CERENIA 24MG TABLETS FOR DOGS

Kraj: Australia

Język: angielski

Źródło: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Składnik aktywny:

MAROPITANT AS MAROPITANT CITRATE

Dostępny od:

ZOETIS AUSTRALIA PTY LTD

INN (International Nazwa):

maropitant as citrate(24mg/Tb)

Forma farmaceutyczna:

ORAL TABLET

Skład:

MAROPITANT AS MAROPITANT CITRATE AMINO-ACID Active 24.0 mg/Tb

Sztuk w opakowaniu:

4 Tablets

Klasa:

VM - Veterinary Medicine

Wyprodukowano przez:

ZOETIS AUSTRALIA

Grupa terapeutyczna:

DOG | PUPPY - OVER 8 WEEKS OLD | BITCH | CASTRATE | PUPPY

Dziedzina terapeutyczna:

CENTRAL NERVOUS SYSTEM

Wskazania:

ANTI-EMETIC | PREVENT NAUSEA | TRAVEL SICKNESS

Podsumowanie produktu:

Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [ANTI-EMETIC, PREVENT NAUSEA, TRAVEL SICKNESS]; PUPPY - OVER 8 WEEKS OLD: [ANTI-EMETIC, PREVENT NAUSEA, TRAVEL SICKNESS]; For the prevention of nauseas & acute vomiting in dogs & puppies (8+ weeks) and the prevention of vomiting due to motion sickness in dogs (16+ weeks).NOT TO BE USED in food producing species of animals. The safety of this product has NOT been established during pregnancy and lactation, and in puppies less than 8 weeks of age. Use with caution in animals suffering from a predisposition to heart disease

Status autoryzacji:

Registered

Data autoryzacji:

2023-07-01

Ulotka dla pacjenta

Copy in the header and footer will not appear on the final printed
label
CERENIA Tabs 24 mg Label
Prepared: 30/07/2013
Page 1 of 10
BLISTER FOIL
MAIN PANEL
_ _ RLP APPROVED
Copy in the header and footer will not appear on the final printed
label
CERENIA Tabs 24 mg Label
Prepared: 30/07/2013
Page 2 of 10
LEAFLET
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CERENIA
®
TABLETS FOR DOGS
DESCRIPTION
Tablets containing 16, 24, 60 or 160 mg of maropitant as maropitant
citrate per
tablet. Maropitant is a neurokinin (NK
1
) receptor antagonist that blocks the
pharmacological action of substance P in the CNS.
INDICATIONS
DOGS: For the prevention of nausea and acute vomiting in dogs and
puppies 8
weeks of age or older and the prevention of vomiting due to motion
sickness in dogs
16 weeks of age or older.
PHARMACOLOGY
Pharmacokinetics
The pharmacokinetic characterisation associated with maropitant after
oral (PO) or
subcutaneous (SC) administration in adult beagle dogs is provided in
the table
below.
PHARMACOKINETIC PARAMETERS IN BEAGLE DOGS (MEAN ± SD OR RANGE)
SC at 1 mg/kg
(n=6)
PO at 2 mg/kg
(n=8)
PO at 8 mg/kg
(n=8)
AUC
0-inf
(hr*ng/mL)
860±137
561±322
7840±5600
C
max
(ng/mL)
92±34
81±32
776±604
T
1/2
(hr)
8.84 (6.07-17.7)
4.03 (2.48-7.09)
5.46 (3.39-7.65)
T
max
(hr)
0.75±1.11
1.9±0.5
1.7±0.7
The absolute bioavailability of maropitant was much higher following
SC injection
(91% at 1 mg/kg) than after PO administration (24% at 2 mg/kg). Oral
bioavailability
may be underestimated due to the presence of nonlinear kinetics and
the resulting
longer T
1/2
seen after IV administration. Although hepatic first-pass metabolism
contributed to the relatively low bioavailability after an oral dose,
prandial status does
not significantly affect the extent of oral bioavailability. Greater
than dose-
proportional drug exposure can be expected with an increase in dose.
Systemic
clearance of maropitant following intravenous (IV) administration was
970, 995 and
533 mL/hr/kg at doses of 1, 2

Charakterystyka produktu

PRODUCT NAME: CERENIA TABLETS FOR DOGS
PAGE: 1 OF 5
THIS REVISION ISSUED: MAY, 2009
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 CHEMICAL PRODUCT AND COMPANY
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
SUBSTANCE:
Maropitant Citrate presented as a tablet.
TRADE NAME:
CERENIA TABLETS FOR DOGS
OTHER NAMES:
This product is sold in several sizes, suited to different varieties
and sizes of dogs.
PRODUCT CODE:
CJ-11,972-10
PFIZER MSDS CODE:
PRODUCT USE:
Anti-emetic for veterinary use as described on the product label.
CREATION DATE:
MAY, 2009
REVISION DATE:
MAY, 2009
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xi, Irritating. T, Toxic. N, Dangerous to the environment. Hazardous
according to the
criteria of ASCC.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R36, R43, R51, R48/22. Irritating to eyes. May cause sensitisation by
skin contact. Toxic to aquatic
organisms. Harmful: danger of serious damage to health by prolonged
exposure if swallowed.
SAFETY PHRASES:
S22, S28, S36, S60, S24/25. Do not breathe dust. After contact with
skin, wash immediately with
plenty of water. Wear suitable protective clothing. This material and
its container must be disposed of as hazardous
waste. Avoid contact with skin and eyes.
SUSDP CLASSIFICATION:
S4
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
: Oval, convex peach coloured tablets of various sizes.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
eye irritant, possible skin sensitiser. This is a physiologically
acti