Cefuroxime 750 mg powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefuroxime Sodium

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

J01DC; J01DC02

INN (International Name):

Cefuroxime Sodium

Dosage:

750 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Prescription type:

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

Therapeutic area:

Second-generation cephalosporins; cefuroxime

Authorization status:

Marketed

Authorization date:

2009-08-21

Patient Information leaflet

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UK-IE V006
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFUROXIME 750 MG
POWDER FOR SOLUTION FOR INJECTION/INFUSION CEFUROXIME
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Cefuroxime is and what it is used for
2.
What you need to know before you use Cefuroxime
3.
How to use Cefuroxime
4.
Possible side effects
5.
How to store Cefuroxime
6.
Contents of the pack and other information
1.
WHAT CEFUROXIME IS AND WHAT IT IS USED FOR
Cefuroxime is an antibiotic used in adults and children. It works by
killing bacteria that cause
infections. It belongs to a group of medicines called
_cephalosporins. _
CEFUROXIME IS USED TO TREAT INFECTIONS
of:
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissue
•
the abdomen
Cefuroxime is also used:
• to prevent infections during surgery.
Your doctor may test the type of bacteria causing your infection and
monitor whether the bacteria are
sensitive to Cefuroxime during your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CEFUROXIME
YOU MUST NOT BE GIVEN CEFUROXIME:
•
IF YOU ARE ALLERGIC
to
ANY CEPHALOSPORIN ANTIBIOTICS
or any of the other ingredients of
Cefuroxime (listed in section 6).
•
if you have ever had a severe allergic (
_hypersensitive_
) reaction to any other type of betalactam
antibiotic (penicillins, monobactams and carbapenems).
•
if you have ever developed a severe skin rash or skin peeling,
blistering and/or mouth sores after
treatment with cefuroxime or any other cephalosporin antibiotics.
→
TELL YOUR DOCTOR BEFORE
you start on Cefuroxime if you think that this applies to you. You
must
not be given Cefuroxime.
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.
WARNINGS AND PRECAUTIONS
Talk to your docto

Summary of Product characteristics

Health Products Regulatory Authority
20 November 2023
CRN00DL69
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefuroxime 750 mg powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 750 mg of cefuroxime (as 789 mg cefuroxime sodium).
Excipients with known effect:
Each vial contains 40.63 mg of sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion
White to cream coloured powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefuroxime Kabi is indicated for the treatment of the infections
listed below in adults and children, including neonates (from
birth) (see sections 4.4 and 5.1).

Community acquired pneumonia.

Acute exacerbations of chronic bronchitis.

Complicated urinary tract infections, including pyelonephritis.

Soft-tissue infections: cellulitis, erysipelas and wound infections.

Intra-abdominal infections (see section 4.4).

Prophylaxis against infection in gastrointestinal (including
oesophageal), orthopaedic, cardiovascular, and
gynaecological surgery (including caesarean section).
In the treatment and prevention of infections in which it is very
likely that anaerobic organisms will be encountered, cefuroxime
should be administered with additional appropriate antibacterial
agents.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Table 1. Adults and children _≥ _40 kg_
INDICATION
DOSAGE
Community acquired pneumonia and acute exacerbations
of chronic bronchitis
750 mg every 8 hours
(intravenously or intramuscularly)
Soft-tissue infections: cellulitis, erysipelas and wound
infections.
Intra-abdominal infections
Complicated urinary tract infections, including
pyelonephritis
1.5 g every 8 hours
(intravenously or intramuscularly)
Severe infections
750 mg every 6 hours (intravenously)
1.5 g every 8 hours (intravenously)
Health Prod