SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

CZV Avian Tuberculin PPD

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Per ml:

Active substance

Purified protein derivative from culture

of Mycobacterium avium, subsp. avium strain D4 ER ………… 25 000 IU

Excipients:

Phenol……………………………………………………………..………5 mg

Ponceau red (E124)…………………………………………………….0.05 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Clear pinkish-red solution for injection

4. CLINICAL PARTICULARS

4.1 Target species

Bovine

Single intradermal test

For use in bovine animals from 6 weeks of age or older where, as a consequence of exposure to slow growing mycobacteria in the environment, cross sensitisation to bovine tuberculin is suspected.

Intradermal comparative test

When used together with CZV Bovine Tuberculin PPD, in vivo diagnosis of cattle from 6 weeks of age that have generated an immune response against M. bovis,differentiating animals reacting to M. bovis from those that have become sensitised to bovine tuberculin as a result of exposure to other mycobacteria or related genera (single intradermal comparative tuberculin test).

4.3 Contraindications

Not applicable.

4.4 Special warnings for each target species

Although field experience suggests that there may be no adverse effect when the product is used in cattle sensitised to M. avium subsp. avium, safety in such animals has not been specifically tested and established, therefore careful monitoring should be done.

It is not recommended to repeat the test until at least 42 days have passed since the previous test in order to avoid false negatives due to a loss of skin responsiveness during a period of post-test desensitization.

When used in chronically infected animals with severe pathology, the tuberculin test may be unresponsive.

Newly infected animals may not react to the tuberculin test until the cell mediated immune response has developed (for most animals this is between 3 – 6 weeks post-infection).

Post-partum immunosuppresion may give rise to false negative results in cattle that have recently calved. A lack of sensitivity to the test can occur in cattle that were recently or concurrently treated with immunosuppressive agents.

The results obtained with this test should be interpreted by taking into account others result obtained in the herd and the clinical and epidemiological factors which have led to the use of this test

Accidental self injection may cause an area of intense irritation, especially in tuberculin-sensitised individuals. It is recommended that, in such an event, seek medical advice immediately and show the package leaflet or label to the physician

4.6 Adverse reactions (frequency and seriousness)

A transitory increase of the temperature up to a maximum of 41.4 ºC, within 3 days after injection, may be observed

4.7 Use during pregnancy, lactation or lay

Although no laboratory safety tests were done in pregnant cattle, there is no information that this kind of preparation will have a negative effect on reproductive performance.

4.8 Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy from the concurrent use of this reagent with any other veterinary medicinal product except CZV Bovine Tuberculin PPD. 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 in the interpretation of tests carried out in cattle which have been previously vaccinated against bovine tuberculosis or Johne’s disease (paratuberculosis) because such vaccinations may cause false positive or false negative results in the tuberculin skin tests N.B. Vaccination of cattle against bovine tuberculosis is currently forbidden in the EU. Vaccination of cattle against paratuberculosis may be forbidden in some EU Member States.

Dose

0.1 ml

Shake well before use

Administration

Injection site shall be clipped and cleansed. A fold of skin within clipped area shall be taken between the forefinger and thumb and measured with callipers and recorded. The dose of CZV Avian tuberculin PPD shall then be injected by the intradermal route into the deeper layers of the skin, in a defined area between the first and second third of the neck. A correct injection shall be confirmed by palpating a small pea-like swelling at each site of injection.

The distance between the two injections (CZV Avian Tuberculin PPD and CZV Bovine Tuberculin PPD) in the comparative intradermal test should be approximately 12- 15 cm. In young animals in which there is no room to separate the sites sufficiently on one side of the neck, one injection must be made on each side of the neck at identical sites in the centre of the middle third of the neck.

The skin-fold thickness of each injection site shall be remeasured 72 4 hours after injection and recorded.

Interpretation of the results:

Avian single intradermal test

The interpretation of reactions shall be based on clinical observations and the recorded increase in skin-fold thickness at the site of injection 72 hours after injection of tuberculin.

(a) Negative reaction: if only limited swelling is observed, with an increase of not more than 2 mm in the thickness of the fold of skin without clinical signs such as diffuse or extensive oedema, exudation, necrosis, pain or inflammation of the lymphatic ducts in that region or of the lymph nodes.

(b) Inconclusive reaction: if no clinical signs such as mentioned in a) are observed and if the increase in skin-fold thickness is more than 2 mm and less than 4 mm.

(c) Positive reaction: if clinical signs such as mentioned in a) are observed or there is an increase of 4 mm or more in the thickness of the fold of skin at the injection site.

Intradermal comparative test when CZV Avian Tuberculin PPD and CZV Bovine Tuberculin PPD are used together:

a) Positive: a positive bovine PPD reaction which is more than 4 mm greater than the avian reaction or the presence of clinical signs diffuse or extensive oedema, exudation, necrosis, pain or inflammation of the lymphatic ducts in that region or of the lymph nodes.

b) Inconclusive: a positive or inconclusive bovine PPD reaction which is from 1 to 4 mm greater than the avian reaction, and absence of clinical signs.

c) Negative: a negative bovine PPD reaction, or a positive or inconclusive bovine PPD reaction but which is equal to or less than a positive or inconclusive avian PPD reaction and the absence of clinical signs in both cases.

No other products except CZV Bovine Tuberculin PPD should be administered before, at the same time or after the intradermal test near to the injection site.

Animals inconclusive to intradermal comparative test that are not removed as reactors by the competent authority shall be subjected to another test after a minimum of 42 days. Animals which are not negative to this second test shall be deemed positive to the test under EU legislation.

Different criteria for interpretation of results may be applied in accordance with national requirements for bovine TB eradication schemes

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

No local or systemic reactions are observed after administration of an overdose (double dose).

4.11 Withdrawal period

Zero days.

5. IMMUNOLOGICAL PROPERTIES

It is used to detect sensitisation to avian tuberculin

ATCvet code:QI02AR02

6. PHARMACEUTICAL PARTICULARS

Phenol

Glycerol

Ponceau red (E124)

Phosphate buffered saline (sodium chloride, disodium phosphate and potassium phosphate)

6.2 Incompatibilities

Do not mix with any other vaccine or immunological product.

6.3 Shelf life

2 years

Use immediately once the vial is opened.

6.4. Special precautions for storage

Store and transport between +2 C – +8 C protected from light.

Do not freeze.

May be stored and transported up to a maximum of +37ºC for a period not longer than 14 days.

6.5 Nature and composition of immediate packaging

Type I hydrolytic glass vials containing 50 doses (5 ml), with a rubber-butyl stopper and aluminium seal or red flip-off aluminium seal.

Type I hydrolytic glass vials containing 20 doses (2 ml) with rubber-butyl stopper and aluminium seal or red flip-off aluminium seal.

Sales presentation: cardboard boxes with 25 vials of 5 ml, 10 vials of 5 ml, 1 vial of 5 ml, 25 vials of 2 ml, 10 vials of 2 ml and 1 vial of 2 ml.

Not all pack sizes may be marketed.

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

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

7. MARKETING AUTHORISATION HOLDER

CZ Veterinaria S.A.

La Relva s/n

Porrino (Pontevedra)

36400

SPAIN

8. MARKETING AUTHORISATION NUMBER

Vm:30824/4000

9. DATE OF FIRST AUTHORISATION

Date:24July 2007

10. DATE OF REVISION OF THE TEXT

Date:March 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

The import, sale, supply and/or use of CZV Avian Tuberculin PPD may be prohibited in certain Member States on the whole or part of their territory pursuant to National animal health policy.

Any person intending to import, sell, supply and/or use CZV Avian Tuberculin PPD must consult the relevant Member States Competent Authorities regarding the current policies and statutory requirements prior to the import, sale, supply or use.

21 May 2014