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 and the neonate are to be expected.
Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal portal of entry.
No animal fertility studies have been conducted with human varicella zoster immunoglobulin. Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
No effects on ability to drive and use machines have been observed.
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 administration.
Local reactions at injection sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash.
The following adverse reactions have been reported from post-marketing experience.
The list presented below 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Not known: Anaphylactic shock, Hypersensitivity
Not known: Headache
Not known: Tachycardia
Not known: Hypotension
Not known: Nausea, Vomiting
Not known: Skin reaction, Erythema, itching, Pruritus
Not known: Arthralgia
Not known: Fever, malaise, chill. At injection site: swelling, pain, erythema, induration, warmth, pruritus, rash, itching.
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