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BTVPUR AlSap 2-4
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Summary for the public


What is BTVPUR AlSap 2-4?

BTVPUR AlSap 2-4 is a vaccine. It is a suspension for injection that contains inactivated (killed) bluetongue serotype 2-4 viruses.


What is BTVPUR AlSap 2-4 used for?

BTVPUR ALSap 2-4 is used in sheep to protect them against bluetongue disease. Bluetongue disease is an infection that is transmitted by midges and caused by the bluetongue virus (serotype 2 and 4). The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease.

The vaccine is given to young animals as an injection under the skin. One injection is enough to vaccinate sheep. The first injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal’s mother is already immune to the disease.

The vaccine will only be used as part of an approved national disease control programme. This is because control of bluetongue is the responsibility of national veterinary authorities in consultation with the European Commission.


How does BTVPUR AlSap 2-4 work?

BTVPUR ALSap 2-4 is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. BTVPUR AlSap 2-4 contains bluetongue viruses that have been inactivated so that they cannot cause the disease. When it is given to sheep, the animals’ immune systems recognise the viruses as ‘foreign’ and make antibodies against the virus. In the future, if the animals are exposed to the bluetongue virus, the immune system will be able to produce antibodies more quickly. This will help to protect against the disease.

BTVPUR AlSap 2-4 contains bluetongue viruses of two types (‘serotype 2 and 4’). The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) to stimulate a better response.


How has BTVPUR AlSap 2-4 been studied?

The safety of the vaccine was studied in an overdose laboratory safety study carried out with BTVPUR AlSap 2-4 in sheep. Results also from a series of laboratory safety trials performed with vaccines of similar composition but including only one of the two serotypes of BTVPUR AlSap 2-4 or different bluetongue serotypes were presented in order to extrapolate safety conclusions, as the vaccine is intended for use in an emergency situation.

The efficacy of the vaccine in sheep was studied in a pivotal laboratory trial using the vaccine in sheep from a young age. Two more laboratory studies where BTVPUR AlSap 2-4 was used were presented to support the efficacy of the vaccine. The company also presented results from a series of trials conducted with vaccines of similar composition but including only one of the two serotypes of BTVPUR AlSap 2-4 in order to extrapolate further efficacy conclusions.

The vaccine was assessed in the context of an emergency situation which means that further studies with BTVPUR AlSap 2-4 are still ongoing and will be assessed.BTVPUR AlSap 2-4 contains bluetongue viruses of two types (‘serotype 2 and 4’). The vaccine also contains ‘adjuvants’ (aluminium hydroxide and saponin) to stimulate a better response.


What benefit has BTVPUR AlSap 2-4 shown during the studies?

The studies showed that the vaccine is safe for sheep and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotypes 2 and 4.
The studies also showed that the vaccine can be used in pregnant and lactating sheep.


What is the risk associated with BTVPUR AlSap 2-4?

Vaccination may be followed by a small local swelling at the injection site (up to 24 cm2) for a short period (up to two weeks).
Animals may show a slight rise in body temperature, normally no more than 1.1°C on average, in the 24 hours following vaccination.


What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?

The withdrawal period is zero days.


What is the time to allow before milk can be taken from the animal for human consumption?

Milk can be taken immediately.


Why has BTVPUR AlSap 2-4 been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of BTVPUR AlSap 2-4 exceed the risks for active immunisation of sheep and cattle to prevent infection, viraemia and clinical signs caused by the bluetongue virus serotypes 2and 4, and recommended that BTVPUR AlSap 2-4 should be given a Marketing Authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

BTVPUR AlSap 2-4 has been authorised under ‘Exceptional Circumstances’. This means that it has not been possible to obtain complete information about BTVPUR AlSap 2-4. Every year, the European Medicines Agency (EMA) will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.


Which information is still awaited for BTVPUR AlSap 2-4?

The company that makes BTVPUR AlSap 2-4 will submit an action plan together with timelines for all of the issues that need to be resolved before the authorisation can revert to normal status. It will also supply regular updates on the use and the safety of the vaccine.


Other information about BTVPUR AlSap 2-4:

The European Commission granted a marketing authorisation valid throughout the EU for BTVPUR AlSap 2-4 to Merial S.A.S. on 5 November 2010. Information on the prescription status of this product may be found on the label/outer package.

Authorisation details
Name: BTVPUR AlSap 2-4
EMEA Product number: EMEA/V/C/000139
Active substance: serotype 2 and incativated bluetongue virus serotype 4
INN or common name: serotype 2 and incativated bluetongue virus serotype 4
Species: Sheep
ATCvet Code: QI04AA02
Exceptional Circumstances: There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.
Marketing Authorisation Holder: Merial S.A.S.
Revision: 0
Date of issue of Market Authorisation valid throughout the European Union: 05/11/2010
Contact address:
Merial S.A.S.
29 avenue Tony Garnier
69007 Lyon
France



Product Characteristics

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS


1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR AlSap 2-4 suspension for injection for sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1ml of vaccine contains:
Active substances:
Bluetongue Virus Serotype 2 antigen
6.8 - 9.5 CCID50*
Bluetongue Virus Serotype 4 antigen
7.1 - 8.5 CCID50*
(*) equivalent to titre prior to inactivation (log 10 )
Adjuvants:
Aluminium hydroxide
2.7 mg
(**) Haemolytic units
30 HU**
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1 Target species
Sheep
4.2 Indications for use, specifying the target species
Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue
virus serotypes 2 and 4.
*(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml,
indicating no infectious virus transmission)
Onset of immunity has been demonstrated 3 and 5 weeks after the primary vaccination course for
serotype 4 and serotype 2, respectively.
The duration of immunity is not yet established.
4.3 Contraindications
None.
4.4 Special warnings for each target species
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.
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Saponin
4.5 Special precautions for use
Special precautions for use in animals
Vaccinate healthy animals only.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
None
4.6 Adverse reactions (frequency and seriousness)
Vaccination may be followed by a small local swelling at the injection site (at most 24 cm 2 ) for a short
period (at most 14 days).
A transient increase in body temperature, normally not exceeding an average of 1.1°C, may occur
within 24 hours after vaccination.
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
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).
4.8 Interaction 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 decided on a case by case basis.
4.9 Amounts to be administered and administration route
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.
Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:
Primary vaccination
One injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born
to immune sheep).
Revaccination
As the duration of immunity is not yet established, any revaccination scheme should be agreed by the
Competent Authority or by the responsible veterinarian, taking into account the local epidemiological
situation.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a
double- dose of the vaccine.
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4.11 Withdrawalperiod
Zero days.
5.
IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Bluetongue virus vaccine, ATCvet code QI04AA02.
The vaccine contains inactivated Bluetongue Virus Serotypes 2 and 4 with aluminium hydroxide and
saponin adjuvants. It induces an active and specific immunity against bluetongue virus serotypes 2 and
4 in the vaccinated animal.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Silicon antifoam
Phosphate buffer
Glycine buffer
Aluminium hydroxide
Saponin
6.2 Incompatibilities
Do not mix with any other veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as package for sale: 1 year
Shelf life after first opening the immediate packaging: immediately after broaching
6.4 Special precautions for storage
Store and transport refrigerated (2°C – 8°C)
Do not freeze
Protect from light
6.5 Nature and composition of immediate packaging
Polypropylene bottle of 50 or 100 ml with butyl elastomer closure.
Box of 1 bottle of 100 doses (1 x 100 ml)
Box of 10 bottles of 100 doses (10 x 100 ml)
Box of 1 bottle of 50 doses (1 x 50 ml)
Box of 10 bottles of 50 doses (10 x 50 ml)
Type I glass bottle of 10 ml with butyl elastomer closure
Box of 1 bottle of 10 doses (1 x 10 ml)
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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.
MARKETING AUTHORISATION HOLDER
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
8.
MARKETING AUTHORISATION NUMBER(S)
EU/2/10/108/001
EU/2/10/108/002
EU/2/10/108/003
EU/2/10/108/004
EU/2/10/108/005
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
05/11/2010
10. DATE OF REVISION OF THE TEXT
05/11/2010
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 BTVPUR AlSap 2-4 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 BTVPUR AlSap 2-4 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(S) 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
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A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) of the biological active substance
MERIAL Animal Health Limited
Biological Laboratory, Ash Road,
Pirbright, Woking, Surrey GU24 0NQ
United Kingdom
MERIAL Laboratoire de Lyon Gerland
254, rue Marcel Mérieux
69342 LYON CEDEX 07
France
Name and address of the manufacturer responsible for batch release
MERIAL
Laboratory of Lyon Porte des Alpes
Rue de l’Aviation,
69800 Saint-Priest
France
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 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
in the scope of Regulation (EC) 470/2009.
The following ingredients of BTVPUR AlSap 2-4 suspension for injection for sheep are included in
Table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
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Pharmaco-
logically
active
substance
Marker
residue
Animal
species
MRLs
Target
tissues
Other
provisions
Therapeutic
classification
Aluminium
hydroxide
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
No entry
No entry
Saponin
Not
applicable
All food
producing
species
No
MRL
required
Not
applicable
No entry
No entry
Glycine
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: phosphate buffer,
silicon antifoam and water for injections. These ingredients, as used in this product, 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 as a matter of priority data relating to the following:
a) Stability of the vaccine: The final report concerning the stability results obtained from 3
batches of each presentation should be provided.
b) Duration of Immunity: Results from 6 and 12 month duration of immunity studies should be
provided.
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.
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ANNEX III
LABELLING AND PACKAGE LEAFLET
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A. LABELLING
10/24
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Box of 1 bottle of 10 ml
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR AlSap 2-4 suspension for injection for sheep
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each dose of 1ml of vaccine contains:
BTV2 antigen 6.8 - 9.5 CCID50*
BTV4 antigen 7.1 - 8.5 CCID50*
Aluminium hydroxide, Saponin, qs 1 dose (*)
(*) see package leaflet
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
PACKAGE SIZE
1 bottle of 10 doses (1 x 10 ml)
5.
TARGET SPECIES
Sheep
6.
INDICATION(S)
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD
Withdrawal period: zero days
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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).
Do not freeze.
Protect from light.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the 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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/10/108/005
12/24
 
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
13/24
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Box of 1 bottle of 50 ml,
Box of 10 bottles of 50 ml,
Box of 1 bottle of 100 ml,
Box of 10 bottles of 100 ml
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR AlSap 2-4 suspension for injection for sheep
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each dose of 1ml of vaccine contains:
BTV2 antigen 6.8 - 9.5 CCID50*
BTV4 antigen 7.1 - 8.5 CCID50*
Aluminium hydroxide, Saponin, qs 1 dose (*)
(*) see package leaflet
3.
PHARMACEUTICAL FORM
Suspension for injection
4.
PACKAGE SIZE
1 bottle of 50 doses (1 x 50 ml)
10 bottles of 50 doses (10 x 50 ml)
1 bottle of 100 doses (1 x 100 ml)
10 bottles of 100 doses (10 x 100 ml)
5.
TARGET SPECIES
Sheep
6.
INDICATION(S)
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use
Read the package leaflet before use.
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8.
WITHDRAWAL PERIOD
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).
Do not freeze.
Protect from light.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the 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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
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16. MARKETING AUTHORISATION NUMBER(S)
EU/2/10/108/003
EU/2/10/108/004
EU/2/10/108/001
EU/2/10/108/002
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Bottle of 10 and 50 ml
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR AlSap 2-4 suspension for injection for sheep
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
BTV 2 antigen 6.8 - 9.5 CCID50
BTV 4 antigen 7.1 - 8.5 CCID50
3.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
10 doses (10 ml)
50 doses (50 ml)
4.
ROUTE(S) OF ADMINISTRATION
Subcutaneous use
5.
WITHDRAWAL PERIOD
Withdrawal period: zero days
6.
BATCH NUMBER
Lot{number}
7.
EXPIRY DATE
EXP {month/year}
Once broached, use immediately
8.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
17/24
 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Bottle of 100 ml
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR AlSap 2-4 suspension for injection for sheep
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each dose of 1ml of vaccine contains:
BTV 2 antigen 6.8 - 9.5 CCID50
BTV 4 antigen 7.1 - 8.5 CCID50
3.
PHARMACEUTICAL FORM
Read package leaflet before use
4.
PACKAGE SIZE
100 doses (100 ml)
5.
TARGET SPECIES
Sheep
6.
INDICATION(S)
Read the package leaflet before use
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD
Withdrawal period: zero days
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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).
Do not freeze
Protect from light.
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.
15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
16. MARKETING AUTHORISATION NUMBER(S)
EU/2/10/108/001
EU/2/10/108/002
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
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B. PACKAGE LEAFLET
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PACKAGE LEAFLET FOR:
BTVPUR AlSap 2-4 suspension for injection for sheep
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
MERIAL
29 avenue Tony Garnier
69007 Lyon,
France
Manufacturer for the batch release :
MERIAL
Laboratory of Lyon Porte des Alpes
Rue de l’Aviation,
69800 Saint-Priest
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BTVPUR AlSap 2-4 suspension for injection for sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml of vaccine contains:
Bluetongue Virus Serotype 2 antigen
6.8 - 9.5 CCID50*
Bluetongue Virus Serotype 4 antigen
7.1 - 8.5 CCID50*
2.7 mg
Saponin
30 HU**
(*) equivalent to titre prior to inactivation (log10)
(**) Haemolytic units
4.
INDICATION(S)
Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by Bluetongue
Virus Serotypes 2 and 4.
*below the level of detection by the validated RT-PCR method at 3.68 log 10 RNA copies/ml,
indicating no infectious virus transmission.
Onset of immunity has been demonstrated 3 and 5 weeks after the primary vaccination course for
serotype 4 and serotype 2, respectively.
The duration of immunity is not yet established.
5.
CONTRAINDICATIONS
None.
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Aluminium hydroxide
6.
ADVERSE REACTIONS
Vaccination may be followed by a small local swelling at the injection site (at most 24 cm² ) for a short
period (at most 14 days).
A transient increase in body temperature, normally not exceeding an average of 1.1°C, may occur
within 24 hours after vaccination.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Sheep
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:
Primary vaccination
One injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born
to immune sheep).
Revaccination
As the duration of immunity is not yet 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
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.
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.
Shelf life after first opening the immediate packaging: immediately after broaching
Do not use after the expiry date (EXP) which is stated on the carton and the label.
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12. SPECIAL WARNINGS
Vaccinate healthy animals only.
Can be used during pregnancy and lactation.
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 decided on a case by case basis.
Do not mix with any other veterinary medicinal product.
No adverse reactions except those mentioned in section ‘Adverse Reactions’ were observed after the
administration of a double-dose of vaccine.
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.
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.
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
05/11/2010
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHER INFORMATION
The vaccine contains inactivated Bluetongue Virus Serotypes 2 and 4 with aluminium hydroxide and
saponin adjuvants. It induces an active and specific immunity against Bluetongue Virus Serotypes 2
and 4 in the vaccinated animal.
Not all pack sizes may be marketed
Box of 1 bottle of 10 doses (1 x 10 ml)
Box of 1 bottle of 50 doses (1 x 50 ml)
Box of 10 bottles of 50 doses (10 x 50 ml)
Box of 1 bottle of 100 doses (1 x 100 ml)
Box of 10 bottles of 100 doses (10 x 100 ml)
23/24
The import, sale, supply and/or use of BTVPUR AlSap 2-4 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 BTVPUR AlSap 2-4 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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Source: European Medicines Agency


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