Adverse reactions : תופעות לוואי

ADVERSE REACTIONS
Induration at the TUBERSOL injection site is the expected reaction for a positive skin test. (See Interpretation of the Test.)
The information pertaining to adverse events has been compiled from historical clinical studies and post-marketing experience with TUBERSOL.
General disorders and administration site conditions
Injection site pain, injection site pruritus and injection site discomfort.
Injection site erythema or injection site rash (without induration) occurring within 12 hours of testing. These reactions do not indicate TB infection.
Injection site hemorrhage and injection site hematoma up to three days after the administration of the test.
Injection site vesicles, injection site ulcer or injection site necrosis in highly sensitive persons.

Injection site scar as a result of strongly positive reactions.

Pyrexia
Immune system disorders
Hypersensitivity, including anaphylaxis/anaphylactic reactions, angioedema, urticaria Respiratory, thoracic, and mediastinal disorders
Stridor, dyspnea
Skin and subcutaneous tissue disorders
Rash, generalized rash
Nervous system disorders
Presyncope, syncope (including syncope associated with tonic-clonic movements and other seizure-like activity) sometimes resulting in transient loss of consciousness with injury 
REPORTING OF ADVERSE EVENTS
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health (www.health.gov.il) according to the National Regulation by using an online form https://sideeffects.health.gov.il