Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
EPINEPHRINE; ARTICAINE HYDROCHLORIDE
HANSAMED LIMITED
N01BB58
ARTICAINE, COMBINATIONS
0.01MG; 40MG
SOLUTION
EPINEPHRINE 0.01MG; ARTICAINE HYDROCHLORIDE 40MG
BLOCK/INFILTRATION
1.7 ML
Ethical
LOCAL ANESTHETICS
Active ingredient group (AIG) number: 0226661001; AHFS:
APPROVED
2000-08-02
PRODUCT MONOGRAPH ULTRACAINE D-S INJECTION _ _ (4% articaine hydrochloride with epinephrine 1:200,000 as epinephrine hydrochloride) ULTRACAINE D-S FORTE INJECTION_ _ (4% articaine hydrochloride with epinephrine 1:100,000 as epinephrine hydrochloride) Solutions for Injection_ _ Local Anesthetic for Dental Use Date of Preparation July 19, 2000 Manufactured by: Sanofi - Aventis Deutschland GmbH DATE OF REVISION: Frankfurt am Main, Hessen, Germany JANUARY 27, 2014 Imported by: HANSAmed Limited 2830 Argentia Road, Unit 5 - 8 Mississauga, Ontario L5N 8G4 Submission Control No. 162166 “ ULTRACAINE ” is the registered trademark of Sanofi-Aventis Deutschland GmbH. _Ultracaine D-S, Ultracaine D-S Forte (articaine + epinephrine solution for injection) _ _Hansamed Ltd _ _Page 2 of 20 _ _ _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................... 3 SUMMARY PRODUCT INFORMATION ........................................................................................... 3 INDICATIONS AND CLINICAL USE ................................................................................................. 3 CONTRAINDICATIONS .................................................................................................................... 3 WARNINGS AND PRECAUTIONS ................................................................................................... 4 ADVERSE REACTIONS .................................................................................................................... 6 DRUG INTERACTIONS .................................................................................................................... 7 DOSAGE AND ADMINISTRATION ................................................................................................... 7 OVERDOSAGE ................................................................................................................................. 8 ACTION AND CLINICAL PHARMACOLOGY .......................... Baca dokumen lengkap