ReproCyc PRRS EU 100ml

1. NAME OF THE MEDICINE FOR VETERINARY USE
ReproCyc® PRRS EU lyophilized and solvent for suspension for injection for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
Active substance
Lyophilized:
Live attenuated virus causing porcine reproductive and respiratory syndrome (PRRS virus), strain 94881 (genotype 1):10 3.9 -10 7.0 TCID 50 *
*Infectious dose on cell cultures 50%
Adjuvant
Solvent:
Carbomer: 2 mg
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Freeze-dried: off-white to milky grey
Solvent: clear, colorless solution

4. CLINICAL FEATURES
4.1 Target species
Swine
4.2 Indications for use, specifying the target species, establishing immunity
For the active immunization of breeding females on farms where there are cases of infection with the virus that causes European porcine reproductive and respiratory syndrome (PRRS virus)
(genotype 1), to reduce the duration of viremia, the percentage of young/viremic sows, the viral load in the blood after exposure to PRRSV, as shown under experimental conditions.
Installation of immunity: 4 weeks
Duration of immunity: 17 weeks
Vaccination of breeding females according to the recommended vaccination schedule described in section 4.9 reduces the occurrence of adverse reproductive function disorders associated with PRRS virus.
In experimental conditions, the reduction of the transplacental transmission of the virus following the control infection was demonstrated. It was also demonstrated in piglets from vaccinated sows
the first 20 days of life, a reduction in the negative impact of PRRS virus infection (mortality, clinical signs and weight gain).
4.3 Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use for boars producing semen for pig herds not exposed to the PRRS virus, as the virus can be shed in the semen.
Do not use for herds of pigs not exposed to the PRRS virus, in which the presence of the PRRS virus has not been established by reliable diagnostic methods.
4.4 Special precautions for each target species
Vaccinate only healthy animals.
Precautions should be taken to avoid transfer of vaccine virus in the herd, for example from seropositive animals to animals not previously exposed to the virus.

4.5 Special precautions for use
Special precautions for use in animals
For up to 5 weeks after vaccination, the vaccine strain can be spread to unvaccinated animals cohabiting with vaccinated ones, but without any clinical consequences. Vaccinated animals can shed the vaccine strain through faecal excretion. The potential excretion of the vaccine strain in the urine of vaccinated animals has not been investigated.
The vaccine strain was detected in newborn piglets (blood, lung samples) when vaccination of young, previously unexposed sows took place in the third trimester of gestation, but without
no clinical consequence.
Precautions must be taken to avoid contamination from vaccinated to unvaccinated animals, which must remain unexposed to the PRRS virus.
Vaccination should aim to achieve homogenous immunity in the target population at farm level.
Breeding animals that have not been exposed to PRRS virus (e.g. young sows from non-PRRS virus-infected herds) and are introduced into a PRRS-infected herd
PRRS must be vaccinated before the first insemination. It is preferable that vaccination is carried out in a separate quarantine unit. A transition period must be observed between vaccination and moving
animals in the breeding unit. This transition period must be longer than the propagation phase of the PRRS MLV vaccine strain, which follows vaccination.
Do not routinely rotate in a herd two or more commercially available PRRS MLV vaccines based on different viral strains. A PRRS vaccine based on the same strain (strain 94881) and licensed
for the immunization of pigs from the age of at least 17 days until the end of the fattening period can be used in the same farm.
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 viral strains of the same genotype on the same farm and at the same time. When switching from one PRRS MLV vaccine to another PRRS MLV vaccine, a transition period must be observed between the last administration of the current vaccine and the first administration of the new vaccine. This transition period should be longer than the propagation period of the current vaccine, which follows vaccination.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
If adverse reactions occur following accidental self-injection, seek medical advice and show the product leaflet or label to the doctor.
4.6 Adverse reactions (frequency and severity)
Within up to 5 days post-vaccination, a transient rise in body temperature (up to 2°C outside physiological limits) frequently occurs. Temperatures return to normal without further treatment 1-4 days after the maximum temperature rise is recorded.
A decrease in appetite can often be observed after vaccination.

Very little swelling or redness of the skin at the injection site may commonly be seen. These reactions (up to 10.5 cm in size, but typically <2 cm) are transient and disappear shortly (within a maximum of 5 days, but usually less than 2 days) without treatment.
Less frequently on the day of vaccination, lateral decubitus and rapid breathing can be observed. These signs disappear spontaneously without any treatment.
The frequency of adverse reactions is defined using the following convention:
- Very common (more than 1 in 10 treated animals showing adverse reactions)
- Common (more than 1 but less than 10 animals in 100 animals treated)
- Uncommon (more than 1 but less than 10 animals in 1000 animals treated)
- Rare (more than 1 but less than 10 animals in 10000 animals treated)
- Very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
4.7 Use during pregnancy, lactation or during the laying period
It can be used during pregnancy and lactation.
Young sows not previously exposed to PRRS virus should not be vaccinated during gestation.
4.8 Interactions with other veterinary medicinal products and other forms of interaction
Safety and efficacy data are available to demonstrate that this vaccine can be mixed with ReproCyc ParvoFLEX and administered at a single injection site.
There is no information available on the safety and efficacy of the vaccine when used with another veterinary medicinal product. The decision to use this vaccine before or after any other veterinary medicinal product will be determined on a case-by-case basis.

4.9 Dose and route of administration
Single intramuscular injection of one dose (2 ml), regardless of body weight.
For reconstitution, transfer the entire contents 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 solvent.
Make sure the lyophilisate is completely reconstituted before use.
Visual appearance after reconstitution: clear, colorless suspension.
Avoid contamination during use.
Use sterile equipment.
Avoid repeated unsealing, for example by using automatic injectors.
Vaccination schedule:
Young sows: for protection against the PRRS virus during pregnancy, vaccination is recommended before integration into the sow herd 2-5 weeks before breeding, after which the vaccination program of the respective herd can be continued.

Sows: it is recommended to vaccinate pregnant or non-pregnant sows once every 3-4 months.
Mixing with ReproCyc ParvoFLEX:
The entire contents of one vial of ReproCyc ParvoFLEX must be used to reconstitute the lyophilisate from one vial of ReproCyc PRRS EU. Therefore, ReproCyc ParvoFLEX replaces the solvent for ReproCyc PRRS EU.

Make sure the lyophilisate is completely reconstituted before use.
Administer a single dose (2 ml) of the mixture intramuscularly.
The following forms of presentation (doses) can be mixed:
ReproCyc PRRS EU (lyophilized) ReproCyc ParvoFLEX
10 doses 10 doses (20 ml)
50 doses 50 doses (100 ml)
100 doses 100 doses (200 ml)

The ReproCyc ParvoFLEX package insert should also be consulted before administering the mixed product.
4.10 Overdose (symptoms, emergency procedures, antidotes)
No other adverse reactions other than those listed in section 4.6 were observed for a single dose following administration of a 10-fold overdose.
4.11 Waiting Period
Zero days.

5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: immunological treatments for Suidae, live viral vaccines for pigs.
The virus that causes porcine reproductive and respiratory syndrome
ATC veterinary code: QI09AD03
The vaccine is designed to stimulate the development of the immune response of pigs to the virus that causes porcine reproductive and respiratory syndrome.

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lyophilized:
Sucrose
Gelatine
Potassium hydroxide
Glutamic acid
Potassium dihydrogen phosphate
Dipotassium phosphate
Sodium chloride
Solvent:
Phosphate buffer solution:
Sodium chloride
Potassium chloride
Potassium dihydrogen phosphate
Disodium phosphate
Water for injections
Carbomer
6.2 Incompatibilities

Do not mix with any other veterinary medicinal product except the solvent provided for use with this veterinary medicinal product or ReproCyc ParvoFLEX.
6.3 Validity Period
Shelf life of the freeze-dried vaccine as packaged for sale: 2 years
Shelf life of the solvent as packaged for sale: 3 years
Shelf life after reconstitution according to directions: 8 hours
Shelf life after mixing with ReproCyc ParvoFLEX: 8 hours
6.4 Special conditions for storage
Store and transport under refrigerated conditions (2°C – 8C).
Do not freeze.
Protect from light.
6.5 Nature and composition of primary packaging
Lyophilized: Type I amber glass vials with bromobutyl rubber stopper and aluminum seal.
Solvent: High density polyethylene (HDPE) bottles with bromo- or chlorobutyl rubber stopper and aluminum seal.
6.6 Special measures for the disposal of unused veterinary medicinal products or waste products derived from the use of such products
Any unused veterinary medicinal product or waste from the use of such products should be disposed of in accordance with local requirements.