Patient leaflet - Zycortal
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Zycortal 25 mg/ml prolonged-release suspension for injection for dogs
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder :
Dechra Regulatory B.V.
Handelsweg 25
5531 AE Bladel
The Netherlands
Manufacturer responsible for batch release :
Eurovet Animal Health B.V.
Handelsweg 25
5531 AE Bladel
The Netherlands
Dales Pharmaceuticals Limited
Snaygill Industrial Estate
Keighley Road
Skipton
North Yorkshire
BD23 2RW
United Kingdom
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Zycortal 25 mg/ml prolonged-release suspension for injection for dogs
Desoxycortone pivalate
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substance:
Desoxycortone pivalate 25 mg/ml
Excipients:
Chlorocresol 1 mg/ml
Zycortal is an opaque white suspension.
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4. INDICATION(S)
For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison’s disease).
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5. CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
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6. ADVERSE REACTIONS
Polydipsia (excessive drinking) and polyuria (excessive urination) were very common adverse reactions in a clinical trial. Inappropriate urination, lethargy, alopecia (hair loss), panting, vomiting, decreased appetite, anorexia, decreased activity, depression, diarrhoea, polyphagia (excessive eating), shaking, tiredness and urinary tract infections were common adverse reactions in a clinical trial.
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Injection site pain has been reported uncommonly in post-authorisation spontaneous reports following the administration of Zycortal.
Pancreas disorders have been reported rarely in post-authorisation spontaneous reports following use of Zycortal. The concurrent administration of glucocorticoids may contribute to these signs.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Dogs.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous use.
Prior to use, gently shake the vial to resuspend the product.
Use an appropriately graduated syringe to accurately administer the required dose volume. This is particularly important when injecting small volumes.
Zycortal replaces the mineralocorticoid hormones only. Dogs with combined glucocorticoid and mineralocorticoid deficiency should also receive a glucocorticoid such as prednisolone taking into account the current scientific knowledge.
Zycortal is intended for long term administration at intervals and doses dependent upon individual response. Tailor the dose of Zycortal and the concurrently administered glucocorticoid replacement therapy to the individual dog based on clinical response and normalization of Na+ and K+ serum concentrations.
Initial dose of Zycortal:
The initial dose is 2.2 mg/kg body weight, administered by subcutaneous injection.
Interim monitoring visit:
Re-evaluate the dog and measure the serum sodium/potassium ratio (Na+/K+ ratio) approximately 10 days after the first dose (which is the time to maximum concentration (Tmax) of desoxycortone). If the dog’s clinical signs have worsened or not resolved, adjust the dose of glucocorticoid and/or investigate other causes of the clinical signs.
Second dose of Zycortal:
At approximately 25 days after the first dose, re-evaluate the dog and measure the Na+/K+ ratio.
- If the dog is both clinically normal and has a normal Na+/K+ ratio (i.e. 27 to 32) on Day 25,
adjust the dose based on the Day 10 Na+/K+ ratio using the guidelines in Table 1, below.
- If the dog is clinically normal and has a Na+/K+ ratio > 32 on Day 25, either adjust the dose
based on the Day 10 Na+/K+ ratio according to Table 1 or delay the dose (see Prolonging the dosing interval ).
- If the dog is either not clinically normal or if the Na+/K+ ratio is abnormal on Day 25, adjust the
dose of glucocorticoid or Zycortal (see Subsequent doses and long term management ).
Table 1: Day 25: Administering the Second Dose of Zycortal
| If the Day 10 Na+/K+ ratio is: | Do not administer Dose 2 on Day 10. | 25 days after the first dose, administer Zycortal, as follows: |
| > 34 | Decrease dose to: 2.0 mg/kg body weight | |
| 32 to < 34 | Decrease dose to: 2.1 mg/kg body weight | |
| 27 to < 32 | Continue 2.2 mg/kg body weight | |
| > 24 to < 27 | Increase dose to: 2.3 mg/kg body weight | |
| < 24 | Increase dose to: 2.4 mg/kg body weight |
Prolonging the dosing interval:
If the dog is clinically normal and the Day 25 Na+/K+ ratio is > 32, it is possible to prolong the dosing interval instead of adjusting the dose as described in Table 1. Evaluate the electrolytes every 5–9 days until the Na+/K+ ratio is < 32, and then administer 2.2 mg/kg of Zycortal.
Subsequent doses and long term management:
Once the optimal dose and dosing interval have been determined, maintain the same regimen. If the dog develops abnormal clinical signs or Na+ or K+ serum concentrations, use the following guidelines for subsequent doses:
- Clinical signs of polyuria/polydipsia: Decrease the glucocorticoid dose first. If the polyuria/polydipsia persists and the Na+/K+ ratio is >32, then decrease the dose of Zycortal without changing the dosing interval.
- Clinical signs of depression, lethargy, vomiting, diarrhoea or weakness: Increase the glucocorticoid dose.
- Hyperkalaemia, hyponatremia or Na+/K+ ratio < 27: Decrease the Zycortal dosing interval by 23 days or increase the dose.
- Hypokalaemia, hypernatremia or Na+/K+ ratio > 32: Decrease the Zycortal dose.
Prior to a stressful situation, consider temporarily increasing the dose of glucocorticoid.
In the clinical trial, the mean final dose of Zycortal was 1.9 mg/kg (range 1.2–2.5 mg/kg) and the mean final dosing interval was 38.7 ± 12.7 days (range 20–99 days) with the majority of dogs having a dosing interval between 20 and 46 days.
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9. ADVICE ON CORRECT ADMINISTRATION
Not applicable.
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10. WITHDRAWAL PERIOD(S)
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Do not store above 30 °C.
Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
Shelf life after first opening the container: 4 months.
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12. SPECIAL WARNING(S)
Special precautions for use in animals :
Use with caution in dogs with congestive heart disease, severe renal disease, primary hepatic failure or oedema.
Before starting treatment with the veterinary medicinal product, it is important that Addison’s disease has been definitively diagnosed. Any dog presenting with severe hypovolaemia, dehydration, pre-renal azotaemia and inadequate tissue perfusion (also known as “Addisonian crisis”) must be rehydrated with intravenous fluid (saline) therapy before starting treatment with the veterinary medicinal product.
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
Avoid contact with the eyes and skin. In case of accidental spillage onto the skin or eyes, wash the affected area with water. If irritation occurs, seek medical advice immediately and show the package leaflet or the label to the physician.
This veterinary medicinal product may cause pain and swelling at the injection site if accidentally selfadministered.
This veterinary medicinal product may cause adverse effects on male reproductive organs and, as a result, fertility.
This veterinary medicinal product may cause adverse developmental effects on unborn children and neonates.
Pregnant and breast-feeding women should avoid administration of this veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Pregnancy and lactation :
The safety of the veterinary medicinal product has not been established during breeding, pregnancy or lactation. Therefore, use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction :
Use caution when administering Zycortal concurrently with medicinal products which affect either serum sodium or potassium concentrations, or cellular transportation of sodium or potassium, for example: trimethoprim, amphotericin B, or digoxin or insulin.
Overdose (symptoms, emergency procedures, antidotes) :
When given to dogs at three to five times the recommended dose, injection site reactions, characterised by erythema and oedema occurred.
As expected from the pharmacodynamic effects, escalating doses of desoxycortone are associated with a dose-related trend for increased serum sodium, and decreased blood urea nitrogen, serum potassium and urine specific gravity. Polyuria and polydipsia may be observed.
Hypertension has been observed in dogs receiving 20 mg/kg of desoxycortone pivalate.
There is no specific antidote. In case of signs of overdose, the dog should be treated symptomatically, and subsequent doses reduced.
Incompatibilities :
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.
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15. OTHER INFORMATION