ROTATEQ SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G1; HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G2; HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G3; HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G4; HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE P1(8)

Available from:

MERCK CANADA INC

ATC code:

J07BH02

INN (International Name):

ROTA VIRUS, PENTAVALENT, LIVE, REASSORTED

Dosage:

2210000UNIT; 2840000UNIT; 2220000UNIT; 2040000UNIT; 2290000UNIT

Pharmaceutical form:

SOLUTION

Composition:

HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G1 2210000UNIT; HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G2 2840000UNIT; HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G3 2220000UNIT; HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE G4 2040000UNIT; HUMAN-BOVINE ROTAVIRUS REASSORTANT TYPE P1(8) 2290000UNIT

Administration route:

ORAL

Units in package:

1X2ML

Prescription type:

Schedule D

Therapeutic area:

VACCINES

Product summary:

Active ingredient group (AIG) number: 0551661001; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-08-01

Summary of Product characteristics

_RotaTeq_
_®_
_ (rotavirus vaccine, live, oral, pentavalent) _
_Page 1 of 30 _
PRODUCT MONOGRAPH
ROTATEQ
®
rotavirus vaccine, live, oral, pentavalent
2 mL Solution
Live, Oral Pentavalent Vaccine Against Rotavirus Gastroenteritis
MERCK CANADA INC.
16750 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.merck.ca
SUBMISSION CONTROL N
O
:213134
DATE OF APPROVAL: JANUARY 30, 2018
_RotaTeq_
_®_
_ (rotavirus vaccine, live, oral, pentavalent) _
_Page 2 of 30 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT
INFORMATION........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
12
OVERDOSAGE
................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 14
STORAGE AND STABILITY
.........................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
18
PHARMACEUTICAL INFORMATION
.........................................................................
18
CLINICAL TRIALS
..................