DUVAXYN T

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TETANUS TOXOID OF CL. TETANI STRAIN Y

Available from:

Elanco Animal Health, Eli Lilly and Company Limited

ATC code:

QI05AB03

INN (International Name):

TETANUS TOXOID OF CL. TETANI STRAIN Y

Dosage:

Unknown

Pharmaceutical form:

Suspension for Injection

Prescription type:

POM

Therapeutic group:

Equine - Food

Therapeutic area:

Clostridium vaccine

Therapeutic indications:

Immunological

Authorization status:

Authorised

Authorization date:

2011-01-07

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Duvaxyn T
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
*Mean potency determined by enzyme linked immunosorbent assay (ELISA) compared to a reference antiserum. Ph.
Eur. 0697.
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Ponies and horses from the age of five months.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of horses and ponies to prevent tetanus infection.
Protective antitoxin antibody titres have been shown to be present within two weeks of completion of the second dose
of the primary vaccination course.
Following administration of the second dose of the primary vaccination course, protective antitoxin antibody titres last
at least 1 year. After each subsequent booster vaccination, antitoxin antibody titres last at least 2 years.
4.3 CONTRAINDICATIONS
Do not vaccinate unhealthy animals.
QUALITATIVE COMPOSITION
Tetanus vaccine for veterinary use.
QUANTITATIVE COMPOSITION
Active Substances;
Per 1.0 ml dose
Tetanus toxoid (purified);
> 30 IU*
ADJUVANT:
Aluminium phosphate
3.5 mg
EXCIPIENTS:
For a full list of excipients, see Section 6.1
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/06/2014_
_CRN 7018074_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Maternally derived antibody (MDA) can interfere with the development of active immunity. Please refer to section 4.9
for advice on vaccination in the presence of MDA.
Animals that have received tetanus antiserum at a therapeutic dosage should not be vaccinated until an interval of at
least 4 weeks has elapsed.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS