DUVAXYN IE-T PLUS

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

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, TETANUS TOXOID OF CL. TETANI STRAIN Y

Tersedia dari:

Elanco Animal Health, Eli Lilly and Company Limited

Kode ATC:

QI05AL01

INN (Nama Internasional):

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

Dosis:

Unknown

Bentuk farmasi:

Suspension for Injection

Jenis Resep:

POM

Kelompok Terapi:

Equine - Food

Area terapi:

Inactivated Equine influenza virus vaccine + inactivated Clostridium vaccine

Indikasi Terapi:

Immunological - Inactivated vaccine

Status otorisasi:

Authorised

Tanggal Otorisasi:

2011-01-07

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Duvaxyn IE-T Plus
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION
Combined equine influenza vaccine (inactivated) and tetanus vaccine for veterinary use.
QUANTITATIVE COMPOSITION
_* Haemagglutinin_
_** Mean potency relative to a reference vaccine of known potency _>_150 IU/dose_
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Ponies and horses from the age of five months.
Active Substances:
Per 1.5 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*
Tetanus toxoid:
18 Lf (RP 1.0)**
ADJUVANTS:
Carbopol 934P
4 mg
Aluminium hydroxide
2.2 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/05/2014_
_CRN 7018028_
_page number: 1_
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, and active immunisation against tetanus to prevent mortality.
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.
Influenza
Influe