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) 40 D antigen units, inactivated poliomyelitis virus (type 2) 8 D antigen units, inactivated poliomyelitis virus (type 3) 32 D antigen units, H. influenzae type b polysaccharide 10 mcg, conjugated to the tetanus protein 18-30 mcg
Indications/Uses
Prophylaxis against DPT, poliomyelitis & invasive infections caused by H. influenzae type b bacterium (eg, meningitis, septicaemia) in childn ≥2 mth.
Dosage/Direction for Use
IM Childn ≥2 mth 2 inj w/ an interval of 2 mth, followed by a booster inj at age of 11 mth. Or, 3 inj at an interval of 1-2 mth, followed by a booster inj w/in the 2nd yr of life.
Contraindications
Hypersensitivity to the components of the vaccine. Encephalopathy. Postpone vaccination in childn w/ fever or acute disease.
Special Precautions
Blood disorder eg, thrombocytopenia or clotting disorders. Febrile convulsions not related to previous vaccination. Fever ≥40°C; collapse or shock-like state w/ hypotonic-hyporesponsive episode; persistent, inconsolable crying lasting ≥3 hr occurring w/in 48 hr of vaccination; convulsion w/ or w/o fever occurring w/in 3 days of vaccination. Allergic reactions. Guillain-Barre syndrome & brachial neuritis. Oedematous reactions of the lower limbs following vaccination containing H. influenzae type b. Patients on immunosuppressive treatment or w/ immune deficiency.
Adverse Reactions
Loss of appetite; nervousness, irritability, abnormal crying; somnolence; vomiting; inj site redness, swelling, pain; fever ≥38°C. Diarrhoea; inj site hardening; insomnia, sleep disorder.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07CA06 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Form
Pentaxim vaccine (pre-filled syringe + vial)
Packing/Price
0.5 mL x 2's
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