Unistrain PRRS Lyophilisate and Solvent for Suspension for Injection for Pigs
Active ingredient: Porcine respiratory and reproductive syndrome virus
Form
Injection
Species
Manufacturer
Laboratorios Hipra SA
VMD MA No.
17533/3005
What it's used for
Under laboratory conditions, vaccination of females reduced the negative impact of PRRS virus infection on piglet performance (mortality and weight gain) w...
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Unistrain PRRS Lyophilisate and Solvent for Suspension for Injection for Pigs — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
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 3 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.
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 solventNº of dose / vialIMID10 doses20 ml-25 doses50 ml-50 doses100 ml10 ml100 doses200 ml20 ml125 doses250 ml25 ml250 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 lyophilisate.
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 lyophilisate. Shake until the lyophilisate 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 3 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.
-
4 weeks before mating.
-
o
o
mating) or
o
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)
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.
Very common
(> 1 animal / 10 animals
treated):
Elevated temperature
, Depression
, Anorexia
Injection site inflammation
, Injection site
reddening
Common
(1 to 10 animals / 100 animals
treated):
Injection site inflammation
, Injection site
nodule
Very rare
(< 1 animal / 10 000 animals
treated, including isolated
reports):
Hypersensitivity reaction
1
Slight transient increases (not greater than 1.5 °C). These reactions
spontaneously resolved without treatment.
Mild and transient. These signs disappeared spontaneously without any
additional treatment.
After intradermal administration. Mild and transient, typically resolving within
2 days.
After intramuscular administration. Mild and transient, typically resolving within
one week.
In such cases, an appropriate symptomatic treatment should be administered.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a
veterinarian, to either the marketing authorisation holder or its local representative
or the national competent authority via the national reporting system. See the
package leaflet for respective contact details.
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 safe use in the target species:
Vaccination should aim to achieve a homogenous immunity in the target
population at farm level. PRRS virus-naïve breeding animals (e.g. replacement
gilts from PRRS virus-negative herds) which are introduced into a 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
respected between vaccination and moving the animals to the breeding unit. This
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 of
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 week 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 foetus during pregnancy and piglets after partum
without any clinical consequence. Therefore, special precautions should be taken
to avoid spreading to susceptible animals.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Breeding females:
Safety and efficacy data are available which demonstrate that this vaccine can be
mixed and administered with ERYSENG PARVO at one injection site by
intramuscular route. 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 products 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 3 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.
Store and transport refrigerated (2 C – 8 C).
Do not freeze.
Protect from light.
Solvent:
Store below 25 C.
Do not freeze.
Protect from light.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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