CEFAZOLIN -VIT

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Beli sekarang

Ciri produk Ciri produk (SPC)
13-12-2022
Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
06-09-2022

Bahan aktif:

CEFAZOLIN AS SODIUM

Boleh didapati daripada:

VITAMED PHARMACEUTICAL INDUSTRIES LTD

Kod ATC:

J01DB04

Borang farmaseutikal:

POWDER FOR SOLUTION FOR INJ/INF

Komposisi:

CEFAZOLIN AS SODIUM 1000 MG/VIAL

Laluan pentadbiran:

I.M, I.V

Jenis preskripsi:

Required

Dikeluarkan oleh:

ACS DOBFAR S.P. A, ITALY

Kawasan terapeutik:

CEFAZOLIN

Tanda-tanda terapeutik:

Treatment of serious infections caused by susceptible organisms and also perioperatively for prophylaxis. Treatment Respiratory tract: Respiratory tract infections due to streptococcus pneumoniae (formerly diplococcus pneumoniae) klebsiella species haemophilus influenzae staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A B - hemolytic streptococci. Cefazolin is effective in the eradication of streptococci from the nasopharynx.However data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available at present. Urinary tract: Infections due to escherichia coli klebsiella species proteus mirabilis and some strains of Enterobacter and enterococci. Skin and skin structure: -hemolytic beta Infections due to Staphylococcus aureus (penicillin-sensitive and penicillin-resistant) group A streptococci and other strains of streptococci. Biliary tract: Infections due to escherichia coli various strains of streptococci proteus mirabilis klebsiella species and staphylococcus aureus. Bone and joint :Infections due to staphylococcus aureus. Genital infections (i.e. prostatitis epididymitis) due to escherichia coli proteus mirabilis klebsiella species and some strains of enterococci.Septicemia due to streptococcus pneumoniae (formerly diplococcus pneumoniae) staphylococcus aureus (penicillin-sensitive and penicillin-resistant) proteus mirabilis escherichia coli and klebsiella species.Endocarditis caused by staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci. Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organism to cefazolin.Perioperative prophylaxis: The prophylactic administraton of cefazolin perioperatively (preoperatively intraoperatively and postoperatively) may reduce the incidence of certain postoperative infectons in patients undergoing surgical procedures (e.g. hysterectomy gastrointestinal surgery and transurethral prostatectomy) that are classified as contaminated or potentially contaminated. The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g. open-heart surgery and prosthetic arthroplasty).

Tarikh kebenaran:

2023-09-30

Ciri produk

                                1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cefazolin-VIT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cefazolin-VIT powder for solution for injection/infusion
Each vial contains 1.048 g cefazolin sodium (equivalent to 1.0 g
cefazolin)
Excipient(s) with known effect:
The sodium content of each vial is 2.2 mmol (50.6 mg).
3.
PHARMACEUTICAL
FORM
Powder for solution for injection/infusion.
The powder is white or almost white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of serious infections caused by susceptible organisms and
also perioperatively for
prophylaxis.
Treatment Respiratory tract:
Respiratory tract infections due to streptococcus pneumoniae (formerly
diplococcus
pneumoniae) klebsiella species haemophilus influenzae staphylococcus
aureus (penicillin-
sensitive and penicillin-resistant) and group A B - hemolytic
streptococci.
Cefazolin is effective in the eradication of streptococci from the
nasopharynx. However data
establishing the efficacy of cefazolin in the subsequent prevention of
rheumatic fever are not
available at present.
Urinary tract:
Infections due to escherichia coli klebsiella species proteus
mirabilis and some strains of
Enterobacter and enterococci.
Skin and skin structure:
-hemolytic beta Infections due to Staphylococcus aureus
(penicillin-sensitive and penicillin-
resistant) group A streptococci and other strains of streptococci.
Biliary tract:
Infections due to escherichia coli various strains of streptococci
proteus mirabilis klebsiella
species and staphylococcus aureus.
Bone and joint:
2
Infections due to staphylococcus aureus.
Genital infections (i.e. prostatitis epididymitis) due to escherichia
coli proteus mirabilis
klebsiella species and some strains of enterococci.
Septicemia due to streptococcus pneumoniae (formerly diplococcus
pneumoniae)
staphylococcus aureus (penicillin-sensitive and penicillin-resistant)
proteus mirabilis
escherichia coli and klebsiella species.
Endocarditis caused by staphylococcus aureus (penicillin-sensitive and
p
                                
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