Porcilis Ery Suspension for Injection for Pigs

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Erysipelothrix rhusiopathiae

זמין מ:

MSD Animal Health UK Limited

קוד ATC:

QI09AB03

INN (שם בינלאומי):

Erysipelothrix rhusiopathiae

טופס פרצבטיות:

Suspension for injection

סוג מרשם:

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

קבוצה תרפויטית:

Pigs

איזור תרפויטי:

Inactivated Bacterial Vaccine

מצב אישור:

Authorized

תאריך אישור:

1997-07-07

מאפייני מוצר

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