NU-CEFUROXIME TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CEFUROXIME (CEFUROXIME AXETIL)

Tersedia dari:

NU-PHARM INC

Kode ATC:

J01DC02

INN (Nama Internasional):

CEFUROXIME

Dosis:

250MG

Bentuk farmasi:

TABLET

Komposisi:

CEFUROXIME (CEFUROXIME AXETIL) 250MG

Rute administrasi :

ORAL

Unit dalam paket:

60/100/250

Jenis Resep:

Prescription

Area terapi:

SECOND GENERATION CEPHALOSPORINS

Ringkasan produk:

Active ingredient group (AIG) number: 0122448001; AHFS:

Status otorisasi:

CANCELLED (UNRETURNED ANNUAL)

Tanggal Otorisasi:

2018-03-28

Karakteristik produk

Page 1 of 26
PRODUCT MONOGRAPH
PR
NU-CEFUROXIME
CEFUROXIME AXETIL TABLETS
250 MG AND 500 MG CEFUROXIME/TABLET
NU-PHARM STANDARD
ANTIBIOTIC
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL ST., UNITS 1 & 2
OCTOBER 20, 2009
RICHMOND HILL, ONTARIO
L4B 1E4
CONTROL#: 133377
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
.........................................................................................................5
DRUG
INTERACTIONS..........................................................................................................6
DOSAGE AND
ADMINISTRATION.........................................................................................6
OVERDOSAGE.......................................................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................7
STORAGE AND STABILITY
...................................................................................................7
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................7
PART II: SCIENTIFIC
INFORMATION.......................................................................................9
PHARMACEUTICAL
INFORMATION.....................................................................................9
CLINICAL
TRIALS.......................................................................................................