Infanrix-IPV

Infanrix-IPV

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 0.5 mL dose Diphtheria toxoid not <30 IU, tetanus toxoid not <40 IU, Bordetella pertussis antigens (pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg, pertactin 8 mcg), inactivated polio viruses [type 1 (Mahoney strain) 40 D-antigen u, type 2 (MEF-1 strain) 8 D-antigen u, type 3 (Saukett strain) 32 D-antigen u]
Indications/Uses
Active immunisation in infants ≥2 mth & as booster dose for childn against DPT & poliomyelitis.
Dosage/Direction for Use
Deep IM Inj in deltoid for older childn & in anterolateral thigh for infants. Primary vaccination 3 doses in 1st yr of life starting from age 2 mth w/ at least 1-mth interval between subsequent doses. When primary course is completed before age 6 mth, booster dose can be given in the 2nd yr of life w/ 6-mth interval after completion of primary vaccination.
Contraindications
Known or previous hypersensitivity. Encephalopathy of unknown aetiology occurring w/in 7 days following previous vaccination w/ pertussis-containing vaccine.
Special Precautions
Hypersensitivity to neomycin & polymyxin. Postpone vaccination in patients suffering from acute severe febrile illness. Not to be administered as IV. History of febrile convulsions; family history of convulsions, sudden infant death syndrome & adverse event following DPT vaccination. Patients w/ thrombocytopenia or bleeding disorder. Immunosuppressed patients. Syncope. Perform review of medical history & clinical exam before vaccination. Carefully consider giving subsequent doses of pertussis-containing vaccines to patients w/ rectal temp ≥40°C, collapse or shock-like state (hypotonic-hyporesponsive episode), persistent, inconsolable crying lasting ≥3 hr w/in 48 hr of vaccination; convulsions w/ or w/o fever w/in 3 days of vaccination. Defer pertussis immunization in childn w/ progressive neurological disorders including infantile spasms, uncontrolled epilepsy, progressive encephalopathy. Pregnancy & lactation. Potential risk of apnoea; consider need for resp monitoring for 48-72 hr in very premature infant (≤28 wk of gestation) & those w/ history of resp immaturity.
Adverse Reactions
Loss of appetite; restlessness, abnormal crying, irritability; headache (6-13 yr), somnolence; inj site reactions (eg, pain, redness, local swelling at inj site (≤50 mm), fever (≥38°C). Nausea, vomiting, diarrhoea; local swelling at inj site (>50 mm), asthenia, malaise, inj site reactions including induration.
Drug Interactions
Concomitant use w/ immunosuppressants.
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
Infanrix-IPV susp for inj 0.5 mL
Packing/Price
0.5 mL x 1's
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