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Tetraxim

Tetraxim

Manufacturer:

Sanofi

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Per 0.5 mL Diphtheria toxoid ≥30 IU, tetanus toxoid ≥40 IU, pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg, inactivated type 1 poliomyelitis virus 40 D-antigen units, inactivated type 2 poliomyelitis virus 8 D-antigen units, inactivated type 3 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 an interval of 2 mth (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 an interval of 1 or 2 mth 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 dose of pertussis vaccine (acellular or whole cell). Postpone vaccination in case of fever or acute disease.
Special Precautions
Must never be injected intravascularly. Immune response may be diminished in childn w/ poor immune defences, or if treated w/ corticosteroids, cytotoxic medicines, RT or other medicines that may weaken the immune system. Wait until the end of treatment or 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 decision to give further doses in case of the following events after a previous Tetraxim vaccination: fever ≥40°C (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 inj of HIB-containing vaccine. Contains phenylalanine, which may be harmful for patients w/ phenylketonuria. Caution in 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.
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.
Drug Interactions
Administer in 2 separate inj sites if to be vaccinated simultaneously w/ another vaccine.
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 susp for inj (pre-filled syringe) 0.5 mL/dose
Packing/Price
1's
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