NOAH Compendium

Printed from NOAH Compendium (https://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2025. All Rights Reserved.
Date: Friday, May 2, 2025 1:38

Release 2.22
Equip Artervac emulsion for injection for horses and ponies (GB)
 
Species: Horses and other equidae
Therapeutic indication: Immunological veterinary medical products: For horses
Active ingredient: Vaccine Antigens
Product:Equip Artervac emulsion for injection for horses and ponies
Product index: Equip Artervac
Withdrawal notes: Zero days.
Incorporating:
Qualitative and quantitative composition
Each 1 ml dose contains:
Active substance:
Equine arteritis virus, strain Bucyrus, inactivated
1.0 – 1.8 RP*
* Relative potency compared to a reference vaccine
Adjuvants:
Squalane
0.2% (v/v)
Pluronic L-121
0.1% (v/v)
Polysorbate 80
0.016% (v/v)
Excipients:
For the full list of excipients, see section "Pharmaceutical particulars".
Pharmaceutical form
Emulsion for injection.
Red/rust coloured emulsion.
Clinical particulars
Target species
Horses and ponies.
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
Duration of immunity: 6 months
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Vaccination does not prevent infection.
Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment
Not applicable.
Other precautions
Vaccination does not have an effect on the shedding of EAV by previously infected carrier stallions.
The effect of the veterinary medicinal product on the fertility of breeding stallions has not been investigated.
Adverse reactions (frequency and seriousness)
Horses and ponies:
Very common
(>1 animal / 10 animals treated):
Injection site swelling1
Elevated temperature2
Common
(1 to 10 animals / 100 animals treated):
Ocular discharge
Nasal discharge
Depression
Rare
(1 to 10 animals / 10,000 animals treated):
Allergic reaction3, Anaphylactic-type reaction3, Localised allergic oedema (oedema of the legs, abdominal oedema, scrotal oedema)3, Urticaria3
1Transient, usually lasting for 2 to 3 days. The swellings are usually less than 4 cm in diameter but in one horse a swelling of 20 cm lasting for 5 days was recorded. All swellings resolved.
2Minor transient (1 to 5 days) increase in body temperature (<40°C).
3If such reactions occur, adrenaline should be administered intramuscularly.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.
Use during pregnancy, lactation or lay
Pregnancy:
Do not use (during the whole or part of the pregnancy).
Interaction with other medicinal products and other forms of interaction
Animals that have received immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amount(s) to be administered and administration route
Shake well before use.
1 ml dose per horse to be administered by intramuscular injection.
Primary course:
A single dose should be administered two times with an interval of 3-6 weeks from an age of nine months onwards.
Booster vaccination:
Booster vaccinations are recommended every 6 months.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Administration of a twofold overdose has no influence on the systemic reactions to vaccination as described in section “Adverse Reactions (frequency and seriousness)”. Local swellings (< 4 cm in size) were observed in 80% of horses administered two doses of vaccine, these swellings were observed for one day only.
Withdrawal period(s)
Zero days.
Pharmacological particulars
Immunological properties
Pharmacotherapeutic group: Inactivated viral vaccines.
ATCvet code: QI05AA07
The vaccine induces an active immunity against equine arteritis virus, strain Bucyrus in horses and ponies.
Pharmaceutical particulars
List of excipients
Eagles Hepes (0.05 % LAH) Medium
Phosphate Buffered Saline
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Protect from light.
Do not freeze.
Nature and composition of immediate packaging
Sterile single-use Type I glass syringes containing one dose each and closed with bromobutyl rubber tips.
Syringes are supplied in a cardboard box of 1, 2 and 10 units.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Zoetis UK Limited
1st Floor, Birchwood Building
Springfield Drive
Leatherhead
Surrey
KT22 7LP
Marketing Authorisation Number
Vm 42058/5147
Significant changes
Date of the first authorisation or date of renewal
17 June 2005
Date of revision of the text
July 2024
Any other information
Prohibition of sale, supply and/or use
Any person intending to manufacture, import, possess, distribute, sell, supply and use this veterinary medicinal product must first consult the relevant competent authority on the current vaccination policies, as these activities may be prohibited in a country on the whole or part of its territory pursuant to national legislation.
Classification of veterinary medicinal product
Veterinary medicinal product subject to prescription.
Find more product information by searching for the ‘Product Information Database’ or ‘PID’ on www.gov.uk.
Legal category
Legal category: POM-V
GTIN
GTIN description:1 x 1 dose:
GTIN:05414736041476