FORTUM 2g powder injection

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

ceftazidime pentahydrate, Quantity: 2.328 g (Equivalent: ceftazidime, Qty 2 g)

Tilgjengelig fra:

Aspen Pharmacare Australia Pty Ltd

Legemiddelform:

Injection, powder for

Sammensetning:

Excipient Ingredients: sodium carbonate

Administreringsrute:

Intravenous

Enheter i pakken:

5 vials x 2g, 1 vial X 2g

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Fortum is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials , but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. Indications include: Severe infections in general: for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems, e.g., infected burns. Respiratory tract infections: for example, pneumonia, bronchopneumonia, infected pleurisy, infected bronchiectasis and bronchitis. Severe ear, nose and throat infections: for example, otitis media, mastoiditis. Urinary tract infections: for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and infections associated with bladder and renal stones. Skin and soft tissue infections: for example, erys

Produkt oppsummering:

Visual Identification: White to cream powder; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

1991-08-13

Informasjon til brukeren

FORTUM

1
FORTUM

INJECTION
_Ceftazidime _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use Fortum.
This leaflet answers some common
questions about Fortum. It does not
contain all of the available
information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Sometimes new risks are
found even when a medicine has
been used for many years. Your
doctor has weighed the expected
benefits of you taking Fortum against
the risks this medicine could have for
you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT IS FORTUM USED
FOR?
Fortum belongs to a group of
medicines called cephalosporins.
Fortum is used to treat a wide range
of infections caused by bacteria.
These infections may affect the chest
(bronchitis or pneumonia), ears,
nose, throat, bladder and urinary
tract, skin and soft tissue, stomach or
bones.
Fortum works by killing the bacteria
that cause these infections.
Your doctor may have prescribed
Fortum for another reason.
There is no evidence that Fortum
injection is addictive.
BEFORE YOU ARE GIVEN
FORTUM
_WHEN YOU MUST NOT BE GIVEN _
_IT: _
You must not be given Fortum if:
*
you have ever had an allergic
reaction to cephalosporins,
penicillins or any of the
ingredients listed toward the end
of this leaflet. (See
"Ingredients")
*
the expiry date (EXP) printed on
the pack has passed.
*
the packaging is torn or shows
signs of tampering
_TELL YOUR DOCTOR IF: _
You must tell your doctor if:
*
you are allergic to foods, dyes,
preservatives or any other
medicines (in particular
cephalosporins, penicillins,
chloramphenicol or lignocaine)
*
you are taking any other
medicines, including medicines
you buy without a prescription
*
you are taking oral contraceptives
(birth control pills)
*
you have had to stop taking
another medicine for your
infection
*
you have kidney or liver
problems
*
you have

Preparatomtale

1
PRODUCT INFORMATION
FORTUM
NAME OF THE MEDICINE:
Fortum (ceftazidime as pentahydrate).
Chemical structure:
O
H
2
.5
O
H
O
CH
3
N
S
S
N
O
O
N
+
O
NH
H
H
O
N
O
N
H
2
CH
3
CAS Registry number: 72558-82-8
DESCRIPTION:
Fortum is a cephalosporin antibiotic for use by injection only. It is
supplied as a white to faintly
yellow powder in vials containing 1 g and 2 g ceftazidime (as
pentahydrate) with sodium
carbonate anhydrous (116 mg per gram of ceftazidime). On the addition
of Water for
Injections, Fortum Injection dissolves with effervescence to produce a
solution for injection.
Fortum Injection contains approximately 52 mg (2.3 mEq) of sodium per
gram of ceftazidime.
1.164 g of pure ceftazidime pentahydrate is equivalent to 1 g
ceftazidime free acid. For
laboratory tests associated with ceftazidime administration,
ceftazidime pentahydrate should
be used.
PHARMACOLOGY:
PHARMACOKINETICS:
Absorption of ceftazidime after oral administration is negligible,
therefore Fortum is intended
for parenteral use only.
In man after a single intramuscular administration of 500 mg and 1 g,
mean peak serum
levels of 18 and 37 mg/L respectively are achieved at 1 hour falling
to 8 and 2 mg/L and 20
and 5 mg/L at 4 and 8 hours respectively for the two doses. Five
minutes after an intravenous
bolus injection of 500 mg, 1 g and 2 g, mean serum levels are
respectively 46, 87 and
170 mg/L falling to 17 and 6 mg/L, 32 and 10 mg/L and 85 and 15 mg/L
at 1 and 4 hours
respectively with the three doses. The serum half-life in adults with
normal renal function is
about 1.8 hours (1.2-2.9 hours). This may be prolonged to 20-35 hours
in anuric patients. In
neonates, the serum half-life of ceftazidime can be 3-4 times greater
than that measured in
adults. The serum protein binding of ceftazidime is low at about 10%.
Ceftazidime is not metabolised in the body and is excreted unchanged
in the active form into
the urine by glomerular filtration. In the presence of normal renal
function approximately 80 to
2
90% of the dose is recovered in the urine wi