DUKORAL VACCINE AGAINST CHOLERA AND ETEC-DIARRHOEA

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

RECOMBINANT CHOLERA TOXIN B SUBUNIT (rCTB); VIBRIO CHOLERAE O1 INABA CLASSIC STRAIN (HEAT INACTIVATED); VIBRIO CHOLERAE O1 INABA EL TOR STRAIN (FORMALIN INACTIVATED); VIBRIO CHOLERAE O1 OGAWA CLASSIC STRAIN (FORMALIN INACTIVATED); VIBRIO CHOLERAE O1 OGAWA CLASSIC STRAIN (HEAT INACTIVATED)

Dostopno od:

AENON PHARMACEUTICALS SEA PTE. LTD.

Koda artikla:

J07AE01

Odmerek:

1 mg/dose

Farmacevtska oblika:

SUSPENSION

Sestava:

RECOMBINANT CHOLERA TOXIN B SUBUNIT (rCTB) 1 mg/dose; VIBRIO CHOLERAE O1 INABA CLASSIC STRAIN (HEAT INACTIVATED) 31.25 x 10^9 bacteria; VIBRIO CHOLERAE O1 INABA EL TOR STRAIN (FORMALIN INACTIVATED) 31.25 x 10^9 bacteria; VIBRIO CHOLERAE O1 OGAWA CLASSIC STRAIN (FORMALIN INACTIVATED) 31.25 x 10^9 bacteria; VIBRIO CHOLERAE O1 OGAWA CLASSIC STRAIN (HEAT INACTIVATED) 31.25 x 10^9 bacteria

Pot uporabe:

ORAL

Tip zastaranja:

Prescription Only

Izdeluje:

Valneva Sweden AB

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2003-02-06

Navodilo za uporabo

DUKORAL
®
VACCINE AGAINST CHOLERA AND ETEC-DIARRHOEA 
Oral suspension (vaccine) and effervescent granules (buffer).
COMPOSITION
I. Vaccine, one dose (3 ml) contains: 
_Vibrio cholerae_ O1 Inaba and Ogawa, classic and El Tor strains, ap-
proximately 1x10
11
 vibrios (heat/formalin inactivated), cholera to-
xin B subunit 1 mg, sodium dihydrogen phosphate, disodium hydro-
gen phosphate, sodium chloride, sterile water.
II. Sodium hydrogen carbonate, one sachet (5.6 g) contains: 
Sodium hydrogen carbonate, citric acid, sodium carbonate, saccha-
rin sodium, sodium citrate, raspberry flavour.
The vaccine is a whitish suspension in a single-dose glass vial. The 
sodium hydrogen carbonate is supplied as white effervescent gran-
ules with a raspberry flavour, which should be dissolved in a glass 
of water. 
Each dose of vaccine is supplied with one sachet of sodium hydro-
gen carbonate.
HOW DOES THE VACCINE WORK?
The vaccine stimulates the immunological defence in the intestinal 
tract and gives protection against cholera and ETEC-diarrhoea. The 
ETEC-bacterium is one of the most common causes of ”travellers’ 
diarrhoea”.  The  occurrence  of  ETEC  varies  a  lot  between  differ-
ent geographical areas. Satisfactory protection against cholera and 
ETEC diarrhoea can be expected about one week after basic im-
munisation is concluded.
INDICATION
Protection against cholera and ETEC-diarrhoea.
_Cholera:_ The vaccine is recommended for adults and children from 
2 years of age who will be visiting areas with an ongoing or antici-
pated epidemic or who will be spending an extended period of time 
in areas in which cholera infection is a risk.
_ETEC:_  The  vaccine  is  recommended  for  adults  and  children  from 
2  years  of  age  who  will  be  visiting  areas  posing  a  great  risk  of 

Lastnosti izdelka

DUKORAL
®
VACCINE AGAINST CHOLERA AND ETEC-DIARRHOEA
Oral suspension (vaccine) and effervescent granules (buffer).
COMPOSITION
I. VACCINE, ONE DOSE (3 ML) CONTAINS:
_Vibrio cholerae_ O1 Inaba and Ogawa, classic and El Tor strains,
approximately 1,25x10
11
vibrios (heat/formalin inactivated), cholera
toxin
B subunit 1 mg, sodium dihydrogen phosphate, disodium
hydrogen phosphate, sodium chloride, sterile water.
II. SODIUM HYDROGEN CARBONATE, ONE SACHET (5.6 G) CONTAINS:
Sodium
hydrogen
carbonate,
citric
acid,
sodium
carbonate,
saccharin sodium, sodium citrate, raspberry flavour.
The vaccine is a whitish suspension in a single-dose glass bottle. The
sodium hydrogen carbonate is supplied as white effervescent
granules with a raspberry flavour, which should be dissolved in a
glass of water. Each dose of vaccine is supplied with one sachet of
sodium hydrogen carbonate.
HOW DOES THE VACCINE WORK?
The vaccine stimulates the immunological defence in the intestinal
tract and gives protection against cholera and ETEC-diarrhoea. The
ETEC-bacterium is one of the most common causes of ”travellers’
diarrhoea”. The occurrence of ETEC varies a lot between different
geographical areas. Satisfactory protection against cholera and
ETEC diarrhoea can be expected about one week after basic
immunisation is concluded.
INDICATION
Protection against cholera and ETEC-diarrhoea.
_Cholera:_ The vaccine is recommended for adults and children from
2 years of age who will be visiting areas with an ongoing or
anticipated epidemic or who will be spending an extended period
of time in areas in which cholera infection is a risk.
_ETEC:_ The vaccine is recommended for adults and children from
2 years of age who will be visiting areas posing a great risk of
diarrhoeal illness caused by enterotoxigenic _Escherichia coli_
(ETEC).
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).
SPECIAL WARNINGS AND