IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULES

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

متاح من:

CATALENT ONTARIO LIMITED

ATC رمز:

M01AE51

INN (الاسم الدولي):

IBUPROFEN, COMBINATIONS

جرعة:

200MG; 30MG

الشكل الصيدلاني:

CAPSULE

تركيب:

IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

OTC

المجال العلاجي:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

ملخص المنتج:

Active ingredient group (AIG) number: 0222394001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2020-01-31

خصائص المنتج

Page 1 of 52
PRODUCT MONOGRAPH
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULES
Ibuprofen (free acid and potassium salt) and Pseudoephedrine
Hydrochloride Capsules
200 mg / 30 mg
Analgesic/Antipyretic/Nasal Decongestant
Catalent Ontario Limited,
2125 Ambassador Dr.
Windsor, ON N9C 3R5
Control No. 227874
Date of Preparation:
January 28, 2020
Page 2 of 52
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
.....................................................................................................
11
DRUG INTERACTIONS
.....................................................................................................
18
DOSAGE AND ADMINISTRATION
.................................................................................
21
OVERDOSAGE
....................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 24
STORAGE AND STABILITY
.............................................................................................
28
SPECIAL HANDLING INSTRUCTIONS
...........................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 29
PART II: SCIENTIFIC
INFORMATION...................................................................................
30
PHARMACEUTICAL INFORMATION
......................................................