Porcilis ERY suspension for injection for pigs

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Erysipelothrix rhusiopathiae strain m2 (serotype 2)

Tersedia dari:

Intervet Ireland Limited

Kode ATC:

QI09AB

INN (Nama Internasional):

Erysipelothrix rhusiopathiae strain m2 (serotype 2)

Dosis:

.

Bentuk farmasi:

Suspension for injection

Jenis Resep:

LR: Licensed Retailer as defined in national legislation

Kelompok Terapi:

Pigs

Area terapi:

Inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia)

Indikasi Terapi:

Immunological - Inactivated Vaccine

Status otorisasi:

Authorised

Tanggal Otorisasi:

2001-04-10

Karakteristik produk

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis Ery suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
ACTIVE SUBSTANCE:
Inactivated lysed antigen concentrate of
_Erysipelothrix rhusiopathiae_
strain M2 (serotype 2): ≥
1ppd*
*ppd = pig protective dose, determined by reference to a standard
vaccine batch.
ADJUVANT:
dl-

-tocopherol acetate: 150mg
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 (sows, gilts, boars and growing pigs).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of healthy pigs to reduce clinical signs and
lesions caused by Erysipelas
disease. To maintain protection, animals should be re-vaccinated at no
more than six monthly
intervals.
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. If spilled on the skin, wash with soap
and water. If ingested, drink
water. If symptoms develop, seek medical advice.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Transient increases in body temperature (0.5°C) within 24 hours may
very commonly occur.
A
mild transient local swelling (less than 5cm in diameter, normally
within 3 days)
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 (more than 1 but less than 10 animals in 100