PERMIT TO ALLOWSUPPLY AND MINOR USE
OF AN UNREGISTERED AGVET CHEMICAL PRODUCT
PERMIT NUMBER – PER 14236
This permit is issued to the Permit Holder in response to an application granted by the APVMA
under section 112 of the Agvet Codes of the jurisdictions set out below. This permit allows a
Supplier (as indicated) to possess The Product for the purposes of supply, the doing of which
would otherwise be an offence under section 78 of the Agvet Code, and to supply The Product
to a person who can use The Product under permit. This permit allows a person, as stipulated
below, to use The Product in the manner specified in this permit in the designated jurisdictions.
This permit also allows the Permit Holder, the Supplier (if not one and the same) and any
person stipulated below to claim that The Product can be used in the manner specified in this
permit.
THIS PERMIT IS IN FORCE FROM 27 MAY 2013 TO 27 MAY2015.
It is in force until it expires or it is cancelled, suspended or surrendered.
Permit Holder and Supplier:
Intervet Australia Pty Ltd
91-105 rpin Street
Bendigo VIC 3554
Persons who can use the product under this permit:
Australian Department of Agriculture, Fisheries and Forestry (DAFF) accredited veterinarians
or DAFF approved veterinarians, under the control and direction of aState/Territory Chief
Veterinary Officer (CVO).
OR
Veterinarians authorised in writing by the State/Territory Chief Veterinary Officer (CVO).
Product to be used:
NOBIVAC RABIES INACTIVATED RABIES VACCINE
Containing: INACTIVATED RABIES VIRUS PASTEUR STRAIN as the only active
constituent.
Animals in which use is permited
Use is permitted in any terrestrial mammal (except pigs) in accordance with the Purposes
outlined below and Condition 5 below.
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DIRECTIONS FOR USE
Animal
Dogs, cats,
Purpose
Dogs and cats intended for export
Dogs involved in quarantine, military or Customs
operations that may come into contact with
animals infected with rabies virus or Australian
bat lyssavirus.
Any exposed terrestrial
mammal (for example:
dog, cat, horse, or
ruminant) except pigs
Dose
As per attached
label or as
directed by the
State/Territory
CVO
In emergencies for all relevant species excluding
porcine species, as part of the response to a
disease incident caused by rabies virus or
Australian bat lyssavirus. This use must be under
the control and direction of the State/Territory
CVO.
CRITICAL USE COMMENTS
Vaccine should be administered subcutaneously or intramuscularly as per the product label.
Vaccine must NOT be frozen and must be brought to ambient temperature before
administration.
The product may be presented as 1mL or 10mL vials. For dosage and administration,
recommended vaccination programme and in-use conditions refer to the product labels in
Attachment 1.
Any adverse reaction should be reported to the AERP coordinator as soon possible.
CONDITIONS OF PERMIT
SUPPLY
1. Intervet Australia Pty Ltd is authorised to supply Nobivac Rabies vaccine to the Chief
Veterinary Officer in the State or Territory of destination, or directly to DAFFaccredited or DAFF-approvedveterinarians.
2. Intervet Australia Pty Ltd is authorised to supply Nobivac Rabies vaccine sourced from
Intervet International BV Wim de Korverstraat 35, NL-5831 AN Boxmeer The
Netherlands.
3. Intervet Australia Pty Ltd must supply the product in a container that must
comply with the following requirements:
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a. be impervious to, and incapable of chemical reaction with, its contents when
under conditions of temperature and pressure that are likely to be encountered in
normal service; and
b. have sufficient strength and impermeability to prevent leakage of its contents
during handling, transport and storage under normal handling conditions; and
c. if it is intended to be opened more than once — be able to be securely and
readily closed and reclosed; and
d. have sufficient excess capacity to prevent it from breaking if its contents expand
during handling, transport or storage; and
e. enable all or any part of its contents to be removed or discharged in such a way
that, with the exercise of no more than reasonable care, the contents cannot:
i. harm any person; or
ii. have an unintended effect that is harmful to the environment
Attached to this container must be a label, which is consistent with Attachment 1.
USE
4. Veterinarians who wish to use the products for the purposes specified in this permit
must read, or have read to them, the permit particularly the information included in
Attachment1.
5. The vaccine must be used only for the vaccination of
(i) dogs and cats intended for export, or
(ii) dogs involved in quarantine, military or customs operations that may come into
contact with animals infected with rabies virus or Australian bat lyssavirus, or
(iii) any terrestrial mammal with direct exposure to a suspect or confirmed
diagnosed case of Australian bat lyssavirus(for example: dog, cat, horse, or
ruminant) except pigs. The use must be under the control and direction of
State/Territory CVO with the agreement of the Consultative Committee on
Emergency Animal Diseases (CCEAD), Animal Health Committee (AHC) or
authorised personnel acting under their direction.
6. Animals vaccinated under Condition 5 (iii) must be permanently identified and a register
must be maintained by the authorising CVO.
Issued by
John Owusu
Delegated Officer
APVMA
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Attachment 1
Nobivac
®
Animal
RABIES
SUSPENSION FOR INJECTION FOR DOGS AND CATS
PRESENTATION
Inactivated vaccine containing ≥ 2 IU Rabies virus strain Pasteur RIV per dose. Also
contains Aluminium phosphate as an adjuvant. 0.1 mg Thiomersal are added as a
preservative.
USES
For the active immunisation against rabies to reduce clinical signs and mortality.
Onset of immunity: an adequate serological response (≥ 0.5 I.U.) has been
demonstrated 2 to 3 weeks after vaccination.
Duration of immunity; 3 years.
DOSAGE AND ADMINISTRATION
A single dose inoculation of 1 mL is sufficient irrespective of size, species or breed of
animal. Sterile equipment should be used for administration. Avoid contamination of
vaccine with traces of chemical sterilising agents.
Do not use chemicals such as disinfectant or spirit to disinfect the skin prior to
inoculation.
Primary course and booster vaccination
DOGS & CATS
Primary vaccination age*
3 months or older
Booster vaccination
every 3 years
Route of administration
intramuscularly or subcutaneously
*
Primary vaccination may be administered at an earlier age (minimum in dogs and
cats of 4 weeks of age), but then a repeat vaccination must be given at the age of 3
months.
Health regulations and requirements in certain countries specify that dogs must be
revaccinated annually against rabies.
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Expiry end of:
Expiry end of:
Batch No.:
Batch No:
107722R1
1 dose
SUSPENSION FOR I.M. OR S.C. INJECTION IN CATS AND DOGS
For animal treatment only. Keep out if the reach and sight of children.
To be supplied only on veterinary prescription.
POM-V
Content per dose (1 mL): inac. Rabies Virus: ≥ 2 IU
Read package leaflet before use. Shake well before use.
Keep container in the outer carton.
Vm 01708/4325
MSD
Nobivac Rabies
Nobivac® Rabies
Can be used during pregnancy in dogs.
Further information
Limited safety data for ferrets are available from monitoring post vaccination reactions.
Ferrets can be vaccinated subcutaneously from 3 months of age. An adequate
serological response (≥ 0.5 I.U.) has been demonstrated 1 month after vaccination
and they should receive a booster vaccination every 18months.
A good immune response is reliant on the reaction of an immunogenic agent and a
fully competent immune system. Immunogenicity of the vaccine antigen will be
reduced by poor storage or inappropriate administration. Immune-competence of the
animal may be compromised by a variety of factors including poor health, nutritional
status, genetic factors, concurrent drug therapy and stress.
Pet Travel Scheme (PETS)
Animals intended for vaccination under the Pet Travel Scheme (PETS) must be
identified by a permanent numbered microchip. This microchip number must be
recorded on the record of the dog, cat and ferret vaccination at the time of rabies
vaccination.
CONTRA-INDICATIONS, WARNINGS, ETC.
Do not use in unhealthy animals. The vaccine may not be effective in animals
incubating the disease at the time of vaccination.
Some animals may be immunologically incompetent and fail to respond to vaccination
(see further information). Animals that have received the corresponding anti-serum or
immunosuppressive drugs should not be vaccinated until an interval of at least 4
weeks has elapsed.
Transient local reactions such as non-painful diffuse to firm swellings of approximately
1 cm in diameter may be observed for up to 3 weeks after subcutaneous vaccination.
In the rare event of a hypersensitivity reaction following vaccination, administer an
antihistamine, corticosteroid or adrenaline, without delay and by the most immediate
route.
After administration of an overdose no other signs than those after a single dose
vaccination may be observed.
The presence of maternal antibodies can interfere with the response to vaccination.
Can be used during pregnancy in dogs. There are no laboratory data on use during
pregnancy in other species, but on the basis of field experience, such use is expected
to be safe.
Safety and efficacy data are available which demonstrate that this vaccine can be
used to reconstitute the freeze dried Intervet vaccines of the Nobivac range containing
one or more of the following: live canine distemper, canine adenovirus, canine
parvovirus and canine parainfluenza and inactivated canine leptospirosis antigens or
live feline viral rhinotracheitis virus, feline calicivirus and feline panleucopenia virus.
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No information is available on the safety and efficacy of this vaccine when used with
any other veterinary medicinal product except the products mentioned above. A
decision to use this vaccine before or after any other veterinary medicinal product
therefore needs to be made on a case by case basis.
Do not mix with any other veterinary medicinal products apart from those listed above.
This product should not be given for at least one month following the administration of
hyperimmune serum or immunosuppressant drugs.
WITHDRAWAL PERIOD
Not applicable.
FOR ANIMAL TREATMENT ONLY. KEEP OUT OF THE REACH AND SIGHT OF
CHILDREN.
PHARMACEUTICAL PRECAUTIONS
Store in a refrigerator (2°C to 8°C). Do not freeze.
Keep the container in the outer carton.
Disposal advice
Any unused veterinary medicinal product or waste material derived from such
veterinary medicinal product should be disposed of in accordance with local
requirements.
LEGAL CATEGORY
POM-V
To be supplied only on veterinary prescription
PACKAGE QUANTITIES
Cardboard box with 1, 10 or 50 glass type 1 vials with 1 mL with a rubber stopper and
aluminium cap. Not all pack sizes may be marketed.
MA NUMBER
Vm 01708/4325
DATE OF TEXT PREPARATION
01/01/2012
MA HOLDER
Intervet UK Ltd.
Walton Manor, Walton. Milton Keynes
Bucks, MK7 7AJ
DISTRIBUTED IN NORTHERN IRELAND BY
Intervet Ireland Ltd.
Magna Drive, MagnaBusinessPark
Citywest Road, Dublin 24
MSD Animal
Health Logo
MANUFACTURER
Intervet International BV
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Wim de Körverstraat 35, NL-5831 AN Boxmeer
Nobivac® Rabies
SUSPENSION FOR INJECTION
RABIES VACCINE
1 dose [10x1 dose]
Nobivac logo
Back Panel
®
Nobivac Rabies
1 dose
Inactivated vaccine containing ≥2 IU Rabies virus strain Pasteur RIV per dose. 0.06 –
0.88 mg Al3+ / mL are added as an adjuvant. 0.1 mL Thiomersal are added as a
preservative.
For administration to cats and dogs by i.m. or s.c. injection.
FOR ANIMAL TREATMENT ONLY
KEEP OUT OF REACH AND SIGHT OF CHILDREN
To be supplied only on veterinary prescription.
POM-V
Nobivac® Rabies
1 dose
Read package leaflet for directions, warnings and disposal advice before use. Store
between +2°C and +8°C. Do not freeze. Keep the container in the outer carton.
Side Panel 2
®
Nobivac Rabies
1 dose
Vm 01708/4325
MA Holder
Intervet UK Ltd.
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Walton Manor, Walton
Milton Keynes, Bucks. MK7 7AJ
Distributed in Northern Ireland
Intervet Ireland Ltd.
Magna Drive
MagnaBusinessPark
Citywest Road, Dublin 24
MSD Animal
Health Logo
Nobivac® Rabies
10 x 1 dose
Inactivated vaccine containing ≥2 IU Rabies virus strain Pasteur RIV per dose. 0.06 –
0.88 mg Al3+ / mL are added as an adjuvant. 0.1 mL Thiomersal are added as a
preservative.
For administration to cats and dogs by i.m. or s.c. injection.
FOR ANIMAL TREATMENT ONLY
KEEP OUT OF REACH AND SIGHT OF CHILDREN
Read package leaflet for directions, warnings and disposal advice before use. Store
between +2°C and +8°C. Do not freeze. Keep the container in the outer carton.
Side Panel 1
®
Nobivac Rabies
10 x 1 dose
MA Holder
Intervet UK Ltd.
Walton Manor, Walton
Milton Keynes, Bucks. MK7 7AJ
Distributed in Northern Ireland
Intervet Ireland Ltd.
Magna Drive
MagnaBusinessPark
Citywest Road, Dublin 24
Manufacturer
Intervet International BV
Wim de Körverstraat 35, NL-5831 AN Boxmeer
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MSD Animal
Health Logo
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Nobivac® Rabies
Batch/Expiry end of:
To be supplied only on veterinary prescription.
Vm 01708/4325
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