FORTUM 2 GRAM

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

CEFTAZIDIME AS PENTAHYDRATE

可用日期:

NOVARTIS ISRAEL LTD., ISRAEL

ATC代码:

J01DD02

药物剂型:

POWDER FOR SOLUTION FOR INJ/INF

组成:

CEFTAZIDIME AS PENTAHYDRATE 2 G/VIAL

给药途径:

I.V

处方类型:

Required

厂商:

SANDOZ AG, SWITZERLAND

治疗组:

CEFTAZIDIME

治疗领域:

CEFTAZIDIME

疗效迹象:

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.

授权日期:

2023-02-28

资料单张

ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
ל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה
אפור
אפור
אפור
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)
ךיראת
:
71.5.71
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.
... תושקובמה תורמחהה תונמוסמ ובש ,ןולעה
ב"צמ
.בוהצ עקר לע
עבצב )ןולעב( ונמוס תורמחה רדגב םניאש
םייוניש
קורי
0

产品特点

_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-