DBL™ Cefotaxime Sodium for Injection

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cefotaxime sodium 1.048 g equivalent to 1 g cefotaxime;  ;  

Available from:

Pfizer New Zealand Limited

INN (International Name):

Cefotaxime sodium 1.048 g (equivalent to 1 g cefotaxime)

Dosage:

1 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Cefotaxime sodium 1.048 g equivalent to 1 g cefotaxime    

Units in package:

Vial, glass, single dose, Clear, type III bromobutyl cap, 1 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

ACS Dobfar SpA

Therapeutic indications:

DBL™ Cefotaxime Sodium for Injection is indicated in the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity. Septicaemia. Respiratory tract infections: acute and chronic bronchitis, bacterial pneumonia, infected bronchiectasis, lung abscess and post-operative chest infections. Urinary tract infections: acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria. Soft tissue infections: cellulitis, peritonitis and wound infections. Bone and joint infections: osteomyelitis, septic arthritis. Obstetric and gynaecological infections: pelvic inflammatory disease. Gonorrhoea: particularly if penicillin-resistant. Other bacterial infections: meningitis and other sensitive infections suitable for parenteral antibiotic therapy. The administration of DBL™ Cefotaxime Sodium for Injection prophylactically may reduce the incidence of certain post-operative infections in patients undergoing surgical procedures that are classified as contaminated or potentially contaminated or in clean operations where infections would have serious effects. Protection is best ensured by achieving adequate local tissue concentrations at the time contamination is likely to occur. DBL™ Cefotaxime Sodium for Injection should therefore be administered immediately prior to surgery and if necessary continued in the immediate post-operative period. Administration should usually be stopped within 24 hours since continuing use of any antibiotic in the majority of surgical procedures does not reduce the incidence of subsequent infections.

Product summary:

Package - Contents - Shelf Life: Vial, glass, single dose, Clear, type III bromobutyl cap - 1 g - 36 months unopened 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 - Vial, glass, single dose, Clear, type III bromobutyl cap - 10 dose units - 36 months unopened 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:

2000-05-08

Summary of Product characteristics

Version: pdfcefov11223
Superceded: pdfcefov11020
Page 1 of 15
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DBL™ Cefotaxime Sodium for Injection 1 g Powder for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of DBL Cefotaxime Sodium for Injection contains 1 g of
cefotaxime sodium.
Each
gram
of
DBL
Cefotaxime
Sodium
for
Injection
contains
approximately
48
mg
(2.09 mmol) of sodium.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for Injection.
DBL Cefotaxime Sodium for Injection is a white to pale yellow
crystalline powder.
The reconstituted product is a pale yellow solution. Variations in the
intensity of colour of the
freshly prepared solution do not indicate change in potency or safety.
The pH of the formulated material is 4.5 to 6.5.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL Cefotaxime Sodium for Injection is indicated in the treatment of
the following infections
either before the infecting organism has been identified or when
caused by bacteria of
established sensitivity:
•
Septicaemia.
•
Respiratory tract infections: acute and chronic bronchitis, bacterial
pneumonia, infected
bronchiectasis, lung abscess and post-operative chest infections.
•
Urinary tract infections: acute and chronic pyelonephritis, cystitis
and asymptomatic
bacteriuria.
•
Soft tissue infections: cellulitis, peritonitis and wound infections.
•
Bone and joint infections: osteomyelitis, septic arthritis.
•
Obstetric and gynaecological infections: pelvic inflammatory disease.
•
Gonorrhoea: particularly if penicillin-resistant.
•
Other bacterial infections: meningitis and other sensitive infections
suitable for parenteral
antibiotic therapy.
•
The administration of DBL Cefotaxime Sodium for Injection
prophylactically may reduce
the
incidence
of
certain
post-operative
infections
in
patients
undergoing
surgical
procedures that are classified as contaminated or potentially
contaminated or in clean
Version: pdfcefov11223
Superceded: pdfcefov11020
Page 2 o