Tetraxim

Tetraxim

Manufacturer:

Sanofi

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Per 0.5 mL Diphtheria toxoid ≥30 IU, tetanus toxoid ≥40 IU, Bordetella pertussis antigens: Pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg, type 1 inactivated poliomyelitis virus 40 D-antigen units, type 2 inactivated poliomyelitis virus 8 D-antigen units, type 3 inactivated poliomyelitis virus 32 D-antigen units
Indications/Uses
Protection against diphtheria, tetanus, pertussis & poliomyelitis in childn from the age of 2 mth.
Dosage/Direction for Use
IM 2 inj at 2-mth intervals (1 at the age of 2 mth & 1 at the age of 4 mth), followed by 1 booster inj at the age of 11 mth, then another booster inj at the age of 6 yr; booster vaccination for childn 11-13 yr who did not receive a vaccine containing the pertussis valence at normal conc at the age of 6 yr. Alternatively, 3 inj at 1- or 2-mth intervals from the age of 2 mth, followed by 1 booster inj w/in the 2nd yr of life, & another booster inj between 4-13 yr of age.
Contraindications
Hypersensitivity to any of the vaccine components; glutaraldehyde, neomycin, streptomycin, or polymyxin B; pertussis vaccine (acellular or whole cell). Allergic reaction after an inj of the same vaccine or a vaccine containing the same substances. Evolving encephalopathy; history of encephalopathy w/in 7 days of a previous pertussis vaccine (acellular or whole cell). Postpone vaccination in case of fever or an acute disease.
Special Precautions
Childn w/ history of Guillain-Barré syndrome or brachial neuritis following receipt of prior vaccine containing tetanus toxoid; current, or history of, allergic reaction following Tetraxim inj; adolescents of childbearing potential. Do not administer intravascularly. Immune response may be diminished in childn w/ poor immune defences, or if treated w/ corticosteroids, cytotoxic medicines, radiotherapy or other medicines that may weaken the immune system; wait until the end of treatment/disease before vaccinating. Vaccination is recommended in patients w/ chronic immunodeficiency eg, HIV infection. Risk of bleeding during IM administration in childn w/ blood disorders (eg, thrombocytopenia) or clotting disorders. Carefully evaluate giving of further doses in case of the following events after a previous Tetraxim vaccination: Fever ≥40℃ (not due to another identifiable cause), collapse or shock-like state w/ hypotonic-hyporesponsive episode, &/or persistent inconsolable crying lasting ≥3 hr, occurring w/in 48 hr of vaccination; convulsions w/ or w/o fever, occurring w/in 3 days of vaccination. Monitor temp for 48 hr after vaccination in childn w/ history of febrile convulsions unrelated to a previous vaccination. Administer Tetraxim & HIB conjugate vaccine into 2 separate inj sites & on different days in case of oedema in the lower limbs following previous HIB-containing vaccine. Contains phenylalanine.
Adverse Reactions
Loss of appetite; nervousness, irritability; abnormal crying; somnolence; headache; vomiting; myalgia; inj site erythema, pain, oedema; fever ≥38°C; malaise. Insomnia, sleep disorder; diarrhoea; inj site induration.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07CA02 - diphtheria-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Form
Tetraxim vaccine susp for inj
Packing/Price
(pre-filled syringe) 0.5 mL x 1's
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