MENVEO SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

MENINGOCOCCAL GROUP A OLIGOSACCHARIDE; MENINGOCOCCAL GROUP C OLIGOSACCHARIDE; MENINGOCOCCAL GROUP W-135 OLIGOSACCHARIDE; MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN

Dostopno od:

GLAXOSMITHKLINE INC

Koda artikla:

J07AH08

INN (mednarodno ime):

MENINGOCOCCUS, A, C, Y, W-135, TETRAVAL. PURIFIED POLYSACC. ANTIGEN CONJUGATED

Odmerek:

10MCG; 5MCG; 5MCG; 5MCG; 47MCG

Farmacevtska oblika:

SOLUTION

Sestava:

MENINGOCOCCAL GROUP A OLIGOSACCHARIDE 10MCG; MENINGOCOCCAL GROUP C OLIGOSACCHARIDE 5MCG; MENINGOCOCCAL GROUP W-135 OLIGOSACCHARIDE 5MCG; MENINGOCOCCAL GROUP Y OLIGOSACCHARIDE 5MCG; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 47MCG

Pot uporabe:

INTRAMUSCULAR

Enote v paketu:

0.5ML

Tip zastaranja:

Schedule D

Terapevtsko območje:

VACCINES

Povzetek izdelek:

Active ingredient group (AIG) number: 0552705002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2010-05-21

Lastnosti izdelka

_ _
_Page 1 of 43_
PRODUCT MONOGRAPH
MENVEO
Meningococcal (Groups A, C, W-135 and Y) Oligosaccharide CRM
197
Conjugate Vaccine
Powder and solution for injection
Active Immunizing Agent
ATC Code J07AH08
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
DATE OF INITIAL APPROVAL:
May 21
st
, 2010
DATE OF REVISION:
June 3, 2020
SUBMISSION CONTROL NO: 236611
_©_
_2020 GlaxoSmithKline Inc., All Rights Reserved _
_Trademarks are owned by or licensed to the GSK group of companies. _
_MENACTRA is a trademark of Sanofi Pasteur Limited._
_GARDASIL 9 is a trademark of Merck Canada Inc._
_MENOMUNE_
_is a trademark of Sanofi Pasteur Limited. _
_ _
_Page 2 of 43_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
4
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
24
OVERDOSAGE
...............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 25
STORAGE AND STABILITY
........................................................................................