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

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

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 200 units/ml 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.

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.

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

Revised images for steps 8 & 9.

Amendment to storage temperature (In-use pen).

Date of revison updated.

Revised images for steps 8 & 9.

Amendment to storage temperature (In-use pen).

Date of revison updated.

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

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

HLG80M

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

HLG72MHLG76M

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.

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

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.

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

19^th October 2017

                                                                                                                                                                                HLG67M

(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