Clinically significant undesirable effects with products containing human tetanus immunoglobulin for intramuscular use may include hypersensitivity and anaphylactic shock.
Other undesirable effects, which may occur with the use of products containing human tetanus immunoglobulin, are tachycardia, hypotension, headache, nausea, vomiting, skin reaction, erythema, pruritus, arthralgia, fever, malaise and chills.
At the injection site may occur the undesirable effects as: swelling, pain, erythema, induration, warmth, rash and itching.
For safety with respect to transmissible agents, see Precautions.
Tabulated list of adverse reactions:
The table presented as follows is according to the MedDRA system organ classification (SOC and Preferred Term Level) and it includes possible undesirable effects with products containing human tetanus immunoglobulin for intramuscular use.
Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). (See Table 2.)
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During a clinical trial conducted with Tetanus Gamma, 30 patients were treated, none of the adverse events occurred was related with the administration of Tetanus Gamma.
No specific data are available for paediatric population.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.