Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
HAEMOPHILUS INFLUENZAE TYPE B-PRP; FILAMENTOUS HAEMAGGLUTININ; PERTACTIN; HEPATITIS B SURFACE ANTIGEN (RECOMBINANT); DIPHTHERIA TOXOID; TETANUS TOXOID; POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED); POLIOVIRUS TYPE 2 MEF1 (INACTIVATED); POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED); PERTUSSIS TOXOID; TETANUS TOXOID ADSORBED
GLAXOSMITHKLINE INC
J07CA02
DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS
10MCG; 25MCG; 8MCG; 10MCG; 25LF; 10LF; 40UNIT; 8UNIT; 32UNIT; 25MCG; 40MCG
SUSPENSION
HAEMOPHILUS INFLUENZAE TYPE B-PRP 10MCG; FILAMENTOUS HAEMAGGLUTININ 25MCG; PERTACTIN 8MCG; HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10MCG; DIPHTHERIA TOXOID 25LF; TETANUS TOXOID 10LF; POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) 40UNIT; POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) 8UNIT; POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) 32UNIT; PERTUSSIS TOXOID 25MCG; TETANUS TOXOID ADSORBED 40MCG
INTRAMUSCULAR
10X0.5ML
Schedule D
VACCINES
Active ingredient group (AIG) number: 1165324001; AHFS:
APPROVED
2004-05-28
_ _ _ _ _INFANRIX hexa, Combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated _ _poliomyelitis and adsorbed conjugated Haemophilus influenzae type b vaccine _ _Page 1 of 33_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION INFANRIX HEXA ADSORBED HIB RECONSTITUTED WITH PEDIARIX Combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis and adsorbed conjugated _Haemophilus influenzae_ type b vaccine 25 limit of flocculation (Lf) [30 International Units (IU)] diphtheria toxoid; 25 mcg filamentous haemagglutinin (FHA); 10 mcg hepatitis B surface antigen (HBsAg); 8 mcg pertactin (PRN); 25 mcg pertussis toxoid (PT); 40 D-antigen units (DU) of type 1 poliovirus, 8 DU type 2 poliovirus, and 32 DU type 3 poliovirus ; 10 Lf (40 IU) tetanus toxoid; 10 mcg of adsorbed purified capsular polysaccharide of Haemophilus influenzae type b (Hib) (PRP) covalently bound to approximately 25 mcg of tetanus toxoid per 0.5 mL dose , Suspension for injection, Intramuscular Single dose pre-filled syringe PEDIARIX (suspension for injection) and Single dose vial adsorbed hib (lyophilized powder for injection) Active immunizing agent ATC Code: J07CA09 GlaxoSmithKline Inc. 100 Milverton Drive Suite 800 Mississauga, Ontario L5R 4H1 Date of Initial Authorization: May 28, 2014 Date of Revision: November 9, 2023 Submission Control No: 276316 _©_ _ 2023 GSK group of companies or its licensor_ _ _ _Trademarks are owned by or licensed to the GSK group of companies _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _INFANRIX hexa, Combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated _ _poliomyelitis and adsorbed conjugated Haemophilus influenzae type b vaccine _ _Page 2 of 33_ RECENT MAJOR LABEL CHANGES SECTION DATE 7 WARNINGS AND PRECAUTIONS, Guillain-Barré Syndrome SEP 2022 4 DOSAGE AND ADMINISTRATION, 4.4 Administration APR 2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME Perskaitykite visą dokumentą