUG20 HLG79M_UK-IE.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Changes 

Minor formatting changes have been made throughout SmPC.  No new text/concepts with exception of below:

 Added (underline) deleted (strikethrough)

 10.          DATE OF REVISION OF THE TEXT

 13 January 2019 23 July 2020

HLG79M

Updated on 29 January 2020

File name

HUMALOG MIX50 100 units-ml cartridge_KP SmPC JAN20 HLG75M_UK-IE.pdf

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 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

4.4            Special warnings and precautions for use

 

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number

of the administered product should be clearly recorded.

 

 

4.8            Undesirable effects

 

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, wWebsite: 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

 

17 May  201816 January 2020

 

 

HLG71MHLG75M

 

Updated on 07 August 2019

File name

HUMALOG MIX50 100 units-ml cartridge_KP SPC MAY18 HLG71M_UK-ROI.pdf

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

No change of content.  SmPC Date of revision of the text:  17 May 2018.

Updated on 07 August 2019

File name

HUMALOG MIX50 100 units-ml cartridge_KP SPC MAY18 HLG71M_UK-ROI.pdf

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

No change of content.  SmPC Date of revision of the text:  17 May 2018.

EDM Updated on 04 September 2018

File name

Humalog-100unitsml-KwikPen_IFU_May18.pdf

Reasons for updating

  • Replace File

EDM Updated on 31 August 2018

File name

Humalog U100KPJR_UK_IE_IFU_May18.pdf

Reasons for updating

  • Replace File

Updated on 05 July 2018

File name

Humalog_Mix50_Kwikpen_PIL_UK-IE_May18.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 29 June 2018

File name

HUMALOG_MIX50_cartridge_KP_SPC_MAY18_HLG71M.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 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change from individual to joint SPC

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

Free text change information supplied by the pharmaceutical company

A major change in this variation is the consolidation of the 10 individual SmPCs (1 per 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 in SmPCs

  • All cartridges to be used in a Lilly reusable pen only
  • Clarification that vials only to be used for intravenous administration
  • 100 u/ml cartridges can be used in compatible pump systems for continuous subcutaneous insulin infusion (CSII)
  • New vial text in section 6.6: ‘Patients using vials must never share needles or syringes. The patient should discard the needle after every injection.’
  • Insulin requirements in Renal/Hepatic impairment text – moved from section 4.4 (Special warnings and precautions for use) to 4.2 (Posology and method of administration)

Updated on 14 June 2018

File name

HUMALOG_MIX50_100_units-ml_KwikPen_SPC_OCT17_HLG65M_UK-ROI.docx

Reasons for updating

  • New SPC for new product

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

EDM Updated on 23 April 2018

File name

Humalog-100unitsml-KwikPen_IFU_30nov2016-01.pdf

Reasons for updating

  • Add New Doc

Updated on 03 November 2017

File name

PIL_13308_559.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 November 2017

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 - manufacturer
  • Change to section 6 - date of revision

Updated on 31 October 2017

Reasons for updating

  • New SPC for new product

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

Updated on 05 December 2016

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 19 January 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to MA holder contact details

Updated on 10 September 2015

Reasons for updating

  • Change of manufacturer
  • Change to side-effects
  • Change to date of revision

Updated on 27 November 2013

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 03 October 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 13 May 2011

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 07 March 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 24 July 2009

Reasons for updating

  • Change to date of revision
  • Change to storage instructions
  • Change to drug interactions
  • Change to further information section

Updated on 26 June 2008

Reasons for updating

  • New PIL for new product