ACAM2000 (smallpox- vaccinia vaccine, live injection, powder, lyophilized, for solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN (UNII: 4SV59689SK) (VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN - UNII:4SV59689SK)

Tilgængelig fra:

Emergent Product Development Gaithersburg Inc.

Indgivelsesvej:

PERCUTANEOUS

Terapeutiske indikationer:

ACAM2000® is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. There are very few absolute contraindications to this vaccine for those who are at high risk for smallpox. The risk for experiencing serious vaccination complications must be weighed against the risks for experiencing a potentially fatal smallpox infection. See Warnings and Precautions (5) for persons who are at higher risk of experiencing serious vaccination complications. Severe Immune Deficiency Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems. Individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive ACAM2000. These individuals may include individuals who are undergoing bone marrow transplantation or individuals with primary or acquired immunodeficiency who require isolation. ACAM2000 has not been studied in pregnant women. Live vaccini

Produkt oversigt:

ACAM2000, Smallpox (Vaccinia) Vaccine, Live, is supplied in multiple-dose 3 mL clear glass vials containing lyophilized powder (freeze‑dried vaccine). After reconstitution with 0.3 mL of diluent, the vial contains approximately 100 nominal doses of 0.0025 mL of vaccinia virus (live), 1.0 - 5.0x108  PFU/mL or 2.5-12.5x105 PFU/dose. Diluent for ACAM2000, 50% (v/v) Glycerin USP, 0.25% (v/v) Phenol USP in Water for Injection USP, is supplied in 3 mL clear glass vials containing 0.6 mL of diluent. Bifurcated needles are supplied in boxes (5 x 5 x 1 in) containing 100 needles. 1 mL tuberculin syringes with 25 gauge x 5/8” needles are supplied for vaccine reconstitution. Both the vaccine and diluent vial stoppers are not made with natural rubber latex. ACAM2000 should be stored in a freezer with an average temperature of -15°C to -25°C (+5°F to -13°F). Prior to reconstitution, ACAM2000 vaccine retains a potency of 1.0x108 PFU or higher per dose for at least 18 months when stored at refrigerated temperatures of +2-8°C (36-46°F). During shipment, ACAM2000 should be maintained at a temperature of ‑10°C or colder. After reconstitution, ACAM2000 vaccine may be administered during a 6 to 8 hour workday at room temperature (20-25°C, 68-77°F). Reconstituted ACAM2000 vaccine may be stored in a refrigerator (2-8°C, 36-46°F) no longer than 30 days, after which it should be discarded [see Dosage and Administration (2.3) ]. Diluent for Smallpox Vaccine, (Vero Cells) Lyophilized, ACAM2000 should be stored at room temperature (15-30°C, 59-86°F). ACAM2000 contains live vaccinia virus that is transmissible, and should be handled as an infectious agent once vials are open. See 2.1 [Instructions for Vaccine Preparation] and 2.2 [Preparation / Handling Precautions and Instructions for Disposal] for details on handling and disposal.

Autorisation status:

Biologic Licensing Application

Indlægsseddel

ACAM2000- SMALLPOX (VACCINIA) VACCINE, LIVE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
Emergent Product Development Gaithersburg Inc.
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MEDICATION GUIDE
Smallpox (Vaccinia) Vaccine, Live
ACAM2000®
Please read this Medication Guide before you receive a vaccination
with ACAM2000. This Guide does
not take the place of talking to your healthcare provider about
ACAM2000 and the smallpox disease.
What is the most important information I should know about
the ACAM2000 smallpox vaccine?
•
If you are at a high risk for being exposed to smallpox, you should be
vaccinated even if you have
health problems, unless you have certain problems with your immune
system. People who have
health problems may have a higher chance of getting serious side
effects from vaccination but are
also those who have a higher chance of dying from the smallpox
disease.
•
ACAM2000 may cause serious heart problems called myocarditis and
pericarditis, or swelling of
the heart tissues. In studies, about 1 in every 175 persons who got
the vaccine for the first time may
have experienced myocarditis and/or pericarditis. On rare occasions
these conditions can result in
an irregular heart beat and death. Your chances of getting heart
problems from the vaccine are
lower if you have already had this vaccine before. You can have
myocarditis and/or pericarditis
even if you have no symptoms. Call your healthcare provider or get
emergency help right away if
you have:
•
chest pain or pressure
•
fast or irregular heartbeat
•
breathing problems
See “What are the possible side effects of ACAM2000?”
•
Because the vaccine has a live virus, it can spread to other parts of
your body or to other people if
you touch the vaccination site and then touch other parts of your body
or other people. The vaccine
virus can spread until the vaccination scab falls off (2 to 4 weeks
after vaccination). If the virus is
spread to a person who should not get the vaccine, the side effects
can be very serious and life-
threatening.
See “How do I care for the s

Produktets egenskaber

ACAM2000- SMALLPOX (VACCINIA) VACCINE, LIVE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACAM2000 SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ACAM2000.
ACAM2000, (SMALLPOX (VACCINIA) VACCINE, LIVE
LYOPHILIZED PREPARATION FOR PERCUTANEOUS SCARIFICATION
INITIAL U.S. APPROVAL: 2007
RECENT MAJOR CHANGES
none
INDICATIONS AND USAGE
ACAM2000
is indicated for active immunization against smallpox disease for
persons determined to be at high risk for
smallpox infection. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
Common adverse events include inoculation site signs and symptoms,
lymphadenitis, and constitutional symptoms, such
as malaise, fatigue, fever, myalgia, and headache (6.1). These adverse
events are less frequent in revaccinated persons
than persons receiving the vaccine for the first time. (6)
Inadvertent inoculation at other sites is the most frequent
complication of vaccinia vaccination. The most common sites
®
Administer ACAM2000 only after being trained on the safe and effective
administration of the vaccine by the
percutaneous route (scarification). (2.3)
A droplet of ACAM2000 is administered by the percutaneous route
(scarification) using 15 jabs of a bifurcated
needle. ACAM2000 should not be injected by the intradermal,
subcutaneous, intramuscular, or intravenous route.
(2.3)
The droplet (0.0025 mL) of reconstituted vaccine is picked up with a
bifurcated needle by dipping needle into
ACAM2000 vial. (2.3)
See full prescribing information for instructions for vaccine
preparation (2.2), administration including provision of the
Medication Guide to vaccinees and instruction to vaccinees about
vaccination site care, (2.3) and interpretation of
response to vaccination. (2.4)
Re-vaccination may be recommended (e.g. every 3 years). (2.5)
Individuals