RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)] —
For most adults,a same
dose, same schedule regardless
of risk of infection with hepatitis B virus
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| Dosing schedule for RECOMBIVAX HB for
adult patients |
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aDialysis
and Predialysis patients should receive dialysis formulation
(40 mcg/1.0 mL)
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- RECOMBIVAX HB is indicated
for vaccination against infection caused by
all known subtypes of hepatitis B virus.
Select
Safety Information
- RECOMBIVAX HB is contraindicated
in the presence of hypersensitivity to yeast
or any component of the vaccine.
- Patients
who develop symptoms suggestive of hypensensitivity
after an injection with RECOMBIVAX HB should
not receive further injections of the vaccine.
- In a group of studies
involving healthy adults, the most frequent
complaints (>1% of injections)
in individuals receiving RECOMBIVAX HB included
injection-site reactions, fatigue/weakness,
headache, fever
(>100°F),
malaise, nausea, diarrhea, pharyngitis, and
upper
respiratory infection.
- Because of the long incubation period for
hepatitis B, it is possible for unrecognized
infection to be present at the time the vaccine
is given. The vaccine may not prevent hepatitis
B in such patients.
- Any serious active infection including febrile
illness is reason for delaying use of the vaccine
except when in the opinion of the physician,
withholding the vaccine entails a greater risk.
- Predialysis and Dialysis Patients: The vaccination
regimen for RECOMBIVAX HB Dialysis Formulation
consists of three 40 mcg doses of vaccine given
according to the following schedule: 1st dose
at elected date; 2nd dose 1 month later; 3rd
dose 6 months after the first dose.
- A booster dose or revaccination with RECOMBIVAX
HB Dialysis Formulation may
be considered in predialysis/dialysis patients
if the anti-HBs level is less than 10 mIU/mL.
- As with any vaccine,
vaccination with RECOMBIVAX HB may not result
in seroprotection of all vaccinees.
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In healthy adults <40 years of age, RECOMBIVAX HB was shown to be highly immunogenic
after the recommended 3-dose series
in clinical studies1…
In adults of all ages…
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- The duration of the protective
effect of RECOMBIVAX HB in healthy vaccinees is unknown
at present, and the need for booster doses is not
yet defined.
- Before administering RECOMBIVAX
HB, please read the Prescribing
Information.
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References: 1. West
DJ, Clinical experience with Hepatitis B vaccines. Am J
Infect Control. 1989;17(3) 172–180. 2. Data
available on request from Merck & Co., Inc., Professional
Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004.
Please specify information package 20703359(1)-HBV
RECOMBIVAX HB is a registered trademark of Merck & Co.,
Inc.
-HBV
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