Artervac
Država: Irska
Jezik: engleski
Izvor: HMA (Heads of Medicines Agencies)
Uputa o lijeku
(PIL)
30-11-2012
Svojstava lijeka
(SPC)
30-11-2012
Aktivni sastojci:
equine arteritis virus inactivated 1 ml
Dostupno od:
Pfizer GmbH
ATC koda:
QI05AA07
Farmaceutski oblik:
Emulsion for injection
Terapijska grupa:
Equine arteritis virus vaccine
Područje terapije:
Horses
Datum autorizacije:
2012-02-23
Uputa o lijeku
Equip Artervac 23.02.2012
1/11
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
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.
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.
Equip Artervac 23.02.2012
2/11
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 legislation EVA is a notifiable disease (UK). Please refer to the national product
literature for recommendations on vaccination to comply with this legislation.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN
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Svojstava lijeka
Equip Artervac 23.02.2012
1/11
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
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.
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.
Equip Artervac 23.02.2012
2/11
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 legislation EVA is a notifiable disease (UK). Please refer to the national product
literature for recommendations on vaccination to comply with this legislation.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN
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