Zinacef 750 mg powder for solution for injection

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Malta Medicines Authority

Pieejams no:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATĶ kods:

J01DC02

SNN (starptautisko nepatentēto nosaukumu):

CEFUROXIME 750 mg

Zāļu forma:

POWDER FOR SOLUTION FOR INJECTION

Kompozīcija:

CEFUROXIME 750 mg

Receptes veids:

POM

Ārstniecības joma:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorizācija statuss:

Authorised

Autorizācija datums:

2006-12-26

Lietošanas instrukcija

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zinacef 250 mg powder for solution for injection
Zinacef 750 mg powder for solution for injection
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 Zinacef is and what it is used for
2.
What you need to know before you are given Zinacef
3.
How Zinacef is given
4.
Possible side effects
5.
How to store Zinacef
6.
Contents of the pack and other information
1.
WHAT ZINACEF IS AND WHAT IT IS USED FOR
Zinacef 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. _
ZINACEF IS USED TO TREAT INFECTIONS OF:
•
the lungs or chest
•
the urinary tract
•
the skin and soft tissue
•
the abdomen
Zinacef 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 Zinacef during your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZINACEF
YOU MUST NOT BE GIVEN ZINACEF:
•
IF YOU ARE ALLERGIC
to
ANY CEPHALOSPORIN ANTIBIOTICS
or any of the other ingredients of Zinacef
(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).
➔
TELL YOUR DOCTOR BEFORE
you start on Zinacef if you think that this applies to you. You must
not be
given Zinacef.
2
TAKE SPECIAL CARE WITH ZINACEF
You must look out for certain symptoms such as allergic reactions,
skin rashes, gastrointestinal disorders
such as diarrhoea or fungal infections while you are being given
Zinacef. This will reduce the r

Produkta apraksts

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zinacef and associated names 250 mg powder for solution for injection
Zinacef and associated names 750 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
250 mg powder for injection
Each vial contains 250 mg of cefuroxime (as cefuroxime sodium).
Each vial contains 14 mg of sodium.
750 mg powder for injection
Each vial contains 750 mg of cefuroxime (as cefuroxime sodium).
Each vial contains 42 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
250 mg, 750 mg powder for solution for injection
Powder for solution for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zinacef 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)
3
INDICATION
DOSAGE
Soft-tissue infections: cellulitis, erysipelas and
wound infections.
Intra-abdominal infections
Complicated urinary tract infections, including
pyelonephritis
1.5 g ev