Vaxchora polvo efervescente y polvo para suspension oral
Introduction
Package Insert: Information for the User
Vaxchora Effervescent Powder and Oral Suspension Powder
Cholera Vaccine (Recombinant, Live, Oral)
Read this package insert carefully before taking this vaccine because it contains important information for you.
- Keep this package insert, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This vaccine has been prescribed only for you, and you should not give it to others.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.
1. What is Vaxchora and what is it used for
Vaxchora is an oral cholera vaccine that stimulates intestinal immune defense. The vaccine is used for protection against cholera in adults and children aged 2 years and older. The vaccine must be taken at least 10 days before traveling to a cholera-affected area.
How Vaxchora works
Vaxchora prepares the immune system (the body's defenses) to defend against cholera. When the person takes the vaccine, the immune system produces proteins called antibodies against cholera bacteria and their toxin, a harmful substance that causes diarrhea. In this way, the immune system is prepared to fight against cholera bacteria if the person comes into contact with them.
2. What you need to know before starting Vaxchora
Do not take Vaxchora:
- if you are allergic to any of the components of this medication (listed in section 6).
- if your immune system is weakened, either from birth or due to treatments that weaken it, such as high doses of corticosteroids, oncological medications, or radiation therapy.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking Vaxchora.
Contact a doctor immediately if you experience the following severe adverse effects (see also section 4):
•severe allergic reactions that cause swelling in the face or throat, urticaria, pruritic exanthema, and shortness of breath and/or a drop in blood pressure and fainting.
If you experience any of the following effects or a combination of nausea, vomiting, diarrhea, or abdominal pain, consult your doctor, pharmacist, or nurse before taking the vaccine. The vaccination should be postponed until after recovery, as the protection against cholera may be reduced.
Not all people who take this vaccine will be completely protected against cholera. It is essential to follow hygiene guidelines and take special care with food, diaper changes, and water consumption in areas affected by cholera.
This vaccine may be less effective if you have HIV.
The bacteria in the vaccine may be present in stool for at least 7 days after taking the vaccine. To avoid contamination, wash your hands thoroughly after using the bathroom and before preparing food for at least 14 days after taking this vaccine.
Children and adolescents
Do not administer this vaccine to children under 2 years of age, as its effectiveness in this age group is unknown.
Other medications and Vaxchora
Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication or vaccine. This includes over-the-counter medications, including herbal remedies. This is because this vaccine may affect how other medications or vaccines work.
Especially, consult your doctor, pharmacist, or nurse if you take:
- antibiotics: this vaccine may not work if taken simultaneously with antibiotics. Do not take this vaccine before 14 days after the last dose of an antibiotic. Avoid antibiotics for at least 10 days after taking this vaccine.
- chloroquine for malaria prevention: this vaccine may not work if taken simultaneously with chloroquine. Take this vaccine at least 10 days before starting chloroquine or 14 days after 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 options apply to you, consult your doctor, pharmacist, or nurse before taking this vaccine.
Taking Vaxchora with food and drinks
You should not eat or drink for 60 minutes before and after taking this vaccine, as this may interfere with the vaccine's effectiveness.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
Driving and operating machinery
The influence of the Vaxchora vaccine on the ability to drive and operate machinery is negligible. However, some of the adverse effects mentioned in section 4 "Possible adverse effects" may temporarily affect the 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 told you that you have an intolerance to certain sugars, consult with them before taking this medication.
This vaccine contains 863 mg of sodium (the main component of table salt/for cooking) per dose. This is equivalent to 43% of the recommended daily sodium intake for an adult. Take this into account if you follow a low-sodium diet.
3. How to Take Vaxchora
Follow exactly the administration instructions of this vaccine indicated by your doctor, pharmacist or nurse. In case of doubt, consult your doctor, pharmacist or nurse again.
The recommended dose is the content of the two vials in the box. However, for children between 2 and less than 6 years old, note Step 8 of the instructions on how to prepare the vaccine, which is shown below.
Protection against cholera is established in 10 days after taking Vaxchora. Your doctor, pharmacist or nurse will indicate how long before traveling you should take the vaccine.
Instructions:
FOLLOW EXACTLY THE PREPARATION INSTRUCTIONS OF THIS VACCINE CONTAINED IN THIS PROSPECTUS Read the following before starting: This vaccine may not work if the following occurs:
Do not touch your eyes during the preparation of the vaccine to avoid contamination. If a spill of liquid or powder occurs, clean the surface with hot water and soap or a bactericidal disinfectant. If a significant spill (more than a few drops of liquid or grains of powder) occurs, discard the vaccine and request a new one from your doctor or pharmacist. DO NOT take the remaining medication. | |
Step 1 | Gather the material:
|
Step 2 | Remove the vaccine from the refrigerator. |
Step 3 | Locate the two vials: the vials are labeled as 1 and 2. Vial 1 contains the "tampón of Vaxchora" and is black and white. Vial 2 contains the "active principle of Vaxchora" and is blue and white. If a vial is not intact, do not use either vial and contact your doctor, pharmacist or nurse to obtain a replacement dose. If you use a vial that is not intact, the effectiveness of the vaccine may be reduced. |
Step 4 | Measure 100 ml of bottled water with or without gas, cold or at room temperature, and pour it into a clean glass. The use of bottled water is necessary for the vaccine to be effective; if you use non-bottled water (for example, tap water), the vaccine may be ineffective. |
Step 5 | Use scissors to cut the top of vial 1. Do not put your fingers in the interior of the vial. Wash your hands if you touch the contents of the vial to reduce the possibility of contamination. |
Step 6 | Empty the contents of vial 1 into the water in the glass. It is effervescent. |
Step 7 | Mix it until the powder is completely dissolved. |
Step 8 | Only for children between 2 and less than 6 years old: Shake and discard half of the buffer solution. (Note: For children over 6 years old and adults, this step is not required). |
Step 9 | Use scissors to cut the top of vial 2. Do not put your fingers in the interior of the vial. Wash your hands if you touch the contents of the vial to reduce the possibility of contamination. |
Step 10 | Empty the contents of vial 2 into the glass. |
Step 11 | Mix it for at least 30 seconds. It is possible that the powder from vial 2 will not completely dissolve. It will form a slightly turbid mixture with some white particles. If desired, after shaking vial 2 for at least 30 seconds, you can add sweetener with stevia (not more than 1 gram or ¼ teaspoon) or sugar (saccharose, not more than 4 grams or 1 teaspoon) and then shake the suspension. DO NOT add other sweeteners, as this may reduce the effectiveness of the vaccine. |
Step 12 | Drink the entire contents of the glass within 15 minutes of preparation. You may be left with some residue in the glass that must be discarded. If you or your child take less than half of the dose, contact your doctor, pharmacist or nurse immediately if you need to repeat a dose. |
Step 13 | Discard the empty vials according to local biosecurity guidelines. Ask your doctor, pharmacist or nurse how to dispose of the materials that have come into contact with the medication. |
Step 14 | If a spill occurs while mixing or taking the medication, or there is any residue (powder or liquid) on the mixing surface, clean the spilled material or residue with hot water and soap or a bactericidal disinfectant, and a cloth or disposable paper towel. Discard the paper towel along with the vials (see above). |
Step 15 | Wash the glass and spoon or stirrer with soap and hot water. |
Step 16 | Wash your hands thoroughly with soap and hot water to avoid contamination. |
If you have any other questions about the use of this medication, ask your doctor, pharmacist or nurse.
4. Possible Adverse Effects
Like all vaccines, this vaccine may produce adverse effects, although not all people will experience them.
Seek immediate medical attention if you experience the following severe adverse effects:
- Severe allergic reactions that cause swelling in the face or throat, hives, itchy rash, shortness of breath, or a drop in blood pressure and fainting.
Other adverse effects:
Frequent adverse effects (may affect more than 1 in 10 people):
- Fatigue,
- Headache,
- Stomach pain,
- Dizziness or vomiting,
- Loss of appetite,
Common adverse effects (may affect up to 1 in 10 people):
- Diarrhea.
Uncommon adverse effects (may affect up to 1 in 100 people):
- Fever,
- Joint pain,
- Dizziness,
- Gas (abdominal distension),
- Rash,
- Dry mouth,
- Constipation,
- Flatulence,
- Belching,
- 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, it is expected that adverse reactions in children will 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, loss of appetite, and fever.
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.
5. Conservation of Vaxchora
Keep this vaccine out of sight and reach of children.
Do not use this vaccine after the expiration date that appears on the box. The expiration date is the last day of the month indicated.
Store in a refrigerator (between 2 °C and 8 °C).
Store in the original packaging to protect it from light and humidity.
In its original packaging, the vaccine is stable for up to 12 hours at 25 °C. At the end of 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 observe that the packets are damaged and contact your doctor, pharmacist, or nurse for a replacement dose.
This medication contains genetically modified organisms. Follow local biosecurity guidelines to dispose of unused medication and all materials that have come into contact with it. Ask your doctor, pharmacist, or nurse how to dispose of the containers and medications you no longer need and all materials that have come into contact with them.
6. Contents of the packaging and additional information
Composition of Vaxchora
- Each dose contains 4 × 108to 2 × 109viable cells of the CVD 103-HgR strain ofVibrio Cholerae1.
- The other components are sucrose, hydrolyzed casein, ascorbic acid, lactose, sodium bicarbonate, and sodium carbonate (see section2. Vaxchora contains lactose, sucrose, and sodium).
- This vaccine contains genetically modified organisms (GMOs).
1Produced using recombinant DNA technology.
Appearance of the product and contents of the packaging
One dose of Vaxchora effervescent powder and oral suspension powder is presented in a box containing two sachets. One sachet contains the effervescent powder of sodium bicarbonate buffer, white to off-white in color. The other sachet contains the oral suspension powder of the active ingredient, white to beige in color.
Marketing Authorization Holder
Bavarian Nordic A/S, Philip Heymans Alle 3,DK-2900 Hellerup, Denmark
IL-CSM GmbH
Marie-Curie-Strasse 8
D-79539 Lörrach
Germany
Last review date of this leaflet:01/2025.
Other sources of information
The detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.
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