Страна: Канада
мова: англійська
Джерело: Health Canada
CEFOTAXIME SODIUM
AUROBINDO PHARMA LIMITED (UNIT VI)
J01DD01
CEFOTAXIME
2G
POWDER FOR SOLUTION
CEFOTAXIME SODIUM 2G
INTRAMUSCULAR
15ML
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0152507002; AHFS:
APPROVED
2010-05-28
PRODUCT MONOGRAPH PR CEFOTAXIME SODIUM FOR INJECTION BP (sterile cefotaxime sodium, 0.5 g, 1 g, 2 g) β-lactam Antibiotic SPONSOR: Aurobindo Pharma Limited (Unit VI) Sy No's: 329/39, 329/40, 329/47, Ida Chitkul village, Patancheru mandal, Sanga Reddy district, Telangana-502 307, INDIA. DISTRIBUTOR: AURO PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, Canada DATE OF REVISION: June 29, 2020. Submission Control No.: 239186 2 TABLE OF CONTENTS ACTION AND CLINICAL PHARMACOLOGY………………………………………... 3 INDICATIONS AND CLINICAL USE………………………………………………….. 3 CONTRAINDICATIONS…………………………………………………….………….. 5 WARNINGS……………………………………………………………………………… 5 PRECAUTIONS…………………………………………………………………………. 6 DRUG INTERACTIONS………………………………………………………………… 7 ADVERSE REACTIONS………………………………………………………………… 8 SYMPTOMS AND TREATMENT OF OVERDOSAGE……………………………….. 11 DOSAGE AND ADMINISTRATION…………………………………………………… 11 STABILITY AND STORAGE RECOMMENDATIONS…............................................. 15 AVAILABILITY OF DOSAGE FORMS………………………………………………... 16 PHARMACEUTICAL INFORMATION………………………………………………… 17 MICROBIOLOGY………………………………………………………………………... 18 PHARMACOLOGY……………………………………………………………………… 21 TOXICOLOGY…………………………………………………………………………… 29 REFERENCES……………………………………………………………………………. 36 3 PR CEFOTAXIME SODIUM FOR INJECTION BP (STERILE CEFOTAXIME SODIUM, 0.5 G, 1 G, 2 Прочитайте повний документ