DUKORAL suspension and effervescent granules for oral suspensionCholera vaccine (inactivated, oral)

DUKORAL is an oral vaccine against cholera that stimulates the immunological defence in the gut. The vaccine protects adults and children from 2 years of age against cholera.

Do not use DUKORAL

• if you are allergic to any ingredient of the vaccine or to formaldehyde.
• if you have an acute stomach disorder or infection with fever (vaccination should be delayed).

Take special care with DUKORAL
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Tell your doctor if you take a medical treatment that affects the immune system or if you have a disease of the immune system (including AIDS). The vaccine may provide you with a lower level of protection than it does for people with healthy immune systems.

The vaccine does not provide complete protection and it is important to adhere to dietary and hygiene advice to avoid diarrhoeal diseases.

Using other medicines
Do not take other medicine 1 hour before and 1 hour after taking the vaccine. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using DUKORAL with food and drink

Avoid food and drink 1 hour before and 1 hour after the vaccination.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you may be pregnant or plan to become pregnant or are breast-feeding. Your doctor will decide if you should receive the vaccine DUKORAL?

Driving and using machines
There are no reasons to suspect that DUKORAL will affect your ability to drive or handle machines

Important information about some of the ingredients of DUKORAL

DUKORAL contains approximately 1.1 g sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Adults and children from 6 years of age: The primary vaccination is 2 doses. Doses are to be taken with an interval of 1 to 6 weeks. For continuous protection, re-vaccination is recommended after 2 years. If up to 2 years have passed since the last vaccination a single dose is sufficient. If more than 2 years have passed since the last vaccination, the primary vaccination (2 doses) should be repeated.

Children of 2 to 6 years of age: The primary vaccination is 3 doses. Only half of the amount of the sodium hydrogen carbonate solution should be mixed with the vaccine. Doses are to be taken with an interval of 1 to 6 weeks. For continuous protection, re-vaccination is recommended after 6 months. If up to 2 years have passed since the last vaccination a single dose is sufficient. If more than 2 years have passed since the last vaccination, the primary vaccination (3 doses) should be repeated.

Protection against cholera can be expected about 1 week after the primary vaccination is completed.

The vaccine is a whitish suspension supplied in a single-dose glass vial. Each dose of vaccine comes with one sachet package that contains white effervescent granules of sodium hydrogen carbonate. The granules should be dissolved in a glass of water and mixed with the vaccine. The sodium hydrogen carbonate solution protects the vaccine from the gastric acid.
Drink the vaccine within 2 hours after mixing with the sodium hydrogen carbonate solution.

Instructions:

1. Dissolve the effervescent granules sodium hydrogen carbonate in a glass of cool water approx. 150 ml. Children 2-6 years pour away half of the solution. 2. Shake the vaccine vial 1 vial 1 dose. 3. Add the vaccine to the sodium hydrogen carbonate solution. Mix well and drink the mixture.

Like all medicines, DUKORAL can cause side effects, although not everybody gets them. The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data)

Uncommon side effects (reported by less than 1 in a 100 but more than 1 in a 1,000 people) include: diarrhoea, stomach pain, stomach cramps, gurgling stomach, bloated stomach, stomach gas and general stomach discomfort, headache

Rare side effects (reported by less than 1 in a 1,000 but more than 1 in a 10,000 people) include: high temperature, generally feeling unwell, nausea, vomiting, loss of /or poor appetite, runny nose, cough and dizziness.

Very rare side effects (reported by less than 1 in a 10,000 people) include: fatigue/feeling tired, shivering, severe diarrhoea, joint pain, sore throat, reduced sense of taste, sweating, being unable to sleep, general pain, hives or nettle rash, other types of rashes, flu-like symptoms, weakness, feeling cold, breathlessness, pins and needles, dehydration (loss of water from the body), swelling of face, high blood pressure, chestiness, itching, and swelling of the lymph glands.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.
Do not use DUKORAL after the expiry date which is stated on the carton.
Store in a refrigerator (2-C ? 8-C). Do not freeze.

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.

What DUKORAL contains

• The active substances are: 31.25x10 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 prior to inactivation
• The other ingredients in the vaccine suspension are sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and water for injections.
• The effervescent granules contain sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate and raspberry flavour.

What DUKORAL looks like and contents of the pack

DUKORAL is presented as a suspension and effervescent granules for oral suspension. The vaccine is a whitish suspension supplied in a vial. The sodium hydrogen carbonate is white effervescent granules with a raspberry flavour supplied in a sachet.

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

Marketing Authorisation Holder and Manufacturer

Crucell Sweden AB, 105 21 Stockholm, Sweden.
+800 3856 7250

This leaflet was last approved in MM/YYYY