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, pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg, pertactin 8 mcg, HBsAg 10 mcg, inactivated poliovirus [type 1 (Mahoney strain) 40 D-antigen unit, type 2 (MEF-1 strain) 8 D-antigen unit & type 3 (Saukett strain) 32 D-antigen unit], HIB polysaccharide (PRP) 10 mcg (conjugated to tetanus toxoid as carrier protein approx 25 mcg)
Indications/Uses
Primary immunisation against DPT, hepatitis B, poliomyelitis & HIB in infants from 6 wk & in infants who received 1st dose of hepatitis vaccine at birth.
Dosage/Direction for Use
Deep IM inj Primary immunisation Full-term infant 3 doses of 0.5 mL w/ at least 1 mth interval between primary doses. Booster dose to be given at least 6 mth after last priming dose & before 18 mth; 2 doses of 0.5 mL w/ at least 1 mth interval between primary doses. Booster dose to be given at least 6 mth after last priming dose & between 11 & 13 mth. Preterm infant born after at least 24 wk of gestation 3 doses of 0.5 mL w/ at least 1 mth of interval between primary doses. Booster dose to be given at least 6 mth after last priming dose & 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
Anaphylactic reaction. Not to be inj intravascularly or intradermally. Not for prevention against diseases caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, HBV, poliovirus or HIB. Postpone vaccination in patients w/ acute severe febrile illness. Temp ≥40°C; collapse or shock-like state; persistent, inconsolable crying lasting ≥3 hr occurring w/in 48 hr of vaccination; convulsions w/ or w/o fever occurring w/in 3 days of vaccination. Thrombocytopenia or bleeding disorder; history of febrile convulsions or Sudden Infant Death Syndrome; syncope. Resp monitoring for 48-72 hr in very preterm infants (≤28 wk of gestation) & w/ previous history of resp immaturity. Immunosuppressed patients. Co-administration w/ pneumococcal conjugate vaccine. Defer pertussis immunization in childn w/ progressive neurological disorders.
Adverse Reactions
Loss of appetite; irritability, abnormal crying, restlessness; somnolence; inj site pain, redness & swelling (≤50 mm), fever ≥38°C. Nervousness; vomiting, diarrhoea; pruritus; inj site swelling (>50 mm) & reactions including induration, fever >39.5°C.
Drug Interactions
Higher febrile reaction rate w/ pneumococcal conjugate vaccine. Adequate immunologic response may not be achieved w/ immunosuppressants. Increased risk of fever, inj site pain, loss of appetite & irritability w/ meningococcal B & 7-valent pneumococcal conjugate vaccine.
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) (pre-filled syringe)
Packing/Price
(vial + pre-filled syringe) 0.5 mL x 2's
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