APOQUEL 3.6 MG TABLETS FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

OCLACITINIB MALEATE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

oclacitinib maleate(3.6mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

OCLACITINIB MALEATE Active 3.6 mg/Tb

Units in package:

100tablets; 20 tablets

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic area:

ANTIPRURITIC

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [ALLERGIC DERMATITIS, ATOPIC DERMATITIS, PRURITIS]; For the treatment of pruritus associated with allergic dermatitis in dogs. For the treatment of the clinical manifestatios of atopic dermatitis in dogs.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

APOQUEL 3.6 MG TABLETS FOR DOGS
68311 / 115483
Product Name:
APVMA Approval No:
Label Name:
APOQUEL 3.6 MG TABLETS FOR DOGS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
Constituent
Statements:
Each tablet contains 3.6 mg oclacitinib maleate
Claims:
For the treatment of pruritus associated with allergic dermatitis in
dogs.
For the treatment of the clinical manifestations of atopic dermatitis
in dogs.
Net Contents:
20 or 100 x 3.6 mg Tablets
Directions for Use:
Restraints:
Contraindications:
This product is contraindicated in animals with known hypersensitivity
to oclacitinib.
This product is contraindicated in dogs with evidence of immune
suppression such as
hyperadrenocorticism or with evidence of progressive malignant
neoplasia, as the active
substance has not been evaluated in these cases.
Precautions:
APOQUEL (oclacitinib) modulates the immune system. APOQUEL may
increase the
susceptibility to infection and the development of papillomas, and may
exacerbate
neoplastic conditions including subclinical neoplastic conditions.
Dogs receiving APOQUEL
should therefore be monitored for the development of infections and
neoplasia.
The safety of the drug has not been studied in breeding male dogs, nor
in pregnant or
lactating female dogs. In the absence of such studies, it is not
recommended to use the
drug in pregnant or lactating bitches or in dogs intended for
breeding.
APOQUEL is not for use in dogs less than 12 months of age or less than
3 kg bodyweight.
The use of Apoquel has not been evaluated in combination with
glucocorticoids,cyclosporine, or other systemic immunosuppressive
agents. RLP APPROVED
Side Effects:
Treatment of pruritus associated with allergic dermatitis:
In two overseas field studies, a total of 321 dogs received 0.4 –
0.6 mg/kg of APOQUEL
twice daily for 14 days.
There were no serious adverse events reported during both studies. The
most reported
abnormal clinical signs were vomiting and diarrh