ProteqFlu
Active substance
ATC code
Species
Horses
Indications
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: 2 weeks 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.
Dose 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.
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: 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).
Adverse reactions
Horses:
|
Rare (1 to 10 animals / 10,000 animals treated): |
Injection site swelling1, increased skin temperature, muscle stiffness, injection site pain |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Injection site abscess |
1 transient, 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.
2 max. 1.5 °C, for 1 day, exceptionally 2 days.
3 the 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.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
ProteqFlu suspension for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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 mg
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Homogeneous opalescent suspension Suspension for injection.
4. CLINICAL PARTICULARS
4.1 Target species
Horses
4.2 Indications for use, specifying the 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. Onset of immunity: 2 weeks 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.
4.3 Contraindications
None
4.4 Special warnings for each target species
Vaccinate healthy animals only.
4.5 Special precautions for use
Special precautions for use in animals: 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.
4.6 Adverse reactions (frequency and seriousness) Horses:
|
Rare (1 to 10 animals / 10,000 animals treated): |
Injection site swelling[1], increased skin temperature, muscle stiffness, injection site pain
Elevated temperature[2] |
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Injection site abscess Apathy, decreased appetite [3] Hypersensitivity reaction [4] |
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
4.8 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.
4.9 Amount(s) to be administered and administration routes
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.
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).
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of overdoses of vaccine, no adverse events other than those described under section 4.6 have been observed.
4.11 Withdrawal period(s) Zero days.
5. IMMUNOLOGICAL PROPERTIES
ATCvet code: QI05AD02.
The vaccine stimulates active immunity against equine influenza.
The vaccine strains vCP2242 and vCP3011 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/eq/Ohio/03 (American strain, Florida sublineage clade 1) and A/eq/Richmond/1/07 (American strain, Florida sublineage clade 2), respectively. After inoculation, the viruses do not multiply in the horse but express the protective proteins. As a consequence, these components induce immunity against equine influenza virus (H3N8).
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Disodium hydrogen orthophosphate
Monopotassium phosphate anhydrous
Water for injections
6.2 Major Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: use immediately.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C - 8 °C).
Do not freeze.
Protect from light.
6.5 Nature and composition of immediate packaging
Type I glass vial.
Butyl elastomer closure and aluminium cap.
Box of 10 vials of 1 dose.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
8. MARKETING AUTHORISATION NUMBER
Vm 04491/5047
9. DATE OF FIRST AUTHORISATION
06 March 2003
10. DATE OF REVISION OF THE TEXT
April 2023
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTSVeterinary medicinal product subject to prescription.
Approved: 26 April 2023
[1] transient, 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.
[2] max. 1.5 °C, for 1 day, exceptionally 2 days.
[3] the day after vaccination.
[4] which 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.
| Art. Nr. | 04491/5047 |
|---|---|
| EAN | 3661103027492 |
