Generic Name and Formulations:
Diphtheria and tetanus toxoids + acellular pertussis adsorbed + inactivated poliovirus vaccine (susp); Hib conjugate (tetanus toxoid conjugate, PRP) (lyophilized pwd); 0.5mL/dose; for IM inj after mixing; contains residual trace amounts of formaldehyde, 2-phenoxyethanol, neomycin, polymyxin B.
Sanofi Pasteur, Inc.
Indications for PENTACEL:
Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age (prior to 5th birthday).
Each dose is 0.5mL IM, in anterolateral thigh (infants) or deltoid muscle. Give as a 4 dose series at 2 months, 4 months, 6 months, and 15–18 months of age. May give 1st dose as early as 6 weeks of age. Previously vaccinated with ≥1 dose of Daptacel, IPV, or Hib conjugate vaccine: Pentacel may be used to complete vaccination series; see full labeling. May give other vaccines concurrently (use separate inj site).
Anaphylaxis associated with any previous dose or component. Encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine. Progressive neurological disorder (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).
Fever (≥105°F within 48hrs), persistent inconsolable crying (lasting ≥3hrs within 48hrs), shock (within 48hrs), seizure (within 3 days), or Guillain-Barre syndrome (within 6 weeks) of previous tetanus toxoid vaccine. Seizure risk (may pretreat with antipyretics, eg, acetaminophen). May defer in acute febrile illness. Have epinephrine inj (1:1000) available. Immune deficiency. Pregnancy (Cat.C): not recommended.
Concomitant vaccines: see full labeling. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.
DTaP-IPV + Hib/PRP-T.
Local reactions: inj site erythema, swelling, tenderness. Systemic reactions: fever, crying, fussiness.
Report adverse events to VAERS at (800) 822-7967 and to Sanofi Pasteur at (800) 822-2463.
Doses—5 (2 vials/dose)