LONGRANGE BOTULINUM VACCINE

País: Australia

Idioma: inglés

Fuente: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingredientes activos:

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

Disponible desde:

ZOETIS AUSTRALIA PTY LTD

Designación común internacional (DCI):

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

formulario farmacéutico:

MISC. VACCINES OR ANTI SERA

Composición:

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 0.1 mg/ml

Unidades en paquete:

100mL; 250mL; 500mL

clase:

VM - Veterinary Medicine

Fabricado por:

ZOETIS AUSTRALIA

Grupo terapéutico:

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

Área terapéutica:

IMMUNOTHERAPY

indicaciones terapéuticas:

BOTULISM

Resumen del producto:

Poison schedule: 0; Withholding period: WHP: Nil.; Host/pest details: CATTLE: [BOTULISM]; Poison schedule: 0; Withholding period: ; Host/pest details: CATTLE: [BOTULISM]; Single shot bivalent botulinum vaccine for cattle.Localised swelling may develop at the site of injection.

Estado de Autorización:

Registered

Fecha de autorización:

2023-07-01

Información para el usuario

APPENDIX2
Australian Government
Australian Pesticides
and
Veterinary Medicines Authority
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary Products)
Select appropriate:
[J
New Product (include all applicable RLPs)
OR
IRI
Variation
(highlight instructions that are
being varied).
Approval
no.
of
label
being
varied:
51492/53078
Signal heading:
FOR
ANIMAL
TREATMENT
ONLY
Product name:
Long
range®
Botulinum
Vaccine
Active
Longrange
Botulinum
Vaccine
contains cultures
of
Clostridium botulinum
constituentls:
type C
~
5 IU/mL and
Clostridium botulinum
typeD~
1.0
IU/ml.
Thiomersal
0.1
mg/mL
is added as a preservative.
Statement
of
Single
shot
bivalent
botulinum
vaccine
for
cattle.
claims:
Net contents:
The vaccine is available
in
1 00 mL, 250
mL
and 500
mL
plastic packs.
Directions
for
Use
DIRECTIONS
FOR
USE
Heading:
READ
THE
ENCLOSED
LEAFLET
BEFORE
USING
THIS
PRODUCT
Cootents
m"'rt
be
loff lo
o"'"
p.ckago
""tu
lmmodlolely
bofo"'
~
Restraints:
N/A
Contraindications:
N/A
V'
Precautions:
Side effects:
Dosage &
administration:
N/A
RLP
ve
Localised swelling
may
develop at the site
of
injection and a firm,
nodular
lump
may
persist for some weeks, even months.
Where the vaccine is dispensed
in
plastic packs, unused vaccine
may
be
held
over for use the next day, provided instructions for resealing are
followed. See
carton for resealing instructions.
The recommended dose
for
cattle
of
all ages is 2.5
ml.
The
route
of
inoculation
is
subcutaneous
(just
under
the
skin).
Injection is high on the neck, behind the ear.
It is important that the vaccine is kept properly mixed before and
during use.
A second priming dose is not required following the first priming
vaccination.
A single dose
of
this vaccine should confer protection against
Clostridium
botulinum
Types C and D toxins
for
up to 12 months.
An annual vaccination is recommended.
Immunity to Botulinum type C and D develops
in
4 weeks (or 28 days)
of
administration
of
this vaccine and should confer protection
for
12 months.
In oul
_,_
.,;,,
7
.
·"·
has no
"'"rli""
to
""

Ficha técnica

PRODUCT NAME: LONGRANGE® BOTULINUM VACCINE
PAGE: 1 OF 6
THIS VERSION ISSUED: 7 MAY 2014
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 1 - IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
38-42 Wharf Road
West Ryde NSW 2114 AUSTRALIA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
PRODUCT IDENTIFIER:
LONGRANGE® BOTULINUM VACCINE
OTHER NAMES:
None.
CHEMICAL FAMILY:
Water solution of ingredients.
APVMA APPROVAL NUMBER:
51492
RECOMMENDED USE:
Single shot bivalent botulinum vaccine for cattle.
RESTRICTIONS ON USE
For veterinary use only.
EMERGENCY PHONE:
1800 814 883 (ALL HOURS)
SECTION 2 - HAZARDS IDENTIFICATION
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:
S23, S36, S24/25. Do not breathe mists. Wear suitable protective
clothing. Avoid contact with skin
and eyes.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
GHS CLASSIFICATION: NOT HAZARDOUS.
GHS LABEL ELEMENTS: NONE. NOT HAZARDOUS.
SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P235: Keep cool. Refrigerate but do not freeze.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P402+P404: Store in a dry place. Store in a closed container.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if recycling or reclaiming is not possible, use a
commercial waste disposal service.
OTHER/SUPPLEMENTARY HAZARDS.