Infanrix Hexa

Infanrix Hexa

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 0.5 mL Diphtheria toxoid, tetanus toxoid, acellular pertussis antigens, inactivated polio virus [type 1 (Mahoney), type 2 (MEF-1) & type 3 (Saukett)], purified capsular polysaccharide of H. influenzae type B (HIB) vaccine (PRP) + HBsAg of HBV
Indications/Uses
Primary & booster vaccination of infants against DPT, hepatitis B, poliomyelitis & disease caused by H. influenzae type b.
Dosage/Direction for Use
Deep IM Full-term infants 3-dose primary vaccination Three 0.5-mL dose, interval of at least 1 mth between primary doses. Booster vaccination: Given at least 6 mth after the last priming dose, preferably before 18 mth of age. 2-dose primary vaccination Two 0.5-mL dose, interval of at least 2 mth between primary doses. Booster vaccination: Given at least 6 mth after the last priming dose, preferably between 11 & 13 mth of age. Preterm infants born after at least 24 wk of gestational age 3-dose primary vaccination vaccination Three 0.5-mL dose, interval of at least 1 mth between primary doses. Booster vaccination: Given at least 6 mth after the last priming dose, preferably before 18 mth of age. Where a dose of hepatitis B vaccine is given at birth, Infanrix hexa can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of 6 wk.
Contraindications
Hypersensitivity to the active substances, or to excipients, or after previous administration of DTP, hepatitis B, polio or Hib vaccines. Encephalopathy of unknown aetiology, occurring w/in 7 days following previous vaccination w/ pertussis-containing vaccine. Postpone vaccination in subjects suffering from acute severe febrile illness.
Special Precautions
If any of the following occur, the decision to give further doses of pertussis-containing vaccine should be carefully considered: 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. Infant or child suffering from a new onset or progression of a severe neurological disorder; thrombocytopenia or bleeding disorder; history of febrile convulsions. Very preterm infants (born ≤28 wk of gestation), or w/ history of resp immaturity. Immunosuppressed patients. Do not administer intravascularly or intradermally. Co-administration w/ pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine. +ve urine test for Hib capsular polysaccharide antigen. Not intended for use in childn >36 mth of age.
Adverse Reactions
Appetite lost; crying abnormal, irritability, restlessness; fever (≥38°C), local swelling at inj site (≤50 mm), fatigue, pain, redness. Nervousness; diarrhoea, vomiting; fever (>39°C), inj site reactions including induration, local swelling at inj site (>50 mm).
Drug Interactions
Higher rate of febrile reactions w/ pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine. Adequate response may not be achieved w/ immunosuppressive therapy.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07CA09 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Form
Infanrix Hexa vaccine (inj)
Packing/Price
(Vial + pre-filled syringe) 0.5 mL x 2's
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