TUR-3 EMULSION FOR INJECTION FOR TURKEYS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

PARAMYXOVIRUS TYPE 3 INACTIVATED, NEWCASTLE DISEASE VIRUS, ULSTER 2C STRAIN INACTIVATED, TURKEY RHINOTRACHEITIS VIRUS

Available from:

Merial Animal Health Limited

ATC code:

QI01CA02

INN (International Name):

PARAMYXOVIRUS TYPE 3 INACTIVATED, NEWCASTLE DISEASE VIRUS, ULSTER 2C STRAIN INACTIVATED, TURKEY RHINOTRACHEITIS VIRUS

Dosage:

Unknown

Pharmaceutical form:

Emulsion for Injection

Prescription type:

POM

Therapeutic group:

Fowl - Turkey

Therapeutic area:

Turkey paramyxovirus vaccine + Turkey rhinotracheitis virus vaccine

Therapeutic indications:

Immunological - Inactivated vaccine

Authorization status:

Authorised

Authorization date:

2006-12-21

Summary of Product characteristics

                                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
IRISH MEDICINES BOAR
                                
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