Vaxchora effervescent powder and powder for oral suspension: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vaxchora effervescent powder and powder for oral suspension

cholera vaccine (recombinant, live, oral)

Read the entire leaflet carefully before taking this vaccine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This vaccine has been prescribed for you only; do not give it to other people.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

What Vaxchora is and what it is used for
What you need to know before taking Vaxchora
How to take Vaxchora
Possible side effects
How to store Vaxchora
Contents of the pack and other information

1. What Vaxchora is and what it is used for

Vaxchora is an oral cholera vaccine that stimulates immune defense in the intestine. The vaccine is used to protect against cholera in adults and children aged 2 years and older. The vaccine should be taken at least 10 days before traveling to an area affected by cholera.

How Vaxchora works

Vaxchora prepares the immune system (the body's defenses) to fight against cholera. When a person takes the vaccine, the immune system produces proteins called antibodies against the cholera bacteria and their toxin, a harmful substance that causes diarrhea. This way, the immune system is prepared to combat cholera bacteria if the person comes into contact with them.

2. What you need to know before taking Vaxchora

Do not take Vaxchora:

if you are allergic to any of the components of this medicine (listed in section 6).
if your immune system is weakened, either from birth or due to treatments that suppress immunity, such as high-dose corticosteroids, anticancer medications, or radiotherapy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Vaxchora.

Contact a doctor immediately if you experience the following serious adverse reactions (see also section 4):

severe allergic reactions causing swelling of the face or throat, hives, itchy rash, and difficulty breathing and/or a drop in blood pressure and fainting.

If you have any of the following symptoms, or a combination of nausea, vomiting, diarrhea, or abdominal pain, consult your doctor, pharmacist, or nurse before taking the vaccine. Vaccination should be postponed until after recovery, as protection against cholera may be reduced.

Not all individuals who receive this vaccine will be fully protected against cholera. It is important to follow hygiene advice and take special care regarding food, diaper changing, and water consumption in areas affected by cholera.

This vaccine may be less effective if you have HIV.

The vaccine bacteria may be present in feces for at least 7 days after taking the vaccine. To avoid contamination, wash your hands thoroughly after using the toilet and before preparing food for at least 14 days after receiving this vaccine.

Children and adolescents

Do not administer this vaccine to children under 2 years of age, as it is unknown whether it is effective in this age group.

Other medicines and Vaxchora

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines or vaccines, including those obtained without a prescription, such as herbal remedies. This is because this vaccine may affect how other medicines or vaccines work.

In particular, consult your doctor, pharmacist, or nurse if you are taking:

Antibiotics: this vaccine may not work if taken simultaneously with antibiotics. Do not take this vaccine within 14 days after your last dose of an antibiotic. Avoid taking antibiotics for at least 10 days after receiving this vaccine.
Chloroquine for malaria prevention: this vaccine may not work if taken at the same time as chloroquine. Take this vaccine at least 10 days before starting chloroquine or 14 days after completing chloroquine treatment.
The typhoid vaccine Ty21a: this vaccine may not work if taken simultaneously with Ty21a. You should take this vaccine at least 2 hours before or after Ty21a.

If any of the above apply to you, consult your doctor, pharmacist, or nurse before taking this vaccine.

Taking Vaxchora with food and drink

Do not eat or drink for 60 minutes before and after taking this vaccine, as this could interfere with the vaccine's effectiveness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

The influence of Vaxchora vaccine on the ability to drive and operate machinery is negligible or none. However, some of the side effects mentioned in section 4 “Possible side effects” may temporarily affect your ability to drive or operate machinery. Do not drive or operate machinery if you do not feel well after vaccination.

Vaxchora contains lactose, sucrose, and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This vaccine contains 863 mg of sodium (the main component of table/cooking salt) per dose. This corresponds to 43% of the recommended daily sodium intake for an adult. Take this into account if you are on a sodium-controlled diet.

3. How to take Vaxchora

Follow exactly the administration instructions for this vaccine provided by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

The recommended dose is the contents of the two packets in the package. However, for children between 2 and less than 6 years of age, refer to Step 8 of the instructions on how to prepare the vaccine, shown below.

Protection against cholera is established within 10 days after taking Vaxchora. Your doctor, pharmacist, or nurse will advise you on how long before travel you should take the vaccine.

Instructions:

FOLLOW THE PREPARATION INSTRUCTIONS FOR THIS VACCINE EXACTLY AS PROVIDED IN THIS PACKAGE INSERT

Please read the following before starting:

Vaxchora may not work if any of the following occur:

Improper storage; the vaccine must be stored in the refrigerator (between 2 °C and 8 °C).
Use of an incorrect amount of water; exactly 100 ml must be used.
Use of the wrong type of water: cold or room temperature bottled water, with or without carbonation, must be used.
Mixing the packets in the wrong order; Packet 1 must be added to the water first. If the packets are mixed in the wrong order, discard the vaccine and contact your doctor or pharmacist for a replacement dose.
Avoid eating and drinking for 60 minutes before and after taking the vaccine, as this may reduce vaccine effectiveness.

Do not touch your eyes during vaccine preparation to avoid contamination.

If there is a spill of liquid or powder, clean the surface with hot water and soap or a bactericidal disinfectant.

If there is a significant spill (more than a few drops of liquid or grains of powder), discard the vaccine and contact your doctor or pharmacist for a new dose. DO NOT take the remaining medication.

Step 1

Gather the following materials:

Clean glass
Stirring utensil
Bottled water (still or carbonated, cold or room temperature, 25 °C or lower)
Measuring device for 100 ml of bottled water (e.g., measuring cup)
Scissors

Step 2

A hand holds a box indicated by an arrow pointing to it

Remove the vaccine from the refrigerator.

Step 3

Two hands holding two separate sachets, the first marked with the number 1 and the second with the number 2, indicating sequence

Locate the two packets: the packets are labeled 1 and 2.

Pocket 1 contains the “Vaxchora buffer” and is black and white. Pocket 2 contains the “Vaxchora® active ingredient” and is blue and white.

If either packet is not intact, do not use either packet and contact your doctor, pharmacist, or nurse for a replacement dose. Using a damaged packet may reduce vaccine effectiveness.

Step 4

A hand pours the contents of a bottle into a glass held by another hand

Measure 100 ml of bottled water, still or carbonated, cold or at room temperature, and pour it into a clean glass.

Using bottled water is necessary for the vaccine to be effective; if non-bottled water (e.g., tap water) is used, the vaccine may be ineffective.

Step 5

Two hands gripping and forcefully separating two halves of a medicinal package or sachet to open it properly

Use scissors to cut the top off Packet 1.

Do not place fingers inside the packet. Wash your hands if you touch the packet contents to reduce the risk of contamination.

Step 6

A hand holds a tilted bottle while pouring its liquid contents out

Empty the contents of Packet 1 into the water in the glass. It is effervescent.

Step 7

Line drawing of a hand holding a spoon and dipping it into a glass full of liquid, with an arrow indicating downward movement

Mix until the powder is completely dissolved.

Step 8 Schematic drawing showing the pouring of liquid from one glass to another to obtain a dose of approximately 50 ml

For children aged 2 to less than 6 years:

Stir and discard half of the buffer solution.

(Note: This step is NOT required for children 6 years of age and older or adults).

Step 9

Two hands using scissors to carefully cut a container or plastic wrapper to extract its contents

Use scissors to cut the top off Packet 2.

Do not place fingers inside the packet. Wash your hands if you touch the packet contents to reduce the risk of contamination.

Step 10

A hand pours the contents of a sealed sachet into a glass full of liquid through a continuous flow of powder

Empty the contents of Packet 2 into the glass.

Step 11

Drawing of a hand dipping a spoon into a glass of liquid

Mix for at least 30 seconds. The powder from Packet 2 may not dissolve completely. It will form a slightly cloudy mixture with some white particles.

If desired, after stirring for at least 30 seconds, a sweetener with stevia (no more than 1 gram or ¼ teaspoon) or sugar (sucrose, no more than 4 grams or 1 teaspoon) may be added to the suspension and stirred. DO NOT add other sweeteners, as this may reduce vaccine effectiveness.

Step 12

Line drawing of a man in profile drinking from a glass held in his left hand

Drink the entire contents of the glass within 15 minutes of preparation. Any residue remaining in the glass should be discarded. If you or your child ingest less than half of the dose, contact your doctor, pharmacist, or nurse immediately to determine if a repeat dose is needed.

Step 13

A hand dropping two numbered slips, one and two, downward

Dispose of empty packets according to local biohazard guidelines.

Ask your doctor, pharmacist, or nurse how to dispose of materials that have come into contact with the medication.

Step 14

Line drawing of a hand pressing a tissue or gauze over a wound from which liquid is oozing

If a spill occurs while mixing or taking the medication, or if residue (powder or liquid on stirring utensil, glass, or other object) remains on the mixing surface, clean up the spilled material or residue preferably with hot water and soap, or a bactericidal disinfectant, using a disposable cloth or paper towel. Discard the paper towel together with the empty packets (see above).

Step 15

Line drawing showing two hands shaking a powder sachet under a water stream

Wash the glass and spoon or stirrer with soap and hot water.

Step 16

Black and white drawing showing the

Wash your hands thoroughly with soap and hot water to avoid contamination.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all vaccines, this vaccine may cause adverse effects, although not everyone will experience them.

Contact a doctor immediately if you experience the following serious adverse effects:

severe allergic reactions causing swelling of the face or throat, hives, itchy rash, difficulty breathing, or a drop in blood pressure and fainting.

Other adverse effects:

Very common adverse effects (may affect more than 1 in 10 people):

fatigue,
headache,
stomach pain,
feeling dizzy or vomiting,
decreased appetite.

Common adverse effects (may affect up to 1 in 10 people):

diarrhoea.

Uncommon adverse effects (may affect up to 1 in 100 people):

fever,
joint pain,
dizziness,
gas (abdominal distension),
rash,
dry mouth,
constipation,
flatulence,
burping,
indigestion,
abnormal stools.

Rare adverse effects (may affect up to 1 in 1,000 people):

chills.

Additional adverse effects in children and adolescents

According to clinical trials, adverse reactions in children are expected to be of a similar type to those in adults. Some adverse reactions were more frequent in children than in adults, such as fatigue, stomach pain, vomiting, decreased appetite, and fever.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vaxchora

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date stated on the carton. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C).

Keep in the original packaging to protect from light and moisture.

When kept in its original packaging, the vaccine is stable for up to 12 hours at 25 °C. After this period, the vaccine must be used immediately or discarded. Avoid exposing Vaxchora to temperatures above 25 °C.

Do not use this vaccine if you notice that the sachets are damaged; contact your doctor, pharmacist, or nurse to obtain a replacement dose.

This medicine contains genetically modified organisms. Local biosafety guidelines must be followed for the disposal of unused medicine and all materials that have come into contact with it. Ask your doctor, pharmacist, or nurse how to dispose of containers, unused medicines, and all materials that have been in contact with them.

6. Contents of the container and other information

Composition of Vaxchora

Each dose contains from 4 × 108 to 2 × 109 viable cells of the CVD 103-HgR strain of Vibrio cholerae1.
The other components are sucrose, hydrolysed casein, ascorbic acid, lactose, sodium bicarbonate and sodium carbonate (see section 2. Vaxchora contains lactose, sucrose and sodium).
This vaccine contains genetically modified organisms (GMOs).

1 Produced using recombinant DNA technology.

Nature and contents of the container

One dose of Vaxchora effervescent powder and powder for oral suspension is supplied in a carton containing two sachets. One sachet contains the effervescent powder of white to off-white sodium bicarbonate buffer. The other sachet contains the active substance powder for oral suspension, white to beige in colour.

Marketing Authorisation Holder

Bavarian Nordic A/S, Philip Heymans Alle 3, DK-2900 Hellerup, Denmark

Manufacturer responsible for manufacturing

IL-CSM GmbH

Marie-Curie-Strasse 8

D-79539 Lörrach

Germany

Date of the most recent revision of this leaflet: 01/2025.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.