CEFOTAXIME Pdr for Soln Inj/Inf 2 Grams
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
CEFOTAXIME SODIUM
Available from:
Teva Pharma B.V.
Dosage:
2 Grams
Pharmaceutical form:
Pdr for Soln Inj/Inf
Authorization date:
2006-11-10
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefotaxime 2 g Powder for Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cefotaxime sodium equivalent to 2 g cefotaxime.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
White or slightly yellow powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of the following severe infections when known or thought very likely to be due to organisms that are
susceptible to cefotaxime (see section 5.1)
Infections of the lower respiratory tract
Infections of the kidneys and other upper urinary tract infections
Infections of the skin and soft tissue
Genital infections caused by gonococci, particularly when penicillin has failed or is unsuitable
Intra-abdominal infections (incl. peritonitis) (cefotaxime should be used in combination with another antibiotic
that can provide anaerobic cover in the treatment of intra-abdominal infections)
Acute meningitis.
Consideration should be given to official local guidance on the appropriate use of antibiotics when using cefotaxime.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cefotaxime sodium may be administered intravenously by bolus injection or infusion or intramuscularly.
Cefotaxime 500 mg and 1 g are suitable for i.v. and i.m. injection. Cefotaxime 2 g is suitable for i.v. injection and i.v.
infusion.
The intramuscular method of administration is reserved for exceptional clinical situations and should undergo a risk-
benefit assessment. It is recommended that no more than 4 ml is injected unilaterally. If the daily dose exceeds 2 g
cefotaxime or if cefotaxime is injected more frequently than twice per day, the i.v. route is recommended.
Intramuscular administration of cefotaxime reconstituted with
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