Cefuroxime 1.5 g Powder for Injection/Infusion

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Cefuroxime Sodium

MAH:

Flynn Pharma Limited

ATC_code:

J01DC; J01DC02

INN:

Cefuroxime Sodium

dosage:

1.5 gram(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:

2000-06-23

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFUROXIME 750MG & 1.5G POWDER FOR INJECTION/INFUSION
Cefuroxime
The name of your medicine is Cefuroxime 750mg & 1.5g Powder for
Injection/Infusion, which will be
referred to as Cefuroxime Injection throughout this document.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 nurse.
-
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 Injection is and what it is used for
2.
What you need to know before you are given Cefuroxime Injection
3.
How Cefuroxime Injection is given
4.
Possible side effects
5.
How to store Cefuroxime Injection
6.
Contents of the pack and other information
1.
WHAT CEFUROXIME INJECTION IS AND WHAT IT IS USED FOR
Cefuroxime injection 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 INJECTION IS USED TO TREAT INFECTIONS OF:
-
the lungs or chest
-
the urinary tract
-
the skin and soft tissue
-
the abdomen
Cefuroxime Injection is also used:
-
to prevent infections during surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFUROXIME INJECTION
YOU MUST NOT BE GIVEN CEFUROXIME INJECTION:
-
IF YOU ARE ALLERGIC (_HYPERSENSITIVE_) TO ANY CEPHALOSPORIN
antibiotics or any other ingredients of
Cefuroxime Injection (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 Injection if you think that this

SPC

Health Products Regulatory Authority
22 May 2023
CRN00DKCN
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefuroxime 1.5 g Powder for Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1.5g cefuroxime (as sodium salt).
Excipients with known effects:
Each vial contains 81.3 mg sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion/ Powder for suspension
for injection
Vials containing a white or almost white powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefuroxime 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
1.5 g every 8 hours
Health Products Regulatory Authority
22 May 2023
CRN00DKCN
Page 2 of 12
pyelonephritis
(intravenously or intramuscularly)
Severe infections
750 mg