Tetanus immunoglobulin interacts in the following cases:
Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps and varicella, for a period of up to 3 months. After administration of tetanus immunoglobulin, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 5 months.
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.
Clinical experience with immunoglobulins suggests that no harmful effects on the neonate are to be expected.
No animal fertility studies have been conducted with Human Tetanus Immunoglobulin. Clinical experience with immunoglobulins suggest 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 administration sites: swelling, soreness, redness, induration, local heat, itching, bruising and rash.
There are no robust data on the frequency of undesirable effects from clinical trials.
The table 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 <1,1000); 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.
The following adverse reactions have been reported from post-marketing experience.
| MedDRA Standard System Organ Class | Adverse reaction | Frequency |
|---|---|---|
| Immune system disorders | Hypersensitivity, anaphylactic shock | Not known |
| Nervous system disorders | Headache, dizziness, tremor | Not known |
| Cardiac disorders | Tachycardia | Not known |
| Vascular disorders | Hypotension | Not known |
| Respiratory, thoracic and mediastinal disorders | Dyspnoea | Not known |
| Gastrointestinal disorders | Nausea, vomiting, glossitis, buccal ulceration | Not known |
| Skin and subcutaneous disorders | Skin reaction, erythema, itching, pruritus, facial oedema | Not known |
| Musculoskeletal and connective tissue disorders | Arthralgia | Not known |
| General disorders and administration site conditions | Fever, malaise, chills, chest pain At injection site: swelling, pain, erythema, induration, warmth, pruritus, rash, itching | Not known |
Anaphylactic reactions occur rarely and are more likely in patients who have antibodies to IgA, or who have had an allergic reaction after blood transfusion or treatment with plasma derivatives.
As with all intramuscular injections, some short term discomfort can be expected at the injection site and in rare instances local induration, which can be minimised by deep intramuscular injection.
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