ACETYLCYSTEINE INJECTION SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ACETYLCYSTEINE

Pieejams no:

TELIGENT OU

ATĶ kods:

R05CB01

SNN (starptautisko nepatentēto nosaukumu):

ACETYLCYSTEINE

Deva:

200MG

Zāļu forma:

SOLUTION

Kompozīcija:

ACETYLCYSTEINE 200MG

Ievadīšanas:

INHALATION

Vienības iepakojumā:

100

Receptes veids:

Ethical

Ārstniecības joma:

ANTIDOTES

Produktu pārskats:

Active ingredient group (AIG) number: 0100024001; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2022-02-01

Produkta apraksts

_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ACETYLCYSTEINE INJECTION
Acetylcysteine Solution USP
200 mg/mL
Solution for Injection, Inhalation or Oral Administration
Mucolytic
Antidote for Acetaminophen Overdose
Teligent OÜ
Akadeemia tee 21/5
Tallinn, Estonia
Importer/Dist:
Teligent Canada Inc.
Mississauga, Ontario
L5R 3P9
Date of Revision:
August 8, 2019
Submission Control No: 230154
_Page 2 of 26_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND STABILITY
..........................................................................................17
SPECIAL HANDLING INSTRUCTIONS
.......................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
DETAILED PHARMACOLOGY
....................................................................