Vaccine Information: Vaxchora (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

VAXCHORA is supplied as shown in Table 8. The contents of both packets are reconstituted with purified bottled or spring bottled water, to form one oral dose of the vaccine.

Table 8: VAXCHORA Product Presentation

Presentation	Carton NDC Number	Components
Single dose carton containing two packets	NDC 70460-004-01	Buffer Component Packet NDC 70460-003-02 Active Component Packet NDC 70460-002-02

16.2 Storage and Handling

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.

Packets should not be out of refrigerated storage for more than 12 hours prior to reconstitution; when out of refrigerated storage, packets should not be exposed to temperatures above 80°F (27°C).

17 PATIENT COUNSELING INFORMATION

Prior to administration of this vaccine, the health care professional should inform the individual of the following:

•

Advise vaccine recipients to exercise caution regarding food and water consumed in cholera-affected areas, in accordance with the recommendations from the Centers for Disease Control and Prevention for the prevention of cholera in travelers.

•

Educate vaccine recipients regarding the most common adverse reactions occurring within 7 days post-vaccination with VAXCHORA (tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, and diarrhea).

•

Inform vaccine recipients that VAXCHORA is a live attenuated vaccine and has the potential for transmission of the vaccine strain to close contacts (e.g., household contacts). For at least 14 days following vaccination with VAXCHORA, vaccine recipients should wash their hands thoroughly after using the bathroom and before preparing or handling food.

•

Register women who receive VAXCHORA while pregnant in the pregnancy registry by calling 1-800-533-5899 [see Pregnancy (8.1)].

•

Instruct vaccine recipients to report adverse reactions to their healthcare provider.

VAXCHORA^® is a registered trademark of Emergent Travel Health Inc.
US License No. 2199Manufactured by: Emergent Travel Health Inc.

Distributed by: Emergent Travel Health Inc., 555 Twin Dolphin Drive, Suite 360, Redwood City, CA 94065, USA

© 2020 Emergent BioSolutions Inc. All rights reserved.

Vax-USPI-v5.0-202012

PRINCIPAL DISPLAY PANEL — Carton

Carton

NDC 70460-004-01

STORE REFRIGERATED
Use After Reconstitution

Cholera Vaccine, Live, Oral
Vaxchora^®

Contents: Single-dose Active Packet (4×10⁸ to 2×10⁹ CFU of
Vibrio cholerae CVD 103-HgR) and Single-dose Buffer Packet.

Prior to administration, reconstitute Buffer in 100 mL of
purified bottled water or spring bottled water. For children
under 6 years of age only, discard half the buffer solution.
After reconstitution, then add Active.
See package insert.

emergent
biosolutions^®

Cholera Vaccine, Live, Oral
Vaxchora^®

emergent
biosolutions^®
Emergent Travel Health Inc. USA

DISTRIBUTED BY:
Emergent Travel Health Inc.
555 Twin Dolphin Drive, Suite 360
Redwood City, CA 94065

Cholera Vaccine, Live Oral
Vaxchora^®

Live vaccine for oral, active immunization against cholera
Store at 36°F to 46°F (2°C to 8°C)

Administration and dosage: see package insert
US License No. 2199

Rx ONLY

GTIN:
S/N:
EXP:LOT:

PRINCIPAL DISPLAY PANEL — Active and Buffer Packets

Buffer and Active Packets

BUFFER COMPONENT
OF VAXCHORA^®
(Cholera Vaccine, Live, Oral)

1

Packet 1 of 2. USE FIRST.

Contents (Single-Dose): Buffer

Directions: Add entire contents
of Packet 1 to 100 mL of purified
bottled or spring bottled water in
disposable cup, then stir.
For children under 6 years of age
only, discard half the buffer solution.
Go to Packet 2. See package insert.

Rx Only — For Oral Administration

EXP: LOT:

NDC 70460-003-02

Emergent Travel Health Inc.
US License No 2199

ACTIVE COMPONENT
of VAXCHORA^®
(Cholera Vaccine, Live, Oral)

2

Packet 2 of 2. USE LAST.

Contents (Single-Dose):
4×10⁸ to 2×10⁹ CFU of
lyophilized Vibrio cholerae
CVD 103-HgR.

Directions: Add contents of Packet 2
to cup and stir to create vaccine. See
package insert.

Rx Only — For Oral Administration

EXP: LOT:

NDC 70460-002-02

Emergent Travel Health Inc.US License No 2199

VAXCHORA cholera vaccine, live, oral kit

Product Information Product Type VACCINE Item Code (Source) NDC:70460-004

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70460-004-01 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKET 1 Part 2 1 PACKET 1

Part 1 of 2 VAXCHORA cholera vaccine, live, oral powder, for suspension

Product Information Item Code (Source) NDC:70460-002 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VIBRIO CHOLERAE CVD 103-HGR STRAIN LIVE ANTIGEN (VIBRIO CHOLERAE CVD 103-HGR STRAIN LIVE ANTIGEN) VIBRIO CHOLERAE CVD 103-HGR STRAIN LIVE ANTIGEN 1200000000 [CFU]

Inactive Ingredients Ingredient Name Strength SUCROSE HYDROLYZED CASEIN (ENZYMATIC; 1000 MW) ASCORBIC ACID ANHYDROUS LACTOSE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70460-002-02 1 POWDER, FOR SUSPENSION in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125597 09/15/2019

Part 2 of 2 BUFFER buffer powder, for suspension

Product Information Item Code (Source) NDC:70460-003 Route of Administration ORAL DEA Schedule

Inactive Ingredients Ingredient Name Strength SODIUM BICARBONATE SODIUM CARBONATE ASCORBIC ACID ANHYDROUS LACTOSE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70460-003-02 1 POWDER, FOR SUSPENSION in 1 PACKET None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125597 02/13/2020

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125597 02/13/2020

Labeler — Emergent Travel Health Inc. (080128378)

Establishment
Name	Address	ID/FEI	Operations
Emergent Biosolutions Berna Gmbh		480030654	API MANUFACTURE (70460-004), API MANUFACTURE (70460-002), API MANUFACTURE (70460-003), MANUFACTURE (70460-004), MANUFACTURE (70460-002), MANUFACTURE (70460-003), ANALYSIS (70460-004), ANALYSIS (70460-002), ANALYSIS (70460-003), PACK (70460-004), PACK (70460-002), PACK (70460-003)

Revised: 12/2020 Emergent Travel Health Inc.