SANDOZ OPIUM & BELLADONNA SUPPOSITORY
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-05-2018
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Active ingredient:
OPIUM; BELLADONNA
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
N02AA02
INN (International Name):
OPIUM
Dosage:
65MG; 15MG
Pharmaceutical form:
SUPPOSITORY
Composition:
OPIUM 65MG; BELLADONNA 15MG
Administration route:
RECTAL
Units in package:
12
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
ANTIMUSCARINICS ANTISPASMODICS
Product summary:
Active ingredient group (AIG) number: 0204829001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2021-07-20
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
SANDOZ OPIUM & BELLADONNA
®
Opium and Belladonna Suppository
Opium 65 mg, and belladonna 15 mg suppository
Analgesic - Antispasmodic
Sandoz Canada Inc.
145 Jules-Léger Street
Boucherville, QC, Canada
J4B 7K8
Date of Preparation:
May 1992
Date of Revision:
May 30, 2018
Submission Control No: 213121
_Sandoz Opium & Belladonna _
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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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART III: PATIENT MEDICATION INFORMATION
.......................................................19
_Sandoz Opium & Belladonna _
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N
SANDOZ OPIUM & BELLADONNA
Opium and Belladonna Suppository
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRE
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