PALLADIA 15MG

Țară: Australia

Limbă: engleză

Sursă: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredient activ:

TOCERANIB

Disponibil de la:

ZOETIS AUSTRALIA PTY LTD

INN (nume internaţional):

toceranib as phosphate(15mg/Tb)

Forma farmaceutică:

ORAL TABLET

Compoziție:

TOCERANIB ENZYME Active 15.0 mg/Tb

Unități în pachet:

(blister); *(bottle); *30 tabs; 20 tabs

Clasă:

VM - Veterinary Medicine

Produs de:

ZOETIS AUSTRALIA

Grupul Terapeutică:

DOG | BITCH | CASTRATE | PUPPY

Zonă Terapeutică:

ANTI-NEOPLASTIC AGENT

Indicații terapeutice:

PATNAIK GRADE II OR III RECURRENT | CUTANEOUS MAST CELL TUMOURS | NODE INVOLVEMENT IN DOGS | WITH OR WITHOUT REGIONAL LYMPH

Rezumat produs:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [PATNAIK GRADE II OR III RECURRENT]; For the treatment of Patanik grade II or III recurrent, cutaneous mast cell tumours with or without regional lymph node involvement in dogs.Contraindicated in dogs < 24 months of age or < 5kg, breeding dogs and pregnant or lactating bitches. See GENERAL SAFETY PRECAUTIONS, etc. on leaflet

Statutul autorizaţiei:

Registered

Data de autorizare:

2023-07-01

Prospect

c
Australian Government
Australian Pesticides
and
Veterinary Medicines Authority
!+"
APPENDIX 2
RLP
Approved
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)
(Veterinary
Products)
Select appropriate:
Cl
New Product (include
all
applicable RLPs)
OR
0
Variation (highlight instructions that are being varied). Approval
no.
of label being varied: 64616/48777.
Signal heading:
Product name:
Active constituenUs:
Statement
of
claims:
Net contents:
Clinical
Pharmacology
PRESCRIPTION ANIMAL REMEDY
KEEP OUT
OF
REACH
OF
CHILDREN
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
Palladia® 15mg
Each film
co~ted
t~blet
contains
15
mg
TOCERANIB (as toceranib phosphate)
For
the
treatment
of
Patnaik grade
II
or
Ill, recurrent, cutaneous
mast
cell
tumours
with
or
without
regional
lymph
node
involvement
in
dogs
30 x 15mg Tablets (bottles),
20
x 15mg Tablets
(blister
pack)
Mechanism
of
Action
Toceranib phosphate
is
a small molecule, multi-kinase inhibitor, that has demonstrated direct
anti-
tumour
and
antiangiogenic
activity
in
in
vivo
and
in
vitro
studies.
Data
from
unpublished,
biochemical and cellular studies suggest that toceranib selectively
inhibits the tyrosine kinase
activity of several members of the split kinase receptor tyrosine
kinase (RTK) family, some of
which are implicated
in
tumour growth, pathological angiogenesis, and metastatic progression
of
cancer.
These include Flk-1/KDR tyrosine kinase (vascular endothelial growth
factor receptor,
VEGFR2),
platelet-derived growth factor receptor (PDGFR)
and
stem cell factor receptor (kit).
Toceranib treatment can induce cell cycle arrest and subsequent
apoptosis
in
tumour cell lines
expressing activating mutations
in
the split kinase
RTK,
c-kit.
Canine mast cell tumour growth is
frequently driven
by
activating mutations
in
c-kit.
Pharmacokinetics
Following intravenous administration, the pharmacokinetics of
toceranib
is
characterised
by
a very
large volume of distribution (>20 Llkg, indicating partitioning into
tissues), a terminal elimination
half-life of about
16
hrs,
and a cle

Caracteristicilor produsului

PRODUCT NAME: PALLADIA
PAGE: 1 OF 5
THIS REVISION ISSUED: AUGUST, 2011
MATERIAL SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Pfizer Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: [phone]
Fax: [phone]
____________________________________
PFIZER AUSTRALIA PTY LTD
A.B.N. 50 008 422 348
CHEMICAL NATURE:
Complex heterocyclic molecule.
TRADE NAME:
PALLADIA
OTHER NAMES:
Toceranib phosphate
PRODUCT USE:
Veterinary pharmaceutical active ingredient.
CREATION DATE:
MAY, 2011
THIS VERSION ISSUED:
AUGUST, 2011
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
T, Toxic. Hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R22, R36, R61, R62, R48/25. Harmful if swallowed. Irritating to eyes.
May cause harm to the unborn
child. Possible risk of impaired fertility. Toxic: danger of serious
damage to health by prolonged exposure if
swallowed.
SAFETY PHRASES:
S2, S22, S45, S53. Keep out of reach of children. Do not breathe dust.
In case of accident or if
you feel unwell, contact a doctor or Poisons Information Centre
immediately (show this MSDS where possible). Avoid
exposure - obtain special instructions before use.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: Orange coloured crystalline solid.
ODOUR:
No data odour.
MAJOR HEALTH HAZARDS:
harmful if swallowed, eye irritant, possible risk of impaired
fertility.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F
F
F
E
E
E
C
C
C
T
T
T
S
S
S
I