POM-V Prescription Required

CZV Bovine Tuberculin PPD, Solution for Injection

Active ingredient: Mycobacterium bovis subsp. bovis

Form

Injection

Species

Cattle

Manufacturer

CZ Vaccines S.A.U.

VMD MA No.

30824/4001

What it's used for

When used together with CZV Avian PPD Tuberculin, in vivo diagnosis of cattle from 6 weeks of age that have generated an immune response against M. bovis,...

Full indications, dosage and side effects ↓

View official SPC (PDF)

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Clinical information

CZV Bovine Tuberculin PPD, Solution for Injection — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.

When used together with CZV Avian PPD Tuberculin, in vivo diagnosis of cattle from 6
weeks of age that have generated an immune response against M. bovis, differentiating
AN: 03637/2024 & 03639/2024
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).

Age of administration: From 6 weeks
Route of administration: Intradermal
Administration Shake well before use.
Injection sites shall be clipped and cleansed. A fold of skin within each clipped area shall
be taken between the forefinger and thumb and measured with callipers and recorded.
The dose of CZV Bovine Tuberculin PPD shall then be injected intradermally into the
deeper layers of the skin, in a defined area between the first and second third of the neck.
AN: 03637/2024 & 03639/2024
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 Bovine Tuberculin PPD and CZV Avian
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
Single intradermal test
a) Positive: if it is observed an increase of 4 mm or more in the thickness of the fold of
the skin at the injection site or 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: if no clinical signs such as mentioned above are observed and if the
increase in skin-fold thickness is more than 2 mm and less than 4 mm.
c) Negative: Increase of not more than 2 mm in the thickness of the fold of skin without
clinical signs.
Animals inconclusive to the single intradermal test shall be subjected to another test after
a minimum of 42 days.
Animals which are not negative to this second test shall be deemed to be positive to the
test.
Animals positive to the single intradermal test may be subjected to an intradermal
comparative test if false positive reaction or interference reaction is suspected.
Intradermal comparative test when CZV Bovine Tuberculin PPD and CZV Avian
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 Avian Tuberculin PPD should be administered before, at
the same time or after the intradermal test near to the injection site.
AN: 03637/2024 & 03639/2024
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 tuberculosis eradication schemes.

None.

Cattle
AN: 03637/2024 & 03639/2024
Very rare
(<1 animal / 10 000 animals
treated, including isolated
reports):
Hyperthermia
1
Up to 41.4°C within 3 days after injection
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or the national competent authority via the
national reporting system. See the package leaflet for respective contact details.

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 desensitisation.
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 immunosuppression 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.

Special precautions for safe use in the target species:
The results obtained with the test should be interpreted by taking into account other results
obtained in the herd and the clinical and epidemiological factors which have led to the use
of this test.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
In case of accidental self-injection, persons who have been exposed to tuberculin protein,
either from a previous tuberculosis vaccination, or from environmental exposure may
develop a reaction within 48 to 72 hours, consisting of a skin reaction of a hard, dense
wheal. Mild itching, swelling, or irritation at the site of the injection are frequent reactions. If
a strong reaction or systemic symptoms occur, seek medical advice immediately and show
the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.

Safety and efficacy data are available which demonstrate that this immunological
veterinary medicinal product can be administered on the same day but not mixed with CZV
Avian Tuberculin PPD.
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 medicinal product 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.

Store and transport refrigerated (2 C – 8 C).
Do not freeze.
Protect from light.
AN: 03637/2024 & 03639/2024
May be stored and transported up to a maximum of 37 ºC for a period not longer than 14
days.
Do not use this veterinary medicinal product after the expiry date which is stated on the
carton after Exp. The expiry date refers to the last day of that month.

Zero days.

This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.