AA-THEO LA TABLET (EXTENDED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

THEOPHYLLINE

Διαθέσιμο από:

AA PHARMA INC

Φαρμακολογική κατηγορία (ATC):

R03DA04

INN (Διεθνής Όνομα):

THEOPHYLLINE

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

TABLET (EXTENDED-RELEASE)

Σύνθεση:

THEOPHYLLINE 100MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100 TABLETS

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

RESPIRATORY SMOOTH MUSCLE RELAXANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0103582002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2019-04-30

Αρχείο Π.Χ.Π.

_ _
_ _
_Pr_
_AA-THEO LA _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AA-THEO
LA
Theophylline Anhydrous
Sustained-Release Tablets, 100, 200, 300 mg and Oral
House Standard
Bronchodilator
ATC Code: R03DA04
AA PHARMA INC.
1165 Creditstone Road, Unit#1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
DEC 31, 1993
Date of Revision:
January 13, 2022
Submission Control Number: 254884
_ _
_ _
_Pr_
_AA-THEO LA _
_Page 2 of 24_
RECENT MAJOR LABEL CHANGES
1 Indications
12/2021
3 Serious Warnings and Precautions Box
12/2021
7 Warnings and Precautions
12/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.4
Administration.....................................................................................................5
5
OVERDOSAGE
.................................