APOQUEL

Country: New Zealand

Language: English

Source: Ministry for Primary Industries

Active ingredient:

oclacitinib maleate

Available from:

Zoetis New Zealand Limited

INN (International Name):

oclacitinib maleate

Composition:

oclacitinib maleate 48.38 g/kg

Therapeutic area:

Anti-inflammatory

Authorization status:

ACVM Registered

Authorization date:

2013-08-08

Summary of Product characteristics

REGISTRANT:
Zoetis New Zealand Limited, 8 Mahuhu Crescent, Auckland
TRADE NAME:
APOQUEL
ACVM NO.:
A10963
PREPARATION DATE:
05 May 2022
PAGE:
1 of 8
BLISTER FOIL (INTERNATIONAL FORMAT)
MAIN PANEL
EXP
LOT
APOQUEL
®
3.6 [5.4] [16] MG
Oclacitinib
For animal treatment only
[Zoetis logo]
REGISTRANT:
Zoetis New Zealand Limited, 8 Mahuhu Crescent, Auckland
TRADE NAME:
APOQUEL
ACVM NO.:
A10963
PREPARATION DATE:
05 May 2022
PAGE:
2 of 8
BOTTLE LABEL (NZ)
MAIN PANEL
DANGER - KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
RESTRICTED VETERINARY MEDICINE
APOQUEL
®
3.6 [5.4] [16] MG OCLACITINIB AS OCLACITINIB MALEATE
For the treatment of pruritus associated with allergic dermatitis in
dogs. For the treatment of clinical
manifestations of atopic dermatitis in dogs.
STORAGE: Store below 25°C (Air Conditioning).
[GHS pictogram]
[Zoetis logo]
20 [100] TABLETS
BOTTLE LABEL (NZ)
SIDE PANEL 1
READ THE ENCLOSED LEAFLET
DOSE: 0.4 mg/kg bodyweight (up to 0.6 mg/kg), twice daily for up to 14
days, and then once daily for
maintenance therapy.
SAFETY DIRECTIONS: Wash hands immediately after handling this product.
Avoid ingestion, and contact with
the skin or eyes. IF IN EYES: Rinse cautiously with water for several
minutes. Remove contact lenses, if
present and easy to do. Continue Rinsing. For advice, contact the
National Poisons Centre 0800 POISON
(0800 764 766) or a doctor immediately.
RESTRICTED VETERINARY MEDICINE
Registered pursuant to the ACVM Act 1997, No. A10963
See www.foodsafety.govt.nz for conditions
Made in [Italy] [USA]
ZOETIS NEW ZEALAND LIMITED
8 Mahuhu Crescent, Auckland
Technical Services 0800 650 277
www.zoetis.co.nz
REGISTRANT:
Zoetis New Zealand Limited, 8 Mahuhu Crescent, Auckland
TRADE NAME:
APOQUEL
ACVM NO.:
A10963
PREPARATION DATE:
05 May 2022
PAGE:
3 of 8
BOTTLE LABEL (NZ)
SIDE PANEL 2
[Barcode]
Lot: / Exp:
CARTON (NZ)
MAIN PANEL
DANGER - KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
RESTRICTED VETERINARY MEDICINE
APOQUEL
®
3.6 [5.4] [16] MG TABLETS FOR DOGS
EACH TABLET CONTAINS 3.6 [5.4] [16