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: 24/09/20

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Summary of Product Characteristics last updated on medicines.ie: 16/9/2020

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Eli Lilly and Company (Ireland) Limited

Eli Lilly and Company (Ireland) Limited

Company Products

Medicine NameActive Ingredients
Medicine Name ABASAGLAR 100 units/mL KwikPen solution for injection in a pre-filled pen Active Ingredients Insulin glargine
Medicine Name Adcirca 20 mg film-coated tablets Active Ingredients Tadalafil
Medicine Name Alimta 100 mg, 500 mg powder for concentrate for solution for infusion Active Ingredients Pemetrexed disodium
Medicine Name Cialis 10mg film-coated tablets Active Ingredients Tadalafil
Medicine Name Cialis 20mg film-coated tablets Active Ingredients Tadalafil
Medicine Name Cialis 5mg film-coated tablets Active Ingredients Tadalafil
Medicine Name Cymbalta 30 mg, 60 mg hard gastro-resistant capsules Active Ingredients duloxetine hydrochloride
Medicine Name Cyramza 10 mg/ml concentrate for solution for infusion Active Ingredients Ramucirumab
Medicine Name Forsteo 20 micrograms/80 microliters solution for injection in pre-filled pen 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
Medicine Name Humulin M3 KwikPen 100 IU/ml suspension for injection Active Ingredients Human Insulin
Medicine Name Humulin S (soluble), 100IU/ml solution for injection in cartridge Active Ingredients Insulin human
1 - 0 of 38 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 24 September 2020 PIL

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 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.

Updated on 16 September 2020

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 2 September 2020 Ed-HCP

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Revised images for steps 8 & 9.

Amendment to storage temperature (In-use pen).

Date of revison updated.

Updated on 2 September 2020 Ed-HCP

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Revised images for steps 8 & 9.

Amendment to storage temperature (In-use pen).

Date of revison updated.

Updated on 2 September 2020 PIL

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 - 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

Reasons for updating

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

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

HLG80M

Updated on 29 January 2020

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

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

 

 

HLG72MHLG76M

Updated on 31 August 2018 Ed-HCP

Reasons for updating

  • Replace document

Updated on 29 August 2018

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

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

Reasons for updating

  • New SmPC for new product

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

Updated on 23 February 2018 SPC

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 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 SPC

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 SPC

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 SPC

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