国家: 塞浦路斯
语言: 希腊文
来源: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
INACTIVATED POLIOMYELITIS VACCINE TYPE 1(MAHONEY); INACTIVATED POLIOMYELITIS VACCINE TYPE 2(MEF-1); INACTIVATED POLIOMYELITIS VACCINE TYPE 3(SAUKETT)
BILTHOVEN BIOLOGICALS B.V. (0000012092) ANTONIE VAN LEEUWENHOEKLAAN 9-13, MA BILTHOVEN, 3721
J07BF03
POLIOMYELITIS, TRIVALENT, INACTIVATED, WHOLE VIRUS
SUSPENSION FOR INJECTION
INACTIVATED POLIOMYELITIS VACCINE TYPE 1(MAHONEY) (8000003623) 40U; INACTIVATED POLIOMYELITIS VACCINE TYPE 2(MEF-1) (8000003624) 8U; INACTIVATED POLIOMYELITIS VACCINE TYPE 3(SAUKETT) (8000003626) 32U
ΥΠΟΔΟΡΙΑ ΧΡΗΣΗ; INTRAMUSCULAR USE
Ειδική άδεια άρθρο 126A
Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 0.5ML () 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή
SHELF LIFE The shelf life is 36 months. SPECIAL PRECAUTIONS DURING STORAGE The vaccine requires a storage temperature between 2 and 8°C. Do not freeze. After opening a multidose vial (containing 5 doses) store between 2 and 8°C and use within 28 days. PACKAGING The vaccine is filled in vials (type 1 hydrolytic glass) and sealed with a rubber stopper (free of latex) and an aluminium flip-off cap and contains 0.5 mL vaccine (single dose) or 2.5 mL vaccine (multidose). SPECIAL INSTRUCTIONS FOR USE AND DISPOSAL. NAME POLIOMYELITIS VACCINE PACKAGE LEAFLET: INFORMATION FOR THE USER No specific requirements. VACCINE VIAL MONITOR (IF PRESENT ON THE VIAL): The Vaccine Vial Monitor (VVM) is present on the vial in the form of a colour dot. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level. The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively. As long as the colour of this square is lighter than the colour of the ring, the vaccine can be used. As soon as the colour of the central square is the same colour as the ring or darker, the vial should be discarded. MARKETING AUTHORIZATION HOLDER Bilthoven Biologicals B.V. Antonie van Leeuwenhoeklaan 9-13 3721 MA Bilthoven The Netherlands Telephone +31 (0)30 8004800 MARKETING LICENSE Poliomyelitis vaccine is licensed in the Netherlands under number RVG 17642 Poliomyelitis vaccine multidose is licensed in the Netherlands under number RVG 114720 DATA OF FIRST LICENSE OR LICENSE RENEWAL First license monodose; December 2 nd , 1993 License renewal; August 25 th , 1994 First license multidose (5-dose): November 12 th , 2014 VERSION WHO package insert, version August 2020 Poliomyelitis vaccine, suspension for injection COMPOSITION One dose of 0.5 mL poliomyelitis vaccine contains the following active components: Inactivated poliomyelitis virus type 1 阅读完整的文件