Do not use for the acute management of diabetic ketoacidosis.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
Very stressful events, inappetance, concomitant treatment with gestagens and corticosteroids or other concomitant diseases (e.g. gastro-intestinal, infectious or inflammatory or endocrine diseases), might influence insulin effectiveness and therefore the insulin dose may need to be adjusted.
Special precautions for use in animals
The insulin dose may need to be adjusted or discontinued in case of remission of the diabetic state in cats or after resolution of transient diabetic stages in dogs (e.g. dioestrus-induced diabetes mellitus, diabetes mellitus secondary to hyperadrenocorticism).
After the daily insulin dose is established, monitoring for diabetic control is recommended.
Treatment with insulin can cause hypoglycaemia, for clinical signs and appropriate treatment, see below.
Adverse reactions (frequency and seriousness)
Hypoglycaemic reactions were very commonly reported in clinical studies: 13% (23 of 176) of treated cats and 26.5% (44 of 166) of treated dogs. These reactions were generally mild in nature. Clinical signs may include hunger, anxiety, unstable locomotion, muscle twitching, stumbling or sinking in the rear legs and disorientation.
In this case immediate administration of a glucose containing solution or gel and/or food is required.
Insulin administration should be temporarily stopped and the next dose of insulin adjusted appropriately.
Local injection site reactions were very rarely reported and resolved without cessation of therapy.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
The safety and efficacy of ProZinc in breeding, pregnant and lactating cats has not been evaluated.
Use only according to the benefit-risk assessment by the responsible veterinarian.
In general, insulin requirements during pregnancy and lactation might be different due to a change in the metabolic state. Therefore, close glucose monitoring and veterinary supervision is advised.
Interaction with other medicinal products and other forms of interaction
Changes in insulin requirements may result from administration of substances which alter glucose tolerance (e.g. corticosteroids and gestagens). Monitoring of glucose concentrations should be performed to adjust the dose accordingly. Similarly, feeding a high protein/low carbohydrate diet may alter insulin requirements (e.g. decrease of insulin dose).
Overdose (symptoms, emergency procedures, antidotes)
An overdose of insulin can result in hypoglycaemia in which case immediate administration of a glucose solution and/or food is required.
Clinical signs may include hunger, increasing anxiety, unstable locomotion, muscle twitching, stumbling or sinking in the rear legs and disorientation.
Insulin administration should be temporarily stopped and the next dose of insulin adjusted appropriately. The owner is advised to have glucose containing products (e.g. honey, dextrose gel) in the household.
Interaction with other medicinal products and other forms of interaction
Changes in insulin requirements may result from administration of substances which alter glucose tolerance (e.g. corticosteroids and gestagens). Monitoring of glucose concentrations should be performed to adjust the dose accordingly. Similarly, feeding cats with a high protein/low carbohydrate diet and changing the diet of any given cat or dog may alter insulin requirements and necessitate a change of insulin dose.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection can provoke clinical signs of hypoglycaemia and there is a low possibility of an allergic reaction in sensitised individuals.
In case of accidental self-injection seek medical advice immediately and show the package leaflet to the physician.