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Date: Sunday, December 1, 2024 18:24

Release 3.236
ProteqFlu suspension for injection (GB)
 
Species: Horses only
Therapeutic indication: Immunological veterinary medical products: For horses
Active ingredient: Vaccine Antigens
Product:ProteqFlu Suspension for Injection
Product index: ProteqFlu
Withdrawal notes: Horses: Zero days
Incorporating:
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
For the full list of excipients, see "Pharmaceutical particulars" section.
Pharmaceutical form
Homogeneous opalescent suspension
Suspension for injection.
Clinical particulars
Target species
Horses
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 injection.
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.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only
Special precautions for use
Special warnings for use in animals:
Not applicable.
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.
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 appetite 3
Hypersensitivity reaction 4
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.
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.
Amount(s) 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: 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).
Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of overdoses of vaccine, no adverse events other than those described under "Adverse reactions (frequency and seriousness)" have been observed.
Withdrawal period
Zero days.
Pharmaceutical particulars
Excipients
Sodium chloride, Disodium hydrogen orthophosphate, Monopotassium phosphate anhydrous, Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product.
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.
Special precautions for storage
Store and transport refrigerated (2 °C - 8 °C).
Do not freeze.
Protect from light.
Nature and composition of immediate packaging
Type I glass vial.
Butyl elastomer closure and aluminium cap.
Box of 10 vials of 1 dose.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
Germany
Marketing Authorisation Number
Vm 04491/5047
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:ProteqFlu Suspension for injection for Horses 10x single dose vials
GTIN:3661103027492