CEFTAZIDIME - VIT

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

CEFTAZIDIME AS PENTAHYDRATE

Boleh didapati daripada:

VITAMED PHARMACEUTICAL INDUSTRIES LTD

Kod ATC:

J01DD02

Borang farmaseutikal:

POWDER FOR SOLUTION FOR INJECTION

Komposisi:

CEFTAZIDIME AS PENTAHYDRATE 1.000 G/VIAL

Laluan pentadbiran:

I.M, I.V

Jenis preskripsi:

Required

Dikeluarkan oleh:

ACS DOBFAR S.P. A, ITALY

Kawasan terapeutik:

CEFTAZIDIME

Tanda-tanda terapeutik:

Ceftazidime-VIT is indicated for the treatment of the infections listed below in adults and children including neonates (from birth).• Nosocomial pneumonia• Broncho-pulmonary infections in cystic fibrosis• Bacterial meningitis• Chronic suppurative otitis media• Malignant otitis externa• Complicated urinary tract infections• Complicated skin and soft tissue infections• Complicated intra-abdominal infections• Bone and joint infections• Peritonitis associated with dialysis in patient on CAPD.Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.Ceftazidime may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.Ceftazidime may be used in the peri-operative prophylaxis of urinary tract infections for patients undergoing trans-urethral resection of the prostate (TURP).The selection of ceftazidime should take into account its antibacterial spectrum, which is mainly restricted to aerobic Gram negative bacteria.Ceftazidime should be co-administered with other antibacterial agents whenever the possible range of causive bacteria would not fall within its spectrum of activity.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

Tarikh kebenaran:

2022-07-31

Ciri produk

_Page 1 of 19 _
Ceftazidime-Vit
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceftazidime-Vit
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftazidime-Vit: each vial contains 1 g ceftazidime (as 1.164 g
sterile ceftazidime
pentahydrate).
Excipient with known effect:
Each vial contains 52.44 mg (2.28 mmol) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ceftazidime-Vit - Powder for solution for injection.
Each vial contains a white or pale-yellow powder.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Ceftazidime-Vit is indicated for the treatment of the infections
listed below in adults
and children including neonates (from birth).
•
Nosocomial pneumonia
•
Broncho-pulmonary infections in cystic fibrosis
•
Bacterial meningitis
•
Chronic suppurative otitis media
•
Malignant otitis externa
•
Complicated urinary tract infections
•
Complicated skin and soft tissue infections
•
Complicated intra-abdominal infections
•
Bone and joint infections
•
Peritonitis associated with dialysis in patient on CAPD.
Treatment of patients with bacteraemia that occurs in association
with, or is suspected
to be associated with, any of the infections listed above.
Ceftazidime may be used in the management of neutropenic patients with
fever that is
suspected to be due to a bacterial infection.
_Page 2 of 19 _
Ceftazidime may be used in the peri-operative prophylaxis of urinary
tract infections for
patients undergoing transurethral resection of the prostate (TURP).
The selection of ceftazidime should take into account its
antibacterial spectrum, which
is mainly restricted to aerobic Gram-negative bacteria (see sections
4.4 and 5.1).
Ceftazidime should be co-administered with other antibacterial agents
whenever the
possible range of causative bacteria would not fall within its
spectrum of activity.
Consideration should be given to official guidelines on the
appropriate use of
antibacterial agents.
4.2.
Posology and method of administration
Posology
Table 1: Adults