Nobivac Flex DHP Live Vaccine

Land: Australien

Sprog: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Indlægsseddel (PIL)

09-08-2022

Produktets egenskaber (SPC)

20-06-2017

Aktiv bestanddel:

CANINE ADENOVIRUS TYPE 2 STRAIN MANHATTAN - LIVE; CANINE DISTEMPER VIRUS STRAIN ONDERSTEPOORT; CANINE PARVOVIRUS STRAIN 154 - LIVE

Tilgængelig fra:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

canine distemper virus+canine adenovirus+canine parvovirus

Lægemiddelform:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sammensætning:

CANINE ADENOVIRUS TYPE 2 STRAIN MANHATTAN - LIVE VACCINE-VIRAL Active 0.0 tcid50; CANINE DISTEMPER VIRUS STRAIN ONDERSTEPOORT VACCINE-VIRAL Active 0.0 tcid50; CANINE PARVOVIRUS STRAIN 154 - LIVE VACCINE-VIRAL Active 0.0 tcid50

Enheder i pakken:

# 20 dose; #vial; *10 dose; *vial; 1 x 25; 1 x 50

Klasse:

VM - Veterinary Medicine

Fremstillet af:

INTERVET AUSTRALIA

Terapeutisk gruppe:

DOG - WITH EXCLUSIONS SEE LABEL

Terapeutisk område:

IMMUNOTHERAPY

Terapeutiske indikationer:

Produkt oversigt:

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 PARVOVIRUS, HEPATITIS :- INFECTIOUS]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG - WITH EXCLUSIONS SEE LABEL: [CANINE ADENOVIRUS - TYPE 1, CANINE ADENOVIRUS - TYPE 2, CANINE DISTEMPER, CANINE PARVOVIRUS, HEPATITIS :- INFECTIOUS]; 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 adenovirus type 2, & to prevent viral excretion caused by ...ONLY healthy dogs should be vaccinated and an adequate clinical examination should be made prior to inoculation. See also SIDE EFFECTS etc. on label.

Autorisation status:

Registered

Autorisation dato:

2023-07-01

Indlægsseddel

Product Name:
APVMA Approval No:
Nobivac Flex DHP Live Vaccine
59043/133057
Label Name:
Nobivac Flex DHP 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
Claims:
Live vaccine to provide protection against canine distemper (CDV),
infectious canine
hepatitis caused by canine adenovirus type 1 (CAV1), canine parvovirus
disease (CPV)
and respiratory disease caused by 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
Nobivac Bb/Pi or 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 earlier than 10 weeks of
age provided at
least 2 weeks has elapsed since the i

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Produktets egenskaber

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: 1 800 033 461
(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

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