Tetraxim Special Precautions

TETRAXIM contains phenylalanine, ethanol and sodium: TETRAXIM contains 12.5 micrograms of phenylalanine in each 0.5 mL dose. Phenylalanine may be harmful for people who have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
TETRAXIM contains 2 mg of alcohol (ethanol) in each 0.5 mL dose. The small amount of alcohol in this medicine will not have any noticeable effects.
TETRAXIM contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium free'.
Driving and using machines: Not applicable. TETRAXIM is intended for paediatric use.
Use in Children: If the child has poor immune defences or if he/she is treated with corticosteroids, cytotoxic medicines, radiotherapy or other medicines that may weaken his/her immune system, the immune response may be diminished. It is then recommended to wait until the end of the treatment or disease before vaccinating. However, vaccination is recommended in subjects with chronic immunodeficiency such as HIV infection, even if the immune response may be limited.
If the child has had Guillain-Barré syndrome (abnormal sensitivity, paralysis) or brachial neuritis (paralysis, diffuse pain in the arm and shoulder) following receipt of a prior vaccine containing tetanus toxoid (vaccine against tetanus), the decision to give any further vaccine containing tetanus toxoid should be evaluated by the doctor.
If the child has blood disorders such as a decrease in platelets (thrombocytopenia) or clotting disorders because of the risk of bleeding which may occur during intramuscular administration.
If the child has or had medical issues or allergies, especially an allergic reaction following an injection of TETRAXIM.
If the child experienced any of the following events after a previous administration of this vaccine, then the decision to give further doses of this pertussis-containing vaccine should be carefully evaluated by the doctor: Fever of 40°C or above within 48 hours of vaccination, not due to another identifiable cause; Collapse or shock-like state with hypotonic-hyporesponsive episode (drop in energy) within 48 hours of vaccination; Persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours of vaccination; Convulsions with or without fever, occurring within 3 days of vaccination.
If the child had febrile convulsions unrelated to a previous vaccination; in this case, it is particularly important to monitor his/her temperature for 48 hours after vaccination and regularly give him/her a treatment to lower the fever, for 48 hours.
If the child has experienced swelling (oedematous reactions) in the lower limbs (legs and feet) following injection of a Haemophilus influenzae type b-containing vaccine; TETRAXIM vaccine and Haemophilus influenzae type b conjugate vaccine should be administered into two separate injection sites and on different days.