Humalog

insulin lispro

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This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Humalog?

Humalog is a range of solutions and suspensions for injection that contain the active substance insulin lispro and are supplied in vials, cartridges and prefilled pens (Humalog KwikPen). The Humalog range comprises fast-acting insulin solutions (Humalog), longer-acting insulin suspensions (Humalog Basal), and combinations of both in various proportions (Humalog Mix):

  • Humalog: insulin lispro solution, available in a standard or a higher strength (100 or 200 units/ml);
  • Humalog Basal: insulin lispro protamine suspension;
  • Humalog Mix25: 25% insulin lispro solution and 75% insulin lispro protamine suspension;
  • Humalog Mix50: 50% insulin lispro solution and 50% insulin lispro protamine suspension.
What is Humalog used for?

Humalog is used to treat adults and children who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed.

The medicine is only available with a prescription.

How is Humalog used?

Humalog, Humalog Basal and Humalog Mix may be given by injection under the skin of the upper arm, thigh, buttock or abdomen (tummy). Humalog 100 units/ml may also be given by continuous infusion using an insulin pump or into a vein. Humalog 200 units/ml must only be injected under the skin, using the KwikPen device in which it is supplied.

Humalog and Humalog Mix are normally given shortly before a meal, but they can be given just after a meal if necessary. Humalog can be used with a longer-acting insulin or with sulphonylureas (a group of diabetes medicines that are taken by mouth).

Patients can inject themselves with this medicine if they have been trained appropriately.

For further information, see the package leaflet.

How does Humalog work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. Humalog is a replacement insulin which is very similar to the insulin made by the body.

The active substance in Humalog, insulin lispro, is produced by a method known as ‘recombinant DNA technology’: it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce insulin lispro.

Insulin lispro is very slightly different from human insulin. The difference means that insulin lispro is absorbed faster by the body than human regular insulin, and can therefore act faster. Insulin lispro is available as Humalog in the soluble form, which acts more or less immediately after injection, and as Humalog Basal in the ‘protamine suspension’ form, which is absorbed much more slowly so that it works for longer. Humalog Mix is a mixture of these two formulations.

The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has Humalog been studied?

Humalog was originally studied in eight clinical trials including 2951 diabetic patients with type 1 or type 2 diabetes. The effectiveness of Humalog was compared to Humulin R (a soluble recombinant DNA human insulin), when added to one or two daily doses of long-acting insulins. The studies measured the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, and fasting glucose levels. Further studies were also done looking at the use of Humalog in 542 children and adolescents (aged 2 to 19), and the use of Humalog in combination with sulphonylureas (oral anti-diabetes medicines).

What benefit has Humalog shown during the studies?

There were no statistical differences between Humalog and Humulin on diabetic control measured by glycosylated haemoglobin or fasting glucose levels.

What is the risk associated with Humalog?

Humalog may cause hypoglycaemia (low blood glucose levels) and must not be given to patients whose blood glucose is already low. Humalog doses might need to be adjusted when given with other medicines that may have an effect on blood glucose levels.

Humalog Mix, Humalog Basal and Humalog 200 units/ml should never be given into a vein.

For the full list of all side effects and restrictions with Humalog, see the package leaflet.

Why has Humalog been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that Humalog’s benefits are greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus. The Committee recommended that Humalog be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Humalog?

A risk management plan has been developed to ensure that Humalog is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Humalog, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that makes Humalog has provided information to patients and healthcare professionals to remind them that there are two strengths of Humalog and to advise them on how to use them safely to avoid medication errors.

Other information about Humalog

The European Commission granted a marketing authorisation valid throughout the European Union for Humalog on 30 April 1996.

For more information about treatment with Humalog, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Humalog : EPAR - Summary for the public BG = bălgarski 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public ES = español 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public CS = čeština 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public DA = dansk 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public DE = Deutsch 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public ET = eesti keel 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public EL = elliniká 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public EN = English 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public FR = français 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public IT = italiano 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public LV = latviešu valoda 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public LT = lietuvių kalba 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public HU = magyar 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public MT = Malti 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public NL = Nederlands 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public PL = polski 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public PT = português 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public RO = română 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public SK = slovenčina 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public SL = slovenščina 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public FI = suomi 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public SV = svenska 2006-09-12 2014-10-28
Humalog : EPAR - Summary for the public HR = Hrvatski 2006-09-12 2014-10-28

This EPAR was last updated on 14/03/2016 .

Authorisation details

Product details

Product details for Humalog
NameHumalog
Agency product numberEMEA/H/C/000088
Active substance

insulin lispro

International non-proprietary name (INN) or common name

insulin lispro

Therapeutic area Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code A10AC04

Publication details

Publication details for Humalog
Marketing-authorisation holder

Eli Lilly Nederland B.V.

Revision24
Date of issue of marketing authorisation valid throughout the European Union30/04/1996

Contact address:

Eli Lilly Nederland B.V.
Grootslag 1-5
NL-3991 RA Houten
The Netherlands

Product information

Product information

23/02/2016  Humalog -EMEA/H/C/000088 -IG/0662

Name Language First published Last updated
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14
Humalog : EPAR - Product Information HR = Hrvatski 2009-08-25 2016-03-14

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28
Humalog : EPAR - All Authorised presentations HR = Hrvatski 2009-02-24 2014-10-28

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Humalog : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-01-08  
Humalog : EPAR - Scientific Discussion HR = Hrvatski 2006-01-08  

Authorised

This medicine is approved for use in the European Union

Preventing medication errors