Country: United Kingdom
Language: English
Source: HMA (Heads of Medicines Agencies)
equine arteritis virus inactivated 1 ml
Pfizer GmbH
QI05AA07
Emulsion for injection
Equine arteritis virus vaccine
Horses
2012-02-23
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 Read the complete document
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 Read the complete document