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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/300817/2013

EMEA/V/C/002634

EPAR summary for the public

ProZinc

Human insulin

This document 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 document 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 and/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.

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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 6 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 6 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.

This summary was last updated in May 2013.

ProZinc

EMA/300817/2013