Land: Kanada
Sprache: Englisch
Quelle: Health Canada
IMIPENEM; CILASTATIN (CILASTATIN SODIUM)
SUN PHARMA CANADA INC
J01DH51
IMIPENEM AND CILASTATIN
250MG; 250MG
POWDER FOR SOLUTION
IMIPENEM 250MG; CILASTATIN (CILASTATIN SODIUM) 250MG
INTRAVENOUS
30ML
Prescription
CARBAPENEMS
Active ingredient group (AIG) number: 0218820002; AHFS:
APPROVED
2021-01-19
_ _ _ _ _Pr_ _TARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP) Page 1 of 57 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TARO-IMIPENEM-CILASTATIN Imipenem and Cilastatin for Injection 250 mg imipenem and 250 mg cilastatin (as cilastatin sodium) per vial 500 mg imipenem and 500 mg cilastatin (as cilastatin sodium) per vial Sterile powder for solution, I.V. Infusion USP ANTIBIOTIC Sun Pharma Canada Inc., 126 East Drive Brampton, ON L6T 1C1 Date of Initial Authorization: MAY 20, 2010 Date of Revision: JULY 22, 2022 Submission Control Number: 260927 _ _ _ _ _Pr_ _TARO-Imipenem-Cilastatin (Imipenem and Cilastatin for Injection, USP) Page 2 of 57 _ RECENT MAJOR LABEL CHANGES 4. DOSAGE AND ADMINISTRATION 07/2022 7. WARNINGS AND PRECAUTIONS 01/2021 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 .......................................................................................................................... 5 1.2 GERIATRICS .......................................................................................................................... 5 2 CONTRAINDICATIONS .......................................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX...................................................................... 5 4 DOSAGE AND ADMINISTRATION .......................................................................................... 6 4. Lesen Sie das vollständige Dokument