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Paxvax, Inc. Drugs
For oral administration only.
2.1 Dosage and Schedule
Administer a single oral dose of VAXCHORA a minimum of 10 days before potential exposure to cholera.
The safety and effectiveness of revaccination with VAXCHORA have not been established.
2.2 Restrictions on Eating and Drinking
Instruct recipients to avoid eating or drinking for 60 minutes before or after oral ingestion of VAXCHORA.
2.3 Preparation, Reconstitution and Administration
Prepare and administer VAXCHORA in a healthcare setting equipped to dispose of medical waste [see Disposal Instructions (2.4)].1. Reconstitution should be completed within 15 minutes of removing the carton from the freezer [see Storage and Handling (16.2)]. Locate the 2 packets: the buffer component (Packet 1) and the active component (Packet 2). 2. Pour 100 mL of cold or room temperature (41°F-72°F; 5°C-22°C) purified bottled water into a clean, disposable cup. Do not use tap water, non-purified bottled water, other beverages, or other liquids. 3. Use scissors to cut the top off the buffer component packet. 4. Empty buffer component packet contents into cup. Effervescence will occur. 5. Using a disposable stirrer, stir until the buffer component completely dissolves. 6. Use scissors to cut the top off the active component packet. 7. Empty the active component packet contents (lyophilized V. cholerae CVD 103-HgR) into the cup containing the buffer solution. 8. Stir for at least 30 seconds and until active component disperses to form a slightly cloudy suspension that may contain some white particulates. The active component may not dissolve completely. 9. VAXCHORA must be consumed within 15 minutes of reconstitution. The recipient should drink the full contents of the cup at once. Some residue may remain in the cup and should be discarded with the cup.
NOTE: If the packets are reconstituted in the improper order, the vaccine must be discarded [see Disposal Instructions (2.4)].
2.4 Disposal Instructions
Dispose of the cup, packets and stirrer according to standard procedures for medical waste.
Inactivate any spilled vaccine and clean any non-disposable equipment used in the preparation of VAXCHORA with 70% isopropyl alcohol or 10% bleach solution.
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