TUR-3 emulsion for injection for turkeys

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Paramyxovirus 3, inactivated, Inactivated newcastle disease virus, Inactivated turkey rhinotracheitis virus

Dostupno od:

Merial Animal Health Limited

ATC koda:

QI01CA02

INN (International ime):

Paramyxovirus 3, inactivated, Inactivated newcastle disease virus, Inactivated turkey rhinotracheitis virus

Doziranje:

8-9.2 log10, 9-10.3 log10, 5-8 log10 EID50/CCID50

Farmaceutski oblik:

Emulsion for injection

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapijska grupa:

Turkeys

Područje terapije:

turkey paramyxovirus + turkey rhinotracheitis virus

Terapijske indikacije:

Immunological - Inactivated Vaccine

Status autorizacije:

Authorised

Datum autorizacije:

2006-12-21

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
TUR-3 emulsion for injection for turkeys.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Emulsion for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Turkeys intended for breeding.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of future breeder turkeys:
- as booster vaccination after priming with live vaccines against
Newcastle Disease and Turkey Rhinotracheitis to
reduce mortality and clinical signs of Newcastle Disease and to induce
a specific seroconversion against Newcastle
Disease and Turkey Rhinotracheitis in vaccinated birds throughout the
laying period
- as vaccination against paramyxovirus type 3 to reduce the decrease
in egg production, as demonstrated by challenge
at peak of lay, and to induce a specific seroconversion against
paramyxovirus type 3 throughout the laying period.
Onset of immunity: 4 weeks after the first dose of the vaccination
schedule. The second dose is required to achieve
protection for the specified duration of immunity.
Duration of immunity: one laying period (demonstrated by serology).
Each dose of vaccine contains:
ACTIVE SUBSTANCES:
Paramyxovirus 3, inactivated strain PMV3, at least
40 HI.U
Newcastle Disease virus, inactivated strain Ulster 2C, at least
50 PD50
Turkey rhinotracheitis virus, inactivated, strain VCO3, at least
9 ELISA.U
ADJUVANT:
Paraffin oil
170 to186 mg
Ester of fatty acids and polyols
6 to 15 mg
For a full list of excipients, see section 6.1.
1 HIU: q.s. to obtain a mean haemagglutination inhibiting antibody
titre of 1 in the vaccinated animal
PD50: Minimum protective dose in accordance with Ph.Eur. 870.
1 ELISA U.: q.s. to obtain a positive serum by ELISA in the vaccinated
bird
I
R
I
S
H
M
E
D
I
C
I
N
E
S
B
O
A
R
D
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_