Unistrain PRRS
Active substance
ATC code
Species
Pigs.
Indications
Breeding females: For active immunisation of breeding females from farms affected with European PRRS virus to reduce reproductive disorders, incidence and duration of viraemia, transplacental virus transmission, virus tissue load and clinical signs in the offspring associated with infection with strains of PRRS virus. Under laboratory conditions, vaccination of females reduced the negative impact of PRRS virus infection on piglet performance (mortality and weight gain) within the first 28 days of life.
Onset of immunity: 30 days after vaccination.
Duration of immunity: 16 weeks after vaccination.
Pigs from 4 weeks of age: For active immunisation of pigs from farms affected with European PRRS virus to reduce clinical signs associated with a PRRS virus infection, the incidence and duration of viraemia and the duration of virus shedding by infected animals. Under experimental conditions, it was demonstrated that vaccination reduces the virus tissue load in the lungs. Under field conditions, where a PRRSV infection occurred during the fattening period, a reduction in mortality and in the negative effects of infection on daily weight gain was demonstrated.
Onset of immunity: 28 days after vaccination.
Duration of immunity: 24 weeks after vaccination.
Dose to be administered and administration route
For intramuscular or intradermal use::
- For the intramuscular route the vaccine should be given in the neck region.
- For the intradermal route:
o in pigs from 4 weeks of age, the vaccine can be given in the neck region,
o in breeding females, the vaccine can be given in the neck region, the perineal zone or the udder.
The ID device supplied by the manufacturing authorisation holder or other suitable needle-free device able to administer 0.2 ml doses (injection stream diameter of 0.25-0.30 mm and a peak force of injection of 0.9-1.3 N) should be used.
Aseptic injection techniques should be observed to avoid introduction of contamination during vaccine administration.
Reconstitute the vaccine with the corresponding solvent:
|
Volume of solvent |
||
|
Nº of dose/ vial |
IM |
ID |
|
10 doses |
20 ml |
- |
|
25 doses |
50 ml |
- |
|
50 doses |
100 ml |
10 ml |
|
100 doses |
200 ml |
20 ml |
|
125 doses |
250 ml |
25 ml |
|
250 doses |
- |
50 ml |
If the solvent is refrigerated, it should be allowed to warm up to a temperature between 15 ºC to 25 ºC before reconstitution of the freeze-dried powder.
Peel the aluminium capsule off the bottle containing the solvent and aspirate in order to remove a certain volume of the contents. Then inject this volume of solvent into the vial containing the freeze-dried powder. Shake until the freezedried powder is completely dissolved. Once reconstituted, withdraw all the suspension obtained from the vaccine vial and inject it into the vial containing the remaining solvent. Shake well before use. The reconstituted vaccine is a homogeneous reddish solution. Avoid the introduction of contamination during reconstitution and use. Use only sterile needles and syringes for administration
The following doses and administration methods should be used:
Pigs from 4 weeks of age:
2 ml via intramuscular injection or 0.2 ml via intradermal administration.
Breeding females:
2 ml via intramuscular injection or 0.2 ml via intradermal administration. A single vaccination should be administered once in each reproductive cycle for protection during the subsequent pregnancy.
In gilts, administer one injection of the reconstituted vaccine per animal 4 weeks before mating.
In sows, administer one injection of the reconstituted vaccine per animal:
o 2 weeks before each mating or
o at 8-9 weeks of each gestation (approximately 60 days after mating) or
o vaccinate sows every 4 months
PRRS-naïve sows should not be vaccinated during pregnancy.
For simultaneous use with ERYSENG PARVO in breeding females from 6 months of age, the mixed administration of UNISTRAIN PRRS and ERYSENG PARVO should only be used when vaccinating animals prior to mating.
The following instructions should be used: the contents of a single vial of UNISTRAIN PRRS should be reconstituted with the contents of a single vial of ERYSENG PARVO in the same way as described for reconstitution with solvent. A single dose (2 ml) of the mixed vaccines should be injected within a period of 2 hours via intramuscular use.
|
UNISTRAIN PRRS |
|
ERYSENG PARVO |
|
10 doses |
+ |
10 doses (20 ml) |
|
25 doses |
+ |
25 doses (50 ml) |
|
50 doses |
+ |
50 doses (100 ml) |
Adverse reactions
Slight transient increases (not greater than 1.5°C) in body temperature following vaccination occurred very commonly in studies. These reactions spontaneously resolved without treatment.
Mild and transient depression or anorexia following vaccination occurred very commonly in studies. These signs disappeared spontaneously without any additional treatment.
After intradermal administration, local reactions (inflammation and/or redness) following vaccination occurred very commonly in studies. These local reactions were mild and transient, typically resolving within 2 days.
After intramuscular administration injection site reactions (small nodules and/or inflammation) following vaccination occurred commonly in studies. The lesions were mild and transient, typically resolving within one week.
Vaccination very rarely caused hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be administered.
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).
