Cefotaxime 2 g powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefotaxime

Available from:

Noridem Enterprises Limited

ATC code:

J01DD; J01DD01

INN (International Name):

Cefotaxime

Dosage:

2 gram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

Third-generation cephalosporins; cefotaxime

Authorization status:

Not marketed

Authorization date:

2020-06-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Cefotaxime 500 mg powder for solution for injection/infusion
Cefotaxime 1 g powder for solution for injection/infusion
Cefotaxime 2 g powder for solution for injection/infusion
cefotaxime
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE
GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor,
pharmacist or nurse.
-
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cefotaxime is and what it is used for
2.
What you need to know before you are given
Cefotaxime
3.
How Cefotaxime is given
4.
Possible side effects
5.
How to store Cefotaxime
6.
Contents of the pack and other information
1.
WHAT CEFOTAXIME IS AND WHAT IT IS USED FOR
Cefotaxime is an antibiotic, i.e. a medicine which is used for
the treatment of bacterial infections of:
•
the lungs (pneumonia)
•
the skin and soft tissue
•
the urinary tract
•
the genitals (including gonorrhoea)
•
the heart valves (endocarditis)
•
the membranes covering the brain (meningitis)
•
the abdomen
•
the blood (so called ‘bacteraemia’)
Furthermore cefotaxime is used to treat the Lyme disease
(borreliosis, an infection primarily caused by tick bites, e.g.
relapsing fever).
Cefotaxime can also be used before and during surgery in
order to prevent possible infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
CEFOTAXIME
YOU MUST NOT BE GIVEN CEFOTAXIME IF YOU:
•
are allergic (hypersensitive) to cefotaxime or to any
cephalosporin antibiotics or any of the other ingredients
of this medicine (listed in section 6).
•
have ever had a severe allergic (hypersensitive)
reaction to any other type of beta-lactam antibiotic

Summary of Product characteristics

Health Products Regulatory Authority
26 June 2020
CRN008LJP
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefotaxime 2 g powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cefotaxime sodium equivalent to 2 g cefotaxime.
Each vial of Cefotaxime contains 96 mg (4.18 mmol) of sodium.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion
A white to slightly yellow powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefotaxime is indicated in the treatment of the following severe
infections when known or thought very likely to be caused by
bacteria that are susceptible to cefotaxime (see section 4.4 and 5.1):
-Bacterial pneumonia
-Complicated infections of the urinary tract including pyelonephritis
-Severe skin and soft tissue infections
-Genital infections, including gonorrhoea
-Intra-abdominal infections (such as peritonitis)
-Bacterial meningitis
-Endocarditis
-Borreliosis
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated with, any of the
infections listed above.
Perioperative prophylaxis. For surgical operations with increased risk
of infections with anaerobic pathogens, e.g. colorectal
surgery, a combination with an appropriate drug with activity against
anaerobes is recommended.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cefotaxime may be administered by intravenous bolus injection or
intravenous infusion or by intramuscular injection after
reconstitution of the solution.
Dosage and mode of administration should be determined by the severity
of the infection, susceptibility of the causative
organism and the patient's condition. Therapy may be started before
the result of microbiological tests are known.
Adults and adolescents over 12 years
Adults and adolescents usually receive 2 to 6 g cefotaxime daily. The
daily dose should be divided in two single doses e