Țară: Canada
Limbă: engleză
Sursă: Health Canada
PERTUSSIS TOXOID; FILAMENTOUS HAEMAGGLUTININ; PERTACTIN; DIPHTHERIA TOXOID; TETANUS TOXOID; INACTIVATED POLIOVIRUS TYPE I; INACTIVATED POLIOVIRUS TYPE II; INACTIVATED POLIOVIRUS TYPE III; HAEMOPHILUS INFLUENZAE TYPE B-PRP AND TETANUS TOXOID CONJUGATE (PRP-T)
GLAXOSMITHKLINE INC
J07CA06
DIPHT-HEMOPH INFLUEN B-PERTUSS-POLIO-TETANUS
25MCG; 25MCG; 8MCG; 30UNIT; 40UNIT; 40UNIT; 8UNIT; 32UNIT; 10MCG
SUSPENSION
PERTUSSIS TOXOID 25MCG; FILAMENTOUS HAEMAGGLUTININ 25MCG; PERTACTIN 8MCG; DIPHTHERIA TOXOID 30UNIT; TETANUS TOXOID 40UNIT; INACTIVATED POLIOVIRUS TYPE I 40UNIT; INACTIVATED POLIOVIRUS TYPE II 8UNIT; INACTIVATED POLIOVIRUS TYPE III 32UNIT; HAEMOPHILUS INFLUENZAE TYPE B-PRP AND TETANUS TOXOID CONJUGATE (PRP-T) 10MCG
INTRAMUSCULAR
250ML
Schedule D
VACCINES
Active ingredient group (AIG) number: 0950281002; AHFS:
APPROVED
2004-08-09
_ _ _ _ _February 17, 2017 _ _Page 1 of 29_ PRODUCT MONOGRAPH INFANRIX ® -IPV/HIB HIBERIX ® RECONSTITUTED WITH INFANRIX ® -IPV Combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, _Haemophilus influenzae_ type b vaccine Sterile suspension for injection Single dose pre-filled syringe or vial INFANRIX ® -IPV (suspension for injection) and Single dose vial HIBERIX ® (lyophilized powder for injection) Active immunizing agent GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 DATE OF APPROVAL: May 29, 2017 SUBMISSION CONTROL NO: 203029 _©_ _ 2017GSK Inc. All Rights Reserved _ _INFANRIX and HIBERIX are registered trademarks of GSKBiologicals SA, used under license by GSKInc_. _ _ _ _ _February 17, 2017 _ _Page 2 of 29_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................ 3 SUMMARY PRODUCT INFORMATION ........................................................... 3 DESCRIPTION....................................................................................................... 3 INDICATIONS AND CLINICAL USE ................................................................. 4 CONTRAINDICATIONS ...................................................................................... 4 WARNINGS AND PRECAUTIONS ..................................................................... 5 ADVERSE REACTIONS ....................................................................................... 7 DRUG INTERACTIONS ..................................................................................... 10 DOSAGE AND ADMINISTRATION ................................................................. 11 OVERDOSAGE ................................................................................................... 13 ACTION AND CLINICAL PHARMACOLOGY ............................................... 13 STORAGE AND STABILITY ............................................................................. 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ......... Citiți documentul complet