Cefuroxime Multichem

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Cefuroxime sodium 802mg Equivalent to cefuroxime 750 mg;  

MAH:

Multichem NZ Limited

INN:

Cefuroxime sodium 802 mg (Equivalent to cefuroxime 750 mg)

dosage:

750 mg

pharmaceutical_form:

Powder for injection

composition:

Active: Cefuroxime sodium 802mg Equivalent to cefuroxime 750 mg  

units_in_package:

Vial, glass, type II transparent vial with grey bromobutyl stopper, green alu & PP flip-off cap, 1vial pack size, 750 mg

class:

Prescription

prescription_type:

Prescription

manufactured_by:

Fresenius Kabi Anti-Infectives S.r.l.

therapeutic_indication:

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. 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, erysipelas and wound infections. - Bone and joint infections for example, osteomyelitis and septic arthritis. - Obstetric and gynecological infections, pelvic inflammatory diseases. - Gonorrhea particularly when penicillin is unsuitable. - Other infections including septicemia, meningitis and peritonitis. - Prophylaxis against infection in abdominal, pelvic, orthopedic, cardiac, pulmonary, esophageal and vascular surgery where there is increased risk from infection

leaflet_short:

Package - Contents - Shelf Life: Vial, glass, type II transparent vial with grey bromobutyl stopper, green alu & PP flip-off cap, 1vial pack size - 1 dose units - 24 months from date of manufacture stored at or below 25°C 5 hours reconstituted stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, type II transparent vial with grey bromobutyl stopper, green alu & PP flip-off cap, 5 vial pack size - 5 dose units - 24 months from date of manufacture stored at or below 25°C 5 hours reconstituted stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, type II transparent vial with grey bromobutyl stopper, green alu & PP flip-off cap, 10 vial pack siz - 10 dose units - 24 months from date of manufacture stored at or below 25°C 5 hours reconstituted stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

authorization_date:

2004-05-04

SPC

NEW ZEALAND DATA SHEET
m-Cefuroxime
powder for injection 750mg and 1.5g
Page 1 of 12
1. PRODUCT NAME
m-Cefuroxime powder for injection 750mg and 1.5g.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
m-Cefuroxime injection contains 750mg or 1.5g of cefuroxime powder (as
cefuroxime sodium) for
injection or infusion.
3. PHARMACEUTICAL FORM
Powder for injection. 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 for intravenous administration. Variations in the intensity
of this colour do not indicate
any change in either the efficacy or safety of the product.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefuroxime is a bactericidal cephalosporin antibiotic which is
resistant to most β-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
Further Information, Pharmacodynamic Effects).
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, erysipelas and wound
infections.
- Bone and joint infections for example, osteomyelitis and septic
arthritis.
- Obstetric and gynaecological infections, pelvic inflammatory
diseases.
-Gonorrhoea particularly when penicillin is unsuitable.
- Other infections including septicaemia, meningitis and peritonitis.
-
Prophylaxis
against
infection
in
abdominal,
pelvic