Tetagam P 250 IU/mL solution for injection (human tetanus immunoglobulin) – for prevention and treatment of tetanus

Tetagam P contains human tetanus immunoglobulin – mainly immunoglobulin G (IgG) with a high content of specific antibodies against the toxin of the bacterium Clostridium tetani. It belongs to the group of immune sera and immunoglobulins and is available as a solution for injection in a pre-filled syringe (250 IU in 1 mL).

Unlike a vaccine, which stimulates the body to produce its own antibodies, Tetagam P immediately provides ready-made antibodies (passive protection). It is used after injuries that may be contaminated with tetanus bacteria in people without adequate vaccination and to treat established tetanus. The medicine is given by a healthcare professional in a healthcare facility.

When is Tetagam P used and how is it given?

Basic information about the medicine

What is Tetagam P used for?

• prevention of tetanus after an injury that may be contaminated with tetanus bacteria – in people who are not adequately vaccinated, whose vaccination status is not known with certainty, or who have a severe deficiency in antibody production;
• treatment of clinically manifest tetanus.

Active tetanus vaccine should always be given together with the immunoglobulin unless there are contraindications or confirmation of adequate vaccination; WHO guidelines and other official recommendations are taken into account.

How is it used and dosed?

Children and adults receive the same dose. The medicine is given into a muscle; before use it is warmed to body temperature, and cloudy solutions or solutions with particles are not used.

Larger volumes (over 2 mL in children up to 20 kg and over 5 mL in people over 20 kg) are divided between different sites. In severe coagulation disorders the medicine may be given under the skin for prevention (no clinical efficacy data support this route).

Special patient groups

• Children: receive the same dose as adults; in children up to 20 kg volumes over 2 mL are divided between several sites.
• Patients with coagulation disorders: when an intramuscular injection is contraindicated, prevention can be given subcutaneously.

Contraindications – when the medicine must not be used

• allergy (hypersensitivity) to human tetanus immunoglobulin or to any excipient.

Precautions and warnings

• do not inject into a vein (risk of shock);
• in IgA deficiency, IgA antibodies may develop and an anaphylactic reaction may occur – the doctor weighs benefits and risks;
• rarely, a drop in blood pressure with an anaphylactic reaction may occur, even in people who previously tolerated immunoglobulin – readiness to treat shock is required;
• the medicine is made from human plasma; the measures taken (donor selection, testing, virus inactivation) are considered effective for HIV, HBV, HCV, HAV and parvovirus B19, but transmission of infection cannot be totally excluded;
• the patient's name and the batch number are recorded at each administration.

Interactions with other medicines, food and drink

• Live attenuated virus vaccines (measles, rubella, mumps, varicella): immunoglobulin may reduce their effectiveness for up to 3 months (up to 5 months for measles) – vaccination is postponed for at least 3 months;
• Serological tests: passively transferred antibodies may give false-positive results (e.g. Coombs test);
• the medicine must not be mixed with other medicines, diluents or solvents.

Pregnancy and breastfeeding

Safety in pregnancy has not been studied in controlled trials, but long clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, the foetus or the newborn are to be expected. The doctor decides on use in pregnancy and breastfeeding.

Driving and using machines

Tetagam P has no or negligible influence on the ability to drive and use machines.

Possible side effects

Rare (up to 1 in 1000 patients):

• allergic reactions including a drop in blood pressure, difficulty breathing and skin reactions, which in some cases may progress to anaphylactic shock;
• cardiovascular reactions, especially if the medicine is accidentally injected into a blood vessel;
• headache, moderate back pain, joint pain, nausea, vomiting, fever, malaise, chills;
• swelling, pain and tenderness at the injection site.

Overdose, missed dose and stopping treatment

The consequences of overdose are not known. The medicine is given by a healthcare professional, and the doctor determines the dose and any repetition according to the type of injury and the clinical picture.

Related information

Tetagam P is a medicine for use in healthcare facilities. Detailed information, including the section for healthcare professionals, is available in the official patient leaflet and summary of product characteristics on the ALIMS website (links in the Sources section).

Composition, pack and manufacturer

• active substance: human tetanus immunoglobulin – per 1 mL: human protein 100–170 mg, of which at least 95% immunoglobulin, with at least 250 IU of antibodies against tetanus toxin;
• excipients: glycine, sodium chloride, hydrochloric acid or sodium hydroxide (for pH adjustment), water for injections; no preservatives; essentially “sodium-free”;
• appearance: clear solution, colourless to pale yellow or light brown;
• pack: 1 pre-filled syringe of type I glass with 1 mL of solution;
• marketing authorisation holder: PharmaSwiss d.o.o., Belgrade; manufacturer: CSL Behring GmbH, Marburg, Germany;
• authorisation number: 000457849 2023 of 10 June 2024.

Storage

• Keep out of the sight and reach of children.
• Store in a refrigerator (2–8 °C), do not freeze; keep in the original package to protect from light.
• Use immediately after opening; do not use cloudy solutions or solutions with particles. Shelf life 3 years.

Frequently asked questions

What is the difference between Tetagam P and tetanus vaccine?

A vaccine stimulates the body to produce its own antibodies, which takes some time. Tetagam P contains ready-made human antibodies against tetanus toxin and gives immediate, passive protection. That is why both are usually given to inadequately vaccinated injured people, on different sides of the body.

When is Tetagam P needed after an injury?

According to the leaflet, after an injury that may be contaminated with tetanus bacteria in people who are not adequately vaccinated, whose vaccination status is not known with certainty, or who have a severe deficiency in antibody production. The doctor makes the assessment.

Do children receive a lower dose?

No. Children and adults receive the same dose – usually 250 IU, and 500 IU for high-risk wounds. In children up to 20 kg, larger volumes are divided between several injection sites.

Does Tetagam P affect other vaccines?

It can. After administration, at least 3 months should pass before vaccination with live virus vaccines (measles, rubella, mumps, varicella), and for measles the effect may last up to 5 months. This does not apply to the tetanus vaccine given at the same time.

Sources

• ALIMS – Patient information leaflet Tetagam P 250 i.j./mL (PIL)
• ALIMS – Summary of product characteristics Tetagam P 250 i.j./mL (SmPC)

Sources checked on: 25 October 2026.