Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
Known hypersensitivity to any of the components of the product.
Known hypersensitivity to human immunoglobulins.
Do not inject intravascularly! Ensure that Tetagam P is not administered into a 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 with 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 minutes after administration of Tetagam P.
Particularly in cases of inadvertent i.v. injection, patients should be observed for longer term (at least 1 hour) after administration.
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 such as 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 the product are recorded in order to maintain a link between the patient and the batch of the product.
Immunoglobulin administration may impair the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella vaccines for a period of up to three months.
After administration of Tetagam P an interval of at least three months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to five months. Therefore, patients receiving measles vaccine should have their antibody status checked.
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, e.g., A, B and D may interfere with some serological tests for red cell allo-antibodies (e.g. Coombs test).
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.
No effects on ability to drive and use maschines have been observed.
In rare cases (≥1/10,000 and <1/1,000) the following adverse reactions may occur:
Immune system disorders: 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 of immunoglobulins.
Generalized reactions: Chills, fever, headache, malaise, nausea, vomiting, arthralgia and moderate back pain.]
Heart and vascular disorders: Cardiovascular reactions particularly if the product is inadvertently injected intravascularly.
Local reactions at the injection site: Local pain, tenderness or swelling.
For safety with respect to transmissible agents, see section 4.4, subsection “Virus safety”.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: http://www.hpra.ie/; E-mail:medsafety@hpra.ie.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, diluents or solvents.
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