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
Very stressful events, inappetence, 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
Special precautions for safe use in the target species:
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 section 3.10.
Special precautions for use in dogs:
In cases where hypoglycaemia is suspected, blood glucose measurements should be taken at the time of occurrence (if possible) as well as shortly prior to the next feeding/injection (where applicable).
Stress and irregular exercise should be avoided. It is recommended to establish a regular twice daily feeding schedule with the owner whether injecting insulin once or twice daily.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Accidental self-injection can provoke clinical signs of hypoglycaemia which may be treated by oral administration of sugar. 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 or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cats and Dogs:
Very common (> 1 animal in 10 animals treated) | Hypoglycaemia (increased appetite, anxiety, twitching, stumbling gait1, disorientation)2. |
Very rare (< 1 animal in 10,000 animals treated, including isolated reports) | Injection site reactions3. |
1 Unstable locomotion and sinking in the rear legs.
2 Generally mild in nature. 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.
3 Resolved without cessation of therapy.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during breeding, pregnancy and lactation.
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 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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
An overdose of insulin can result in hypoglycaemia in which case immediate administration of a glucose containing solution or gel 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.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal
products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.