ProZinc
Active substance
ATC code
Species
Dogs
Indications
For the treatment of diabetes mellitus in dogs to achieve reduction of hyperglycaemia and improvement of associated clinical signs.
Dose to be administered and administration route
Subcutaneous use.
If the animal owner is to administer the product, suitable training/advice should be provided by the prescribing veterinarian before using for the first time.
Dosage:
The veterinarian should re-evaluate the animal at appropriate intervals and make adjustments to the treatment protocol, for instance dose and dosing regimen, until adequate glycaemic control has been attained.
Any dose adjustment (i.e. increase of dose) should be in general performed after several days (e.g. 1 week) since full action of insulin requires an equilibration phase. Dose reductions due to observed hypoglycaemia or suspected Somogyi effect (rebound hyperglycaemia) may be of 50% or higher (potentially including a temporary pause of insulin administration).
Once adequate glycaemic control is achieved intermittent glucose monitoring should be performed, especially when there is a change in clinical signs, and further adjustments in the insulin dose might be necessary.
General guidance:
Dosing should be individualised and based on the clinical presentation of each patient. To achieve optimal control of diabetes mellitus, dose adjustments should primarily be based on clinical signs. Blood parameters such as fructosamine, maximum blood glucose and decrease of blood glucose concentrations in blood glucose curves conducted over a sufficient period of time to determine a blood glucose nadir should be used as supporting tools. Re-evaluation of clinical signs and laboratory parameters should be performed as recommended by the attending veterinarian.
Initiation
For initiation of treatment, the recommended dose is 0.5 to 1.0 IU insulin/kg bodyweight once daily every morning (approx. every 24 h).
For newly diagnosed diabetic dogs, a starting dose of 0.5 IU insulin/kg once daily is recommended.
Management
Adjustments of insulin dose on a once daily regimen, if required, should generally be done in a conservative and gradual manner, (e.g. up to 25% increase/decrease of the dose per injection).
If insufficient improvement in diabetic control is observed after an adequate dose adjustment period of 4 to 6 weeks on once daily treatment, the following options may be considered:
| - | Further adjustments of insulin dose on once daily treatment may be necessary; in particular if dogs undertake increased physical activity, have a change of their usual diet or during concomitant illness. |
| - | Switching to twice daily dosing: In such cases, it is recommended to reduce the dose per injection by one third (e.g. 12 kg dog being treated once daily with 12 IU insulin/injection may be switched to 8 IU insulin/injection administered twice daily). The product should be administered in the morning and in the evening, approx. 12 hours apart. Further adjustments of insulin dose on twice daily treatment may be necessary. |
Depending on the underlying cause (e.g. dioestrus-induced diabetes mellitus), dogs can develop diabetic remission, although seldom. In those cases sufficient endogenous insulin production will be regained and the exogenous insulin dose will need to be adjusted or ceased.
Method of administration:
A U-40 syringe must be used.
The suspension should be mixed by gently rolling the vial prior to withdrawing each dose from the vial.
The dose should be given concurrently with or immediately after a meal.
Particular care should be taken with regard to the accuracy of dosing.
The veterinary medicinal product should be administered by subcutaneous injection.
Avoid introduction of contamination during use.
After gently rolling the vial, ProZinc suspension has a white, cloudy appearance.
A white ring may be seen in the neck of some vials, but this does not affect the quality of the product.
Agglomerates (e.g. clumps) can form in insulin suspensions: do not use the product if visible agglomerates persist after gently rolling the vial.
Adverse reactions
Hypoglycaemic reactions were very commonly reported in a clinical study: 26.5% (44 of 166) of treated dogs. These reactions were generally mild in nature. Clinical signs may include hunger, anxiety, unstable locomotion, muscle twitching, stumbling or sinking in the rear legs and disorientation.
In this case 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.
Local injection site reactions were very rarely reported and resolved without cessation of therapy.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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| Art. Nr. | |
| EAN | 5012917025279 |
