Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
QUETIAPINE (QUETIAPINE FUMARATE)
APOTEX INC
N05AH04
QUETIAPINE
200MG
TABLET (IMMEDIATE RELEASE)
QUETIAPINE (QUETIAPINE FUMARATE) 200MG
ORAL
15G/50G
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0131858003; AHFS:
APPROVED
2020-07-31
_APO-QUETIAPINE FUMARATE (Quetiapine tablets)_ _Page 1 of 71_ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-QUETIAPINE FUMARATE Quetiapine tablets Immediate-Release Tablets, 25 mg, 100 mg, 200 mg and 300 mg quetiapine (as quetiapine fumarate), Oral USP Antipsychotic Agent Apotex Inc. 150 Signet Drive Toronto, Ontario M9L 1T9 Canada Date of Initial Authorization: July 31, 2020 Date of Revision: December 6, 2022 Submission Control No: 265729 _APO-QUETIAPINE FUMARATE (Quetiapine tablets)_ _Page 2 of 71_ _ _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS - Musculoskeletal - Rhabdomyolysis 12/2022 7 WARNINGS AND PRECAUTIONS - Psychiatric 12/2022 1 INDICATIONS, 1.1 Pediatrics 12/2022 2 CONTRAINDICATIONS 12/2022 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 12/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment, Dosing Considerations in Special Populations, Pediatric Use 12/2022 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 12/2022 7 WARNINGS AND PRECAUTIONS, Weight Gain 12/2022 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 12/2022 7 WARNINGS AND PRECAUTIONS, 7.3 Pediatrics 12/2022 7 WARNINGS AND PRECAUTIONS, Use in Geriatric Patients with Dementia 12/2022 7 WARNINGS AND PRECAUTIONS, Skin 12/2022 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 1 INDICATIONS ............................................................................................................. 4 1.1 Pediatrics ................................................................................................................... 4 1.2 Geriatrics.................................................................................................................... 4 2 CONTRAINDICATIONS .... Διαβάστε το πλήρες έγγραφο