ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Bovilis BTV8 suspension for injection for cattle and sheep
2.
1 ml dose contains:
Active substance:
Bluetongue Virus Serotype 8 (prior to inactivation):500 Antigenic Units *.
(* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log
2
)
Adjuvants
Aluminium hydroxide (as 100%)
16.7 mg
For a full list of excipients, see section 6.1.
3.
Suspension for injection
4.
Cattle and sheep
Sheep
To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to
prevent viraemia
*
.
*(cycling value (Ct) >30 by a validated rRT-PCR method, indicating absence of infectious virus)
Cattle
To stimulate active immunity in cattle from 6 weeks of age against bluetongue virus serotype 8 to
reduce viraemia*.
* (for details see section 4.4)
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 6 months
None
2/19
Saponin
0.31 mg
This vaccine has been shown to reduce but not prevent viraemia in cattle. The extent of this
reduction has been shown by epidemiological modelling studies to be likely to reduce virus
transmission to an extent that can limit the spread of an outbreak in a vaccinated population.
This vaccine has been tested for safety in sheep and cattle. 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 and cattle.
No information is available on the use of the vaccine in seropositive animals, including those with
maternally derived antibodies.
Vaccinate healthy animals only.
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 leaflet or
the label to the physician.
Vaccination may result in a slight rise in temperature (usually not more than 0.5°C, in individual cases
up to about 2°C) for up to three days after vaccination, and temporary swellings at the injection site.
In sheep these swellings typically last for up to three weeks.
In cattle small palpable swellings may still be present up to six weeks after vaccination in
approximately one third of the vaccinated animals.
Occasional hypersensitivity reactions may occur.
The vaccine can be used during pregnancy and lactation.
The safety and efficacy of the vaccine has not been established in breeding males. In these categories
of animals the vaccine should be used only according to the benefit/risk assessment by the responsible
veterinarian and/or the national Competent Authorities, depending on the current vaccination policies
against 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.
Before using the vaccine allow it to reach ambient temperature (15 - 25°C).
Shake the bottle before use and periodically during use.
Use clean and sterile vaccination equipment and avoid the introduction of contamination.
It is recommended to use a multiject vaccination system.
3/19
Sheep
Primary vaccination
:
Sheep from 1 month of age: subcutaneous injection of a single dose of 1 ml
Revaccination
:
As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by
the Competent Authority or by the responsible veterinarian, taking into account the local
epidemiological situation
Cattle
Primary vaccination
Cattle from 6 weeks of age: subcutaneous injection of two doses of 1 ml, administered with an interval
of approximately 3 weeks.
Revaccination:
As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by
the Competent Authority or by the responsible veterinarian, taking into account the local
epidemiological situation.
No adverse reactions other than those described in section 4.6 were observed following administration
of a double dose in cattle and sheep. However, the temperature rise may be 0.5°C higher and the
swellings may be more pronounced and palpable for a longer period. In sheep, swellings may still be
palpable after six weeks.
Zero days.
5.
Inactivated viral vaccine, to stimulate active immunity against Bluetongue Virus Serotype 8
ATCvet code: Sheep: QI04AA02
Cattle: QI02AA08
6.
6.1 List of excipients
Trometamol
Sodium chloride
Maleic acid
Simeticone emulsion
Aluminium hydroxide
Saponin
Water for injection
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
4/19
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 12 months
Shelf-life after first opening the immediate packaging: 8 hours, provided the product is not subject to
temperatures above 37°C or contaminated.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C)
Protect from light
Do not freeze.
6.5 Nature and composition of immediate packaging
PET vials of 10, 20, 50, 100, 200, 250 or 500 ml, with a rubber stopper and aluminium cap.
Pack size: cardboard box with 1 or 10 vials.
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 the local requirements.
7.
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
8.
EU/2/10/106/001 - 014
9.
06/09/2010
06/09/2010
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use of this veterinary medicinal product is only allowed under the
particular conditions established by European Community legislation on the control of Bluetongue.
Any person intending to import, sell, supply and/or use Bovilis BTV8 must consult the relevant
Member State’s competent authority on the current vaccination policies prior to the import, sale,
supply and/or use.
5/19
ANNEX II
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER 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
6/19
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
Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Netherlands
Intervet International GmbH
Osterather Strasse 1a
DE-50739 Köln
Germany
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.
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
7/19
D. STATEMENT OF THE MRLs
The following constituents of the intended product Bovilis BTV8 are included in Table 1 of the Annex
to Commission Regulation (EU) No 37/2010:
Pharmacologically
active substance
Marker
residue
Animal
Species
MRL
Target
Tissues
Other
Provisions
Therapeutic
Classification
Aluminium
hydroxide
Not
applicable
All food
producing
species
No MRL
required
Not
applicable
No entry No entry
Quillaia saponins
Not
applicable
All food
producing
species
No MRL
required
Not
applicable
No entry No entry
Sodium Chloride
Not
applicable
All food
producing
species
No MRL
required
Not
applicable
No entry No entry
Simeticone
emulsion
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: trometamol, maleic
acid and water for injection. At the doses at which they will be administered, these excipients are
considered as not falling within the scope of Regulation (EC) No 470/2009.
E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING
AUTHORISATION HOLDER
1. The applicant is required to submit data as requested in post-authorisation commitments and 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. The
above information will be evaluated and approved by the CVMP and will form part of the
subsequent annual reassessment.
2. 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.
3. 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.
8/19
ANNEX III
LABELLING AND PACKAGE LEAFLET
9/19
A. LABELLING
10/19
PARTICULARS TO APPEAR ON THE OUTER PACKAGE (CARTON)
10, 20, 50, 100, 200, 250 or 500 ml PET vials
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE (LABEL for greater units)
100,
200,
250 or 500 ml PET vials
1.
Bovilis BTV8 suspension for injection for cattle and sheep
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Bluetongue Virus Serotype 8: 500 Antigenic Units/ml.
Adjuvant: aluminium hydroxide, saponin.
3.
Suspension for injection
4.
PACKAGE SIZE
100 ml
200 ml
250 ml
500 ml
Box of 1 vial of 10ml
Box of 1 vial of 20ml
Box of 1 vial of 50ml
Box of 1 vial of 100ml
Box of 1 vial of 200ml
Box of 1 vial of 250ml
Box of 1 vial of 500 ml
Box of 10 vials of 10ml
Box of 10 vials of 20ml
Box of 10 vials of 50ml
Box of 10 vials of 100ml
Box of 10 vials of 200ml
Box of 10 vials of 250ml
Box of 10 vials of 500 ml
5.
Cattle and sheep
11/19
6.
To stimulate active immunity against Bluetongue Virus Serotype 8
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
Read the package leaflet before use.
8.
Withdrawal period: zero days
9.
SPECIAL WARNING(S), IF NECESSARY
10. EXPIRY DATE
EXP {month/year}
Once broached, use within 8 hours
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2 °C – 8 °C)
Protect from light
Do not freeze.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with 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.
12/19
Intervet International BV
Wim de Körverstraat 35,
5831 AN Boxmeer
The Netherlands
EU/2/10/106/001 - 014
17. MANUFACTURER’S BATCH NUMBER
<Lot>{number}
13/19
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
10, 20 or 50 ml PET vials
1.
Bovilis BTV8
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
Bluetongue Virus Serotype 8: 500 Antigenic Units/ml.
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10ml
20ml
50 ml
4.
ROUTE(S) OF ADMINISTRATION
S.C. injection
5.
Withdrawal period: zero days
6.
BATCH NUMBER
<Lot> {number}
7.
EXPIRY DATE
EXP {month/year}
Once broached, use within 8 hours.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
14/19
B. PACKAGE LEAFLET
15/19
PACKAGE LEAFLET FOR:
Bovilis BTV8
Suspension for injection for cattle and sheep
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer for batch release
Intervet International BV
Wim de Körverstraat 35,
5831 AN Boxmeer
The Netherlands
2.
Bovilis BTV8
suspension for injection for cattle and sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose (1 ml) contains:
Active ingredient: Bluetongue Virus Serotype 8: 500 Antigenic Units*
(* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log
2
)
Adjuvants: aluminium hydroxide, saponin
4.
Sheep
To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to
prevent viraemia
*
.
*(cycling value (Ct) >30 by a validated rRT-PCR method, indicating absence of infectious virus)
Cattle
To stimulate active immunity in cattle from 6 weeks of age against bluetongue virus serotype 8 to
reduce viraemia*.
* (for details see section 12)
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 6 months
5.
None
6.
Vaccination may result in a slight rise in temperature (usually not more than 0.5°C, in individual cases
up to about 2°C) for up to three days after vaccination, and temporary swellings at the injection site. In
16/19
sheep, these swellings typically last for up to three weeks, while in cattle small palpable swellings may
still be present up to six weeks after vaccination in approximately one third of vaccinates. After
administration of a double dose in cattle and sheep no other reactions were observed. However, the
temperature rise may be 0.5°C higher and the swellings may be more pronounced and palpable for a
longer period. In sheep, swellings may still be palpable after six weeks.
Occasional hypersensitivity reactions may occur.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Cattle and sheep
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Sheep
Primary vaccination
:
Sheep from 1 month of age: subcutaneous injection of a single dose of 1 ml
Revaccination
:
As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by
the Competent Authority or by the responsible veterinarian, taking into account the local
epidemiological situation
Cattle
Primary vaccination
Cattle from 6 weeks of age: subcutaneous injection of two doses of 1 ml, administered with an interval
of approximately 3 weeks.
Revaccination:
As the duration of immunity is not yet fully established, 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
Before using the vaccine allow it to reach ambient temperature (15 - 25°C).
Shake the bottle before use and periodically during use.
Use clean and sterile vaccination equipment and avoid the introduction of contamination.
It is recommended to use a multiject vaccination system.
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), protect from light, do not freeze.
17/19
Do not use after the expiry date which is stated on the label after EXP.
Once broached use within 8 hours, provided the product is not subject to temperatures above 37°C or
contaminated.
12. SPECIAL WARNING(S)
This vaccine has been shown to reduce but not prevent viraemia in cattle. The extent of this
reduction has been shown by epidemiological modelling studies to be likely to reduce virus
transmission to an extent that can limit the spread of an outbreak in a vaccinated population.
This vaccine has been tested for safety in sheep and cattle.
If used in other domestic or 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 and cattle.
No information is available on the use of the vaccine in seropositive animals, including those with
maternally derived antibodies.
Vaccinate healthy animals only.
The vaccine can be used during pregnancy and lactation.
The safety and efficacy of the vaccine has not been established in breeding males. In these categories
of animals the vaccine should be used only according to the benefit/risk assessment by the responsible
veterinarian and/or the national Competent Authorities, depending on the current vaccination policies
against 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.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
the label to the physician.
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
06/09/2010
15. OTHER INFORMATION
Bovilis BTV8 is an inactivated viral vaccine, to stimulate active immunity against Bluetongue Virus
Serotype 8.
For animal treatment only.
The vaccine is presented in cardboard boxes with 1 or 10 PET vials containing 10, 20, 50, 100, 200,
250 or 500 ml, closed with a rubber stopper and aluminium cap.
Not all pack sizes may be marketed.
The import, sale, supply and/or use of this veterinary medicinal product is only allowed under the
particular conditions established by European Community legislation on the control of Bluetongue.
18/19
Any person intending to import, sell, supply and/or use Bovilis BTV8 must consult the relevant
Member State’s competent authority on the current vaccination policies prior to the import, sale,
supply and/or use.
For any information about this veterinary medicinal product, please contact the local representative of
the marketing authorisation holder.
19/19
Source: European Medicines Agency
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