País: Canadá
Idioma: inglés
Fuente: Health Canada
OXYCODONE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
PURDUE PHARMA
N02AA55
OXYCODONE AND NALOXONE
5.00MG; 2.50MG
TABLET (EXTENDED-RELEASE)
OXYCODONE HYDROCHLORIDE 5.00MG; NALOXONE HYDROCHLORIDE 2.50MG
ORAL
10/14/20/28/30/50/56/60/98/100/250
Narcotic (CDSA I)
OPIATE AGONISTS
Active ingredient group (AIG) number: 0252684004; AHFS:
APPROVED
2012-06-06
_TARGIN_ _® _ _(Oxycodone Hydrochloride/Naloxone Hydrochloride Controlled Release) _ _Page 1 of 63 _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION N TARGIN ® Oxycodone Hydrochloride/Naloxone Hydrochloride Controlled Release Tablets Tablets, 5/2.5 mg, 10/5 mg, 20/10 mg and 40/20 mg, Oral Purdue Pharma Standard Opioid Analgesic Purdue Pharma 3381 Steeles Avenue East Suite 310 Toronto, ON M2H 3S7 Date of Initial Authorization: December 16, 2009 Date of Revision: January 08, 2024 Submission Control Number: 273393 TARGIN ® is a trademark of Purdue Pharma _TARGIN_ _® _ _(Oxycodone Hydrochloride/Naloxone Hydrochloride Controlled Release) _ _Page 2 of 63_ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 10/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dose Adjustment 10/ 2023 7 WARNING AND PRECAUTIONS, Addiction, Abuse and Misuse 10/2023 7 WARNING AND PRECAUTIONS, Dependence/Tolerance 10/ 2023 7 WARNING AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 10/ 2023 7 WARNING AND PRECAUTIONS, Neurologic 10/ 2023 7 WARNING AND PRECAUTIONS, Reproductive Health: Female and Male Potential 10/ 2023 7 WARNINGS AND PRECAUTIONS, Respiratory 10/2023 7 WARNING AND PRECAUTIONS, 7.1 Special Populations, Patients with Hepatic and Renal Impairment 10/ 2023 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ..................................................................................... 2 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS.............................................................................................................. 4 1.1 Pediatrics ........................................................................................................... 4 1.2 Geriatrics........................................................................................................... Leer el documento completo