Composition:Recombinant Cholera B subunit and Inactivated Whole Cell of Vibrio Cholera
DESCRIPTION
Oravacs is an Enteric-coated Capsule containing light yellow or light brown lyophilized powder.
INDICATIONS
Indicated for protection against Cholera in children 2 years of age and older,teenagers and adults having contacts or risk of spread,mainly including:
· People living in the area with poor hygienic condition,epidemic area and high risk of epidemic area
· Travelers and travel service providers,inhabitant living on waters
· Workers in diet and food-processing industry,medical prevention staff
· People living in the area suffering from natural disasters
· Military staff carrying out the outdoor military logistics task
· People working in harbors and places along the railway,
· Workers dealing with sewers,feces,and garbage.
USAGE/DOSAGE/ADMINISTRATION
This preparation is for oral consumption
Those who are immunized for the first time,take one capsule each day on day 0,7 and 28
Those who have already had immunization,take three capsules the same as the initial immunization before prevalent season.
ADVERSE REACTIONS
No adverse reactions.Few people might have mild abdominal pain,urticaria,nausea and diarrhea,which can be self-cured.If there is a fatal side effect,get a
medical treatment as quickly as possible.
CONTRAINDICATIONGS
· Should not be used by subjects with fever,severe hypertension,heart,liver and kidney diseases,HIV and active tuberculosis.
· Should not be used by pregnant women and infants under 2 years old.
· Stop use in subjects who are allergic to this preparation and have adverse reaction after administration.
PRECAUTIONS
Prior to the administration,a competent medical expert is required for intensive guidance.
· To get a better result,it is recommended to take the vaccine 2 hours after meal and do not consume any food within 1 hour after taking the vaccine
· Two days after consuming the vaccine do not take raw,cold,oily,sour and spicy food
· Avoid freezing,cannot use after frozen
· After the sealing process,do not use the products if the capsules split
· Do not use after expiration date or if capsule has any odd smell
· Postpone intake if there is acute infection or febrile diseases unless recommended by medical doctors.
Due to the brittleness of the enteric-coated capsule,when taking out the capsule please use the side of the foil without the text print,peel off the foil from the edge and take out the capsule carefully to avoid breakage.
FORMULATION
Each capsule of OraVacs contains Inactivated Whole Cell of vibrio Cholera 5.0×1010
and Recombinant Cholera B subunit 1 mg
STORAGE
Store at 2℃~8℃ in dry place.DO NOT FREEZE.
PACKAGE
Aluminium-Aluminium Package
1 capsule/pack,2 capsules/pack,3 capsules/pack
SHELF LIFE
Two years
APPROVAL DOCUMENTS NO.
Guo Yao Zhun Zi S20030092
Manufacturer
Company:Shanghai United Cell Biotechnology Co,Ltd.