Infanrix Hexa

Infanrix Hexa

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 0.5 mL Diphtheria toxoid not <30 IU, tetanus toxoid not <40 IU, Bordetella pertussis antigens (pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg, pertactin 8 mcg), HBsAg 10 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], HIB polysaccharide (polyribosylribitol phosphate, PRP) 10 mcg (conjugated to tetanus toxoid approx 25 mcg)
Indications/Uses
Primary & booster vaccination of infants against DPT, hepatitis B, poliomyelitis & HIB.
Dosage/Direction for Use
Deep IM Full-term infants Primary vaccination 2 or 3 doses of 0.5 mL w/ at least 1 mth interval between doses. Booster After vaccination w/ 3 doses: Give at least 6 mth after last priming dose & preferably before age 18 mth. After vaccination w/ 2 doses: Give at least 6 mth after last priming dose preferably between age 11 & 13 mth. Pre-term infants born after at least 24 wk of gestational age Primary vaccination 3 doses of 0.5 mL w/ at least 1 mth interval between doses. Booster Give at least 6 mth after last priming dose & preferably before 18 mth.
Contraindications
Hypersensitivity to vaccine or after previous inj. Encephalopathy of unknown aetiology, occurring w/in 7 days following previous vaccination w/ pertussis-containing vaccine.
Special Precautions
Postpone in patients w/ acute severe febrile illness. Not to be administered intravascularly or intradermally. Not for prevention against diseases caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, HBV, poliovirus or HIB. Thrombocytopenia or bleeding disorder; immunocompromised patients. Syncope. History of febrile convulsions. Perform review of medical history & clinical exam before vaccination. Carefully consider giving further doses of pertussis-containing vaccines in patients w/ 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. Concomitant use w/ pneumococcal conjugate vaccine. Observe +ve urine test w/in 2 wk following vaccination. Potential risk of apnoea & need for 48-72 hr resp monitoring in very preterm infants (≤28 wk gestation) & those w/ history of resp immaturity. Defer pertussis immunisation in childn w/ progressive neurological disorders including infantile spasms, uncontrolled epilepsy or progressive encephalopathy. Not intended for use in adults.
Adverse Reactions
Loss of appetite; irritability, abnormal crying, restlessness; somnolence; pain, redness, local swelling at inj site (≤50 mm), fever (≥38°C). Nervousness; vomiting, diarrhoea; pruritus; local swelling at inj site (>50 mm), fever (>39.5°C), inj site reactions including induration.
Drug Interactions
Higher rate of febrile reactions w/ pneumococcal conjugate vaccine. More frequent occurrence of fever, inj site pain, appetite loss & irritability w/ MenB vaccine & 7-valent pneumococcal conjugate vaccine. Concomitant use w/ immunosuppressants.
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
0.5 mL x 2's
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