Target species
Horses.
Indications for use for each target species
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: 2 weeks 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.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
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.
Adverse reactions (frequency and seriousness)
Horses:
Rare (1 to 10 animals / 10,000 animals treated): | Injection site swelling1, increased skin temperature, muscle stiffness, injection site pain Elevated temperature2 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site abscess Apathy, decreased appetite3 Hypersensitivity reaction4 |
1transient, usually regresses within 4 days; 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.
2max. 1.5 °C, for 1 day, exceptionally 2 days.
3the day after vaccination.
4which may require appropriate symptomatic treatment.
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 its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Boehringer Ingelheim’s inactivated vaccine against rabies.
The vaccines should be given at different sites.
Administration routes and dosage
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).
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Following the administration of overdoses of vaccine, no adverse events other than those described under section "Adverse reactions (frequency and seriousness)" have been observed.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Official control authority batch release is required for this product.
Withdrawal period
Zero days.