PROZINC 10ML 40UI/ML | INSULIN FOR DOGS AND CATS

PROZINC

INJECTABLE SUSPENSION FOR CATS AND DOGS

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

• Insulin human* 40 IU as protamine zinc insulin

One IU (International Unit) corresponds to 0,0347 mg of human insulin.

* Produced using recombinant DNA technology.

Excipients:

• Protamine sulfate 0,466 mg
• Zinc oxide 0,088mg
• Phenol 2,5mg

PHARMACEUTICAL FORM

Injectable suspension.

Cloudy, white, aqueous suspension.

CLINICAL DATA

target species

Cats and dogs.

Indications for use, specifying the target species

For the treatment of diabetes mellitus in cats and dogs to reduce hyperglycemia and improve associated clinical signs.

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Contraindications

Do not use in the acute treatment 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 situations, lack of appetite, concomitant treatment with progestogens and corticosteroids or other concomitant diseases (such as gastrointestinal, infectious, inflammatory or endocrine diseases) may affect the efficacy of insulin and, therefore, it may be necessary to adjust the insulin dose.

Special precautions for use

Special precautions for use in animals

Insulin doses 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 (eg diestrus-induced diabetes mellitus, diabetes mellitus secondary to hyperadrenocorticism).

Once the daily dose of insulin is set, monitoring is recommended to control diabetes.

Insulin treatment may cause hypoglycemia, so consult clinical signs and appropriate treatment.

Special precautions for use in dogs

In cases where hypoglycaemia is suspected, blood glucose should be measured at the time of onset (if possible) and also shortly before the next nocturnal intake/nocturnal injection (where applicable).

Stress and irregular exercise should be avoided. It is recommended to establish with the owner a regular feeding schedule twice a day whether he injects insulin once or twice a day.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Accidental self-injection may cause clinical signs of hypoglycaemia, which can be treated with oral administration of sugar. There is a low possibility of an allergic reaction in hypersensitive people.

In case of accidental self-injection, consult a doctor immediately and show him the package leaflet or the label.

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Adverse reactions (frequency and seriousness)

Hypoglycemic reactions were reported very frequently 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, unsteady locomotion, muscle spasms, stumbling or claudication of the hind limbs, and disorientation.

In this case, the immediate administration of a solution or gel containing glucose and/or food is necessary.

Insulin administration should be temporarily stopped and the next insulin dose should be titrated accordingly.

Local reactions at the injection site have been reported very rarely, which subsided without interruption of treatment.

The frequency of adverse reactions should be classified according to the following groups:

Very common (more than 1 animal for every 10 animals treated presents adverse reactions)

Frequently (more than 1 but less than 10 animals per 100 animals treated)

Infrequently (more than 1 but less than 10 animals per 1.000 animals treated)

Rarely (more than 1 but less than 10 animals per 10.000 animals treated)

Very rarely (less than 1 animal per 10.000 animals treated, including isolated cases)

Use during pregnancy, lactation or lay

The safety and efficacy of ProZinc in breeding, pregnant and lactating animals have not been investigated.

Use only in accordance with the benefit/risk assessment carried out by the responsible veterinarian.

In general, insulin requirements during pregnancy and lactation may be different due to changes in metabolic status. Therefore, strict glucose control and veterinary supervision are recommended.

Interaction with other medicinal products and other forms of interaction

Changes in insulin requirements may be the result of the administration of substances that impair glucose tolerance (eg corticosteroids and progestogens). Glucose concentrations should be monitored to adjust the dose accordingly. Similarly, feeding cats a high-protein, low-carbohydrate diet and changing the diet of any cat or dog can alter insulin requirements and necessitate a change in insulin dose.

Dosage and route of administration

subcutaneous route.

If the drug is to be administered by the owner of the animal, the prescribing veterinarian should provide appropriate training/advice before first use.

Dosage:

The veterinarian should reassess the animal at appropriate intervals and adjust the treatment protocol, eg, dose and dosing regimen, until adequate glycemic control is achieved.

Any dose adjustment (eg dose increase) should generally be made after a few days (eg 1 week) as full insulin action requires a equilibration phase. Dose reduction due to observed hypoglycaemia or suspected Somogyi effect (relapse of hyperglycaemia) may be 50% or greater (potentially including a temporary pause in insulin administration).

Once adequate glycemic control is achieved, intermittent glucose monitoring should be performed, especially when there is a change in clinical signs or diabetic remission is suspected, and further insulin dose adjustments may be necessary.

• Cats:

The recommended starting dose is 0,2 to 0,4 IU insulin/kg body weight every 12 hours.

For cats previously controlled on insulin, a higher starting dose up to 0,7 IU insulin/kg body weight may be appropriate.

Insulin dose adjustments, if necessary, should be made between 0,5 and 1 IU of insulin per injection.

Cats may go into diabetic remission, in which case sufficient endogenous insulin production will resume and the exogenous insulin dose will need to be adjusted or discontinued.

• Dogs:

General guidance:

The dosage must be individualized and based on the clinical manifestation of each animal. To achieve optimal control of diabetes mellitus, dosage adjustments should be based primarily on clinical signs. Blood parameters such as fructosamine, peak blood glucose, and falling blood glucose concentrations in blood glucose curves performed over a period of time sufficient to determine a blood glucose nadir should be used as supportive tools.

Reassessment of clinical signs and laboratory parameters should be performed as recommended by the veterinarian.

Home

For initiation of treatment, the recommended dose is 0,5 to 1,0 IU insulin/kg body weight once daily every morning (approx. every 24 h).

For newly diagnosed diabetic dogs, an initial dose of 0,5 IU insulin/kg once daily is recommended.

Driving

Insulin dose adjustments in the once-daily regimen, if necessary, should generally be made conservatively and gradually (eg, up to 25% increase/decrease in dose per injection).

If insufficient improvement in diabetes control is observed after an adequate titration period of 4 to 6 weeks with once daily treatment, the following options may be considered:

• Additional insulin dose adjustments may be necessary for once-a-day treatment; in particular, if the dogs engage in increased physical activity, change their usual diet, or during a concomitant illness.
• Change to twice daily administrations: In such cases, it is recommended to reduce the dose per injection by one third (e.g. for a 12 kg dog being treated once daily with 12 IU insulin/injection it may be changed to 8 IU of insulin/injection given twice a day). The veterinary medicinal product should be administered in the morning and in the evening, approx. 12 hours apart. Additional insulin dose adjustments may be necessary in twice daily treatment.

Depending on the underlying cause (eg, diestrus-induced diabetes mellitus), dogs may develop diabetic remission, although more rarely than cats. In such cases, sufficient endogenous insulin production will recover and the exogenous insulin dose will need to be adjusted or discontinued.

PROZINC