BOPRIVA VACCINE FOR CATTLE

מדינה: אוסטרליה

שפה: אנגלית

מקור: APVMA (Australian Pesticides and Veterinary Medicines Authority)

מרכיב פעיל:

GNRF - PROTEIN CONJUGATE; THIOMERSAL

זמין מ:

ZOETIS AUSTRALIA PTY LTD

INN (שם בינלאומי):

GnRF-protein conjugate(400ug/mL)

טופס פרצבטיות:

MISC. VACCINES OR ANTI SERA

הרכב:

GNRF - PROTEIN CONJUGATE BIOLOGICAL-PROTEIN Active 400.0 ug/ml; THIOMERSAL MERCURY Other 0.1 mg/ml

יחידות באריזה:

100mL; 20mL; 50mL

סיווג:

VM - Veterinary Medicine

תוצרת:

ZOETIS AUSTRALIA

קבוצה תרפויטית:

BULL | HEIFER | BOVINE | MALE CATTLE

איזור תרפויטי:

IMMUNOTHERAPY

סממני תרפויטית:

POSTPONE OESTRUS | REDUCING TESTOSTERONE PRODUCTION

leaflet_short:

Poison schedule: 4; Withholding period: WHP: N/A TRADE ADVICE EXPORT SLAUGHTE R INTERVAL (ESI): 0 days.; Host/pest details: BULL: [REDUCING TESTOSTERONE PRODUCTION]; HEIFER: [POSTPONE OESTRUS]; Poison schedule: 4; Withholding period: ; Host/pest details: BULL: [REDUCING TESTOSTERONE PRODUCTION]; HEIFER: [POSTPONE OESTRUS]; For temporary suppression of testosterone in post-pubertal bulls and oestrus behaviour in post-pubertal heifers.Contraindicated for use in breeding stock. Accidental vaccination of breeding stock of either sex may affect subsequent fertility. See Side Effects, etc. on label also.

מצב אישור:

Registered

תאריך אישור:

2023-07-01

עלון מידע

-------------------------------------~.-~-~----·-
•
•
APPENDIX2
AUSTRALIAN
GOVERNMENT
AUSTRALIAN PESTICIDES AND
VETERINARY MEDICINES AUTHORITY
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
RLP
Approved
Select appropriate:
D
New Product (include
all
applicable RLPs)
OR
I2Sl
Variation (highlight instructions that are being varied). Approval
no.
of label being varied:
63172/60326
Signal heading:
Product name:
Active
constituent/s:
Statement of
claims:
Net contents:
Directions for Use
Heading:
Restraints:
Contraindications:
Precautions:
Side effects:
Dosage
&
administration:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Bopriva"' Vaccine for Cattle
BOPRIVA
is prepared from
an
analogue of GnRF linked to a carrier protein.
It
is
adjuvanted with a synthetic aqueous adjuvant to increase the level and
duration of immunity.
Each
ml
of vaccine provides 400pg
GnRF-protein
conjugate.
Thiomersal
0.1
mg/ml
has been added as a preservative.
FOR TEMPORARY SUPPRESSION
OF
TESTOSTERONE
IN
POST-PUBERTAL BULLS AND
OESTRUS BEHAVIOUR
IN
POST-PUBERTAL HEIFERS
BOPRIVA
is
available
in
20ml,
50ml
and
100ml
plastic
multi-dose
containers.
DIRECTIONS FOR USE
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
N/A
Contraindicated for use
in
breeding stock.
Accidental vaccination of breeding
stock of either sex may affect subsequent fertility.
N/A
SIDE EFFECTS:
Transient
injection
site
swelling
can
be
expected
after vaccination,
with
resolution within
3 to 5 weeks.
Cattle given Bopriva can show transient
pyrexia
and
recover
to
a
normal
temperature
within
2
to
3
days
post
vaccination.
On
rare occasions a post vaccination anaphylactic reaction to the
vaccine may occur and require prompt veterinary treatment.
Unused vaccine may
be
stored and used for
up
to
30
days after first opening.
Store unused material upright, at 2°C to 8°C (refrigerated) and
protect from
light.
On
each
subsequent
reuse,
swab
the
opening
with
a
suitable
disinfectant (for example, methylated spirits) both before

מאפייני מוצר

PRODUCT NAME: BOPRIVA VACCINE FOR CATTLE
PAGE: 1 OF 5
THIS REVISION ISSUED: OCTOBER, 2015
MATERIAL SAFETY DATA SHEET
Issued by: Zoetis 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
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]
CHEMICAL NATURE:
Water solution of ingredients.
TRADE NAME:
BOPRIVA VACCINE FOR CATTLE
PRODUCT USE:
For temporary suppression of testosterone in post-pubertal bulls and
oestrus
behaviour in post-pubertal heifers.
CREATION DATE:
JUNE, 2010
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid until August, 2016.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R61, R62. May cause harm to the unborn child. Possible risk of
impaired fertility.
SAFETY PHRASES:
S45. In case of accident or if you feel unwell, contact a doctor or
Poisons Information Centre
immediately (show this MSDS where possible).
SUSMP CLASSIFICATION:
S4 (Aust), S2 (NZ)
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
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
: Aqueous solution.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
may cause harm to unborn children, possible risk of impaired
fertility. This is a
physiologically active product and so contact should be minimised,
especially if the user is taking a form of
medication, as interactions can sometimes give unexpected and
undesired results.
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
INHALATION:
SHORT TERM EXPOSURE:
Avail