CEFOTAXIME SODIUM FOR INJECTION BP POWDER FOR SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CEFOTAXIME SODIUM

Disponível em:

AUROBINDO PHARMA LIMITED (UNIT VI)

Código ATC:

J01DD01

DCI (Denominação Comum Internacional):

CEFOTAXIME

Dosagem:

2G

Forma farmacêutica:

POWDER FOR SOLUTION

Composição:

CEFOTAXIME SODIUM 2G

Via de administração:

INTRAMUSCULAR

Unidades em pacote:

15ML

Tipo de prescrição:

Prescription

Área terapêutica:

THIRD GENERATION CEPHALOSPORINS

Resumo do produto:

Active ingredient group (AIG) number: 0152507002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2010-05-28

Características técnicas

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