Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: In total, 1X10Power 11 bacteria strains: Vibrio cholerae, Vibrio cholerae, Vibrio cholerae, Vibrio cholerae, cholera toxin
laboratory: Sbl Vaccin AB

Suspension and effervescent granules for oral suspension
Box of 2 Doses (Bottle + Sachet-dose)
All forms

Indication

DUKORAL is indicated for active immunization against Vibrio cholerae (cholera vibrio) serogroup O1 disease in adults and children 2 years of age and older traveling to areas where the disease is endemic / epidemic.

DUKORAL should be used according to official recommendations, which take into account the epidemiological variability and risk of contracting a disease in different geographical areas and travel conditions.

DUKORAL should not replace the usual protective measures. In case of diarrhea, rehydration measures should be instituted.

Dosage DUKORAL Suspension and effervescent granules for oral suspension Box of 2 doses (Bottle + sachet-dose)

Schedule of primary immunization

Usually, the first vaccination with DUKORAL includes 2 doses for adults and children aged 6 years and over. Children from 2 to 6 years old should receive 3 doses. Doses should be administered at intervals of at least one week. If more than 6 weeks elapse between doses, the primary vaccination should be repeated.

Immunization should be completed at least 1 week before exposure to V. cholerae O1.

Recall dose

To ensure continued protection against cholera, a single booster dose is recommended within 2 years for adults and children 6 years and older, and after 6 months for children aged 2 to 6 years. No clinical efficacy data evaluated the use of booster doses. However, immunological data suggest that if less than 2 years have elapsed since the last vaccination, a single booster dose should be given. If more than two years have elapsed since the last vaccination, the primary vaccination must be renewed.

Children under 2 years old

DUKORAL has been administered to children aged 1 to 2 years in tolerance and immunogenicity studies, but protective efficacy has not been studied in this age group. It is therefore not advisable to administer DUKORAL in children under 2 years.

Elderly

There is limited data on the protective efficacy of the vaccine in subjects over 65 years of age.

Administration mode

This vaccine is to be administered orally. It is in the form of a vaccine suspension to be mixed with a solution of sodium bicarbonate before ingestion. Sodium bicarbonate is presented as effervescent granules that must be dissolved in a glass of fresh water (about 150 ml). The vaccine suspension must then be mixed with the sodium bicarbonate solution and drunk within 2 hours. Avoid drinking and eating 1 hour before and 1 hour after vaccination. Oral administration of other drugs should be avoided 1 hour before and 1 hour after administration of DUKORAL.

Children 2-6 years old: Half of the sodium bicarbonate solution must be removed and the remaining portion (approximately 75 ml) is mixed with the entire contents of the vial containing the vaccine.

Against indications

Hypersensitivity to the active substances, to any of the excipients or to formaldehyde.

The administration of DUKORAL should be delayed in subjects with acute gastrointestinal disorder or acute febrile illness.

Dukoral side effects

The safety of DUKORAL has been evaluated in adults and children from 2 years of age in clinical trials in endemic and non-endemic countries for cholera and enterotoxigenic Escherichia coli (ETEC), which produces heat-labile enterotoxin. (LT). Over 94, 000 doses of DUKORAL have been administered in clinical trials. In trials evaluating tolerance, the mode of surveillance, the definition of symptoms and the follow-up period could be different. In the majority of studies, adverse events were assessed by passive surveillance. The most commonly reported adverse events, such as gastrointestinal symptoms including abdominal pain, diarrhea, loose stools, nausea and vomiting, occurred at the same frequency in the vaccine and placebo groups.

Classification according to frequency: Very common (≥1 / 10); frequent (≥1 / 100, <1/10); uncommon (≥1 / 1, 000), <1/100); rare (≥1 / 10, 000, <1/1000); very rare (<1 / 10, 000), not known (can not be estimated based on available data).

Within each frequency group, adverse effects are presented in descending order of severity.

Metabolism and nutrition disorders

Rare

Loss or lack of appetite

Very rare

dehydration

Nervous system disorders

Rare

cephalalgia

Rare

Fear of heights

Very rare

Drowsiness, insomnia, unconsciousness, loss of taste sensitivity

Respiratory, thoracic and mediastinal disorders

Rare

Respiratory symptoms (including rhinitis and coughing)

Gastrointestinal disorders

Rare

Diarrhea, abdominal cramps, abdominal pain, gurgling

intestinal / abdominal (gas), abdominal discomfort

Rare

Vomiting, nausea

Very rare

Sore throat, dyspepsia

Skin and subcutaneous tissue disorders

Very rare

Sweats, rash

Musculoskeletal and systemic disorders

Very rare

arthralgia

General disorders and administration site conditions

Rare

Fever, discomfort

Very rare

Fatigue, chills

Adverse reactions noted in post marketing surveillance

Additional adverse events reported during post-marketing surveillance are listed below.

Infections and infestations: Gastroenteritis

Hematologic and lymphatic system disorders: Lymphadenitis

Nervous system disorders: Paresthesia

Vascular disorders: Hypertension

Respiratory, Thoracic and Mediastinal Disorders: Dyspnoea, Intensification of Sputum

Gastrointestinal disorders: Flatulence

Skin and subcutaneous tissue disorders: Urticaria, Quincke's edema, pruritus

General disorders and administration site conditions: Pain, flu-like symptoms, asthenia, chills

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