SINGVAC 1 YEAR SINGLE SHOT BIVALENT BOTULINUM VACCINE FOR CATTLE

Ország: Ausztrália

Nyelv: angol

Forrás: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Vedd Meg Most

Letöltés Betegtájékoztató (PIL)
19-06-2017
Letöltés Termékjellemzők (SPC)
19-06-2017

Aktív összetevők:

CLOSTRIDIUM BOTULINUM TYPE C TOXOID; CLOSTRIDIUM BOTULINUM TYPE D TOXOID; THIOMERSAL

Beszerezhető a:

VIRBAC (AUSTRALIA) PTY LTD

INN (nemzetközi neve):

Cl botulinum type C+Cl botulinum type D

Gyógyszerészeti forma:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Összetétel:

CLOSTRIDIUM BOTULINUM TYPE C TOXOID VACCINE-TOXOID Active 0.0 P; CLOSTRIDIUM BOTULINUM TYPE D TOXOID VACCINE-TOXOID Active 0.0 P; THIOMERSAL MERCURY Other 0.13 g/L

db csomag:

200mL; 500mL; 50mL

Osztály:

VM - Veterinary Medicine

Terápiás csoport:

BULL | CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | MALE CAT

Terápiás terület:

IMMUNOTHERAPY

Terápiás javallatok:

BOTULISM

Termék összefoglaló:

Poison schedule: 0; Withholding period: WHP: NIL.; Host/pest details: BULL: [BOTULISM]; CATTLE: [BOTULISM]; For the prevention of botulism caused by Clostridium botulinum types C and D.

Engedélyezési státusz:

Registered

Engedély dátuma:

2023-07-01

Betegtájékoztató

                                VIRBAC (AUSTRALIA)
PTY
LIMITED
Page
1
of
3
PRODUCT NAME:
Singvac 1 Year Single Shot Bivalent Botulinum Vaccine
for
Cattle
APVMA
NUMBER:
48836/60381
VERSION DATE:
10 Sep
2013
PACK SIZES:
SO
ml/
200
ml/
500
ml
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary
Products)
Select appropriate:
[]New
Product (include all applicable RLPs) OR
x Variation (highlight instructions that are being varied). Approval
no.
of
label being
varied
48836/0806
Signal
heading:
READ
USER
SAFETY INFORMATION BEFORE OPENING
OR
USING
FOR
ANIMAL
TREATMENT
ONLY
Product
name:
SingVac
1
YEAR
SINGLE SHOT
BIVALENT BOTULINUM VACCINE FOR
CATTLE
Active constituent/s:
An
oil-based double emulsion vaccine containing toxoid
of
Clostridium botulinum
types C
(5.0 iulmL) and D (1.0 iulmL).
Contains 0.13 giL thiomersal
Statement of
claims:
A
vaccine
for
the
active
immunisation
of
cattle
and
breeding
bulls
against
botulism
(carrion
poisoning).
Net
contents:
50
mL
I
200mL
I
500
mL
Directions
for
Use
READ ENCLOSED
LEAFLET
BEFORE USING THIS PRODUCT.
Heading:
DIRECTIONS FOR USE:
Restraints:
NIA
Contraindications:
NIA
Precautions:
NIA
Side
effects:
SINGVAC 1 YEAR SINGLE SHOT BIVALENT BOTULINUM VACCINE FOR CATTLE
is
formulated to minimise site reactions. However, small local swellings
may
occur at the
injection site in a small proportion
of
cattle. Such swellings are sterile and will regress
spontaneously over 6-8 weeks.
Dosage
&
SHAKE
WELL
BEFORE
USE AND KEEP THOROUGHLY MIXED DURING USE.
administration:
2 mL dose injected under the skin, high on the neck.
A single dose
is
sufficient to protect animals being vaccinated for the first time.
Annual
vaccination
is
recommended.
VACCINATION PROGRAM
Primary
vaccination
A single dose
of
2 mL will generate protective levels
of
circulating antibodies against
Clostridium botulinum
types C and D toxins in cattle
of
all ages. Immunity develops within
35
RLP
days
of
vaccination.
Approv,•d
Revaccination
An annual booster vaccination
is
recommended.
Administration
The vaccine
may
be administered by using a sterile hypod
                                
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Termékjellemzők

                                VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
SINGVAC 1 YEAR SINGLE
SHOT BIVALENT
BOTULINUM VACCINE.DOC
REVISION GHS - A
SAFETY DATA SHEET
Product Name:
Singvac® 1 Year Single Shot Bivalent Botulinum Vaccine for
Cattle
PAGE: 1 OF 5
DATE OF ISSUE
21 DECEMBER, 2015
EMERGENCY: VIRBAC: 02 9772 9772 OR 1800 242 100 (BUSINESS HOURS ONLY)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
COMPANY:
VIRBAC (AUSTRALIA) PTY. LTD
ABN 77 003 268 871
ADDRESS
361 Horsley Rd, Milperra, NSW 2214, Australia
Locked Bag 6000, Milperra Business Centre, NSW 1891, Australia
TELEPHONE:
(02) 9772 9772 or 1800 242 100
FAX:
(02) 9772 9773
EMERGENCY PHONE
As above during business hours.
After Hours - Poisons Information Centre: 13 1126
from anywhere in Australia, (0800 764 766 in New Zealand)
CHEMICAL NATURE:
An oil-based double emulsion vaccine containing toxoid of _Clostridium
botulinum _
types C and D.
TRADE NAME:
SINGVAC
® 1 YEAR SINGLE SHOT BIVALENT BOTULINUM VACCINE FOR CATTLE
APVMA CODE:
48836
PRODUCT USE:
V
accine for prevention of botulism caused by _Clostridium botulinum_
types C and D in
cattle.
CREATION DATE:
FEBRUARY, 2010
THIS VERSION ISSUED:
DECEMBER, 2015
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA
Australia.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA and IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSMP CLASSIFICATION:
Not scheduled
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required
                                
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