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mORCVAX
ORAL CHOLERA VACCINE
The vaccine is a liquid formulation of oral Cholera vaccine containing O1 (consisting of V.Cholerae classical type and Eltor) and O139 of Vibrio cholerae inactivated with either heat or formaldehyde. The manufacturing process consists of following steps: culture in appropriate medium, inactivate by formaldehyde or heat, concentrate by centrifugation or filtration, remove cholera toxin. The formulation of final bulk is calculated by Lipopolysaccharide (LPS) content to ensure concentration of the antigens required to stimulate immunogenicity for the prevention of cholera disease.
Vaccine information
Description
The Oral Cholera Vaccine – mORCVAX is produced from cholerea bacteria strain O1 (consisting of V.Cholerae classical type and Eltor) and O139. The manufacturing process consists of following steps: culture in appropriate medium, inactivate by formaldehyde or heat, concentrate by centrifugation or filtration, remove cholera toxin. The formulation of final bulk is calculated by Lipopolysaccharide (LPS) content to ensure concentration of the antigens required to stimulate immunogenicity for the prevention of cholera disease.
COMPOSITION
1.5 ml consists of:
- 600 E.U. LPS cholerae O1, El Tor, Phil. 6973 (inactivated by formaldehyde)
- 600 E.U. LPS cholerae O139, 4260B (inactivated by formaldehyde)
- 300 E.U. LPS cholerae O1, Cairo 50 (inactivated by formaldehyde)
- 300 E.U. LPS cholerae O1, Cairo 50 (inactivated by heat)
- 300 E.U. LPS cholerae O1, Cairo 48 (inactivated by heat)
- Thimerosal ≤ 0.02 % (w/v).
INDICATION
- For children from above 2 years old (> 24 months) and adults are at areas with high frequency of cholera disease.
- For people entering the endemic area.
CONTRAINDICATION
- Acute infectious intestinal diseases.
- Temporary acute and chronic diseases.
- In use of immuno-suppressive drugs, cancer drugs.
- In case of allergic or anaphylactic reaction with the first dose, do not continue.
ADVERSE REACTION
After using, nausea or vomiting maybe occur, other adverse effects are not serious and no hospital treatment required.
PRECAUTIONS
- Precautions
Protection against cholera disease:
Not all people who take the vaccine will be fully protected against cholera disease. This vaccine will not protect against diarrhoea caused by other organisms. Therefore users have to comply with immunization schedule strictly and other preventive such as to avoid contact with contaminated sources (patient of cholera disease, contaninated food/water, ….), to ensure personal hygiene (wash hands before eating and after using toilet facilities,…).
Pregnancy:
This vaccine should not use for pregnant women unless the benefits outweigh the risks. If getting pregnant while using this vaccine, contact to your doctor immediately.
Breast-feeding women: This vaccine may be safely used while breast–feeding.
Further more information contact to healthcare professional.
- Warning
No use vaccine for child under 2 years of old.
Shake well before use. The opened vial should be used within 6 hours in sterile storage condition at 2-8ºC.
ADMINISTRATION AND DOSAGE
- Oral administration.
- Dosage: 1.5 ml/dose.
- Primary immunization: two doses with 14 day intervals.
- Booster immunization: at risk of outbreak of endemic cholera, use two doses with 14 day intervals.
DRUG INTERACTIONS
No full studies on drug interactions.
There may be an interaction between the vaccine and any of the following:
- Immunosuppressants e.g., azathioprine, cyclosporine, prednisone, dexamethasone, etanercept, infliximab, tacrolimus, sirolimus…;
- Other orally vaccines/ medications: do not take 1 hour before after taking the vaccine.
If you are taking any of these medicines, advise with your doctor or pharmacist.
OVERDOSE & TREATMENT
- Overdose study is unfeasible. Up to now, no overdose case report has received from user.
- No medical treatment of that has been studied. However as a common vaccine it should not take overdose.
STORAGE
Stored and transported at 2 – 8°C, do not freeze. Do not use the vaccine when frozen.
SHELF LIFE
24 months from manufacturing date at 2 – 8°C.
PACKING SIZE
- 7.5 ml (5 doses)/vial x 10 vials/ box.
- 1.5 ml (1 dose)/vial x 10 vials/ box.
SPECIFICATION
Manufacturer
NOTICE
- SHAKE WELL BEFORE USE
- KEEP OUT OF REACH OF CHILDREN.
- READ THE LEAFLET CAREFULLY BEFORE USE
*** All complaints about this vaccine must be reported directly, with information about series number, expiration date and relevant evidence (if any) to the manufacturer: Company for Vaccines and Biological Production No.1 (VABIOTECH). Address: No. 1 Yersin, Pham Đinh Ho Ward, Hai Ba Trung District, Hanoi. Phone: +84-24-39717710
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