Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE); NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE)
MYLAN PHARMACEUTICALS ULC
N07BC51
BUPRENORPHINE, COMBINATIONS
8MG; 2MG
TABLET
BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) 8MG; NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) 2MG
SUBLINGUAL
7/100
Narcotic (CDSA I)
OPIATE PARTIAL AGONISTS
Active ingredient group (AIG) number: 0252216002; AHFS:
CANCELLED POST MARKET
2019-09-17
_ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N MYLAN-BUPRENORPHINE/NALOXONE Buprenorphine (as Buprenorphine Hydrochloride) and Naloxone (as Naloxone Hydrochloride Dihydrate) Sublingual Tablets 2 mg / 0.5 mg and 8 mg / 2 mg Partial Opioid Agonist and Opioid Antagonist Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Date of Revision: March 29, 2019 Submission Control No: 225699 _Page 2 of 60 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................................ 3 SUMMARY PRODUCT INFORMATION .................................................................................. 3 INDICATIONS AND CLINICAL USE ........................................................................................ 3 CONTRAINDICATIONS ............................................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................................................ 5 ADVERSE REACTIONS ............................................................................................................ 17 DRUG INTERACTIONS ............................................................................................................ 24 DOSAGE AND ADMINISTRATION ........................................................................................ 27 DRUG ABUSE AND DEPENDENCE ....................................................................................... 32 OVERDOSAGE .......................................................................................................................... 33 ACTION AND CLINICAL PHARMACOLOGY ...................................................................... 34 STORAGE AND STABILITY .................................................................................................... 38 SPECIAL HANDLING INSTRUCTIONS ................................................................................. 39 DOSAGE FORMS, COMPOSITION AND PACKA Đọc toàn bộ tài liệu