Liprolog

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 its 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 Liprolog?

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

  • Liprolog: insulin lispro solution, available in a standard or a higher strength (100 or 200 units/ml);
  • Liprolog Basal: insulin lispro protamine suspension;
  • Liprolog Mix25: 25% insulin lispro solution and 75% insulin lispro protamine suspension;

Liprolog Mix50: 50% insulin lispro solution and 50% insulin lispro protamine suspension.

What is Liprolog used for?

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

The medicine is only available with a prescription.

How is Liprolog used?

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

Liprolog and Liprolog Mix are normally given shortly before a meal, but they can be given just after a meal if necessary. Liprolog 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 Liprolog 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. Liprolog is a replacement insulin which is very similar to the insulin made by the body.

The active substance in Liprolog, 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 Liprolog in the soluble form, which acts more or less immediately after injection, and as Liprolog Basal in the ‘protamine suspension’ form, which is absorbed much more slowly so that it works for longer. Liprolog 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 Liprolog been studied?

Liprolog was originally studied in eight clinical trials including 2,951 patients with type-1 or type-2 diabetes. The effectiveness of Liprolog was compared with that of Humulin R (a soluble recombinant-DNA human insulin), when they were added to long-acting insulins given once or twice a day. The studies measured the level of a substance in the blood called ‘glycosylated haemoglobin’ (HbA1c), which gives an indication of how well the blood glucose is controlled, and ‘fasting’ blood glucose levels (measured at least eight hours after eating). Studies were also done looking at the use of Liprolog in 542 children and adolescents (aged between two and 19 years), and the use of Liprolog in combination with sulphonylureas (antidiabetic medicines taken by mouth).

What benefit has Liprolog shown during the studies?

Liprolog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.

What is the risk associated with Liprolog?

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

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

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

Why has Liprolog been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that Liprolog’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 Liprolog be given marketing authorisation.

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

A risk management plan has been developed to ensure that Liprolog 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 Liprolog, including the appropriate precautions to be followed by healthcare professionals and patients.

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

Other information about Liprolog:

The European Commission granted a marketing authorisation valid throughout the European Union for Liprolog on 1 August 2001.

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

Name Language First published Last updated
Liprolog : EPAR - Summary for the public BG = bălgarski 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public ES = español 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public CS = čeština 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public DA = dansk 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public DE = Deutsch 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public ET = eesti keel 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public EL = elliniká 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public EN = English 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public FR = français 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public IT = italiano 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public LV = latviešu valoda 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public LT = lietuvių kalba 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public HU = magyar 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public MT = Malti 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public NL = Nederlands 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public PL = polski 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public PT = português 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public RO = română 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public SK = slovenčina 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public SL = slovenščina 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public FI = suomi 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public SV = svenska 2009-09-26 2014-10-27
Liprolog : EPAR - Summary for the public HR = Hrvatski 2009-09-26 2014-10-27

This EPAR was last updated on 22/11/2016 .

Authorisation details

Product details

Product details for Liprolog
NameLiprolog
Agency product numberEMEA/H/C/000393
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 Liprolog
Marketing-authorisation holder

Eli Lilly Nederland B.V.

Revision21
Date of issue of marketing authorisation valid throughout the European Union01/08/2001

Contact address:

Eli Lilly Nederland BV
Grootslag 1-5,
NL-3991 RA Houten
The Netherlands

Product information

Product information

10/11/2016  Liprolog -EMEA/H/C/000393 -WS/1054

Name Language First published Last updated
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22
Liprolog: EPAR - Product Information HR = Hrvatski 2009-08-28 2016-11-22

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
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27
Liprolog: EPAR - All Authorised presentations HR = Hrvatski 2009-09-26 2014-10-27

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. Liprolog is also indicated for the initial stabilisation of diabetes mellitus.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Liprolog : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-08-28 2016-11-22
Liprolog-H-C-393-X-0092 : EPAR - Assessment Report - Extension HR = Hrvatski 2014-10-27  

Initial marketing-authorisation documents

Name Language First published Last updated
Liprolog: EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-06-19  
Liprolog : EPAR - Scientific Discussion HR = Hrvatski 2006-06-19  

Authorised

This medicine is approved for use in the European Union