COMPANION C4 QUADRIVALENT LIVING VACCINE FOR DOGS

Land: Australia

Språk: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiv ingrediens:

CANINE DISTEMPER VIRUS - LIVING; CANINE PARAINFLUENZA VIRUS; CANINE ADENOVIRUS TYPE 2 LIVE (CAV II); CANINE PARVO VIRUS

Tilgjengelig fra:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

canine distemper virus(1000U/dose)+canine adenovirus(10000U/dose) + others

Legemiddelform:

MISC. VACCINES OR ANTI SERA

Sammensetning:

CANINE DISTEMPER VIRUS - LIVING VACCINE-VIRAL Active 0.0 Undefined; CANINE PARAINFLUENZA VIRUS VACCINE-VIRAL Active 0.0 Undefined; CANINE ADENOVIRUS TYPE 2 LIVE (CAV II) VACCINE-VIRAL Active 0.0 Undefined; CANINE PARVO VIRUS VACCINE-VIRAL Active 0.0 Undefined

Enheter i pakken:

10 x 1mL; 20 x 1mL; 25 x 1mL; 50 x 1mL; Vial = 1mL

Klasse:

VM - Veterinary Medicine

Produsert av:

INTERVET AUSTRALIA

Terapeutisk gruppe:

DOG | BITCH | CASTRATE | PUPPY

Terapeutisk område:

IMMUNOTHERAPY

Indikasjoner:

CANINE ADENOVIRUS - TYPE 2 | CANINE DISTEMPER | CANINE PARAINFLUENZA | CANINE PARVOVIRUS | VACCINE | EQUINE ROTAVIRUS | PARVOVIRUS

Produkt oppsummering:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [CANINE ADENOVIRUS - TYPE 2, CANINE DISTEMPER, CANINE PARAINFLUENZA, CANINE PARVOVIRUS, VACCINE]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CANINE ADENOVIRUS - TYPE 2, CANINE DISTEMPER, CANINE PARAINFLUENZA, CANINE PARVOVIRUS, VACCINE]; For vaccination against distemper, contagious hepatitis, parvovirus, and parainfluenza infections in dogs.AVOID USING in dogs receiving corticosteroids or in pregnant bitches.

Autorisasjon status:

Registered

Autorisasjon dato:

2023-07-01

Informasjon til brukeren

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
INTERVET AUSTRALIA PTY LIMITED
PRODUCT NAME:
COMPANION C4 QUADRIVALENT LIVING VACCINE FOR DOGS
ELABEL APPLICATION NO:
DC12-21362273E8
APVMA APPROVAL NO:
56438/ 100864
PRODUCT NO:
56438
VERSION NO:
5.0
APPLICATION STARTED:
2014-Oct-31 15:44:06
VERSION CREATED:
2015-Feb-27 15:26:00
STARTED BY:
Lyn Lavidis
PRINTED:
2015-Feb-27 15:42:22
LABEL NAME:
COMPANION C4 QUADRIVALENT LIVING VACCINE FOR DOGS
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
ACTIVE CONSTITUENTS:
Each single dose vial contains (minimum titres in TCID50):
-live, attenuated canine distemper virus
……………………………..10^3
-live, attenuated canine adenovirus type 2 (infectious hepatitis) ...
10^4
-live, attenuated canine parvovirus
…………………………………..10^5
-live, attenuated canine parainfluenza
virus………………………....10^5
CLAIMS:
For vaccination against distemper, infectious hepatitis, parvovirus
and parainfluenza
infections in dogs.
NET CONTENTS:
1 dose (1 mL after reconstitution)
10 x single dose vials
20 x single dose vials
25 x single dose vials
50 x single dose vials
DIRECTIONS FOR USE:
DIRECTIONS FOR USE:
Only healthy dogs possessing normal temperatures should be vaccinated.
AVOID USING chemicals to disinfect the skin, needles or syringes
before vaccination as
this could inactivate the viruses.
CONTRAINDICATIONS:
CONTRAINDICATIONS:
This product should not be used in dogs receiving corticosteroids or
in pregnant bitches. RLP APPROVED
For Official Use Only
DOSAGE AND
ADMINISTRATION:
DOSAGE AND ADMINISTRATION
Use Immediately after reconstitution with 1mL of a suitable diluent
(i.e water for Injections
BP) transferred aseptically.
Note: The removable label should only be removed after the dose has
been given.
Under Normal circumstances:
Primary vaccination in puppies from 8 weeks of age: inject
subcutaneously or
intramuscularly 2 doses of vaccine at an interval of

Preparatomtale

PRODUCT NAME: COMPANION™ C4 QUADRIVALENT LIVING VACCINE
FOR DOGS
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 5
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: [phone]
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Solid plug is freeze dried live virus. Liquid is saline for
reconstitution.
TRADE NAME:
COMPANION™ C4 QUADRIVALENT LIVING VACCINE FOR DOGS
PRODUCT CODE:
3973
RECOMMENDED USE:
For the active immunisation of dogs against canine distemper,
contagious hepatitis,
canine parvovirus and canine parainfluenza type II viruses.
APVMA NO:
56438
CREATION DATE:
November, 2006
THIS VERSION ISSUED:
July, 2009
and is valid for 5 years from this date.
STATEMENT OF HAZARDOUS NATURE:
THIS PRODUCT IS CLASSIFIED AS:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S22. Do not breathe dust.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Pale yellow freeze dried powder for reconstitution.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. In addition
product is unlikely to
cause any discomfort or irritation.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. In addition product is unlikely to cause any discomfort in
normal use.
LONG TERM EXPOSURE:
No data for health effects associated with long term skin exposure.
EYE CONTACT:
SHORT TERM EXPOSURE
: This product may be mildly irritating to eyes, but is unlikely to
cause