Porcilis Ery+Parvo+Lepto suspension for injection for pigs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
E.rhusiopathiae strain m2; Porcine parvo virus; Leptospira canicola; Leptospira icterohaemorrhagiae; Leptospira australis; Leptospira grippotyphosa; Leptospira pomona; Leptospira tarassovi
Available from:
Intervet International BV
ATC code:
QI09AL07
INN (International Name):
E.rhusiopathiae strain m2; Porcine parvo virus; Leptospira canicola; Leptospira icterohaemorrhagiae; Leptospira australis; Leptospira grippotyphosa; Leptospira pomona; Leptospira tarassovi
Dosage:
.
Pharmaceutical form:
Suspension for injection
Prescription type:
LM: Licensed Merchant as defined in relevant national legislation
Therapeutic group:
Pigs
Therapeutic area:
porcine parvovirus + erysipelothrix + leptospira
Therapeutic indications:
Immunological - Inactivated Vaccine
Authorization status:
Authorised
Authorization number:
VPA10847/006/001
Authorization date:
2016-12-16

Read the complete document

Health Products Regulatory Authority

25 June 2019

CRN0094HY

Page 1 of 4

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 dose of 2 ml contains:

Active substances:

Inactivated strains of:

Erysipelothrix rhusiopathiae, serotype 2 (strain M2)

​≥ 1 ppd

Porcine parvovirus (strain 014)

​≥ 130 U

Leptospira interrogans serogroup Canicola serovar Portland-Vere

(strain Ca-12-000)

​≥ 2816 U

Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni

(strain Ic-02-001)

​≥ 210 U

Leptospira interrogans serogroup Australis serovar Bratislava (strain As-05-073)

​≥ 1310 U

Leptospira kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)

​≥ 648 U

Leptospira interrogans serogroup Pomona serovar Pomona (strain Po-01-000)

​≥ 166 U

Leptospira santarosai serogroup Tarassovi serovar Gatuni (strain S1148/02)

​≥ 276 U

Adjuvant:

dl-α-tocopheryl acetate

​150 mg

Excipient:

Formaldehyde (preservative)

0.4 - 1 mg

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

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

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Suspension for injection.

Homogenous white to nearly white suspension after shaking.

4 CLINICAL PARTICULARS

4.1 Target Species

Pig for reproduction.

4.2 Indications for use, specifying the target species

For the active immunization 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 foetal 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.

Health Products Regulatory Authority

25 June 2019

CRN0094HY

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Onset of immunity:

E. rhusiopathiae: 3 weeks

Porcine parvovirus: 10 weeks

Leptospira serogroups: 2 weeks

Duration of immunity:

E. rhusiopathiae: 6 months

Porcine parvovirus: 12 months

Leptospira serogroup Australis: 6 months

Leptospira serogroups Canicola, Icterohaemorrhagiae,

Grippotyphosa, Pomona and Tarassovi: 12 months

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.

4.6 Adverse reactions (frequency and seriousness)

An increase in body temperature may very commonly occur up until two days after vaccination. The observed mean increase

was 0.5 °C (in individual cases the maximum increase was 1.5 °C). Transient local reactions, mostly consisting of red, mild to

hard, non-painful swellings are a very common observation. 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. In individual animals intermediate systemic reactions, such as vomiting, redness, rapid

breathing and twitching, may rarely be observed, which resolve in a few minutes. In individual animals transient reductions in

feed intake or activity may uncommonly occur. Feed intake and activity are completely restored within a week.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

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 interactions

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.

Health Products Regulatory Authority

25 June 2019

CRN0094HY

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4.9 Amounts to be administered and administration route

Before use allow the vaccine to reach room temperature.

Shake well before use.

Avoid introduction of contamination.

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 Erysipelotrix rhusiopathiae containing product

should be given to maintain immunity against Erysipelotrix 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 reactions 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 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group:Immunologicals for Suidae. Inactivated viral and inactivated bacterial vaccine for pigs. ATC vet

code: QI09AL07.

The 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 Vughiaand L. borgpetersenii serogroup Tarassovi serovar Tarassovi.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Formaldehyde

dl-α-tocopheryl acetate

Polysorbate 80

Simethicone

Sodium chloride

Potassium Chloride

Potassium dihydrogen phosphate

Disodium phosphate dihydrate

Water for injection

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product.

Health Products Regulatory Authority

25 June 2019

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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

Intervet International BV

Wim de Körverstraat 35

NL - 5831 AN BOXMEER

Netherlands

8 MARKETING AUTHORISATION NUMBER(S)

VPA10847/006/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16

December 2016

10 DATE OF REVISION OF THE TEXT

June 2018

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