suspension and effervescent granules for oral suspension 
Cholera vaccine (inactivated, oral)

Read all of this leaflet carefully before you start using this vaccine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This vaccine has been prescribed for you only. Do not give it to others.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.
  • Make sure that you have mixed the vaccine with buffer solution as explained in this leaflet. See section 3.

In this leaflet: 
1. What Dukoral is and what it is used for 
2. What you need to know before you use Dukoral 
3. How to use Dukoral 
4. Possible side effects 
5. How to store Dukoral 
6. Contents of the packaging and other information 

1. What Dukoral is and what it is used for

Dukoral is an oral vaccine against cholera that stimulates the immune system in the gut. The vaccine protects adults and children from the age of 2 against cholera.

Dukoral causes your body to produce its own protection against cholera. After receiving the vaccine, your body will make substances called antibodies, which fight cholera bacteria and the poison ( toxin et) that causes diarrhea.

2. What you need to know before using Dukoral

Do not use Dukoral

  • if you are allergic to any of the ingredients of the vaccine (listed in section 6) or to formaldehyde.
  • if you have a stomach ache or have an infection with a fever (vaccination should then be postponed).

Warnings and cautions

Talk to your doctor before taking Dukoral

  • if you are taking any medicines that affect your immune system
  • if you have a disease that affects the immune system (including HIV – infection ).

There is a certain risk that the vaccine provides poorer protection than in those with intact immune systems.

The vaccine does not provide complete protection and it is important to follow dietary and hygiene advice to avoid diarrhea.

Children

Do not give this vaccine to children younger than 2 years as the protection in this group has not been studied.

Other medicines and Dukoral

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Do not take other medicines starting 1 hour before and until 1 hour after taking the vaccine.

Dukoral with food and drink

Avoid food and drink starting 1 hour before and until 1 hour after vaccination.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this vaccine.

Driving and using machines

There is no reason to suspect that Dukoral will affect your ability to drive or use machines.

Dukoral contains sodium

Dukoral contains approximately 1.1 g of sodium per dose. This should be considered by patients on a low-salt diet.

3. How to use Dukoral

Always use this medicine exactly as described in this leaflet or as your doctor advised. Consult a doctor if you are unsure.

Adults and children from 6 years: The basic vaccination is 2 doses taken orally (by mouth) at least 1 week (up to 6 weeks).

  • Take the first dose at least 2 weeks before you start your journey.
  • Take the second dose at least 1 week after the first dose and at least one week before the trip.

The protection starts to work about 1 week after the last dose.

To maintain protection, a new dose is recommended within 2 years. If you received your last dose of vaccine within 2 years, one dose is enough to renew your protection. If more than 2 years have passed since you received your last vaccination dose, the basic vaccination (2 doses ) should be repeated.

Children 2 to under 6 years of age: The basic vaccination is 3 doses taken orally (by mouth) at least 1 week (up to 6 weeks). Only half the amount of the buffer solution should be mixed with the vaccine.

  • Give the first dose to the child at least 3 weeks before you start your journey.
  • Give the second dose to the baby at least 1 week after the first dose.
  • Give the third dose at least 1 week after the second dose and at least one week before starting your journey.

The protection starts to work about 1 week after the last dose.

To maintain protection, a new dose is recommended within 6 months. If less than 6 months have passed since the last vaccination, a dose will be sufficient to renew the protection. If more than 6 months have passed since the last vaccination, the basic vaccination (3 doses ) should be repeated.

Suspension one provided in a single-dose glass bottle is an off-white suspension. Each bottle comes with a bag containing white soda granules consisting of sodium bicarbonate. The effervescent granules should be dissolved in a glass of cold water and the buffer solution obtained should be mixed with the suspension. It is important to use the buffer solution, as it protects the vaccine from stomach acid.

Drink the whole mixture one within 2 hours after it has been mixed with the buffer solution.

Instructions for use:

Icons

To prepare the buffer solution, dissolve the effervescent granules in a glass of cold water (approx. 150 ml) by stirring gently.

Do not use any other liquid.

Children 2 to under 6 years of age: pour off half of the buffer solution.

2. Shake the Dukoral® suspension bottle (1 bottle = 1 dose )

3. Pour the contents of the Dukoral® suspension bottle into the glass with the buffer solution (see 1). Mix by stirring gently.

4. Drink the whole mixture within 2 hours. Avoid food and drink starting 1 hour before and up to 1 hour after drinking mixture one.

If you take more Dukoral then you should

If you take the doses less than a week apart, contact your doctor, pharmacist, or nurse.

Overdose is unlikely as each bottle of Dukoral contains only one dose.

If you have taken more than one dose at a time, contact your doctor, pharmacist, or nurse.

If you forget to take Dukoral.

You can take the second dose of Dukoral up to 6 weeks after the first dose (children 2 to 6 years of age should take 3 doses ). If more than 6 weeks have passed, contact your doctor, pharmacist, or nurse.

If you have any further questions on the use of this vaccine, contact your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Dukoral can cause side effects, although not everybody gets them.

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

  • severe diarrhea with fluid loss from the body
  • severe allergic reactions that cause swelling of the face or throat and shortness of breath

Other side effects:

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

  • Diarrhea, stomach pain, stomach cramps, bubbly and bloated stomach, gas, and general discomfort in the stomach
  • Headache

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

  • Fever
  • General malaise, dizziness
  • Nausea, vomiting, decreased or poor appetite
  • Swelling and irritation inside the nose and cough

Very rare side effects (may affect up to 1 in 10,000 people)

  • Rash
  • Sore throat, impaired sense of taste
  • fatigue/tirednessSweating, chills
  • Joint pain
  • Difficulty sleeping

No known frequency (occurs in an unknown number of users)

  • Flu-like symptoms, chest tightness, chills, general pain, feeling weak
  • Hives, itching
  • Swollen lymph nodes
  • Numbness and tingling
  • High blood pressure

5. How to store Dukoral

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° –8 ° C). Do not freeze.

Product stored in the outer carton, in an unopened bottle and sachet, is stable at temperatures up to 25 ° C for a period of 14 days. At the end of this period, the product should be used or discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are:31.25×10 9 bacteria * of each of the following V. cholerae O1 strains: Inaba classical biotype (heat-inactivated), Inaba El Tor biotype (formalin-inactivated), Ogawa classical biotype (heat-inactivated), Ogawa classical biotype (formalin-inactivated).Recombinant cholera toxin B subunit (rCTB) 1 mg.
    * bacterial content before inactivation
  • The other ingredients in the vaccine suspension are sodium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, and water for injections.
  • Effervescent granules contain sodium bicarbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate, and raspberry aroma.

What the medicine looks like and the contents of the pack

Dukoral is provided as a suspension and effervescent granules for oral suspension. The vaccine is an off-white suspension in a vial. Effervescent granules are white with raspberry flavor and are packaged in a sachet.

Dukoral is available in packs of 1, 2, and 20 doses. Not all pack sizes may be marketed.

Muhammad Nadeem

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