RP Vacc emulsion for injection for pigeons 
 
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch release: 
PHARMAGAL-BIO spol. s r.o., Murgašova 5, 94901 Nitra, Slovak Republic
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
 
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
 
Each 0.3 ml dose contains
 
Active substances:
Inactivated Pigeon Rotavirus, strain Ro/D                                            
Inactivated Pigeon Paramyxovirus type 1 (PPMV1), strain 988M           ≥ 6.47 log2 HI**
 
* ELISA units in chicken
** Haemagglutination inhibition in chicken
 
 
For active immunization of pigeons from the age of 4 weeks onwards:
to reduce frequency and severity of clinical signs, gross lesions and virus shedding caused by pigeon rotavirus group A, genotype G18P[17] (PiRV), 
to reduce mortality, frequency and severity of clinical signs caused by paramyxovirus type 1 (PMV1).
 
Onset of immunity:               2 weeks after the primary vaccination scheme
Duration of immunity:          8 months (PiRV) / 9 months (PMV1) after the primary vaccination scheme
                                           (demonstrated by challenge)
                                            
In field studies, antibody levels comparable to those demonstrated by the challenge, were found even one year after the last injection.
6. ADVERSE REACTIONS
Mild apathy appearing one day after vaccination and painfulness at the site of application immediately after injection (not accompanied by swelling) lasting usually for maximum 1 day after the vaccination are common.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
7. TARGET SPECIES
Pigeon
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
One dose: 0.3 ml
Administer intramuscularly into the femoral muscle.
Primary vaccination scheme:
First dose: from 4 weeks of age onwards
Second dose: 3 weeks later
 
Please view and read the enclosed leaflet in the vial for more information