ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Equilis Prequenza Te, suspension for injection, for horses
2.
Per dose of 1 ml:
Active substances:
Tetanus toxoid and purified haemagglutinin subunits from equine influenza viruses:
A/equine-1/ Prague/1/ 56
100 AU
1
A/equine-2/ Newmarket/1/93
50 AU
A/equine-2/ Newmarket/2/93
50 AU
Tetanus toxoid
40 Lf
2
Adjuvants:
Purified Saponin
375 micrograms
Phosphatidylcholine
62.5 micrograms
For a full list of excipients, see section 6.1.
3.
Suspension for injection
4.
Horses
Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs
and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Influenza
Onset of immunity: 2 weeks after the primary vaccination course
Duration of immunity: 5 months after the primary vaccination course
12 months after the first revaccination
Tetanus
Onset of immunity: 2 weeks after the primary vaccination course
Duration of immunity: 17 months after the primary vaccination course
24 months after the first revaccination
None
1
Antigenic units
2
Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur. potency test
2
Cholesterol
125 micrograms
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were
revaccinated in the last two months of gestation, because of possible interference by maternally
derived antibodies.
Only healthy animals should be vaccinated.
Not applicable
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
In case of accidental self-injection, seek medical advice immediately and show the package insert or
the label to the physician.
A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2
days. Pain at the injection site can occur in rare cases which may result in temporary functional
discomfort (stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence,
may occur for 1 day, and up to 3 days in exceptional circumstances.
Can be used during pregnancy and lactation.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the
same day but not mixed with Tetanus Serum from Intervet (see section 4.9).
No information is available on the safety and efficacy of this vaccine when used with any other
veterinary medicinal product except the product 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.
Intramuscular use
Vaccination schedule:
Primary vaccination course
Administer one dose (1 ml), by intramuscular injection, according to the following schedule:
•
3
Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
Revaccination
Influenza
The first revaccination (third dose) against equine influenza is given 5 months after the primary
vaccination course. This revaccination results in immunity to equine influenza lasting at least 12 months.
The second revaccination is given 12 months after the first revaccination.
The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the
strains A/equi 1/Prague 56, A/equi 2/Newmarket-1/93 and A/equi 2/Newmarket-2/93, is recommended
to maintain immunity levels for the influenza component (see scheme).
Tetanus
The first revaccination is given not later than 17 months after the primary vaccination course.
Thereafter a maximum interval of two years is recommended (see scheme).
V1
V2
5
V3
12
V4
12
V5
30
12
V6
0
1
6
18
30
42 months
Prequenza
Te
Prequenza
Prequenza
Prequenza Te
Prequenza
Prequenza Te
Prequenza
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be
given at the age of 4 months followed by the full vaccination programme (Primary vaccination course at
6 months of age and 4 weeks later)
Concurrent active and passive immunisation (emergency vaccination)
The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that
have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given
concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate
injection site, using separate syringes and needles. This will lead to a passive protection against tetanus
for at least 21 days after concurrent administration. The second dose of the vaccine (V2) should be
administered 4 weeks later. A third vaccination with Equilis Prequenza Te should be repeated at least
four weeks later. Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce
active immunity against tetanus compared to horses vaccinated with
Equilis Prequenza Te in the absence
of tetanus antitoxin serum.
Following the administration of a double dose of vaccine, no side-effects other than those described
under 4.6 have been observed except for some depression at the day of vaccination
Zero days
5.
To stimulate active immunity against Equine influenza and tetanus
ATC-vet code: QI05AL01
6.
6.1
List of excipients
Lactose, phosphate buffer, chloride buffer, traces of thiomersal, traces of formaldehyde
4
V1
V2
V3
V6
12
5
V4
V5
12
12
0
1
6
18
42 months
Prequenza
Te
Prequenza
Te
Prequenza
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
6.4 Special precautions for storage
Store at 2-8
°
C, protected from light. Do not freeze.
6.5 Nature and composition of immediate packaging
Type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a
halogenobutyl stopper.
Package size:
Cardboard box with 10 glass vials of 1 ml.
Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Intervet International B.V.
Wim de Körverstraat 35
NL-5831 AN Boxmeer
The Netherlands
EU/2/05/057/001-004
08/07/2005 / 27/07/2010
27/07/2010
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable
5
ANNEX II
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
BATCH RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
6
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substance(s)
Novartis Vaccines and DIagnostics GmbH and Co.
Emil-von-Behring-Str. 76
35 041 Marburg
Germany
CSL Ltd.
45 Poplar Road
Parkville
3052 Victoria
Australia
Laboratorios Intervet S.A.
Poligono El Montalvo
Apartado 3006
Salamanca 37080
Spain
Name and address of the manufacturer responsible for batch release
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Netherlands
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
Veterinary medicinal product subject to prescription.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO SAFE AND EFFECTIVE USE
Not applicable
D. STATEMENT OF THE MRLs
The active substance being a principle of biological origin intended to produce active immunity is not
in the scope of Regulation (EC) 470/2009.
The following constituents of Equilis Prequenza Te are included in Table 1 (Allowed substances) of
the annex to Commission Regulation (EU) No 37/2010 as follows:
7
Pharmaco-
logically active
substance
Marker
residue
Animal
species
MRLs
Target
tissues
Other
provisions
Therapeutic
classification
Saponin
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
No entry
No entry
Sodium
phosphate
(Na
2
HPO
4
) –
covered by
entry for food
additives with
an E number
(E339)
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
Only substances
approved as
additives in
foodstuffs for
human
consumption,
with the
exception of
preservatives
listed in part C of
Annex III to
European
Parliament and
Council
Directive
95/2/EC
No entry
Potassium
phosphate
(KH
2
PO
4
) –
covered by
entry for food
additives with
an E number
(E340)
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
Only substances
approved as
additives in
foodstuffs for
human
consumption,
with the
exception of
preservatives
listed in part C of
Annex III to
European
Parliament and
Council
Directive
95/2/EC
No entry
Sodium
chloride (NaCl)
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
No entry
No entry
Magnesium
chloride
(MgCl
2
)
Not
applicble
All food
producing
species
No
MRL
required
Not
applicable
No entry
No entry
Calcium
chloride (CaCl
2
)
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
No entry
No entry
Thiomersal
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
For use only as
preservative in
multidose
vaccines at a
No entry
8
Pharmaco-
logically active
substance
Marker
residue
Animal
species
MRLs
Target
tissues
Other
provisions
Therapeutic
classification
concentration not
exceeding 0,02%
Formaldehyde
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
No entry
No entry
In addition to the above constituents the product contains the following excipients: lactose, cholesterol
and phosphatidylcholine. These excipients are considered as not falling within the scope of Regulation
(EC) No 470/2009.
9
ANNEX III
LABELLING AND PACKAGE INSERT
10
A. LABELLING
11
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
1.
Equilis Prequenza Te
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per dose of 1 ml:
A/equine-1/Prague 56 (100 AU), A/equine-2/Newmarket/1/93 (50 AU),
A/equine-2/Newmarket/2/93 (50 AU), Tetanus toxoid 40 Lf.
3.
Suspension for injection
4.
PACKAGE SIZE
1, 5 or 10 x 1 dose
5.
Horses
6.
Active immunisation of horses against equine influenza and tetanus
7.
METHOD AND ROUTE OF ADMINISTRATION
i.m. use
8.
Zero days
9.
SPECIAL WARNING(S), IF NECESSARY
Read package leaflet before use.
12
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Store at 2-8 °C, protected from light. Do not freeze.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read package leaflet before use.
13. THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only – to be supplied only on veterinary prescription.
14. THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
Keep out of the reach and sight of children.
Intervet International B.V.
16. MARKETING AUTHORISATION
NUMBER
(S)
EU/2/05/057/001-004
17. MANUFACTURER'S BATCH NUMBER
Lot {number}
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1.
Equilis Prequenza Te
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
1 dose
4.
ROUTE(S) OF ADMINISTRATION
i.m.
5.
6.
BATCH NUMBER
Lot {number}
7.
EXPIRY DATE
EXP {month/year}
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET FOR:
Equilis Prequenza Te, suspension for injection, for horses
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA, IF DIFFERENT
Intervet International B.V.
Wim de Körverstraat 35
NL-5831 AN Boxmeer
The Netherlands
2.
Equilis Prequenza Te, suspension for injection, for horses
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Per dose of 1 ml:
Active substances
Tetanus toxoid and purified haemagglutinin subunits from equine influenza viruses:
A/equine-1/ Prague/1/ 56
100 AU
3
A/equine-2/ Newmarket/1/93
50 AU
A/equine-2/ Newmarket/2/93
40 Lf
4
Adjuvant
Purified saponin
375 micrograms
Phosphatidylcholine
62.5 micrograms
4.
Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and
virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Influenza
Onset of immunity: 2 weeks after the primary vaccination course
Duration of immunity: 5 months after the primary vaccination course
12 months after the first revaccination
Tetanus
Onset of immunity: 2 weeks after the primary vaccination course
Duration of immunity: 17 months after the primary vaccination course
24 months after the first revaccination
3 Antigenic units
4 Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur. potency test
16
50 AU
Tetanus toxoid
Cholesterol
125 micrograms
5.
None
6.
A diffuse hard or soft swelling (max. diameter 5 cm) may occur at the injection site, regressing within 2
days. Pain at the injection site can occur in rare cases which may result in temporary functional discomfort
(stiffness). In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1
day, and up to 3 days in exceptional circumstances.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Horses
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
1 ml. Intramuscular use
Vaccination schedule
:
Primary vaccination course
Administer one dose (1 ml), by intramuscular injection, according to the following schedule:
•
Revaccination
Influenza
The first revaccination (third dose) against equine influenza is given 5 months after the primary vaccination
course. This revaccination results in immunity to equine influenza lasting at least 12 months.
The second revaccination is given 12 months after the first revaccination.
The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains
A/equi 1/Prague 56, A/equi 2/Newmarket-1/93 and A/equi 2/Newmarket-2/93, is recommended to maintain
immunity levels for the influenza component (see scheme).
Tetanus
The first revaccination is given not later than 17 months after the primary vaccination course.
Thereafter a maximum interval of two years is recommended (see scheme).
V1
V2
V1
V2
5
V3
12
V4
12
V5
12
V6
0
1
6
42 months
18
30
Prequenza
Prequenza
Te
Prequenza
Te
Prequenza
Te
Prequenza
Prequenza Te
Prequenza
17
Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later
V3
V6
12
5
V4
V5
12
12
42 months
0
1
6
18
30
Prequenza
Te
Prequenza
Te
Prequenza
Prequenza
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given
at the age of 4 months followed by the full vaccination programme (Primary vaccination course at 6 months
of age and 4 weeks later)
Concurrent active and passive immunisation (emergency vaccination)
The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that
have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given
concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate injection
site, using separate syringes and needles. This will lead to a passive protection against tetanus for at least
21 days after concurrent administration. The second dose of the vaccine (V2) should be administered 4
weeks later. A third vaccination with Equilis Prequenza Te should be repeated at least four weeks later.
Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce active immunity
against tetanus compared to horses vaccinated with Equilis Prequenza Te in the absence of tetanus
antitoxin serum.
9.
ADVICE ON CORRECT ADMINISTRATION
Allow the vaccine to reach room temperature (15-25
°
C) before use.
Administer 1 ml of vaccine i.m..
10. WITHDRAWAL PERIOD
Zero days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children. Store at 2-8°C, protected from light. Do not freeze. Do not use
after the expiry date stated on the label.
12. SPECIAL WARNING(S)
Only healthy animals should be vaccinated. In case of accidental self-injection, seek medical advice
immediately and show this package insert or the label to the physician.
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were
revaccinated in the last two months of gestation, because of possible interference by maternally derived
antibodies.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the
same day but not mixed with Tetanus Serum from Intervet (see section 8).
No information is available on the safety and efficacy of this vaccine when used with any other veterinary
medicinal product except the product 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 product.
18
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products
should be disposed of in accordance with local requirements.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
27/07/2010
15. OTHER INFORMATION
Cardboard box with 10 glass vials of 1 ml.
Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
Not all pack sizes may be marketed.
19
Source: European Medicines Agency
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