Cefuroxime 250mg Powder for Injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFUROXIME

Available from:

Villerton Invest S.A. Rue Edward Steichen 14, 2540, Luxembourg

ATC code:

J01DC02

INN (International Name):

CEFUROXIME 250 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION POWDER FOR SUSPENSION FOR INJECTION

Composition:

CEFUROXIME 250 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2019-09-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFUROXIME 250MG POWDER FOR INJECTION
CEFUROXIME SODIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your
pharmacist.
• This medicine has been prescribed for you. Do NOT pass it on to
others. It may harm them even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or your pharmacist.
IN THIS LEAFLET:
1. What Cefuroxime Injection is and what it is used for
2. Before you are given Cefuroxime Injection
3. How Cefuroxime Injection is given
4. Possible side effects
5. How to store Cefuroxime Injection
6. Further information
1. WHAT CEFUROXIME INJECTION IS AND WHAT IT IS USED FOR
Your medicine contains the active substance Cefuroxime, which is one
of a group of medicines called
antibiotics. These are used to kill the bacteria or ‘germs’ that
cause infections.
Your doctor has decided to give you Cefuroxime Injection because you
have an infection, or to protect you
from infection before an operation.
2. BEFORE YOU ARE GIVEN CEFUROXIME INJECTION
DO NOT TAKE CEFUROXIME INJECTION:
• If you are allergic (hypersensitive) to cefuroxime or other
similar antibiotics (called “cephalosporins”)
• If you have had a severe allergic reaction to penicillin or other
similar antibiotics (called “beta-lactams”)
• If you had an immediate allergic reaction when given penicillin or
similar antibiotics.
If you are unsure about any of these, ask your doctor.
TAKE SPECIAL CARE WITH CEFUROXIME INJECTION
If you have been told that your kidneys are not working as well as
they should be. Talk to your doctor if this
applies to you.
If you have previously had an allergic reaction to penicillin or other
similar antibiotics, you should tell your
doctor. It may be alright for you to be given this medicine.
If the allergic reaction was s

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cefuroxime 250mg Powder for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each vial contains 250mg cefuroxime (as sodium salt)
3.
PHARMACEUTICAL FORM
Powder for solution for injection
Powder for suspension for injection
Vial containing white or almost white sterile powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefuroxime 250mg Powder for Injection 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
750 mg every 8 hours
2
exacerbations of chronic bronchitis
(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
(intravenously or intramuscularly)
Severe infections
750 mg every 6 hours (intravenously)
1.5 g every 8 hours (intravenously)
Surgical prophylaxis for gastrointestinal,
gynaecological surgery (including
caesarean section) and orthopaedic
operations
1.5 g with the induction of anaesthesia. This