Cholera Vaccine, Inactivated, Whole Cell

Registered South African indications:

• Prevention of cholera

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to formaldehyde
• Acute gastrointestinal illness
• Acute febrile illness

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Human immunodeficiency virus 
• Patients with endogenous or iatrogenic immunosuppression
• Sodium controlled diet

Forms avail. in SA and covered in this monograph: sus

Cholera
- Active immunisation against cholera of travelers visiting an endemic area

• Oral (sus): 3ml, weekly for 2 weeks

If more than 6 weeks elapse between doses, basic immunisation should be restarted

Immunisation should be completed at least 1 week prior to potential exposure

See additional prescribing points

Paed. forms avail. in SA and covered in this monograph: sus

Cholera
- Active immunisation against cholera of travelers visiting endemic area

Younger than 2 years

• Not established for use

Between 2-6 years

• Oral (sus): 3ml, weekly for 3 weeks; Booster: 3ml, 6 months after last dose

Older than 6 years

• See adult dosage

If more than 6 weeks elapse between doses, basic immunisation should be restarted

Immunisation should be completed at least 1 week prior to potential exposure

For children between 2-6 years, half the amount of the
sodium hydrogen carbonate solution is discarded and the remaining part is mixed with the vaccine

See additional prescribing points

Pregnancy

• FDA Pregnancy Category Not Rated (NR)

Breastfeeding

• Caution; no information available

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no information available

Central Nervous System Disorders

• Headache
• Dizziness
• Drowsiness
• Insomnia
• Fainting
• Malaise
• Paraesthesia

Cardiovascular Disorders

• Hypertension

Respiratory Disorders

• Respiratory symptoms 
• Dyspnoea
• Increased sputum

Gastrointestinal Disorders

• Diarrhoea
• Abdominal cramps
• Abdominal pain
• Abdominal gurgling
• Abdominal discomfort
• Nausea and vomiting
• Sore throat
• Dyspepsia
• Gastroenteritis
• Flatulence

Endocrine and Metabolic Disorders

• Loss of appetite
• Dehydration

Musculoskeletal Disorders

• Joint pain

Skin and Subcutaneous Tissue Disorders

• Sweating
• Rash
• Urticaria
• Angioedema
• Pruritus

Immune, Blood and Lymphatic System Disorders

• Fever
• Lymphadenitis
• Flu-like syndrome

Sensory Disorders 

• Reduced sense of taste

No information available

None routine

Booster

• If up to 2 years have elapsed since the last vaccination for adults and up to 6 months for children aged 2-6 years a single booster dose should be given 
• If more than 2 years have elapsed since the last vaccination and more than 6 months for children aged 2-6 years the primary course should be repeated

Administration directions

• Before ingestion, the vaccine suspension should be mixed with a buffer (sodium hydrogen carbonate) solution
• The sodium hydrogen carbonate is supplied as effervescent granules, which should be dissolved in a glass of cool water (approx. 150ml)
• The vaccine suspension should then be mixed with the buffer solution and drunk within 2 hours
• Food and drink should be avoided 1 hour before and 1 hour after vaccination
• Oral administration of other medicinal products should be avoided within 1 hour before and 1 hour after administration

Most enterotoxigenic Escherichia coli (ETEC) strains produce an enterotoxin, which is structurally, pathophysiologically and immunologically similar to cholera toxin. This enterotoxin is neutralised by antibodies against cholera toxin subunit B. This means that the inactive cholera vaccine  also will protect against diarrhoeal illness caused by ETEC. Cholera and ETEC infections are limited to the intestinal tract. Therefore intestinal immunity is required for protection. The most efficient way of inducing intestinal immunity has been shown to be oral administration.

Suspension (per 3ml) 1mg

• Dukoral (Sanofi) originator