CEFAZOLIN - FRESENIUS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CEFAZOLIN AS SODIUM

Available from:

NEOPHARM (ISRAEL) 1996 LTD

ATC code:

J01DB04

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

CEFAZOLIN AS SODIUM 1000 MG

Administration route:

I.V, I.M

Prescription type:

Required

Manufactured by:

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

Therapeutic group:

CEFAZOLIN

Therapeutic area:

CEFAZOLIN

Therapeutic indications:

Cefazolin - Fresenius is indicated in the treatment of serious infections due to susceptible micro-organisms.

Authorization date:

2018-04-30

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CEFAZOLIN - FRESENIUS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefazolin (as sodium cefazolin) 1000 mg
Excipient(s) with known effect: Each vial contains 48.4 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for I.V/I.M injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefazolin - Fresenius is indicated in the treatment of the following
serious infections due to
susceptible organisms:
RESPIRATORY TRACT INFECTIONS: Due to _S.Aureus_ (methicillin
sensitive).
Species for which acquired resistance can be a problem: _S.
pneumoniae_, _H.influenzae,_ and group
A beta-hemolytic streptococci.
Injectable benzathine penicillin is considered to be the drug of
choice in treatment and
prevention of streptococcal infections, including the prophylaxis of
rheumatic fever.
Data establishing the efficacy of Cefazolin - Fresenius in the
subsequent prevention of
rheumatic fever are not available at present.
URINARY TRACT INFECTIONS: Due to _E coli_.
SKIN AND SKIN STRUCTURE INFECTIONS: Due to _S. Aureus_ (methicillin
sensitive).
Species for which acquired resistance can be a problem: group A
beta-hemolytic streptococci,
and other strains of streptococci.
BILIARY TRACT INFECTIONS: Due to E coli, S. aureus. Species for which
acquired resistance can
be a problem: various strains of streptococci.
BONE AND JOINT INFECTIONS: Due to _S. aureus_.
GENITAL INFECTIONS: (i.e., prostatitis, epididymitis) due _to E.
_C_oli._
SEPTICEMIA: Due to, S. _ aureus_ (methicillin sensitive), _ E coli._
Species for which acquired
resistance can be a problem: S. _pneumonia._
ENDOCARDITIS: Due to _S_. _aureus_ (methicillin sensitive).
Species for which acquired resistance can be a problem: group A
beta-hemolytic streptococci.
PERIOPERATIVE
PROPHYLAXIS:
The
prophylactic
administration
of
Cefazolin
-
Fresenius
preoperatively, intraoperatively, and postoperatively may reduce the
incidence of certain
postoperative infections