COOPERS OVILIS CAMPYVAX- CAMPYLOBACTER VACCINE FOR SHEEP

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CAMPYLOBACTER FETUS SUB-SPECIES FETUS - INACTIVATED; CAMPYLOBACTER JEJUNI SUB-SPECIES JEJUNI - INACTIVATED; THIOMERSAL

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

Campylobacter jejuni+vaccine - Campylobacter fetus

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

CAMPYLOBACTER FETUS SUB-SPECIES FETUS - INACTIVATED VACCINE-MICROBIAL Active 0.0 orgs/mL; CAMPYLOBACTER JEJUNI SUB-SPECIES JEJUNI - INACTIVATED VACCINE-MICROBIAL Active 0.0 orgs/mL; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

100mL; 250mL; 500mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

SHEEP EWE (FEMALE) | FEMALE SHEEP | OVINE

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

CAMPYLOBACTER FETUS FETUS | CAMPYLOBACTER ABORTION | CONTROL OF REPRODUCTIVE LOSS

Product summary:

Poison schedule: 0; Withholding period: WITHHOLDING PERIOD: MEAT: NIL MILK: NIL WOOL: NIL TRADE ADVICE: EXPORT SL AUGHTER INTERVAL(ESI): NOT REQUIRED.; Host/pest details: SHEEP EWE (FEMALE): [CAMPYLOBACTER FETUS FETUS]; For use as an aid in control of reproductive losses (including abortions) due to Campylobacter infections in sheep.NOT for use in ewes which are severely debilitated or stressed.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

I
'
I
Registered Product Name: Coopers Ovilis
CampyVaxTM
-
Campylobacter Vaccine for Sheep
Page 1
of
II
Pack
Sizes: 100mL, 250mL, 500mL
Date (Version Control): 05/04/2013
Description: IMMEDIATE CONTAINER LABEL
APVMA: 61563/49252
Panel labels, text above the header and below the footer are not
included in this label text.
FOR
ANIMAL
TREATMENT ONLY
Coopers Ovilis CampyVax'M
-campylobacter
Vaccine
for
Sheep.
ACTIVE
CONSTITUENTS:
Inactivated
whole
cell preparations
of
_Campylobacter jejuni 1 x _
_10_
_8 _
_orgs/mL _
and
_Campylobacter _
_fetus _
_fetus 1 x _
_1cf _
_orgs/mL. _
Preservative:
O.lmg/mL
Thiomersal.
For use
as
an
aid in control
of
reproductive losses (including abortions) due
to
_Campylobacter _
infections in sheep.
READ
THE
ENCLOSED
LEAFLET
BEFORE
USING
THIS
PRODUCT.
Shake
well
to
mix
before use and
to
keep mixed during use
Dose:
2 mL by subcutaneous injection
into
the
neck.
+
RLP
Approved
Vaccination schedule: Unvaccinated breeding ewes should receive a
sensitiser vaccination
prior
to
joining
and a booster dose a
minimum
of
3 weeks later. Thereafter, all breeding ewes should
receive an annual booster before joining.
It
is
essential
that
ewe
lambs, maiden ewes, and
newly
purchased breeding ewes receive
two
vaccinations before
introduction
to
the
breeding flock.
Whole
flock vaccination
is
recommended.
FIRST
AID:
If
poisoning occurs, contact a
doctor
or
Poisons Information Centre.
_Australia Phone 131126. _
USER
SAFETY
INFORMATION: Extreme caution should be used when injecting oil
emulsion vaccines
to
avoid injecting yourself. Accidental self-inoculation may cause
inflammatory reactions
or
allergic
response which requires correct medical management. Medical advice
should be sought
as
soon
as
possible in
the
event
of
self inoculation.
Do
not
splash
in
eyes.
Rinse
off
skin and
eyes
with water.
Keep
out
of
reach
of
children.
WITHHOLDING
PERIOD:
Meat: NIL
Milk:
NIL
Wool: NIL
TRADE
ADVICE:
Export Slaughter Interval
(ESI):
ESI
not
required.
Registered Product Name: Coopers Ovilis CampyVaxTM -
Campylobacter Vacci

Summary of Product characteristics

PRODUCT NAME: COOPERS OVILIS CAMPYVAX - CAMPYLOBACTER
VACCINE FOR SHEEP
THIS REVISION ISSUED: NOVEMBER, 2013
PAGE: 1 OF 5
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: [phone]
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia
CHEMICAL NATURE:
Inactivated bacteria in a suitable medium; applied by injection.
TRADE NAME:
COOPERS OVILIS CAMPYVAX - CAMPYLOBACTER VACCINE FOR SHEEP
RECOMMENDED USE:
Animal vaccine for use as described on the product label.
APVMA NO:
61563
CREATION DATE:
November, 2013
THIS VERSION ISSUED:
November, 2013
and is valid for 5 years from this date.
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, S25. Do not breathe mists. Avoid contact with eyes.
SUSDP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
White liquid suspension.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. In addition
product is unlikely to
cause any discomfort or irritation.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. In addition product is unlikely to cause any discomfort in
normal use.
LONG TERM EXPOSURE:
No data for health effects associated with long term skin exposure.
EYE CONTACT:
SHORT TERM EXPOSURE
: This product may be mildly irritating to eyes, but is unlikely to
cause anything more than mild
discomfort which should disappear once product is removed.
LONG TERM EXPOSURE
: No data for health effects as