SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Scabivax Forte

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

per dose of 0.02 mL

Active ingredient

Orf virus 10^5.4- 10^6.5TCID₅₀

Excipients

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Solution for cutaneous administration

4. CLINICAL PARTICULARS

4.1 Target species

Sheep, from one day of age.

For the active immunisation of sheep and lambs against Orf to reduce clinical signs and/or lesions of the disease.

Immunity develops within 4-8 weeks of vaccination and is protective against severe signs of contagious pustular dermatitis for at least 12 months.

The vaccine should not be used on farms or in flocks where Orf disease is not a problem.

Do not vaccinate ewes less than 7 weeks before lambing. Do not vaccinate pregnant ewes except at the recommended stage of pregnancy.

4.4 Special warnings for each target species.

None

4.5 Special precautions for use, including special precautions to be taken by the person administering the medicinal product to animals

i. Special precautions for use in animals

Scabivax Forte is a live virus vaccine, and thus care must be taken to apply the vaccine only to the intended vaccination site and to not contaminate other sites such as mouth, feet, superficial wounds or abraded skin of the animal. Vaccinated lambs may transmit the disease to ewes’ udders.

Ewes that are vaccinated prior to lambing should not be moved to the proposed place of lambing until sufficient time has passed for the scabs to drop off (minimum of 7 weeks).

Where indoor housing is practiced, routine cleansing and disinfection of the premises is an important aid in the control of Orf. In cases where vaccination of lambs cannot be delayed until turnout, veterinary advice should be sought as to how to minimise the risk of infection.

Ewes with unvaccinated lambs at foot are best to have their vaccination delayed until the lambs are weaned, except in case of emergency. Vaccinate these ewes as for pregnant ewes.

For a period of up to 7 weeks after vaccination, or until the scabs resulting from the vaccine “take” have dropped totally, animals will be shedding virus infected scabs. During this time, vaccinated animals should not be:

Care must be taken not to contaminate the ground area with vaccine or used materials due to the persistence of Orf virus in the environment.

Do not vaccinate ewes or lambs during wet weather.

Vaccination of ewes before lambing will not provide protective immunity to the lambs via the colostrum. Therefore, if Orf disease is a problem in the lamb flock as well, the lambs should also be vaccinated to ensure protection throughout the entire flock.

ii. Special precautions to be taken by the person administering the product to animals

Orf disease is caused by a virus which is communicable to man. The vaccine is capable of causing a skin infection in humans so should not be used by immuno-suppressed individuals. In the case of accidental self-administration (injection or scratch), ingestion or spillage onto the skin or into the eye, seek medical advice immediately and show the package insert or label to the physician. Rubber gloves should be worn when handling this product or dismantling the Applicator. Hands and arms should be washed after vaccination.

4.6 Adverse reactions (frequency and seriousness)

Effects other than those which characterise the vaccine “take” have not been observed.

4.7 Use during pregnancy, lactation or lay

No adverse effect has been recorded as a result of the use of this vaccine during pregnancy, at 7-8 weeks prior to lambing; do not use within 7 weeks of lambing. Do not use in other stages of pregnancy.

Lactating ewes can be vaccinated; ewes with lambs at foot should only be vaccinated at the recommended site.

4.8 Interaction with other medications

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.

Care should be taken to avoid treatment of the animals near the period of vaccination with substances or medicaments that might interfere with the “take” of this live vaccine.

4.9 Amounts to be administered and administration route

Dosage: 0.02 ml administered by skin scarification.

This vaccine must be administered to sheep and lambs using an applicator, such as the Scabivax Forte Applicator, that dispenses a 0.02 ml dose of vaccine and prevents back flush. Refer to Section 4.5 ii) for information on risks to the operator.

Prior to first vaccination and each subsequent vaccination session, and at the end of each vaccination session, the Applicatorshould be (re)sterilised.Do not use disinfectants to clean the Applicator as residues may harm the vaccine when next used.

When using the Scabivax Forte Applicator, place the vaccine bottle into the plastic sleeve supplied with the Applicator, when ready to commence vaccination. Ensure the Applicator is in an upright position, to avoid scratching the operator. Push the bottle, now inside the sleeve, firmly onto the draw off needle until it can go no further. Ensure the needle punctures the centre of the rubber circle on the top of the bottle. In order to prime the Applicator for vaccine application, ensure the Applicator is in the locked position. Holding the vaccinator so that it points to the ground, press down on the base of the vaccine bottle in a “pump like” action. Priming should take approximately 10 pumps. When the vaccine flows onto the scratcher prongs, the Applicator is primed and ready for use. The small drop of liquid, measured to a precise dose, is supported by the Applicator prongs until the product is applied. Prior to vaccination of each subsequent animal, the Applicator must be pumped once to recharge the Applicator prongs with a precise dose of vaccine.

Ewes that are vaccinated prior to lambing should not be moved to the proposed place of lambing until sufficient time has passed for the scabs to drop off (minimum of 7 weeks).

Where indoor housing is practiced, routine cleansing and disinfection of the premises is an important aid in the control of Orf. In cases where vaccination of lambs cannot be delayed until turnout, veterinary advice should be sought as to how to minimise the risk of infection.

Site of administration:

Ewes: Pregnant ewes should be vaccinated behind the elbow or in the axilla (i.e., between the top of the foreleg and the chest wall), to prevent infection of the udder and subsequent transmission to lambs. Vaccinate ewes 7-8 weeks before lambing. Do not vaccinate ewes less than 7 weeks before lambing.

Ewes with unvaccinated lambs at foot are best to have their vaccination delayed until the lambs are weaned, except in case of emergency. Vaccinate these ewes as for pregnant ewes.

Lambs: Lambs may be vaccinated at any time from birth. Young (ie. unweaned) lambs should be vaccinated in the axilla.

Method of administration:

Restrain the lamb or sheep over a rail or similar with the bare skin exposed. To apply the vaccine, place the Applicator prongs onto the skin and commence making a 4 to 5 cm scratch. The vaccine dose will be evenly deposited along the scratch. The Applicator must be held at an angle to the skin (approximately 45 degrees). Press firmly to ensure there is sufficient skin damage to enable an effective vaccination “take”. The scratch should be just sufficient to break the top layer of the skin but not deep enough to draw blood.

As frequently as required, wipe the Applicator tip on a piece of cotton-wool or tissue to remove grease, dirt and wool collected from the sheep’s skin, taking care not to contaminate the hands. It is advisable to have a plastic bag open and pinned up to receive used materials. Burn or sterilise used materials as soon as possible after use.

At the site of vaccination, erythema local to the line(s) of scarification are to be expected as the initial, observable effect, days 1-14 post-vaccination. Vesicles and pustules may then be observed, from approximately day 3-14 post-vaccination, and restricted to the site of scarification. Rupture of these vesicles and pustules, and scab formation, can be expected from about day 7 post-vaccination. These effects are expected in up to 100% of animals treated and are commonly referred to as vaccine “takes”; they indicate successful vaccination. In susceptible animals (those at risk of Orf virus infection) the aim is to obtain a “take” in each animal vaccinated. Animals which are immune because of previous vaccination or infection may not develop these “takes”.

It is strongly recommended that the effectiveness of vaccination be assessed by examination of a selected group of sheep and/or lambs, one week to 10 days after vaccination. A more or less continuous line of pustules should be visible along the track of the scratch made on the skin. The pustules progress to form scabs which gradually dry and fall off by 7 weeks after vaccination.

Susceptible sheep or lambs must “take” in order to become immunised against Orf disease. Failure to “take” may be due to poor vaccination technique, improper handling of the vaccine resulting in loss of potency, or because the sheep are already immune. Revaccination once should be considered where a “take” has not occurred.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Secondary bacterial infection may be observed in association with the scarification wounds; specific therapy may be required.

4.11 Withdrawal period

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Live viral vaccine.

ATC vet code:QI04AD01.

To stimulate active immunity against contagious pustular dermatitis (Orf) virus.

6.1 List of excipients

Patent Blue V (E 131)

HEPES buffer

Sodium hydrogen carbonate

Eagles Minimum essential medium with non-essential amino acids

Foetal bovine serum

NZ Amine type B

Sucrose

Gelatin

Glutamine

Glycerol

Water for injections

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

Do not administer or treat with surface-active agents such as antiseptics, sprays or dips within 7 days before or after administration of the vaccine. Do not administer corticosteroids or other immunosuppressive drugs within 28 days before or after administration of the vaccine.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Shelf life after first opening the immediate packaging: 8 hours

This product does not contain preservative.

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

Cardboard box with 1 glass bottle containing 50 doses of liquid vaccine, sealed with a rubber stopper and aluminium cap.

The Scabivax Forte Applicator is supplied separately.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

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

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm01708/4584

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date:11 September 2008

10. DATE OF REVISION OF THE TEXT

Date:December 2011