PALLADIA 10MG

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: APVMA (Australian Pesticides and Veterinary Medicines Authority)

সক্রিয় উপাদান:

TOCERANIB

থেকে পাওয়া:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

toceranib as phosphate(10mg/Tb)

ফার্মাসিউটিকাল ফর্ম:

ORAL TABLET

রচনা:

TOCERANIB ENZYME Active 10.0 mg/Tb

প্যাকেজ ইউনিট:

(blister); *(bottle); *30; 20 tabs; 999

শ্রেণী:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

ANTI-NEOPLASTIC AGENT

থেরাপিউটিক ইঙ্গিত:

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

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2023-07-01

তথ্য লিফলেট

AUSTRALIAN GOVERNMENT
AUSTRALIAN PESTICIDES
AND
VETERINARY
MEDICINES
AUTHORITY
APPENDIX2
•
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Select appropriate:
RLP
Approved
0
New Product (include all applicable RLPs)
OR
0
Variation (highlight instructions that are being varied). Approval
no.
of label being varied: 64617/48778.
Signal
heading:
Product
name:
Active
constituent/s:
Statement
of
claims:
Net
contents:
Clinical
Pharmacology
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
PALLADIA® 10MG
Each film coated tablet contains 10
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 10MG TABLETS (BOTTLES),
20
X 10MG 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unpublished,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 cleara

পণ্য বৈশিষ্ট্য

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