ReproCyc^® PRRS EU

• Products

 For active immunisation of breeding females from farms affected with PRRSV type I.

From the breeding herd

Reduction of Viraemia:

Viraemia is reduced in herds vaccinated with ReproCyc PRRS EU. Proportion of viraemic gilts at the time of farrowing (16–29 days post challenge.

Reduction of piglet mortality:

Piglet mortality during the suckling period is reduced among piglets born to sows vaccinated with ReproCyc^® PRRS EU.

Piglet growth:

Average weight at weaning is greater among piglets born to sows vaccinated with ReproCyc^® PRRS EU

ImpranFLEX^®:

ImpranFLEX^® promotes rapid onset of immunity due to immediate presentation of free antigen, and long-lasting immunity from the aqueous polymer.
ImpranFLEX^® maximises immunity with ReproCyc^® PRRS EU.

Safety:

Injection site reactions are minimised in herds vaccinated with ReproCyc^® PRRS EU.

Designed to optimise production stability by protecting against the reproductive impact of the disease. REDUCES: the negative reproductive disorders associated with PRRSV the proportion of viraemic gilts / sows after exposure to PRRSV viral load and the duration of viraemia in sows / gilts exposed to the virus transplacental virus transmission from infected females to piglets the negative impact of infection on piglets born to vaccinated sows in terms of mortality, clinical signs, and weight gain   ImpranFLEX® delivers an optimal balance of efficacy and safety

Active immunisation of breeding females from farms affected with PRRSV type I

* One 2 ml dose administered via a single intramuscular injection

* Can be used in sows in mass vaccination programmes in all stages of the reproductive cycle (including gestation and lactation)

* Onset of immunity at 5 weeks with a duration of 17 weeks

* Adjuvanted vaccine with ImpranFLEX^®

ReproCyc^® PRRS EU summary of product information

Composition
Each dose (2 ml) contains:

• Lyophilisate: Active substance Live attenuated Porcine Respiratory and Reproductive Syndrome Virus (PRRSV), strain 94881 (genotype 1): 10^3.9-10^7.0 TCID₅₀(Tissue Culture Infectious Dose 50%)

• Solvent: Adjuvant ImpranFLEX^®: Carbomer, 2.0 mg

Target species
Pigs (breeding females)

Indications for use
For active immunisation of breeding females from farms affected with European (genotype 1) Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) to reduce the duration of viraemia, the proportion of viraemic gilts/sows and viral loads in blood after exposure to PRRSV as shown under experimental conditions.

Onset of immunity: 5 weeks
Duration of immunity: 17 weeks

Vaccination of breeding females according to the recommended schedule reduces the negative reproductive disorders associated with PRRSV.
Under experimental challenge conditions a reduction in transplacental virus transmission after challenge was additionally demonstrated. In piglets from vaccinated sows, a reduction in the negative impact of PRRS virus infection (mortality, clinical signs and weight gain) was also demonstrated during the first 20 days of life.

Contraindications
Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in boars producing semen for naïve herds, as PRRSV can be shed in semen. Do not use in PRRS naïve herds in which the presence of PRRSV has not been established using reliable diagnostic methods.

Special warnings for each target species
Precautions should be taken to avoid the transfer of the vaccine virus within the herd, e.g. from positive animals to naïve animals.

Special precautions for use in animals
Vaccinate only clinically healthy animals.
The vaccine strain may spread up to 5 weeks after vaccination to unvaccinated animals in contact but without any clinical consequence. Vaccinated animals may excrete the vaccine strain by faecal excretion. The potential excretion of the vaccine strain in the urine of vaccinated animals has not been investigated.
The vaccine strain has been detected in new-born piglets (blood, lung samples) when vaccinating naïve gilts during last third of gestation but without any clinical consequence.
Care should be taken to avoid spread of vaccine virus from vaccinated animals to unvaccinated animals that should remain free from PRRSV.
It is advised to vaccinate all breeding females within a herd. Newly introduced PRRSV-naïve females (e.g. replacement females from PRRSV-negative herds) should be vaccinated prior to pregnancy.
For optimal PRRSV control programme, all animals in a herd should be vaccinated.

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
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).

A transient increase in body temperature (up to 2°C above the physiological range) commonly occurs up to 5 days post-vaccination. Temperatures return to the normal range without additional treatment, 1 to 4 days after the maximum temperature increase is observed.
Commonly, reduced appetite may be observed after vaccination. Uncommonly, recumbency and accelerated breathing can be observed on the day of vaccination. These signs disappear spontaneously without any treatment.
Commonly, very minimal swelling or redness of the skin at the injection site may be observed. These reactions (up to 8cm but typically < 2 cm in size) are transient and subside within a short time (maximum of 5 days but typically less than 2 days) without treatment.

Use during pregnancy, lactation and lay
Can be used during pregnancy and lactation. PRRSV naïve gilts should not be vaccinated during pregnancy.

Interaction 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.

Amounts to be administered and administration route
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Dosage and method of administration:
Single intramuscular injection of one dose (2 ml), irrespective of body weight.
For reconstitution, transfer the entire content of the solvent vial to the vial containing the lyophilisate and reconstitute the lyophilisate as follows: 10 doses in 20 ml, 50 doses in 100 ml and 100 doses in 200 ml of the solvent.
Ensure that the lyophilisate is completely reconstituted before use.
Avoid introduction of contamination during use.
Use sterile equipment.
Avoid multiple broaching, for example by using automatic injectors.

Regime of vaccination:

• Gilts: for protection against PRRSV during pregnancy vaccination is recommended before integration into the sow herd between 2 and 5 weeks prior to breeding. Gilts can then be subjected to the same vaccination programme as the sow herd.

• Sows: mass vaccination is recommended in a whole herd programme, in which all the pregnant and non-pregnant sows in the herd are vaccinated every three to four months.

Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse events other than those listed for a single dose were observed following a 10-fold overdose administration.

Withdrawal period
Zero days.