Patient leaflet - BTVPUR Alsap 8
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml of vaccine contains:
Active substances:
Bluetongue virus serotype 8 antigen..........................
-
(*) Antigen content (VP2 protein) by immuno-assay
Adjuvants:
Aluminium hydroxide................................................
Saponin.......................................................................
-
(** ) Haemolytic units
3. PHARMACEUTICAL FORM
Suspension for injection.
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4. CLINICAL PARTICULARS
4.1 Target species
Sheep and cattle
4.2 Indications for use, specifyi
Active immunisation of sheep a bluetongue virus serotype 8.
* (below the level of detection by indicating no infectious virus tran
e target species
e to prevent viraemia* and to reduce clinical signs caused by
the validated RT-PCR method at 3.14 log10 RNA copies/ml, smission)
Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.
The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
4.3 Contra
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 and cattle.
4.5 Special precautions for use
Vaccinate healthy animals only.
Special precautions to be taken by the person administering the veterinary medicinal prod animals
or a short
None
4.6 Adverse reactions (frequency and seriousness)
Vaccination may be followed by a small local swelling at the injection site (at mos period (at most 14 days).
, may occur
A transient increase in body temperature, normally not exceeding an avera within 24 hours after vaccination.
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy in ewes. Can be used during pregnancy and lactation in cows.
The safety and the efficacy of the vaccine has 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 th rent vaccination policies against Bluetongue Virus (BTV).
4.8 Interaction with other medicinal products 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
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.
4.11 Withdrawal period
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code: QI04AA02 (sheep QI02AA08 (cattle).
The vaccine contains inactivated bluetongue virus serotype 8 with aluminium hydroxi adjuvants. It induces an active and specific immunity against bluetongue virus serotyp vaccinated animal.
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6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Aluminium hydroxide
Purified saponin Silicon antifoam Phosphate buffer Glycine buffer Water for injection
-
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 (10-ml bottle): 18 months.
Shelf life of the veterinary medicinal product as package for sale (50-ml and 100-ml bottles): 2 years.
Shelf life after first opening the immediate packaging: immediately after broaching.
6.4 Special precautions for storage
°C-8 °C).
Store and transpor 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 × 100 ml).
Box of 10 bottles of 100 doses (10 × 100 ml).
Box of 1 bottle of 50 doses (1 × 50 ml).
Box of 10 bottles of 50 doses (10 × 50 ml).
Type I glass bottle of 10 ml with butyl elastomere closure.
Box of 1 bottle of 10 doses (1 × 10 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 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/2/09/094/001
EU/2/09/094/002
EU/2/09/094/003
EU/2/09/094/004
EU/2/09/094/005
F THE AUTHORISATION
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9. DATE OF FIRST AUTHORISATION/RENEW 17/03/2009
10. DATE OF REVISION OF THE TEX
PROHIBITION OF SALE
Detailed information on this pro.
lable on the website of the European Medicines Agency
PLY AND/OR USE
The import, sale, supply and/or use of BTVPUR AlSap 8 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 8 must consult the relevant Member State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
A.
ANNEX II
MANUFACTURERS OF THE BIOL AL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
CONDITIONS OR RESTRIC
REGARDING SUPPLY OR USE
B.
C.
STATEMENT OF THE
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers 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 REGARDING SUPPLY OR USE
Veterinary medicinal product subject to prescription.
According to Article 71 of Directive 2001/82/
the European Parliament and of the Council as
amended, Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal product on the whole or part of their territory if it is established that:
a)
the administration of the product to animals will interfere with the implementation of a national programme 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 w territory in questi
product is intended to confer immunity is largely absent from the
C.
STATEMENT OF THE MRLs
The active within the
nce being a principle of biological origin intended to produce active immunity is not of Regulation (EC) No 470/2009.
The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Withdrawal period: zero days.
9. SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
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10. EXPIRY DATE
EXP {month/year}
Shelf life after first opening the immediate packaging: immediately after broaching.
11. SPECIAL STORAGE CONDITIONS
Store and transport refrigerated (2 °C-8 °C).
Do not freeze.
Protect from light.
EU/2/09/094/002
EU/2/09/094/003
EU/2/09/094/004
EU/2/09/094/005
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Bottle of 10 and 50 ml
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Bottle of 100 ml
5. TARGET SPECIES
Sheep and cattle
6. INDICATION(S)
Withdrawal period: zero days.
9. SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
EXP {month/year}
Once broached, use immediately.
PACKAGE LEAFLET FOR:
BTVPUR AlSap 8 suspension for injection
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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 responsible for batch release :
MERIAL
Laboratory of Lyon Porte des Alpes
Rue de l’Aviation,
69800 Saint-Priest
France
2. NAME OF THE VETERINARY MEDICINAL PRO
BTVPUR AlSap 8 suspension for injection
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each dose of 1 ml of vaccine contains: Bluetongue virus serotype 8 antigen..
> 2.1 log10 pixels*
................... 2.7 mg
................30 HU
o-assay
Aluminium hydroxide........................
Saponin...............................................
-
() antigen content (VP2 protein) by i () Haemolytic units
-
4. INDICATION(S)
Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by Bluetongue virus serotype 8 (BTV 8).
*below the level of detection by the validated RT-PCR method at 3.14 log10 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 for cattle and sheep is 1 year after the primary vaccination course.
5.
TRAINDICATIONS
None.
-
6. ADVERSE REACTIONS
Vaccination may be followed by a small local swelling at the injection site (at most 32 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.
ISTRATION
7. TARGET SPECIES
Sheep and cattle.
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF
Administer one dose of 1 ml subcutaneously according to the following v
on scheme:
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 PERIO
Zero days.
Kee
11. SPECIAL
GE PRECAUTIONS
h 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 this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
12. SPECIAL WARNINGS
Special precautions for use in animals:
Vaccinate healthy animals only.
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.
Pregnancy and lactation:
Can be used during pregnancy in ewes. Can be used during pregnancy and lactation in cows.
Fertility:
The safety and the efficacy of the vaccine has 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).
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.
Overdose (symptoms, emergency procedures, antidotes): *
No adverse reactions except those mentioned in section ‘Adverse Reactions’ were observed after the administration of a double-dose of vaccine.
Incompatibilities:
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 to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
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 8 with aluminium hydroxide and saponin adjuvants. It induces an active and specific immunity against Bluetongue virus serotype 8 in the vaccinated animal.
Not all pack sizes may be marketed.
Box of 1 bottle of 10 doses (1 × 10 ml).
Box of 1 bottle of 50 doses (1 × 50 ml).
Box of 10 bottles of 50 doses (10 × 50 ml).
Box of 1 bottle of 100 doses (1 × 100 ml).
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