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Enzovax

Item Number: ENZV

Enzovax

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  • 10 dose

    Estimated dispatch on Friday

    £ 37.09

    Web code: Q11407

  • 20 dose

    Estimated dispatch on Friday

    £ 74.25

    Web code: Q10090

  • 50 dose

    £ 173.35

    Web code: Q10088

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Description


Data Sheets

Enzovax® Species:Sheep

Therapeutic indication:Immunological veterinary medical products: For sheep

Active ingredient:Vaccine Antigens

Product:Enzovax®

Product index:Enzovax®

Sheep - meat:7 days

Qualitative and quantitative composition

Active substance: Live, attenuated strain ts 1B Chlamydophila abortus 105.0 -106.9 IFU per dose*.

For a full list of excipients, see section “Pharmaceutical Particulars”.

* Inclusion-body Forming Units.

Pharmaceutical form

Lyophilisate and solvent for suspension for injection.

Lyophilisate: Off-white to cream-coloured pellet.

Solvent: Colourless solution.

Clinical particulars

Target species

Susceptible female breeding sheep.

Indications for use

For the active immunisation of susceptible female breeding sheep to reduce abortion caused by Chlamydophila abortus infection. Challenge studies have demonstrated that protection against Enzootic abortion and excretion of Chlamydophila abortus post-challenge is undiminished for at least three years post vaccination with Enzovax. Field studies in endemically infected flocks maintaining a policy of vaccinating incoming ewes with Enzovax indicate that enzootic abortion levels remain very low in ewes vaccinated 4 years previously.

Contraindications

Do not vaccinate pregnant animals. Do not vaccinate animals less than 4 weeks before mating. Do not vaccinate animals which are being treated with antibiotics, particularly tetracyclines.

Special warnings for each target species

Chlamydophila abortus is only one of the causes of abortion in sheep. If the abortion rate remains unchanged in flocks which have been vaccinated with Enzovax it is recommended that veterinary advice is sought. The epidemiology of abortion due to Chlamydophila abortus in ewes involves a long incubation period. Ewes that abort in any lambing season have usually been infected at the previous lambing. Field trial data indicate that vaccinating incubating ewes will reduce the incidence of abortion, but a proportion can still go on to abort. Care should be taken in handling such abortions as susceptible humans may be at risk of infection. A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.

Special precautions for use

None.

Operator warnings

Enzovax should not be handled by pregnant women or women of child bearing age as the vaccine may cause abortion. Enzovax should not be handled by persons who are immuno-deficient (e.g. AIDS sufferers, persons undergoing chemotherapy or taking immuno-suppressive drugs). If in any doubt, you should consult your GP.

To the user:

Operators should wear gloves when handling the vaccine. Care should be taken to avoid self-injection, but if this occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydophila vaccine has occurred.

To the physician:

Tetracycline therapy is the current recognised treatment for infection with Chlamydophila abortus in humans.

Adverse reactions

A transient temperature rise may be observed after vaccination (average of up to 1.5°C for a maximum of 3 days). In very rare cases abortions may occur where the vaccine strain can be identified.

Use during pregnancy or lactation

Do not use during pregnancy.

Interactions

Safety/and or efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Toxovax. However, it should be given at separate sites. 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

Dose: 2 ml by intramuscular or subcutaneous injection.

Reconstitution: The vaccine is reconstituted with Unisolve immediately prior to use, allowing 2 ml of solvent per dose. If using the vented transfer device push one end of the device through the centre of the vaccine vial using a firm, twisting action. Similarly, push the Unisolve vial onto the opposite end of the device taking care to ensure the spike penetrates the centre of the vial bung. Carefully allow solvent to flow into the vaccine vial without completely filling it. Ensure the vaccine plug is fully dissolved and then invert until all the vaccine suspension drains into the solvent vial. Remove the empty vaccine vial and the transfer spike from the solvent vial and place them into an appropriate disinfectant solution. Alternatively, remove approximately 5 ml of Unisolve from the vial with a syringe and needle, inject into the vaccine vial and swirl gently until the vaccine plug is fully dissolved. Remove the vaccine suspension from the vial, re-inject into the solvent vial and mix gently. Great care should be taken not to generate an aerosol. After reconstitution the vaccine should be kept cool and used as soon as possible (within 2 hours).

Administration: Ewe lambs, where it is intended to breed from them, may be vaccinated from 5 months of age. Shearlings and older ewes should be vaccinated during the 4 month period prior to mating. Vaccination must take place at least 4 weeks before mating.

Injection equipment: To minimise the risk of self-injection the vaccine should be administered using a disposable automatic syringe fitted with a guarded needle system according to the manufacturer's instructions. It is vital that a vented draw off tube is used with this equipment. Regular checks should be made to ensure the syringes are properly calibrated. Carefully attach the vial of reconstituted vaccine to the injection equipment and avoid creating aerosols during the priming process. It may be advisable to wear a visor while carrying out this operation.

Re-vaccination policy: Challenge studies have demonstrated that protection against Enzootic abortion and excretion of Chlamydophila abortus post-challenge is undiminished for at least three years post vaccination with Enzovax. Re-vaccination is recommended every 3-4 years depending on farm management practices and conditions.

Field studies in endemically infected flocks maintaining a policy of vaccinating incoming ewes with Enzovax indicate that enzootic abortion levels remain very low in ewes vaccinated 4 years previously.

Overdose

No particular symptoms at ten times dose other than a transient pyrexic response similar to that seen after a single dose but up to 2 °C.

Withdrawal periods

Meat and offal: 7 days.

Pharmacological particulars

ATC Vet code: QI04AE01

Pharmacotherapeutic group

To stimulate active immunity against Chlamydophila abortus.

Pharmaceutical particulars

Excipients

Vaccine only:

Monosodium glutamate

Sucrose

Bovine serum albumin

Water for injection.

Unisolve

Sucrose,

Potassium dihydrogen phosphate

Disodium phosphate dihydrate

Sodium chloride

Water for Injection

Major incompatibilities

Do not mix with any other veterinary medicinal product except the solvent, Unisolve.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 1 year.

Solvent in glass vials: 5 years and in PET vials: 18 months.

Shelf life after dilution or reconstitution according to directions: 2 hours.

Special precautions for storage

Vaccine:

Store and transport refrigerated (2°C - 8°C).

Do not freeze. Protect from light.

Solvent:

Store below 25 °C (if stored separately). Do not freeze.

Immediate packaging

Carton with 1 vial of vaccine and 1 vial of Unisolve and one transfer spike.

Vaccine:

Type I Ph.Eur. glass vial, closed with a rubber stopper and sealed with a colour coded aluminium cap, containing a freeze dried plug of vaccine (10, 20, 50 or 100 doses) with the appropriate volume of solvent.

Solvent:

Type II glass vials (Ph. Eur) containing 20, 40, 100 or 200 ml closed with a halogenated butylrubber stopper and an aluminium crimp cap.

Polyethylene terephthalate (PET) vials containing 40 or 100 ml closed with a halogenated butylrubber stopper and an aluminium crimp cap.

Not all pack sizes may be marketed.

Disposal

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

Marketing Authorisation Number

UK: Vm 01708/4523

Significant changes

Date of the first authorisation or date of renewal

10 July 2008.

Date of revision of the text

November 2020.

Any other information

For animal treatment only. Keep out of the sight and reach of children.

Legal category

Legal category:POM-V

ENZV 20DOSE: Data Sheet

Delivery

Shipping charges mainland UK zone1

ValueWeightDelivery Charge
Over £49.00Any WeightFREE
Under £49.00No weight limit£4.50
Under £49.00Under 250g£2.99

Most orders are despatched the same day and standard delivery is 3 to 5 working days from despatch. FAST Expedited options are available.

NB: Orders placed with faster delivery must be placed before 13:00 to ensure same day dispatch (excluding weekends and bank holidays). Please also check on the product page that the items ordered show 'In Stock' otherwise your order will be delayed until the stock becomes available, which in most cases will only be 24hrs.

Estimated "Usually shipped in" information is shown against most products

Overseas orders

Postage outside of the UK is from £4.50

Prescription Items

Prescription items will be sent on receipt of a valid signed and dated prescription.

Pick up

We offer a pickup service for orders placed over the phone.

Please ring us on 01833 641112 for more information.

Refrigerated Items

Refrigerated items will be sent by carrier or Royal Mail with coolpacks unless you pay for a premium for a refrigerated delivery. We will contact you prior to despatch for your instructions.

Returns

We want you to be completely satisfied with any purchase. If not any item* can be returned to us within 14 days of receipt for exchange or refund Please give us a ring for a returns number on 01833 641112 or alternatively email [email protected] to obtain a returns number.

*Due to legal requirements medicines may not be returned except to correct an error in despatch or in response to an "official recall". If an item is believed to be faulty it should be returned for inspection and it may be necessary to forward it to the manufacturers for testing before replacements or refunds can be authorised. This does not infringe legal rights. Please contact our customer services for a "Returns Number" which must appear on the outside of the package or it will not be accepted. We advise customers to use an insured method of shipping and to retain proof of despatch. We may refuse returns on products specially obtained or manufactured to order. Items must be returned unsoiled and unused and sent adequately packed and carriage paid.

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