Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
LIDOCAINE HYDROCHLORIDE; EPINEPHRINE (EPINEPHRINE BITARTRATE)
ASPEN PHARMACARE CANADA INC.
N01BB52
LIDOCAINE, COMBINATIONS
20MG; 0.005MG
SOLUTION
LIDOCAINE HYDROCHLORIDE 20MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 0.005MG
BLOCK/INFILTRATION
20ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0201284006; AHFS:
APPROVED
2017-08-17
_XYLOCAINE Parenteral Solutions, lidocaine hydrochloride / lidocaine hydrochloride and epinephrine bitartrate _ _ _ _Page 1 of 34 _ PRESCRIBING INFORMATION INCLUDING PATIENT MEDICATION INFORMATION XYLOCAINE ® PARENTERAL SOLUTIONS Lidocaine Hydrochloride Injection USP 0.5% lidocaine hydrochloride (5 mg/mL) 1% lidocaine hydrochloride (10 mg/mL) 2% lidocaine hydrochloride (20 mg/mL) Lidocaine Hydrochloride and Epinephrine Injection USP 1% lidocaine hydrochloride (10 mg/mL) with 1:200,000 epinephrine (as bitartrate) (0.005 mg/mL) 1% lidocaine hydrochloride (10 mg/mL) with 1:100,000 epinephrine (as bitartrate) (0.010 mg/mL) 2% lidocaine hydrochloride (20 mg/mL) with 1:200,000 epinephrine (as bitartrate) (0.005 mg/mL) Local Anesthetic N01BB52 Aspen Pharmacare Canada Inc. 8 – 1155 North Service Road West Oakville, Ontario L6M 3E3 Date of Initial Authorization: DEC 31, 1954 Date of Revision: MAR 07, 2023 Submission Control Number: 267392 _ _ _XYLOCAINE Parental Solutions, lidocaine hydrochloride / lidocaine hydrochloride and epinephrine bitartrate _ _ _ _Page 2 of 34 _ RECENT MAJOR LABEL CHANGES Not applicable. 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 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS ............................................................................................................. 4 1.1 Pediatrics .................................................................................................................. 4 1.2 Geriatrics .................................................................................................................. 4 2 CONTRAINDICATIONS ........................................... Baca dokumen lengkapnya