ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
ZULVAC 1+8 Ovis suspension for injection for sheep
2.
Each dose of 2 ml of vaccine contains:
Active substances:
Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1
Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02
RP* ≥ 1
*Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious
in sheep.
Adjuvant:
Aluminium hydroxide
4 mg (Al
3+
)
Saponin
0.4 mg
Excipient:
Thiomersal
0.2 mg
For a full list of excipients, see section 6.1.
3.
Suspension for injection
4.
Sheep
Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by
Bluetongue Virus, serotypes 1 and 8.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Onset of immunity: 21 days after completion of the primary vaccination scheme
Duration of immunity: 12 months
None.
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in
these species should be undertaken with care and it is advisable to test the vaccine on a small number
of animals prior to mass vaccination. The level of efficacy for other species may differ from that
observed in sheep.
2/18
No information is available on the use of the vaccine in seropositive animals including those with
maternally derived antibodies.
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
None
A transient increase in rectal temperature, not exceeding 1.2°C, may occur during the 24 hours
following vaccination.
Vaccination may be followed in most animals by a local reaction at the injection site. These reactions
take the form in most cases of a general swelling of the injection site (persisting for not more than 7
days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 48 days).
Can be used during pregnancy. No data is available on safety in lactating animals.
The safety and the efficacy of the vaccine have not been established in breeding males. In this category
of animals the vaccine should be used only according to the benefit/risk assessment by the responsible
veterinarian and/or national Competent Authorities on the current vaccination policies against
Bluetongue Virus (BTV).
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.
Subcutaneous use.
Apply usual aseptic procedures.
Shake gently immediately before use.
Avoid bubble formation, as this can be irritating at the site of injection.
The entire content of the bottle should be used immediately after broaching and during the same
procedure.
Avoid multiple vial broaching.
In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi-
injection type vaccination system when larger dose presentations are used.
Primary vaccination:
Administer one dose of 2 ml according to the following vaccination scheme:
1
st
injection: from 1.5 months of age.
2
nd
injection: after 3 weeks
3/18
Revaccination:
Any revaccination scheme should be agreed by the Competent Authority or by the responsible
veterinarian, taking into account the local epidemiological situation.
A transient increase in rectal temperature, not exceeding 0.6°C, may occur during the 24 hours
following administration of a two-fold overdose.
Administration of a two-fold overdose may be followed in most animals by a local reaction at the
injection site. These reactions take the form in most cases of a general swelling of the injection site
(persisting for not more than 9 days) or of palpable nodules (subcutaneous granuloma, possibly
persisting for more than 63 days).
4.11 Withdrawalperiod
Zero days.
5.
Pharmacotherapeutic group: Inactivated viral vaccines – Bluetongue virus vaccine.
ATC vet code: QI04AA02
To stimulate active immunity against Bluetongue Virus, serotypes 1 and 8 in sheep.
6.
6.1 List of excipients
Aluminium hydroxide
Saponin
Thiomersal
Potassium chloride
Potassium dihydrogen phosphate
Disodium hydrogen phosphate dodecahydrate
Sodium chloride
Water for injections
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: 1 year.
Shelf-life after first opening the immediate packaging: use immediately after broaching.
6.4. Special precautions for storage
Store and transport refrigerated (2°C - 8°C).
Protect from light.
Do not freeze.
4/18
6.5 Nature and composition of immediate packaging
High Density Polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer stopper and
aluminium seal containing 10, 50 or 120 doses of vaccine.
Pack sizes
Pack of 1 bottle of 10 doses (20 ml).
Pack of 1 bottle of 50 doses (100 ml).
Pack of 1 bottle of 120 doses (240 ml).
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal product 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.
PFIZER Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
8.
EU/2/11/120/001-003
9.
14/03/2011
14/03/2011
Detailed information on this 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 Zulvac 1+8 Ovis 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 Zulvac 1+8 Ovis must consult the relevant Member State’s
competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
5/18
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
E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
AUTHORISATION HOLDER
6/18
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substance(s)
Fort Dodge Veterinaria S.A. (Spain)
Ctra. Camprodón s/n "la Riba"
17813 Vall de Bianya
Gerona
Spain
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
Gerona
Spain
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 of 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.
The use of this veterinary medicinal product is only allowed under the particular conditions established
by European Community legislation on the control of Bluetongue.
The holder of this marketing authorisation must inform the European Commission about the marketing
plans for the medicinal product authorised by this decision.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO SAFE AND EFFECTIVE USE
Not applicable
7/18
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.
The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for
which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are
required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used
as in this product.
E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
AUTHORISATION HOLDER
1. The applicant is required to submit as a matter of priority data relating to the following:
a) In process control tests carried out on at least 3 vaccine antigen batches of different sizes,
produced within the range of 250-1000 litres.
b) Final data supporting the 12 months storage time at 2°-8°C of vaccine antigen(s).
c) Final data for testing the efficacy of antimicrobial preservation.
d) Full set of data, according to the reported timelines, in order to demonstrate the claimed stability
of finished product
e) A validated test to quantify the saponin content in the finished product is awaited
Progress on the above issues should be reported 6 months following the authorisation of the
product.
2. The applicant is required to submit in 6 months following the authorisation of the product, an action
plan together with timelines for all points that require resolution in order for the authorisation to
revert to normal status status. The above information will be evaluated and approved by the
CVMP and will form part of the subsequent annual reassessment.
3. For the first and subsequent annual reassessments the Marketing Authorisation Holder should
provide annually an updated risk assessment on the continuous use of the vaccine taking into
account the continued need for the vaccine, its history of use over the previous twelve months and
progress made in addressing the items that require resolution in order for the authorisation to revert
to normal status.
4. The applicant is required to submit 6-monthly Periodic Update Safety reports starting once the MA
has been approved and, in addition to the legal requirements applicable to reporting of suspected
adverse reactions, the applicant is required to specifically monitor and evaluate the following
suspected adverse reactions in the PSURs: abortions, spontaneous death, effects on milk production,
local reactions, pyrexia, lethargy and hypersensitivity reactions, including severe allergic reactions.
The frequency of submissions of PSUR reports will be assessed at the annual reassessment of the
product.
8/18
ANNEX III
LABELLING AND PACKAGE LEAFLET
9/18
A. LABELLING
10/18
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Preprinted carton box 1 x 20ml, 1 x 100ml and 1 x 240 ml
Vial label 20ml, 100 ml and 240 ml
1.
ZULVAC 1+8 Ovis suspension for injection for sheep
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Per dose of 2 ml
Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1
Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02
Aluminium hydroxide,
Saponin,
Thiomersal.
3.
Suspension for injection
4.
PACKAGE SIZE
20ml
100 ml
240 ml
5.
Sheep
6.
Active immunisation of sheep from 1.5 months of age for the prevention of viraemia caused by
Bluetongue Virus, serotypes 1 and 8.
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
Read the package leaflet before use.
11/18
8.
Withdrawal period: Zero days.
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Once broached use immediately.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2°C - 8°C).
Protect from light.
Do not freeze.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material according to local requirements.
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.
PFIZER Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
United Kingdom
EU/2/11/120/001
EU/2/11/120/002
EU/2/11/120/003
12/18
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
13/18
B. PACKAGE LEAFLET
14/18
PACKAGE LEAFLET
ZULVAC 1+8 Ovis
Suspension for injection for sheep
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
2.
ZULVAC 1+8 Ovis suspension for injection for sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 2 ml of vaccine contains:
Active substance:
Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1
Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02
RP* ≥ 1
*Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious
in sheep.
Adjuvant:
Aluminium hydroxide
4 mg (Al
3+
)
Saponin
0.4 mg
Excipient:
Thiomersal
0.2 mg
4.
Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by
Bluetongue Virus, serotypes 1 and 8.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Onset of immunity: 21 days after completion of the primary vaccination scheme
Duration of immunity: 12 months
15/18
5.
None.
6.
A transient increase in rectal temperature, not exceeding 1.2°C, may occur during the 24 hours
following vaccination.
Vaccination may be followed in most animals by a local reaction at the injection site. These reactions
take the form in most cases of a general swelling of the injection site (persisting for not more than 7
days) or of palpable nodules (subcutaneous granuloma possibly persisting for more than 48 days).
A transient increase in rectal temperature, not exceeding 0.6°C, may occur during the 24 hours
following administration of a two fold overdose.
Administration of a two fold overdose may be followed in most animals by a local reaction at the
injection site. These reactions take the form in most cases of a general swelling of the injection site
(persisting for not more than 9 days) or of palpable nodules (subcutaneous granuloma possibly
persisting for more than 63 days).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Sheep
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous use.
Apply usual aseptic procedures.
Shake gently immediately before use. Avoid bubble formation, as this can be irritating at the site of
injection. The entire content of the bottle should be used immediately after broaching and during the
same procedure. Avoid multiple vial broaching.
Primary vaccination:
Administer one dose of 2 ml according to the following vaccination scheme:
1
st
injection: from 1.5 months of age.
2
nd
injection: after 3 weeks
Revaccination:
Any revaccination scheme should be agreed by the Competent Authority or by the responsible
veterinarian, taking into account the local epidemiological situation.
9.
ADVICE ON CORRECT ADMINISTRATION
In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi-
injection type vaccination system when larger dose presentations are used.
16/18
10. WITHDRAWAL PERIOD
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).
Protect from light.
Do not freeze
Once broached use immediately.
12. SPECIAL WARNING(S)
Only use in healthy animals.
No information is available on the use of the vaccine in seropositive animals including those with
maternally derived antibodies.
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in
these species should be undertaken with care and it is advisable to test the vaccine on a small number
of animals prior to mass vaccination. The level of efficacy for other species may differ from that
observed in sheep.
Can be used during pregnancy. No data is available on safety in lactating animals.
The safety and the efficacy of the vaccine have not been established in breeding males. In this category
of animals the vaccine should be used only according to the benefit/risk assessment by the responsible
veterinarian and/or national Competent Authorities on the current vaccination policies against
Bluetongue virus (BTV).
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 veterinary medicinal product.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
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 protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
14/03/2011
Detailed information on this product is available on the website of the European Medicines Agency
17/18
15. OTHERINFORMATION
Pack sizes
1 bottle of 10 doses (20 ml).
1 bottle of 50 doses (100 ml).
1 bottle of 120 doses (240 ml).
Not all pack sizes may be marketed.
The import, sale, supply and/or use of Zulvac 1+8 Ovis 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 Zulvac 1+8 Ovis must consult the relevant Member State’s
competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
18/18
Source: European Medicines Agency
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