Cefuroxime Venus Pharma 1500 mg powder for solution for injection or infusion

Land: Malta

Språk: engelska

Källa: Medicines Authority

Tillgänglig från:

Venus Pharma GmbH Am Bahnhof 1-3, Werne, D 59368, Germany

ATC-kod:

J01DC02

INN (International namn):

CEFUROXIME 1500 mg

Läkemedelsform:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Sammansättning:

CEFUROXIME 1500 mg

Receptbelagda typ:

POM

Terapiområde:

ANTIBACTERIALS FOR SYSTEMIC USE

Produktsammanfattning:

Licence number in the source country: NOT APPLICAPABLE

Bemyndigande status:

Authorised

Tillstånd datum:

2022-05-31

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFUROXIME VENUS PHARMA 750 MG POWDER FOR SOLUTION FOR INJECTION OR
INFUSION
CEFUROXIME VENUS PHARMA 1500 MG POWDER FOR SOLUTION FOR INJECTION OR
INFUSION
CEFUROXIME (AS CEFUROXIME SODIUM)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Cefuroxime Venus Pharma is and what it is used for
2. What you need to know before you are given Cefuroxime Venus Pharma
3. How Cefuroxime Venus Pharma is given
4. Possible side effects
5. How to store Cefuroxime Venus Pharma
6. Contents of the pack and other information
1. WHAT CEFUROXIME VENUS PHARMA IS AND WHAT IT IS USED FOR
Cefuroxime Venus Pharma 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 VENUS PHARMA IS USED TO TREAT INFECTIONS OF
:
• the lungs or chest
• the urinary tract
• the skin and soft tissue
• the abdomen
Cefuroxime Venus Pharma 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 this medicine during your treatment.
2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFUROXIME VENUS PHARMA
YOU MUST NOT BE GIVEN CEFUROXIME VENUS PHARMA:
•
IF YOU ARE ALLERGIC
to
ANY CEPHALOSPORIN ANTIBIOTICS
or any of the other ingredients of this medicine
(listed in section 6).
• if you have ever had a severe allergic (
_hypersensitive_
) reaction to any

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Cefuroxime Venus Pharma 750 mg powder for solution for injection or
infusion
Cefuroxime Venus Pharma 1500 mg powder for solution for injection or
infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefuroxime Venus Pharma 750 mg powder for solution for injection or
infusion
Each vial contains Cefuroxime Sodium equivalent to Cefuroxime 750 mg
Each vial of cefuroxime sodium contains approximately 39 mg sodium.
Cefuroxime Venus Pharma 1500 mg powder for solution for injection or
infusion
Each vial contains Cefuroxime Sodium equivalent to Cefuroxime 1500 mg
Each vial of cefuroxime sodium contains approximately 78 mg sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for injection or infusion
White or almost white, slightly hygroscopic powder
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefuroxime 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
2
• 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 intramuscu