Pays: Israël
Langue: anglais
Source: Ministry of Health
JAPANESE ENCEPHALITIS PURIFIED INACTIVATED VACCINE
KAMADA LTD, ISRAEL
J07BA02
SUSPENSION FOR INJECTION
JAPANESE ENCEPHALITIS PURIFIED INACTIVATED VACCINE 6 AU / 0.5 ML
I.M
Required
VALNEVA SCOTLAND LTD, UK
ENCEPHALITIS, JAPANESE, INACTIVATED, WHOLE VIRUS
Ixiaro is indicated for active immunization against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older. Ixiaro should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.
2016-04-30
HEAD OFFICE 2 Holtzman St., Science Park, P.O. Box 4081, Rehovot, 7670402, Israel | Tel. +972-8-9406472 | Fax. +972-89406473 PLANT Kibbutz Beit Kama, M.P Negev 8532500, Israel | Tel. +972-8-9913111 | Fax. +972-8-9912083 רבמצד 8 201 ,ה/דבכנ ת/חקור ,ה/אפור ןוכדיע לע עידוהל תשקבמ עדהמק תרבח עדימ :רישכתה רובע ,ןלהל טרופמכ IXIARO ; וראיסקיא SUSPENSION FOR INJECTION IM ןוישירל םאתהב םיליעפ םיביכרמ : JAPANESE ENCEPHALITIS PURIFIED INACTIVATED VACCINE 6 AU / 0.5 ML :היוותה Ixiaro is indicated for active immunization against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older. Ixiaro should be considered for use in individuals at risk of exposure through travel or in the course of their occupation. יונישה תוהמ םי : רטשמ ןוכדיע ה ןונימ .תואירבה דרשמ רושיאב , יעסב ןכדוע אפורל ןולעה ף 4.2 םאתהב םיפיעסה ונכדוע ףסונב . 4.8 ו - 5.1 ) םהבש םיפיעסה יתת קר ןלהל םיטרופמ ושענ רקיע םייונישה שדח טסקט . הצוח וקב ושענ תוקיחמ ;יתחת וקב שגדומ ושגדוה תורמחה . בוהצב :( 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS (18-65 YEARS OF AGE)_ _ The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule: First dose at Day 0. Second dose: 28 days after first dose. Rapid schedule Adults 18-65 years of age: Persons aged 18-65 years can be vaccinated in a rapid schedule as follows: First dose at Day 0. Second dose: 7 days after first dose. With both schedules, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4). It is recommended that vaccinees who received the first dose of IXIARO complete the primary 2-dose vaccination course with IXIARO. If the primary i Lire le document complet
PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT IXIARO suspension for injection Japanese encephalitis vaccine (inactivated, adsorbed) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) of IXIARO contains: Japanese encephalitis virus strain SA 14 -14-2 (inactivated) 1,2 6 AU 3 corresponding to a potency of ≤ 460 ng ED50 1 produced in Vero cells 2 adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al 3+ ) 3 Antigen Units Excipients with known effect: This medicine contains potassium, less than 1mmol/dose and sodium, less than 1mmol/dose. Phosphate Buffered Saline 0.0067 M (in PO4) has the following saline composition: NaCl – 9 mg/mL KH2PO4 – 0.144 mg/mL Na2HPO4 – 0.795 mg/mL For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Clear liquid with a white precipitate. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IXIARO is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older. IXIARO should be considered for use in individuals at risk of exposure through travel or in the course of their occupation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS (18-65 YEARS OF AGE) _ _ The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule: First dose at Day 0. Second dose: 28 days after first dose. Rapid schedule Adults 18-65 years of age: Persons aged 18-65 years can be vaccinated in a rapid schedule as follows: First dose at Day 0. Second dose: 7 days after first dose. With both schedules, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4). It is recommended that vaccinees who received the first dose of IXIARO complete the primary 2-dose vaccination course with IXIARO. If the primary immunization of two injections is not completed, full protection against the disease might not be achie Lire le document complet