FORTUM 1 GRAM

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

CEFTAZIDIME AS PENTAHYDRATE

Commercializzato da:

NOVARTIS ISRAEL LTD., ISRAEL

Codice ATC:

J01DD02

Forma farmaceutica:

POWDER FOR SOLUTION FOR INJ/INF

Composizione:

CEFTAZIDIME AS PENTAHYDRATE 1 G/VIAL

Via di somministrazione:

I.M, I.V

Tipo di ricetta:

Required

Prodotto da:

SANDOZ AG, SWITZERLAND

Gruppo terapeutico:

CEFTAZIDIME

Area terapeutica:

CEFTAZIDIME

Indicazioni terapeutiche:

Fortum 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.

Data dell'autorizzazione:

2023-02-28

Foglio illustrativo

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ךיראת
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תילגנאב רישכת םש
םושירה רפסמו
:
23499)
-
40
-
23497); FORTUM 2 GRAM (046
-
44
-
FORTUM 1 GRAM (046
םושירה לעב םש
:
GLAXOSMITHKLINE (ISRAEL) LTD
! דבלב תורמחהה טורפל דעוימ הז ספוט
ןולעב
ןולעב
ןולעב
אפורל
אפורל
אפורל
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
UNDESIRABLE EFFECTS
…
SKIN
AND
SUBCUTANEOUS
TISSUE DISORDERS
Common - Maculopapular or
urticarial rash
Uncommon - Pruritus
Very rare
Unknown -
Toxic epidermal
necrolysis Stevens-Johnson
syndrome Erythema
multiforme Angioedema
…
…
SKIN
AND
SUBCUTANEOUS
TISSUE
DISORDERS
Common - Maculopapular or
urticarial rash
Uncommon - Pruritus
Very rare
Unknown -
Toxic epidermal
necrolysis Stevens-Johnson
syndrome Erythema multiforme
Angioedema
Drug Reaction with Eosinophilia
and
Systemic
Symptoms
(DRESS)
4
…
4
There have been rare reports where
DRESS has been associated with
ceftazidime.
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Scheda tecnica

_Page 1 of 16 _
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
FORTUM 1 GRAM
FORTUM 2 GRAM
1.
NAME OF THE MEDICINAL PRODUCT
Fortum 1 gram
Fortum 2 gram
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fortum 1 gram: Vials contain 1g ceftazidime (as pentahydrate) with
sodium carbonate
(118mg per gram of ceftazidime).
Fortum 2 gram: Vials contain 2g ceftazidime (as pentahydrate) with
sodium carbonate
(118mg per gram of ceftazidime).
Excipient known effect
Fortum 1 gram: Each vial contains 52 mg (2.26 mmol) of sodium per
vial.
Fortum 2 gram: Each vial contains 104 mg (4.52 mmol) of sodium per
vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Fortum 1 gram - Powder for solution for injection or infusion
Fortum 2 gram - Powder for solution for injection or infusion
Vials containing white to cream sterile powder.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fortum 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 16 _
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-