Patient leaflet - Vaxchora
1. What Vaxchora is and what it is used for
Vaxchora is an oral vaccine against cholera that stimulates the immunological defence in the gut. The vaccine is used for protection from cholera in adults and children aged 2 years and older. The vaccine must be taken at least 10 days before travelling to a cholera-affected area.
How Vaxchora works
Vaxchora prepares the immune system (the body's defences) to defend itself against cholera. When a person takes the vaccine, the immune system makes proteins called antibodies against the cholera bacterium and its toxin (harmful substance) that causes diarrhoea. In this way the immune system is ready to fight cholera bacteria if the person comes into contact with it.
2. What you need to know before you take Vaxchora
Do not take Vaxchora:
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– if you are allergic to any of the ingredients in this medicine (listed in section 6).
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– if you had allergic reactions when you previously took Vaxchora.
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– if you have a weakened immune system, for example, if you were born with a weakened
immune system or if you are having treatments such as high-dose corticosteroid treatment, cancer medicines or radiotherapy that can weaken the immune system.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Vaxchora.
Not everyone taking Vaxchora will be fully protected against cholera. It is important to continue to follow hygiene advice and take special care with food and water in cholera-affected areas.
Vaxchora may be less effective if you have HIV.
Bacteria from the vaccine may be present in your stool for at least 7 days after you take the vaccine. To prevent any contamination, wash your hands thoroughly after visiting the toilet, changing nappies and before preparing food for at least 14 days after you take Vaxchora.
Children and adolescents
Do not give this vaccine to children younger than 2 years of age because it is not known how well it works in this age group.
Other medicines and Vaxchora
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines or vaccines. This includes medicines obtained without a prescription, including herbal medicines. This is because Vaxchora can affect the way some other medicines and vaccines work.
In particular tell your doctor, pharmacist or nurse if you are taking:
- antibiotics – Vaxchora may not work if you take it while you are also taking antibiotics. Take Vaxchora no earlier than 14 days after the last dose of an antibiotic. Avoid antibiotics for 10 days after taking Vaxchora.
- chloroquine for malaria prevention – Vaxchora may not work if you take it while you are also taking chloroquine. Take Vaxchora at least 10 days before starting chloroquine or 14 days after taking chloroquine.
- the typhoid vaccine Ty21a – Vaxchora may not work if it is taken at the same time as Ty21a. You should take Vaxchora at least 2 hours before or after taking Ty21a.
If any of the above apply to you, talk to your doctor, pharmacist or nurse before taking Vaxchora.
Vaxchora with food and drink
You must not eat or drink for 60 minutes before and after taking Vaxchora as this may reduce the vaccine’s effectiveness.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Vaxchora is not likely to affect your ability to drive or use machines. However, do not drive or use any machines if you are feeling unwell.
Vaxchora contains lactose, sucrose, and sodium
If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.
This vaccine contains 863 mg of sodium (the main component of cooking/table salt) per dose. This is equivalent to 43% of the recommended daily dietary intake of sodium for an adult. Please take this into account if you are on a controlled sodium diet.
3. How to take Vaxchora
Always take this vaccine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The recommended dose is the contents of both sachets in the carton. However for children 2 to less than 6 years old take note of Step 8 in 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 tell you how soon before travelling to take the vaccine.
Instructions:
PREPARE THIS VACCINE EXACTLY AS DESCRIBED IN THIS LEAFLET
Please read the following before you begin:
Vaxchora may not work if the following occurs:
- Incorrect storage; the vaccine must be stored in the refrigerator.
- Using the incorrect amount of water; 100 mL must be used.
- Using the incorrect type of water; bottled water that is cold or room temperature and non
carbonated must be used.
- Mixing the sachets in the wrong order; sachet 1 must be added to the water first. If the sachets are mixed in the wrong order you must discard the vaccine and request a replacement dose.
- Eating or drinking; must be avoided 60 minutes before and after taking the vaccine, eating or drinking can reduce the effectiveness of the vaccine.
Do not touch your eyes when you prepare the vaccine to avoid contamination.
If any powder or liquid gets spilt, clean the surface with hot water and soap or an antibacterial disinfectant.
If there is a significant spill (more than a few drops of liquid or grains of powder), dispose of the vaccine and get a new one from your doctor or pharmacist; DO NOT take the remaining medication.
Step 1 Gather materials:
- Clean cup
- Utensil to stir
- Bottled water (non-carbonated, cold or room temperature, 25°C or less)
- Item to measure 100 mL of bottled water (e.g. measuring jug)
- Scissors____________________________
Remove the vaccine from the refrigerator.
Locate the two sachets: the sachets are labelled 1 and 2.
Sachet 1 contains “Sodium hydrogen carbonate effervescent powder” (buffer) and is black and white. Sachet 2 contains “Vaxchora® Active ingredient” and is blue and white.
If a sachet is not intact, do not use either sachet and contact your doctor, pharmacist or nurse about acquiring a replacement dose; using a sachet that is not intact can reduce the effectiveness of the vaccine..
Step 4
Measure 100 mL of bottled cold or room temperature non-carbonated drinking water and pour into a clean cup.
Using bottled water is necessary for the vaccine to be effective -using non-bottled (e.g. tap water) may render the vaccine ineffective.
Step 5
Use scissors to cut off the top of sachet 1.
| Do not put your fingers into the sachet. Wash your hands if you touch the sachet contents, in order to reduce the chance of contamination. | ||
| Step 6 | Empty the contents of sachet 1 into the water in the cup. It will fizz. | |
| Step 7 | Stir until the powder completely dissolves. | |
| Step 8 | co / | For children age 2 to <6 years only: Pour away and discard half of the buffer solution. (Note: For children over 6 years and adults this step is NOT required) |
| 1 " rl | ||
| o =8 50 mL — – J |
Step 9 Use scissors to cut off the top of sachet 2.
Do not put your fingers into the sachet. Wash your hands if you touch the sachet contents, in order to reduce the chance of contamination.
Step 10
Empty the contents of sachet 2 into the cup.
| Step 11 X. \ \\ \ |
^“2 form a slightly cloudy mixture with some white particles. —y If desired, after stirring in sachet 2 for at least 30 seconds, stevia sweetener (no more than 1 gram or % teaspoon) or sugar (sucrose, not Z:j more than 4 grams or 1 teaspoon) may be added, and then stirred into the suspension. DO NOT add other sweeteners as this may reduce the effectiveness of the vaccine. |
| Step 12 ← yJ | --Drink the full contents of the cup within 15 \ minutes of preparing it. Some residue may Zi r remain in the cup and must be discarded. If y y you or your child take less than half of the / -i dose, contact your doctor, pharmacist, or /z \ nurse right away about the need for a repeat dose. |
| Step 13 J®| | Dispose of the empty sachets according to local biosafety guidelines. Ask your doctor, pharmacist or nurse how to throw away medicine waste material. |
| Step 14 f | If a spill occurs while stirring or drinking the medication, or there is any residue (powder or liquid left behind from a stirring utensil, cup, or other object) on the mixing surface, clean up spilled material or residue preferably with a disposable paper towel/cloth using hot water and soap or antibacterial disinfectant. Discard the paper towel together with the sachets (see above). |
| Step 15 L3 fe | Wash the cup and spoon or stirrer with soap and hot water. 1 |
Step 16
Wash your hands thoroughly with soap and hot water to prevent contamination.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all vaccines, this vaccine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you get the following serious side effects:
- serious allergic reactions causing swelling of the face or throat,hives, itchy rash, breathlessness and/or a drop in blood pressure and fainting.
Other side effects:
Very common side effects (may affect more than 1 in 10 people)
- headache,
- stomach pains,
- feeling or being sick,
- lack of appetite,
- tiredness.
- Common side effects (may affect up to 1 in 10 people) diarrhoea.
Uncommon side effects (may affect up to 1 in 100 people)
- flatulence,
- constipation,
- bloating (abdominal distension),
- indigestion,
- abnormal faeces,
- dry mouth,
- burping,
- fever,
- dizziness,
- joint pain,
- rash.
- Rare side effects (may affect up to 1 in 1,000 people): chills.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vaxchora
Keep this vaccine out of the sight and reach of children.
Do not use Vaxchora after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Store in the original package.
Vaxchora in the original package is stable for up to 12 hours at 25°C. Avoid exposing Vaxchora to temperatures above 25°C.
Do not use this vaccine if you notice the sachets are damaged and contact your doctor, pharmacist, or nurse for a replacement dose.
This medicine contains genetically-modified organisms. Local biosafety guidelines should be followed for unused medicine or waste material. Ask your doctor, pharmacist or nurse how to throw away medicines you no longer use or waste material.
6. Contents of the pack and other information
What Vaxchora contains
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– Each dose contains 4×108 to 2×109 viable cells of V. cholerae strain CVD 103-HgR.
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– The other ingredients are sucrose, hydrolysed casein, ascorbic acid, lactose, sodium bicarbonate,
and sodium carbonate.
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– This vaccine contains genetically modified organisms (GMOs).
What Vaxchora looks like and contents of the pack
The carton contains two sachets. One sachet contains white-to-off-white buffer sodium hydrogen carbonate effervescent powder. The other sachet contains white-to-beige active ingredient vaccine powder.
Marketing Authorisation Holder
Emergent Netherlands B.V, Strawinskylaan 411, 1077XX Amsterdam, Netherlands.
Manufacturer
IL-CSM GmbH
Marie-Curie-Strasse 8
D-79539 Lorrach
Germany
This leaflet was last revised in MM/YYYY.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
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CLINICAL PARTICULARS
4.1 Therapeutic indications
Vaxchora is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older.
This vaccine should be used in accordance with official recommendations.
4.2 Posology and method of administration
Posology
Adults and children aged 2 years and older
A single oral dose should be administered at least 10 days prior to potential exposure to V. cholerae O1.
Revaccination
No data are available on revaccination interval.
Paediatric population
The safety and efficacy of Vaxchora in children less than 2 years has not been established. No data are available.
EXPIRY DATE
EXP
SPECIAL STORAGE CONDITIONS
Store in a refrigerator.