COMPANION C3 TRIVALENT LIVING VACCINE FOR DOGS

Land: Australien

Sprog: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiv bestanddel:

CANINE DISTEMPER VIRUS - LIVING; CANINE ADENOVIRUS TYPE 2 - LIVE (INFECTIOUS HEPATITIS); CANINE PARVOVIRUS - LIVE

Tilgængelig fra:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

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

Lægemiddelform:

MISC. VACCINES OR ANTI SERA

Sammensætning:

CANINE DISTEMPER VIRUS - LIVING VACCINE-VIRAL Active 0.0 P; CANINE ADENOVIRUS TYPE 2 - LIVE (INFECTIOUS HEPATITIS) VACCINE-VIRAL Active 0.0 P; CANINE PARVOVIRUS - LIVE VACCINE-VIRAL Active 0.0 P

Enheder i pakken:

10 SD Vls; 20 SD Vls; 25 SD Vls; 50 SD Vls; Vial = 1mL

Klasse:

VM - Veterinary Medicine

Fremstillet af:

INTERVET AUSTRALIA

Terapeutisk gruppe:

DOG | BITCH | CASTRATE | PUPPY

Terapeutisk område:

IMMUNOTHERAPY

Terapeutiske indikationer:

CANINE DISTEMPER | CANINE PARVOVIRUS | HEPATITIS :- INFECTIOUS | VACCINE | CANINE ADENOVIRUS TYPE 1 | CANINE ADENOVIRUS TYPE 2 | EQUINE ROTAVIRUS | INFECTIOUS CANINE HEPATITIS | PARVOVIRUS

Produkt oversigt:

Poison schedule: 4; Withholding period: WHP: N/A.; Host/pest details: DOG: [CANINE DISTEMPER, CANINE PARVOVIRUS, HEPATITIS :- INFECTIOUS, VACCINE]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [CANINE DISTEMPER, CANINE PARVOVIRUS, HEPATITIS :- INFECTIOUS, VACCINE]; For vaccination against distemper, infectious hepatitis and parvovirus infections in dogs.AVIOD USING in dogs receiving corticosteroids. AVOID USING in pregnant bitches. AVOID USING chemicals to disinfect the skin, needles or syringes before vaccination as this could inactivate the viruses

Autorisation status:

Registered

Autorisation dato:

2023-07-01

Indlægsseddel

TEMPLATE FOR RELEVANT
LABEL
PARTICULARS (RLPs)
(Veterinary
Products)
APVMA No:
56445
Date: 16
October
2014
Product
Name: COMPANION C3 TRIVALENT LIVING VACCINE FOR DOGS
Select appropriate:
o New Product (include all applicable RLPs)
OR
[8]
Variation (highlight instructions that are being varied). Approval
no.
of
label being
var
ied:
56445/53759
RLP
App
roved
Label Components include in product label: Vial
and
Pack
insert
Label Particular
Text
Signal heading:
PRESCRIPTION
ANIMAL
REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Product name:
COMPANION
®
C3
TRIVALENT
LIVING
VACCINE
FOR
DOGS
Active constituenVs:
Each 1
ml
vial contains live attenuated canine:
Distemper virus
10
3
Adenovirus type 2 (infectious hepatitis)
10
4
Parvovirus
10
5
ACTIVE CONSTITUENTS:
Each single dose vial contains (minimum titres
in
TCID
50
):
-live, attenuated canine distemper virus
..
..
..
...
..
..............
..
........ 1 0
3
-live, attenuated canine adenovirus type 2 (infectious hepat
it
i
s)
..
10
4
-live, attenuated canine parvovirus .........
..
.
..
. ....
..
....................
10
5
ACTIVE CONSTITUENTS:
Each single dose vial contains (minimum titres in TC
ID
so
):
-live, attenuated canine distemper virus (CDV) strain Lederle ATCC
VR-128) ... 10
3
-live, attenuated canine adenovirus type 2 (CAV2) strain Manhattan
............ 10
4
-live, attenuated canine parvovirus (CPV) strain CPV 780916
.......................
10
5
Version:
16
October
2014
56445/62729
Label
components
Vial, Pack insert front and back
Vi
al,
Pack insert front and back
Vial
Pack insert front
Pack insert back
Page
1
of
5
LABEL PARTICULAR
TEXT
Statem
ent
of
clai
m
s:
For vaccination against Distemper, Inf
ec
tious Hepatitis and Parvovirus
in
fections in
dogs.
Net
co
nt
en
ts:
1 dose (1 ml after reconstitution)
10 [20,25,50] single dose vials (1
ml
after reconstitution)
Direct
ions
for
Use
READ THE REVERSE SIDE OF THE PACK INSERT BEFORE USING THE
Hea
d
ing:
PRODUCT.
DIRECTIONS FOR USE:
Only healthy dogs possessing normal temperatur
es
should be vacc

Produktets egenskaber

PRODUCT NAME: COMPANION™ C3 TRIVALENT 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:
Trivalent living vaccine.
TRADE NAME:
COMPANION™ C3 TRIVALENT LIVING VACCINE FOR DOGS
PRODUCT CODE:
3972
RECOMMENDED USE:
For the active immunisation of dogs against canine distemper,
contagious hepatitis and
canine parvovirus.
APVMA NO:
56445
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:
S45. In case of accident or if you feel unwell, contact a doctor or
Poisons Information Centre
immediately (show the label where possible).
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Freeze dried powder (pale yellow) 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:
POTENTIAL HEALTH EFFECTS
EMERGENCY OVERVIEW
SECTION 2 - HAZARDS IDENTIF