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1.
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NAME OF THE VETERINARY MEDICINAL
PRODUCT
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TRIVACTON 6
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2.
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QUALITATIVE AND QUANTITATIVE
COMPOSITION
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Each dose of 5-ml of vaccine
contains:
- E. coli
K99 antigen, at least ………………………………..……………….…1.15
SA.U
- E. coli
Y antigen, at least …………………………………..……………………..0.9
SA.U
-
E. coli 31A antigen,
at least……………………………………………………….1.6 SA.U
- E. coli
F41 antigen, at least ………………………………………………………0.7
SA.U
- Inactivated bovine
rotavirus, at least ………………………………………3.0 SN.U
- Inactivated bovine
coronavirus, at least ………………………………….1.9 SN.U
- Aluminium hydroxide (expressed in
Al+++)
………………………………..3.5 mg
- Saponin
……………………………………………………………………………………….1.5 mg
- Thiomersal*
………………………………………………………………………………..0.5 mg
- Excipient q.s.
………………………………………………..………………………………..5 ml
1 SA.U: q.s.
to obtain an agglutinating antibody titre of
1 log10
in mice after an administration of
vaccine.
1 SN.U: q.s.
to obtain a neutralising antibody titre of
1 log10
in guinea-pigs after two administrations of
vaccine.
* Multidose containers only
For full list of excipients,
see section 6.1
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3.
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PHARMACEUTICAL FORM
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Suspension for injection.
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4.
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CLINICAL PARTICULARS
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4.1
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Target species
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Cattle (pregnant females)
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4.2
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Indications for use, specifying
the target species
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For
administration to pregnant cows and heifers to stimulate
serological and colostral antibodies against rotavirus and
coronavirus antigens and against K99, Y, 31A and F41 antigens
of Escherischia coli in susceptible animals, which may be passed to the calf to
reduce neonatal diarrhoea infection caused by agents containing
these antigens.
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4.3
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Contra-indications
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None.
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4.4
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Special warnings for each target
species
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None.
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4.5
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Special precautions for use
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(i) Special precautions for use
in animals
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None.
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(ii) Special precautions to be
taken by the person administering the veterinary medicinal product
to the animals
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None.
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4.6
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Adverse reactions (frequency and
seriousness)
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. Local reaction at the site of
injection (≤10 cm), may appear after vaccination. This usually
disappears within 14 days.
. A slight increase in mean
rectal temperature (≤0.5°C) may be observed on the day following
the injection.
. Any
injection of bacterial cells, even inactivated, may occasionally
cause hypersensitivity reactions. In such case, a symptomatic
treatment should be provided.
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4.7
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Use during pregnancy, lactation
or lay
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For vaccination of pregnant
cattle.
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4.8
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Interaction with other medicinal
products and other forms of interaction
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No information is available on
the safety and efficacy from the concurrent
use of this vaccine with any
other. Therefore the safety and efficacy of this product when used
with any other (either when used on the same day or at different
times) has not been demonstrated.
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4.9
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Amounts to be administered and
administration route
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Shake well before use.
Subcutaneous route.
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Inject one 5-ml dose according
to the following schedule:
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Pregnant cows
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Primary vaccination
. First injection: 1 to 2
months before calving.
. Second injection: 2 to 4
weeks after first injection, at least 2 weeks
prior to calving.
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-
Boosters
No data has been provided to
support the use of a single dose booster regime. However,
experience in the field suggests that a single dose of the vaccine
administered two weeks before calving may provide enhanced antibody
levels in the colostrum against the component antigens.
Ensure that each calf rapidly
ingests a sufficient quantity of colostrum.
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4.10
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Overdose (symptoms, emergency
procedures, antidotes), if necessary
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After administration of a double
dose of vaccine, a local reaction at the site of injection may
appear as a slight oedema evolving to a firm swelling, usually
disappearing within 14 days of vaccination.
A slight transient temperature
rise (mean 0.7°C) may be observed for two days following the
injection.
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4.11
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Withdrawal periods
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Zero days.
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5.
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IMMUNOLOGICAL PROPERTIES
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Inactivated
adjuvanted vaccine which stimulates the production of antibodies to
rotavirus, coronavirus and E.
coli.
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ATC Vet
Code: QI02AL01
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6.
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PHARMACEUTICAL PARTICULARS
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6.1
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List of excipients
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Aluminium hydroxide
Saponin
Thiomersal (multidose
containers only)
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6.2
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Major incompatibilities
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Do not mix with any other
vaccine or immunological product.
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6.3
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Shelf-life
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Shelf-life of the veterinary
medicinal product as packaged for sale: 18 months.
Open bottle should be used
immediately.
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6.4
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Special precautions for
storage
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Store between +2°C and +8°C,
protected from light.
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6.5
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Nature and composition of
immediate packaging
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Nature of basic packaging
elements :
Type I glass
Butyl elastomer closure
Aluminium cap
Packaging :
10-dose (glass) bottle, box of 1
bottle.
20-dose (glass) bottle, box of
1 bottle.
1-dose (glass) bottle, box of
10 bottles.
Not all pack sizes may be
marketed.
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6.6
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Special precautions for the
disposal of unused veterinary medicinal product or waste materials
derived from the use of such products, if appropriate
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Any unused product or waste material
should be disposed of in accordance with national guidelines.
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7.
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MARKETING AUTHORISATION
HOLDER
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Merial Animal Health
Limited
PO Box 327
Sandringham House
Sandringham Avenue
Harlow Business Park
Harlow, Essex, CM19 5TG
United Kingdom
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8.
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MARKETING AUTHORISATION
NUMBER(S)
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Vm 08327/4106
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9.
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DATE OF FIRST
AUTHORISATION/RENEWAL OF THE AUTHORISATION
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31 May 2006
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10.
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DATE OF REVISION OF THE TEXT
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March 2008.
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