EQUIP ARTERVAC EMULSION FOR INJECTION FOR HORSES AND PONIES

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

EQUINE ARTERITIS VIRUS INACTIVATED, STRAIN BUCYRUS

Tersedia dari:

Zoetis Ireland Limited

Kode ATC:

QI05AA07

INN (Nama Internasional):

EQUINE ARTERITIS VIRUS INACTIVATED, STRAIN BUCYRUS

Bentuk farmasi:

Emulsion for Injection

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Kelompok Terapi:

Equine - Food

Area terapi:

equine arteritis virus

Indikasi Terapi:

Immunological - Inactivated vaccine

Status otorisasi:

Authorised

Tanggal Otorisasi:

2013-06-21

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Equip Artervac emulsion for injection for horses and ponies.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Emulsion for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses and ponies from the age of 9 months.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of horses and ponies against equine
arteritis in order to reduce clinical signs and shedding
of virus in nasal secretion after infection.
Onset of immunity:
3 weeks post primary vaccination
Duration of immunity: 6 months
4.3 CONTRAINDICATIONS
Do not use in sick animals.
Each dose of 1 ml contains :
ACTIVE SUBSTANCE
Inactivated Equine Arteritis Vaccine, Bucyrus strain
RP*=1.0-1.8
* Relative Potency compared to a reference vaccine
ADJUVANT
Squalane*
1.61 mg
*As component of MetaStim (that also contains Pluronic L-121 and
Polysorbate 80)
EXCIPIENT
Eagles Hepes (0.05 % LAH) Medium
qs to 1.0 ml
For a full list of excipients, see section 6.1.
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccination does not prevent infection.
Vaccination does not have an effect on the shedding of EAV by
previously infected carrier stallions.
The effect of the vaccine on the fertility of breeding stallions has
not been investigated.
Under some national legisl