ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
BTVPUR AlSap 1 suspension for injection for sheep and cattle.
2.
Each dose of 1 ml contains:
Active substances:
.Bluetongue Virus Serotype 1 antigen
8.1 CCID50*
Adjuvants:
. Al
3+
(as hydroxide)
2.7 mg
(**)
Haemolytic units
30 HU**
For a full list of excipients, see section 6.1.
3.
Suspension for injection.
4.
Sheep and cattle
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by
bluetongue virus serotype 1.
*(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 weeks after the primary vaccination course.
The duration of immunity is not yet established in cattle or sheep.
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 and cattle.
2
(*)
equivalent to titre prior to inactivation (log
10
)
. Saponin
Vaccinate healthy animals only.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
None
Vaccination may be followed by a small local swelling at the injection site (at most 32 cm² in cattle
and 24 cm
2
in sheep) which becomes residual 35 days later (≤ 1 cm
2
).
A transient increase in body temperature, normally not exceeding an average of 1.1°C, may occur
within 24 hours after vaccination.
Can be used during pregnancy in ewes. Can be used during pregnancy and lactation in cows
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.
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
In sheep
- First injection: from 1 month of age in naive animals (or from 2.5 months of age in young
animals born to immune sheep).
-
Second injection: after 3-4 weeks
In cattle
-
First injection: from 1 month of age in naive animals (or from 2.5 months of age in young
animals born to immune cattle).
-
Second injection: after 3-4 weeks
Revaccination
As the duration of immunity is not yet established in cattle or sheep, any revaccination scheme should
be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local
epidemiological situation.
3
Very rare and transient apathy can be observed after the administration of a double-dose of the
vaccine. No other adverse reactions except those mentioned in section 4.6 were observed.
4.11 Withdrawalperiod
Zero days.
5.
Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code QI04AA02 (sheep) and
QI02AA08 (cattle).
The vaccine contains inactivated Bluetongue Virus Serotype 1 with aluminium hydroxide and saponin
adjuvants. It induces an active and specific immunity against bluetongue virus serotype 1 in the
vaccinated animal.
6.
6.1 List of excipients
Aluminium hydroxide
Saponin
Silicon antifoam
Phosphate buffer
Glycine buffer
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: 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)
Do not freeze
Protect from light
6.5 Nature and composition of immediate packaging
Polypropylene bottle of 50 or 100 ml with butyl elastomere 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 elastomere closure
Box of 1 bottle of 10 doses (1 x 10 ml)
4
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.
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
8.
EU/2/10/112/001
EU/2/10/112/002
EU/2/10/112/003
EU/2/10/112/004
EU/2/10/112/005
9.
17/12/2010
17/12/2010
Detailed information of this product is available on the website of the European Medicines Agency
PROHIBITION OF SALE, SUPPLY AND/OR USE
The import, sale, supply and/or use of BTVPUR AlSap 1 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 1 must consult the relevant Member
State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or
use.
5
ANNEX II
A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCEAND
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
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
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 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 THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Not applicable.
7
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 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) Stability of the vaccine: Results from stability studies with the following intervals should be
provided: T0, T9, T15, T21 and T27.
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.
8
ANNEX III
LABELLING AND PACKAGE LEAFLET
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Box of 1 bottle of 10 ml,
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.
BTVPUR AlSap 1 suspension for injection for sheep and cattle
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each dose of 1ml contains:
BTV1 antigen 8.1 CCID
50
*
Aluminium hydroxide, Saponin, qs 1 dose (*)
(*)
see package leaflet
3.
Suspension for injection
4.
PACKAGE SIZE
1 bottle of 10 doses (1x 10 ml)
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.
Sheep and cattle
6.
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use
Read the package leaflet before use.
11
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).
Do not freeze.
Protect from light.
12. SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Read the package leaflet.
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.
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
EU/2/10/112/005
EU/2/10/112/003
EU/2/10/112/004
EU/2/10/112/001
12
EU/2/10/112/002
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Bottle of 10 and 50 ml
1.
BTVPUR AlSap 1 suspension for injection for sheep and cattle
2.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
BTV 1 antigen ...................................................................................................................... 8.1 CCID
50
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: 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.
14
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Bottle of 100 ml
1.
BTVPUR AlSap 1 suspension for injection for sheep and cattle
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each dose of 1ml contains Bluetongue Virus
Serotype 1 antigen ................................................................................................................. 8.1 CCID
50
3.
4.
PACKAGE SIZE
100 doses (100 ml)
5.
Sheep and cattle
6.
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.
15
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 .
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.
MERIAL
29, avenue Tony Garnier
69007 Lyon
FRANCE
EU/2/10/112/001
EU/2/10/112/002
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET FOR:
BTVPUR AlSap 1 suspension for injection for sheep and cattle
1.
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
BTVPUR AlSap 1 suspension for injection for sheep and cattle
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml contains:
.Bluetongue Virus Serotype 1 antigen
8.1 CCID50*
.Al
3+
(as hydroxide)
2.7 mg
.Saponin
30 HU**
(*)
equivalent to titre prior to inactivation (log10)
(**)
Haemolytic units
4. INDICATION(S)
Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by
Bluetongue Virus Serotype 1.
*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 weeks after the primary vaccination course.
The duration of immunity is not yet established in cattle or sheep.
5. CONTRAINDICATIONS
None.
18
6.
Vaccination may be followed by a small local swelling at the injection site (at most 32 cm² in cattle
and 24 cm² in sheep) which becomes residual 35 days later (≤ 1 cm
2
).
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.
Sheep and cattle.
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
In sheep
-
1
st
injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals
born to immune sheep).
-
2
nd
injection: after 3-4 weeks
In cattle
-
1
st
injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals
born to immune cattle).
-
2
nd
injection: after 3-4 weeks.
Revaccination
As the duration of immunity is not yet established in cattle or sheep, 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.
19
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.
12. SPECIAL WARNINGS
Vaccinate healthy animals only.
Can be used during pregnancy in ewes. Can be used during pregnancy and lactation in cows
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.
Very rare and transient apathy can be observed after the administration of a double-dose of the
vaccine. No other adverse reactions except those mentioned in section ‘Adverse Reactions’ were
observed.
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.
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
to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
17/12/2010
Detailed information on this product is available on the website of the European Medicines Agency
15. OTHER INFORMATION
The vaccine contains inactivated Bluetongue Virus Serotype 1 with aluminium hydroxide and saponin
adjuvants. It induces an active and specific immunity against Bluetongue Virus Serotype 1 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)
20
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)
The import, sale, supply and/or use of BTVPUR AlSap 1 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 1 must consult the relevant Member
State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or
use.
21
Source: European Medicines Agency
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