Dukoral

Dukoral

Manufacturer:

Valneva Sweden AB

Distributor:

Biogenetech
Concise Prescribing Info
Contents
Per dose (3 mL) Vibrio cholerae (O1 Inaba & Ogawa, classic & El Tor strains) approx 1.25 x 1011 bacteria (heat/formalin inactivated), recombinant cholera toxin B subunit (rCTB) 1 mg. Sachet: Na hydrogen carbonate 5.6 g
Indications/Uses
Protection against cholera & enterotoxigenic E. coli (ETEC)-diarrhoea in adult & childn ≥2 yr.
Dosage/Direction for Use
Cholera Primary vaccination: Adult & childn >6 yr 2 doses at least 1-6 wk apart. Childn 2-6 yr 3 doses at least 1-6 wk apart. Re-vaccination: Adult If last dose was administered <2 yr, administer single dose w/in 2 yr. If >2 yr, repeat primary vaccination (2 doses). Childn 2-6 yr If last dose was administered <6 mth, administer single dose w/in 6 mth. If >6 mth, repeat primary vaccination (3 doses). ETEC-diarrhoea Adult & childn Primary vaccination: 2 doses at least 1-6 wk apart.
Administration
Should be taken on an empty stomach: Take 1 hr before or after food/drink. Dissolve the granules in a glass (approx 150 mL for adults or 75 mL for childn) of cool water, then mix soln w/ the vaccine susp. Drink w/in 2 hr.
Contraindications
Hypersensitivity to vaccine or formaldehyde. Acute stomach disorder or infection w/ fever.
Special Precautions
Patients w/ immune system disease including AIDS. Patients taking medicines affecting immune system. Controlled Na diet. Pregnancy & lactation. Not to be given in childn <2 yr.
Adverse Reactions
Severe diarrhea w/ water loss; serious allergic reactions causing face or throat swelling & breathlessness. Diarrhoea, stomach pain; cramps & gas, gurgling & bloated stomach, general stomach discomfort; headache.
ATC Classification
J07AE - Cholera vaccines ; Used for active immunizations.
Presentation/Packing
Form
Dukoral vaccine
Packing/Price
(vial) 3 mL x 1's
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