SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis Ery+Parvo+Lepto suspension for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 2 ml dose contains:

Active substances: Inactivated strains of:
Erysipelothrix rhusiopathiae, serotype 2 (strain M2)	≥ 1 ppd1
Porcine parvovirus (strain 014) Leptospira interrogans serogroup Canicola serovar	≥ 130 U2
Portland-vere (strain Ca-12-000) Leptospira interrogans serogroup Icterohaemorrhagiae	≥ 2816 U2
serovar Copenhageni (strain Ic-02-001) Leptospira interrogans serogroup Australis serovar	≥ 210 U2
Bratislava (strain As-05-073) Leptospira kirschneri serogroup Grippotyphosa serovar	≥ 1310 U2
Dadas (strain Gr-01-005) Leptospira interrogans serogroup Pomona serovar Pomona	≥ 648 U2
(strain Po-01-000) Leptospira santarosai serogroup Tarassovi serovar Gatuni	≥ 166 U2
(strain S1148/02) Adjuvant:	≥ 276 U2
dl-α-tocopheryl acetate	150 mg

¹Pig protective dose as compared to a reference preparation known to be protective in pigs.

²As determined in the in vitro antigenic mass ELISA potency test.

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Homogenous white to nearly white suspension after shaking.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs for reproduction.

4.2 Indications for use, specifying the target species

For the active immunisation of pigs:

- to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2.

- to reduce transplacental infection, viral load and fetal mortality caused by Porcine parvovirus.

- to reduce clinical signs (increase of body temperature and reduction in feed intake or activity), infection and bacterial excretion caused by L. interrogans serogroup Canicola serovar Canicola.

- to reduce clinical signs (increase of body temperature and reduction in feed intake or activity), severity of infection and foetal mortality caused by L. interrogans serogroup Pomona serovar Pomona.

- to reduce infection caused by L. interrogans serogroup Icterohaemorrhagiae serovars Copenhageni and Icterohaemorrhagiae, L. interrogans serogroup Australis serovar Bratislava, L. kirschneri serogroup Grippotyphosa serovars Grippotyphosa and Bananal/Liangguang, L. weilii serogroup Tarassovi serovar Vughia and L. borgpetersenii serogroup Tarassovi serovar Tarassovi.

Onset of immunity:

E. rhusiopathiae: 3 weeks

Porcine parvovirus: 10 weeks Leptospira serogroups: 2 weeks

Duration of immunity:

E. rhusiopathiae: 6 months Porcine parvovirus: 1 year

Leptospira serogroup Australis: 6 months

Leptospira serogroups Canicola, Icterohaemorrhagiae,

Grippotyphosa, Pomona and Tarassovi: 1 year

4.3 Contraindications

None.

4.4 Special warnings for each target species

Vaccinate healthy animals only.

4.5 Special precautions for use

Special precautions for use in animals: Not applicable.

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

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment: Not applicable.

4.6 Adverse reactions (frequency and seriousness) Pig for reproduction:

Very common (>1 animal / 10 animals treated):	Elevated temperature1 Injection site swelling2
Uncommon (1 to 10 animals / 1,000 animals treated):	Decreased activity3, reduced food intake3
Rare (1 to 10 animals / 10,000 animals treated):	Vomiting4, reddening of the skin4, tachypnoea4, twitching4
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Hypersensitivity reaction

¹The observed mean increase was 0.5 °C (in individual cases the maximum increase was 1.5 °C) up until two days after vaccination.

²Local reactions, mostly consisting of red, mild to hard, non-painful swellings. In general, local reactions may have a diameter of ≤ 5 cm, in very rare cases local reactions in individual animals can be up to 20 cm in diameter. All local reactions disappear completely within approximately 2 weeks after vaccination.

³Feed intake and activity are completely restored within a week. ⁴Intermediate systemic reactions, resolve in a few minutes.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See section “Contact details” of the package leaflet.

4.7 Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy and lactation.

4.8 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.

4.9 Amount(s) to be administered and administration route

Before use allow the vaccine to reach room temperature.

Shake well before use.

Avoid introduction of contamination by multiple broaching.

For intramuscular use.

Administer a single dose of 2 ml in the neck region.

Basic vaccination scheme: Pigs which have not yet been vaccinated shall be given a primary injection 6 to 8 weeks before the expected date of insemination and a booster injection 4 weeks later.

Revaccination: A single revaccination with the veterinary medicinal product should be given once a year. Six months post each vaccination with the veterinary medicinal product, a single revaccination with an Erysipelothrix rhusiopathiae containing product should be given to maintain immunity against Erysipelothrix rhusiopathiae. In case of known infection pressure with L. interrogans serogroup Australis, a single revaccination with the veterinary medicinal product should be given every six months, as it is unknown if or for how long the duration of immunity for this serogroup persists beyond six months.

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

No adverse events other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.

4.11 Withdrawal period(s) Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for Suidae. Inactivated viral and inactivated bacterial vaccine for pigs. ATCvet code: QI09AL07.

The veterinary medicinal product stimulates the development of active immunity in pigs against E. rhusiopathiae, Porcine parvovirus, L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovars Copenhageni and Icterohaemorrhagiae, L. interrogans serogroup Australis serovar

Bratislava, L. kirschneri serogroup Grippotyphosa serovars Grippotyphosa and Bananal/Liangguang, L. interrogans serogroup Pomona serovar Pomona, L. weilii serogroup Tarassovi serovar Vughia and L. borgpetersenii serogroup Tarassovi serovar Tarassovi.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Polysorbate 80

Simethicone

Sodium chloride

Potassium chloride

Potassium dihydrogen phosphate

Disodium phosphate dihydrate 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 first opening the immediate packaging: 10 hours.

6.4 Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

Protect from light.

6.5 Nature and composition of immediate packaging

PET vials of 20 ml (10 doses), 50 ml (25 doses), 100 ml (50 doses) or 250 ml (125 doses) are closed with a halogenobutyl rubber stopper (type I, Ph. Eur.) and sealed with an aluminium cap.

Pack size:

Cardboard box with 1 vial of 20 ml.

Cardboard box with 10 vials of 20 ml. Cardboard box with 1 vial of 50 ml.

Cardboard box with 10 vials of 50 ml.

Cardboard box with 1 vial of 100 ml.

Cardboard box with 1 vial of 250 ml.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products 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

MSD Animal Health UK Limited

Walton Manor, Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm 01708/5084

9. DATE OF FIRST AUTHORISATION

22 December 2016

10. DATE OF REVISION OF THE TEXT

October 2023

11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Approved 05 October 2023