CEFUROXIME - FRESENIUS 750 MG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

CEFUROXIME AS SODIUM SALT

Διαθέσιμο από:

NEOPHARM (ISRAEL) 1996 LTD

Φαρμακολογική κατηγορία (ATC):

J01DC02

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION OR SUSPENSION FOR INJECTION OR INFUSION

Σύνθεση:

CEFUROXIME AS SODIUM SALT 750 MG

Οδός χορήγησης:

I.M, I.V

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

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

Θεραπευτική ομάδα:

CEFUROXIME

Θεραπευτική περιοχή:

CEFUROXIME

Θεραπευτικές ενδείξεις:

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

Ημερομηνία της άδειας:

2018-01-31

Αρχείο Π.Χ.Π.

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,