DUVAXYN IE PLUS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

INFLUENZA VIRUS ANTIGEN STRAIN A/EQUI 1/PRAGUE 56 INACTIVATED, INFLUENZA VIRUS ANTIGEN STRAIN A/EQUI 2/NEWMARKET 1/93 INACTIVATED, INFLUENZA VIRUS INACTIVATED STRAIN A/EQUI-2/SUFFOLK/89

Available from:

Elanco Animal Health, Eli Lilly and Company Limited

ATC code:

QI05AA01

INN (International Name):

INFLUENZA VIRUS ANTIGEN STRAIN A/EQUI 1/PRAGUE 56 INACTIVATED, INFLUENZA VIRUS ANTIGEN STRAIN A/EQUI 2/NEWMARKET 1/93 INACTIVATE

Dosage:

Unknown

Pharmaceutical form:

Suspension for Injection

Prescription type:

POM

Therapeutic group:

Equine - Food

Therapeutic area:

Equine influenza virus vaccine

Therapeutic indications:

Immunological - Inactivated vaccine

Authorization status:

Authorised

Authorization date:

2011-01-07

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Duvaxyn IE Plus.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Equine influenza vaccine (inactivated).
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
Active immunisation of horses and ponies from 5 months of age against equine influenza of H7N7 and H3N8 types
(European and American strains), including the South Africa/4/03 and A/equi-2/Richmond/1/07 strains, to reduce
clinical signs and virus excretion after infection.
Onset of immunity has been demonstrated by virulent challenge for equine influenza strains South Africa 4/03,
Richmond 1/07 and Sussex/89, and by serology for vaccine strains Prague/56, Newmarket 1/93 and Suffolk 89.
Duration of immunity has been demonstrated by virulent challenge for equine influenza strain Sussex/89 and by
serology for all other strains.
Onset of immunity:
2 weeks after administration of the 2nd dose
Duration of immunity:
6 months after administration of the 2nd dose
12 months after administration of the 3rd dose and subsequent annual booster injections
4.3 CONTRAINDICATIONS
Do not vaccinate unhealthy animals.
ACTIVE SUBSTANCES:
Per 1.0 ml dose
Inactivated equine influenza virus, strains:
- A/equi-1/Prague/56
15 - 18 µg HA*
- A/equi-2/Suffolk/89 (European type)
15 -18 µg HA*
- A/equi-2/Newmarket/1/93 (American type)
15 - 18 µg HA*
ADJUVANT:
Per 1.0 ml dose
Carbopol 934P
4 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1
*
Haemagglutinin
IRISH MEDICINES BOARD
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_Date Printed 29/05/2014_
_CRN 7018028_
_page number: 1_
4.4 SPECIAL WARNI