Infanrix-IPV+Hib

Infanrix-IPV+Hib

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Concise Prescribing Info
Contents
Combined diphtheria-tetanus-acellular pertussis, enhanced inactivated polio & H. influenzae type b vaccine
Indications/Uses
Active immunisation in infants ≥2 mth against diphtheria, tetanus, pertussis (DTP), poliomyelitis & H. influenzae type b (Hib). Booster dose for childn who have previously been immunised w/ DTP, polio & Hib antigens.
Dosage/Direction for Use
Primary vaccination Three 0.5-mL doses by deep IM in the anterolateral aspect of the thigh, in the 1st 6 mth of life. Can start from 2 mth of age, w/ at least 1 mth interval between subsequent doses. Booster dose Recommended in the 2nd yr of life, w/ an interval of at least 6 mth after completion of primary vaccination schedule.
Contraindications
Hypersensitivity to any component of the vaccine, or after previous administration of DTP, inactivated polio or Hib vaccines. Encephalopathy of unknown aetiology, occurring w/in 7 days following previous vaccination w/ pertussis-containing vaccine.
Special Precautions
Postpone vaccination in subjects suffering from acute severe febrile illness. If any of the following occurs, the decision to give subsequent doses of pertussis-containing vaccine should be carefully considered: Rectal temp ≥40°C w/in 48 hr, not due to another identifiable cause; collapse or shock-like state w/in 48 hr of vaccination; persistent, inconsolable crying lasting ≥3 hr, w/in 48 hr of vaccination; convulsions w/ or w/o fever, w/in 3 days of vaccination. Childn w/ progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy; subjects w/ thrombocytopenia or bleeding disorder; hypersensitivity to neomycin & polymyxin; immunosuppressed patients. Do not administer IV. Not recommended in adults, adolescents or childn >5 yr. +ve urine test for Hib capsular polysaccharide antigen w/in 1-2 wk of vaccination. Potential risk of apnoea & the need for resp monitoring for 48-72 hr should be considered for very premature infants (born ≤28 wk of gestation) & those w/ history of resp immaturity.
Adverse Reactions
Appetite lost; irritability, crying abnormal, restlessness; somnolence; inj site reactions eg, pain & redness, local swelling at the inj site (≤50 mm), fever (≥38°C). Diarrhoea, vomiting; inj site reactions including induration, local swelling at the inj site (>50 mm).
Drug Interactions
Can be administered concomitantly w/ hepatitis B vaccine. Different inj vaccines should always be administered at different inj sites. Adequate response may not be achieved in patients receiving immunosuppressive therapy.
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
(Vial + pre-filled syringe) 0.5 mL x 2's
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