ProteqFlu - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET

ProteqFlu suspension for injection for horses

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder :

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelhe­im/Rhein

GERMANY

Manufacturer responsible for the batch release :

Boehringer Ingelheim Animal Health France SCS

Laboratoire Porte des Alpes

Rue de l'Aviation

69800 Saint Priest

FRANCE

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

ProteqFlu suspension for injection for horses

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

One dose of 1 ml 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*

• * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.

Adjuvant:

Carbomer.

• 4. INDICATION(S)

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.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

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.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s) during the course of one treatment)

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Horses

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

1st scheme – vaccination against equine influenza:

Administer one dose (1 ml of ProteqFlu), 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 of ProteqFlu 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).

2nd scheme – vaccination against equine influenza and tetanus:

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:

o against tetanus: injection of 1 dose at an interval of maximum 2 years with ProteqFlu-Te.

o 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).

• 9. ADVICE ON CORRECT ADMINISTRATION

For the administration of the vaccine, use sterile and antiseptic-free and/or disinfectant-free material. Shake the vaccine gently before use.

Intramuscular use (preferably in the neck region).

• 10. WITHDRAWAL PERIOD(S)

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C – 8 °C). Do not freeze. Protect from light.

Use immediately after opening.

Do not use after the expiry date stated on the label.

• 12. SPECIAL WARNING(S)

Special precautions for use in animals :

Only healthy animals should be vaccinated.

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.

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction:

No interaction has been observed when the vaccine was administered simultaneously, but at a separate site, with Boehringer Ingelheim’s i­nactivated vaccine against rabies.

Overdose (symptoms, emergency procedures, antidotes) :

Following the administration of overdoses of vaccine, no side-effects other than those described under “Adverse reactions” have been observed.

Incompatibilities :

Do not mix with any veterinary medicinal product.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency

• 15. OTHER INFORMATION