Tetraxim Special Precautions

Make sure the vaccine is not injected by intravascular route (the needle must not penetrate a blood vessel) nor by the intradermal route.
If the child suffers from thrombocytopenia or clotting problems as there is a risk of bleeding during intramuscular administration.
If the child already presented with febrile convulsions, not related to a previous vaccine injections; in this case it is particularly important that temperature be monitored in the 48 hours following vaccination and that antipyretic treatment be regularly administered to help reduce fever, for 48 hours.
Syncope can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling and injury, and to manage syncope.
If any of the following events are known to have occurred in temporal relation to receipt of vaccine (the decision to give further doses of pertussis-containing vaccine should be carefully considered): Fever ≥ 40°C within 48 hours 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, occurring within 48 hours of vaccination; Convulsions with or without fever, occurring within 3 days of vaccination.
If the child suffers/suffered from medical problems or allergic reactions, especially allergic reactions following injection of TETRAXIM.
If the child presented Guillain-Barre syndrome (abnormal sensitivity, paralysis) or brachial neuritis (paralysis, diffuse pain in the arm and shoulder) following receipt of a prior vaccine containing tetanus toxoid should be evaluated by the doctor.
If the child presented oedematous reactions (or swelling) occurring in the lower limbs after injection of a vaccine containing the Haemophilus influenzae type b valence, the two vaccines, diphtheria-tetanus-pertussis-poliomyelitis vaccine and the Haemophilus influenzae type b conjugate vaccine should be administered in two separate injection sites and on two different days.
If the child follows a treatment that suppresses their immune defences or if the child presents with immunodeficiency: it is then recommended to wait until the end of the treatment or disease before vaccinating. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even if the antibody response may be limited.
A history of afebrile convulsions not related to a previous vaccine injection should be assessed by a specialist before deciding to vaccinate.
As with all injectable vaccines, appropriate medical treatment must be readily available and close supervision provided should a rare anaphylactic reaction occur following administration of the vaccine.
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'.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
EFFECT ON ABILITY TO DRIVE AND USE MACHINES: Not applicable.
TETRAXIM is intended for paediatric only.