The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy or on the foetus are to be expected.
Clinical experience with immunoglobulins suggests that no harmful effects on the neonate are to be expected.
No effects on ability to drive and use machines have been observed.
There are no robust data on the frequency of undesirable effects from clinical trials.
The following undesirable effects have been reported:
Rare: Hypersensitivity, anaphylactic shock
Rare: Headache
Rare: Tachycardia
Rare: Hypotension
Rare: Nausea, vomiting
Rare: Skin reaction, erythema, pruritus
Rare: Arthralgia
Rare: Fever, malaise, chill, fatigue, influenza like illness, At injection site: swelling, pain, erythema, induration, warmth, pruritus, rash
Deep intramuscular injection may reduce the risk of local induration.
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