VIBROVAX VACCINE

Country: Australia

Bahasa: Inggeris

Sumber: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Bahan aktif:

FORMALIN; CAMPYLOBACTER FETUS VENEREALIS BIOTYPE INTERMEDIUS SUBT1; CAMPYLOBACTER FETUS (VIBRO FETUS) (REFER ALIASES)

Boleh didapati daripada:

ZOETIS AUSTRALIA PTY LTD

INN (Nama Antarabangsa):

vaccine - Campylobacter fetus

Borang farmaseutikal:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Komposisi:

FORMALIN UNGROUPED Active 2.0 ul/ml; CAMPYLOBACTER FETUS VENEREALIS BIOTYPE INTERMEDIUS SUBT1 VACCINE-MICROBIAL Active 0.0 P; CAMPYLOBACTER FETUS (VIBRO FETUS) (REFER ALIASES) VACCINE-MICROBIAL Active 0.0 Q.S

Unit dalam pakej:

100mL; 20mL; 250mL; 500mL; 50mL

Kelas:

VM - Veterinary Medicine

Dikeluarkan oleh:

ZOETIS AUSTRALIA

Kumpulan terapeutik:

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

Kawasan terapeutik:

IMMUNOTHERAPY

Tanda-tanda terapeutik:

BOVINE VENEREAL CAMPYLOBACTERIOSIS (BVC) | BOVINE VIBRIOSIS

Ringkasan produk:

Poison schedule: 0; Withholding period: WITHOLDING PERIODS: Nil TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI): ESI n ot applicable.; Host/pest details: CATTLE: [BOVINE VENEREAL CAMPYLOBACTERIOSIS (BVC)]; Poison schedule: 0; Withholding period: ; Host/pest details: CATTLE: [BOVINE VENEREAL CAMPYLOBACTERIOSIS (BVC)]; For the prevention of bovine venereal campylobacteriosis (vibriosis).This vaccine is not suitable for the immunisation of sheep

Status kebenaran:

Registered

Tarikh kebenaran:

2023-07-01

Risalah maklumat

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
ZOETIS AUSTRALIA PTY LTD
PRODUCT NAME:
VIBROVAX VACCINE
ELABEL APPLICATION NO:
DC14-05349425E32
APVMA APPROVAL NO:
52391/101293
PRODUCT NO:
52391
VERSION NO:
2.0
APPLICATION STARTED:
2014-Nov-26 11:20:31
VERSION CREATED:
2015-May-26 14:20:42
STARTED BY:
Ziauddin Hashmi
PRINTED:
2015-Jul-14 14:55:59
LABEL NAME:
VIBROVAX VACCINE
SIGNAL HEADINGS:
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Campylobacter fetus subspecies venerealis (biotypes venerealis and
intermedius) each 4
mg/mL (as formol culture concentrates)
2 µL/mL Formalin added as an antiseptic
CLAIMS:
For the prevention of Bovine Venereal Campylobacteriosis (Vibriosis).
NET CONTENTS:
20 mL
50 mL
100 mL
250 mL
500 mL
DIRECTIONS FOR USE:
Read the enclosed leaflet for full instructions
DIRECTIONS FOR USE
Shake well before use and keep thoroughly mixed during use.
For Subcutaneous Use Only
RESTRAINTS:
N/A
CONTRAINDICATIONS:
This vaccine is not suitable for the immunisation of sheep.
PRECAUTIONS:
N/A
SIDE EFFECTS:
As Vibrovax Vaccine is an oily adjuvant vaccine, there may be some
swelling at the site of
vaccination, but this will gradually disappear.
DOSAGE AND
ADMINISTRATION:
Dosage and administration RLP APPROVED
For Official Use Only
Use all product within 12 hours of opening. Contents must be stored in
a cooler and left in
outer package until immediately before use. Residual vaccine left in
the container must be
discarded and not retained for future use.
Before vaccine is injected, the proposed site of inoculation on the
animal's skin may be
cleaned by swabbing with cotton-wool soaked in an antiseptic solution,
such as methylated
spirits.
Adult cows and heifers more than 18 months old: previously
unvaccinated animals should
be given a single dose of 5 mL. Thereafter, give either one dose of 5
mL every two years
or one dose of 2 mL annually. Animals should be vaccinated about four
to six weeks before
the commencement of mating.
Heifers less than 18 months old: Two doses of 5 mL. The second

Ciri produk

PRODUCT NAME: VIBROVAX® VACCINE
PAGE: 1 OF 5
This revision issued: December, 2011
MATERIAL SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Pfizer Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: [phone]
Fax: [phone]
____________________________________
PFIZER AUSTRALIA PTY LTD
A.B.N. 50 008 422 348
CHEMICAL NATURE:
Oil-water emulsion of formol cultures and other ingredients.
TRADE NAME:
VIBROVAX
® VACCINE
PRODUCT USE:
For the prevention of vibriosis in cattle.
CREATION DATE:
DECEMBER, 2004
THIS VERSION ISSUED:
DECEMBER, 2011
and is valid for 5 years from this date.
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 the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: Opaque oil-water emulsion.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F
F
F
E
E
E
C
C
C
T
T
T
S
S
S
INACTIVATED CULTURES AND TOXOIDS ARE NOT REGARDED AS PATHOGENIC IN
HUMANS.
SELF INJECTION: IN ALL INSTANCES OF ACCIDENTAL SELF INJECTION CONTACT
A DOCTOR AS SOON AS POSSIBLE. FURTHER
INFORMATION ON TREATMENT IS AVAILABLE FROM POISONS INFORMATION CENTRE.
PHONE 131 126.
INHALATION
SHORT TERM EXPOSURE:
The spray mist may be discomforting to the upper respiratory tract and
lungs, and repeated
exposure may cause sensi