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Date: Thursday, July 18, 2024 1:06

Description: Zoetis logo
Release 4.277
Zylexis for Horses
 
Species: Horses and other equidae
Therapeutic indication: Immunological veterinary medical product (non vaccine): For horses
Active ingredient: Vaccine Antigens
Product:Zylexis® for Horses
Product index: Zylexis for Horses
Withdrawal notes: Horses: Zero days
Incorporating:
Presentation
Zylexis for Horses is presented as a lyophilisate and solvent for suspension for intramuscular injection.
Each 2 ml dose contains inactivated Parapoxvirus ovis, strain D1701 ≥ 1 RP*.
* Relative Potency compared to a reference vaccine.
Uses
Zylexis for Horses acts by stimulation of non-specific immune mechanisms and is of potential clinical value in the reduction of clinical signs of equine respiratory disease associated with stress/crowding.
In a field study, reduction of clinical signs (defined as the first time-point at which significant differences were evident between groups) was shown on day 5 after administration of the full treatment schedule and lasted less than a week.
Dosage and administration
For horses from 10 months of age.
Aseptically reconstitute the lyophilisate with the solvent provided. Shake well before use. The entire contents of the reconstituted vial should be administered intramuscularly as a single dose irrespective of body weight of the animal.
Dosage regimen
Three injections of a single dose for each animal are recommended.
The first two injections are administered with a 48-hour interval (day 0 and day 2) and the 3rd injection is administered on day 9.
To ensure efficacy of the treatment, it is important that the first dose of the product is administered shortly before or up to the day of crowding or exposure to other stressful conditions. It is important that the complete treatment schedule of 3 doses is administered.
Advice on correct administration
Sterile needles and syringes should be used for administration.
Syringes and needles should not have been sterilised chemically or be above ambient temperature. Do not use chemicals to disinfect or sterilise skin.
Shake well before use.
Aseptic precautions should be observed.
Contra-indications, warnings, etc
The product should not be used for treatment of animals with chronic diseases with unclear causality.
No information is available to support the use of the authorised schedule in pregnant mares. There is no information concerning safety in stallions.
No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product. A decision to use this product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Do not mix with any other veterinary medicinal product.
Hyperthermia associated with general malaise and musculoskeletal signs (stiffness, abnormal posture, tense muscle) have been observed very rarely in spontaneous reports.
Hypersensitivity reactions (i.e. circulatory shock, tachycardia, abdominal pain, convulsion) may occur very rarely. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- 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).
In an overdose (4 ml) safety study carried out in 1 day-old horses, no systemic or local reactions were observed.
All suspected adverse reactions and any suspected lack of efficacy should be reported to the Zoetis UK Ltd technical helpline on 0845 300 8034.
Withdrawal period
Zero days.
User warnings
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Pharmaceutical precautions
Store in a refrigerator (2°C – 8°C).
Protect from light.
Do not freeze.
Use immediately after reconstitution.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Boxes containing 5 glass vials of lyophilisate together with 5 glass vials of the solvent.
Further information
The exact mechanism of action of inactivated Parapoxvirus ovis is not fully understood but may involve the stimulation and increase of the non-specific immune mechanisms.
In a mouse model, it has been demonstrated that Parapoxvirus ovis induces an autoregulatory cytokine response that involves the up regulation of T helper (Th) 1 type cytokines (IL-12, IL-18, IFNγ) and their subsequent down regulation which is accompanied by induction of IL-4. Furthermore, Parapoxvirus ovis induces phagocytic activity and oxidative burst in various animal species including horses as demonstrated by ex vivo experiments.
In horses, it has been shown that administration of the product stimulates the proliferation of lymphocytes and increases the production of IFNγ in vivo.
It was also shown that administration of the product to horses increases the production of other cytokines such as TNFα, IFN β, IL15 and IL18 in vivo.
This is a limited Marketing Authorisation. A full set of supporting efficacy data is not available for this product.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 42058/4174
Significant changes
GTIN
GTIN description:5 x 2 ml:
GTIN:05414736021669