PMS-BENZYDAMINE MOUTHWASH/GARGLE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BENZYDAMINE HYDROCHLORIDE

Διαθέσιμο από:

PHARMASCIENCE INC

Φαρμακολογική κατηγορία (ATC):

A01AD02

INN (Διεθνής Όνομα):

BENZYDAMINE

Δοσολογία:

0.15%

Φαρμακοτεχνική μορφή:

MOUTHWASH/GARGLE

Σύνθεση:

BENZYDAMINE HYDROCHLORIDE 0.15%

Οδός χορήγησης:

BUCCAL

Μονάδες σε πακέτο:

100ML/250ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MOUTHWASHES AND GARGLES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0113801001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

1999-01-25

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
PMS-BENZYDAMINE
Benzydamine Mouthwash, BP
Benzydamine Hydrochloride 1.5 mg/mL (0.15% w/v)
LOCAL ANALGESIC
PHARMASCIENCE INC.
6111 Royalmount Avenue Suite #100
Montreal, QC, CANADA, H4P 2T4
www.pharmascience.com
Date of Preparation:
October 26, 2017
Submission Control No: 210244
_Product Monograph pms-BENZYDAMINE Page 2 of 13_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
3
DOSAGE AND ADMINISTRATION
................................................................................
4
OVERDOSAGE
..................................................................................................................
4
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 4
STORAGE AND STABILITY
...........................................................................................
5
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 5
PART II: SCIENTIFIC INFORMATION
.................................................................................
6
PHARMACEUTICAL INFORMATION
...........................................................................
6
CLINICAL TRIALS
............................................................................................................
7
DETAILED PHARMACOLOGY
.......................................................................................
7
TOXICOLOGY
...................................................................................................................
7
REFERENCES