Nobivac Flex DHPPi Live Vaccine

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CANINE ADENO VIRUS TYPE 2; CANINE DISTEMPER VIRUS; CANINE PARAINFLUENZA VIRUS; CANINE PARVO VIRUS

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

canine distemper virus+canine adenovirus+canine parvovirus + others

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

CANINE ADENO VIRUS TYPE 2 VACCINE-VIRAL Active 0.0 TCI50/do; CANINE DISTEMPER VIRUS VACCINE-VIRAL Active 0.0 TCI50/do; CANINE PARAINFLUENZA VIRUS VACCINE-VIRAL Active 0.0 TCI50/do; CANINE PARVO VIRUS VACCINE-VIRAL Active 0.0 TCI50/do

Units in package:

10 single; 1x20; 1x25; 1x50; dose vials

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

DOG - WITH EXCLUSIONS SEE LABEL

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

CANINE ADENOVIRUS - TYPE 1 | CANINE ADENOVIRUS - TYPE 2 | CANINE DISTEMPER | CANINE PARAINFLUENZA | CANINE PARVOVIRUS | HEPATITIS :- INFECTIOUS | RESPIRATORY DISEASE | CANINE ADENOVIRUS TYPE 1 | CANINE ADENOVIRUS TYPE 2 | INFECTIOUS CANINE HEPATITIS | PARVOVIRUS

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - WITH EXCLUSIONS SEE LABEL: [CANINE ADENOVIRUS - TYPE 1, CANINE ADENOVIRUS - TYPE 2, CANINE DISTEMPER, CANINE PARAINFLUENZA, CANINE PARVOVIRUS, HEPATITIS :- INFECTIOUS, RESPIRATORY DISEASE]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG - WITH EXCLUSIONS SEE LABEL: [CANINE ADENOVIRUS - TYPE 1, CANINE ADENOVIRUS - TYPE 2, CANINE DISTEMPER, CANINE PARAINFLUENZA, CANINE PARVOVIRUS, HEPATITIS :- INFECTIOUS, RESPIRATORY DISEASE]; Live vaccine to provide protection against canine distemper, infectious canine hepatitis caused by canine adenovirus type 1, canine parvovirus disease, respiratory disease caused by canine parainfluenza, canine adenovirus type 2 and to prevent viral...ONLY healthy dogs should be vaccinated and an adequate clinical examination should be made prior to inoculation. See also SIDE EFFECTS etc. on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
Nobivac Flex DHPPi Live Vaccine
56912/133059
Label Name:
Nobivac Flex DHPPi Live Vaccine
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each single dose contains:
≥4.0 log₁₀ TCID₅₀ CANINE DISTEMPER VIRUS STRAIN
ONDERSTEPOORT
≥4.0 log₁₀ TCID₅₀ CANINE ADENOVIRUS TYPE 2 STRAIN MANHATTAN
≥7.0 log₁₀ TCID₅₀ CANINE PARVOVIRUS STRAIN 154
≥5.5 log₁₀ TCID₅₀ CANINE PARAINFLUENZA STRAIN CORNELL
Claims:
Live vaccine to provide protection against canine distemper (CDV),
infectious canine
hepatitis caused by canine adenovirus type 1 (CAV1), canine parvovirus
disease (CPV),
respiratory disease caused by canine parainfluenza (CPi), canine
adenovirus type 2
(CAV2). This vaccine provides cross protection against CPV-2a, CPV-2b
and CPV-2c and
prevents viral excretion caused by canine parvovirus infection.
Net Contents:
10 x single dose vials (1 mL after reconstitution)
[20 x single dose vials (1 mL after reconstitution)]
[25 x single dose vials (1 mL after reconstitution)]
[50 x single dose vials (1 mL after reconstitution)]
Directions for Use:
Restraints:
Contraindications:
Precautions:
Only healthy dogs should be vaccinated and an adequate clinical
examination should be
made prior to inoculation. RLP APPROVED
Side Effects:
Occasionally a mild anaphylactic type hypersensitivity reaction may
occur after vaccination,
as is possible after inoculation of any foreign protein. Such types of
reaction are in most
cases self-limiting but may occasionally need veterinary intervention.
Dosage and
Administration:
USE ALL PRODUCT WITHIN 30 MINUTES OF RECONSTITUTION.
The contents of one vial of reconstituted vaccine should be injected
subcutaneously.
Reconstitute immediately prior to use by the addition of 1.0 mL of
sterile water for injection
or sterile phosphate buffer.
Vaccination may commence from 6 weeks of age. The final vaccination of
the puppy
vaccination course should be administered no ea

Summary of Product characteristics

PRODUCT NAME: NOBIVAC® INJECTABLES
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 viruses, together with buffering and other
ingredients necessary for
successful reconstitution.
TRADE NAME:
NOBIVAC
® INJECTABLES
OTHER NAMES:
Nobivac
®
DHPPi, DHP & Pi Continuum products
RECOMMENDED USE:
For the protection of dogs against diseases listed on the individual
product labels.
APVMA NO:
56912, 59043 & 59824
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