CEFTAZIDIME FRESENIUS 1 G

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CEFTAZIDIME AS PENTAHYDRATE

Available from:

NEOPHARM (ISRAEL) 1996 LTD

ATC code:

J01DD02

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

CEFTAZIDIME AS PENTAHYDRATE 1000 MG/VIAL

Administration route:

I.V, I.M

Prescription type:

Required

Manufactured by:

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

Therapeutic area:

CEFTAZIDIME

Therapeutic indications:

Ceftazidime is indicated for the treatment of the infections listed below in adults and children includingneonates (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 patients 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 (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 regarding the appropriate use of antibacterial agents

Authorization date:

2021-05-31

Summary of Product characteristics

1
SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ceftazidime Fresenius 1 g
Ceftazidime Fresenius 2 g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ceftazidime Fresenius 1000 mg powder for solution for injection
Each vial contains 1000 mg of ceftazidime (as Ceftazidime
pentahydrate)
Ceftazidime Fresenius 2000 mg powder for solution for injection or
infusion
Each bottle contains 2000 mg of ceftazidime (as Ceftazidime
pentahydrate)
Excipients with known effect:
This medicinal product contains 2.3 mmol (52 mg) sodium for 1000 mg
Ceftazidime.
This medicinal product contains 4.6 mmol (104 mg) sodium for 2000 mg
Ceftazidime.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ceftazidime Fresenius 1000 mg: Powder for solution for IV or IM
injection.
Ceftazidime Fresenius 2000 mg: Powder for solution for IV or IM
injection or infusion.
White or pale yellow powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceftazidime 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 patients on CAPD.
2
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