Summary of safety profile:
Clinically significant undesirable effects with products containing human hepatitis B immunoglobulin for intravenous use may include hypersensitivity, anaphylactic shock and renal failure acute.
Other possible undesirable effects, which may occur with the use of products containing human hepatitis B immunoglobulin for intravenous use are: headache, tachycardia, hypotension, nausea, vomiting, skin reaction, erythema, itching, pruritus, arthralgia, fever, malaise and chills.
Tabulated list of adverse reactions:
The table presented as follows is according to the MedDRA System Organ Classification (SOC) and Preferred Term Level (PT) and it includes undesirable effects occurring with the use of human hepatitis B immunoglobulin for intravenous 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).
There are no robust data on the frequency of undesirable effects from clinical trials.
The following data are in line with the safety profile of human hepatitis B immunoglobulin for intravenous use, and confirmed by the post marketing experience; as the post marketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reactions. (See Table 2.)
Click on icon to see table/diagram/image
During graft re-infection preventive therapy very rare cases of intolerance reactions may be linked to an interval increase between two administrations.
For safety information with respect to transmissible agents, see Precautions.
Although no specific data are avalaible on paediatric population, it is expected that frequency, nature and severity of adverse reactions do not differ between children and adults.
Reporting of suspected adverse reactions:
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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.