Humalog Mix25 100 units/ml suspension for injection in cartridge

  • Name:

    Humalog Mix25 100 units/ml suspension for injection in cartridge

  • 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 Mix25). 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 - 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

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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)

 

6.5   Nature and contents of container

Vial

The suspension is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with aluminium seals.  Dimeticone or silicone emulsion may have been used to treat the vial stoppers.

10 ml Vial: Pack of 1 vial. Not all packs may be marketed

Cartridge

The suspension is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may have been used to treat the cartridge plunger, and/or the glass cartridge.

 3 ml Cartridge: Packs of 5 or 10 cartridges. Not all packs may be marketed.

 KwikPen

The suspension is contained in type I flint glass cartridges, sealed with halobutyl disc seals and plunger heads and secured with aluminium seals.  Dimeticone or silicone emulsion may have been used to treat the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges are sealed in a disposable pen injector, called the “KwikPen”.  Needles are not included.

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

10.          DATE OF REVISION OF THE TEXT

 13 January 2019 23 July 2020

 

HLG78M

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

 

HLG70MHLG74M

 

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 12 August 2019 PIL

Reasons for updating

  • Change to name of medicinal product

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 - excipient warnings
  • 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 10 May 2018

Reasons for updating

  • New SmPC for new product

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

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 31 October 2017 SPC

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
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

changes from joint to individual SmPC

Changes

 

Added (underline) deleted (strikethrough)

 

 

4.2       Posology and method of administration

 

Paediatric population

Administration of Humalog Mix25 to children below 12 years of age should be considered only in case of an expected benefit when compared to soluble insulin.

 

 

4.4       Special warnings and precautions for use

 

Administration of insulin lispro to children below 12 years of age should be considered only in case of an expected benefit when compared to soluble insulin.

 

 

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

 

 

                                                                                                                                                                                HLG61M

Updated on 7 April 2017 SPC

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Changes

6.             Pharmaceutical Particulars

6.5          Nature and contents of container and special equipment for use, administration or implantation

………..

5 x 3ml HUMALOG Mix25 cartridges for a 3ml pen.

2 x (510 x 3ml) HUMALOG Mix25 cartridges for a 3ml pen.

 

5 x 3ml HUMALOG Mix50 cartridges for a 3ml pen.

2 x (510 x 3ml) HUMALOG Mix50 cartridges for a 3ml pen.

………..

 

8.             Marketing Authorisation NUMBERS

                ………..

5 x 3ml HUMALOG Mix25 cartridges for a 3ml pen:               EU/1/96/007/008

2 x (510 x 3ml) HUMALOG Mix25 cartridges for a 3ml pen:  EU/1/96/007/024

 

5 x 3ml HUMALOG Mix50 cartridges for a 3ml pen:                EU/1/96/007/006

2 x (510 x 3ml) HUMALOG Mix50 cartridges for a 3ml pen:  EU/1/96/007/025

                ………..

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

10 November 2016     17 March 2017

Updated on 7 April 2017 PIL

Reasons for updating

  • New PIL for new product

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 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 1 December 2016 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • 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

 

Throughout SPC, the abbreviated term for units, ‘U’, is replaced with the full spelling (i.e.- ‘units’). 

 

 

10.          DATE OF REVISION OF THE TEXT

 

01 January 2016   10 November 2016

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 18 January 2016 SPC

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 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • 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

 

4.             CLINICAL PARTICULARS

4.4         Special warnings and precautions for use

 

……………

 

Combination of HUMALOG Mix25 or HUMALOG Mix50 with pioglitazone:

Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and HUMALOG Mix25 or HUMALOG Mix50 is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

 

Instructions for use and handling

Cartridges: To prevent the possible transmission of disease, each cartridge must be used by one patient

only, even if the needle on the delivery device is changed.

 

KwikPens: To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.

 

 

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 UK: www.mhra.gov.uk/yellowcard, or Ireland: Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, www.imb.ie, imbpharmacovigilance@imb.ie.

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 the UK: Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.

 

 

6.             PHARMACEUTICAL PARTICULARS

6.6          Special precautions for disposal and other handling

 

                ……………..

 

HUMALOG Mix25 or HUMALOG Mix50 100U/ml suspension for injection in cartridges

 

Instructions for use and handling

Cartridges: To prevent the possible transmission of disease, each cartridge must be used by one patient only, even if the needle on the delivery device is changed.

               

                …………….

               

Humalog Mix25 or HUMALOG Mix50 100U/ml KwikPen, suspension for injection

 

a)       Instructions for use and handling

KwikPens: To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.



7.            MARKETING AUTHORISATION HOLDER

 

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht Grootslag 1-5, NL-3991 RA, Houten
The Netherlands

 

 

10.          DATE OF REVISION OF THE TEXT

 

14 November 2013          01 January 2016

Updated on 30 November 2013 SPC

Reasons for updating

  • 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.             CLINICAL PARTICULARS

 

4.8            Undesirable effects

Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer.  Severe hypoglycaemia may lead to loss of consciousness and in extreme cases, death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors, e.g., a patient’s level of diet and exercise.

Local allergy in patients is common (1/100 to <1/10). Redness, swelling, and itching can occur at the site of insulin injection. This condition usually resolves in a few days to a few weeks. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique. Systemic allergy, which is rare (1/10,000 to <1/1,000) but potentially more serious, is a generalised allergy to insulin. It may cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating.  Severe cases of generalised allergy may be life-threatening.

Lipodystrophy at the injection site is uncommon (1/1,000 to <1/100).

Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.

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 UK: www.mhra.gov.uk/yellowcard, or Ireland: Pharmacovigilance Section, Irish Medicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, www.imb.ie, imbpharmacovigilance@imb.ie.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

Revision date changed to:
14 November 2013

 

 

 

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 29 June 2012 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

(Humalog Mix25 vials only)


6.             Pharmaceutical Particulars


6.3          Shelf-life

 

Unopened vials

 

2 years     3 years

 

 

10.          DATE OF REVISION OF THE TEXT

 

Revision date changed to:

 

 

13 April 2012

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 12 May 2011 SPC

Reasons for updating

  • 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

PLEASE NOTE:  the SPC has been updated throughout in order to reflect QRD template changes and the removal of Humalog Mix 25 & Mix50 Pen information.

 

 

Changes

 

4.             CLINICAL PARTICULARS

 

4.8          Undesirable effects

 

Added (new) text:

 

Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.

 

 

10.          DATE OF REVISION OF THE TEXT

 

Revision date changed to:

 

 

18 April 2011

Updated on 8 March 2011 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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



Added (new) text:

 

Changes

 

4.             CLINICAL PARTICULARS

 

4.4          Special warnings and precautions for use

 

 

Combination of Humalog Mix25 or Humalog Mix50 with pioglitazone:

Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Humalog Mix25 or Humalog Mix50 is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

Revision date changed to.

 

17 February 2011

 

 

 

Updated on 4 March 2011 PIL

Reasons for updating

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

Updated on 4 August 2010 SPC

Reasons for updating

  • Change to joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

SPC updated to add Mix25 vial & Mix50 Cartridge information only. No other information has changed.

 

Individual affiliate contact details deleted from SPC consistent with other European SPCs

 

This brings the Irish SPC version in line with EU licence.


Header updated (see underlined):

HUMALOG MIX25                                                                              
100U/ml suspension for injection in vial                                               
100U/ml suspension for injection in cartridge                                     
100U/ml Pen, suspension for injection
100U/ml KwikPen, suspension for injection

HUMALOG MIX50

100U/ml suspension for injection in cartridge

100U/ml Pen, suspension for injection

100U/ml KwikPen, suspension for injection

 

 

Revision date remains unchanged.

 

10.          DATE OF REVISION OF THE TEXT

 

                01 July 2009

 

 

 

Updated on 9 September 2009 PIL

Reasons for updating

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

Updated on 16 July 2009 SPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company



4.             CLINICAL PARTICULARS

4.5          Interaction with other medicinal products and other forms of interaction

 

Added (bold):

 

Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),

 

 

 

5.             PHARMACOLOGICAL PROPERTIES

 

5.1          Pharmacodynamic properties

 

Updated:

 

 

 

 

 

 

 

 

 

Hypoglycaemic activity

                            

Time, hours

 

 


 

 

 

 

 

 

 

 

 

Hypoglycaemic
activity

 

0

4

8

12

16

20

24

Humalog Mix50

Humalog Basal

Time, hours

 

 

 

 

6.             PHARMACEUTICAL PARTICULARS

 

6.3          Shelflife

 

Added:

 

Unused cartridges & pre-filled pens

 

Added (bold) Deleted (strikethrough):

 

3 years 2 years

 

Added (bold) deleted (strikethrough):

 

After cartridge insertion, or after first use (prefilled pen) insertion of the cartridge in a pen, or the first use of the prefilled pen, the solution should be used within 28 days. when stored below 30°C.

 

6.4          Special precautions for storage

 

Added:

 

Unused cartridge and unused pre-filled pens

 

Store in a refrigerator (2°C-8°C).  Do not freeze.  Do not expose to excessive heat or direct sunlight.

 

Added:

 

After cartridge insertion or first use (pre-filled pen)

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

 

 

6.6                Special precautions for disposal and other handling

 

Re-formatted to provide better clarity between the pen and Kwikpen instructions.

 

 


 

9.             DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Dates changed as per EMEA request:

 

Date of first authorisation:        30 April 1996

 

Date of last renewal:                   30 April 2006

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

                01 July 2009

Updated on 3 June 2008 SPC

Reasons for updating

  • Change to marketing authorisation holder address

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

Free text change information supplied by the pharmaceutical company

Addition:

This SPC has been revised in its entirety adding Humalog KwikPen MIX25/MIX50 text throughout – there are no other content

changes and the date of revision of the text remains the same.

10. DATE OF REVISION OF THE TEXT

31 January 2008

Updated on 10 March 2008 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

6.             PHARMACEUTICAL PARTICULARS

 

6.6          Special precautions for disposal and other handling

 

 

Deleted from section 4.2 and inserted into section 6.6:

 

 

Instructions for use and handling

The vial is to be used in conjunction with an appropriate syringe (100 U markings).

 

a)         Preparing a dose

 

Vials containing Humalog Mix25 should be rotated in the palms of the hands before use to resuspend the insulin until it appears uniformly cloudy or milky. Do not shake vigorously as this may cause frothing which may interfere with the correct measurement of the dose. The vials should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the vial, giving it a frosted appearance.

 

Humalog Mix25

 

1.         Wash your hands.

 

2.         If using a new vial, flip off the plastic protective cap, but do not remove the stopper.  

 

3.         Draw air into the syringe equal to the prescribed Humalog Mix25 dose.  Wipe the top of the vial with an alcohol swab.  Put the needle through rubber top of the Humalog Mix25 vial and inject the air into the vial.

 

4.         Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand.

 

5.         Making sure the tip of the needle is in the Humalog Mix25, withdraw the correct dose into the syringe.

 

6.         Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount of Humalog Mix25 in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.

 

7.         Remove the needle from the vial and lay the syringe down so that the needle does not touch anything.

 

b)         Injecting a dose

 

1.         Choose a site for injection.

 

2.         Clean the skin as instructed.

 

3.         Stabilise the skin by spreading it or pinching up a large area.  Insert the needle and inject as instructed.

 

4.         Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.

 

5.         Dispose of the syringe and needle safely.

 

6.         Use of the injection sites should be rotated so that the same is not used more than approximately once a month.

 

 

 

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

31 January 2008

Updated on 6 March 2008 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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)

Updated on 13 June 2007 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 31 May 2007 SPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

4.             CLINICAL PARTICULARS

 

4.5          Interaction with other medicinal products and other forms of interaction

 

Added text in bold

 

Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers, octreotide, or alcohol.

 

 

 

5.             PHARMACOLOGICAL PROPERTIES

 

Changes in bold text and deletions in strikethrough

 

5.1          Pharmacodynamic properties

 

 

Insulin-Naive Patients

n = 78

Not Insulin-Naive Patients

n = 97

Mean total daily insulin dose at endpoint

0.63IU/kg

0.42IU/kg

Haemoglobin A1c - reduction1

1.30%

(mean at baseline = 8.7%)

1.00%

(mean at baseline = 8.5%)

Reduction of the mean of combined morning/evening two-hour postprandial blood glucose1

3.46mM

2.48mM

Reduction of the mean fasting blood glucose1

0.55mM

0.65mM

Incidence of hypoglycaemia at endpoint

2825%

25%

Bodyweight gain2

2.172.33 kg

0.96 kg

 

1From baseline to end of Humalog Mix25 treatment.

2In patients randomised to Humalog Mix25 during the first crossover period.

 

 

 

10.          DATE OF REVISION OF THE TEXT

 

New date

 

3 May 2007

Updated on 24 October 2006 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • 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

5.             PHARMACOLOGICAL PROPERTIES

 

5.1          Pharmacodynamic properties

 

Added:

 

In two 8-month open label crossover studies, Type 2 diabetes patients who were either new to insulin therapy or already using one or two injections of insulin received 4 months of treatment with Humalog Mix25 (used twice daily with metformin) and insulin glargine (used once daily with metformin) in a randomised sequence.  Detailed information can be found in the following table.

 

 

Insulin-Naive Patients

n = 78

Not Insulin-Naive Patients

n = 97

Mean total daily insulin dose at endpoint

0.63IU/kg

0.42IU/kg

Haemoglobin A1c – reduction1

1.30%

(mean at baseline = 8.7%)

1.00%

(mean at baseline = 8.5%)

Reduction of the mean of combined morning/evening two-hour postprandial blood glucose1

3.46mM

2.48mM

Reduction of the mean fasting blood glucose1

0.55mM

0.65mM

Incidence of hypoglycaemia at endpoint

28%

25%

Bodyweight gain2

2.17 kg

0.96 kg

 

1From baseline to end of Humalog Mix25 treatment.

2In patients randomised to Humalog Mix25 during the first crossover period.

 

9.             Date of First Authorisation/Renewal of the Authorisation

 

Dates changed:

 

Date of first authorisation:                         Humalog Mix25 cartridge:           30 April 1996

                                                                        Humalog Mix25 Pen:                    30 April 1996

Humalog Mix50 Pen:                    30 April 1996

 

Date of renewal of the authorisation:       Humalog Mix25 cartridge:           30 April 2006

Humalog Mix25 Pen:                    30 April 2006

Humalog Mix50 Pen:                    30 April 2006

 

10.          DATE OF REVISION OF THE TEXT

 

New date:

 

1 September 2006

Updated on 31 July 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 July 2006 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • 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.             CLINICAL PARTICULARS

 

4.2          Posology and method of administration

 

Added:

 

Instructions for use and handling for all presentations now under this section instead of section 6.6.

 

4.8          Undesirable effects

 

Added:

 

No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors, eg, a patient’s level of diet and exercise.

 

Re-worded:

 

Local allergy in patients is common (1/100 to <1/10).  Redness, swelling, and itching can occur at the site of insulin injection.  This condition usually resolves in a few days to a few weeks.  In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.  Systemic allergy, which is rare (1/10,000 to <1/1,000) but potentially more serious, is a generalised allergy to insulin.  It may cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating.  Severe cases of generalised allergy may be life-threatening.

 

Lipodystrophy at the injection site is uncommon (1/1,000 to <1/100).

 

6.             PHARMACEUTICAL PARTICULARS

 

6.5          Nature and contents of container

 

Added:

 

2 x (5 x 3ml) Humalog Mix25 cartridges for a 3ml pen.

 

2 x (5 x 3ml) Humalog Mix25 100U/ml Pens.

2 x (5 x 3ml) Humalog Mix50 100U/ml Pens.

 

Not all packs may be marketed.

 

8.             Marketing Authorisation NUMBERS

 

Added:

 

2 x (5 x 3ml) Humalog Mix25 cartridges for a 3ml pen:              EU/1/96/007/024

 

2 x (5 x 3ml) Humalog Mix25 100U/ml Pens:                               EU/1/96/007/027

2 x (5 x 3ml) Humalog Mix50 100U/ml Pens:                               EU/1/96/007/028


 

9.             Date of First Authorisation/Renewal of the Authorisation

 

Re-worded:

 

Date of first authorisation:                         Humalog Mix25 cartridge:           19 November 1998

Humalog Mix25 Pen:                    19 November 1998

Humalog Mix50 Pen:                    19 November 1998

 

Date of renewal of the authorisation:       Humalog Mix25 cartridge:           9 February 2006

Humalog Mix25 Pen:                    9 February 2006

Humalog Mix50 Pen:                    9 February 2006

 

10.          DATE OF REVISION OF THE TEXT

 

9 February 2006

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

Updated on 27 January 2004 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Updated on 2 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

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