ROTATEQ SOLUTION

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

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)

มีจำหน่ายจาก:

MERCK CANADA INC

รหัส ATC:

J07BH02

INN (ชื่อสากล):

ROTA VIRUS, PENTAVALENT, LIVE, REASSORTED

ปริมาณ:

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

แบบฟอร์มเภสัชกรรม:

SOLUTION

องค์ประกอบ:

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

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

1X2ML

ประเภทใบสั่งยา:

Schedule D

พื้นที่บำบัด:

VACCINES

สรุปสินค้า:

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

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2006-08-01

สรุปลักษณะสินค้า

_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
..................