GALLIMUNE SE + ST, WATER-IN-OIL EMULSION FOR INJECTION

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

INACTIVATED SALMONELLA ENTERITIDIS PT4, AT LEAST, INACTIVATED SALMONELLA TYPHIMURIUM DT 104, AT LEAST

제공처:

Merial Animal Health Limited

ATC 코드:

QI01AB01

INN (International Name):

INACTIVATED SALMONELLA ENTERITIDIS PT4, AT LEAST, INACTIVATED SALMONELLA TYPHIMURIUM DT 104, AT LEAST

복용량:

Unknown

약제 형태:

Emulsion for Injection

처방전 유형:

POM

치료 그룹:

Fowl - Chicken

치료 영역:

Salmonella vaccine

치료 징후:

Immunological - Inactivated vaccine

승인 상태:

Authorised

승인 날짜:

2007-06-22

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Gallimune Se + St, water-in-oil emulsion for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.3-ml dose of vaccine contains:
ACTIVE SUBSTANCES:
Inactivated _Salmonella _Enteritidis PT4, at least..........................................................171 SAT.U
Inactivated _Salmonella _Typhimurium DT 104, at least................................................ 149 SAT.U
ADJUVANT:
Paraffin oil...................................................................................................................... q.s. 0.3 ml
EXCIPIENT:
Thiomersal, at most................................................................................................................ 30 µg 

The concentrations are expressed by the antibody titre obtained during the potency test. One unit (U) corresponding to an antibody titre of 1.
SAT: Slow Agglutination Test .
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Water-in-oil emulsion for injection.
White emulsion.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (layer pullets).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of layer pullets to:
-
reduce _Salmonella _Enteritidis dissemination in the ovary, as demonstrated 4 days after challenge;
This has been tested 25 weeks after vaccination and has been demonstrated to persist until 58 weeks of age.
-
reduce _Salmonella _Typhimurium and _Salmonella _Enteritidis dissemination in the intestinal tract.
This has been tested 4 weeks after vaccination and has been demonstrated to persist until 61 weeks of age for
_Salmonella _Typhimurium and 52 weeks of age for _Salmonella _Enteritidis.
4.3 CONTRAINDICATIONS
Please refer to section 4.7 “Use during pregnancy, lactation or lay”. 
4.4 SPECIAL WARNINGS FOR E