NOBIVAC KC CONTINUUM VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

BORDETELLA BRONCHISEPTICA; CANINE PARAINFLUENZA VIRUS

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

vaccine - canine Bordetella+vaccine - canine parainfluen

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

BORDETELLA BRONCHISEPTICA VACCINE-MICROBIAL Active 0.0 Undefined; CANINE PARAINFLUENZA VIRUS VACCINE-VIRAL Active 0.0 Undefined

Units in package:

10x1 vials; 20 x 1dose; 25 x 1dose; 50 x 1dose; 5x1 vials

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

DOG - OVER 4 WEEKS OLD | PUPPY

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

KENNEL COUGH | INFECTIOUS TRACHEOBRONCHITIS

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - OVER 4 WEEKS OLD: [KENNEL COUGH]; Live intranasal vaccine to aid in protection against kennel cough disease caused by Bordetella bronchiseptica & canine parainfluenza virus for at least 12 months following vaccination.Dogs should be at least 4 weeks of age. Only healthy dogs should be vaccinated.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
INTERVET AUSTRALIA PTY LIMITED
PRODUCT NAME:
NOBIVAC KC CONTINUUM VACCINE
ELABEL APPLICATION NO:
DC12-33310838E3
APVMA APPROVAL NO:
59010/100769
PRODUCT NO:
59010
VERSION NO:
4.0
APPLICATION STARTED:
2014-Oct-23 13:41:29
VERSION CREATED:
2015-Feb-13 11:44:06
STARTED BY:
Lyn Lavidis
PRINTED:
2015-Feb-13 15:27:01
LABEL NAME:
NOBIVAC KC CONTINUUM VACCINE
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Contains avirulent live Bordetella bronchiseptica and canine
parainfluenza virus.
Contains per dose:
10^8.0 CFU Bordetella bronchiseptica
10^4.0 TCID50 Canine parainfluenza virus
ACTIVE CONSTITUENTS:
Each single dose contains at least:
10^8.0 cfu Bordetella bronchiseptica (living, B-C2 strain) and 10^4.0
TCID50 canine
parainfluenza virus (living, Cornell strain).
CLAIMS:
Live intranasal vaccine to aid in protection against Kennel Cough
disease caused by
Bordetella bronchiseptica and canine parainfluenza virus for at least
12 months following
vaccination.
NET CONTENTS:
10 x single dose vials
20 x single dose vials
25 x single dose vials
50 x single dose vials
5 x single dose vials
Single dose vial.
DIRECTIONS FOR USE:
DIRECTIONS FOR USE:
PRECAUTIONS:
PRECAUTIONS
This product should not be used on dogs less than 4 weeks of age.
This product should be administered at least 72 hours prior to the
anticipated risk of
exposure (e.g. kennelling). RLP APPROVED
For Official Use Only
This product should only be administered to healthy dogs. Nobivac® KC
contains live
attenuated B. bronchiseptica, dogs on antibacterial therapy with
activity against B.
bronchiseptica are unlikely to respond to vaccination.
SIDE EFFECTS:
SIDE EFFECTS
Occasionally, particularly in very young susceptible puppies, signs of
upper respiratory
tract disease may sometimes be seen, including mild discharges from
the eyes and nose,
sneezing and coughing. Signs are generally transient, but in
occasional cases may persist

Summary of Product characteristics

PRODUCT NAME: NOBIVAC® KC CONTINUUM VACCINE
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:
Freeze dried mix of bacteria and virus, together with buffering and
other ingredients
necessary for successful reconstitution.
TRADE NAME:
NOBIVAC
® KC CONTINUUM VACCINE
RECOMMENDED USE:
For the protection of dogs against Kennel Cough disease caused by
_Bordetella _
_bronchiseptica_, and canine parainfluenza virus.
APVMA NO:
59010
CREATION DATE:
July, 2006
THIS VERSION ISSUED:
July, 2009
and is valid for 5 years from this date.
NOTE: These products are sold in two parts; a freeze dried solid and a
sterile diluent. As the diluent is essentially water,
offering no reasonably anticipated possibility of hazard, this MSDS
concentrates on the freeze dried solid component.
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, S25. Do not breathe dust. Avoid contact with eyes.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Milky white solid.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
PATHOGENICITY:
THE ORGANISMS IN THIS PRODUCT ARE NOT PATHOGENIC FOR HUMANS._._
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. However
product may be mildly
irritating, although unlikely to cause anything more than mild
transient discomfort.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this