Target species
Pigs.
Indications for use
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 associated with infection with strains of PRRS virus. Under laboratory conditions, vaccination reduced the negative impact of PRRS virus infection on piglet performance (mortality and weight gain) within the first 28 days of life.
The onset of immunity is 30 days after vaccination demonstrated by challenge.
The duration of immunity is 16 weeks demonstrated by challenge.
Breeding females: 2ml via intramuscular injection or 0.2ml via intradermal administration.
Pigs from 4 weeks of age: 2ml via intramuscular injection or 0.2ml via intradermal administration. 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 experimental 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: 4 weeks after vaccination.
Duration of immunity: 24 weeks.
Contra-indications
Do not use in case of hypersensitivity to the active ingredient or to any of the excipients.
Do not use in naïve herds in which the presence of European PRRSV has not been established through reliable diagnostic virological methods.
No data are available on the safety of the vaccine for the reproductive performance in boars.
Special warnings for each target species
Vaccinate healthy animals only.
Precautions should be taken to avoid the transfer of the virus within the herd, e.g. from seropositive animals to seronegative animals.
Maternally derived antibodies can interfere with the efficacy of the vaccine. In the presence of high maternally derived antibodies, timing of initial vaccination of piglets should be planned accordingly.
Special precautions for use
Special precautions for use in animals
Vaccination should aim to achieve a homogenous immunity in the target population at farm level. PRRSV virus-naive breeding animals (e.g. replacement gilts from PRRS virus-negative herds) which are introduced in PRRSV-infected herd should be vaccinated prior to first insemination. Vaccination should preferably be done in a separated quarantine unit. A transition period should be longer than the shedding phase of the PRRS MLV vaccine following vaccination.
Do not routinely rotate two or more commercial PRRS MLV vaccines based on different strains in a herd.
In order to limit the potential risk of recombination between PRRS MLV vaccine strains of the same genotype, do not use different PRRS MLV vaccines based on different strains of the same genotype on the same farm at the same time. In the case of transitioning from one PRRS MLV vaccine to another PRRS MLV vaccine, a transition period should be respected between the last administration and the current vaccine and the first administration of the new vaccine. This transition period should be longer than the shedding period of the current vaccine following vaccination.
The vaccine virus may be shed after vaccination e.g. in the faeces and/or in nasal or oral secretions of vaccinated animals.
Following vaccination of breeding females the vaccine strain may be shed for up to nine days. Following vaccination of 4 weeks old pigs, shedding of the vaccine strain may last for up to 29 days. The vaccine strain can spread to non-vaccinated cohabitant animals, including the fetus during pregnancy and piglets after partum without any clinical consequence. Therefore, special precautions should be taken to avoid spreading to susceptible animals, if necesary.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case adverse reactions develop following accidental self-injection, seek medical advice and show the package leaflet or the label to the physician.
Adverse reactions
Slight transient increases (no greater than 1.5°C) in body temperature can be observed following vaccination, which spontaneously resolve without treatment.
Mild and transient depression or anorexia folowing vaccination occurred very commonly in studies. These signs disappear 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 in 100 animals treated)
- uncommon (more than 1 but less than 10 in 1000 animals treated)
- rare (more than 1 but less than 10 in 10,000 animals treated)
- very rare (less than 1 in 100,000 animals treated, including isolated reports)
Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
Interactions
Breeding females:
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with ERYSENG PARVO and administered at one injection site. The product literature of ERYSENG PARVO should be consulted before administration of the mixed products.
The mixed administration of UNISTRAIN PRRS and ERYSENG PARVO should only be used when vaccinating animals prior to mating.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Pigs from 4 weeks of age:
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 made on a case by case basis.
Amounts to be administered and administration route
The method of administration is by intramuscular or by intradermal route.
For the intramuscular, the vaccine should be given in the neck region.
For the intradermal route:
In pigs from 4 weeks of age the vaccine can be given in the neck region.
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 nozzle diameter: 0.25-0.30 mm an da peak of force of injection of 0.9-1.3 N) should be used.
Aseptic injection techniques should be observed to avoid introduction of contamination during the 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 freeze-dried 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 only. A single vaccination should be administrated 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, 2 weeks before mating or at 8-9 weeks of gestation (approximately 60 days after mating) or vaccinate sows each every month
PRRS-naive 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) |
Overdose
Breeding females: Negative effects in the reproductive parameters could not be excluded following administration of a 10x overdose in naïve pregnant females. Particular care and attention to the correct reconstitution of the vaccine and management of the vaccination procedure should be taken in order to avoid accidental overdose. Special precautions should be taken to avoid overdose in naïve pregnant females.
No adverse reactions were observed in seropositive gilts and sows or in their offspring following the administration of a 10x overdose during the 2nd or 3rd trimester of gestation. However, viremia in piglets may be uncommonly observed in seropositive sows vaccinated with a 10x overdose during the 3rd trimester of pregnancy.
Pigs from 4 weeks of age: No adverse reactions were observed in naïve piglets following administration of a 10x overdose other than those mentioned previously.
Withdrawal periods
Zero days