Clinical Pharmacology Details


DTP-HEPB-HIB Fully liquid combined vaccine


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Indications & Dose:

Active immunisation of infants and toddlers for protection against diphtheria, tetanus, pertussis, hepatitis B, and invasive illness caused by H. influenzae type b. Can be used interchangeably with other DTP-HepB-Hib vaccines.


DOSAGE Applicable national vaccination recommendations and/or WHO guidelines are to be followed.


Primary vaccination of infants (first year of life): 3 doses of 0.5ml each, at least one month apart, starting as early as 6 weeks of age. Can be given to children who have received hepatitis B vaccine at birth. Should not be used for hepatitis B vaccination at birth.


Reinforcing vaccination of toddlers (13–24 months after birth): one booster dose of 0.5ml.


METHOD OF ADMINISTRATION Intramuscular injection in the anterolateral thigh or alternatively in the deltoid region in children 13–24 months after birth. Simultaneous administration as a separate injection with other common childhood vaccines, according to locally recommended immunisation schedules is possible.

Contraindications:

known hypersensitivity to any vaccine component; having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B or Hib vaccines; who have experienced an encephalopathy of unknown aetiology after a previous vaccination with vaccine containing pertussis (in these cases vaccination should be continued with diphtheria, tetanus, hepatitis B and Hib vaccines).


Undesirable effects


- Gastrointestinal disorders: Common: diarrhoea, vomiting.


-General disorders and administration site conditions:Very common: injection site reactions (erythema, induration, pain).


Common: fever. Rare: influenza-like illness.


- Metabolism and nutrition disorders:Common: feeding disorders.


-Nervous system disorders: Common: sleepiness.


-Psychiatric disorders: Very common: crying.


 Common: irritability. Uncommon: persistent crying.


-Respiratory, thoracic and mediastinal disorders:


Rare: coughing.


-Skin and subcutaneous tissue disorders: Uncommon: rash.

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