Fortum

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ceftazidime pentahydrate 2 g

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Ceftazidime pentahydrate 2 g

Dosage:

2 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Ceftazidime pentahydrate 2 g Excipient: Sodium carbonate

Units in package:

Vial, 2000 mg

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Glaxo Operations UK Limited t/a Glaxo Welcome Operations

Therapeutic indications:

Treatment of single or multiple infections caused by susceptible organisms. May be used alone as first choice medicine before the results of sensitivity tests are available. May be used in combination with an aminoglycoside or most other ?- lactam antibiotics. May be used with an antibiotic against anaerobes when the presence of Bacteroides fragilis is suspected.

Product summary:

Package - Contents - Shelf Life: Vial, - 2000 mg - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1984-07-19

Patient Information leaflet

1
CONSUMER MEDICINE INFORMATION
FORTUM INJECTION
CEFTAZIDIME PENTAHYDRATE, 500 MG, 1 G AND 2 G INJECTION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully.
This leaflet answers some common questions about FORTUM injection. 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. Your doctor has weighed the
risks of you being administered
Fortum Injection against the benefits this medicine is expected to
have for you.
If you have any concerns about using this medicine, ask your doctor or
pharmacist.
Keep this leaflet. You may need to read it again.
WHAT FORTUM IS USED FOR
FORTUM Injection contains an antibiotic called ceftazidime, which
treats infections caused by
bacteria, in different parts of the body.
FORTUM injection belongs to a group of antibiotics called
cephalosporins. These antibiotics work by
either killing the bacteria that cause the infections or stopping
their growth.
FORTUM will not work against infection cased by viruses such as colds
or the flu (influenza).
Ask your doctor if you have any questions or if you aren't sure why
FORTUM injection has been
prescribed for you.
FORTUM is only available with a doctor's prescription.
FORTUM is not addictive.
BEFORE YOU ARE GIVEN FORTUM
_WHEN YOU MUST NOT BE GIVEN IT _
Do not use FORTUM if you have ever had an allergic reaction to FORTUM,
other cephalosporins or
any of the ingredients listed at the end of this leaflet.
_BEFORE YOU START USING FORTUM _
You must tell your doctor if:
you have had an allergic reaction to penicillin or cephalosporin
antibiotics
You may have an increased chance of being allergic to FORTUM if you
are allergic to penicillins.
you have had or have kidney problems
you need a low salt intake
you are pregnant, trying to become pregnant or breastfeeding
2
you are taking any other medicines, including medicines you buy
without a prescription from a
pharmacy, supermarket or health food shop.
Some medicines may affect the way othe

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
FORTUM ceftazidime (as pentahydrate) 500 mg, 1 g or 2 g powder for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FORTUM powder for injection contains either 500 mg, 1 g or 2 g of
ceftazidime (as
pentahydrate).
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
A white to faintly yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FORTUM is indicated for the treatment of adults and children including
neonates with
single or multiple infections caused by susceptible organisms.
May be used alone as first choice medicine before the results of
sensitivity tests are
available.
May be used in combination with an aminoglycoside or most other
beta-lactam
antibiotics.
May be used with an antibiotic against anaerobes when the presence of
_Bacteroides _
_fragilis_ is suspected.
Susceptibility to ceftazidime will vary with geography and time and
local susceptibility
data should be consulted where available (see section 5.1
Pharmacodynamic
properties).
Indications include:
-
Severe infections e.g.
-
septicaemia, bacteraemia, peritonitis, meningitis.
-
infections in immunosuppressed patients.
-
infections in patients in intensive care, e.g. infected burns.
-
Respiratory tract infections including lung infections in cystic
fibrosis.
-
Ear, nose and throat infections.
2
-
Urinary tract infections.
-
Skin and soft tissue infections.
-
Gastrointestinal, biliary and abdominal infections.
-
Bone and joint infections.
-
Infections associated with haemo- and peritoneal dialysis and with
continuous
ambulatory peritoneal dialysis (CAPD).
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
Dosage depends upon the severity, sensitivity, site and type of
infection and upon
the age and renal function of the patient.
ADULTS:
1-6 g/day in 2 or 3 divided doses by intravenous (i.v.) or
intramuscular (i.m.) injection.
Urinary tract and less severe infections:
- 500 mg or 1 g every 12 hours.
Most infections:
- 1 g every 8 hours or