Monograph Details
|
|
Immune System
> Immunization
|
|
RECOMBIVAX HB PEDIATRIC/ADOLESCENT |
| Manufacturer |
|
Merck & Co., Inc. |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
HB. |
| Generic Name |
|
Hepatitis B surface antigen vaccine (recombinant) 5micrograms/0.5mL; susp for IM inj; aluminum hydroxide adsorbed; preservative-free. |
| Also |
• RECOMBIVAX HB ADULT
• RECOMBIVAX HB DIALYSIS
|
| Indications |
|
Hepatitis B immunization. |
| Adults and Children |
|
Use correct formulation; see literature. Give IM into anterolateral thigh for children; deltoid for adults. May give SC if risk of hemorrhage. Patients 0–19yrs of age (three-dose regimen): give 1st dose of 5micrograms at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose). Or, for patients 11–15yrs of age, may use alternate two-dose regimen: give 1st dose of 10micrograms at elected date and repeat after 4–6 months (2nd dose). Patients ≥20yrs of age: give 1st dose of 10micrograms at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose). Dialysis and pre-dialysis patients: give 1st dose of 40micrograms at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose); consider booster dose if antibody levels fall to <10mIU/mL). High-risk infants (mother is HBsAg positive or unknown) or if exposed to HBsAg: give hepatitis B immune globulin also (see literature). |
| Contraindications |
|
Yeast hypersensitivity. |
| Precautions |
|
Have epinephrine inj (1:1000) available. Serious active infection. Severely compromised cardiopulmonary status. Pregnancy (Cat.C). Nursing mothers. |
| Adverse Reactions |
|
Local reactions, irritability, fatigue, headache, fever, malaise, nausea, diarrhea, anorexia, pharyngitis, upper respiratory infection, anaphylaxis. |
| How Supplied |
Single-dose vials: Ped/Adolescent 5mcg/0.5mL (yellow cap)—1, 10
Adult 10mcg/1mL (green cap)—1, 10
Dialysis 40mcg/1mL (blue cap)—1 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
