DUKORAL Oral suspension / Granules Ref.[27525] Active ingredients: Cholera, inactivated, whole cell

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Valneva Sweden AB, S-105 21 Stockholm, Sweden +46 (0)8 735 1000 infodukoral@valneva.com

Product name and form

Dukoral suspension and effervescent granules for oral suspension.

Cholera vaccine (inactivated, oral).

Pharmaceutical Form

Suspension and effervescent granules for oral suspension:

  • Suspension for oral suspension
  • Granules for oral suspension in a sachet.

Qualitative and quantitative composition

Each dose of vaccine suspension (3 ml) contains:

  • A total of 1.25x1011 bacteria of the following strains:

Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 31.25x109 bacteria* Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) 31.25x109 bacteria* Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) 31.25x109 bacteria* Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x109 bacteria*

  • Recombinant cholera toxin B subunit (rCTB) 1 mg (produced in V. cholerae O1 Inaba, classical biotype strain 213.)

* Bacterial count before inactivation.

Excipients:

Sodium dihydrogen phosphate dihydrate 2.0 mg, disodium hydrogen phosphate dihydrate 9.4 mg, sodium chloride 26 mg, sodium hydrogen carbonate 3600 mg, sodium carbonate anhydrous 400 mg, saccharin sodium 30 mg, sodium citrate 6 mg.

One dose contains approximately 1.1 g sodium.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Cholera, inactivated, whole cell
List of Excipients

Suspension for oral suspension:

Sodium dihydrogen phosphate dihydrate
Disodium hydrogen phosphate dihydrate
Sodium chloride
Water for injections

Granules for oral suspension in a sachet:

Sodium hydrogen carbonate
Citric acid
Sodium carbonate, anhydrous
Saccharin sodium
Sodium citrate
Raspberry flavour

Pack sizes and marketing

The vaccine suspension is filled in a volume of 3 ml in vials (type I glass) with a rubber stopper (bromobutyl rubber) and a screw cap.

The effervescent granules are filled in an amount of 5.6 g in sachets with an inner layer of polyester/LD-polyethylene and an outer layer of aluminium/LD-polyethylene.

Each dose of vaccine is supplied as one vial of suspension together with one sachet of effervescent granules.

Pack sizes: 1x1 dose, 2x1 dose, 20x1 dose

Not all pack sizes may be marketed.

Marketing authorization holder

Valneva Sweden AB, S-105 21 Stockholm, Sweden
+46 (0)8 735 1000
infodukoral@valneva.com

Marketing authorization dates and numbers

EU/1/03/263/001-003

Date of first authorisation: 28 April 2004
Date of latest renewal: 25 March 2009

Drugs

Drug Countries
DUKORAL Austria, Canada, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, South Africa

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