Monograph Details
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Immune System
> Immunization
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PEDIARIX |
| Manufacturer |
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GlaxoSmithKline Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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DTaP + HB + IPV. |
| Generic Name |
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Diphtheria and tetanus toxoids, acellular pertussis vaccine, aluminum hydroxide adsorbed; hepatitis B vaccine (recombinant), aluminum phosphate adsorbed; inactivated polio vaccine; for IM inj; contains traces of formaldehyde, yeast protein, neomycin, polymyxin B, polysorbate 80; preservative-free. |
| Indications |
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Immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliovirus (types 1, 2, and 3) in infants age 6 weeks up to 7 years (before 7th birthday) born of HBsAg-negative mothers. |
| Children |
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Each dose is 0.5mL IM in deltoid or anterolateral thigh. Give 1st dose preferably at 2 months of age (may give as early as 6 weeks of age); then give 2nd dose 6–8 weeks later; then give 3rd dose 6–8 weeks later (preferably 8 weeks between doses). Previously vaccinated with one or more doses of individual components: see literature. Not for use as booster dose. |
| Adults |
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Not recommended. |
| Contraindications |
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Febrile illness. Acute infection. Anaphylaxis associated with previous dose. Encephalopathy within 7 days after previous DTaP or DTwP vaccination. Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy). |
| Precautions |
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May defer in acute febrile illness or active infection. Fever (≥105 F within 48 hours), persistent inconsolable crying (≥3 hours within 48 hours), shock (within 48 hours), or convulsions (within 3 days) after previous DTaP or DTwP vaccine: see literature. Neurologic or CNS disorders. Seizure risk (may give antipyretic). Coagulation disorders. Have epinephrine available. Latex allergy (syringes). Immunodeficiency. Pregnancy (Cat.C). |
| Interactions |
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Immunosuppressants: may get suboptimal response. |
| Adverse Reactions |
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Local reactions (pain, erythema, swelling), restlessness/sleepiness, fever, crying (>1 hour), loss of appetite; rare: seizure, anaphylaxis. |
| How Supplied |
Single-dose vials—10
Single-dose prefilled syringes—5 |
| Additional Resources |
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• Related Prescribing Note |
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