Porcilis AR-T DF Suspension for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Bordetella bronchiseptica, Pasteurella multocida

Available from:

MSD Animal Health UK Limited

ATC code:

QI09AB04

INN (International Name):

Bordetella bronchiseptica, Pasteurella multocida

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Inactivated Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2000-11-16

Summary of Product characteristics

Issued: April 2022
AN: 02836/2021
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis AR-T DF suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
- Protein dO (non-toxic deletion derivative of
_Pasteurella multocida _dermonecrotic toxin)

6.2 log2 TN titre
1
- Inactivated _Bordetella bronchiseptica _cells

5.5 log2 Aggl. titre
2
1
Mean toxin neutralising titre obtained after repeated vaccination of a
half dose in rabbits.
2
Mean agglutination titre obtained after a single vaccination of a half
dose in rabbits
ADJUVANT:
dl-α-tocopherol acetate
150 mg
EXCIPIENT:
Formaldehyde
≤1 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (sows and gilts).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the reduction of clinical signs of progressive atrophic rhinitis
in piglets by passive oral
immunisation with colostrum from dams actively immunised with the
vaccine.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
None.
Issued: April 2022
AN: 02836/2021
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Vaccinate only healthy animals
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
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)
A mean transient increase in body temperature of 1.5 °C, in some pigs
up to 3 °C, which
could lead to an abortion, can generally be measured on the day of
vaccination or the
following day. Reduced activity and lack of appetite on the day of
vaccination very
commonly occurs and/or a transient swelling (max diameter: 10 cm) for
up to two weeks
may arise at the site of injection. In very rare cases other immediate
hypersensitivity
reactions, e.g. vomiting, dyspnoea