PORCILIS ERY

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

ERYSIPELOTHRIX RHUSIOPATHIAE STRAIN M2 (SEROTYPE 2)

제공처:

Intervet Ireland Limited

ATC 코드:

QI09AB

INN (국제 이름):

ERYSIPELOTHRIX RHUSIOPATHIAE STRAIN M2 (SEROTYPE 2)

복용량:

Unknown

약제 형태:

Suspension for Injection

처방전 유형:

LM-Licensed Merchant

치료 그룹:

Porcine

치료 영역:

Inactivated bacterial vaccines (including Mycoplasma, Toxoid and Chlamydia vaccines)

치료 징후:

Immunological - Inactivated vaccine

승인 상태:

Authorised

승인 날짜:

2001-04-10

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis ERY.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose (2 ml)
ACTIVE SUBSTANCE:
_Erysipelothrix rhusiopathiae _strain M2 (serotype 2)
> 1 ppd*
*ppd = pig protective dose, determined by reference to a standard vaccine batch
Adjuvant:
dl- -tocopherol acetate
150.0 mg
Excipients:
Formaldehyde
0.05%
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (sows, gilts, boars and growing pigs).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the 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
Do not vaccinate unhealthy animals.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
In the case of accidental self-injection, seek medical advice immediately and show the package insert 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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/07/2012_
_CRN 7012940_
_page number: 1_
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Vaccination reactions normally consist of a slight (0.5
°
C), transient (normal within 24 hours) rise in body temperature. A mild
local swelling (less than 5 cm in diameter, normal within 3 days) and some reluctance to move may be seen in a very small
proportion (<5