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IMMUNOHBs

IMMUNOHBs Adverse Reactions

hepatitis b immunoglobulin

Manufacturer:

Kedrion

Distributor:

Biogenetech
Full Prescribing Info
Adverse Reactions
The table presented as follows is according to the MedDRA system organ classification (SOC and Preferred Term Level).
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 undesirable effects have been reported: See Table 2.

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For safety with respect to transmissible agents, see Precautions.
Paediatric population: Frequency, type and severity of adverse reactions in children are not expected to be different from those of adult population.
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.
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