Cefuroxime Actavis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cefuroxime sodium 789mg equivalent to cefuroxime 750 mg;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Cefuroxime sodium 789 mg (equivalent to cefuroxime 750 mg)

Dosage:

750 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Cefuroxime sodium 789mg equivalent to cefuroxime 750 mg  

Prescription type:

Prescription

Manufactured by:

ACS Dobfar SpA

Therapeutic indications:

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. Indications include:

Product summary:

Package - Contents - Shelf Life: Vial, Glass, uncoloured type III vial with bromobutyl type I rubber stopper - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2014-02-24

Summary of Product characteristics

Version 1.0
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
CEFUROXIME ACTAVIS (750 mg, 1.5 g, powder for injection/infusion)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CEFUROXIME ACTAVIS vials contain 750 mg, or 1.5 g of cefuroxime (as
cefuroxime sodium)
powder for injection or infusion.
3.
PHARMACEUTICAL FORM
Powder for injection/ infusion.
Cefuroxime is a white to or almost white powder which is produces an
off-white suspension for
intramuscular use or a yellow solution of intravenous administration
after reconstitution with water.
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
PHARMACEUTICAL PARTICULARS
and
PHARMACODYNAMIC PROPERTIES
).
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,