CODEINE PHOSPHATE INJECTION USP LIQUID

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CODEINE PHOSPHATE

متاح من:

SANDOZ CANADA INCORPORATED

ATC رمز:

R05DA04

INN (الاسم الدولي):

CODEINE

جرعة:

30MG

الشكل الصيدلاني:

LIQUID

تركيب:

CODEINE PHOSPHATE 30MG

طريقة التعاطي:

INTRAMUSCULAR

الوحدات في الحزمة:

10X1ML/25X1ML

نوع الوصفة الطبية :

Narcotic (CDSA I)

المجال العلاجي:

OPIATE AGONISTS

ملخص المنتج:

Active ingredient group (AIG) number: 0104398004; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2005-08-11

خصائص المنتج

_Codeine Phosphate Injection USP _
_ _
_Page 1 of 34 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
CODEINE PHOSPHATE INJECTION USP
Codeine Phosphate
Solution for Injection 30mg/mL
USP
Opioid Analgesic–Antitussive
Sandoz Canada Inc.
Date of Revision:
110 Rue de Lauzon
December 16, 2019
Boucherville, QC, Canada
J4B 1E6
Submission Control No: 225996
_Codeine Phosphate Injection USP _
_ _
_Page 2 of 34 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
PART III: CONSUMER MEDICATION INFORMATION
..................................................26
_