Active ingredient: Human tetanus immunoglobulin, pasteurized
Approved by Paul-Erhlich-Institut Federal Agency for Sera and Vaccines (Germany)
1 ml contains:
Human immunoglobulin 100-170 mg
with antibodies to tetanus toxin at least 250 IU
Aminoacetic acid (glycine) as stabilizer 22.5 mg
water for injections
Tetagam P contains antibodies to tetanus toxin. Tetagam P is prepared from pooled donor's plasma containing spesific antibodies against the toxin of Clostridium tetani. Currently 0.01 I.U. Of tetanus antitoxin per ml of serum are considered to be the minimum level at which tetanus will not occur in the event that tetanus toxin is produced in the human body
Prophylaxis in persons with recent injuries who have no immunity, or incomplete immunity, againts tetanus.
Therapy of clinically manifest tetanus
Simultaneous prophylaxis by administration of 250 I.U. of Tetagam P and 0.5 ml of absorbed tetanus vaccine at contralateral sites of the body. For wounds which cannot be surgically managed satisfactority or which have been neglected, and for extensive burns, the dose to be recommended is 500 I.U. in the katter case it is advisable to administer a second injection of 250 I.U. of Tetagam P at 3-4 weeks interval if patient immunosuppresed or if active immunization with tetanus vaccine contra indication.
Children and adults are to receive the same dose.
Adults: 3000 units to 6000 units as a single dose.
Children: 500 units to 3000 units as single dose.
The given dose should be administered by multi-site i.m. Injection.
Injections of Tetagam P must be given by the intramuscular route only. Note that there is an increased risk of unintentional intravascular injection in patients who have repeatedly received intramuscular injections.
An intravascular injection may cause the patient to develop shock-like symptoms, especially in cases of antibody deficiency syndrome. Therefore it is recommended to ensure by aspiration that no vessel has been penetrated.
For simultaneous prophylaxis in patients undergoing anticoagulant therapy Tetagam P may be administered subcutaneously. Tetagam P may be administered at body temperature, preferably ventrogluteally with the patient lying down. If comparatively large total doses are required, it is advisable to administer them in divided doses. This applies in the case of doses above 2 ml for children weighing up to 20 kg, and doses above 5 ml for persons weighing above 20 kg.
Do not inject intravascularly!
CONTRA - INDICATIONS
In case of severe thrombocytopenia or clotting disorders in which intramuscular injection are contraindicated, Tetagam P can only be administered subcutaneously.
Tetagam P is contraindicated in individuals who are known to have had an anaphylactoid or severe systemic response to immunosodium globulin and/or with Ig A deficiencies with current presence of Antibodies to Ig A.
Administration of Tetagam P during pregnancy only if clearly needed and should be monitored closely and carefully.
Occasionally, transient tenderness or swelling at the injection site, cutaneous reactions and elevation of temperature may occur
In rare cases nausea, vomiting, and also circulatory reactions (e.g. Tachycardia, bradycardia, hypotension, sweating, vertigo) and allergoid reactions (e.g. With flush, urticaria, dyspnoea) have been observed, extending in isolated cases as far as shock.
In particular, unintentional intravascular application may lead to the occurrence or symptoms extending as far as shock. In those cases the patient must be monitored over a certain lapse of time (approximately 2 hours)
Immediate measures depending on the degree of severity: Antihistamine, if necessary adrenaline, high doses of corticosteroids, volume replacement, oxygen.
STORAGE and STABILITY
Tetagam P is to be stored at +2 to +8oC.
It must not be used beyond the expiry date given on the pack and container. Once an ampoule has been opened its contents should be used immediately.
Tetanus is a severe, acute infectious disease caused by the toxin of tetanus bacilli and manifests itself as a tonic spasm of the muscle. In the majority of cases infection occurs when earth contaminated with the tetanus bacilli comes into contact with a wound.
Tetagam P is a clear, colourless to yellowish solution of the immunoglobulin fraction. The preparation contains no preservative.
Tetagam P is prepared exclusively from plasma of healthy donors. Each plasma donation is tested in compliance with the official requirements.
The special steps used in the manufacture of the preparation, especially the ethanol fraction step and heat treatment in aqueous solution at 60oC of 10 hours (pasteurization), result in extensive viral partitioning.
INTERACTIONS WITH OTHER AGENTS
After administration of immunoglobulins, an interval of at least 3 months should be allowed before vaccination with parenteral live virus vaccines (e.g) mumps, measles, rubella and the relevant combination vaccines, as well as varicella vaccine).
When serological tests are performed after the administration of immunoglobulin it should be remembered that immunoglobulin concentrates provide the patient with a wide range of antibodies which may lead to false-positive results for some time. When such antibody assays are carried out, the emount of immunoglobulin administered, the length of time between the administration of the immunoglobulin and the test, and the sensitivity of the test method should be taken into account.
1 ampoule containing 1 ml
Reg. No. DKI 9894900543A1
PT. Dexa medica,
ZLB Behring GmbH
HARUS DENGAN RESEP DOKTER