Ország: Kanada
Nyelv: angol
Forrás: Health Canada
LIDOCAINE HYDROCHLORIDE
EUGIA PHARMA INC.
N01BB02
LIDOCAINE
2%
SOLUTION
LIDOCAINE HYDROCHLORIDE 2%
BLOCK/INFILTRATION
100
Ethical
Active ingredient group (AIG) number: 0101280001; AHFS:
APPROVED
2023-06-29
Page 1 of 26 PRESCRIBING INFORMATION LIDOCAINE INJECTION BP LIDOCAINE HYDROCHLORIDE 1% w/v (10 mg/mL) and 2% w/v (20 mg/mL) Sterile solution for injection Preservative Free Local Anesthetic EUGIA PHARMA INC Date of Preparation: 3700 Steeles Avenue West, Suite # 402 June 29, 2023 Woodbridge, Ontario, L4L 8K8 Canada Submission Control No: 275439 Page 2 of 26 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION .................................................................... 3 INDICATIONS AND CLINICAL USE .......................................................................... 3 CONTRAINDICATIONS ............................................................................................... 4 WARNINGS AND PRECAUTIONS .............................................................................. 4 ADVERSE REACTIONS .............................................................................................. 10 DRUG INTERACTIONS .............................................................................................. 12 DOSAGE AND ADMINISTRATION .......................................................................... 14 OVERDOSAGE ............................................................................................................ 17 ACTION AND CLINICAL PHARMACOLOGY ........................................................ 18 STORAGE AND STABILITY ...................................................................................... 20 SPECIAL HANDLING INSTRUCTIONS ................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................... 21 PART II: SCIENTIFIC INFORMATION ............................................................................... 22 PHARMACEUTICAL INFORMATION ...................................................................... 22 REFERENCES ................................................................... Olvassa el a teljes dokumentumot