ProteqFlu-Te suspension for injection for horses 10 dose

ProteqFlu-Te suspension for injection for horses 10 dose

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; Clostridium tetani toxoid = 30 IU. 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, 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.

Dosage and administration

For intramuscular use.

For 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).

Contra-indications, warnings, etc

For animal treatment only.

There are no contraindications. 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, abscessation 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.

Only healthy animals should be vaccinated. 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. Do not mix with any other 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 the reach and sight 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.