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
Dukoral suspension and effervescent granules for oral suspension.
Cholera vaccine (inactivated, oral).
| Pharmaceutical Form |
|---|
|
Suspension and effervescent granules for oral suspension:
|
Each dose of vaccine suspension (3 ml) contains:
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*
* 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 Granules for oral suspension in a sachet: Sodium hydrogen carbonate |
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.
Valneva Sweden AB, S-105 21 Stockholm, Sweden
+46 (0)8 735 1000
infodukoral@valneva.com
EU/1/03/263/001-003
Date of first authorisation: 28 April 2004
Date of latest renewal: 25 March 2009
| Drug | Countries | |
|---|---|---|
| DUKORAL | Austria, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, United Kingdom, South Africa |
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