FENTANYL CITRATE INJECTION SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

FENTANYL (FENTANYL CITRATE)

متاح من:

JAMP PHARMA CORPORATION

ATC رمز:

N01AH01

INN (الاسم الدولي):

FENTANYL

جرعة:

50MCG

الشكل الصيدلاني:

SOLUTION

تركيب:

FENTANYL (FENTANYL CITRATE) 50MCG

طريقة التعاطي:

INTRAMUSCULAR

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Narcotic (CDSA I)

المجال العلاجي:

OPIATE AGONISTS

ملخص المنتج:

Active ingredient group (AIG) number: 0123302002; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2020-10-23

خصائص المنتج

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
FENTANYL CITRATE INJECTION
Solution for injection
fentanyl 50 mcg / mL as fentanyl citrate
For epidural, intramuscular or slow intravenous administration
USP
Narcotic Analgesic
Adjunct to Anesthesia
Jamp Pharma Corporation
Date of Preparation: October 21, 2019
1310 rue Nobel
Boucherville, Québec,
Canada J4B 5H3
Submission Control No: 230156
_Fentanyl Citrate Injection. _
_Page 2 of 45_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
....................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................
17
OVERDOSAGE
.................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 22
STORAGE AND STABILITY
..........................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
........................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................26
PART II: SCIENTIFIC INFORMATION
................................................................................28
PHARMACEUTICAL INFORMATION
................