Concise Prescribing Info
Contents
Per 0.5 mL Diphtheria toxoid ≥30 IU, tetanus toxoid ≥40 IU, Bordetella pertussis antigens: pertussis toxoid 25 mcg, filamentous haemagglutinin 25 mcg, inactivated poliomyelitis virus type 1 (Mahoney strain) 40 DU, inactivated poliomyelitis virus type 2 (MEF-1 strain) 8 DU, inactivated poliomyelitis virus type 3 (Saukett strain) 32 DU, polysaccharide of HIB 10 mcg, conjugated to tetanus protein 18-30 mcg
Indications/Uses
Joint prevention of diphtheria, tetanus, pertussis, poliomyelitis & invasive infections caused by H. influenzae type b (eg, meningitis, septicaemia, cellulitis, arthritis, epiglottitis); primary vaccination in infants from 2 mth & booster vaccination 1 yr after primary vaccination during the 2nd yr of life.
Dosage/Direction for Use
IM Infant Primary dose 3 doses of 0.5 mL at 4-wk intervals using a 2, 4, 6 mth schedule. Booster dose 1 inj w/in the 2nd yr of life or at least 6 mth after the last priming dose.
Contraindications
Hypersensitivity to any component of Pentaxim, glutaraldehyde, neomycin, streptomycin, or polymyxin B, & to pertussis vaccine (acellular or whole cell). Life-threatening reaction after previous inj of the vaccine or a vaccine containing the same substances. Postpone vaccination in case of fever or acute disease. Evolving encephalopathy. Encephalopathy w/in 7 days after previous dose of any vaccine containing pertussis antigens. Uncontrolled neurologic disorder or uncontrolled epilepsy.
Special Precautions
Do not inject intravascularly or intradermally. Reduced immunogenicity by immunosuppressive treatment or immunodeficiency. Guillain-Barre syndrome or brachial neuritis; thrombocytopenia or bleeding disorder. Vaccination must be preceded by medical history screening especially w/ regard to vaccination history & any occurrence of undesirable events & a clinical exam. Carefully consider giving further doses in: Fever ≥40°C not due to another identifiable cause, collapse or shock-like state (hypotonic-hyporesponsive episode), persistent, inconsolable crying lasting ≥3 hr w/in 48 hr vaccination, convulsions w/ or w/o fever occurring w/in 3 days of vaccination. Monitor temp & regularly give antipyretics for 48 hr following vaccination. Assess history of afebrile convulsion not related to a previous vaccine inj. Administer in 2 separate inj sites & on 2 different days the 2 vaccines, diphtheria-tetanus-pertussis-poliomyelitis vaccine & the H. influenzae type b conjugate vaccine in the event of oedematous reactions occurring in the lower limbs after inj. Does not protect against invasive diseases caused by serotypes other than H. influenza type b nor against meningitis from other origins. Potential risk of apnoea; monitor resp for 48-72 hr after primary immunisation to very premature infants (≤28 wk of gestation) & particularly for those w/ previous history of resp immaturity; do not w/hold or delay vaccination. Interference w/ lab urine test. Phenylketonuria. Intended for paed use only.
Adverse Reactions
Loss of appetite; nervousness, irritability, abnormal crying; somnolence; vomiting; inj site erythema, oedema, pain, fever ≥38°C. Insomnia, sleep disturbances; diarrhoea; inj site induration.
Drug Interactions
+ve urine test w/in 1-2 wk following vaccination; perform other tests to confirm HIB infection during this period.
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 vaccine
Packing/Price
(powd) 0.5 mL x 2's (Rp708,979/boks)
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