Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
Japanese encephalitis virus, Quantity: 6 AgU
Seqirus Pty Ltd
Japanese encephalitis virus
Injection, suspension
Excipient Ingredients: aluminium hydroxide hydrate; sodium chloride; monobasic potassium phosphate; dibasic sodium phosphate; water for injections
Intramuscular
single pre-filled syringe 0.5 mL dose
(S4) Prescription Only Medicine
JESPECT is indicated for active immunisation against Japanese Encephalitis (JE) virus for persons 18 years of age and older. JESPECT should be considered for use in persons who plan to reside in or travel to areas where JE is endemic (common) or epidemic (seasonal), especially during the transmission season. JESPECT is indicated for persons who work with JE virus in laboratories and in industry.
Visual Identification: clear liquid with a white precipitate. A white/cloudy liquid/suspension forms upon agitation; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2009-01-30
Jespect ® Consumer Medicine Information Page 1 of 4 JESPECT ® _(jess-pect)_ INACTIVATED JAPANESE ENCEPHALITIS VACCINE (ADSORBED) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about JESPECT ® . It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you having JESPECT ® against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT THIS VACCINE, TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET. YOU MIGHT NEED TO READ IT AGAIN. WHAT JESPECT ® IS USED FOR JESPECT ® is a vaccine. It helps prevent Japanese encephalitis _(en-kef-al-i-tis)_, a severe and often fatal infection of the brain. Some of those who recover from the disease are often left with brain damage. Japanese encephalitis is caused by the Japanese encephalitis virus that mainly occurs in Asia. The virus is transmitted to humans by infected mosquitoes that feed on human blood. JESPECT ® is used to vaccinate persons 18 years and older who: • plan to live in or travel to areas where Japanese encephalitis is common or seasonal. Your doctor will explain your individual risk of catching the disease • work with Japanese encephalitis virus. JESPECT ® is given as two injections 28 days apart. The vaccination course should be completed at least one week before potential exposure to the Japanese encephalitis virus. _HOW JESPECT_ _®_ _ WORKS _ JESPECT _®_ _ _works by getting your body to produce its own protection against the Japanese encephalitis virus. The vaccine does not contain live virus and cannot give you the illness. After you have been given JESPECT ® , your body makes substances called antibodies. These antibodies fight the Japanese encephalitis virus. When you come into contact with the virus, your body is usually ready to destroy it. Most people who receive both doses of the vaccine will produce enough anti Прочитајте комплетан документ
JESPECT ® Product Information Page 1 AUSTRALIAN PRODUCT INFORMATION – JESPECT [INACTIVATED JAPANESE ENCEPHALITIS VACCINE (ADSORDED)] SUSPENSION FOR INJECTION 1 NAME OF THE MEDICINE Inactivated Japanese Encephalitis Vaccine (adsorbed). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION JESPECT ® Japanese Encephalitis (JE) Virus, purified inactivated vaccine is a sterile, ready to use suspension for intramuscular (IM) injection. The vaccine is prepared by propagating Japanese encephalitis virus strain (SA 14 -14-2) in Vero cells. No preservatives or antibiotics are added to the formulation. JESPECT ® is a clear liquid with white precipitate and when shaken before use a white/cloudy suspension forms. JESPECT ® is supplied in pre-filled syringes without needles. Each 0.5 mL dose of vaccine contains 6 antigen units (AgU) of purified, inactivated JE virus. Each dose of vaccine also contains the following excipients: 0.1% aluminium hydroxide, hydrated corresponding to 0.25 mg aluminium, and Phosphate Buffered Saline. 3 PHARMACEUTICAL FORM JESPECT ® is supplied as a 0.5 mL suspension in a pre-filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer) in a pack size of 1 needle-less syringe. To attach needle, remove the syringe cap by gently twisting it. Do not attempt to snap or pull the tip off as this may damage the syringe. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS JESPECT ® is indicated for active immunisation against Japanese Encephalitis (JE) virus for persons 18 years of age and older. JESPECT ® should be considered for use in persons who plan to reside in or travel to areas where JE is endemic (common) or epidemic (seasonal), especially during the transmission season. JESPECT ® is indicated for persons who work with JE virus in laboratories and in industry. JESPECT ® Product Information Page 2 4.2 DOSE AND METHOD OF ADMINISTRATION PRIMARY VACCINATION The primary vaccination series consists of a total of two doses of 0.5 mL each according to the following schedule: First dose Прочитајте комплетан документ