Claforan Powder for Solution for Injection 1g
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
24-02-2023
Summary of Product characteristics
(SPC)
24-02-2023
Active ingredient:
Cefotaxime sodium
Available from:
Sanofi-Aventis Ireland Limited T/A SANOFI
ATC code:
J01DD; J01DD01
INN (International Name):
Cefotaxime sodium
Dosage:
1 gram(s)
Pharmaceutical form:
Powder for solution for injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Third-generation cephalosporins; cefotaxime
Authorization status:
Marketed
Authorization date:
1981-05-13
Patient Information leaflet
CLAFORAN POWDER FOR SOLUTION FOR INJECTION 500MG
CLAFORAN POWDER FOR SOLUTION FOR INJECTION 1G
Cefotaxime (as Cefotaxime Sodium)
The following instruction is extracted from the SPC.
TECHNICAL INFORMATION FOR THE PREPARATION AND ADMINISTRATION OF
CEFOTAXIME
1. NAME OF THE MEDICINAL PRODUCT
Claforan Powder for Solution for Injection 500mg
Claforan Powder for Solution for Injection 1g
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Claforan powder for solution for injection 500mg
Each vial contains cefotaxime sodium equivalent to 500mg cefotaxime
base
Excipient(s) with known effect
Sodium 24mg (see section 4.4)
Claforan powder for solution for injection 1g
Each vial contains cefotaxime sodium equivalent to 1g cefotaxime base.
Excipient(s) with known effect
Sodium 48mg (see section 4.4)For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for injection or infusion. A white to pale
yellow-white crystalline powder.
4. CLINICAL PARTICULARS
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Dosage:
Claforan may be administered intravenously or by slow injection or
infusion or intramuscularly. The
dosage, route and frequency of administration should be determined by
the severity of infection,
the sensitivity of causative organism and condition of the patient.
Therapy may be initiated before
the results of sensitivity tests are known.
_Adults: _The recommended dosage for mild to moderate infections is 1g
12 hourly. However, dosage
may be varied according to the severity of the infection, sensitivity
of causative organisms and
condition of the patient. Therapy may be initiated before the results
of sensitivity tests are known.
In severe infections dosage may be increased up to 12g daily given in
3 or 4 divided doses. For
infections caused by sensitive Psuedomonas spp. daily doses of greater
than 6 g will usually be
required.
Dosage in Gonorrhea: A single injection of 1g may be administered
intramuscularly or intravenously.
_Children: _The usual dosage range is 100-150mg/kg/day in 2 to 4
divided doses. However, in very
sev
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Summary of Product characteristics
Health Products Regulatory Authority
23 February 2023
CRN00CPW7
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Claforan Powder for Solution for Injection 1g
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cefotaxime sodium equivalent to 1g cefotaxime base.
Excipient(s) with known effect
Sodium 48mg (see section 4.4)
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
A white to pale yellow-white crystalline powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PROPERTIES: Claforan is a broad-spectrum bactericidal cephalosporin
antibiotic. Claforan is exceptionally active _in vitro_ against
Gram-negative organisms sensitive or resistant to first or second
generation cephalosporins. It is similar to other
cephalosporins in activity against Gram-positive organisms.
INDICATION: Claforan 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:
Septicaemias
Respiratory Tract Infections such as acute and chronic bronchitis,
bacterial pneumonia, infected bronchiectasis, lung abscess
and post-operative chest infections.
Urinary Tract Infections such as acute and chronic pyelonephritis,
cystitis and asymptomatic bacteriuria.
Soft Tissue Infections such as cellulitis, peritonitis and wound
infections.
Bone and Joint Infections such as osteomyelitis, septic arthritis.
Obstetric and Gynaecological Infections such as pelvic inflammatory
disease.
Gonorrhoea particularly when penicillin has failed or is unsuitable.
Other Bacterial Infections, meningitis and other sensitive infections
suitable for parenteral antibiotic therapy.
PROPHYLAXIS:
The administration of Claforan 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.
Health
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