Cefotaxime 2g Powder for solution for injection or infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Cefotaxime sodium

Verfügbar ab:

Wockhardt UK Limited

ATC-Code:

J01DD; J01DD01

INN (Internationale Bezeichnung):

Cefotaxime sodium

Dosierung:

2 gram(s)

Darreichungsform:

Powder for solution for injection/infusion

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Third-generation cephalosporins; cefotaxime

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2003-09-19

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
Cefotaxime 500mg powder for solution for injection or infusion
Cefotaxime 1g powder for solution for injection or infusion
Cefotaxime 2g powder for solution for injection or infusion
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS
MEDICINE.

Keep this leaflet. You may need to read it again while you are
receiving your treatment.

If you have any further questions, please ask your doctor or nurse.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
The name of your medicine is cefotaxime 500mg, 1g or 2g powder for
solution for injection or infusion. In the
rest of this leaflet it is called cefotaxime for injection.
IN THIS LEAFLET:
1. What cefotaxime for injection is and what it is used for
2. Before you are given cefotaxime for injection
3. How cefotaxime for injection should be given
4. Possible side effects
5. How to store cefotaxime for injection
6. Further information
1. WHAT CEFOTAXIME FOR INJECTION IS AND WHAT IT IS USED FOR
Cefotaxime belongs to a group of medicines called cephalosporins which
are antibiotics. These medicines
work by killing bacteria that cause infections.
Cefotaxime for injection is used for the treatment of a range of
serious bacterial infections including
infections of the blood stream (septicaemia), bones (osteomyelitis),
the heart valves (endocartitis), the
membranes covering the brain (meningitis) and the lining of the
abdomen (peritonitis), and to prevent and
treat infections following surgical operations.
2. BEFORE YOU ARE GIVEN CEFOTAXIME FOR INJECTION
CEFOTAXIME FOR INJECTION SHOULD NOT BE GIVEN IF:

You are allergic to cefotaxime or any other cephalosporin.

You have previously had a severe allergic reaction to penicillin or
any other beta-lactam antibiotic
If any of the above app

Fachinformation

Health Products Regulatory Authority
13 November 2019
CRN009G5D
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefotaxime 2g Powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cefotaxime sodium equivalent to 2g of cefotaxime.
Each gram of cefotaxime contains approximately 48mg (2.09mmol) of
sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion (Powder for injection or
infusion).
White to slightly yellow powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Cefotaxime is indicated in the treatment of serious infections,
either before the infecting organism has been identified or
when caused by bacteria of established sensitivity, including
osteomyelitis,
septicaemia,
bacterial endocarditis,
meningitis, and
peritonitis.
and other serious bacterial infections suitable for parenteral
antibiotic therapy.
2. Cefotaxime may be used for pre-operative prophylaxis in patients
undergoing surgical procedures, that may be classified as
contaminated or potentially so.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cefotaxime may be administered intravenously, by bolus injection or by
infusion, or by intramuscular injection. The dosage,
route and frequency of administration should be determined by the
severity of infection, the sensitivity of causative organisms
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
three or four divided doses. For infections caused by
sensitive Pseudomonas species daily doses of greater than 6g will
usually be required.
Child