ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Suvaxyn PCV suspension for injection for pigs
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One dose of 2 ml contains:
Active substance:
Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine
Circovirus type 2 ORF2 protein
1.6 RP* 5.3
Adjuvants:
Sulfolipo-cyclodextrin (SLCD) 4.0 mg
Squalane 64.0 mg
Excipients:
Thiomersal 0.1 mg
*
Relative Potency unit determined by ELISA antigen quantification (
in vitro
potency test) compared
to a reference vaccine.
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For a full list of excipients, see section 6.1.
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Suspension for injection
h
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Pigs (piglets) from 3 weeks of age.
A
Active immunisation of pigs over the age of 3 weeks against Porcine Circovirus type 2 (PCV2) to
reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with
PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality
associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
n
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Onset of immunity: from 3 weeks post-vaccination.
Duration of immunity: 19 weeks post-vaccination.
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None.
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a
Do not use in breeding boars.
The benefit of the vaccination of pigs with very high levels of maternally-derived antibodies, e.g. due
to vaccination of their mothers, has not been demonstrated.
2
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Vaccinate only healthy animals.
Avoid stress in the animals before and after the time of vaccination.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
None.
A transient increase in body temperature (up to 1.7°C) is very common during the first 24 hours after
vaccination. This resolves spontaneously within 48 hours without treatment.
Local tissue reactions in the form of swelling at the injection site are very common and may last for up
to 26 days. The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a
larger swelling may occur. In clinical studies, a post-mortem examination of the injection site,
performed 8 weeks after the administration of a single dose of the vaccine, revealed a mild to
moderate granulomatous inflammation of the muscular fibres at the injection site.
Vomiting occurs commonly (1-10 % in average, but up to 25% in a particular herd) during the first
hour after vaccination, but no consequential negative effects are observed.
Anaphylactic reactions are uncommon. In case of such reactions, appropriate treatment is
recommended. If left untreated, anaphylactic reactions might be lethal.
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Do not use during pregnancy and lactation.
4.8
Interactions with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other
veterinary medicinal product. 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.
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Shake well before administration and intermittently during the process of vaccination.
The use of a multi-dosing syringe is recommended. Use vaccination devices according to the
manufacturer’s instructions.
The vaccine is to be administered aseptically.
Administer one dose of 2 ml to piglets in the neck behind the ear.
Vaccination schedule:
One injection from 21 days of age.
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a
double dose of vaccine.
3
Intramuscular use.
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Zero days.
5.
IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Swine inactivated viral vaccine, ATC Vet Code: QI09AA07
The vaccine strain is an inactivated recombinant Porcine Circovirus type 1 expressing the Porcine
Circovirus type 2 ORF2 protein. It is intended to stimulate active immunity against PCV2 in piglets.
6.1
List of excipients
Thiomersal
MEM without phenol red
Sodium bicarbonate
Hepes acid
Water for injections
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6.2
Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3
Shelf life
Shelf life of the veterinary medicinal product as package for sale: 18 months.
Shelf life after first broaching the immediate packaging: use immediately.
6.4
Special precautions for storage
Store and transport refrigerated (2°C – 8°C).
Do not freeze.
Protect from light.
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Cardboard box containing polyethylene bottles with a chlorobutyl elastomer closure and sealed with
an aluminium cap.
Cardboard box of 1 bottle of 10 doses (20 ml), 50 doses (100ml) or 125 doses (250 ml).
Cardboard box of 10 bottles of 10 doses (20 ml), 50 doses (100ml) or 125 doses (250 ml).
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
Any unused product or waste material should be disposed of in accordance with the local
requirements.
4
6.5
Nature and composition of immediate packaging
material derived from the use of such products, if appropriate
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Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
8.
MARKETING AUTHORISATION NUMBERS
EU/2/09/099/001-006
24/07/2009
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Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use of Suvaxyn PCV is or may be prohibited in certain Member States
on the whole or part of their territory pursuant to national animal health policy. Any person intending
to import, sell, supply and/or use Suvaxyn PCV must consult the relevant Member State’s competent
authority on the current vaccination policies prior to the import, sale, supply and/or use.
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ANNEX II
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE 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
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A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
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Name and address of the manufacturer of the biological active substance(s)
Pfizer Animal Health
2000 Rockford Road
Charles City, Iowa 50616-9101
USA
Name and address of the manufacturer responsible for batch release
Fort Dodge Veterinaria S.A. (Spain)
Ctra. Camprodón s/n "la Riba"
17813 Vall de Bianya
Girona
Spain
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B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
To be supplied only on veterinary prescription.
According to Article 71 of Directive 2001/82/EC the European Parliament and of the Council
as
amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary
medicinal product on the whole or part of their territory if it is established that:
a)
the administration of the veterinary medicinal product to animals will interfere with the
implementation of national programmes for the diagnosis, control and eradication of animal
diseases, or will cause difficulties in certifying the absence of contamination in live animals or
in foodstuffs or other products obtained from treated animals.
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely
absent from the territory.
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Not applicable.
D. STATEMENT OF THE MRLs
The active substance being a principle of biological origin intended to produce active immunity is not
within the scope of Regulation (EC) No 470/2009.
Constituents of
Suvaxyn PCV suspension for injection for pigs are included in Table 1 of Commission
Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their
classification regarding maximum residue limits in foodstuffs of animal origin.
7
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO SAFE AND EFFECTIVE USE
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ANNEX III
LABELLING AND PACKAGE LEAFLET
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A. LABELLING
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PARTICULARS TO APPEAR ON THE OUTER PACKAGE
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Boxes of 10 bottles of 10, 50 or 125 doses
Boxes of 1 bottle of 10, 50 or 125 doses
1.
Suvaxyn
PCV suspension for injection for pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per dose of 2 ml:
Active substance:
Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine
Circovirus type 2 ORF2 protein
1.6 RP 5.3
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Sulfolipo-cyclodextrin (SLCD)
4.0 mg
Squalane
64.0 mg
Excipients:
Thiomersal
0.1 mg
3.
Suspension for injection
4.
PACKAGE SIZE
Box of 1 bottle of 10 doses
Box of 1 bottle of 50 doses
Box of 1 bottle of 125 doses
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5.
Pigs (piglets).
6.
For active immunisation of pigs over the age of 3 weeks against Porcine Circovirus Type 2 (PCV2).
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Single intramuscular injection of one dose (2 ml).
Read the package leaflet before use.
10
Adjuvants:
Box of 10 bottles of 10 doses
Box of 10 bottles of 50 doses
Box of 10 bottles of 125 doses
8.
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Withdrawal period: Zero days.
9.
SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP {month/year}
Use immediately after broaching.
11. SPECIAL STORAGE CONDITIONS
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Store and transport refrigerated (2°C – 8°C).
Do not freeze.
Protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Disposal: read the package leaflet.
13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only - to be supplied only on veterinary prescription.
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Keep out of the reach and sight of children.
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
EU/2/09/099/001-006
11
14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
17. MANUFACTURER’S BATCH NUMBER
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Batch {number}
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PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
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Bottle label 50 and 125 doses
1.
Suvaxyn
PCV suspension for injection for pigs
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per dose of 2 ml:
Active substance:
Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine
Circovirus type 2 ORF2 protein
1.6 RP 5.3
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Sulfolipo-cyclodextrin (SLCD)
4.0 mg
Squalane
64.0 mg
Excipients:
Thiomersal
0.1 mg
3.
4.
PACKAGE SIZE
50 doses
125 doses
5.
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For active immunisation of pigs over the age of 3 weeks against Porcine Circovirus Type 2 (PCV2).
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use.
Read the package leaflet before use.
8.
Withdrawal period: Zero days.
13
Adjuvants:
Pigs (piglets).
9.
SPECIAL WARNING(S), IF NECESSARY
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10. EXPIRY DATE
EXP {month/year}
Use immediately after broaching.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2°C – 8°C).
Do not freeze.
Protect from light.
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12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
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”
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Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
EU/2/09/099/002
EU/2/09/099/003
EU/2/09/099/005
EU/2/09/099/006
14
17. MANUFACTURER’S BATCH NUMBER
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Batch {number}
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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
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Bottle label 10 doses
1.
Suvaxyn
PCV suspension for injection for pigs
2.
QUANTITY OF THE ACTIVE SUBSTANCES
Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2
protein 1.6 RP 5.3
3.
CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES
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10 doses (20 ml)
4.
ROUTE(S) OF ADMINISTRATION
Intramuscular use
5.
Withdrawal period: Zero days.
6.
BATCH NUMBER
Batch {number}
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EXPIRY DATE
EXP {month/year}
Use immediately after broaching.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
16
7.
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B. PACKAGE LEAFLET
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PACKAGE LEAFLET FOR:
Suvaxyn
PCV suspension for injection for pigs
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1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder
:
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
Manufacturer for the batch release
:
Fort Dodge Veterinaria S.A.
Ctra. Camprodón s/n “La Riba”
17813 Vall de Bianya (Gerona)
Spain
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2.
s
Suvaxyn PCV suspension for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
h
o
One dose of 2 ml contains:
Active substance:
A
Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine
Circovirus type 2 ORF2 protein
1.6 RP* 5.3
Adjuvants:
Sulfolipo-cyclodextrin (SLCD) 4.0 mg
Squalane 64.0 mg
Excipients:
Thiomersal 0.1 mg
*
Relative Potency unit determined by ELISA antigen quantification (
in vitro
potency test) compared
to a reference vaccine.
n
g
k
4.
Active immunisation of pigs over the age of 3 weeks against Porcine Circovirus Type 2 (PCV2) to
reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with
PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality
associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Onset of immunity: from 3 weeks post-vaccination.
Duration of immunity: 19 weeks post-vaccination
18
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5.
CONTRAINDICATIONS
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None.
6.
A transient increase in body temperature (up to 1.7°C) is very common during the first 24 hours after
vaccination. This resolves spontaneously within 48 hours without treatment.
Local tissue reactions in the form of swelling at the injection site are very common and may last for up
to 26 days. The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a
larger swelling may occur. In clinical studies, a post-mortem examination of the injection site,
performed 8 weeks after the administration of a single dose of the vaccine, revealed a mild to
moderate granulomatous inflammation of the muscular fibres at the injection site.
Vomiting occurs commonly (1-10 % in average, but up to 25% in a particular herd) during the first
hour after vaccination, but no consequential negative effects are observed.
Anaphylactic reactions are uncommon. In case of such reactions, adrenaline and/or corticosteroids
should be administered intramuscularly. If left untreated, anaphylactic reactions might be lethal.
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If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Pigs (piglets) from 3 weeks of age.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 21 days of
age.
9.
ADVICE ON CORRECT ADMINISTRATION
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10. WITHDRAWAL PERIOD
Zero days
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store and transport refrigerated (2°C – 8°C).
Do not freeze.
Protect from light.
Do not use after the expiry date (EXP) which is stated on the carton and the bottle.
19
Shake well before administration and intermittently during the process of vaccination.
The vaccine is to be administered aseptically.
The use of a multi-dosing syringe is recommended. Use vaccination devices according to the
manufacturer’s instructions.
Use immediately after broaching.
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12. SPECIAL WARNING(S)
Vaccinate only healthy animals.
Avoid stress in the animals before and after the time of vaccination.
Do not use in breeding boars.
Do not use during pregnancy and lactation.
The benefit of the vaccination of pigs with very high levels of maternally-derived antibodies, e.g. due
to vaccination of their mothers, has not been demonstrated.
No information is available on the safety and efficacy of this vaccine when used with any other
veterinary medicinal product. 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 vaccine or immunological product.
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Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon
how to dispose of medicines no longer required. These measures should help to protect the
environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency
http://www.ema.europa.eu
.
15. OTHER INFORMATION
The vaccine strain is an inactivated recombinant Porcine Circovirus type 1 expressing the Porcine
Circovirus type 2 ORF2 protein. It is intended to stimulate active immunity against PCV2 in piglets.
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Not all pack sizes may be marketed.
België/Belgique/Belgien
Pfizer Animal Health s.a.,
Tél.: +32 (0)2 554 62 11
Luxembourg
Pfizer Animal Health s.a.,
Tél.: + 32 (0)2 554 62 11
Република България
Pfizer Luxembourg SARL
Tel: + 359 2 970 41 71
Magyarország
Pfizer Kft.
Tel: +361 488 3695
20
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Cardboard box of 1 bottle of 10 doses (20 ml), 50 doses (100ml) or 125 doses (250 ml).
Cardboard box of 10 bottles of 10 doses (20 ml), 50 doses (100ml) or 125 doses (250 ml).
Česká Republika
Pfizer Animal Health
Tel: +420 283 004 111
Malta
Agrimed Limited
Tel: +356 21 465 797
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Danmark
Pfizer Oy Animal Health,
Tlf: +358 (0)9 4300 40
Nederland
Pfizer Animal Health B.V.,
Tel: +31 (0)10 4064 600
Deutschland
Pfizer GmbH
Tel: +49 30-5500 5501
Norge
Pfizer Oy Animal Health,
Tlf: +358 (0)9 4300 40
Eesti
Pfizer Animal Health
Tel: +370 5 269 17 96
Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 52 11 57 20
Ελλάδα
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
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Polska
Pfizer Trading Polska Sp. z.o.o.
Tel: +48 22 335 61 00
España
Pfizer S.L.
Tel: +34 91 4909900
Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 55 00
France
Pfizer
Tél: +33 (0)1 58 07 46 00
Romania
Pfizer Romania SRL
Tel: + 0040 21 207 28 93
Ireland
Pfizer Healthcare Ireland, Trading As:
Pfizer Animal Health
Tel: +353 (0) 1 467 6500
Slovenija
Pfizer Luxembourg SARL
Tel: +386 (0) 1 52 11 670
Ìsland
Pfizer Oy Animal Health,
Tel: +358 (0)9 4300 40
Slovenská Republika
Pfizer Luxembourg SARL o.z.
Tel: +
421 2 3355 5500
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Suomi/Finland
Pfizer Oy Animal Health,
Puh/Tel: +358 (0)9 4300 40
Kύπρος
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Sverige
Pfizer Oy Animal Health,
Tel: +358 (0)9 4300 40
Latvija
Pfizer Animal Health
Tel: +370 5 269 17 96
United Kingdom
Pfizer Ltd
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel.: +370 5 269 17 96
21
Italia
Pfizer Italia S.r.l.,
Tel: +39 06 3318 2933
Source: European Medicines Agency
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