Tetraxim

Tetraxim

Manufacturer:

Kalventis Sinergi Farma
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, inactivated poliomyelitis virus type 1 (Mahoney strain) 40 D antigen units, inactivated poliomyelitis virus type 2 (MEF-1 strain) 8 D antigen units, inactivated poliomyelitis virus type 3 (Saukett strain) 32 D antigen units
Indications/Uses
Joint prevention of diphtheria, tetanus, pertussis & poliomyelitis for booster vaccination between 5 & 13 yr.
Dosage/Direction for Use
IM Booster vaccination 5-13 yr 1 inj.
Contraindications
Hypersensitivity to any component of Tetraxim, glutaraldehyde, neomycin, streptomycin or polymyxin B or pertussis vaccines (acellular or whole-cell pertussis) or after previous inj. Evolving encephalopathy (cerebral lesions) or encephalopathy w/in 7 days of a previous dose of a pertussis vaccine (acellular or whole-cell pertussis). Postpone vaccination if fever or acute disease occurs.
Special Precautions
Not to be inj intravascularly or intradermally. Thrombocytopenia or clotting problems. Monitor temp for 48 hr after vaccination in childn w/ history of febrile convulsions unrelated to a previous vaccination. Syncope; phenylketonuria. Carefully consider giving further doses of pertussis-containing vaccine in: Fever ≥40°C; collapse or shock-like state w/ hypotonic-hyporesponsive episode (drop in energy) w/in 48 hr of vaccination; 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. 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; oedematous reactions of lower limbs after inj of H. influenzae type b-containing vaccine. Diphtheria-tetanus-pertussis-poliomyelitis vaccine & the H. influenzae type b conjugate vaccine should be administered in 2 separate inj sites & on 2 different days. Immunosuppressed patients. Assess history of afebrile convulsions not related to a previous vaccine inj. Intended for paed use only.
Adverse Reactions
Loss of appetite; nervousness, irritability, abnormal crying; somnolence, headache; vomiting; myalgia; inj site erythema, pain & oedema, fever ≥38°C, malaise. Insomnia, sleep disturbances; 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 (inj)
Packing/Price
(pre-filled syringe) 0.5 mL x 1's (Rp524,275/boks)
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