Dukoral

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

recombinant cholera toxin B subunit, vibrio cholerae 01

Available from:

Valneva Sweden AB

ATC code:

J07AE01

INN (International Name):

cholera vaccine (inactivated, oral)

Therapeutic group:

Vaccines

Therapeutic area:

Cholera; Immunization

Therapeutic indications:

Dukoral is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas.The use of Dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions.Dukoral should not replace standard protective measures. In the event of diarrhoea measures of rehydration should be instituted.

Product summary:

Revision: 14

Authorization status:

Authorised

Authorization date:

2004-04-28

Patient Information leaflet

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUKORAL SUSPENSION AND EFFERVESCENT POWDER FOR ORAL SUSPENSION
Cholera vaccine (inactivated, oral)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS VACCINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
This vaccine has been prescribed for you only. Do not pass it on to
others.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See Section 4.
-
Make sure to mix the vaccine with buffer solution as described in this
leaflet. See Section 3.
WHAT IS 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 pack and other information
1.
WHAT DUKORAL IS AND WHAT IT IS USED FOR
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.
Dukoral causes your body to produce its own protection against
cholera. After getting the vaccine,
your body will make substances called antibodies, which fight the
cholera bacteria and toxin that
cause diarrhoea.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DUKORAL
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).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Dukoral
•
if you take a medical treatment that affects the immune system
•
if you have a disease of the immune system (including HIV infection).
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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
_ _
Dukoral suspension and effervescent powder for oral suspension
Cholera vaccine (inactivated, oral)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of vaccine suspension (3 ml) contains:
−
A total of 1.25x10
11
bacteria of the following strains:
_Vibrio cholerae_
O1 Inaba, classical biotype
_ _
(heat inactivated)
31.25x10
9
bacteria*
_Vibrio cholerae_
O1 Inaba, El Tor biotype (formalin inactivated)
31.25x10
9
bacteria*
_Vibrio cholerae_
O1 Ogawa, classical biotype (heat inactivated)
31.25x10
9
bacteria*
_Vibrio cholerae_
O1 Ogawa, classical biotype (formalin inactivated)
31.25x10
9
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.
3.
PHARMACEUTICAL FORM
Suspension and effervescent powder for oral suspension:
-
Suspension for oral suspension
-
Powder for oral suspension in a sachet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dukoral is indicated for active immunisation against disease caused by
_Vibrio cholerae_
serogroup O1
in adults and children from 2 years of age who will be visiting
endemic/epidemic areas.
The use of Dukoral should be determined on the basis of official
recommendations taking into
consideration the variability of epidemiology and the risk of
contracting disease in different
geographical areas and travelling conditions.
Dukoral should not replace standard protective measures. In the event
of diarrhoea measures of
rehydration should be instituted.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Primary vaccination schedule _
The standard primar