REPROCYC PRRS EU 100ML 50DOSES

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
ReproCyc PRRS EU lyophilized and solvent for suspension for injection for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
Freeze-dried:
Sustancia assets
Live attenuated porcine reproductive and respiratory syndrome virus (PRRSV), strain 94881
(genotype 1)
At least: 103,9 DICC
50 – 107,0 CCID50*
*Infective dose 50 in cell culture
Solvent:
adjuvant
Carbomer: 2,0 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilized and solvent for injectable suspension.
Lyophilized: whitish to milky gray
Solvent: clear, colorless solution
4. CLINICAL DATA
4.1 Target species
Porcine (breeding females)
4.2 Indications for use, specifying the target species
For the active immunization of breeding females in farms affected by the virus
of European porcine reproductive and respiratory syndrome (PRRSV) (genotype 1) to reduce the
duration of viraemia, the proportion of gilts/viremic gilts and the viral load in
blood after exposure to PRRSV, as demonstrated under conditions
experimental.

Vaccination of breeding females according to the recommended schedule described in the
section 4.9, reduces negative reproductive disorders associated with PRRSV.

Under experimental challenge conditions, a reduction in the
transplacental transmission of the virus after challenge. In piglets born from sows
vaccinated, a reduction in the negative impact of infection by the virus was also demonstrated.
PRRS virus (mortality, clinical signs and weight gain) during the first 20 days of
life.
4.3 Contraindications
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in pigs producing semen for negative herds, as PRRSV can
be excreted in the semen.
Do not use in farms negative to PRRS where the presence of PRRSV has not been
established by reliable diagnostic methods.
4.4 Special warnings for each target species
Precautions must be taken to avoid transmission of the vaccine virus on the farm,
p. eg, from positive animals to negative animals.
4.5 Special precautions for use
Special precautions for use in animals
Vaccinate only clinically healthy animals.
The vaccine strain can be spread up to 5 weeks after vaccination, to animals not
vaccinated who are in contact with vaccinated animals, but without clinical consequences.
Vaccinated animals can excrete the vaccine strain through fecal excretion. I don't know
has studied the possible excretion of the vaccine strain through the urine of animals
vaccinated.
The vaccine strain has been detected in newborn piglets (blood samples,
pulmonary) when negative gilts have been vaccinated during the last third of the
pregnancy, but without clinical consequences.
Precautions should be taken to prevent the spread of the vaccine virus from animals
vaccinated to those not vaccinated that must be kept free of PRRSV.
It is recommended to vaccinate all breeding females on the farm. The females
PRRS virus negative and recently introduced on the farm (e.g. female
PRRS virus negative herds) must be vaccinated before pregnancy.
For an optimal PRRSV control program, all animals in a single
exploitation.
Special precautions to be taken by the person administering the medicinal product
vet to animals
In case of development of adverse reactions after accidental self-injection,
consult a doctor and show him the package leaflet or label.
4.6 Adverse reactions (frequency and seriousness)

A transient increase in body temperature frequently occurs (up to 2ºC per
above the physiological range) up to 5 days after vaccination. The temperatures
return to the normal range without additional treatment, between 1 and 4 days after the observation of the
maximum temperature rise.
Reduced appetite can frequently be observed after vaccination.
Infrequently, decubitus and accelerated breathing can be observed on the same day of the
vaccination. These signs disappear spontaneously without any treatment.
Very minimal swelling or reddening of the skin can often be seen on the
injection site. These reactions (up to 8 cm in size, but usually < 2 cm) are
transient and disappear without treatment in a short period of time (maximum of 5 days,
but usually less than 2 days).
The frequency of adverse reactions should be classified according to the following groups:
– Very common (more than 1 animal in 10 presents adverse reactions during a
treatment)
– Frequently (more than 1 but less than 10 animals per 100)
– Infrequently (more than 1 but less than 10 animals per 1.000)
– Rarely (more than 1 but less than 10 animals per 10.000)
– Very rarely (less than 1 animal per 10.000, including isolated cases).
4.7 Use during pregnancy, lactation or lay
It can be used during gestation and lactation.
PRRSV negative gilts should not be vaccinated during gestation.
4.8 Interaction with other medicinal products and other forms of interaction
There is no information available on the safety or efficacy of the use of this vaccine with
any other veterinary drug. The decision on the use of this vaccine before or
after the administration of any other veterinary drug should be performed
case by case.
4.9 Amounts to be administered and administration route
Dosage and method 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
contains 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.
Ensure complete reconstitution of the lyophilisate before use.
Avoid introduction of contamination during use.
Use sterile equipment.
Avoid multiple perforations using, for example, automatic syringes.
Vaccination schedule:
Gilts: For protection against PRRSV during gestation, it is recommended
vaccinate before integrating them into the sow farm between 2 and 5 weeks before
of the covering. Later, gilts can be subjected to the same
vaccination program than that of the farm.

Adult sows: It is recommended to vaccinate in "sheet" in a complete vaccination program
of the holding, in which all pregnant and non-pregnant sows of the
farm are vaccinated every 3 – 4 months.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects other than those listed in section 4.6 have been observed. for a single
dose after administration of an overdose 10 times higher.
4.11 Waiting time(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: porcine reproductive and respiratory syndrome virus
ATCvet code: QI09AD03
The vaccine has been designed to stimulate the development of an immune response in
pigs to porcine reproductive and respiratory syndrome virus.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Freeze-dried:
sucrose
Gelatin
Potassium hydroxide
Glutamic acid
Potassium dihydrogen phosphate
Potassium hydrogen phosphate
Sodium chloride
Solvent:
Phosphate buffered solution
Sodium chloride
Potassium chloride
Potassium dihydrogen phosphate
sodium hydrogen phosphate
Water for injections
carbomer
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for
its use with the veterinary medicinal product.
6.3 Validity period

6.4 Special precautions for storage
Store and transport refrigerated (between 2°C and 8°C).
Do not freeze.
Protect from light.
6.5 Nature and composition of immediate packaging
Freeze-dried:
Type I amber glass vials with a bromobutyl rubber stopper and aluminum seal.
Solvent:
High density polyethylene (HDPE) vials with a bromobutyl rubber stopper or
chlorobutyl and aluminum seal.
Cardboard box containing 1 vial of lyophilisate of 20 ml (10 doses), 100 ml (50 doses) or 200 ml
(100 doses) and 1 vial of solvent of 20 ml, 100 ml or 200 ml.
Cardboard box containing 12 or 25 lyophilized vials of 20 ml (10 doses), 100 ml (50 doses) or
200 ml (100 doses).
Cardboard box containing 12 or 25 vials of solvent of 20 ml, 100 ml or 200 ml.
Not all formats may be marketed.

Any unused veterinary medicinal product or residues derived from it must be disposed of
in accordance with local regulations.
7. MARKETING AUTHORIZATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhine
Germany,
8. MARKETING AUTHORIZATION NUMBER(S)
3200 ESP
9. DATE OF THE FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Date of first authorization: 06/03/2015
SALE, DISPENSATION AND/OR USE
Veterinary use. Medicine subject to a veterinary prescription.
Administration under control or supervision of the veterinarian.

See technical sheet