COPHYLAC DROPS

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

NORMETHADONE HYDROCHLORIDE; P-HYDROXYEPHEDRINE HYDROCHLORIDE

제공처:

BAUSCH HEALTH, CANADA INC.

ATC 코드:

R05DA20

INN (International Name):

COMBINATIONS

복용량:

10MG; 20MG

약제 형태:

DROPS

구성:

NORMETHADONE HYDROCHLORIDE 10MG; P-HYDROXYEPHEDRINE HYDROCHLORIDE 20MG

관리 경로:

ORAL

패키지 단위:

15ML

처방전 유형:

Narcotic (CDSA I)

치료 영역:

ANTITUSSIVES

제품 요약:

Active ingredient group (AIG) number: 0204869001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2004-11-02

제품 특성 요약

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
N
COPHYLAC

Normethadone HCl and p-Hydroxyephedrine HCl Drops
Drops, Normethadone HCl 10 mg/mL (1%) and p-Hydroxyephedrine HCl 20
mg/mL (2%)
ANTITUSSIVE
BAUSCH HEALTH, CANADA INC.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
DATE OF REVISION:
June 24, 2020
Submission Control No: 230752
_COPHYLAC_
_®_
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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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
PART III: CONSUMER MEDICATION INFORMATION
..................................................16
_COPHYLAC_
_®_
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N
COPHYLAC

Normethadone Hydrochloride and p