TUR-3 emulsion for injection for turkeys

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

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

Διαθέσιμο από:

Boehringer Ingelheim Vetmedica GmbH

Φαρμακολογική κατηγορία (ATC):

QI01CA02

INN (Διεθνής Όνομα):

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

Δοσολογία:

.

Φαρμακοτεχνική μορφή:

Emulsion for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Turkeys

Θεραπευτική περιοχή:

turkey paramyxovirus + turkey rhinotracheitis virus

Θεραπευτικές ενδείξεις:

Immunological - Inactivated Vaccine

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2006-12-21

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
29 May 2020
CRN009PHD
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
TUR-3 emulsion for injection for turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
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
Health Products Regulatory Authority
29 May 2020
CRN009PHD
Page 2 of 4
- 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).
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPEC