Država: Kanada
Jezik: angleščina
Source: Health Canada
INACTIVATED RABIES VIRUS (FLURY LEP)
BAVARIAN NORDIC AS
J07BG01
RABIES, INACTIVATED, WHOLE VIRUS
2.5UNIT
POWDER FOR SOLUTION
INACTIVATED RABIES VIRUS (FLURY LEP) 2.5UNIT
INTRAMUSCULAR
15G/50G
Schedule D
VACCINES
Active ingredient group (AIG) number: 0165642001; AHFS:
APPROVED
2010-02-05
_ _ _ _ _ _ _Page 1 of 37_ PRODUCT MONOGRAPH RABAVERT Rabies Vaccine Lyophilized powder for reconstitution with a diluent 2.5 IU of rabies antigen Therapeutic Classification: Active Immunising Agent Bavarian Nordic A/S Philip Heymans Alle 3 DK-2900 Hellerup Denmark Control #: 249134 DATE OF INITIAL APPROVAL: April 29, 2005 DATE OF REVISION: July 23, 2021 _ _ _Trademarks are owned by Bavarian Nordic A/S _ _ _ _ _ _ _ _Page 2 of 37_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................... 3 DESCRIPTION ........................................................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................ 4 CONTRAINDICATIONS ............................................................................................ 7 WARNINGS AND PRECAUTIONS ............................................................................ 8 ADVERSE REACTIONS............................................................................................11 DRUG INTERACTIONS ............................................................................................14 DOSAGE AND ADMINISTRATION .........................................................................15 OVERDOSAGE .........................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY.........................................................18 STORAGE AND STABILITY ....................................................................................19 SPECIAL HANDLING INSTRUCTIONS ...................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING ..........................................20 PART II: SCIENTIFIC INFORMATION ......................................................................... 21 PHARMACEUTICAL INF Preberite celoten dokument