SINGVAC 3 YEAR SINGLE SHOT BIVALENT BOTULINUM VACCINE FOR CATTLE

Maa: Australia

Kieli: englanti

Lähde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiivinen ainesosa:

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

Saatavilla:

VIRBAC (AUSTRALIA) PTY LTD

INN (Kansainvälinen yleisnimi):

Cl botulinum type C(5iu/mL)+Cl botulinum type D(1iu/mL)

Lääkemuoto:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Koostumus:

CLOSTRIDIUM BOTULINUM TYPE C TOXOID VACCINE-TOXOID Active 5.0 IU/ml; CLOSTRIDIUM BOTULINUM TYPE D TOXOID VACCINE-TOXOID Active 1.0 IU/ml; THIOMERSAL MERCURY Other 0.13 g/L

Kpl paketissa:

!100 DOSES; !200mL; #250 DOSES; #500mL; *25 DOSES; *50mL

luokka:

VM - Veterinary Medicine

Terapeuttinen ryhmä:

BULL - BREEDING | CATTLE | COW - PREGNANT | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | D

Terapeuttinen alue:

IMMUNOTHERAPY

Käyttöaiheet:

BOTULISM

Tuoteyhteenveto:

Poison schedule: 0; Withholding period: WHP: NIL ESI: N/A; Host/pest details: BULL - BREEDING: [BOTULISM]; CATTLE: [BOTULISM]; COW - PREGNANT: [BOTULISM]; For the prevention of botulism caused by Clostridium botulinum types C and D. A vaccine for the active immunisation of cattle and breeding bulls against botulism (carrion poisoning) for three years.Small local swellings may occur at injection site in a small proportion of cattle

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2023-07-01

Pakkausseloste

Virbac (Australia) Pty Limited
Page
1
of
3
PRODUCT
NAME:
Singvac 3 Year Single Shot Bivalent Botulinum Vaccine
for
Cattle
APVMA NUMBER:
58461/60301
VERSION
DATE:
10 Sep 2013
PACK
SIZES:
50
ml/200
ml/500
ml
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary
Products)
Select appropriate:
D New Product (Include all applicable RLPs)
OR
x Variation (highlight instructions that are being varied). Approval
no.
of
label being varied
58461/1007
Signal
heading:
READ USER SAFETY
d
IUN
B~~TR~NLY
OR USING
FOR
I
Kt:A
I lVI!
Product
name:
Sin~~~~®-
3 YEAR
SINGLE SHOT
BIVALENT BOTULINUM VACCINE FOR CATTLE
Active
An oil-based double emulsion vaccine containing toxoid
of
Clostridium botulinum
types C
constituent!s:
(5.0 iu/mL) and D (1.0 iu/mL).
i
' 0.13
q/L
I
Statement of
For the prevention
of
botulism caused
by
Clostridium botulinum
types C and
D.
claims:
A vaccine for the active Immunisation
of
cattle and breeding bulls against botulism (carrion
poisoning) for three years.
Net
contents:
50
mL
/200mL
I
500 mL
Directions
for
Use
DIRECTIONS FOR USE:
_A'• _
Restraints:
NIA
Contraindications:
NIA
Precautions:
N/A
Side
effects:
SINGVAC 3 YEAR SINGLE SHOT BIVALENT BOTULINUM VACCINE FOR
CATILE
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
'over
6-8 weeks.
Dosage
&
' USE AND KEEP
1
..
IG
USE.
administration:
USE
ALL
PRODUCT WITHIN 24 HOURS
OF
OPENING.
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. A
second
dose
Is
not necessary until boosting
is
required
36
months later. In non-endemic areas,
where Infection
is
rare, a 36 month booster interval may not provide optimal protection
and
annual vaccination
is
recommended.
General directions:
For use through oil
vu"o~couulc
i
·~.
3 Year
vcovviHcoouo
~
+
SINGVAC 3 YEAR SINGLE SHOT BIVALENT BOTULINUM VACCINE FOR CATTLE
is
a
non-mineral oil formulation containin

Valmisteyhteenveto

VIRBAC (AUSTRALIA) PTY. LTD.
DOCUMENT NO:
SINGVAC 3 YEAR SINGLE
SHOT BIVALENT
BOTULINUM VACCINE -
58461 (0210).DOC
REVISION GHS - A
SAFETY DATA SHEET
Product Name:
Singvac® 3 Year Single Shot Bivalent Botulinum Vaccine for
Cattle
PAGE: 1 OF 5
DATE OF ISSUE
3 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:
[phone] or 1800 242 100
FAX:
[phone]
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
® 3 YEAR SINGLE SHOT BIVALENT BOTULINUM VACCINE FOR CATTLE
APVMA CODE:
58461
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 equipme