ProZinc

insulin human

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This is a summary of the European public assessment report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is ProZinc?

ProZinc is a veterinary medicine that contains the active substance human insulin. It is available as a suspension for injection (40 IU/ml).

What is ProZinc used for?

ProZinc is used to treat cats with diabetes. It is given as an injection under the skin twice daily either at the same time or immediately after a meal. The correct dose is determined individually for each cat depending on weight and needs to be adjusted depending on the response to treatment.

How does ProZinc work?

Diabetes is a disease in which the pancreas does not make enough insulin to control the level of blood glucose (sugar) in the blood or when the body is unable to use insulin effectively. This results in increased blood glucose levels and associated clinical signs such as polyuria (increase in urine volume), polydipsia (increase in water intake) and weight loss. ProZinc is an insulin to which protamine and zinc have been added to create crystals. These are absorbed more slowly after injection and take longer to reach their target in the body than naturally produced insulin. This means the medicine has a longer duration of action. ProZinc works in the 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.

The active ingredient of ProZinc, insulin human (rDNA), is produced by a method known as ‘recombinant DNA technology’: it is made by yeast cells into which a gene (segment of DNA) has been introduced that makes the yeast cells able to produce insulin.

How has ProZinc been studied?

ProZinc was studied in a field study involving 176 diabetic cats of various ages and breeds.The main measure of effectiveness was improvement in control of diabetes six weeks after starting treatment, which was determined by improvement of blood-sugar measurements and at least one of three clinical signs: bodyweight, polyuria and polydipsia.

What benefit has ProZinc shown during the studies?

The study showed that after six weeks of treatment, average blood sugar levels decreased and clinical signs improved, for example average body weight increased. Based on the main measure of effectiveness 116 out of 139 cats (84%) were considered to be treated successfully.

What is the risk associated with ProZinc?

The most common side effect during treatment with ProZinc (which may affect more than 1 in 10 animals) is hypoglycaemia (low blood glucose levels) which may result in signs such as hunger, anxiety, unsteady movement, muscle twitching, stumbling or sinking in the rear legs and disorientation. These hypoglycaemic events were generally mild in nature.

ProZinc must not be used in cats which are hypersensitive (allergic) to insulin or any of the other ingredients.

For a full list of the side effects and restrictions with ProZinc, see the package leaflet.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

If the product is accidentally self-injected, medical advice should be sought immediately and the package leaflet or label shown to the doctor.

Why has ProZinc been approved?

The CVMP concluded that the benefits of ProZinc exceed the risks for the approved indication and recommended that ProZinc be given a marketing authorisation. The benefit / risk balance may be found in the scientific discussion module of this EPAR.

Other information about ProZinc:

The European Commission granted a marketing authorisation valid throughout the European Union for ProZinc on 12 July 2013. Information on the prescription status of this product may be found on the label / outer package.

Name Language First published Last updated
ProZinc : EPAR - Summary for the public BG = bălgarski 2013-08-06  
ProZinc : EPAR - Summary for the public ES = español 2013-08-06  
ProZinc : EPAR - Summary for the public CS = čeština 2013-08-06  
ProZinc : EPAR - Summary for the public DA = dansk 2013-08-06  
ProZinc : EPAR - Summary for the public DE = Deutsch 2013-08-06  
ProZinc : EPAR - Summary for the public ET = eesti keel 2013-08-06  
ProZinc : EPAR - Summary for the public EL = elliniká 2013-08-06  
ProZinc : EPAR - Summary for the public EN = English 2013-08-06  
ProZinc : EPAR - Summary for the public FR = français 2013-08-06  
ProZinc : EPAR - Summary for the public IT = italiano 2013-08-06  
ProZinc : EPAR - Summary for the public LV = latviešu valoda 2013-08-06  
ProZinc : EPAR - Summary for the public LT = lietuvių kalba 2013-08-06  
ProZinc : EPAR - Summary for the public HU = magyar 2013-08-06  
ProZinc : EPAR - Summary for the public MT = Malti 2013-08-06  
ProZinc : EPAR - Summary for the public NL = Nederlands 2013-08-06  
ProZinc : EPAR - Summary for the public PL = polski 2013-08-06  
ProZinc : EPAR - Summary for the public PT = português 2013-08-06  
ProZinc : EPAR - Summary for the public RO = română 2013-08-06  
ProZinc : EPAR - Summary for the public SK = slovenčina 2013-08-06  
ProZinc : EPAR - Summary for the public SL = slovenščina 2013-08-06  
ProZinc : EPAR - Summary for the public FI = suomi 2013-08-06  
ProZinc : EPAR - Summary for the public SV = svenska 2013-08-06  
ProZinc : EPAR - Summary for the public HR = Hrvatski 2013-08-06  

This EPAR was last updated on 07/09/2017 .

Authorisation details

Product details

Product details for ProZinc
NameProZinc
Agency product numberEMEA/V/C/002634
Active substance

insulin human

International non-proprietary name (INN) or common name

insulin human

Species Cats
Anatomical therapeutic chemical veterinary (ATCvet) codes QA10AC01


Publication details

Publication details for ProZinc
Marketing-authorisation holder

Boehringer Ingelheim Vetmedica GmbH

Revision6
Date of issue of marketing authorisation valid throughout the European Union12/07/2013

Contact address:

Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 73
55216 Ingelheim/Rhein
Germany

Product information

Product information

01/09/2017  ProZinc -EMEA/V/C/002634 -IG/0831

Name Language First published Last updated
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07
ProZinc : EPAR - Product Information HR = Hrvatski 2013-08-06 2017-09-07

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
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  
ProZinc : EPAR - All Authorised presentations HR = Hrvatski 2013-08-06  

Pharmacotherapeutic group

Insulins and analogues for injection, intermediate acting Insulin (human)

Therapeutic indication

For the treatment of diabetes mellitus in cats to achieve reduction of hyperglycaemia and improvement of associated clinical signs

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
ProZinc : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2014-05-21 2017-09-07

Initial marketing-authorisation documents

Name Language First published Last updated
ProZinc : EPAR - Public assessment report HR = Hrvatski 2013-08-06  
CVMP summary of positive opinion for ProZinc HR = Hrvatski 2013-05-17