Cefuroxime

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Cefuroxime sodium 1578mg equivalent to to cefuroxime 1500mg

Tilgængelig fra:

Devatis Limited

Dosering:

1.5 g

Lægemiddelform:

Powder for injection

Sammensætning:

Active: Cefuroxime sodium 1578mg equivalent to to cefuroxime 1500mg

Recept type:

Prescription

Terapeutiske indikationer:

Cefuroxime is a bactericidal cephalosporin antibiotic which is resistant to most ?-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms. It is indicated for the treatment of infections before the infecting organism has been identified or when caused by sensitive bacteria.

Produkt oversigt:

Package - Contents - Shelf Life: Vial, glass, Type I colourless 25 cc with rubber stopper and sealed with aluminium flip-off cap (1 vial) - 1.5 g - 36 months from date of manufacture stored at or below 25°C protect from light 5 hours reconstituted (not refrigerated) stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type I colourless 25 cc with rubber stopper and sealed with aluminium flip-off cap (5 vials) - 7.5 g - 36 months from date of manufacture stored at or below 25°C protect from light 5 hours reconstituted (not refrigerated) stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type I colourless 25 cc with rubber stopper and sealed with aluminium flip-off cap (10 vials) - 15 g - 36 months from date of manufacture stored at or below 25°C protect from light 5 hours reconstituted (not refrigerated) stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Autorisation dato:

2017-11-09

Produktets egenskaber

CEFUROXIME DEVATIS 250 mg, 750 mg & 1.5 g
Powder for Injection/Infusion
Module 1.3.1 New Zealand Data Sheet
DEVATIS LIMITED Property-Strictly Confidential
Version: NZ-V05 / March 2023
Page 1/10
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
CEFUROXIME DEVATIS 250 mg, 750 mg & 1.5 g Powder for
Injection/Infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each 250 mg vial contains cefuroxime sodium equivalent to 250 mg
cefuroxime.
Each 750 mg vial contains cefuroxime sodium equivalent to 750 mg
cefuroxime.
Each 1.5 g vial contains cefuroxime sodium equivalent to 1.5 g
cefuroxime.
Excipient with known effect:
Each 250 mg vial contains
13.55 mg sodium.
Each 750 mg vial contains
40.65 mg sodium.
Each 1.5 g vial contains
81.38 mg sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for injection/ infusion.
Cefuroxime is a white to faintly yellow powder to which appropriate
amounts of water are added to prepare
an off-white suspension for intramuscular use or a yellow solution of
intravenous administration.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Cefuroxime is a bactericidal cephalosporin antibiotic which is
resistant to most ß-lactamases and is active
against a wide range of Gram-positive and Gram-negative organisms.
It is indicated for the treatment of infections before the infecting
organism has been identified or when caused
by sensitive bacteria. Susceptibility to cefuroxime sodium will vary
with geography and time and local
susceptibility data should be consulted where available (see section
5.1).
Indications include

Respiratory tract infections for example, acute and chronic
bronchitis, infected bronchiectasis, bacterial
pneumonia, lung abscess and post-operative chest infections.

Ear, nose and throat infections for example, sinusitis, tonsillitis,
pharyngitis and otitis media.

Urinary
tract
infections
for
example, acute
and
chronic
pyelonephritis, cystitis and
asymptomatic
bacteriuria.

Soft-tissue infections for example, cellulitis, erysi