PEDIAPHARM NAPROXEN SUSPENSION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

NAPROXEN

Διαθέσιμο από:

MEDEXUS PHARMACEUTICALS INC.

Φαρμακολογική κατηγορία (ATC):

M01AE02

INN (Διεθνής Όνομα):

NAPROXEN

Δοσολογία:

25MG

Φαρμακοτεχνική μορφή:

SUSPENSION

Σύνθεση:

NAPROXEN 25MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

474ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0109634006; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2016-01-06

Αρχείο Π.Χ.Π.

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_Page 1 of 40_
PRODUCT MONOGRAPH
PR
PEDIAPHARM NAPROXEN SUSPENSION
Naproxen oral suspension U.S.P.
25 mg/mL Suspension
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Medexus Inc.
35 Nixon Road, Unit 1
Bolton, Ontario
L7E 1K1
Date of Preparation:
DEC 15, 2022
Submission Control No.: 269863
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_Page 2 of 40_
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
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
..........................................................................................................26
DETAILED PHARMACOLOGY
......................................