Fortum for injection Pdr for Soln for Injection 1g

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFTAZIDIME PENTAHYDRATE

Available from:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

J01DD02

INN (International Name):

CEFTAZIDIME PENTAHYDRATE 1 g

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

CEFTAZIDIME PENTAHYDRATE 1 g

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2006-02-01

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
FORTUM 250 MG POWDER FOR SOLUTION FOR INJECTION
FORTUM 500 MG POWDER FOR SOLUTION FOR INJECTION
FORTUM 1 G POWDER FOR SOLUTION FOR INJECTION
FORTUM 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
FORTUM 2 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
FORTUM 3 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Ceftazidime
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Fortum is and what it is used for
2.
What you need to know before you are given Fortum
3.
How Fortum is given
4.
Possible side effects
5.
How to store Fortum
6.
Contents of the pack and other information
1.
WHAT FORTUM IS AND WHAT IT IS USED FOR
Fortum is an antibiotic used in adults and children (including newborn
babies). It works by killing
bacteria that cause infections. It belongs to a group of medicines
called
_cephalosporins._
FORTUM IS USED TO TREAT SEVERE BACTERIAL INFECTIONS OF
:
•
the lungs or chest
•
the lungs and bronchi in patients suffering from cystic fibrosis
•
the brain (
_meningitis_
)
•
the ear
•
the urinary tract
•
the skin and soft tissues
•
the abdomen and abdominal wall (
_peritonitis_
)
•
the bones and joints.
Fortum can also be used:
•
to prevent infections during prostate surgery in men
•
to treat patients with low white blood cell counts (
_neutropenia_
) who have a fever due to a
bacterial infection.
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2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FORTUM
YOU MUST NOT BE GIVEN FORTUM:
•
IF YOU ARE ALLERGIC
to
CEFTAZIDIME
or any of the other ingredients of this medicine (listed in
section 6).
•
if you have had a
SEVERE ALLERGIC REACTION
to any
O

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
2
1
.
NAME OF THE MEDICINAL PRODUCT
Fortum

for Injection 1 g
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fortum 1 g
Each vial contains 1 g ceftazidime (as pentahydrate) with sodium
carbonate (118 mg per gram of
ceftazidime).
Excipient with known effect
Each vial contains 52 mg (2.3 mmol) of sodium per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
1 g powder for solution for injection
Powder for solution for injection
Vials containing white to cream sterile powder.
4.
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 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 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).
3
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
Posol