SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

UNISTRAIN PRRSlyophilisate and solvent for suspension for injection for pigs.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose contains:

Freeze-dried powder:

Active substance:

Live attenuated Porcine reproductive and respiratory syndrome virus (PRRSV), strain VP-046 BIS ………………………………………………………………….… 10^3.5-10^5.5CCID₅₀

(cell culture infectious dose)

Solvent:

Phosphate buffer solution.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lyophilisate and solvent for suspension for injection.

Lyophilisate: white to yellowish powder.

Solvent: Homogeneous-clear solution.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs.

4.2 Indications for use, specifying the target species

Breeding females: For active immunisation of breeding females from farms affected with European PRRS virus to reduce reproductive disorders, incidence and duration of viraemia, transplacental virus transmission, virus tissue load and clinical signs associated with infection with strains of PRRS virus. Under laboratory conditions, vaccination of females reduced the negative impact of PRRS virus infection on piglet performance (mortality and weight gain) within the first 28 days of life. The onset of immunity is 30 days after vaccination and the duration of immunity is 16 weeks demonstrated by challenge.

Pigs from 4 weeks of age: For active immunisation of pigs from farms affected with European PRRS virus to reduce clinical signs associated with a PRRS virus infection, the incidence and duration of viraemia and the duration of virus shedding by infected animals. Under experimental conditions, it was demonstrated that vaccination reduces the virus tissue load in the lungs. Under field conditions, where a PRRSV infection occurred during the fattening period, a reduction in mortality and in the negative effects of infection on daily weight gain was demonstrated. The onset of immunity is 4 weeks after vaccination and the duration of immunity is 24 weeks.

4.3 Contraindications

Do not use in case of hypersensitivity to the active ingredient or to any of the excipients.

Do not use in naïve herds in which the presence of European PRRSV has not been established through reliable diagnostic virological methods.

No data are available on the safety of the vaccine for the reproductive performance in boars.

4.4 Special warnings for each target species

Precautions should be taken to avoid the transfer of the virus within the herd, e.g. from seropositive animals to seronegative animals.

Maternally derived antibodies can interfere with the efficacy of the vaccine. In the presence of high maternally derived antibodies, timing of initial vaccination of piglets should be planned accordingly.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate healthy animals only.

For an optimal control of PRRS virus, it is advised to mass vaccinate all target pigs within a herd from the earliest recommended age onwards. Newly introduced PRRSV-naïve females (e.g. replacement females from PRRSV-negative herds) should be vaccinated prior to pregnancy.

The vaccine virus may be shed after vaccination e.g. in the faeces and/or in nasal or oral secretions of vaccinated animals.

Following vaccination of breeding females the vaccine strain may be shed for up to nine days. Following vaccination of 4 week old pigs, shedding of the vaccine strain may last for up to 29 days. The vaccine strain can spread to non-vaccinated cohabitant animals, including the fetus during pregnancy and piglets after partum without any clinical consequence. Therefore, special precautions should be taken to avoid spreading to susceptible animals, if necessary.

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.

4.6 Adverse reactions (frequency and seriousness)

Very common:

Slight transient increases (not greater than 1.5°C) in body temperature can be observed following vaccination, which spontaneously resolve without treatment

Mild and transient depression or anorexia may be observed after vaccination. These signs disappear spontaneously without any additional treatment.

After intradermal administration, local reactions (inflammation and/or redness) may be observed following vaccination. These local reactions are mild and transient, typically resolving within 2 days.

Common:

After intramuscular administration injection site reactions (small nodules and/or inflammation) may be observed following vaccination. The lesions are mild and transient, typically resolving within one week.

Very rare:

Vaccination might exceptionally cause hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be administered.

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).

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Breeding females:

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with ERYSENG PARVO and administered at one injection site. The product literature of ERYSENG PARVO should be consulted before administration of the mixed products.

The mixed administration of UNISTRAIN PRRS and ERYSENG PARVO should only be used when vaccinating animals prior to mating.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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.

Pigs from 4 weeks of age:

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

The method of administration is by intramuscular or by intradermal route.

For both the intramuscular and intradermal routes, the vaccine should be given in the neck region. For the intradermal route, the ID device supplied by the manufacturing authorisation holder or other suitable needle-free device able to administer 0.2 ml doses (force of injection spring: 400-190N; stream nozzle diameter: 0.25mm) should be used.

Reconstitute the vaccine with the corresponding solvent:

If the solvent is refrigerated, it should be allowed to warm to a temperature between 15 ºC to 25 ºC before reconstitution of the freeze-dried powder. Peel the aluminium capsule off the bottle containing the solvent and aspirate in order to remove a certain volume of the contents. Then inject this volume of solvent into the vial containing the freeze-dried powder. Shake until the freeze-dried powder is completely dissolved. Once reconstituted, withdraw all the suspension obtained from the vaccine vial and inject it into the vial containing the remaining solvent. Shake well before use. The reconstituted vaccine is a homogeneous reddish solution. Avoid the introduction of contamination during reconstitution and use. Use only sterile needles and syringes for administration

The following doses and administration methods should be used:

Pigs from 4 weeks of age:

2 ml via intramuscular injection or 0.2 ml via intradermal administration.

Breeding females:

2 ml via intramuscular injection only. A single vaccination should be administrated once in each reproductive cycle for protection during the subsequent pregnancy. In gilts, administer one injection of the reconstituted vaccine per animal 4 weeks before mating. In sows, administer one injection of the reconstituted vaccine per animal, 2 weeks before mating or at 8-9 weeks of gestation (approximately 60 days after mating).

In each gestation, vaccinate the females according to the above-mentioned schedules. For simultaneous use with ERYSENG PARVO in breeding females from 6 months of age, the mixed administration of UNISTRAIN PRRS and ERYSENG PARVO should only be used when vaccinating animals prior to mating.

The following instructions should be used: the contents of a single vial of UNISTRAIN PRRS should be reconstituted with the contents of a single vial of ERYSENG PARVO in the same way as described for reconstitution with solvent. A single dose (2 ml) of the mixed vaccines should be injected within a period of 2 hours via intramuscular use.

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

Breeding females: Negative effects in the reproductive parameters could not be excluded following administration of a 10x overdose in naïve pregnant females. Particular care and attention to the correct reconstitution of the vaccine and management of the vaccination procedure should be taken in order to avoid accidental overdose. Special precautions should be taken to avoid overdose in naïve pregnant females.

Pigs from 4 weeks of age: No adverse reactions were observed in naïve piglets following administration of a 10x overdose other than those mentioned in section 4.6.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Live viral vaccines, Porcine Reproductive and Respiratory Syndrome (PRRS) virus vaccine.

ATCvet code: QI09AD03.

To stimulate active immunity against virulent EuropeanPRRS virus (type I) in pigs and breeding females.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Freeze-dried powder:

Disodium phosphate dodecahydrate

Potassium dihydrogen phosphate

Gelatine

Povidone

Monosodium glutamate

Sodium chloride

Potassium chloride

Sucrose

Water for injections

Solvent:

Disodium phosphate dodecahydrate

Potassium dihydrogen phosphate

Sodium chloride

Potassium chloride

Water for injections

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product, except with the solvent supplied with the product or with ERYSENG PARVO.

6.3 Shelf life

Shelf life of the freeze-dried powder as packaged for sale: 2 years.

Shelf life of the solvent as packaged for sale in glass containers: 5 years.

Shelf life of the solvent as packaged for sale in PET containers: 3 years.

Shelf life after reconstitution with solvent: within 4 hours.

Shelf life after mixing with ERYSENG PARVO: 2 hours.

6.4. Special precautions for storage

Freeze-dried powder: Store and transport refrigerated (2° C - 8° C). Do not freeze. Protect from light.

Solvent: Store and transport below +25°C. Do not freeze. Protect from light.

6.5 Nature and composition of immediate packaging

Freeze-dried powder: Colourless Type I glass vial closed with a bromobutyl rubber closure and an aluminium cap.

Solvent: Colourless Type I glass vial (10 and 20 ml), Type II glass vial (50, 100 and 250 ml) or PET vials (10, 20, 50, 100 and 250 ml) closed with a bromobutyl rubber closure and an aluminium cap.

Package sizes:

Intramuscular use:

Cardboard box containing 1 vial with 10 doses of freeze-dried powder and 1 vial with 20 ml of solvent.

Cardboard box containing 1 vial with 25 doses of freeze-dried powder and 1 vial with 50 ml of solvent.

Cardboard box containing 1 vial with 50 doses of freeze-dried powder and 1 vial with 100 ml of solvent.

Cardboard box containing 1 vial with 100 doses of freeze-dried powder and 1 vial with 200 ml of solvent.

Cardboard box containing 1 vial with 125 doses of freeze-dried powder and 1 vial with 250 ml of solvent.

Cardboard box containing 10 vials with 10, 25, 50, 100 or 125 doses of freeze-dried powder.

Cardboard box containing 10 vials with 20, 50, 100, 200 or 250 ml of solvent.

Intradermal use:

Cardboard box containing 1 vial with 50 doses of freeze-dried powder and 1 vial with 10 ml of solvent.

Cardboard box containing 1 vial with 100 doses of freeze-dried powder and 1 vial with 20 ml of solvent.

Cardboard box containing 1 vial with 125 doses of freeze-dried powder and 1 vial with 25 ml of solvent.

Cardboard box containing 10 vials with 50, 100 or 125 doses of freeze-dried powder.

Cardboard box containing 10 vials with 10, 20 or 25 ml of solvent.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Laboratorios Hipra, S.A.

Avda. La Selva, 135

17170 Amer (Girona)

Spain

8. MARKETING AUTHORISATION NUMBER

Vm17533/4016

9. DATE OF FIRST AUTHORISATION

06 March 2013

10. DATE OF REVISION OF TEXT

October 2015

PROHIBITION OF SALE, SUPPLY AND/OR USE

The import, sale, supply and/or use of UNISTRAIN PRRS is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.

Any person intending to import, sell, supply and/or use must consult the relevant Member State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or use.

Approved: 08 October 2015