Product class:
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Authorized package
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Medicinal product class:
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Veterinary medicine
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Package code:
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1510726
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Name of medicinal product:
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Btvpur
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Active substances:
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|
ATC code:
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QI02AA08; QI04AA02
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Dosage form:
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suspension for injection
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Route of administration:
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subcutaneous use
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Strengh:
|
|
Amount in package:
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50annus 1TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
|
|
Additional information:
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|
Indication:
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Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue
virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).
Active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1, 2, 4 and/or
8, and to reduce clinical signs caused by bluetongue virus serotypes 1, 4 and/or 8 (combination of
maximum 2 serotypes).
*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: 3 weeks (or 5 weeks in sheep for BTV2) after the primary vaccination course for
BTV-1, BTV-2 (cattle), BTV-4 and BTV-8 serotypes.
Duration of immunity: 1 year after primary vaccination course.
|
Safety features:
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No
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Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
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Labelling:
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|
Withdrawal time:
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0 päeva.
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Species:
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lammas, veis
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Boehringer Ingelheim Vetmedica GmbH
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Marketing authorization number:
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EU/2/10/113
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Marketing authorization issued on:
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December 17, 2010
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Entry/Changing date:
September 20, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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