VAXCHORA- cholera vaccine, live, oral kit

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

VIBRIO CHOLERAE CVD 103-HGR STRAIN LIVE ANTIGEN (UNII: V9G528E9E0) (VIBRIO CHOLERAE CVD 103-HGR STRAIN LIVE ANTIGEN - UNII:V9G528E9E0)

متاح من:

Emergent Travel Health Inc.

الخصائص العلاجية:

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in persons 2 through 64 years of age traveling to cholera-affected areas. The effectiveness of VAXCHORA has not been established in persons living in cholera-affected areas. The effectiveness of VAXCHORA has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. VAXCHORA has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups. Do not use in persons who have a history of severe allergic reaction (e.g., anaphylaxis) to any ingredient of VAXCHORA or to a previous dose of any cholera vaccine [see Description (11)]. Risk Summary VAXCHORA is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Maternal cholera disease is associated with adverse pregnancy outcomes including fetal death. Fetal/neonatal adverse reactions The vaccine strain may be shed in the stool of the vaccinated mother for at least 7 days, with a potential for transmission of the vaccine strain from mother to infant during vaginal delivery. Risk Summary VAXCHORA is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to VAXCHORA. The safety and effectiveness of VAXCHORA have not been established in children younger than 2 years of age. The safety and effectiveness of VAXCHORA have not been established in adults 65 years of age or older. The safety and effectiveness of VAXCHORA have not been established in immunocompromised individuals. The immunologic response to VAXCHORA may be diminished in immunocompromised individuals [see Drug Interactions (7.3)] .

ملخص المنتج:

VAXCHORA is supplied as shown in Table 8. The contents of both packets are reconstituted with bottled water (purified, spring, or sparkling [carbonated]), to form one oral dose of the vaccine. Single dose carton containing two packets NDC 70460-004-01 Buffer Component Packet NDC 70460-003-02 Active Component Packet NDC 70460-002-02 Store VAXCHORA buffer component and active component packets refrigerated at 36°F to 46°F (2°C to 8°C). Protect from light and moisture. Packages may be stored at 48°F to 77°F (9°C to 25°C) for no more than 24 hours prior to reconstitution.

الوضع إذن:

Biologic Licensing Application

خصائص المنتج

VAXCHORA- CHOLERA VACCINE, LIVE, ORAL
EMERGENT TRAVEL HEALTH INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VAXCHORA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VAXCHORA.
VAXCHORA (CHOLERA VACCINE, LIVE, ORAL)
SUSPENSION FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
VAXCHORA is a vaccine indicated for active immunization against
disease caused by _Vibrio cholerae_
serogroup O1. VAXCHORA is approved for use in persons 2 through 64
years of age traveling to cholera-
affected areas. (1)
Limitations of Use:
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DOSAGE AND ADMINISTRATION
•
•
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DOSAGE FORMS AND STRENGTHS
Suspension for oral administration supplied as a packet of the buffer
component and a packet of the
active component (lyophilized _V. cholerae_ CVD 103-HgR). After
preparation, a single dose of VAXCHORA is
100 mL for persons 6 years through 64 years of age or 50 mL for
children 2 through 5 years of age. (3)
CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to any ingredient of
VAXCHORA or to a previous dose of any
cholera vaccine. (4)
WARNINGS AND PRECAUTIONS
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•
ADVERSE REACTIONS
The most common adverse reactions for adults (incidence > 3%) were
tiredness (31%), headache (29%),
abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%)
and diarrhea (4%). (6)
The most common adverse reactions for children and adolescents
(incidence ≥10%) were:
®
The effectiveness of VAXCHORA has not been established in persons
living in cholera-affected areas.
(1.1)
The effectiveness of VAXCHORA has not been established in persons who
have pre-existing immunity
due to previous exposure to _V. cholerae_ or receipt of a cholera
vaccine. (1.1)
VAXCHORA has not been shown to protect against disease caused by _V.
cholerae_ serogroup O139 or
other non-O1 serogroups. (1.1)
For oral administration only.
Prepare and administer VAXCHORA in a healthcare setting equipped to
dispose of medical waste.
(2.3)
Prepare V