Presentation

Caninsulin is an aqueous suspension of insulin containing 40 iu per ml of highly purified porcine insulin Ph. Eur., 30% of which is amorphous zinc insulin and 70% crystalline zinc insulin.  Methylparahydroxybenzoate Ph. Eur. 0.1% w/v is present as a preservative.

Uses

Caninsulin 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 Caninsulin.

Dosage and administration

An insulin-syringe with insulin unit markings for a 40 iu/ml solution must be used.

DOGS: 
Caninsulin should be administered once daily by intramuscular or subcutaneous injection.

To achieve a balance between the generation of glucose and the effect of Caninsulin, feeding must be synchronised to the treatment and the daily ration should be divided into two equal parts. Composition and quantity of the daily food intake should be constant.  The Caninsulin injection should be given with the first half of the daily ration and the second meal given about 7.5 hours later (e.g. 08.30 and 16.00).  Each meal should be fed at the same time each day.

The dose depends on the degree of deficit in the animal's own insulin production and therefore is different in each case. The suggested initial daily dose is 1 iu per kg bodyweight plus a weight dependent supplement dose (see table), although it is recognised that some veterinary surgeons prefer to start therapy at around 0.5 iu per kilogram which is also acceptable.

Subsequent adjustment to establish the maintenance dose should be made by increasing or decreasing the daily dose by approximately 10% per alteration in dose according to the results of measurement of the glucose levels in the blood or urine.  Alterations in dose should not normally be made more frequently than every 3 or 4 days.

Plasma glucose measurements provide a more accurate assessment of insulin activity during the stabilisation period, since glycosuria will not occur until the renal threshold for glucose is reached at about 10 mmol/l. Normal plasma glucose levels are around 4-5 mmol/l therefore abnormal increases in plasma glucose up to but not above the renal threshold will not be detected by urine glucose measurement.

Fluctuations in plasma glucose levels are unlikely to be reflected by urine glucose measurements since glucose levels at urination will be in proportion to average plasma glucose levels over the previous 5-8 hours. Furthermore, unless a degree of glycosuria is maintained the development of hypoglycaemia will not be detected by urine glucose measurement.

CATS:

Caninsulin should be administered twice daily at an interval of 12 hours by subcutaneous injection. 

The composition and quantity of the daily food intake should be constant.  The insulin dose depends on the degree of deficit in the animal's own insulin production determined by serial blood glucose measurements, and is different for each individual.  The initial dose is 0.5 iu/kg twice daily if the baseline blood glucose concentration is 20 mmol/l (i.e. 3.6 g/l or 360 mg/dl) or greater, and 0.25 iu/kg if the baseline blood glucose concentration is less than 20 mmol/l (i.e. 3.6g/l or 360 mg/dl).

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 measurements.  Alterations in dose should not normally be made more frequently than every 3 or 4 days, and 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.

General:

Once the maintenance dose has been established and the animal is stabilised, a long term management programme 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 monitoring to detect under or overdosage of insulin and adjustment of dose if required.  Careful stabilisation and monitoring and control during maintenance will help to limit the chronic problems associated with diabetes including cataracts (dogs), fatty liver (dogs and cats) etc.  Various approaches to maintenance have been described in the literature.  One widely practised system is for the owner to check the urine.

A more clinically rational approach is for the owner to monitor and record the animal's general health (including well being, thirst and appetite) and check urine samples only as considered clinically useful by the veterinary surgeon.  The veterinary surgeon checks the patient every 2-4 months (or more often if there are problems) including its health and the owners records.
 

The plasma glucose is also measured at this time and a fructosamine level may also be useful.  Adjustments to the insulin dose are made by the veterinary surgeon based on full analysis of the clinical data and the laboratory results.

Owners and veterinary surgeons should be aware of Somogyi overswing which is a response to an overdose of insulin insufficient to cause an actual hypoglycaemia.  As a partial hypoglycaemia begins to develop a hormonal response is triggered which results in 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 will be interpreted as a requirement for increase in the insulin dose rather than a decrease.  This situation can progress to an overdose so large as to cause clinical hypoglycaemic effects. 

The ability for owners to recognise the signs of hypo- or hyperglycaemia and respond appropriately is important if control is to be achieved during maintenance therapy. 

In the cat diabetic remission is possible.

Before Caninsulin 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 requires administration of insulin to restore blood glucose levels to the normal range.

Contra‑indications, warnings, etc

1. Caninsulin is a medium duration insulin and is not intended for the treatment of animals with severe acute diabetes presenting in a ketoacidotic state. 
2. The use of progestagens (oestrus inhibitors) in patients suffering from diabetes mellitus should be avoided.  Ovariohysterectomy may have to be considered.
3. Stress and irregular extra exercise must be avoided. Care must be taken with the use of corticosteroids.
4. It is important to establish a strict feeding schedule in consultation with the owner which will include a minimum of fluctuations and changes.
5. Administration of Caninsulin must be carried out by an adult responsible for the welfare of the animal.
6. Caninsulin must not be administered by the intravenous route. 

For animal treatment only.  Keep out of reach of children. 

Pharmaceutical precautions

Store upright and refrigerated at between +2 and 8°C.  After first opening store refrigerated at between +2 and 8°C, or not above 25 °C. Protect from light. Do not freeze. Following withdrawal of the first dose use the product within 28 days.

Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon or to a local pharmacy. 

Legal category
POM-V

Package quantities
2.5 ml vials in multiple packs
10 ml vials in single packs

Further information
An owner’s manual giving guidance on the administration of Caninsulin and the principles of effective maintenance therapy is available.

Marketing Authorisation number

Vm 01708/4244

Marketing Authorisation holder
Intervet UK Ltd.
Walton
Milton Keynes
Buckinghamshire MK7 7AJ

Distributed in Northern Ireland by:

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Date of preparation
September 2005

Item code: 000506                                        Print version: 60964/Oct 05/MP/4K