Infanrix-IPV+Hib

Infanrix-IPV+Hib

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 0.5 mL dose Diphtheria toxoid not <30 IU (25 Lf), tetanus toxoid not <40 IU (10 Lf), Bordetella pertussis antigens (pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg, pertactin 8 mcg), inactivated polio virus [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], HIB polysaccharide 10 mcg (conjugated to tetanus toxoid approx 25 mcg)
Indications/Uses
Active immunisation in infants ≥2 mth against DPT, poliomyelitis & HIB. Booster dose for childn previously immunised with DPT, polio & HIB antigens.
Dosage/Direction for Use
Deep IM Inj in the anterolateral thigh. Primary vaccination: 3 doses in 1st 6 mth of life starting from the age of 2 mth w/ at least 1 mth interval between subsequent doses. Booster dose: Given in the 2nd yr of life w/ at least 6 mth interval after completion of primary vaccination schedule.
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. Does not protect against diseases caused by other types of H. influenzae nor against meningitis caused by other organisms. History of febrile convulsions; family history of convulsions, sudden infant death syndrome & adverse event following DPT, IPV &/or HIB vaccination. Patients w/ thrombocytopenia or bleeding disorder. Immunosuppressed patients eg, on immunosuppressive therapy. Syncope. Excretion of capsular polysaccharide antigen in urine. Perform review of medical history & clinical exam before vaccination. Carefully consider giving subsequent dose of pertussis-containing vaccine in 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 occurring w/in 3 days of vaccination. Defer pertussis immunization in childn w/ progressive neurological disorders eg, infantile spasms, uncontrolled epilepsy or progressive encephalopathy. Pregnancy & lactation. Potential risk of apnoea & consider need for resp monitoring for 48-72 hr in very premature infants (≤28 wk gestation) & those w/ previous history of resp immaturity. Not recommended in adults, adolescents or childn >5 yr.
Adverse Reactions
Loss of appetite; irritability, abnormal crying, restlessness; somnolence; inj site reactions (eg, pain & redness), local swelling at inj site (≤50 mm), fever (≥38°C). Diarrhoea, vomiting; inj site reactions (eg, induration), local swelling at inj site (>50 mm).
Drug Interactions
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
Infanrix-IPV+Hib vaccine (inj)
Packing/Price
0.5 mL x 2's
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