COMPOSITION
Each dose (0.1 ml = minimum 2.000 UI) contains:
Active substance: purified tuberculoprotein (PPD) extracted from Mycobacterium bovis cultures, AN5 strain, minimum 0.06-0.14 mg
Excipients: phenol, Tween
TARGET SPECIES
Cattle, swine, sheep, goats, equines, carnivorous animals
INDICATIONS
It is used for the in vivo tuberculosis diagnosis by the allergic, single and comparative intradermal assay.
CONTRAINDICATIONS
Do not carry out the intradermal assay:
- Less than 42 days after another allergic examination with tuberculins or paratuberculin;
- Less than 10 days after immunosuppressive treatments;
- On the last pregnancy month and on the first month after birth;
- In sick animals
ADVERSE REACTIONS
The product does not cause general adverse reactions.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
The dose is 0.1 ml.
The official intradermal tuberculination tests are:
a) single intradermal test which consists of a single injection of bovine tuberculin (ROMTUBER PPD BOVINE);
b) comparative intradermal test which consists of a single injection of bovine tuberculin and one of avian tuberculin at the same time.
The doses of injected tuberculins contain:
a) minimum 2.000 U.I. bovine tuberculin
b) minimum 2.000 U.I. avian tuberculin
Carry out the tuberculination tests by injection of tuberculin (in the skin of the neck). The injection site will be at the border between the anterior third and the middle third of the neck. When administering both the bovine and the avian tuberculin in the same animal, inject the avian tuberculin approximately 10 cm from the upper line of the neck and the bovine tuberculin approximately 12 cm below, parallel with the shoulder or on different parts of the neck; in young animals which do not have sufficient area on a single part of the neck to separate these sites, inoculate on one side of the neck, in identical places, located in the center of the middle third of the neck.
REACTION INTERPRETATION
It is based on the clinical observations and increase/increases recorded at the inoculation site, 72 hours after tuberculin injection.
a) the reaction is negative if there is only a limited swelling, with no more than 2 mm increase of the skin fold thickness, without clinical signs such as diffuse or extended edema, sweat, necroses, pains or inflammation of the lymphatic ducts or lymph nodes in the area;
b) the reaction is inconclusive if there are no clinical signs as mentioned in section a) and if there is a 2-4 mm increase of the skin fold.
c) The reaction is positive if there are clinical signs such as: diffuse edema, sweat, necroses, inflammation of the lymphatic ducts and if the skin fold at the inoculation site has a 4 mm or larger increase.
The interpretation of the intradermal tuberculin official tests is:
Single intradermal assay:
a) positive, a positive reaction as mentioned under section c);
b) inconclusive, an inconclusive reaction as mentioned under section b);
c) negative, a negative reaction as mentioned under section a).
The animals with inconclusive reaction at the single intradermal assay will be subjected to another assay after at least 42 days. The animals with no negative reaction at the second assay should be considered positive. The animals with positive reaction at the single intradermal assay can be subjected to a comparative intradermal assay.
Comparative intradermal assay to determine and maintain the official tuberculin-free status of a flock
a) positive a positive reaction at the bovine tuberculin 4 mm greater than the reaction at avian tuberculin or the presence of clinical signs;
b) inconclusive, a positive or inconclusive reaction at the bovine tuberculin which is 1 – 4 mm greater than the reaction to avian tuberculin and the absence of clinical signs;
c) negative, a negative reaction at bovine tuberculin or a positive or inconclusive reaction at the bovine tuberculin but equal or less than a positive or inconclusive reaction at avian tuberculin, as well as the absence of clinical signs in both cases.
The animals with inconclusive reaction at the single intradermal assay will be subjected to another assay after at least 42 days. The animals with no negative reaction at the second assay should be considered positive.
ADVICE ON CORRECT ADMINISTRATION
Administer ROMTUBER PPD BOVINE with special boiling-sterilized tuberculination syringes and needles. Shelf life after unsealing is 6 hours. Do not inoculate in areas with skin lesions. Until reading the results, keep animals away from physical effort and bad weather. The efficacy of tuberculination depends on the genetic constitution, age, intercurrent infections, alimentation and stress. Carry out internal antiparasitic treatment 3 weeks before tuberculination. Carry out tuberculination minimum two weeks before vaccination.
WITHDRAWAL PERIOD
Meat, milk = 0 days
OTHER INFORMATION
Vials with 2, 5, 10 ml and 20, 50, 100 doses/vial
