Immunorho Adverse Reactions

Summary of the safety profile: Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Rarely human immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administrations.
Local reactions at infusion site: swelling, soreness, redness, induration, local heat, itching, bruising and rash.
Tabulated list of adverse reactions: The table as follows has been drawn up according to the MedDRA system organ classification (SOC and Preferred Term Level). The table reports undesirable effects associated with the use of human anti-D immunoglobulin for intramuscular use.
There are no robust data on the frequency of adverse reactions derived from clinical trials.
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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Paediatric population: No specific data are available on paediatric population.
For safety with respect to transmissible agents, see Precautions.
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.