Description
Immunoglobulin
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
1 mL of solution for injection contains:
Human proteins 100 – 180 mg of which human immunoglobulins not less than 90 % with tetanus
toxin antibodies 250 IU
List of excipients
Glycine, Sodium Chloride, Water for Injection.
PHARMACEUTICAL FORM
Solution for Injection containing immunoglobulins, mainly immunoglobulin G (IgG), with 250 IU
of active substance.
1 ml of solution for injection with tetanus toxin potency of 250 IU, in vial with pierceable rubber
stopper or in pre-filled syringe.
THERAPEUTIC INDICATIONS
a) Immediate prophylaxis after tetanus prone injuries in patients not adequately vaccinated, in
patients whose immunisation status is not known with certainty, and in patients with severe
deficiency in antibody production.
b) Treatment of clinically manifest tetanus.
CONTRAINDICATIONS
Hypersensitivity to any of the components. Hypersensitivity to human immunoglobulins.
SPECIAL PRECAUTIONS FOR USE
Ensure that TETANUS GAMMA is not administered into a blood vessel, because of the risk of
shock.
True hypersensitivity reactions are rare.
Rarely, human tetanus immunoglobulin can induce a fall in blood pressure with anaphylactic
reaction, even in patients who had tolerated previous treatment with human immunoglobulin.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the
injection. In case of shock, standard medical treatment for shock should be implemented.
