Euvichol-Plus

Euvichol-Plus

vaccine, cholera

Manufacturer:

Eubiologics

Distributor:

Averroes Pharma
Full Prescribing Info
Contents
Vibrio cholerae O1 Inaba Cairo 48 (heat inactivated), Vibrio cholerae O1 Inaba Phil 6973 El Tor (formalin inactivated), Vibrio cholerae O1 Ogawa Cairo 50 (formalin/heat inactivated), Vibrio cholerae O139 4260 B (formalin inactivated).
Description
One dose (1.5 mL) contains: Active ingredients: Heat inactivated V. cholerae O1 Inaba Cairo 48 classical biotype 300 L.E.U, Formalin inactivated V. cholerae O1 Inaba Phil 6973 El Tor biotype 600 L.E.U, Formalin inactivated V. cholerae O1 Ogawa Cairo 50 classical biotype 300 L.E.U, Heat inactivated V. cholerae O1 Ogawa Cairo 50 classical biotype 300 L.E.U, Formalin inactivated V. cholerae O139 4260B 600 L.E.U.
Indications/Uses
Euvichol-Plus is indicated for active immunization against Vibrio cholerae but the efficacy against Vibrio cholerae serogroup O139 was not demonstrated.
The vaccine can be administered to anyone above the age of 1 year. Data for the safety and efficacy of the vaccine in infants (less than 1 year of age) is not available. The earliest onset of protection can be expected 7-10 days after the completion of the primary series of the vaccine.
Dosage/Direction for Use
Two doses of vaccines should be given at an interval of two weeks.
Route of Administration: The vaccine is only recommended for oral administration.
Overdosage
No case of overdose has been reported.
Contraindications
The vaccine should not be administered to persons with either known hypersensitivity to any component of the vaccine, or having shown signs of severe reaction due to the previously taken dose.
Immunization with Euvichol-Plus should be delayed in the presence of any acute illness, including acute gastrointestinal illness or acute febrile illness.
Special Precautions
As with any vaccine, immunization with Euvichol-Plus may not protect 100% of susceptible persons.
As with all vaccines, appropriate medical treatment should always be readily available in case of a rare event of anaphylactic reactions following the administration of the vaccine. For this reason, it is recommended that the person should remain under medical supervision for at least 30 minutes after vaccination.
This vaccine contains residual formaldehyde. Caution should be taken in subjects with known hypersensitivity to formaldehyde.
The safety and immune response of Euvichol-Plus has not been clinically evaluated in individual with HIV/AIDS.
No specific clinical study has been conducted to evaluate the efficacy and safety of Euvichol-Plus in pregnant and lactation women. Therefore, the vaccine is not recommended for use in pregnancy.
No clinical study has been performed to evaluate the efficacy and safety of Euvichol-Plus in infants (less than 1 year of age). Therefore, the vaccine is not recommended for use in infants.
Use In Pregnancy & Lactation
The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy or lactation is not recommended.
Side Effects
2,999 healthy children and adults (1-40 years) were participated in the clinical study for evaluating the safety.
After taking the vaccines, during first 7 days, the most frequently reported adverse drug reactions in the clinical trial were headache, fever, diarrhea, nausea/vomiting and myalgia and 102 subjects (3.40%) among 2,999 subjects were reported. The incidence rate for children and adults is described on the table as follows. (See Table 1.)

Click on icon to see table/diagram/image

After taking the vaccines, adverse drug reactions were examined for a period of 28 days. 69 subjects (2.30%) among 2,999 subjects were reported with the adverse effects, and gastrointestinal disorders were reported the highest numbers i.e., 35 subjects (1.17%). The adverse drug reactions during the study (28 days) were described on the table as follows.
(Uncommon: 0.1~5%, Rare: less than 0.1%) (See Table 2.)

Click on icon to see table/diagram/image
Drug Interactions
Appropriate studies have not been conducted to determine the interaction with other medicinal products.
Caution For Usage
Instructions for Use: 1. The vaccine should be administered to anyone above the age of 1 year.
2. Two doses of vaccine should be given at an interval of two weeks.
3. The vaccine is presented as a suspension. Therefore, after shaking the vaccine container rigorously, 1.5 mL of the vaccine should be squirted into the mouth. Take a sip of water if necessary.
4. The frozen vaccines should not be taken.
5. The vaccine should not be administered parenterally (intramuscularly, subcutaneously or intravenously).
Storage
The vaccine should be stored at 2°C ~ 8°C. Do not freeze.
Vaccine Vial Monitors (VVMs) are a part of the label attached on Euvichol-Plus supplied through EuBiologics Co., Ltd. The color dot which appears on the label of the vaccine is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vaccine has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its color will change progressively. As long as the color of this square is lighter than the color of the ring, the vaccine can be used. As soon as the color of the central square is the same color as the ring or of a darker color than the ring, the vaccine should be discarded.
Shelf-Life: The suspension can be used within 24 months form the date of manufactured if kept as recommended.
ATC Classification
J07AE01 - cholera, inactivated, whole cell ; Belongs to the class of cholera bacterial vaccines.
Presentation/Packing
Vaccine (oral) 1.5 mL (yellow to yellowish suspension in vial) x 5's, 10's, 50's.
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