Full Prescribing Info
Contents
Live attenuated Japanese encephalitis virus.
Description
A human dose of 0.5 ml contains: Live-attenuated JE virus 5.4 log PFU above (Seed strain: SA14-14-2), Gelatin 4.8 mg less, Sucrose 21 mg less, Lactose 21 mg less, Urea 2.4 mg less, Human Serum Albumin 3.0 mg less, Sterile Diluent (sterile water for injection) 0.5 ml.
CD.JEVAX, Japanese Encephalitis Vaccine, live is a sterile, lyophilized vaccine for subcutaneous use, prepared by passaging Japanese encephalitis (JE) virus, strain SA14-14-2 in monolayer of primary hamster kidney cell culture.
The product looks like a light yellow crisp cake. After reconstitution, it shall turn into a clear, orange-red or light pink liquid.
Indications/Uses
Prophylactic immunization against Japanese Encephalitis.
Dosage/Direction for Use
Administration of CD.JEVAX: Primary immunization for persons at least 9 months of age and older, a single dose of 0.5 ml subcutaneously, and a booster dose can be given from 3 months to 1 year after primary dose.
How to administer CD.JEVAX: After reconstitution with the diluent (sterile water for injection), the vaccine should be used within 1 hour.
The deltoid muscle of right or left arm is the recommended site of injection. The skin at the site of injection first should be disinfected with alcohol or iodine tincture and allowed to dry thoroughly before injection.
The vaccine should not be injected into a blood vessel.
Vaccine recipients should be monitored during and after receiving CD.JEVAX and if any reactions (fever, convulsion etc.) are observed, a healthcare provider should be contacted.
As for any vaccine, adequate treatment provision, including epinephrine, should be available for immediate use in case an anaphylactic reaction occur.
Contraindications
Persons with a proven or suspected history of hypersensitivity anaphylactic reaction to any component of the vaccine, including gelatin; Persons with fever, acute infectious disease, tympanitis or active untreated tuberculosis; Persons with malnutrition, general allergy and convulsion; Persons with cardiac, liver or kidney troubles; During pregnancy or lactation; Persons undergoing any type of immunosuppressive therapy; Persons with a weak or not proper functioning immune system.
Use In Pregnancy & Lactation
Do not administer during pregnancy or lactation.
Adverse Reactions
As is the case for all medications, also the administration of CD.JEVAX can cause adverse reactions.
Clinical reactions are observed in a small percentage of the vaccinees after administrate of CD.JEVAX.
Some events as follows have been reported after injection, which normally does not last longer than 2 days, mostly relieved spontaneously; commonly no particular treatment is required, in case of necessity, symptomatic treatment might be recommended: Fever (Increase temperature above 37.5°C); Rash and Nausea; Local redness, pain or sensitivity; Crying, lost of appetite, sleepiness or sleep problems (children).
Drug Interactions
Although no interactions are known with other medication, the healthcare provider should question the vaccinee, parent or guardian on recent or current medication usage.
Currently no clinical data is available of administration of CD.JEVAX at the same time with any other vaccine. However it is advisable to observe a period of at least 2 to 4 weeks when given prior or after to CD.JEVAX.
Caution For Usage
Before administer CD.JEVAX: Prior to injection the healthcare provider should question the vaccinee or his/her parent, or guardian on his/her recent medical history.
Remove plastic tab of flip-off cap. Do not remove the rubber stopper. Cleanse stopper with a suitable disinfectant. Reconstitute only with the diluent (sterile water for Injection). Shake vial thoroughly.
The vaccine should be inspected visually for extraneous particulate matter and/or discoloration prior to administration whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
The vaccine should be reconstituted just before use and not be frozen or stored again after reconstitution.
Storage
The vaccine should be stored and shipped at 2-8°C, protected from light. The diluents should be stored at between 2~30°C.
ATC Classification
J07BA02 - encephalitis, Japanese, inactivated, whole virus ; Belongs to the class of encephalitis viral vaccines.
Presentation/Packing
Inj (vial) 10's + 0.5 mL diluent (10's).
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