Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
Japanese encephalitis virus, Quantity: 4 PFU
Biocelect Pty Ltd
Japanese encephalitis virus
Injection, powder for
Excipient Ingredients: Albumin; mannitol; glutamic acid; histidine; sodium chloride; potassium hydroxide; lactose monohydrate; water for injections
Subcutaneous
1 powder vial and 1 diluent vial, 1 syringe and 2 needles
(S4) Prescription Only Medicine
IMOJEV is indicated for prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in individuals from 9 months of age and over.
Visual Identification: A white to creamy white homogeneous cake which might be retracted.; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2010-08-23
IMOJEV® I M O J E V ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING IMOJEV? Imojev contains the active ingredient Japanese encephalitis virus (live, attenuated). Imojev is used to help to protect you or your child against Japanese encephalitis. For more information, see Section 1. Why am I using Imojev? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE IMOJEV? Do not use if you have ever had an allergic reaction to Imojev or any of the ingredients listed at the end of the CMI Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Imojev? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Imojev and affect how it works. Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other vaccines or medicines, including medicines obtained without a prescription. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE IMOJEV? Imojev is given by your doctor, nurse or pharmacist. More instructions can be found in Section 4. How do I use Imojev? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING IMOJEV? THINGS YOU SHOULD DO Tell your doctor, nurse or pharmacist before you receive the vaccine: • If you or your child is allergic to the active ingredients, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you or your child can use this medicine. • If you or your child has an illness with febrile or acute disease. The vaccination should be postponed until after you or your child has recovered, • If you or your child has lowered immunity due to treatment with medicines such as corticosteroids or other medicines used to treat ca Läs hela dokumentet
. imoj-ccdsv10-piv5-18mar20 Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION – IMOJEV (JAPANESE ENCEPHALITIS VIRUS (LIVE, ATTENUATED) 1 NAME OF THE MEDICINE Japanese encephalitis virus (live, attenuated) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Imojev is a monovalent, live attenuated viral vaccine. The virus was obtained via recombinant DNA technology. It is based on the 17D-204 yellow fever vaccine virus in which two genes have been replaced by the corresponding genes from Japanese encephalitis (JE) virus. These are the premembrane (prM) and envelope (E) coding sequences of the SA14-14-2 live attenuated JE vaccine virus. The immunising antigens are the prM and E proteins from the SA14-14-2 vaccine virus. AFTER RECONSTITUTION: ACTIVE INGREDIENTS: Live, attenuated, recombinant Japanese encephalitis virus*: 4.0 - 5.8 log PFU** * Propagated in Vero cells ** Plaque Forming Unit For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Powder for injection and diluent. The powder is a white to creamy white homogeneous cake which might be retracted from the sides of the vial. The diluent is a clear solution. After reconstitution, Imojev is a colourless to amber suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imojev is indicated for prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in individuals from 9 months of age and over. 4.2 DOSE AND METHOD OF ADMINISTRATION _PRIMARY VACCINATION: _ Individuals 9 months of age and over: a 0.5 mL single injection of the reconstituted vaccine. _ _ . imoj-ccdsv10-piv5-18mar20 Page 2 of 21 _BOOSTER: _ • Adult population (18 years of age and over) There is no need for a booster dose up to 5 years after the administration of a single dose of Imojev. • Paediatric population (9 months to 17 years of age inclusive) A booster dose of Imojev should be given after primary vaccination in order to confer long term protection. The booster dose should be given preferably 12 months after primary vaccination and can be Läs hela dokumentet