PORCINE PARVAC VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PORCINE PARVO VIRUS - INACTIVATED; THIOMERSAL

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

porcine parvovirus

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

PORCINE PARVO VIRUS - INACTIVATED VACCINE-VIRAL Active 0.0 P; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

100mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

PIGS | BOAR | GILT | PIGLET | SOW | SWINE

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

PARVOVIRUS

Product summary:

Poison schedule: 0; Withholding period: WHP: Nil; Host/pest details: PIGS: [PARVOVIRUS]; Poison schedule: 0; Withholding period: ; Host/pest details: PIGS: [PARVOVIRUS]; For the prevention of parvovirus in swine.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

APPENDIX2
AUSTRALIAN
GOVERNMENT
AUSTRALIAN PESTICIDES AND
VETERINARY MEDICINES AUTHORITY
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Select appropriate:
IJ
New Product (include all applicable RLPs)
OR
0 Variation (highlight instructions that are being varied). Approval
no.
of
label being varied: 53608/0509.
Signal
heading:
Product
name:
Active constituenVs:
.•
Statement of claims:
Net
contents:
Directions for
Use
Heading:
Restraints:
Contraindications:
PRECAUTIONS:
Side
effects:
Dosage
&
ADMINISTRATION:
FOR ANIMAL TREATMENT ONLY
PORCINE PARVAC VACCINE
CONTAINS INACTIVATED PORCINE PARVOVIRUS AT 1 0
5
·
5
TCID
5
OFML
EQUIVALENT
0.1
MG/ML THIOMERSAL ADDED
PORCINE PARVAC
is an adjuvanted vaccine containing beta-propiolactone inactivated
porcine parvovirus
at
1
o'·
TCIDsolmL equivalent. The virus was grown aseptically
in
a
continuous
cell
line.
An
aluminium
salt is
included to
enhance
the
response to
vaccination and to increase the duration
of
immunity. Thiomersal
0.1
mg/ml
is added
as a preservative.
For the prevention of parvovirus
in
swine
100 mL (50 doses)
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
Contents must be left in outer package until immediately before use
Shake
well
before use and keep thoroughly mixed during use
Please refer to the resealing section and the product insert
for
further information on
storage and handling after opening.
For
Subcutaneous Use Only
NA
~
NA
RLP
NA
Approved
Localised swelling may develop
at
the site
of
injection and a firm nodular lump may
persist for some weeks
or
even months.
DOSAGE AND ADMINISTRATION
This product can be stored and used for up to 30 days after first
opening.
On each
subsequent
reuse,
swab
the
opening
with
a
suitable
disinfectant
(for
example,
methylated spirits) both before and after using.
A sterile needle and syringe must be
used each time product is removed.
There may be settling
of
the adjuvant after storage but material is easily resuspended
by inversion
of
the container.
SHAKE WELL BEFORE USE AND

Summary of Product characteristics

PRODUCT NAME: PORCINE PARVAC® VACCINE
PAGE: 1 OF 6
THIS VERSION ISSUED: 19 FEBRUARY 2015
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
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
PRODUCT IDENTIFIER:
PORCINE PARVAC® VACCINE
OTHER NAMES:
None.
APVMA APPROVAL NO:
53608
CHEMICAL FAMILY:
Inactivated Porcine parvovirus in an aqueous medium.
RECOMMENDED USE:
Animal vaccine for use as described on the product label.
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 Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S23, S25, S36. Do not breathe mists. Avoid contact with eyes. Wear
suitable protective clothing.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
GHS LABEL ELEMENTS: NONE
SIGNAL WORD: NONE – NOT HAZARDOUS.
GHS CLASSIFICATION: 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.
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.
P411: Store at temperatures preferably between 2 and 8°C, but do not
freeze.
P403+P233: Store in a well-ventilated place. Keep container tightly
closed.
DISPOSAL
P501: Dispose of small quantities and empty containers by w