INFANRIX HEXA SUSPENSION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

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

Inapatikana kutoka:

GLAXOSMITHKLINE INC

ATC kanuni:

J07CA02

INN (Jina la Kimataifa):

DIPHTHERIA-PERTUSSIS-POLIOMYELITIS-TETANUS

Kipimo:

10MCG; 25MCG; 8MCG; 10MCG; 25LF; 10LF; 40UNIT; 8UNIT; 32UNIT; 25MCG; 40MCG

Dawa fomu:

SUSPENSION

Tungo:

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

Njia ya uendeshaji:

INTRAMUSCULAR

Vitengo katika mfuko:

10X0.5ML

Dawa ya aina:

Schedule D

Eneo la matibabu:

VACCINES

Bidhaa muhtasari:

Active ingredient group (AIG) number: 1165324001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2004-05-28

Tabia za bidhaa

_ _
_ _
_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