Special Warning : אזהרת שימוש

4.4      Special warnings and precautions for use
As with any injectable vaccine, appropriate medical treatment should be readily available and the patient should be closely monitored if an anaphylactic reaction occurs after the administration of the vaccine.
Immunosuppressivetreatment or an immunodeficiency condition may induce a decrease in the immune response to the vaccine. It is therefore recommended to wait untilthe end of treatment before vaccinating or to ensure that the subject is well protected. Nevertheless, the vaccination of chronically immunosuppressed subjects, such those infected with HIV, is recommended if the underlying illnessallows even a limitedantibody response.
In order to prevent hypersensitivity reactions, avoid administration in individuals who have received a full primary vaccination or booster dose withinthe previous 5 years.
In subjects who presented with Guillain-Barré syndrome or brachial plexus neuropathy during the previous administration of a vaccine containing tetanus toxoid, the decision to vaccinate with a vaccine containing tetanus toxoid should be based on a careful evaluation of the potential risks and benefits. Vaccination is usually warranted when the primary vaccination schedule is not complete (that is, less than three doses administered).
Do not inject by intravascular route: make sure the needle does not penetrate a blood vessel.
Syncope (fainting), can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be put in placeto prevent any injurydue to fainting and to manage syncopal reactions.
Imovax dT contains less than 1 mmol (39 mg) potassium, and less than 1 mmol (23 mg) sodium per dose, that is to say essentially “potassium-free” and “sodium-free”.
Traceability:
In order to improve the traceability of biological medicinal products, the name of the administered product should be clearly recorded. It is recommended to record the batch number as well.


Effects on Driving

4.7   Effects on ability to drive and use machines
No studies on theeffects on the ability to drive and use machines have been performed.