Страна: Израел
Език: английски
Източник: Ministry of Health
A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE VIRUS; A/SINGAPORE/INFIMH-16-0019/2016 (H3N2) - LIKE VIRUS; B/COLORADO/06/2017- LIKE VIRUS (B/VICTORIA/2/87 LINEAGE); B/PHUKET/3073/2013 - LIKE VIRUS (B/YAMAGATA/16/88 LINEAGE)
MEDICI MEDICAL LTD, ISRAEL
J07BB01
SUSPENSION FOR INJECTION
B/PHUKET/3073/2013 - LIKE VIRUS (B/YAMAGATA/16/88 LINEAGE) 15 MCG/DOSE; A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE VIRUS 15 MCG/DOSE; A/SINGAPORE/INFIMH-16-0019/2016 (H3N2) - LIKE VIRUS 15 MCG/DOSE; B/COLORADO/06/2017- LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) 15 MCG/DOSE
I.M, DEEP S.C.
Required
SANOFI PASTEUR, FRANCE
INFLUENZA, INACTIVATED, WHOLE VIRUS
INFLUENZA, INACTIVATED, WHOLE VIRUS
For the prevention of influenza.
2012-11-30
_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה_ _אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה_ _אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה_ _ _ _ _ _ _ _ ןכדועמ(_ _ ןכדועמ(_ _ ןכדועמ(_ _.102.50_ _.102.50_ _.102.50_ _)_ _)_ _)_ _ _ _ _ _ _ רשוא – 61.6 _______________ ךיראת 05.06.16 ________ ש םושירה רפסמו תילגנאב רישכת ם ____ ____ 031 -05 -21760 -00 _ VAXIGRIP םושירה לעב םש _ מ"עב לקידמ יצידמ ___________________________________ ! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט 2 . QUALITIVE AND QUANTITIVE COMPOSITION יוניש בכרה 21.6-21.7 A/California/7/2009 (H1N1)pdm09– like virus ….15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) -like virus 15 micrograms HA** B/Brisbane/60/2008 –like virus 15 micrograms HA** 4.1 TERAPEUTIC INDICATIONS תפסות טסקט VAXIGRIP is indicated in adults and children from 6 months of age. 4.2 POSOLOGY AND METHOD OF תפסות ןוכדעו טסקט POSOLOGY Adults: 0.5 ml. ADMINISTRATION _Paediatric population _ Children aged 36 months onwards: 0.5 ml. Children aged 6 to 35 months: 0.25 ml. Clinical data are limited. See Section 6.6 for more information on administration of the 0.25 ml dose. A 0.5 ml dose may be given, if this is required by national recommendations. For children aged less than 9 years who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks. Children aged less than 6 months: the safety and efficacy of VAXIGRIP in children aged less than 6 months have not been established. No data are available. METHOD OF ADMINISTRATION To be administered via intramuscular or deep subcutaneous route. For adults and children from 36 months of age: the preferred site for intramuscular injection is the deltoid muscle. 35 months of age: the preferred Прочетете целия документ
1 NAME OF THE MEDICINAL PRODUCT VAXIGRIP, suspension for injection in prefilled syringe. Influenza vaccine (split virion, inactivated). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Split influenza virus*, inactivated containing antigens equivalent to the following strains: • A/California/7/2009 (H1N1)pdm09– like virus ….15 micrograms HA** • A/Hong Kong/4801/2014 (H3N2) -like virus 15 micrograms HA** • B/Brisbane/60/2008 –like virus 15 micrograms HA** per 0.5 ml dose. * propagated in fertilized hens’ eggs from healthy chicken flocks ** haemagglutinin This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for the 2016-2017 season. For a full list of excipients, see section 6.1 . VAXIGRIP may contain traces of eggs, such as ovalbumin, traces of neomycin, of formaldehyde and of octoxinol-9, which are used during the manufacturing process (see Section 4.3.). 3 PHARMACEUTICAL FORM Suspension for injection in prefilled syringe. The vaccine, after shaking gently, is a slightly whitish and opalescent liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention of influenza. VAXIGRIP is indicated in adults and children from 6 months of age. The use of VAXIGRIP should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults: 0.5 ml. Paediatric population Children aged 36 months onwards: 0.5 ml. Children aged 6 to 35 months: 0.25 ml. Clinical data are limited. See Section 6.6 for more information on administration of the 0.25 ml dose. A 0.5 ml dose may be given, if this is required by national recommendations. For children aged less than 9 years who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks. Children aged less than 6 months: the safety and efficacy of VAXIGRIP in children aged less than 6 months have not been established. No data are available. METHOD OF ADMINISTRATION To be administered via intramuscular or deep subcutaneous route. For adults and children from 3 Прочетете целия документ