ProteqFlu-Te 10 doses
ProteqFlu-Te 10 doses
*THIS PRODUCT IS TRANSPORTED IN THE COOLING SECTION OF THE TRANSPORT COMPANY'S AIRCRAFT*
Qualitative and quantitative composition
One dose contains:
Active substances: Influenza A/eq/Ohio/03 [H3N8] recombinant Canarypox virus (vCP2242) ≥ 5.3 log10 FAID50*
Influenza A/eq/Richmond/1/07 [H3N8] recombinant Canarypox virus (vCP3011) ≥5.3 log10 FAID50*
*Fluorescent assay infectious dose 50%
Clostridium tetani toxoid ≥ 30 IU**
**antitoxic antibody titre induced after repeated vaccination in guinea pig sera according to PH. Eur.
Adjuvant: Carbomer 4 mg
For the full list of excipients, see below.
Suspension for injection.
Indications for use
Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality.
Onset of immunity: 14 days after primary vaccination course.
Duration of immunity induced by the vaccination scheme:
- 5 months after the primary vaccination course.
- After the primary vaccination course and the booster injection 5 months later; 1 year with regard to equine influenza and 2 years with regard to tetanus.
Special warnings for each target species
Special precautions for use in animals
Only healthy animals should be vaccinated.
Special precautions to be taken by the person administering the product to animals
In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
A transient swelling which usually regresses within 4 days may appear at the injection site. In rare occasions, swelling can reach a diameter up to 15-20 cm, with duration up to 2-3 weeks, that may require symptomatic treatment.
Pain, local hyperthermia and muscle stiffness can occur in rare cases. In very rare occasions, abcessation may be observed.
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.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- Very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with Merial’s inactivated vaccine against rabies.
Amounts to be administered and administration route
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 with ProteqFlu-Te: First injection from 5-6 months of age, second injection 4-6 weeks later.
Revaccination: 5 months after primary vaccination course with ProteqFlu-Te.
Followed by: - against tetanus: injection of 1 dose at an interval of maximum 2 years with ProteqFlu-Te.
- against equine influenza: injection of 1 dose every year, alternatively with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum 2 years for the tetanus component.
In case of increased infection risk or insufficient colostrum intake, an additional initial injection of ProteqFlu-Te 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).
Following the administration of overdoses of vaccine, no side-effects other than those described under Adverse reactions have been observed.
Carbomer, Sodium chloride, Disodium hydrogen orthophosphate, Monopotassium phosphate anhydrous, Water for injections
Do not mix with any other product.
Shelf life of the product as packaged for sale: 18 months. Use immediately after opening.