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.

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.

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.

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.

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.

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:

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.

Zero days.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

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.

Boxes containing 5 glass vials of lyophilisate together with 5 glass vials of the solvent.

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.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Vm 42058/4174