AURO CEFUROXIME INJECTION 1500 mg

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Aurogen South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH VIAL CONTAINS CEFUROXIME SODIUM EQUIVALENT TO CEFUROXIME 1500,0 mg

Authorization status:

Registered

Authorization date:

2012-07-06

Patient Information leaflet

_APPLICANT/PHCR: _
_ AUROGEN SOUTH AFRICA (PTY) LTD _
_PRODUCT PROPRIETARY NAME: AURO CEFOTAXIME 250 MG, 500 MG, 1000 MG,
2000 MG _
_DOSAGE FORM AND STRENGTH: POWDER FOR INJECTION 250 MG, 500 MG, 1000
MG, 2000 MG _
_ _
_AMENDED: 29/01/2021 _
AURO CEFOTAXIME 250 MG, 500 MG, 1000 MG AND 2000 MG
PAGE 1 OF 7
_(Cefotaxime 250 mg, 500 mg, 1000 and 2000 mg, Powder for Injection) _
1
APPROVED PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your
pharmacist.
- This medicine has been prescribed for you personally and you should
not share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
S4
1.
AURO CEFOTAXIME 250 mg (Powder For Injection)
2.
AURO CEFOTAXIME 500 mg (Powder For Injection)
3.
AURO CEFOTAXIME 1000 mg (Powder For Injection)
4.
AURO CEFOTAXIME 2000 mg (Powder For Injection)
Cefotaxime Sodium equivalent to Cefotaxime
1.
WHAT AURO CEFOTAXIME CONTAINS
The active substance is Cefotaxime Sodium.
1.
Each vial contains Cefotaxime Sodium equivalent to CEFOTAXIME 250 MG.
2.
Each vial contains Cefotaxime Sodium equivalent to CEFOTAXIME 500 MG.
3.
Each vial contains Cefotaxime Sodium equivalent to CEFOTAXIME 1000 MG.
4.
Each vial contains Cefotaxime Sodium equivalent to CEFOTAXIME 2000 MG.
_ _
2.
WHAT AURO CEFOTAXIME IS USED FOR
AURO CEFOTAXIME is indicated for the treatment of infections caused by
susceptible strains of
organisms in the following infections:-
UPPER RESPIRATORY TRACT INFECTIONS:
•
Pneumococcal infections – Pneumonia, bronchitis, cellulites, otitis
media
_APPLICANT/PHCR: _
_ AUROGEN SOUTH AFRICA (PTY) LTD _
_PRODUCT PROPRIETARY NAME: AURO CEFOTAXIME 250 MG, 500 MG, 1000 MG,
2000 MG _
_DOSAGE FORM AND STRENGTH: POWDER FOR INJECTION 250 MG, 500 MG, 1000
MG, 2000 MG _
_ _
_AMENDED: 29/01/2021 _
AURO CEFOTAXIME 250 MG, 500 MG, 1000 MG AND 2000 MG
PAGE 2 OF 7
_(Cefotaxime 250 mg, 500 mg, 1000 and 2000

Summary of Product characteristics

_APPLICANT/PHCR: _
_ AUROGEN SOUTH AFRICA (PTY) LTD _
_PRODUCT PROPRIETARY NAME: AURO CEFOTAXIME 250 MG, 500 MG, 1000 MG,
2000 MG _
_ _
_DOSAGE FORM AND STRENGTH: POWDER FOR INJECTION 250 MG, 500 MG, 1000
MG, 2000 MG _
_ _
_ _
_AMENDED: 29/01/2021 _
AURO CEFOTAXIME 250 MG, 500 MG, 1000 MG AND 2000 MG
PAGE 1 OF 9
_(Cefotaxime 250 mg, 500 mg, 1000 and 2000 mg, Powder for Injection) _
APPROVED PROFFESSIONAL INFORMATION
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
1.
AURO CEFOTAXIME 250 mg (Powder For Injection)
2.
AURO CEFOTAXIME 500 mg (Powder For Injection)
3.
AURO CEFOTAXIME 1000 mg (Powder For Injection)
4.
AURO CEFOTAXIME 2000 mg (Powder For Injection)
COMPOSITION:
1.
Each vial contains Cefotaxime Sodium equivalent to CEFOTAXIME 250 MG.
2.
Each vial contains Cefotaxime Sodium equivalent to CEFOTAXIME 500 MG.
3.
Each vial contains Cefotaxime Sodium equivalent to CEFOTAXIME 1000 MG.
4.
Each vial contains Cefotaxime Sodium equivalent to CEFOTAXIME 2000 MG.
PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad Spectrum antibiotics
PHARMACOLOGICAL ACTION:
Cefotaxime is a bactericidal semi-synthetic third-generation
cephalosporin. The antibacterial action
results from inhibition of bacterial cell wall synthesis by binding
essential target proteins in bacterial
cytoplasmic membranes. Cefotaxime has activity against a wide range of
bacterial organisms (Gram-
positive and Gram-negative), including beta-lactamase producing
strains.
PHARMACOKINETICS:
Cefotaxime is metabolised in the liver to both active and inactive
metabolites, and is approximately 90%
excreted in the urine. Approximately 30% of the dose of Cefotaxime is
excreted unchanged, while 15%-
_APPLICANT/PHCR: _
_ AUROGEN SOUTH AFRICA (PTY) LTD _
_PRODUCT PROPRIETARY NAME: AURO CEFOTAXIME 250 MG, 500 MG, 1000 MG,
2000 MG _
_ _
_DOSAGE FORM AND STRENGTH: POWDER FOR INJECTION 250 MG, 500 MG, 1000
MG, 2000 MG _
_ _
_ _
_AMENDED: 29/01/2021 _
AURO CEFOTAXIME 250 MG, 500 MG, 1000 MG AND 2000 MG
PAGE 2 OF 9
_(Cefotaxime 250 mg, 500 mg, 1000 and 2000 mg, Powder for