Palladia

Country: New Zealand

Language: English

Source: Ministry for Primary Industries

Active ingredient:

toceranib phosphate

Available from:

Zoetis New Zealand Limited

INN (International Name):

toceranib phosphate

Composition:

toceranib phosphate 124.69 g/kg

Therapeutic area:

Antineoplastic Agent

Authorization status:

ACVM Registered

Authorization date:

2012-11-23

Summary of Product characteristics

REGISTRANT:
Zoetis New Zealand Limited, 8 Mahuhu Crescent, Auckland
TRADE NAME:
PALLADIA
ACVM NO.:
A010834
PREPARATION DATE:
7 November 2018
PAGE:
1 of 17
BLISTER FOIL (INTERNATIONAL FORMAT)
FOR ANIMAL TREATMENT ONLY
PALLADIA
®
10 [15] [50] MG
10 [15] [50] mg/Tablet TOCERANIB
Batch
Exp
[Zoetis logo]
REGISTRANT:
Zoetis New Zealand Limited, 8 Mahuhu Crescent, Auckland
TRADE NAME:
PALLADIA
ACVM NO.:
A010834
PREPARATION DATE:
7 November 2018
PAGE:
2 of 17
BLISTER CARTON (ANZ)
MAIN PANEL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
PALLADIA
® 10 [15] [50] MG
EACH FILM COATED TABLET CONTAINS 10 [15] [50] MG TOCERANIB (AS
TOCERANIB PHOSPHATE)
For the treatment of Patnaik grade II or III recurrent, cutaneous mast
cell tumours with or without
regional lymph node involvement in dogs.
20 TABLETS
[Zoetis logo]
BLISTER CARTON (ANZ)
SIDE PANEL 1
PALLADIA
® 10 [15] [50] MG TABLETS FOR DOGS
BLISTER CARTON (ANZ)
SIDE PANEL 2
[Barcode]
For Oral Use
BLISTER CARTON (ANZ)
END FLAP
Store below 30°C (Room Temperature).
Batch:
Expiry:
REGISTRANT:
Zoetis New Zealand Limited, 8 Mahuhu Crescent, Auckland
TRADE NAME:
PALLADIA
ACVM NO.:
A010834
PREPARATION DATE:
7 November 2018
PAGE:
3 of 17
BLISTER CARTON (ANZ)
REAR PANEL
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
CONTRAINDICATIONS:
THIS
PRODUCT
IS
CONTRAINDICATED
FOR
USE
IN
BREEDING
DOGS,
AND
PREGNANT OR LACTATING BITCHES.
TABLETS MUST NOT BE SPLIT. DO NOT BREAK OR CRUSH TABLETS.
Administer an initial dosage of 3.25 mg/kg body weight orally every
second day (see Table 5 of
leaflet). Dose reductions of 0.5 mg/kg (to a minimum dose of 2.2 mg/kg
every second day) and
dose interruptions (cessation of PALLADIA for up to two weeks) may be
utilised, if needed to
manage adverse reactions (see Table 6 of leaflet). Adjust dose based
on approximately weekly
veterinary assessments for the first 6 weeks and approximately every 6
weeks thereafter.
PALLADIA may be administered with or without food.
SAFETY DIRECTI