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Medicinal Products

Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1528398
Name of medicinal product: Bluevac btv8
Active substances:
Bluetongue virus vaccine
Estonian, English, Latin
ATC code: QI04AA02; QI02AA08
Dosage form: suspension for injection
Route of administration: subcutaneous use
Strengh:  
Amount in package: 252ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Sheep For active immunisation of sheep to prevent the viraemia* caused by bluetongue virus serotype 1 or 4 or 8) and to reduce clinical signs caused by bluetongue virus serotype 8 *Below the level of detection by the validated RT-PCR method at 1 log10 TCID50/ml for serotypes 8 and 4, and 1.3 log 10TCID 50/ml for serotype 1. Onset of immunity: 21 days after completion of the primary vaccination scheme. Duration of immunity: 1 year after completion of the primary vaccination scheme. Cattle For active immunisation of cattle to prevent viraemia*caused by bluetongue virus serotype 1 or 4 or 8. *Below the level of detection by the validated RT-PCR method at 1 log10 TCID50/ml for serotypes 8 and 4, and 1.3 log10TCID50/ml for serotype 1. Onset of immunity: BTV, serotype 1: 28 days after completion of the primary vaccination scheme BTV, serotype 4: 21 days after completion of the primary vaccination scheme BTV, serotype 8: 31 days after completion of the primary vaccination scheme Duration of immunity: 1 year after completion of the primary vaccination scheme.
Safety features: No
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Withdrawal time: 0 päeva.
Species: veis, lammas
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: CZ Veterinaria S.A. 
Marketing authorization number: EU/2/11/122 
Marketing authorization issued on: April 14, 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Entry/Changing date: September 16, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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