TRYPTAN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TRYPTOPHAN

Διαθέσιμο από:

BAUSCH HEALTH, CANADA INC.

Φαρμακολογική κατηγορία (ATC):

N06AX02

INN (Διεθνής Όνομα):

TRYPTOPHAN

Δοσολογία:

750MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

TRYPTOPHAN 750MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS ANTIDEPRESSANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0111038005; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2021-06-11

Αρχείο Π.Χ.Π.

_Pr_
_TRYPTAN_
_®_
_ L-Tryptophan Product Monograph Page 1 of 15_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRYPTAN
®
L-Tryptophan
250 mg; 500 mg; 750 mg tablets
1 g Tablets
500 mg Capsules
Oral
Adjunct in the Management of Affective Disorders
Bausch Health, Canada Inc.
Date of Initial Authorization:
2150 St-Elzear Blvd. West
February 23, 1994
Laval, Quebec
H7L 4A8
Date of Revision:
June 9, 2021
Submission Control Number: 247785
_ _
_Pr_
_TRYPTAN_
_®_
_ L-Tryptophan Product Monograph Page 2 of 15_
RECENT MAJOR LABEL CHANGES
NONE
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
....................................................................................
2
TABLE OF CONTENTS
.........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
4
1
INDICATIONS.............................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
4
4
DOSAGE AND ADMINISTRATION
.............................................................................
4
4.2
Recommended Dose and Dosage Adjustment
................................................... 4
4.4
Administration....................................................................................................
4
5
OVERDOSAGE
..........................................................................................................
5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
....................... 5
7
WARNINGS AND PRECAUTIONS
.............................................................................
6
8
ADVERSE REACTIONS
.............................................................................................
7
8.1
Adverse Reaction Overview
.............