ProteqFlu
Introduction
Company name: Merial Animal Health Ltd
Address: PO Box 327
Sandringham House
Harlow Business Park
Harlow
Essex CM19 5TG
Telephone: Companion Animals 0870 6000123
Production Animals 0800 592699
Fax: 01279 775888
Email: ukenquiry@merial.com
Website: www.merial.com
Presentation
Suspension for injection for horses. One dose contains Influenza A/equi-2/Ohio/03 [H3N8] recombinant Canarypox virus (vCP2242) ≥ 5.3 log10 FAID50; Influenza A/equi-2/Newmarket/2/93 [H3N8] recombinant Canarypox virus (vCP1533) ≥ 5.3 log10 FAID50.
Adjuvant:Carbomer.
Uses
Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
Onset of immunity: 14 days after primary vaccination course.
Duration of immunity induced by the vaccination scheme: 5 months after primary vaccination course and 1 year after the third vaccination.
Dosage and administration
For intramuscular use.
For the administration of the vaccine, use sterile and antiseptic-free and/or disinfectant-free material. Shake the vaccine gently before use.
Administer one dose (1 ml), by intramuscular injection, preferably in the neck region, according to the following schedule:
Primary vaccination course: first injection from 5-6 months of age, second injection 4-6 weeks later.
Revaccination: 5 months after primary vaccination course followed by annual booster injections.
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
Contra-indications, warnings, etc
For animal treatment only.
There are no contraindications. A transient swelling (max. diameter 5 cm) which regresses within 4 days may appear at the injection site. Pain and local hyperthermia can occur in rare cases. A slight increase in temperature (max. 1.5 °C) may occur for 1 day, exceptionally 2 days. In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination. In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Only healthy animals should be vaccinated. Can be used during pregnancy and lactation. No interaction has been observed when the vaccine was administered simultaneously, but at a separate site, with MERIAL’s inactivated vaccine against rabies. Do not mix with any veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Withdrawal periods
Zero days.
Pharmaceutical precautions
Keep out of reach of children.
Use immediately after opening.
Store and transport at 2°C – 8°C (in a refrigerator), protected from light. Do not freeze.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Legal category
POM-V
Packaging Quantities
Box of 10 vials of 1 dose.
Further information
None.
Marketing authorisation number
EU/2/03/037/005.
Significant Changes
New influenza strain (Ohio/3). | 11/06/2008 |