Zinacef 250 mg Powder for Solution or Suspension for Injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Cefuroxime sodium

Tilgjengelig fra:

GlaxoSmithKline (Ireland) Limited

ATC-kode:

J01DC; J01DC02

INN (International Name):

Cefuroxime sodium

Dosering :

250 milligram(s)

Legemiddelform:

Powder for solution for injection

Resept typen:

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

Terapeutisk område:

Second-generation cephalosporins; cefuroxime

Autorisasjon status:

Marketed

Autorisasjon dato:

1978-08-21

Informasjon til brukeren

Reason for update:
UKIE TII WS - Excipients Update, M3 Harmonisation and GDS v33 updates
Market: Ireland
Agency Approval Date:
Text Date: 14/07/2020
Text Issue and Draft No.: Issue 8 draft 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZINACEF
250 mg powder for solution or suspension for injection
750 mg powder for solution or suspension for injection
1.5g powder for solution for injection or 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 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).
Reason for update:
UKIE TII WS - Excipients Update, M3 Harmonisation and GDS v33 updates
Mark

Preparatomtale

Health Products Regulatory Authority
16 December 2021
CRN009WWR
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zinacef 250 mg Powder for Solution or Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg of cefuroxime (as cefuroxime sodium).
Each vial contains 14 mg of sodium.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for solution for injection.
A white to cream powder.
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)
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
16 December 2021
CRN009WWR
Page 2 of 11
pyelonephritis
(intravenously or intramuscularly)
Severe infections
750 mg every 6 hours (intravenously)
1.5 g every 8 hours (intravenously)
Surgic