CERENIA INJECTABLE SOLUTION

Država: Avstralija

Jezik: angleščina

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktivna sestavina:

MAROPITANT AS MAROPITANT CITRATE

Dostopno od:

ZOETIS AUSTRALIA PTY LTD

INN (mednarodno ime):

maropitant as citrate(10mg/mL)

Farmacevtska oblika:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sestava:

MAROPITANT AS MAROPITANT CITRATE AMINO-ACID Active 10.0 mg/ml

Enote v paketu:

20mL

Razred:

VM - Veterinary Medicine

Izdeluje:

ZOETIS AUSTRALIA

Terapevtska skupina:

CAT | DOG | PUPPY - OVER 8 WEEKS OLD | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY

Terapevtsko območje:

CENTRAL NERVOUS SYSTEM

Terapevtske indikacije:

ANTI-EMETIC | PREVENT NAUSEA

Povzetek izdelek:

Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANTI-EMETIC, IMPROVEMENT IN RECOVERY FROM GENERAL ANAESTHESIA, PERI-OPERATIVE, PREVENT NAUSEA]; DOG: [ANTI-EMETIC, IMPROVEMENT IN RECOVERY FROM GENERAL ANAESTHESIA, PERI-OPERATIVE, PREVENT NAUSEA]; PUPPY - OVER 8 WEEKS OLD: [ANTI-EMETIC, IMPROVEMENT IN RECOVERY FROM GENERAL ANAESTHESIA, PERI-OPERATIVE, PREVENT NAUSEA]; For the prevention and treatment of nausea & emesis in dogs and cats.NOT TO BE USED in food producing species of animals. Injectable is NOT for vomiting induced by motion sickness. Safety of this product has NOT been established during pregnancy and lactation and in puppies less than 16 weeks of age (see product leaflet).

Status dovoljenje:

Registered

Datum dovoljenje:

2023-07-01

Navodilo za uporabo

Copy in the header and footer will not appear on the final printed
label
CERENIA Injectable Solution
Prepared: 29/07/2013
VIAL LABEL
MAIN PANEL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CERENIA
®
INJECTABLE SOLUTION
10 MG/ML MAROPITANT as maropitant citrate
For the prevention and treatment of nausea and emesis in dogs and
cats.
20 mL
Zoetis [logo]
Pharma Code
SIDE PANEL
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Zoetis Australia Pty Ltd
Wharf Road, West Ryde, NSW
APVMA: 61840/56208
Store below 30°C (Room Temperature).Do not freeze. Protect from
light.
LA:
CODE:
Batch:
Expiry:
_ _
Page 1 of 11 RLP APPROVED
Copy in the header and footer will not appear on the final printed
label
CERENIA Injectable Solution
Prepared: 29/07/2013
LEAFLET
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CERENIA
®
INJECTABLE SOLUTION
DESCRIPTION
A clear colourless, to light yellow solution for injection containing
10 mg/mL
maropitant as maropitant citrate. Maropitant is a neurokinin (NK
1
) receptor
antagonist that blocks the pharmacological action of substance P in
the CNS.
INDICATIONS
For the prevention of vomiting in dogs and cats, except that induced
by motion
sickness. For the treatment of acute vomiting in cats over 16 weeks of
age, dogs and
puppies 8 weeks of age or older, in combination with other veterinary
and supportive
measures. Aids in the prevention and treatment of nausea.
PHARMACOLOGY
Pharmacokinetics
Dogs
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 highe

Lastnosti izdelka

PRODUCT NAME: CERENIA® INJECTABLE SOLUTION
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® INJECTABLE SOLUTION
APVMA APPROVAL NO:
61840
OTHER NAMES:
None.
CHEMICAL FAMILY:
Maropitant, is a neurokinin (NK
1
) receptor antagonist.
RECOMMENDED USE:
For the prevention and treatment of nausea and emesis in dogs and
cats.
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:
R43, R52. May cause sensitisation by skin contact. Harmful to aquatic
organisms.
SAFETY PHRASES:
S28, S60, S24/25. After contact with skin, wash immediately with
plenty of soap and water. 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 irritation.
H373: May cause damage to organs through prolonged or repeated
exposure.
H401: Toxic to aquatic life.
PREVENTION
P102: Keep out of reach of children.
P261: Avoid breathing mists.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contacted areas thoroughly after handling.
P272: Contaminated work clothing should not be allowed out of the
workplace.
P273: Avoid release to the environment.
P