Target species
Dogs and cats.
Indications for use
The veterinary medicinal product is an intermediate acting insulin product containing porcine insulin, which is structurally identical to canine insulin. It is indicated in cases of diabetes mellitus (insulin deficiency) in dogs and cats, where the required blood levels are achieved by using an individually adjusted dose of the veterinary medicinal product.
Contraindications
Do not administer by the intravenous route.
The veterinary medicinal product is a medium duration insulin and is not intended for the treatment of animals with severe acute diabetes presenting in a ketoacidotic state.
Do not use in cases of hypoglycaemia.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
In the cat diabetic remission is possible.
Special precautions for use
Before the veterinary medicinal product is administered owners should be instructed to have a box of powdered glucose at home. Signs of hunger, increasing anxiety, unstable locomotion, muscle twitching, stumbling or sinking in the rear legs and disorientation indicate progression of hypoglycaemia and requires immediate administration of glucose solution and food to restore blood glucose levels.
Polyuria, polydipsia and polyphagia in combination in chronic cases with weight loss, general bad condition, loss of hair or abnormal furry coat and lethargy are the most common clinical symptoms of hyperglycaemia and require administration of insulin to restore blood glucose levels to the normal range.
The use of progestagens (oestrus inhibitors) in patients suffering from diabetes mellitus should be avoided.
Stress and irregular extra exercise must be avoided. Care must be taken with the use of corticosteroids. Ovariohysterectomy may have to be considered.
It is important to establish a strict feeding schedule in consultation with the owner which will include a minimum of fluctuations and changes.
Administration of the veterinary medicinal product must be carried out by an adult responsible for the welfare of the animal.
The veterinary medicinal product must be administered with specific U-40 sterile single-use syringes (vial) or with VetPen (cartridge).
Operator warnings
Accidental self-injection can provoke clinical signs of hypoglycaemia and there is a low possibility of an allergic reaction. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
In the unlikely event of accidental eye and skin contact, wash the area with clean, running water.
Adverse reactions
Dogs and cats:
Rare (1 to 10 animals / 10,000 animals treated): | Hypoglycaemia Injection site reaction * |
*The reaction is usually mild and reversible. Local injection site reactions are reported very rarely in cats.
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 or lactation or lay
Pregnancy and lactation:
The use of the veterinary medicinal product is not contraindicated during pregnancy or lactation but requires close veterinary supervision to account for changes in metabolic requirements during this period.
Interactions
Changes in insulin requirements may result from administration of substances which alter glucose tolerance, such as corticosteroids, thiazide diuretics, progestogens, amitraz and alpha-2 agonists, such as medetomidine, dexmedetomidine, xylazine. Monitoring of glucose concentrations should be used to adjust the dose accordingly. Similarly, changes in diet or exercise may alter insulin requirements.
Amounts to be administered and administration route
Subcutaneous use.
The veterinary medicinal should be administered once or twice daily, as appropriate, by subcutaneous injection. Alternate the injection site daily. Before first use shake the vial thoroughly until a homogeneous, uniformly milky suspension is obtained. Foam on the surface of the suspension formed during shaking should be allowed to disperse before the veterinary medicinal product is used and, before each subsequent use, the veterinary medicinal product should be gently mixed to maintain a homogeneous, uniformly milky suspension before use. Agglomerates can form in insulin suspensions: do not use the veterinary medicinal product if visible agglomerates persist after shaking thoroughly.
Vial: Before each use, invert the vial a few times before use until a homogenous suspension is obtained. A 40 IU/ml insulin syringe should be used.
Cartridge: Before each use, invert the vial a few times before use until a homogenous suspension is obtained. The glass cartridge is designed to be used with the injector VetPen 8 or VetPen 16.
VetPen is accompanied by a package leaflet with detailed instruction for use to be followed. The injection procedure when using VetPen is as follows:
When changing between dosing devices (syringes or VetPen), owners should be advised to monitor their animal closely to detect any changes in behavior or clinical condition. A dose adjustment may be required.
A once daily injection is sufficient to reduce the blood glucose concentration in most diabetic dogs.
However, the duration of action may vary, making it necessary to administer the insulin dose twice daily to some diabetic dogs.
In diabetic cats, it is necessary to administer the veterinary medicinal product twice daily.
The dose depends on the degree of deficit in the animal's own insulin production and is therefore different in each case.
Stabilisation phase
Dog: Insulin therapy is initiated with the starting dose of 0.5 to 1.0 IU/kg bodyweight once daily, rounded down to the lowest entire number of units.
Subsequent adjustment to establish the maintenance dose should be made by increasing or decreasing the daily dose by approximately 10% according to the evolution of the diabetes clinical signs and to the results of serial blood glucose measurement. Alterations in dose should not normally be made more frequently than every 3 days.
The duration of insulin action as determined by blood glucose curve, may require treatment to be administered twice daily. In such cases, the dose per injection must be decreased by 25 % so that the total daily dose is less than doubled. For example for a 10 kg dog receiving 5 IU once daily, the new dose (rounded down to the nearest whole unit) would be 3 IU per injection initially. The new doses should be administered at 12-hour intervals. Further dose adjustments should be made progressively as previously explained. Following switching to twice daily dosing, it is recommended that the clinical signs and blood glucose response be monitored closely.
To achieve a balance between the generation of glucose and the effect of the veterinary medicinal product, feeding should be synchronised with the treatment and the daily ration divided into two meals. The composition and quantity of the daily food intake should be constant. In dogs treated once daily, the second meal is usually fed at the time of peak insulin effect. In dogs treated twice daily, feeding coincides with insulin administration. Each meal should be fed at the same time each day.
Cat: The initial dose is 1 IU or 2 IU per injection based on the baseline blood glucose concentration, as presented in the following table. Cats require twice daily administration.
Cat blood glucose concentration | Starting dose per cat |
<20 mmol/l or < 3.6 g/l (<360 mg/dl) | 1 IU twice daily |
≥20 mmol/l or ≥ 3.6 g/l (≥360 mg/dl) | 2 IU twice daily |
The starting dose should not exceed 2 IU per injection.
The composition and quantity of the daily food intake should be constant.
Subsequent adjustment to establish the maintenance dose should be made by increasing or decreasing the daily dose according to the results of serial blood glucose measurement. Alterations in dose should not normally be made more frequently than every week. Increments of 1 IU per injection are recommended. Due to the day-to-day variation in the blood glucose response, and the variations in insulin responsiveness that are seen with time, larger or more frequent increases in dose are not recommended.
Maintenance phase in dogs and cats
Once the maintenance dose has been reached and the animal is stabilised, a long term management program needs to be established. The aim should be to manage the animal in such a way as to minimise the variations in its insulin requirement. This includes clinical monitoring to detect under or over dosage of insulin and adjustment of dose if required. Careful stabilisation and monitoring will help to limit the chronic problems associated with diabetes, including cataracts (dogs), fatty liver (dogs and cats), etc.
Follow up examinations should be performed every 2-4 months (or more often if there are problems) to monitor the animal’s health, the owners records and biochemical parameters (like blood glucose and/or fructosamine concentration). Adjustments to the insulin dose should be made based on interpretation of the clinical signs supported by the laboratory results.
Somogyi overswing, also called rebound hyperglycaemia, is a response to an overdose of insulin insufficient to cause, potentially fatal, hypoglycaemia. As hypoglycaemia begins to develop, a hormonal response is triggered which results in the release of glucose from hepatic glycogen stores. This results in rebound hyperglycaemia which may also manifest as glycosuria for part of the 24-hour cycle. There is a danger that the Somogyi overswing is interpreted as a requirement for increase in the insulin dose rather than a decrease. This can be avoided by basing decisions on serial blood glucose measurements rather than single point measurements.
The ability of pet owners to recognise the signs of hypo- or hyperglycaemia and respond appropriately is very important.
Overdose
Insulin overdose can result in clinical symptoms of hypoglycemia. Before the product is administered owners should be instructed to have a box of powdered glucose at home. Signs of hunger, increasing anxiety, unstable locomotion, muscle twitching, stumbling or sinking in the rear legs and disorientation indicate progression of hypoglycaemia and require immediate administration of glucose solution and food to restore blood glucose levels.
Hypoglycemia, as a result of an overdose of insulin, may trigger a hormonal response and a release of glucose (Somogyi overswing). (See section: Amounts to be administered and administration route).
Withdrawal periods
Not applicable.