Χώρα: Καναδάς
Γλώσσα: Αγγλικά
Πηγή: Health Canada
TAPENTADOL (TAPENTADOL HYDROCHLORIDE)
APOTEX INC
N02AX06
TAPENTADOL
100MG
TABLET (IMMEDIATE RELEASE)
TAPENTADOL (TAPENTADOL HYDROCHLORIDE) 100MG
ORAL
100
Narcotic (CDSA I)
Active ingredient group (AIG) number: 0152846002; AHFS:
APPROVED
2022-02-17
N APO-TAPENTADOL (tapentadol) Page 1 of 58 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N APO-TAPENTADOL Tapentadol Tablets Tablets, 50 mg, 75 mg, and 100 mg Tapentadol (as tapentadol hydrochloride), oral Opioid Analgesic APOTEX INC. 150 Signet Drive Toronto (Ontario) M9L 1T9 Date of Initial Authorization: January 15, 2018 Date of Revision: February 16, 2022 Submission Control No: 259139 N APO-TAPENTADOL (tapentadol) Page 2 of 58 RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Opioid induced hyperalgesia 02/2022 7 Warnings and Precautions, Serotonin toxicity / Serotonin syndrome 02/2022 7 Warnings and Precautions, Reproductive Health: Female and Male Potential, Fertility 02/2022 7 Warnings and Precautions, Sleep apnea 02/2022 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES .............................................................................. 2 TABLE OF CONTENTS ................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 4 1. INDICATIONS ........................................................................................................... 4 1.1 Pediatrics (<18 years) ......................................................................................... 4 1.2 Geriatrics (≥ 65 years of age) .............................................................................. 4 2. CONTRAINDICATIONS ............................................................................................. 4 3. SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................... 5 4. DOSAGE AND ADMINISTRATION ........................................................................... 6 4.1 Dosing Considerations ........................................................................................ 6 4.2 Recommended Dose and Dosage Adjustment ................................................... 7 4.4 Administration .................................. Διαβάστε το πλήρες έγγραφο