NU-CEFUROXIME TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
04-11-2009
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Aktivna sestavina:
CEFUROXIME (CEFUROXIME AXETIL)
Dostopno od:
NU-PHARM INC
Koda artikla:
J01DC02
INN (mednarodno ime):
CEFUROXIME
Odmerek:
250MG
Farmacevtska oblika:
TABLET
Sestava:
CEFUROXIME (CEFUROXIME AXETIL) 250MG
Pot uporabe:
ORAL
Enote v paketu:
60/100/250
Tip zastaranja:
Prescription
Terapevtsko območje:
SECOND GENERATION CEPHALOSPORINS
Povzetek izdelek:
Active ingredient group (AIG) number: 0122448001; AHFS:
Status dovoljenje:
CANCELLED (UNRETURNED ANNUAL)
Datum dovoljenje:
2018-03-28
Lastnosti izdelka
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.......................................................................................................
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