Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Cholera vaccin

Generic name
Cholera vaccin
Brand name
ATC Code
J07AE01

Pharmacokinetics in children

Niet van toepassing

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

On-label

Licensed use Licensed use

Registration Status Title

Primaire vaccinatie cholera:
ORAAL
> 6 jaar: 2 doses met 1 week interval
2-5 jaar: 3 doses met 1 week interval

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Available formulations

Per ml susp. oraal:
Vibrio cholerae Inaba, geïnactiveerd 10417 milj.kiem
Vibrio cholerae El Tor Inaba, geïnactiveerd 10417 milj.kiem
Vibrio cholerae Ogawa, geïnactiveerd 20833 milj.kiem
Choleratoxine-B-subunit 0.333 mg

 

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Dosages

Cholera vaccination
  • Oral
    • 2 years up to 6 years
      [1]
      • 3 ml/dose 3 doses with an interval of 1-6 weeks.
      • Directions for administration:

        Before administration, mix with 75 ml of sodium hydrogen carbonate solution, made using the effervescent granules supplied. Do not eat or drink from 1 hour before until 1 hour after ingestion.

        • Take the last dose at least 1 week before the start of potential exposure to cholera bacteria;
        • for continuous protection: revaccinate every 6 months with 1 dose; if more than 6 months have elapsed since the last vaccination, the primary series of 3 doses should be repeated in full.
    • ≥ 6 years
      [1]
      • 3 ml/dose 2 doses with an interval of 1-6 weeks.
      • Directions for administration:

        Before administration, mix with 150 ml of sodium hydrogen carbonate solution, made using the effervescent granules supplied. Do not eat or drink from 1 hour before until 1 hour after ingestion.

        • Take the last dose at least 1 week before the start of potential exposure to cholera bacteria;
        • for continuous protection, revaccinate adults and children from age 6 years every 2 years with 1 dose; if more than 2 years have passed since the last vaccination, the primary series of 2 doses should be repeated in full; 

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Adult Side Effects

Soms (0,1-1%): diarree, buikpijn, buikkramp, gasvorming. Hoofdpijn.

Zelden (0,01-0,1%): koorts, malaise. Misselijkheid, braken, verminderde eetlust. Duizeligheid. Rinitis, hoesten.

Zeer zelden (< 0,01%): dyspepsie, keelpijn. Dehydratie, sufheid, slapeloosheid, flauwvallen, verminderde smaak. Zweten, exantheem. Gewrichtspijn, vermoeidheid, rillingen.

Verder zijn gemeld: gastro-enteritis, lymfadenitis, paresthesie, hypertensie, dyspneu, verhoogde sputumproductie, jeuk, urticaria, angio-oedeem, griepachtige verschijnselen, asthenie.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in adults

De toediening uitstellen bij acute gastro-intestinale aandoeningen of een acute aandoening die gepaard gaat met koorts.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Haemophilus influenzae B vaccines
J07AG01
Meningococcal vaccines
J07AH09
J07AH07
J07AH08
Pertussis vaccines
J07AJ52
Pneumococcal vaccines
J07AL02
Tuberculosis vaccines
J07AN01
Typhoid vaccines
J07AP03
J07AP01

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Reference

  1. Valneva SWeden AB, SmPC Dukoral (EU/1/03/263/001-3) 23-10-2018, www.geneesmiddelinformatiebank.nl

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Changes

Changes