MENINGITEC SUSPENSION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

MENINGOCOCCAL GROUP C OLIGOSACCHARIDE; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN

זמין מ:

NURON BIOTECH B.V.

קוד ATC:

J07AH07

INN (שם בינלאומי):

MENINGOCOCCUS C, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED

כמות:

10MCG; 15MCG

טופס פרצבטיות:

SUSPENSION

הרכב:

MENINGOCOCCAL GROUP C OLIGOSACCHARIDE 10MCG; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 15MCG

מסלול נתינה (של תרופות):

INTRAMUSCULAR

יחידות באריזה:

10 X 0.5ML

סוג מרשם:

Schedule D

איזור תרפויטי:

VACCINES

leaflet_short:

Active ingredient group (AIG) number: 0243741002; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2016-04-04

מאפייני מוצר

PRODUCT MONOGRAPH
MENINGITEC
®
MENINGOCOCCAL SEROGROUP C CONJUGATE VACCINE
(DIPHTHERIA CRM
197 PROTEIN)
SUSPENSION
FOR INTRAMUSCULAR INJECTION
THERAPEUTIC CLASSIFICATION
ACTIVE IMMUNIZING AGENT
Nuron Biotech B.V.
Strawinskylaan 1143, Toren 11-C, 1077XX
Amsterdam, The Netherlands
DATE OF PREPARATION: September 10, 2013
CONTROL #: 168241 DATE OF APPROVAL: NOVEMBER 13, 2013
PRODUCT MONOGRAPH
MENINGITEC
®
Meningococcal Serogroup C Conjugate Vaccine
(Diphtheria CRM
197
Protein)
Suspension For Intramuscular Injection
Active Immunizing Agent
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................3
INDICATIONS AND CLINICAL
USE...........................................................................................6
CONTRAINDICATIONS
................................................................................................................7
WARNINGS
....................................................................................................................................7
PRECAUTIONS
..............................................................................................................................8
Drug Interactions
..................................................................................................................9
Pregnancy
...........................................................................................................................14
Lactation.............................................................................................................................14
Pediatric
.............................................................................................................................14
Geriatric
.............................................................................................................................14
ADVERSE REACTIONS
..............................................................................................................15
Clinical
Trials..............................