Overview

ProZinc is a veterinary medicine used to treat cats and dogs with diabetes. It contains the active substance human insulin.

ProZinc can only be obtained with a prescription and is available as a suspension for injection (40 IU/ml). It is given as an injection under the skin twice daily for cats and once daily for dogs either at the same time or immediately after a meal. The correct dose is determined individually for each animal depending on weight and needs to be adjusted depending on the response to treatment. For dogs, if there is insufficient response to treatment after 4 – 6 weeks, the dose and/or frequency can be changed.

For more information about using ProZinc, see the package leaflet or contact your veterinarian or pharmacist.

Diabetes is a disease in which the pancreas does not make enough insulin to control the level of blood glucose (sugar) 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. ProZinc works in the same way as naturally produced insulin with a longer duration of action, 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, human insulin, 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.

In a field study involving 139 diabetic cats of various ages and breeds, after 6 weeks of treatment with ProZinc average blood sugar levels decreased and clinical signs improved, for example average body weight increased; 116 out of 139 cats (84%) were considered to be treated successfully.

In an EU field study involving diabetic dogs, ProZinc was as effective as an authorised veterinary insulin, with improvement of at least one blood sugar measurement and at least one of three clinical signs: bodyweight, polyuria and polydipsia. After 12 weeks, 113 out of 134 ProZinc treated dogs (84%) were successfully treated, compared to 91 out of the 111 control dogs (82%).

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 are generally mild in nature. A glucose containing solution or gel and/or food is required to be given to the animal immediately.

ProZinc must not be used in cats or dogs which are hypersensitive (allergic) to insulin or any of the other ingredients. Because of its prolonged action, it must also not be used for the short-term management of diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood).

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

Accidental self-injection can result in clinical signs of low blood glucose levels which can be treated by taking sugar by mouth. There is a low chance of an allergic reaction in sensitised people.

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

The European Medicines Agency decided ProZinc’s benefits are greater than its risks and it can be authorised for use in the EU.

ProZinc received a marketing authorisation valid throughout the EU on 12 July 2013.

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Latest procedure affecting product information: II/0019/G

07/11/2019

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Product details

Name of medicine
ProZinc
Active substance
Insulin human
International non-proprietary name (INN) or common name
insulin human
Species
  • Cats
  • Dogs
Anatomical therapeutic chemical veterinary (ATCvet) code
QA10AC01

Pharmacotherapeutic group

Insulins and analogues for injection, intermediate-acting

Therapeutic indication

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

Authorisation details

EMA product number
EMEA/V/C/002634
Marketing authorisation holder
Boehringer Ingelheim Vetmedica GmbH

Binger Strasse 73
55216 Ingelheim/Rhein
Germany

Marketing authorisation issued
12/07/2013
Revision
9

Assessment history

News on ProZinc

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