POM-V
Prescription Required
Suvaxyn PRRS MLV Lyophilisate and Solvent for Suspension for Injection for Pigs
Active ingredient: Porcine respiratory and reproductive syndrome virus
Form
Injection
Species
Pigs
Manufacturer
Zoetis UK Limited
VMD MA No.
42058/5075
What it's used for
Onset of immunity: 3 weeks. Duration of immunity: 26 weeks. Fattening pigs: In addition, intramuscular vaccination of seronegative 1-day-old piglets was de...
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Clinical information
Suvaxyn PRRS MLV Lyophilisate and Solvent for Suspension for Injection for Pigs — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
Onset of immunity: 3 weeks.
Duration of immunity: 26 weeks.
Fattening pigs:
In addition, intramuscular vaccination of seronegative 1-day-old piglets was
demonstrated to reduce lung lesions against challenge administered at 26 weeks
post vaccination. Intramuscular vaccination of seronegative 2-week-old piglets was
demonstrated to reduce lung lesions and oral shedding against challenge
administered at 28 days and at 16 weeks post-vaccination.
Additionally, nasal vaccination of seronegative 3-day-old piglets reduced viraemia,
nasal shedding and lung lesions against challenge administered at 21 days post-
vaccination. Nasal vaccination of seropositive 3-day-old piglets reduced viraemia,
nasal shedding and lung lesions against challenge administered 10 weeks post-
vaccination.
Gilts and sows:
In addition, pre-pregnancy vaccination of clinically healthy gilts and sows, non-PRRS
virus-naïve (i.e. either previously immunised against PRRS virus via vaccination or
exposed to PRRS virus via field infection) or PRRS virus-naïve, was demonstrated to
reduce the transplacental infection caused by PRRS virus during the last third of
pregnancy, and to reduce the associated negative impact on reproductive
performance (reduction of the occurrence of stillbirths, of piglet viraemia at birth and
at weaning, of lung lesions and of viral load in lungs in piglets at weaning).
Duration of immunity: 26 weeks.
Fattening pigs:
In addition, intramuscular vaccination of seronegative 1-day-old piglets was
demonstrated to reduce lung lesions against challenge administered at 26 weeks
post vaccination. Intramuscular vaccination of seronegative 2-week-old piglets was
demonstrated to reduce lung lesions and oral shedding against challenge
administered at 28 days and at 16 weeks post-vaccination.
Additionally, nasal vaccination of seronegative 3-day-old piglets reduced viraemia,
nasal shedding and lung lesions against challenge administered at 21 days post-
vaccination. Nasal vaccination of seropositive 3-day-old piglets reduced viraemia,
nasal shedding and lung lesions against challenge administered 10 weeks post-
vaccination.
Gilts and sows:
In addition, pre-pregnancy vaccination of clinically healthy gilts and sows, non-PRRS
virus-naïve (i.e. either previously immunised against PRRS virus via vaccination or
exposed to PRRS virus via field infection) or PRRS virus-naïve, was demonstrated to
reduce the transplacental infection caused by PRRS virus during the last third of
pregnancy, and to reduce the associated negative impact on reproductive
performance (reduction of the occurrence of stillbirths, of piglet viraemia at birth and
at weaning, of lung lesions and of viral load in lungs in piglets at weaning).
Reconstitute the lyophilisate with the supplied solvent. In cases where the vials
containing the solvent and the lyophilisate are stored separately, verify prior to
reconstituting the lyophilisate that the lot number mentioned on the vial containing the
solvent is identical to the lot number mentioned on the vial containing the lyophilisate.
Reconstitute the vaccine with the corresponding solvent:
Number of doses per vial (lyophilisate) Volume of solvent needed 25 ds50 ml50 ds100 ml125 ds250 ml
Transfer approximately 5 ml of solvent to the vial containing the lyophilisate and
ensure complete reconstitution. Transfer back the reconstituted solution into the
solvent vial (containing the remaining solvent): 25 doses are reconstituted into 50 ml
solvent, 50 doses are reconstituted into 100 ml solvent, and 125 doses are
reconstituted into 250 ml solvent.
Number of doses per vial (lyophilisate) Volume of solvent needed 100 ds50 ml
Transfer approximately 5 ml of solvent to the vial containing the lyophilisate and
ensure complete reconstitution. Transfer back the reconstituted solution into the
solvent vial (containing the remaining solvent): 100 doses are reconstituted into 50 ml
solvent.
After reconstitution, the suspension should be orange coloured liquid which might
contain a loose resuspendable sediment.
Dosage:
Intramuscular administration: 2 ml 0.5 ml in the neck.
Nasal administration: 2 ml administered as 1 ml in each nostril. Nasal administration:
0.5 ml administered in one nostril.
Vaccination schedule:
Pigs for fattening from 1 day of age onwards:
A single dose of 2 ml 0.5 ml is given to pigs via intramuscular administration.
Pigs for fattening from 3 days of age onwards:
A single dose of 2 ml is given to pigs via intramuscular administration, or a single
dose of 2 ml is given to pigs via nasal route by administering 1 ml in each nostril
using a sterile syringe not connected to a needle. A single dose of 0.5 ml is given to
pigs via intramuscular administration, or a single dose of 0.5 ml is given to pigs via
nasal route by administration in one nostril using a sterile syringe not connected to a
needle.
Gilts and sows:
A single dose of 2 ml 0.5 ml is given via intramuscular administration prior to
introduction into the sow herd, approximately 4 weeks prior to breeding. A single
booster dose is given every 6 months.
Use sterile syringes and needles.
The use of a multi-dosing syringe is recommended. Use vaccination devices
according to the manufacturer’s instructions. Needles for administration should be
appropriate for the size of the pig.
containing the solvent and the lyophilisate are stored separately, verify prior to
reconstituting the lyophilisate that the lot number mentioned on the vial containing the
solvent is identical to the lot number mentioned on the vial containing the lyophilisate.
Reconstitute the vaccine with the corresponding solvent:
Number of doses per vial (lyophilisate) Volume of solvent needed 25 ds50 ml50 ds100 ml125 ds250 ml
Transfer approximately 5 ml of solvent to the vial containing the lyophilisate and
ensure complete reconstitution. Transfer back the reconstituted solution into the
solvent vial (containing the remaining solvent): 25 doses are reconstituted into 50 ml
solvent, 50 doses are reconstituted into 100 ml solvent, and 125 doses are
reconstituted into 250 ml solvent.
Number of doses per vial (lyophilisate) Volume of solvent needed 100 ds50 ml
Transfer approximately 5 ml of solvent to the vial containing the lyophilisate and
ensure complete reconstitution. Transfer back the reconstituted solution into the
solvent vial (containing the remaining solvent): 100 doses are reconstituted into 50 ml
solvent.
After reconstitution, the suspension should be orange coloured liquid which might
contain a loose resuspendable sediment.
Dosage:
Intramuscular administration: 2 ml 0.5 ml in the neck.
Nasal administration: 2 ml administered as 1 ml in each nostril. Nasal administration:
0.5 ml administered in one nostril.
Vaccination schedule:
Pigs for fattening from 1 day of age onwards:
A single dose of 2 ml 0.5 ml is given to pigs via intramuscular administration.
Pigs for fattening from 3 days of age onwards:
A single dose of 2 ml is given to pigs via intramuscular administration, or a single
dose of 2 ml is given to pigs via nasal route by administering 1 ml in each nostril
using a sterile syringe not connected to a needle. A single dose of 0.5 ml is given to
pigs via intramuscular administration, or a single dose of 0.5 ml is given to pigs via
nasal route by administration in one nostril using a sterile syringe not connected to a
needle.
Gilts and sows:
A single dose of 2 ml 0.5 ml is given via intramuscular administration prior to
introduction into the sow herd, approximately 4 weeks prior to breeding. A single
booster dose is given every 6 months.
Use sterile syringes and needles.
The use of a multi-dosing syringe is recommended. Use vaccination devices
according to the manufacturer’s instructions. Needles for administration should be
appropriate for the size of the pig.
Do not use in herds where European PRRS virus has not been detected by reliable
diagnostic methods.
Do not use in boars producing semen, as PRRS virus can be shed in semen.
Do not use in PRRS virus-naïve pregnant gilts and sows in the second half of
gestation because the vaccine strain may cross the placenta. The administration of
the vaccine to pregnant PRRS virus-naïve gilts and sows in the second half of
gestation may have an impact on their reproductive performance.
diagnostic methods.
Do not use in boars producing semen, as PRRS virus can be shed in semen.
Do not use in PRRS virus-naïve pregnant gilts and sows in the second half of
gestation because the vaccine strain may cross the placenta. The administration of
the vaccine to pregnant PRRS virus-naïve gilts and sows in the second half of
gestation may have an impact on their reproductive performance.
Pigs for fattening
Very common
(>1 animal / 10 animals treated):
Elevated temperature
Common
(1 to 10 animals / 100 animals
treated):
Injection site swelling
Uncommon
(1 to 10 animals / 1,000 animals
treated):
Anaphylactic-type reactions (e.g. vomiting,
tremors and/or mild depression)
1
Transient; observed within 4 days after vaccination. On average 0.5 °C and up to 1.4
°C individually.
In general below 2 cm in diameter; resolves in 3 days.
Observed shortly after vaccination.
Resolves without treatment within few hours.
Pre-breeding PRRS virus-naïve gilts and sows
Very common
(>1 animal / 10 animals
treated):
Elevated temperature
Injection site swelling
1
Transient; observed 4 hours post vaccination. On average 0.2 °C and up to 1.0 °C
individually.
In general below
0.5 cm in diameter; resolves spontaneously within 5 days without
treatment.
PRRS virus-naïve gilts and sows in the first half of gestation
Very common
(>1 animal / 10 animals treated):
Elevated temperature
Injection site swelling
1
Transient; observed 4 hours post vaccination. On average 0.8 °C and up to 1.0 °C
individually.
In general, below 1.4 cm in diameter; resolves spontaneously within 9 days without
treatment.
Non-PRRS virus-naïve gilts and sows in the second half of gestation
Very common
(>1 animal / 10 animals treated):
Elevated temperature
Injection site swelling
1
Transient; observed 4 hours post vaccination. On average 0.4 °C and up to 0.6 °C
individually.
In general below 5 cm in diameter; resolves spontaneously within 32 days without
treatment.
Lactating sows
Very common
(>1 animal / 10 animals treated):
Elevated temperature
Decreased appetite
Injection site swelling
1
Up to 2.2 ºC. Observed 2 days post vaccination; resolves spontaneously within 4
days without treatment.
Observed 1 - 4 days post vaccination and resolves spontaneously within 3 days
without treatment.
Up to 11 cm in diameter; Resolves spontaneously within 3 days without treatment.
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 the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
Very common
(>1 animal / 10 animals treated):
Elevated temperature
Common
(1 to 10 animals / 100 animals
treated):
Injection site swelling
Uncommon
(1 to 10 animals / 1,000 animals
treated):
Anaphylactic-type reactions (e.g. vomiting,
tremors and/or mild depression)
1
Transient; observed within 4 days after vaccination. On average 0.5 °C and up to 1.4
°C individually.
In general below 2 cm in diameter; resolves in 3 days.
Observed shortly after vaccination.
Resolves without treatment within few hours.
Pre-breeding PRRS virus-naïve gilts and sows
Very common
(>1 animal / 10 animals
treated):
Elevated temperature
Injection site swelling
1
Transient; observed 4 hours post vaccination. On average 0.2 °C and up to 1.0 °C
individually.
In general below
0.5 cm in diameter; resolves spontaneously within 5 days without
treatment.
PRRS virus-naïve gilts and sows in the first half of gestation
Very common
(>1 animal / 10 animals treated):
Elevated temperature
Injection site swelling
1
Transient; observed 4 hours post vaccination. On average 0.8 °C and up to 1.0 °C
individually.
In general, below 1.4 cm in diameter; resolves spontaneously within 9 days without
treatment.
Non-PRRS virus-naïve gilts and sows in the second half of gestation
Very common
(>1 animal / 10 animals treated):
Elevated temperature
Injection site swelling
1
Transient; observed 4 hours post vaccination. On average 0.4 °C and up to 0.6 °C
individually.
In general below 5 cm in diameter; resolves spontaneously within 32 days without
treatment.
Lactating sows
Very common
(>1 animal / 10 animals treated):
Elevated temperature
Decreased appetite
Injection site swelling
1
Up to 2.2 ºC. Observed 2 days post vaccination; resolves spontaneously within 4
days without treatment.
Observed 1 - 4 days post vaccination and resolves spontaneously within 3 days
without treatment.
Up to 11 cm in diameter; Resolves spontaneously within 3 days without treatment.
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 the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
Vaccinate healthy animals only.
Do not vaccinate pigs younger than 3 days by nasal route since the concurrent intake
of colostrum may interfere with the efficacy of the vaccine.
Special precautions for safe use in the target species:
Vaccination should aim to achieve a homogenous immunity in the target population
at farm level.
Care should be taken to avoid the introduction of the vaccine strain into an area
where PRRS virus is not already present.
After intramuscular vaccination animals may excrete the vaccine strain for more than
16 weeks. After nasal vaccination animals may excrete the vaccine strain for more
than 10 weeks. The vaccine strain can spread to in-contact pigs. The most common
spreading route is via direct contact, but spreading via contaminated objects or an
airborne spread cannot be excluded.
Special precautions should be taken to avoid spreading of the vaccine strain to
unvaccinated animals (e.g. PRRS virus-naïve pregnant gilts and sows in the second
half of gestation) that should remain free from PRRS virus.
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.
In order to limit the potential risk of recombination between PRRS 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. Do
not routinely rotate two or more commercial PRRS MLV vaccines based on different
strains in a herd.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Not applicable.
Special precautions for the protection of the environment:
Not applicable.
Do not vaccinate pigs younger than 3 days by nasal route since the concurrent intake
of colostrum may interfere with the efficacy of the vaccine.
Special precautions for safe use in the target species:
Vaccination should aim to achieve a homogenous immunity in the target population
at farm level.
Care should be taken to avoid the introduction of the vaccine strain into an area
where PRRS virus is not already present.
After intramuscular vaccination animals may excrete the vaccine strain for more than
16 weeks. After nasal vaccination animals may excrete the vaccine strain for more
than 10 weeks. The vaccine strain can spread to in-contact pigs. The most common
spreading route is via direct contact, but spreading via contaminated objects or an
airborne spread cannot be excluded.
Special precautions should be taken to avoid spreading of the vaccine strain to
unvaccinated animals (e.g. PRRS virus-naïve pregnant gilts and sows in the second
half of gestation) that should remain free from PRRS virus.
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.
In order to limit the potential risk of recombination between PRRS 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. Do
not routinely rotate two or more commercial PRRS MLV vaccines based on different
strains in a herd.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Not applicable.
Special precautions for the protection of the environment:
Not applicable.
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.
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).
The solvent may be stored outside a refrigerator at 15 °C – 25 °C.
Do not freeze.
Protect from light.
The solvent may be stored outside a refrigerator at 15 °C – 25 °C.
Do not freeze.
Protect from light.
Zero days.
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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Same active ingredient
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These products share the same active ingredient and may be suitable alternatives. Always consult your vet.
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