Generic Name and Formulations:
Diphtheria and tetanus toxoids, acellular pertussis vaccine; aluminum hydroxide adsorbed; susp for IM inj; preservative-free; contains traces of formaldehyde, polysorbate 80.
Indications for INFANRIX:
Diphtheria, tetanus, and pertussis immunization in children 6 weeks up to 7 years of age (before 7th birthday).
Each dose is 0.5mL IM. Primary series: Give 1st dose preferably at 2 months of age (may give as early as 6 wks of age); then give 2nd dose 4–8 wks later, then give 3rd dose 4–8 wks later, then give 4th dose at 15–20 months of age (6–12 months after 3rd dose); may give 5th dose at 4–6 yrs of age, unless 4th dose was given after 4th birthday. Or, may be used to complete a DTaP vaccination series initiated with Pediarix.
Anaphylaxis associated with any previous diphtheria, tetanus, pertussis vaccine. Encephalopathy within 7 days of a previous pertussis vaccine. Progressive neurologic disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).
Guillain-Barre syndrome within 6 weeks of previous tetanus vaccination. Fever (≥105°F within 48 hours), persistent inconsolable crying (≥3 hours within 48 hours), shock (within 48 hours), or seizures (within 3 days) after previous pertussis vaccine: see literature. Seizure risk: may give antipyretics. Latex allergy (prefilled syringes). Have epinephrine available. Pregnancy (Cat.C): not applicable.
Concomitant vaccines: see literature. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.
Local reactions, fever, irritability/fussiness, crying, drowsiness, loss of appetite, vomiting, diarrhea.
Report adverse events to VAERS at (800) 822-7967 and to GlaxoSmithKline at (888) 825-5249.
Single-dose vials—10; Single-dose prefilled Tip-Lok syringe—5 (without needles)