Cefuroxime Dr. Eberth 1500 mg Powder for solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFUROXIME SODIUM

Available from:

Dr. Friedrich Eberth Arzneimittel GmbH Am Bahnhof 2, Ursensollen 92289, Germany

ATC code:

J01DC02

INN (International Name):

CEFUROXIME SODIUM 1500 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

CEFUROXIME SODIUM 1500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2016-06-10

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cefuroxime Dr. Eberth 1500 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 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 Dr. Eberth is and what it is used for
2.
What you need to know before you are given Cefuroxime Dr. Eberth
3.
How Cefuroxime Dr. Eberth is given
4.
Possible side effects
5.
How to store Cefuroxime Dr. Eberth
6.
Contents of the pack and other information
1.
WHAT CEFUROXIME DR. EBERTH IS AND WHAT IT IS USED FOR
Cefuroxime Dr. Eberth 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 DR. EBERTH IS USED TO TREAT INFECTIONS
of:

the lungs or chest

the urinary tract

the skin and soft tissue

the abdomen.
Cefuroxime Dr. Eberth is also used:

to prevent infections during surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFUROXIME DR. EBERTH
YOU MUST NOT BE GIVEN CEFUROXIME DR. EBERTH:

IF YOU ARE ALLERGIC
(hypersensitive) to
CEFUROXIME SODIUM
or
ANY CEPHALOSPORIN ANTIBIOTICS
.

if you have ever had a severe allergic (hypersensitive) reaction to
any other type of betalactam
antibiotic (penicillins, monobactams and carbapenems).

TELL YOUR DOCTOR BEFORE
you start on Cefuroxime Dr. Eberth if you think that this applies to
you. You must not be given Cefuroxime Dr. Eberth.
WARNINGS AND PRECAUTIONS
Page 2 of 7
Talk to your doctor or nurse before Cefuroxime Dr. Eberth is given to
you.
You must look out for certain symptoms such as allergic reactions and
gastrointestinal disorders such
as diarrhoea while you are being given Cef

Summary of Product characteristics

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Cefuroxime Dr. Eberth 750 mg Powder for solution for
injection/infusion
Cefuroxime Dr. Eberth 1500 mg Powder for solution for
injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cefuroxime sodium equivalent to750 mg cefuroxime
and 1500 mg cefuroxime
resp.
The total quantity of sodium per vial is as follows:
strength
Amount of sodium per vial
750 mg
1.8 mmol corresponding to 40.7 mg sodium
1500 mg
3.6 mmol corresponding to 81.4 mg sodium
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion
White to light yellow powder
.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefuroxime Dr. Eberth 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.
Page 2 of 13
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
(in