Suvaxyn PRRS MLV - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Suvaxyn PRRS MLV lyophilisate and solvent for suspension for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose (2 ml) contains:

Lyophilisate:

Active substance:

Modified live PRRSV*, strain 96V198: 102.2 – 105.2CCID50**

• * Porcine respiratory and reproductive syndrome virus

• * * Cell culture infectious dose 50%

Solvent:

Sodium chloride 0.9% solution: qs 1 dose.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection.

Lyophilisate: off-white freeze-dried pellet.

Solvent: clear, colourless solution.

4. CLINICAL PARTICULARS4.1 Target species

Pigs (pigs for fattening, gilts and sows)

• 4.2 Indications for use, specifying the target species

For active immunisation of clinically healthy pigs from 1 day of age in a porcine respiratory and reproductive syndrome (PRRS) virus contaminated environment, to reduce viraemia and nasal shedding caused by infection with European strains of PRRS virus (genotype 1).

Onset of immunity: 21 days after vaccination.

Duration of immunity: 26 weeks after vaccination.

Fattening pigs:

In addition, vaccination of seronegative 1-day-old piglets was demonstrated to significantly reduce lung lesions against challenge administered at 26 weeks post vaccination. Vaccination of seronegative 2-week-old piglets was demonstrated to significantly reduce lung lesions and oral shedding against challenge administered at 28 days and at 16 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).

4.3 Contraindications

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.

• 4.4 Special warnings for each target species

Vaccinate healthy animals only.

• 4.5 Special precautions for use

Special precautions for use in animals

Care should be taken to avoid the introduction of the vaccine strain into an area where PRRS virus is not already present.

Vaccinated animals may excrete the vaccine strain for more than 16 weeks following vaccination. The vaccine strain can spread to in contact pigs. The most common spreading route is via direct contact, but spreading via contaminated objects or via the air 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 second half of gestation) that should remain free from PRRS virus.

It is advised to vaccinate all target pigs within a herd from the earliest recommended age onwards. Newly introduced PRRS virus-naïve females (e.g. replacement gilts from PRRS virus-negative herds) should be vaccinated prior to introduction into the herd of non-PRRS virus-naïve animals and prior to pregnancy.

In order to limit the potential risk of recombination between PRRS vaccine strains do not use different PRRS MLV vaccines on the same farm at the same time. Do not routinely rotate two or more commercial PRRS MLV vaccines in a herd with the intention to improve cross-protection.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

None.

• 4.6 Adverse reactions (frequency and seriousness)

A transient increase in rectal temperature (0.5 °C on average, and up to 1.4 °C individually) may very commonly occur within 4 days after vaccination. Local reactions in the form of swellings are common and resolve spontaneously within 3 days. The area of local tissue reaction is in general below 2 cm in diameter. Anaphylactic-type reactions (vomiting, tremors and/or mild depression) may uncommonly occur in piglets shortly after vaccination. These resolve without treatment within few hours.

A minor and transient increase in rectal temperature (0.2 °C on average, and up to 1.0 °C individually) may very commonly occur 4 hours post vaccination in pre-breeding PRRS virus-naïve gilts and sows. Local reactions in the form of swellings are very common and resolve spontaneously within 5 days. The area of local tissue reaction is in general below 0.5 cm in diameter.

A minor and transient increase in rectal temperature (0.8 °C on average, and up to 1.0 °C individually) may very commonly occur 4 hours post vaccination in PRRS virus-naïve gilts and sows in the first half of gestation. Local reactions in the form of swellings are very common and resolve spontaneously within 9 days. The area of local tissue reaction is in general below 1.4 cm in diameter.

A minor and transient increase in rectal temperature (0.4 °C on average, and up to 0.6 °C individually) may very commonly occur 4 hours post vaccination in non-PRRS virus-naïve gilts and sows in the second half of gestation. Local reactions in the form of swellings are very common and resolve spontaneously within 32 days. The area of local tissue reaction is in general below 5 cm in diameter.

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).

• 4.7 Use during pregnancy, lactation or lay

Pregnancy:

Can be used in PRRS virus-naïve gilts and sows pre-breeding or in the first half of gestation. Can be used in non-PRRS virus-naïve gilts and sows in the second half of gestation.

Lactation:

The safety of the vaccine has not been established during lactation.

• 4.8 Interactions with other medicinal products and other forms of interaction

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.

• 4.9 Amounts to be administered and administration route

Intramuscular use.

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. 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.

Dosage:

2 ml in the neck.

Vaccination schedule:

Pigs for fattening: A single dose of 2 ml is given to pigs from 1 day of age onwards.

Gilts and sows: A single dose of 2 ml is given prior to introduction into the sow herd, approximately 4 weeks prior to breeding. A single booster dose is given every 6 months.

Mass vaccination can be used in herds in which the prevalence of European PRRS virus has been established.

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Upon administration of a 10-fold overdose in piglets, anaphylactic-type reactions (tremor, apathy and/or vomiting) were very commonly observed shortly after vaccination; these signs resolved without treatment within a few hours. A transient increase in rectal temperature (0.3 °C on average, and up to 1.2 °C individually) very commonly occurred 24 hours post vaccination. Local reactions, in the form of soft/hard swelling (below or equal to 0.7 cm diameter) without heat or pain, were very commonly observed at the injection site and resolved within 5 days.

The administration of a 10-fold overdose to PRRS virus-naïve pre-breeding or pregnant gilts and sows in the first or second half of pregnancy induced similar adverse reactions as those described under section 4.6. The maximum size of the local reactions was bigger (2 cm) and the maximum duration was in general longer (up to 9 days in pre-breeding sows).

After the administration of a 10-fold overdose to non-PRRS virus-naïve gilts and sows in the second half of pregnancy a transient increase in rectal temperature (0.3 °C on average, and up to 0.6 °C individually) occurred 4 hours post vaccination. A local reaction involving transiently the whole neck region was very commonly observed (red-purple dark, erythematous swelling, causing itching, vesicle formation, increased local temperature, and, occasionally, pain). The reaction evolved to form hard tissue and formation of a scab, which very commonly lasted up to more than 44 days.

• 4.11 Withdrawal period

Zero days.

• 5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: immunologicals for Suidae, live viral vaccines.

ATCvet code: QI09AD03.

The vaccine contains a modified live PRRS virus (genotype 1, subtype 1). It stimulates active immunity against PRRS virus. Vaccine efficacy has been demonstrated in laboratory vaccination and challenge studies using a genotype 1 subtype 1 strain.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Lyophilisate:

Dextran 40

Casein hydrolysate

Lactose monohydrate

Sorbitol 70% (solution)

Sodium hydroxide

Water for injections

Dilution medium

Solvent:

Sodium chloride

Water for injections

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after reconstitution: use immediately.

6.4 Special precautions for storage

Store and transport refrigerated (2 °C – 8 °C).

The solvent may be stored outside a refrigerator at 15 °C – 25 °C.

For storage conditions of the reconstituted medicinal product, see section 6.3.

Do not freeze.

Protect from light.

• 6.5 Nature and composition of immediate packaging

Vaccine (lyophilisate):

Ph. Eur. Type 1 hydrolytic glass vials of 15 ml (25, 50 or 125 doses), with a bromobutyl elastomer closure and sealed with an aluminium cap.

Solvent:

High-density polyethylene (HDPE) vials of 50, 100 or 250 ml of solvent, with a chlorobutyl elastomer closure and sealed with an aluminium cap.

Cardboard box of 1 vial of 15 ml (25 doses) and 1 vial of 50 ml of solvent.

Cardboard box of 1 vial of 15 ml (50 doses) and 1 vial of 100 ml of solvent.

Cardboard box of 1 vial of 15 ml (125 doses) and 1 vial of 250 ml of solvent.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products, if appropriate

7. MARKETING AUTHORISATION HOLDER

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

8. MARKETING AUTHORISATION NUMBERS

EU/2/17/215/001–003

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorization: 24/08/2017.