দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
CODEINE (CODEINE MONOHYDRATE, CODEINE SULFATE TRIHYDRATE)
PURDUE PHARMA
R05DA04
CODEINE
150MG
TABLET (EXTENDED-RELEASE)
CODEINE (CODEINE MONOHYDRATE, CODEINE SULFATE TRIHYDRATE) 150MG
ORAL
50
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0153086002; AHFS:
MARKETED
1995-12-31
_CODEINE CONTIN_ _®_ _ (codeine controlled release tablets) _ _Page 1 of 39_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N CODEINE CONTIN ® Codeine Controlled Release Tablets Tablets, 50 mg, 100 mg, 150 mg and 200 mg, Oral Purdue Pharma Standard Opioid Analgesic Purdue Pharma 575 Granite Court Pickering, ON L1W 3W8 Date of Initial Approval: June 02, 1995 Date of Revision: August 7, 2020 Submission Control No: 237940 CODEINE CONTIN ® is a registered trademark of Purdue Pharma _CODEINE CONTIN_ _®_ _ (codeine controlled release tablets) _ _Page 2 of 39_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, Sept 2018 1 INDICATIONS, 1.1 Pediatrics, Sept 2018 2 CONTRAINDICATIONS, Sept 2018 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Life-threatening Respiratory Depression: OVERDOSE, Sept 2018 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment (Opioid Rotation), Sept 2018 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment, Adjustment or Reduction of Dosage, Sept 2018 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment, Children under 12, Sept 2018 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance, Use in Drug and Alcohol Addiction, Sept 2018 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Sept 2018 7 WARNINGS AND PRECAUTIONS, Neonatal Opioid Withdrawal Syndrome (NOWS), July 2020 7 WARNINGS AND PRECAUTIONS, Neurologic, Sept 2018 7 WARNINGS AND PRECAUTIONS, Neurologic, Serotonin Toxicity/Serotonin Syndrome, July 2020 7 WARNINGS AND PRECAUTIONS, Respiratory, Sleep Apnea, July 2020 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.1 Pregnant Women, Sept 2018 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.2 Breast-feeding, Sept 2018 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3 Pediatrics, Sept 2018 9 DRUG INTERACTIONS, 9.2 Overview, Sept 2018 10 ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Pediatrics, Sept 2018 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES .............................................. সম্পূর্ণ নথি পড়ুন