Concise Prescribing Info
Contents
Per 0.5 mL Diphtheria toxoid ≥20 IU; tetanus toxoid ≥40 IU; Bordetella pertussis antigens: Pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg; inactivated poliomyelitis virus: Type 1 (Mahoney) 40 D antigen u, type 2 (MEF-1) 8 D antigen u, type 3 (Saukett) 32 D antigen u; HIB polysaccharide 10 mcg conjugated w/ tetanus protein 18-30 mcg
Indications/Uses
Joint prevention of diphtheria, tetanus, pertussis, poliomyelitis & invasive HIB infections (eg, meningitis, septicaemia, cellulitis, arthritis, epiglottitis); primary vaccination in infants from 2 mth & as booster vaccination 1 yr after primary vaccination during 2nd yr of life.
Dosage/Direction for Use
IM Infant ≥2 mth Primary vaccination 3 doses of 0.5 mL at 1-2 mth intervals. Booster vaccination 1 inj 1 yr after primary vaccination usually between 16 & 18 mth.
Contraindications
Hypersensitivity to Pentaxim; glutaraldehyde, neomycin, streptomycin or polymyxin B; pertussis vaccine (acellular or whole cell). Severe reaction after previous inj of vaccine or vaccine containing the same substances. Postpone vaccination in case of fever or acute illness. Progressive encephalopathies. Encephalopathy w/in 7 days of previous dose of any vaccine containing pertussis antigens.
Special Precautions
Appropriately treat & monitor patient if rare anaphylactic reaction occurs after vaccination. Do not inj intravascularly & intradermally. Immunogenicity may be reduced by immunosuppressives or immunodeficiency state. Carefully evaluate potential benefits & risks of continuing vaccination in subjects who have had Guillain-Barré syndrome or brachial plexus neuropathy during previous administration of tetanus toxoid containing vaccine. Individuals w/ thrombocytopenia or coagulation disorders. Search medical history & physical exam prior to vaccination. Carefully consider giving further doses if the following events occur w/in 48 hr after vaccination: Fever ≥40°C (w/ no other identifiable cause), collapse or shock-like state w/ hypotonic-hyporesponsive episode, persistent & inconsolable crying lasting ≥3 hr; seizures w/ or w/o fever w/in 3 days after vaccination. Monitor temp & regularly give antipyretics for 48 hr following vaccination. Assess history of febrile convulsions & non-febrile seizures unrelated to previous vaccination. Administer the 2 vaccines (diphtheria-tetanus-pertussis-poliomyelitis & HIB conjugate) at 2 separate inj sites & on different days in the event of oedematous reactions of the lower limbs occurring after inj of HIB-containing vaccine. No protection against invasive diseases caused by serotypes other than HIB or meningitis from other origins. Contains phenylalanine, ethanol & Na. Carefully consider potential risk of apnoea & need for resp monitoring for 48-72 hr when administering the primary vaccination doses in very premature infants (born at ≤28 wk of pregnancy) particularly those w/ history of resp immaturity. Intended for paed use only.
Adverse Reactions
Appetite loss; nervousness, irritability, abnormal crying & screaming; somnolence; vomiting; inj site erythema, oedema & pain, fever ≥38°C. Insomnia, sleep disorders; diarrhoea; inj site induration.
Drug Interactions
+ve urine test for 1-2 wk after vaccination may be observed; perform other tests to confirm HIB infection during this time.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07CA06 - diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus ; Belongs to the class of combined bacterial and viral vaccines.
Presentation/Packing
Form
Pentaxim powd for susp for inj (pre-filled syringe)
Packing/Price
(+ 1 vial lyophilised powd) 0.5 mL x 2's
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