Zylexis For Horses
Revised: May 2014
AN: 00008/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zylexis for Horses
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 2 ml:
Active substance: Inactivated Parapoxvirus ovis, strain D1701 that generates a minimum of 460 IFN Units *
*: interferon units as determined in an in vitro stimulation assay in cattle lymphocytes.
Excipients: Solvent: Water for Injection (WFI): q.s. 2 ml
For a full list of excipients, see section 6.1.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection
Whitish coloured lyophilisate.
Clear and colourless solvent.
CLINICAL PARTICULARS
Target species
Horses, from 10 months of age
Indications for use, specifying the target species
Zylexis for horses acts by stimulation of the non-specific immune mechanisms and is of potential clinical value in the reduction of clinical signs of stress/crowding associated equine respiratory disease.
In a field study, reduction of clinical signs (defined as the first time-point at which significant differences were evidenced between groups) was shown on day 5 after administration of the full treatment schedule and lasted less than a week. This is a Limited Marketing Authorisation. A full set of supporting efficacy data is not available for this product.
Contraindications
None
Special warnings for each target species
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.
Special precautions for use
Special precautions for use in animals
The product should not be used for treatment of animals with chronic diseases with unclear causality.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
No local or systemic reactions are expected after the administration of the recommended dose of Zylexis for horses.
Use during pregnancy, lactation or lay
No information is available to support the use of the authorised schedule in pregnant mares. There is no information concerning safety in stallions.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this 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.
Amounts to be administered and administration route
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 the 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-hours interval (day 0 and day 2) and the third injection should be administered on day 9.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In an overdose (4 ml) safety study carried out in horses, no systemic or local reactions were observed.
Withdrawal period
Zero days.
PHARMACOLOGICAL PROPERTIES
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 mice 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.
ATCVet code:QL03AX
PHARMACEUTICAL PARTICULARS
List of excipients
Casein hydrolysate
Dextran 40
Lactose
Sorbitol 70% (solution)
Sodium hydroxide
MEM with Earle’s Salts
Water for injection
Incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life: 24 months.
Use immediately after reconstitution.
Special precautions for storage
Store in a refrigerator (2°C – 8°C). Protect from light. Do not freeze.
Nature and composition of immediate packaging
One glass vial, type 1, containing the lyophilisate (1 dose for horses) and 1 glass vial, type 1, containing 2 ml of solvent.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Pack sizes
Boxes containing 1, 3, 5 or 6 glass vial(s) containing the lyophilisate together with 1, 3, 5 or 6 glass vial(s) of the solvent
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste material should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBER
Vm:42058/4174
DATE OF FIRST AUTHORISATION
Date: 23 April 2012
DATE OF REVISION OF THE TEXT
Date: May 2014
13 May 2014
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