Contraindications:
- Do not use Zenrelia Tablet for Dogs 4.8mg in dogs showing signs of immune suppression.
- Do not use in dogs with evidence of progressive malignant neoplasia.
- Do not use in cases of hypersensitivity to ilunocitinib or any of the excipients.
Special Precautions for Use in Dogs:
- Use in dogs younger than 12 months of age is not recommended and should only be undertaken after a benefit-risk assessment by your veterinary surgeon.
- For dogs on long-term treatment, regular re-weighing is recommended to adjust the dose if there is a significant change in bodyweight.
- The product's use has not been evaluated in dogs with hepatic (liver) or renal (kidney) disease. Use in these cases should be based on a benefit-risk assessment by your veterinary surgeon.
- Ilunocitinib can affect the immune system, potentially increasing susceptibility to opportunistic infections and exacerbating neoplastic conditions. Dogs receiving Zenrelia Tablet for Dogs 4.8mg should be monitored for the development of infections and new growths.
- Initiating treatment may cause a decrease in certain white blood cell counts (leukocytes) and a reduction in red blood cell parameters. These changes typically stabilise within the first month of treatment and are usually not clinically relevant. However, periodic monitoring of complete blood counts and serum biochemistry is recommended for long-term treatment.
- The use of Zenrelia Tablet for Dogs 4.8mg in dogs with anaemia has not been evaluated and should be based on a benefit-risk assessment by your veterinary surgeon.
- When treating pruritus associated with allergic dermatitis, investigate and treat any underlying causes (e.g., flea allergic dermatitis, contact dermatitis, food hypersensitivity). For allergic dermatitis and atopic dermatitis, also investigate and treat complicating factors such as bacterial, fungal, or parasitic infections/infestations.
Use During Pregnancy, Lactation, or in Breeding Dogs:
- The safety of Zenrelia Tablet for Dogs 4.8mg has not been established in pregnant, lactating, or breeding dogs. Laboratory studies in rats have shown evidence of foetotoxic effects. Therefore, its use is not recommended during pregnancy, lactation, or in dogs intended for breeding.
Interaction with Other Medicinal Products:
- Concurrent use with other drugs that have potential immunosuppressive effects (e.g., systemic glucocorticoids, cyclosporin A) must only be based on a benefit-risk assessment by the responsible veterinary surgeon.
- Gastric pH modifiers may affect the oral bioavailability of ilunocitinib and should be used with caution.
Adverse Events (Side Effects):
Common adverse events (affecting 1 to 10 out of 100 treated animals) include:
- Emesis (vomiting)
- Diarrhoea
Adverse events of undetermined frequency include:
- Pododermatitis (paw inflammation)
- Papilloma (small, benign growths on the skin)
Reporting adverse events to your veterinary surgeon or the national competent authority is important for ongoing safety monitoring.
Symptoms of Overdose:
In studies, signs of overdose included generalised demodicosis, gum infections, interdigital cysts, papillomas, swollen feet (interstitial oedema), scabs on the paws, and paw thickening/discolouration. A mild-to-moderate reduction in red blood cell mass was also recorded. In severe cases, signs of coccidiosis (haemorrhagic diarrhoea, vomiting, weight loss, pale mucous membranes) were observed, leading to severe clinical signs in some animals. There is no specific antidote for overdose. If signs of overdose occur, the product should be withdrawn, and the signs treated symptomatically by a veterinary professional.
Special Precautions for Persons Administering the Product:
- Accidental ingestion of Zenrelia Tablet for Dogs 4.8mg may cause gastro-intestinal effects.
- In case of accidental ingestion, seek immediate medical advice and show the package leaflet or the label to the physician.
- Wash hands thoroughly after administering the product.
