Human tetanus immunoglobulin.
Each mL of injection solution contains human protein immunoglobulin (at least 95%) 100-170 mg, with antibodies to tetanus toxin at least 250 IU.
It also contains aminoacetic acid (glycine), sodium chloride, hydrochloric acid or sodium hydroxide (in small amounts for pH adjustment), water for injections.
Immune sera and immunoglobulin, human tetanus immunoglobulin. ATC Code: J06B B02.
Post-exposure prophylaxis. Immediate prophylaxis after tetanus prone injuries in patients not adequately vaccinated; whose immunisation status is not known with certainty; with severe deficiency in antibody production.
Therapy of clinically manifest tetanus. Tetanus immunoglobulin should always be administered in conjunction with an active tetanus vaccination unless there are contraindications or confirmation of adequate vaccination.
Children and adults to receive the same dose.
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 hrs; deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as foreign-body injury (eg, 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 2nd injection of Tetagam P 250 IU after the exudative phase of the burn has subsided (about 36 hrs after onset of the burn).
Therapy of Clinically Manifest Tetanus: Single doses of 3000-6000 IU (in combination with other appropriate clinical procedures). Regarding frequency, interval of injection and duration of therapy repeated doses depend on the clinical picture.
Administration: Tetagam P should be administered via the IM route. Tetagam P is a ready-to-use solution and should be administered at body temperature.
Do not use solutions which are cloudy or contain residues (deposits/particles).
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 >2 mL for children up to 20 kg body weight (bw) and doses >5 mL for persons >20 kg bw.
When simultaneous vaccination is necessary the immunoglobulin and the vaccine should be administered at 2 different sites.
In the presence of a severe thrombocytopenia or other coagulation disorders, in the case of which IM injections are contraindicated. Tetagam P may also be given SC (under the skin) 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 SC route.
For acute therapy, if IM administration is not clinically appropriate, an alternative IV product may be used.
If patient have any further questions on the use of Tetagam P, ask the physician or pharmacist.
Hypersensitivity to human immunoglobulins and to any of the components of Tetagam P.
Do not inject IV. Ensure that Tetagam P is not administered into blood vessel because of the risk of shock. True hypersensitivity reactions are rare. Tetagam P contains a small quantity of IgA. Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment Tetagam P against the potential risks of hypersensitivity reactions.
Rarely human tetanus immunoglobulin can induce a fall in blood pressure with anaphylactic reactions, even in patients who had tolerated previous treatment with normal human immunoglobulin.
Therapeutic measures depend on the nature and severity of the event. The current medical standards for shock treatment are to be observed.
Patients should be observed for at least 20 min after administration of Tetagam P.
Particularly, in cases of inadvertent IV injection, patients should be observed for longer term (at least 1 hr) after administration.
Virus Safety: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses eg, HIV, HBV and HCV and for the non-enveloped viruses HAV and parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
It is strongly recommended that every time that Tetagam P is administered to a patient, the name and batch number of Tetagam P are recorded in order to maintain a link between the patient and the batch of the Tetagam P.
Effects on the Ability to Drive or Operate Machinery: No effects on the ability to drive and use machines have been observed.
Use in pregnancy & lactation: The safety of Tetagam P for use in human pregnancy has not been established in controlled clinical trials. Long lasting clinical experience with immunoglobulins does indicate that no harmful effects on the course of pregnancy, on the foetus or the neonate are to be expected.
The safety of Tetagam P for use in human pregnancy has not been established in controlled clinical trials. Long lasting clinical experience with immunoglobulins does indicate that no harmful effects on the course of pregnancy, on the foetus or the neonate are to be expected.
In rare cases the following adverse reactions may occur: Allergic reactions including fall in blood pressure, dyspnoea, cutaneous reactions, in isolated cases reaching as far as anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration; generalised reactions eg, chills, fever, headache, malaise, nausea, vomiting, arthralgia and moderate back pain; cardiovascular reactions particularly if Tetagam P is injected intravascularly.
At the injection site local pain, tenderness or swelling can be observed in rare cases.
For safety with respect to transmissible agents see Precautions.
If patient experience reactions which are not mentioned in the use of Tetagam P, inform the physician or pharmacist.
Vaccinations with Live Attenuated Virus Vaccines: Immunoglobulin administration may impair the efficacy of live attenuated virus vaccines eg, measles, rubella, mumps and varicella vaccines for a period of up to 3 months.
After administration of Tetagam P an interval of at least 3 months should elapse before vaccination with live virus vaccines. In the case of measles, this impairment may persist for up to 5 months. Therefore, patients receiving measles vaccine should have their antibody status checked.
Interference with Serological Testing: It has to be considered that when serological test results are interpreted, the transitory rise of passively transferred antibodies after immunoglobulin injection may result in misleading positive test results.
Passive transmission of antibodies to erythrocyte antigens eg, A, B and D may interfere with some serological tests for red cell allo-antibodies (eg, Coombs test).
Incompatibilities: In the absence of compatibility studies, Tetagam P must not be mixed with other medicinal products, diluents or solvents.
Store at +2°C to +8°C. Do not freeze. Protect from light.
Once the container has been opened, the contents have to be used immediately.
Any unused product or waste material should be disposed of in accordance with local requirements.
J06BB02 - tetanus immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Pre-filled syringe 250 IU/mL (clear, colorless to pale-yellow up to light-brown solution) x 1's.