ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
BLUEVAC BTV8 suspension for injection for cattle and sheep
2.
Each ml of vaccine contains:
Active substance:
Bluetongue virus inactivated, serotype 8: 10
6.5
CCID
50
*
(*) equivalent to titre prior to inactivation (log
10
)
Adjuvants:
Aluminium hydroxide ………………………………………. 6 mg
Purified saponin (Quil A)…………………………………… 0.05 mg
Excipients:
Thiomersal
0.1 mg
For a full list of excipients, see section 6.1.
3.
Suspension for injection
4.
Sheep and cattle
Sheep
For the active immunisation of sheep to prevent viraemia* from 2.5 months of age and to reduce clinical
signs caused by bluetongue virus serotype 8.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Onset of immunity: 20 days after the second dose
Duration of immunity: 1 year after the second dose.
Cattle
For the active immunisation of cattle to prevent viraemia* from 2.5 months of age caused by bluetongue
virus serotype 8.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Onset of immunity: 31 days after the second dose.
Duration of immunity: 1 year after the second dose.
None.
2/21
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
and cattle.
Vaccinate healthy animals only
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
None.
An average increase in body temperature can occasionally be observed varying between 0.5 and 1.0 ºC in
sheep and cattle. It lasted not longer than 24 to 48 hours. Transient fever was observed in rare cases.
Occasionally, temporary local reactions occur at the injection site in the form of a normally painless
nodule of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears within 14 days, at the latest. In
some cases loss of appetite can occur.
Can be used during pregnancy in ewes and cows.
There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.
The safety and efficacy of the vaccine has not been established in breeding males (sheep and cattle) . 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.
Shake well before use. Avoid multiple vial broaching. Avoid introduction of contamination.
Primary vaccination:
Sheep from 2.5 months of age:
3/21
Administer two doses of 2 ml subcutaneously with a 3 week interval.
Cattle from 2.5 months of age:
Administer two doses of 4 ml subcutaneously with a 3 week interval.
Revaccination:
1 dose per year.
Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian,
taking into account the local epidemiological situation.
Occasionally a slight increase of the temperature (0.5 ºC – 1.0 ºC) is observed for 24-48 hours after the
administration of a double dose of the vaccine. Painless swellings occur occasionally with a size up to
2 cm in sheep and up to 4.5 cm in cattle after a double dose.
4.11 Withdrawalperiod
Zero days.
5.
Pharmacotherapeutic group: Bluetongue virus vaccine, ATCvet codes QI04AA02 (sheep) and QI02AA08
(cattle).
BLUEVAC BTV8 stimulates active immunity against bluetongue virus, serotype 8
6.
6.1 List of excipients
Aluminium hydroxide
Purified saponin (Quil A)
Thiomersal
Phosphate buffered saline (sodium chloride, disodium phosphate and potassium phosphate, 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.
6.4. Special precautions for storage
Store and transport refrigerated (2 C – 8 C).
Do not freeze.
Protect from light.
4/21
6.5 Nature and composition of immediate packaging
High density polyethylene (HDPE) bottles of 52 ml, 100 ml or 252 ml with bromobutyl stoppers and
aluminium seals.
Package size:
Cardboard box with 1 bottle containing either 26 sheep doses or 13 cattle doses (52 ml)
Cardboard box with 1 bottle containing either 50 sheep doses or 25 cattle doses (100 ml)
Cardboard box with 1 bottle containing either 126 sheep doses or 63 cattle doses (252 ml)
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused product or waste materials derived from such veterinary medicinal products should be disposed
of in accordance with local requirements.
7.
CZ Veterinaria, S.A.
La Relva s/n, P.O. Box 16
36400 Porriño (Spain)
Tel: + 34 986 33 04 00
Fax: + 34 986 33 65 77
czv@czveterinaria.com
8.
EU/2/11/122/001-003
9.
14.04.2011
14.04.2011
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 BLUEVAC BTV8 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 BLUEVAC BTV8 must consult the relevant Member State’s competent
authority on the current vaccination policies prior to the import, sale, supply and/or use.
5/21
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
6/21
AUTHORISATION HOLDER
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
CZ Veterinaria, S.A.
La Relva s/n, P.O. Box 16
36400 Porriño (Spain)
Name and address of the manufacturer responsible for batch release
CZ Veterinaria, S.A.
La Relva s/n, P.O. Box 16
36400 Porriño (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.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
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.
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.
7/21
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: provision of the corresponding results of in process control tests carried out
on antigen batches of different sizes, produced within the range of 250-5200 litres,
b) Controls at formulation step: provision of timelines as well as the documents and results for the
establishment, validation and implementation of the antigen quantification test at formulation step
c) Saponin content on basis of the Quil A content: The applicant should finalise the development and
validation of the quantification method for saponin and provide the final report as soon as it is
issued.
d) Stability of the inactivated antigen for 12 months at +2-8°C: the ongoing study should be finalised
and data should be provided immediately in case of potentially out-of-specification results in the
course of the study
e) Provisional shelf life of 12 months: the relevant intended study should be conducted and data should
be provided immediately in case of potentially out-of-specification results in the course of the study.
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 as detailed in Annex I of the CVMP AR. 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.
8/21
ANNEX III
LABELLING AND PACKAGE INSERT
9/21
A. LABELLING
10/21
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Cardbox of 1 bottle of 52 ml
Cardbox of 1 bottle of 100 ml
Cardbox of 1 bottle of 252 ml
1.
BLUEVAC BTV8 suspension for injection for cattle and sheep
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml of vaccine contains:
BTV8 antigen 10
6.5
CCID
50
*
Aluminium hydroxide, Purified saponin (Quil A), Thiomersal
(*) See package leaflet
3.
Suspension for injection
4.
PACKAGE SIZE
1 bottle of 52 ml
1 bottle of 100 ml
1 bottle of 252 ml
5.
Sheep and cattle
6.
For active immunisation against bluetongue virus serotype 8 to prevent viraemia (sheep and cattle) and to
reduce clinical signs (sheep) from 2.5 months of age.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
Shake well before use.
Read the package leaflet before use.
11/21
8.
Withdrawal period: Zero days
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10. EXPIRY DATE
EXP {month/year}
Once open, use immediately
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2ºC -8ºC).
Do not freeze.
Protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
MATERIALS, IF ANY
Any unused product or waste materials derived from such veterinary medicinal products should be
disposed of 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.
CZ Veterinaria, S.A.
P.O. Box 16
36400 Porriño (Spain)
12/21
EU/2/11/122/001 bottle of 52 ml
EU/2/11/122/002 bottle of 100 ml
EU/2/11/122/003 bottle of 252 ml
17. MANUFACTURER’S BATCH NUMBER
Batch: {number}
13/21
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Bottle of 100 ml and 252 ml
1.
BLUEVAC BTV8 suspension for injection for cattle and sheep
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each ml of vaccine contains Bluetongue virus serotype 8 antigen ……… 10
6.5
CCID
50
Aluminium hydroxide, Purified saponin (Quil A), Thiomersal
3.
Suspension for injection
4.
PACKAGE SIZE
Bottle of 100 ml
Bottle of 252 ml
5.
Sheep and cattle
6.
For active immunisation against bluetongue virus serotype 8 to prevent viraemia (sheep and cattle) and to
reduce clinical signs (sheep) from 2.5 months of age.
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
Read the package leaflet before use.
14/21
10. EXPIRY DATE
EXP {month/year}
Once opened, use immediately.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2ºC -8ºC)
Do not freeze.
Protect from light.
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE
MATERIALS, IF ANY
Any unused product or waste materials derived from such veterinary medicinal products should be
disposed of 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.
CZ Veterinaria, S.A.
P.O. Box 16
36400 Porriño (Spain)
EU/2/11/122/002
EU/2/11/122/003
17. MANUFACTURER’S BATCH NUMBER
Batch: {number}
15/21
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Bottle of 52 ml
1.
BLUEVAC BTV8 suspension for injection for cattle and sheep
2.
QUANTITY OF THE ACTIVE SUBSTANCE
BTV 8 antigen ……… 10
6.5
CCID
50
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
52 ml
4.
ROUTE OF ADMINISTRATION
Subcutaneous use
5.
Withdrawal period: Zero days
6.
BATCH NUMBER
Batch: {number}
7.
EXPIRY DATE
EXP {month/year}
Once opened, use immediately.
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
16/21
B. PACKAGE LEAFLET
17/21
PACKAGE LEAFLET
BLUEVAC BTV8
Suspension for injection for cattle and sheep
1.
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer:
CZ Veterinaria, S.A.
La Relva s/n P.O. Box 16
36400 Porriño
Spain
2.
BLUEVAC BTV8 Suspension for injection for cattle and sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml of vaccine contains:
Bluetongue virus inactivated, serotype 8 ……………………………………. 10
6.5
CCID
50
*
Aluminium hydroxide ………………………………………………………… 6 mg
Purified saponin (Quil A) …………………………………………………….. 0.05 mg
hioersal
0.1 g
4.
INDICATION
Sheep
For the active immunisation of sheep from 2.5 months of age.to prevent viraemia* and to reduce clinical
signs caused by bluetongue virus serotype 8.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Onset of immunity:
20 days after the second dose
Duration of immunity:
1 year after the second dose.
Cattle
For the active immunization of cattle from 2.5 months of age.to prevent viraemia* caused by bluetongue
virus serotype 8
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Onset of immunity:
31 days after the second dose
Duration of immunity:
1 year after the second dose.
5.
None.
18/21
(*)
equivalent to titre prior to inactivation (log 10)
6.
An average increase in body temperature can occasionally be observed varying between 0.5 and 1.0 ºC in
sheep and cattle. It lasts not longer than 24 to 48 hours. Transient fever was observed in rare cases.
Occasionally, temporary local reactions occur at the injection site in the form of a normally painless
nodule of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears within 14 days, at the latest. In
some cases loss of appetite can occur.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Sheep and cattle
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Subcutaneous use.
Shake well before use. Avoid multiple vial broaching. Avoid introduction of contamination.
Primary vaccination:
Sheep from 2.5 months of age:
Administer two doses of 2 ml subcutaneously with a 3 week interval.
Cattle form 2.5 months of age:
Administer two doses of 4 ml subcutaneously with a 3 week interval.
Revaccination:
1 dose per year
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
Do not mix with any other veterinary medicinal product.
10. WITHDRAWAL PERIOD
Zero days.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of reach and sight of children.
Store and transport refrigerated (2ºC -8ºC).
Do not freeze.
Protect from light.
19/21
Use immediately once the vial is opened.
Do not use after the expiry date stated on the label/carton
12. SPECIAL WARNING(S)
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
and cattle.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
None
Use during pregnancy and lactation
Can be used during pregnancy in ewes and cows. There is no negative impact on the milk yield using the
vaccine in lactating ewes and cows.
The safety and efficacy of the vaccine has not been established in breeding males (sheep and cattle). 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).
Interactions
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.
Occasionally a slight increase of the temperature (0.5 – 1.0 ºC) is observed for 24-48 hours after the
administration of a double dose of the vaccine. Painless swellings occur occasionally with a size up to
2 cm in sheep and up to 4.5 cm in cattle after administration of a double dose.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused 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
14.04.2011
Detailed information on this product is available on the website of the European Medicines Agency
20/21
15. OTHER INFORMATION
Immunological properties
Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code QI04AA02 (sheep) and QI02AA08
(cattle).
BLUEVAC BTV8 stimulates active immunization against bluetongue virus, serotype 8
Not all pack sizes may be marketed.
Box of 1 bottle of 52 ml
Box of 1 bottle of 100 ml
Box of 1 bottle of 252 ml
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the
marketing authorisation holder.
Deutschland
Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
D-55216 Ingelheim/Rhein
Tel:+49-(0) 1803 660 660
France
Boehringer Ingelheim France
Division Santé Animale
12, rue André Huet
F-51100 Reims
Österreich
Boehringer Ingelheim RCV GmbH&Co KG
Dr. Boehringer Gasse 5-11
A-1121 Vienna
Tel: +43-(0) 1 80 105 2875
21/21
Source: European Medicines Agency
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