Humalog 100 units/ml, solution for injection in cartridge (3ml) (insulin lispro)

  • Name:

    Humalog 100 units/ml, solution for injection in cartridge (3ml) (insulin lispro)

  • 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

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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). 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 4.4 - Special warnings and precautions for use
  • 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 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 - 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 changes have been made throughout sections of the PIL.

Updated on 21 August 2020

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.6 - Pregnancy and lactation
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SmPC

Free text change information supplied by the pharmaceutical company

Changes

 

The SmPC for Humalog 100 units/mL vial, cartridge, KwikPen, Junior KwikPen, Tempo Pen now includes new text relating to the non-marketed Tempo pen.

 

In addition, other minor formatting changes have been made throughout SmPC sections.

 Added (underline) deleted (strikethrough)

 

1.       NAME OF THE MEDICINAL PRODUCT

 Humalog 100 units/ml solution for injection in vial

Humalog 100 units/ml solution for injection in cartridge

Humalog 100 units/ml KwikPen solution for injection in a pre-filled pen

Humalog 100 units/ml Junior KwikPen solution for injection in a pre-filled pen

Humalog 100 units/ml Tempo Pen solution for injection in a pre-filled pen

 

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

………

 KwikPen and Tempo Pen

Each pre-filled pen contains 300 units of insulin lispro in 3 ml solution.

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

……… 

4.       CLINICAL PARTICULARS

 4.2   Posology and method of administration

Posology

The dosage dose should be determined by the physician, according to the requirement of the patient.

………

Humalog KwikPens

Humalog KwikPen is available in two strengths. The Humalog 100 units/ml KwikPen (and Humalog 200 units/ml KwikPen, see separate SmPC) delivers 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.

Humalog Tempo Pen

The Humalog 100 units/ml Tempo Pen delivers 1 – 60 units in steps of 1 unit 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. The Tempo Pen can be used with the optional transfer module Tempo Smart Button (see section 6.6).

As with any insulin injection, when using the Tempo Pen, Smart Button and the mobile application, the patient should be instructed to check their blood sugar levels when considering or making decisions about another injection if they are unsure how much they have injected.

………

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 medicinal product should be clearly recorded.

……….

Tempo Pen

The Tempo Pen contains a magnet (see section 6.5) that may interfere with the functions of an implantable electronic medical device, such as a pacemaker. The magnetic field extends to approximately 1.5 cm.

……….

6.             PHARMACEUTICAL PARTICULARS

6.2       Incompatibilities

Vial

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Cartridge, KwikPen, and Junior KwikPen and Tempo Pen

These medicinal products should not be mixed with any other insulin or any other medicinal product.

Vial

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.4       Special precautions for storage

……….

KwikPen, and Junior KwikPen and Tempo Pen

Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached.

……….

6.5   Nature and contents of container

……….

Junior KwikPen

Type I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutyl plunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 ml cartridges are sealed in a disposable pen injector, called the “Junior KwikPen”. Needles are not included.

3 ml Junior KwikPen: Packs of 1 pre-filled pen, 5 pre-filled pens or a multipack of 10 (2 packs of 5) pre-filled pens. Not all packs may be marketed.

Tempo Pen

Type I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutyl plunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 ml cartridges are sealed in a disposable pen injector, called the “Tempo Pen”. The Tempo Pen contains a magnet (see section 4.4). Needles are not included.

3 ml Tempo Pen: Packs of 5 prefilled pens or a multipack of 10 (2 packs of 5) prefilled pens. Not all packs may be marketed.

6.6   Special precautions for disposal and other handling

……….

Humalog Tempo Pen

The Tempo Pen is designed to work with the Tempo Smart Button. The Tempo Smart Button is an optional product that can be attached to the Tempo Pen dose knob and aids in transmitting Humalog dose information from the Tempo Pen to a compatible mobile application. The Tempo Pen injects insulin with or without the Tempo Smart Button attached. To transmit data to the mobile application, follow the instructions provided with the Tempo Smart Button and the instructions with the mobile application.

 8.             MARKETING AUTHORISATION NUMBER(S)

……….

EU/1/96/007/046

EU/1/96/007/047

10.          DATE OF REVISION OF THE TEXT

13 January 2019 23 July 2020

 

 

HLG77M

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

 

 

HLG69MHLG73M

Updated on 13 December 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Change to the alternative manufacturer only - PIL section 6.

Updated on 7 August 2019

Reasons for updating

  • File format updated to PDF

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 5 July 2018 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 - how to take/use
  • Change to section 6 - date of revision

Updated on 29 June 2018

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 SmPC

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 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 used for
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 31 October 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 7 April 2017 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 5 December 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • 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 20 January 2016 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 19 January 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

Updated on 8 May 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 27 November 2013 PIL

Reasons for updating

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

Updated on 3 October 2013 PIL

Reasons for updating

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

Updated on 13 May 2011 PIL

Reasons for updating

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

Updated on 4 March 2011 PIL

Reasons for updating

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

Updated on 28 September 2009 PIL

Reasons for updating

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

Updated on 13 June 2007 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 31 July 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 21 June 2006 PIL

Reasons for updating

  • Change to date of revision

Updated on 14 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie