CERENIA 16MG TABLETS FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MAROPITANT AS MAROPITANT CITRATE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

maropitant as citrate(16mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

MAROPITANT AS MAROPITANT CITRATE AMINO-ACID Active 16.0 mg/Tb

Units in package:

4 Tablets

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

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

Therapeutic area:

CENTRAL NERVOUS SYSTEM

Therapeutic indications:

ANTI-EMETIC | PREVENT NAUSEA | TRAVEL SICKNESS

Product summary:

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

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

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label
CERENIA Tablets 16 mg Label
Prepared: 30/07/2013
Page 1 of 10
BLISTER FOIL
MAIN PANEL
_ _ RLP APPROVED
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label
CERENIA Tablets 16 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

Summary of Product characteristics

PRODUCT NAME: CERENIA® TABLETS FOR DOGS
PAGE: 1 OF 7
THIS VERSION ISSUED: 19 NOVEMBER, 2015
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 1 - IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
PRODUCT IDENTIFIER:
CERENIA® TABLETS FOR DOGS
APVMA APPROVAL NUMBERS:
62421, 62422, 62422, 62424.
OTHER NAMES:
This product is sold in several sizes, suited to different varieties
and sizes of dogs.
OTHER NAMES:
None.
CHEMICAL FAMILY:
Maropitant, is a neurokinin (NK
1
) receptor antagonist.
RECOMMENDED USE:
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.
RESTRICTIONS ON USE
For veterinary use only.
EMERGENCY PHONE:
1800 814 883 (ALL HOURS)
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xn, Harmful. Xi, Irritating. N, Dangerous to the environment.
Hazardous according to
the criteria of SWA.
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 soap and water. Wear suitable protective clothing. This
material and its container must be disposed of as
hazardous waste. Avoid contact with skin and eyes.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
GHS CLASSIFICATION: HAZARDOUS.
GHS LABEL ELEMENTS:
SIGNAL WORD: WARNING
PRECAUTIONARY STATEMENTS
H317: May cause an allergic skin reaction.
H320: Causes eye irritat