Condition on Arrival
- Should not have been frozen; refrigerate on arrival.
Storage
- Store vaccine at 2°C to 8°C (36°F to 46°F);
storage above or below the recommended temperature may
reduce potency; DO NOT FREEZE since freezing
destroys potency.
Handling
- The vaccine should be used as supplied; no dilution
or reconstitution is necessary. The full recommended
dose of the vaccine should be used.
- Shake well before withdrawal and use. Thorough agitation
is necessary to maintain suspension of the vaccine.
- Parenteral drug products should be inspected visually
for extraneous particulate matter and discoloration prior
to administration whenever solution and container permit.
After thorough agitation, the vaccine is a slightly opaque,
white suspension.
General Tips
- If you have questions about the condition of the vaccine
at the time of delivery, you should immediately place
vaccine in recommended storage; and call the Merck Vaccine
Customer Center at 1-877-VAX-MERCK (1-877-829-6372), or call
the CDC at 1-800-CDC-INFO (1-800-232-4636).
- Rotate stock so that the shortest-dated vaccine is
used first.1
- Ensure that the refrigerator is plugged into an outlet
in a protected area where it cannot be disconnected accidentally.1
- Record refrigerator and freezer temperatures twice
a day in a temperature
log.1
- It is important to use a separate sterile syringe and
needle for each individual patient to prevent transmission
of infectious agents from one person
to another.
- Needles should be disposed of properly and should not
be recapped.2
- All vaccines must be discarded after the expiration
date; expired or damaged Vaccines for Children (VFC)
vaccines must be returned to your State Immunization
Program.
- For vaccines that are used as supplied, no reconstitution
is necessary. Click
here for a demonstration of proper handling when
reconstitution is not required.
- For general questions concerning the proper storage
and handling of Merck vaccines, please contact the Merck
Vaccine Customer Center at 1-800-MERCK-90 (1-800-637-2590),
Monday through Friday, 8:00 am to 7:00
pm ET.
- Before administering RECOMBIVAX HB,
please read the Prescribing
Information.
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.
- 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.
- In 3 clinical studies involving
healthy infants and children receiving 3 doses (5
mcg/0.5 mL) of RECOMBIVAX HB, the most frequent
complaints (>1% of injections) included irritability,
fever
(>101°F oral equivalent), diarrhea, fatigue/weakness, diminished
appetite, and rhinitis. In a study that compared the three-dose regimen (5
mcg) with the two-dose regimen (10 mcg) of the vaccine in adolescents, the
overall frequency of adverse reactions was generally similar. For a list of
adverse reactions, please read the Prescribing
Information.
- 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.
- As with any vaccine, vaccination with RECOMBIVAX HB
may not result in seroprotection of all vaccinees.
- Before administering RECOMBIVAX HB, please read the Prescribing
Information.
References: 1.
Centers for Disease Control and Prevention. Vaccine management:
Recommendations for storage and handling selected biologicals:
In: Atkinson W, Wolfe C, eds. Epidemiology and Prevention
of Vaccine-Preventable Diseases. 9th ed. Atlanta,
Ga: Dept of Health and Human Services; 2006: Appendix C. 2. Centers
for Disease Control and Prevention. National Immunization
Program. Vaccine storage and handling. Available at: http://www2a.cdc.gov/nip/isd/shtoolkit/splash.html.
Accessed November 9, 2006.
RECOMBIVAX HB is a registered trademark
of Merck & Co., Inc.
View storage and handling
requirements for all Merck vaccines.
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