Infanrix Hexa Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Brand Resources

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.

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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.

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Overdosage

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Contraindications

Hypersensitivity to vaccine or after previous inj. Encephalopathy of unknown aetiology occurring w/in 7 days following previous vaccination w/ pertussis-containing vaccine.

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Special Precautions

Anaphylactic reactions. 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.

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Use In Pregnancy & Lactation

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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.

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Drug Interactions

Higher febrile reaction rate w/ pneumococcal conjugate vaccine. Adequate 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.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Infanrix Hexa detailed prescribing information

Storage

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Description

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Action

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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.

Regulatory Classification

Presentation/Packing

Form

Infanrix Hexa vaccine (inj) (pre-filled syringe)

Packing/Price

(vial + pre-filled syringe) 0.5 mL x 2's

Infanrix Hexa

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma