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Date: Sunday, May 19, 2024 2:29

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Release 3.67
Equip EHV1,4
 
Species: Horses and other equidae
Therapeutic indication: Immunological veterinary medical products: For horses
Active ingredient: Vaccine Antigens
Product:Equip® EHV1,4
Product index: Equip EHV1,4
Withdrawal notes: Horses: Zero days
Incorporating:
Presentation
Inactivated EHV1, strain 438/77: RP ≥ 1*, inactivated EHV4, strain 405/76: RP ≥ 1* and 6 mg Carbopol 934P as adjuvant.
* Relative Potency ELISA compared to a reference vaccine which has been shown to be efficacious in horses.
Uses
For active immunisation of horses to reduce clinical signs due to infection with Equine Herpesvirus 1 and 4 and to reduce abortion caused by EHV-1 infection.
Dosage and administration
One dose per horse to be administered by deep intramuscular injection.
Primary course
A single dose should be administered from 5 months of age followed by a second injection after an interval of 4-6 weeks.
In the event of increased infection risk, for example when a foal has consumed insufficient colostrum or there is a risk of early exposure to field infections with EHV-1 or EHV-4, earlier vaccination may be given. In these circumstances the foal should receive a single dose from 3 months of age followed by the above mentioned full primary vaccination course.
Booster
Following completion of the primary course, a single dose should be administered every 6 months.
Use in pregnant mares
To reduce abortion due to EHV-1 infection, pregnant mares should be vaccinated during the 5th, 7th and 9th month of pregnancy with a single 1.5 ml dose on each occasion.
Contra-indications, warnings, etc
Do not vaccinate unhealthy horses.
Can be used during pregnancy.
No information is available on the compatibility of this vaccine with any other. Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
Do not mix with any other medicinal product.
The vaccine may not be effective in animals incubating the disease at the time of vaccination.
In the event of an allergic or anaphylactic reaction, immediate treatment should be given with a soluble glucocorticoid intravenously (e.g. dexamethasone sodium phosphate), adrenaline intramuscularly or anti-histamine intramuscularly.
Animals that have received immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.
Syringes and needles should not have been sterilised chemically or be above ambient temperature. Do not use chemicals to disinfect or sterilise the skin.
Shake well before use.
Aseptic precautions should be observed.
Adverse Reactions
A transient local swelling at the injection site was very commonly observed. Usually, the local swelling does not measure more than 5 cm in diameter and disappears within a few to 6 days post vaccination. A transient increase in rectal temperature during up to 2 days following dosing not exceeding 1.7°C was commonly observed. These clinical signs usually resolve with no need for treatment.
Rarely, stiff gait, anorexia and lethargy have been reported. Hypersensitivity reactions may occur in very rare cases. In case of such reactions, appropriate treatment is recommended.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports
Withdrawal period
Zero days
Pharmaceutical precautions
The vaccine has to be stored and transported in its original unopened undamaged packing in the dark at +2°C - +8°C. Exposure to heat and/or direct sunlight has to be avoided. Do not freeze.
For animal treatment only.
Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
Packaging quantities
2, 10 and 50 dose packs.
Not all pack sizes may be marketed.
Further information
Equine Herpesvirus (EHV) is associated with respiratory disease, abortions, perinatal mortality and, occasionally, neurological disorders.
EHV disease has a complex epidemiology. Clinically and subclinically infected horses and latent carriers may excrete virus.
Epizootics of herpesvirus disease are most commonly associated with management activities that bring together in close proximity large number of horses under conditions that produce stress; i.e. weaning, transport and intermingling of horses originating from diverse locations.
Abortion due to EHV infection usually occurs in the last 4 months of gestation but the time interval between infection and abortion may be several weeks.
Effective control of EHV induced respiratory disease and abortions involves application of carefully executed management practices, including vaccination to minimise the spread of disease and the level of virus challenge.
It is recommended to vaccinate all horses on the premises, according to the recommendations of the datasheet. If horses are not vaccinated in accordance with the datasheet recommendations for Equip EHV1,4 the immune responses may be impaired.
The primary vaccination programme against respiratory disease has been developed to coincide with the expected decline of maternally derived antibody (MDA). In some foals MDA can decline earlier than 5 months of age, for example when regular booster vaccination of the dam has not taken place, or when there has been no recent field infection. Under these circumstances, the timing of the vaccination programme should be planned accordingly.
This vaccine does not prevent respiratory disease, abortion or perinatal mortality caused by other agents.
In any animal population there will be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine and the animal's ability to respond. Immune competence can be influenced by genetic factors, intercurrent infection, age, nutritional status, concurrent drug therapy, stress, etc.
Disposal
Dispose of waste material by incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Marketing Authorisation Number
Vm 42058/4060
Significant changes
GTIN
GTIN description:10 x 1 dose:
GTIN:08714015025256