TEVA-DOXYLAMINE/PYRIDOXINE DR TABLET (DELAYED-RELEASE)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
12-05-2016
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Aktiva substanser:
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Tillgänglig från:
TEVA CANADA LIMITED
ATC-kod:
R06AA59
INN (International namn):
DOXYLAMINE, COMBINATIONS
Dos:
10MG; 10MG
Läkemedelsform:
TABLET (DELAYED-RELEASE)
Sammansättning:
DOXYLAMINE SUCCINATE 10MG; PYRIDOXINE HYDROCHLORIDE 10MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
ANTIHISTAMINES
Produktsammanfattning:
Active ingredient group (AIG) number: 0213346001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2010-07-06
Produktens egenskaper
PRODUCT MONOGRAPH
PR
TEVA-DOXYLAMINE/PYRIDOXINE DR
(doxylamine succinate and pyridoxine hydrochloride)
Delayed release tablets, 10 mg/ 10 mg
Antinauseant against Nausea and Vomiting of Pregnancy
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 108249, 163410, 176476, 194536
Date of Preparation:
May 12, 2016
2
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
...............................................................................................
6
DRUG INTERACTIONS
...............................................................................................
9
DOSAGE AND ADMINISTRATION
.........................................................................
10
OVERDOSAGE
...........................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 11
STORAGE AND STABILITY
.....................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
.................................................................. 15
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 15
PART II: SCIENTIFIC INFORMATION
................................................................... 16
PHARMACEUTICAL INFORMATION
.....................................................................
16
CLINICAL TRIALS
.....................................................................................................
18
TO
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