Insuvet

Introduction

Company name: Schering-Plough Animal Health

Address: Division of Schering-Plough Ltd

Breakspear Road South

Harefield, Uxbridge

Middlesex UB9 6LS

Telephone: 01895 626000

Fax: 01895 672429

Email: spahuk@spcorp.com

Website: www.spah.co.uk

Presentation

Insuvet Neutral

Neutral Insulin Injection B.P. Each vial contains 10 ml of clear solution of highly purified bovine insulin. Each ml contains 100 i.u. insulin.

Insuvet Lente

Insulin Zinc Suspension (Mixed) B.P., Ph. Eur. Each vial contains 10 ml of white injectable suspension of highly purified bovine insulin. Each ml contains 100 i.u. insulin.

Insuvet Protamine Zinc

Protamine Zinc Insulin B.P., Ph. Eur. Each vial contains 10 ml of white injectable suspension of highly purified bovine insulin. Each ml contains 100 i.u. insulin.

Uses

The treatment of insulin dependent diabetes mellitus in the dog and cat only.

Insuvet Neutral

Insuvet Neutral has a rapid onset and short duration of activity when administered intravenously, intramuscularly or subcutaneously, and is normally used to treat dogs or cats presented in a ketoacidotic state.

Insuvet Lente

Insuvet Lente has a medium to extended duration of action and is administered subcutaneously. The onset of action is normally 1–3 hours post administration, with a maximum effect at 6–12 hours and a maximum duration 18–28 hours.

Insuvet Protamine Zinc

Insuvet Protamine Zinc has a medium to extended duration of action and is administered subcutaneously. The onset of action is normally 2–5 hours post administration, with a maximum effect at 12–24 hours and a maximum duration of 24–36 hours.

The veterinary surgeon should be aware that the onset, peak and duration of activity has been reported as being variable between dogs and, in cats, can be half that achieved in dogs.

Dosage and administration

Ketoacidotic animals

Where a cat or dog is presented in a ketoacidotic state, it is essential to correct the fluid and metabolic imbalance before stabilisation is undertaken. Fluid and electrolyte therapy is necessary and continual assessment of blood chemistry is recommended. At this point the hyperglycaemia may be left until the animal is eating again, but if insulin therapy is to be commenced, continuous low dose intravenous infusion of Insuvet Neutral is advised at a dose of 5 iu per 100 ml of electrolyte, administered at 50–100 ml electrolyte per hour for dogs, and 50 ml per hour for cats. In the rare case of a ketoacidotic cat or dog with hyperosmolarity, rehydration, electrolyte and insulin therapy are all paramount.

Hyperglycaemic animals

Where the cat or dog is presented in a non-ketoacidotic hyperglycaemic state, stabilisation can be undertaken immediately. Depending on the degree of hyperglycaemia this may be accomplished by initiating therapy with Insuvet Lente or Insuvet Protamine Zinc, using a commencing dose of 0.5 iu/kg administered subcutaneously. Blood glucose must be monitored closely to establish the effect of the insulin dose.

An isocaloric daily ration to maintain a healthy weight should be established. A portion of the daily ration (normally between 1/3 and ½ for cats, and between ¼ and 1/3 for dogs) is fed within the hour before dosing with insulin. This applies whether the animal is dosed once daily, or in cases where twice daily dosing is required. The remaining portion should be offered at the estimated maximum hypoglycaemic state if dosing once a day, and at a similar time after the second dose if dosing twice a day. Once glucose levels have been established the insulin dose and feeding regime may be adjusted accordingly. Whenever the type of insulin, dose or feeding regime is altered, close monitoring of blood glucose should be undertaken.

Once stabilised, animals may go home but it should be borne in mind that the insulin dose may need adjustment at this time and close monitoring initially is recommended.

When adjusting doses of insulin it is recommended that the maximum change made, either increase or decrease, is 2 iu daily. It is important to realise that the full effects of an initial dose or dose change may not be seen until up to 3 days afterwards. Blood glucose should be monitored when changing doses and this possible 3 days delay should be considered before making further changes.

Contra-indications, warnings, etc

Insulin is contraindicated in hypoglycaemia.

Injections should be made immediately upon withdrawal from the vial.

Insuvet Lente and Insuvet Protamine Zinc must be given only by subcutaneous injection. The requirement for insulin will vary with changes in diet and exercise, during illness, stress, pregnancy, liver or kidney diseases and when other medication with hypo or hyperglycaemic activity is given.

Insulin antagonism may develop. Recognised causes in the dog include exogenous glucocorticoid administration, hyperadrenocorticism, oestrus, pregnancy and chronic infection.

Overdosage causes hypoglycaemia which must be treated immediately with intravenous dextrose. If the animal is at home and convulsing, sugared water or syrup should be carefully introduced into the animal's mouth until the convulsions stop and veterinary attention can be provided.

Avoid contact with skin. Care should be taken to avoid accidental self-injection. In the event of accidental self injection, medical advice MUST be sought immediately, showing the Doctor this label and any other product literature. Persons who are hypersensitive (allergic) to insulin or other ingredients in the product should wear rubber gloves when handling this product.

For animal treatment only.

Keep out of the reach of children.

Pharmaceutical precautions

Insuvet should be stored at 2°C - 8°C. Do not freeze. Insuvet Lente and Insuvet Protamine Zinc vials should be shaken gently by inversion several times before the dose is withdrawn. The vial must not be used if the contents do not re-disperse. Following withdrawal of the first dose, use the product within 28 days. Discard unused material. Unused product and associated waste should be disposed of in a accordance with any guidance from an appropriate waste regulation authority.

Legal category

POM-V (previously POM)

Packaging Quantities

10 ml vials.

Further information

It is recommended that 0.5 ml 100 unit insulin sterile disposable syringes are used for administration, and a new syringe and needle is used for each injection.

If excessive levels of insulin are administered, blood glucose will fall rapidly. Physiological responses bring about a compensatory increase (Somogyi over- swing). Veterinary surgeons should consider this when animals apparently require excessive doses of insulin.

Marketing authorisation number

Insuvet Neutral:

Vm 0201/4021

Insuvet Lente:

Vm 0201/4022

Insuvet Protamine Zinc:

Vm 0201/4023