CEFUROXIME - FRESENIUS 750 MG

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

CEFUROXIME AS SODIUM SALT

MAH:

NEOPHARM (ISRAEL) 1996 LTD

ATC_code:

J01DC02

pharmaceutical_form:

POWDER FOR SOLUTION OR SUSPENSION FOR INJECTION OR INFUSION

composition:

CEFUROXIME AS SODIUM SALT 750 MG

administration_route:

I.M, I.V

prescription_type:

Required

manufactured_by:

LABESFAL - LABORATORIOS ALMIRO S.A, FRESENIUS KABI GROUP, PORTUGAL

therapeutic_group:

CEFUROXIME

therapeutic_area:

CEFUROXIME

therapeutic_indication:

Cefuroxime -Fresenius is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth).• 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 • Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section)• Nose infections for example, sinusitis• Septic arthritis

authorization_date:

2018-01-31

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
CEFUROXIME -FRESENIUS 750 MG
CEFUROXIME -FRESENIUS 1500 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CEFUROXIME -FRESENIUS 750 MG
Each vial contains 750 mg of cefuroxime (as 789 mg cefuroxime sodium).
Each vial contains 40.63 mg of sodium.
For the full list of excipients, see section 6.1
CEFUROXIME -FRESENIUS 1500 MG
Each vial contains 1500 mg of cefuroxime (as 1578 mg cefuroxime
sodium)
Each vial contains 81.26 mg of sodium .
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
CEFUROXIME -FRESENIUS 750 MG
Powder for solution or suspension for injection or infusion
CEFUROXIME -FRESENIUS 1500 MG
Powder for solution for inj /inf
White or almost white powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CEFUROXIME-FRESENIUS
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)
•
Nose infections for example, sinusitis
•
Septic arthritis
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,