GALLIMUNE 302 ND+IB+EDS

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

INACTIVATED NEWCASTLE DISEASE VIRUS, ULSER 2C STRAIN, AT LEAST, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, AT LEAST, INACTIVATED EGG DROP SYNDROME VIRUS (EDS76), V127 STRAI, AT LEAST

제공처:

Merial Animal Health Limited

ATC 코드:

QI01AA13

INN (International Name):

INACTIVATED NEWCASTLE DISEASE VIRUS, ULSER 2C STRAIN, AT LEAST, INACTIVATED INFECTIOUS BRONCHITIS VIRUS, MASS41 STRAIN, AT LEAST

복용량:

50

약제 형태:

Emulsion for Injection

처방전 유형:

POM

치료 그룹:

Fowl - Chicken

치료 영역:

Newcastle disease virus / paramyxovirus vaccine + Avian infectious bronchitis virus vaccine + Avian

치료 징후:

Immunological - Inactivated vaccine

승인 상태:

Authorised

승인 날짜:

2005-11-25

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIMUNE 302 ND+IB+EDS
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Water-in oil emulsion for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (breeder and layer pullets).
Each 0.3-ml dose of vaccine contains:
ACTIVE SUBSTANCES:
Inactivated Newcastle Disease virus, Ulster 2C strain, at least
50PD
50
1
Inactivated Infectious Bronchitis virus, Mass41 strain, at least
18 HI.U
Inactivated Egg Drop Syndrome virus (EDS76), V127 strain, at least
180 HI.U
The concentrations are expressed by the antibody titre obtained during the potency test. One unit
(U) corresponding to an antibody titre of 1.
HI: haemaglutination inhibiting
[1]: Minimum protective dose according to monograph 0870 of Ph. Eur.
ADJUVANT(S):
Paraffin oil
170 to 186 mg
EXCIPIENT(S):
Thiomersal, at most
30 µg
Formaldehyde, at most
43.2 µg
For a full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 21/11/2016_
_CRN 7023943_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Booster immunisation of breeder and layer pullets after vaccination with live vaccines against:
.
Newcastle Disease virus, in order to reduce egg drop linked to Newcastle Disease infection,
.
Infectious Bronchitis virus, in order to reduce egg drop linked to Infectious Bronchitis infection caused by the Mass41
strain.
Active immunisation of breeder and layer pullets in order to reduce egg drop linked to infection with Egg Drop Syndrome virus
EDS76 without priming.
Onset of immunity: 4 weeks after vaccination.
Duration of immunity: one laying period.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EA