Cefuroxime 250 mg Powder for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefuroxime sodium

Available from:

Stravencon Ltd

ATC code:

J01DC; J01DC02

INN (International Name):

Cefuroxime sodium

Dosage:

250 milligram(s)

Pharmaceutical form:

Powder for solution for injection

Prescription type:

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

Therapeutic area:

Second-generation cephalosporins; cefuroxime

Authorization status:

Not marketed

Authorization date:

2015-08-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFUROXIME 250 MG POWDER FOR SOLUTION FOR INJECTION
CEFUROXIME 750 MG POWDER FOR SOLUTION FOR INJECTION
CEFUROXIME 1500 MG 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 of the 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 are given Cefuroxime .
3. How Cefuroxime is given.
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 the 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 Stravencon during your treatment.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN CEFUROXIME
YOU MUST NOT BE GIVEN CEFUROXIME:
•
IF YOU ARE ALLERGIC to ANY CEPHALOSPORIN ANTIBIOTICS
•
if you have ever had a severe allergic (_hypersensitive_)
reaction to any other type of betalactam antibiotic
(penicillins, monobactams and carbapenems).
è
TELL YOUR DOCTOR BEFORE you start on Cefuroxime if
you think that this applies to you. You must not be given
Cefuroxime.
TAKE SPECIAL CARE WITH CEFUROXIME
You must look out for certain symptoms such as allergic
reactions, skin rashes, gastrointestinal disorders such as
diarrhoea or fung

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefuroxime 250 mg Powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefuroxime sodium equivalent to 250mg of cefuroxime.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
250 mg powder for solution for injection.
White or almost white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefuroxime is indicated for the treatment of 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 treatment and prevention of infections in which it is very likely
that anaerobic organisms will be encountered,
cefuroxime should be administered with 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_
_40kg_
Cefuroxime strength
Amount of sodium per vial
250 mg
13.8 mg
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
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