CLINDAMYCIN INJECTION IN 5% DEXTROSE SOLUTION

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)

มีจำหน่ายจาก:

BAXTER CORPORATION

รหัส ATC:

J01FF01

INN (ชื่อสากล):

CLINDAMYCIN

ปริมาณ:

900MG

แบบฟอร์มเภสัชกรรม:

SOLUTION

องค์ประกอบ:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 900MG

เส้นทางการบริหาร:

INTRAVENOUS

หน่วยในแพ็คเกจ:

15G/50G

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

LINCOMYCINS

สรุปสินค้า:

Active ingredient group (AIG) number: 0105830010; AHFS:

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2019-02-04

สรุปลักษณะสินค้า

_Clindamycin Injection in 5% Dextrose_
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CLINDAMYCIN INJECTION IN 5% DEXTROSE
Ready-to-use bags, clindamycin 6 mg / mL (300 mg / 50 mL), 12 mg / mL
(600 mg /
50 mL) and
18 mg / mL (900 mg / 50 mL) (as clindamycin phosphate)
STERILE SOLUTION
ANTIBIOTIC
Baxter Corporation
7125 Mississauga Road
Mississauga, Ontario
L5N 0C2
Date of Revision:
February 1, 2019
Submission Control No: 212923
Baxter and GALAXY are trademarks of Baxter International Inc.
_Clindamycin Injection in 5% Dextrose_
_Page 2 of 33 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
.....................................................................................................
5
WARNINGS AND PRECAUTIONS
....................................................................................
5
ADVERSE REACTIONS
......................................................................................................
8
DRUG INTERACTIONS
....................................................................................................
10
DOSAGE AND ADMINISTRATION
................................................................................
11
OVERDOSAGE
...................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 13
STORAGE AND STABILITY
............................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 16