TETAGAM-P Solution for injection Ref.[51090] Active ingredients: Tetanus immunoglobulin

Children and adults are to receive the same dose.

Posology

Prophylaxis of tetanus prone wounds

250 IU, unless the risk is thought to be extremely high.

The dose may be increased to 500 IU in case of:

• infected wounds where surgically appropriate treatment cannot be achieved within 24 hours
• deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as foreign-body injury (e.g., bites, stings or shots)
• burns, congelations
• tissue necrosis
• septicaemic abortion
• adults weighing more than the average.

In case of extensive burns it is advisable to administer a second injection of 250 IU Tetagam P after the exsudative phase of the burn has subsided (about 36 hours after onset of the burn).

Therapy of clinically manifest tetanus

Single doses of 3,000 to 6,000 IU (in combination with other appropriate clinical procedures). Regarding frequency, interval of injection and duration of therapy repeated doses depend on the clinical picture.

Method of administration

Tetagam P should be administered via the intramuscular route. If comparatively large total volumes are required, it is advisable to administer them in divided doses at different sites. This applies in the case of doses above 2 ml for children up to 20 kg bw and doses above 5 ml for persons above 20 kg bw.

In case of simultaneous vaccination the immunoglobulin and the vaccine should be administered at contralateral sites of the body.

In the presence of a severe coagulation disorder, in the case of which intramuscular injections are contraindicated, Tetagam P may be given subcutaneously for prophylaxis.

Afterwards the injection site should be compressed with a swab. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.

For acute therapy, if intramuscular administration is not clinically appropriate, an alternative intravenous product may be used. See section 6.6 “Special precautions for disposal and other handling” for further information regarding method of administration.

Consequences of an overdose are not known.

3 years.

Once the container has been opened the contents have to be used immediately.

Tetagam P is to be stored at +2°C to +8°C (refrigerator). Do not freeze!

Keep container in the outer carton in order to protect its contents from light.

Immediate container:

SCF syringe of colourless tube glass, glass type I according to Ph. Eur.

Presentations:

Pack with 1 prefilled syringe with 1 ml.

Pack with 10 prefilled syringes with 1 ml.

Pack with 1 prefilled syringe with 2 ml.

Not all pack sizes may be marketed

Do not use solutions which are cloudy or contain residues (deposits/particles).

Tetagam P is ready for use and should be administered at body temperature.

Any unused product or waste material should be disposed of in accordance with local requirements.