Apoquel (6 - 9 kg)
Active substance
ATC code
Species
Dogs.
Indications
Treatment of pruritus associated with allergic dermatitis in dogs. Treatment of clinical manifestations of atopic dermatitis in dogs.
Dose to be administered and administration route
For oral use.
The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
For maintenance therapy, the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day. The requirement for long-term maintenance therapy should be based on an individual benefit-risk assessment.
These tablets can be administered with or without food.
The dosing table below shows the number of tablets required. The tablets are breakable along the score line.
|
Bodyweight (kg) of dog |
Strength and number of tablets to be administered: |
||
|
Apoquel 3.6 mg tablets |
Apoquel 5.4 mg tablets |
Apoquel 16 mg tablets |
|
|
3.0–4.4 |
½ |
||
|
4.5–5.9 |
½ |
||
|
6.0–8.9 |
1 |
||
|
9.0–13.4 |
1 |
||
|
13.5–19.9 |
½ |
||
|
20.0–26.9 |
2 |
||
|
27.0–39.9 |
1 |
||
|
40.0–54.9 |
1½ |
||
|
55.0–80.0 |
2 |
||
Adverse reactions
Dogs:
Very common (>1 animal / 10 animals treated): | pyoderma, skin lump, papilloma |
Common (1 to 10 animals / 100 animals treated): | lethargy, lipoma, polydipsia, increased appetite nausea, vomiting, diarrhoea, anorexia histiocytoma, fungal skin infection, pododermatitis otitis lymphadenopathy cystitis aggression |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | anaemia, lymphoma, convulsion |
Treatment-related clinical pathology changes were restricted to an increase in mean serum cholesterol and a decrease in mean leukocyte count, however, all mean values remained within the laboratory reference range. The decrease in mean leukocyte count observed in oclacitinib-treated dogs was not progressive, and affected all white blood cell counts (neutrophil, eosinophil and monocyte counts) except lymphocyte counts. Neither of these clinical pathology changes appeared clinically significant.
Regarding susceptibility to infection and neoplastic conditions, see section 4.5 "Special precautions for use".
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
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