Porcilis Ery Suspension for Injection for Pigs

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Erysipelothrix rhusiopathiae

Tersedia dari:

MSD Animal Health UK Limited

Kode ATC:

QI09AB03

INN (Nama Internasional):

Erysipelothrix rhusiopathiae

Bentuk farmasi:

Suspension for injection

Jenis Resep:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Kelompok Terapi:

Pigs

Area terapi:

Inactivated Bacterial Vaccine

Status otorisasi:

Authorized

Tanggal Otorisasi:

1997-07-07

Karakteristik produk

Revised: December 2022
AN: 00678/2022
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Ery suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCE:
Inactivated
lysed
antigen
concentrate
of
Erysipelothrix
rhusiopathiae
strain
M2
(serotype 2): ≥ 1 pig protective dose (ppd)*
*as measured in the Ph. Eur. Potency test.
ADJUVANT:
dl-

-tocopherol acetate: 150 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Aqueous white or nearly white liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs to prevent clinical signs of
Erysipelas disease caused
by all relevant Erysipelothrix rhusiopathiae serotypes (serotype 1 and
2).
Onset of immunity: 3 weeks
Duration of immunity: 6 months
4.3
CONTRAINDICATIONS
None.
Revised: December 2022
AN: 00678/2022
Page 2 of 4
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Sick and weak animals should not be vaccinated.
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)
In laboratory studies and field trials:
Transient increases in body temperature (0.5°C) within 24 hours may
very commonly
occur. Mild transient local swelling (Ø 1-10mm) until 8 days after
vaccination may
very commonly occur. Transient reluctance to move may commonly occur.
In post marketing experience:
In very rare cases, a hypersensitivity reaction may occur.
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 (m