MENINGITEC SUSPENSION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-11-2013
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Active ingredient:
MENINGOCOCCAL GROUP C OLIGOSACCHARIDE; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN
Available from:
NURON BIOTECH B.V.
ATC code:
J07AH07
INN (International Name):
MENINGOCOCCUS C, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED
Dosage:
10MCG; 15MCG
Pharmaceutical form:
SUSPENSION
Composition:
MENINGOCOCCAL GROUP C OLIGOSACCHARIDE 10MCG; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN 15MCG
Administration route:
INTRAMUSCULAR
Units in package:
10 X 0.5ML
Prescription type:
Schedule D
Therapeutic area:
VACCINES
Product summary:
Active ingredient group (AIG) number: 0243741002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2016-04-04
Summary of Product characteristics
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..............................
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