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Date: Sunday, October 6, 2024 20:29

Release 3.159
Equilis® Prequenza Te suspension for injection for horses (GB)
 
Species: Horses only
Therapeutic indication: Immunological veterinary medical products: For horses
Active ingredient: Vaccine Antigens
Product:Equilis® Prequenza Te suspension for injection for horses (GB)
Product index: Equilis® Prequenza Te suspension for injection for horses (GB)
Withdrawal notes: Horses: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose (1 ml) contains:
Active substances:
Equine influenza virus strains:
A/equine-2/South Africa/4/03 50 AU1
A/equine-2/Newmarket/2/93 50 AU
Tetanus toxoid 40 Lf2
1 Antigenic units
2 Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph.Eur. potency test
Adjuvants:
Iscom-Matrix containing:
Purified Saponin 375 µg
Cholesterol 125 µg
Phosphatidylcholine 62.5 µg
For the full list of excipients, see section "Pharmaceutical particulars".
Pharmaceutical form
Suspension for injection.
Clear opalescent suspension.
Clinical particulars
Target species
Horses
Indications for use
Active immunisation of horses from 6 months of age against equine influenza to reduce clinical signs and virus excretion after infection, and active immunisation against tetanus to prevent mortality.
Influenza
Onset of immunity: 2 weeks after the primary vaccination course.
Duration of immunity: 5 months after the primary vaccination course.
1 year after the first revaccination. Tetanus
Onset of immunity: 2 weeks after the primary vaccination course.
Duration of immunity: 17 months after the primary vaccination course.
2 years after the first revaccination.
Contraindications
None.
Special warnings for each target species
Foals should not be vaccinated before the age of 6 months, especially when born to mares that were revaccinated in the last two months of gestation, because of possible interference by maternally derived antibodies.
Special precautions for use
Vaccinate healthy animals only.
Operator warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
Horses:
Rare
(1 to 10 animals / 10,000 animals treated):
Injection site swelling1, Injection site pain2.
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Fever3, Lethargy3, Inappetence3, Hypersensitivity reaction4.
1 A diffuse hard or soft swelling (max. diameter 5 cm), regressing within 2 days. A local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur in very rare cases.
2 Pain at the injection site may result in temporary functional discomfort (stiffness).
3 Fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
4 Including anaphylaxis (sometimes fatal). If such a reaction occurs, appropriate treatment should be administered without delay.
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
Can be used during pregnancy and lactation.
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from MSD Animal Health (see section "Amounts to be administered and administration route").
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
Intramuscular use.
Allow the vaccine to reach room temperature before use.
Vaccination schedule:
Primary vaccination course
Administer one dose (1 ml), by intramuscular injection, according to the following schedule:
∙ Primary vaccination course: first injection from 6 months of age, second injection 4 weeks later.
Revaccination
Influenza
It is recommended that a single booster dose should only be administered to horses that have already received a primary vaccination course using vaccines that contain the same types of equine influenza virus included in this vaccine. A primary vaccination course may be considered necessary in horses that have not been suitably primed. The first revaccination (third dose) against equine influenza is given 5 months after the primary vaccination course. This revaccination results in immunity to equine influenza lasting at least 12 months.
The second revaccination is given 12 months after the first revaccination.
The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/equine-2/South Africa/4/03 and A/equine-2/Newmarket-2/93, is recommended to maintain immunity levels for the influenza component (see scheme).
Tetanus
The first revaccination is given not later than 17 months after the primary vaccination course.
Thereafter a maximum interval of two years is recommended (see scheme).
V1
V2
5
V3
12
V4
12
V5
12
V6
0
Prequenza Te
1
Prequenza Te
6
Prequenza
18
Prequenza Te
30
Prequenza
42 months
Prequenza Te
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (Primary vaccination course at 6 months of age and 4 weeks later).

Concurrent active and passive immunisation (emergency vaccination)
The vaccine can be used together with Tetanus Serum from MSD Animal Health for treatment of injured horses that have not been immunised against tetanus. In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus Serum from MSD Animal Health at a separate injection site, using separate syringes and needles. This will lead to a passive protection against tetanus for at least 21 days after concurrent administration. The second dose of the vaccine (V2) should be administered 4 weeks later. A third vaccination with Equilis Prequenza Te should be repeated at least four weeks later. Concurrent use of Equilis Prequenza Te and Tetanus Serum from MSD Animal Health may reduce active immunity against tetanus compared to horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin serum.
Overdose
Following the administration of a double dose of vaccine, no side-effects other than those described in section “Adverse Reactions” have been observed except for some depression at the day of vaccination.
Withdrawal periods
Zero days.
Pharmacological particulars
ATCvet code: QI05AL01
Pharmacotherapeutic group
Immunologicals for Equidae, inactivated viral and inactivated bacterial vaccines.
To stimulate active immunity against Equine influenza and tetanus in horses.
Pharmaceutical particulars
Excipients
Phosphate buffer
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
Immediate packaging
Type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Type I glass pre-filled syringes of 1 ml (1 dose), containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Package sizes:
Cardboard box with 10 glass vials of 1 ml (1 dose).
Cardboard box with 1, 5 or 10 pre-filled syringes of 1 ml (1 dose) with needles.
Not all pack sizes may be marketed.
Disposal
Medicines should not be disposed of via wastewater.
Any unused veterinary medicinal 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)
UK(NI): Intervet International B.V., The Netherlands
Marketing Authorisation Number
UK(GB): Vm 01708/5031
Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation: 08 July 2005.
Date of last renewal: 27 July 2010.
Date of revision of the text
September 2023
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Equilis Prequenza TE 5x1ds:
GTIN:8713184054944
GTIN description:Equilis Prequenza-TE 10x1ds:
GTIN:8713184054906