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FORTUM FOR INJECTION 3G

Active substance(s): CEFTAZIDIME PENTAHYDRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Fortum for Injection 3 g

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Fortum for Injection: Vials contain 3 g ceftazidime (as pentahydrate) with sodium
carbonate (118 mg per gram of ceftazidime).

3

PHARMACEUTICAL FORM
Powder for solution for injection or infusion

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 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 (see
sections 4.4 and 5.1).
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

Posology
Table 1: Adults and children ≥ 40 kg
Intermittent Administration
Infection

Dose to be administered

Broncho-pulmonary infections in
cystic fibrosis
Febrile neutropenia
Nosocomial pneumonia
Bacterial meningitis
Bacteraemia*
Bone and joint infections
Complicated skin and soft tissue
infections
Complicated intra-abdominal
infections
Peritonitis associated with dialysis in
patients on CAPD
Complicated urinary tract infections
Per-operative prophylaxis for
transurethral resection of prostate
(TURP)
Chronic suppurative otitis media
Malignant otitis externa
Continuous infusion
Infection
Febrile neutropenia
Nosocomial pneumonia
Broncho-pulmonary infections in

100 to 150 mg/kg/day every 8 h,
maximum 9 g per day1
2 g every 8 h

1-2 g every 8 h

1-2 g every 8 h or 12 h
1 g at induction of anaesthesia, and a
second dose at catheter removal
1 g to 2 g every 8 h
Dose to be administered
Loading dose of 2 g followed by a

cystic fibrosis
Bacterial meningitis
Bacteraemia*
Bone and joint infections
Complicated skin and soft tissue
infections
Complicated intra-abdominal
infections
Peritonitis associated with dialysis in
patients on CAPD

continuous infusion of 4 to 6 g every
24 h1

1

In adults with normal renal function 9 g/day has been used without adverse effects. *When
associated with, or suspected to be associated with, any of the infections listed in 4.1.

Table 2: Children < 40 kg
Infants and toddlers
Infection Usual
>2 months and
children <40 kg
Intermittent Administration
C
Chronic
Ma
Neutropenic
B
B
Bact

Complic
Pe

dose

omplicated urinary
tract infections
suppurative
otitis media
lignant otitis
externa
children
roncho-pulmonary
infections in cystic
fibrosis
acterial meningitis
eraemia*
Bone and joint
infections
Complicated skin and
soft tissue infections
ated intraabdominal infections
ritonitis associated
with dialysis in
patients on CAPD

100-150 mg/kg/day in three
divided doses, maximum 6
g/day

ebrile neutropenia
omial
pneumonia
roncho-pulmonary
infections in cystic

Loading dose of 60-100
mg/kg followed by a
continuous infusion 100-200
mg/kg/day, maximum 6
g/day

150 mg/kg/day in three
divided doses, maximum 6
g/day

100 – 150 mg/kg/day in three
divided doses, maximum 6
g/day

Continuous Infusion
F
Nosoc
B

B
Bact

Complic
Pe

fibrosis
acterial meningitis
eraemia*
Bone and joint
infections
Complicated skin and
soft tissue infections
ated intraabdominal infections
ritonitis associated
with dialysis in
patients with CAPD
Infection Usual

Neonates and infants
≤ 2 months
Intermittent Administration

dose

Most infections

25-60 mg/kg/day in two
divided doses1
1
In neonates and infants ≤ 2 months, the serum half life of ceftazidime can be
three to four times that in adults.
*Where associated with, or suspects to be associated with, any of the infections
listed in section 4.1.
Paediatric population
The safety and efficacy of Fortum administered as continuous infusion to neonates
and infants ≤ 2 months has not been established.
Elderly
In view of the age related reduced clearance of ceftazidime in elderly patients, the
daily dose should not normally exceed 3 g in those over 80 years of age.
Hepatic impairment
Available data do not indicate the need for dose adjustment in mild or moderate liver
function impairment. There are no study data in patients with severe hepatic
impairment (see also section 5.2). Close clinical monitoring for safety and efficacy is
advised.
Renal impairment
Ceftazidime is excreted unchanged by the kidneys. Therefore, in patients with
impaired renal function, the dosage should be reduced (see also section 4.4).
An initial loading dose of 1 g should be given. Maintenance doses should be based on
creatinine clearance:
Table 3: Recommended maintenance doses of Fortum in renal impairment –
intermittent infusion
Adults and children ≥ 40 kg
Creatinine Approx

. serum

Recommended

Frequency of dosing

clearance
creatinine
Ml/min
μmol/l(mg/dl)
50-31 150-200
(1.7-2.3)
30-16 200-350
(2.3-4.0)
15-6 350-500
(4.0-5.6)
<5 >500
(>5.6)

unit dose of Fortum
(g)
1 12

(hourly)

1 24
0.5 24
0.5

48

In patients with severe infections the unit dose should be increased by 50% or the
dosing frequency increased. In children the creatinine clearance should be adjusted
for body surface area or lean body mass.
Children < 40 kg
Approx. serum
creatinine*
μmol/l(mg/dl)
50-31 150-200
(1.7-2.3)
30-16 200-350
(2.3-4.0)
15-6 350-500
(4.0-5.6)
<5 >500
(>5.6)

Creatinine
clearance
(ml/min)**

Recommended
individual dose
mg/kg body weight

Frequency of dosing
(hourly)

25 12
25 24
12.5 24
12.5 48

*The serum creatinine values are guideline values that may not indicate exactly the same degree of
reduction for all patients with reduced renal function.
** Estimated based on body surface area, or measured.

Close clinical monitoring for safety and efficacy is advised.
Table 4: Recommended maintenance doses of Fortum in renal impairment –
continuous infusion
Adults and children ≥ 40 kg
Creatinine clearance
Approx. Serum
(ml/min)
creatinine µmol/l (mg/dl)
50-31 150-200
(1.7-2.3)
30-16 200-350
≤ 15

(2.3-4.0)
> 350
(>4.0)

Frequency of dosing
(hourly)
Loading dose of 2 g
followed by 1 g to 3 g /24
hours
Loading dose of 2 g
followed by 1 g /24 hours
Not evaluated

Caution is advised in dose selection. Close clinical monitoring for safety and efficacy
is advised.
Children < 40 kg
The safety and effectiveness of Fortum administered as continuous infusion in renally
impaired children < 40 kg has not been established, Close clinical monitoring for
safety and efficacy is advised.
If continuous infusion is used in children with renal impairment, the creatinine
clearance should be adjusted for body surface area or lean body mass.
Haemodialysis
The serum half-life during haemodialysis ranges from 3 to 5 h.
Following each haemodialysis period, the maintenance dose of ceftazidime
recommended in the tables 5 & 6 should be repeated.
Peritoneal dialysis
Ceftazidime may be used in peritoneal dialysis and continuous ambulatory peritoneal
dialysis (CAPD).
In addition to intravenous use, ceftazidime can be incorporated into the dialysis fluid
(usually 125 to 250mg for 2 litres of dialysis solution).
For patients in renal failure on continuous arterio-venous haemodialysis or high-flux
haemofiltration in intensive therapy units: 1 g daily either as a single dose or in
divided doses. For low-flux haemofiltration, follow the dose recommended under
renal impairment.
For patients on veno-venous haemofiltration and veno-venous haemodialysis, follow
the dosage recommendations in the tables 5 & 6 below.
Table 5: Continuous veno-venous haemofiltration dose guidelines
Residual
renal function
(creatinine
clearance
ml/min)
0
5
10
15
20
1

Maintenance dose (mg) for an ultrafiltration rate (ml/min) of1:
5 16.7

33.3

50

250 250 500 500
250 250 500 500
250 500 500 750
250 500 500 750
500 500 500 750

Maintenance dose to be administered every 12 h.

Table 6: Continuous veno-venous haemodialysis dose guidelines
Residual

Maintenance dose (mg) for a dialysate in flow rate of 1:

renal
function
(creatinine
clearance
in ml/min)
0
5
10
15
20
1

1.0 litre/h
Ultrafiltration rate (litre/h)
0.5
1.0 2.0 0.5
500
500
500
500
750

2.0 litre/h
Ultrafiltration rate (litre/h)
1.0 2.0

500 500 500
500 750 500
500 750 500
750 750 750
750 1000 750

Maintenance dose to be administered every 12 h.

500 750
500 750
750
1000
750
1000
750 1000

Method of administration
The dose depends on the severity, susceptibility, site and type of infection and on the
age and renal function of the patient.
Fortum 3 g should be administered by intravenous injection or infusion.
Fortum solutions may be given directly into the vein or introduced into the tubing of a
giving set if the patient is receiving parenteral fluids. The standard recommended
route of administration is by intravenous intermittent injection or intravenous
continuous infusion.
4.3.
Contra-indications
Hypersensitivity to ceftazidime, to any other cephalosporin or to any of the excipients
listed in section 6.1.
History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of
beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).
4.4

Special warnings and precautions for use

Hypersensitivity
As with all beta-lactam antibacterial agents, serious and occasionally fatal
hypersensitivity reactions have been reported. In case of severe hypersensitivity
reactions, treatment with ceftazidime must be discontinued immediately and adequate
emergency measures must be initiated.
Before beginning treatment, it should be established whether the patient has a history
of severe hypersensitivity reactions to ceftazidime, to other cephalosporins or to any
other type of beta-lactam agent. Caution should be used if ceftazidime is given to
patients with a history of non-severe hypersensitivity to other beta-lactam agents.
Spectrum of activity
Ceftazidime has a limited spectrum of antibacterial activity. It is not suitable for use
as a single agent for the treatment of some types of infections unless the pathogen is
already documented and known to be susceptible or there is a very high suspicion that
the most likely pathogen(s) would be suitable for treatment with ceftazidime. This
particularly applies when considering the treatment of patients with bacteraemia and
when treating bacterial meningitis, skin and soft tissue infections and bone and joint
infections. In addition, ceftazidime is susceptible to hydrolysis by several of the

extended spectrum beta lactamases (ESBLs). Therefore information on the
prevalence of ESBL producing organisms should be taken into account when
selecting ceftazidime for treatment.
Pseudomembranous colitis

Antibacterial agent-associated colitis and pseudo-membranous colitis have
been reported with nearly all anti-bacterial agents, including ceftazidime, and may
range in severity from mild to life-threatening. Therefore, it is important to consider
this diagnosis in patients who present with diarrhoea during or subsequent to the
administration of ceftazidime (see section 4.8). Discontinuation of therapy with
ceftazidime and the administration of specific treatment for Clostridium difficile
should be considered. Medicinal products that inhibit peristalsis should not be given.
Renal function
Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal
products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely
affect renal function.
Ceftazidime is eliminated via the kidneys, therefore the dose should be reduced
according to the degree of renal impairment. Patients with renal impairment should
be closely monitored for both safety and efficacy. Neurological sequelae have
occasionally been reported when the dose has not been reduced in patients with renal
impairment (see section 4.2 and 4.8).
Overgrowth of non-susceptible organisms
Prolonged use may result in the overgrowth of non-susceptible organisms (e.g.
Enterococci, fungi) which may require interruption of treatment or other appropriate
measures. Repeated evaluation of the patient’s condition is essential.
Test and assay interactions
Ceftazidime does not interfere with enzyme-based tests for glycosuria, but slight
interference (false-positive) may occur with copper reduction methods (Benedict’s,
Fehling’s, Clinitest).
Ceftazidime does not interfere in the alkaline picrate assay for creatinine.
The development of a positive Coombs’ test associated with the use of ceftazidime in
about 5% of patients may interfere with the cross-matching of blood.
Sodium content
Important information about one of the ingredients of Fortum:
3 g powder for solution for injection or infusion.
Fortum 3 g contains 156 mg of sodium per vial.
This should be considered for patients who are on a controlled sodium diet.
4.5

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been conducted with a probenecid and
furosemide.
Concurrent use of high doses with nephrotoxic medicinal products may
adversely affect renal function (see section 4.4).
Chloramphenicol is antagonistic in vitro with ceftazidime and other
cephalosporins. The clinical relevance of this finding is unknown, but if
concurrent administration of ceftazidime with chloramphenicol is proposed,
the possibility of antagonism should be considered.
4.6

Fertility, pregnancy and lactation
Pregnancy
There are limited amounts of data from the use of ceftazidime in pregnant
women. Animal studies do not indicate direct or indirect harmful effects with
respect to pregnancy, embryonal/foetal development, parturition or postnatal
development (see section 5.3).
Fortum should be prescribed to pregnant women only if the benefit outweighs
the risk.
Breast-feeding
Ceftazidime is excreted in human milk in small quantities but at therapeutic
doses of ceftazidime no effects on the breast-fed infant are anticipated.
Ceftazidime can be used during breast-feeding.
Fertility
No data are available.

4.7

Effects on ability to drive and use machines

4.8

No studies on the effects on the ability to drive and use machines have been
performed. However, undesirable effects may occur (e.g. dizziness), which
may influence the ability to drive and use machines (see section 4.8).
Undesirable effects

The most common adverse reactions are eosinphilia, thrombocytosis, phlebitis or
thrombophlebitis with intravenous administration, diarrhoea, transient increases in
hepatic enzymes, maculopapular or uticarcial rash, pain and/or inflammation
following intramuscular injection and positive Coomb’s test.
Data from sponsored and unsponsored clinical trials have been used to determine the
frequency of common and uncommon undesirable effects. The frequencies assigned
to all other undesirable effects were mainly determined using post-marketing data and
refer to a reporting rate rather than a true frequency. Within each frequency grouping,

undesirable effects are presented in order of decreasing seriousness. The following
convention has been used for the classification of frequency:
Very common ≥1/10
Common ≥1/100 and <1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1000
Very rare <1/10,000
Unknown (cannot be estimated from the available data)
System
Organ Class
Infections
and
infestations
Blood and
lymphatic
system
disorders
Immune
system
disorders

Nervous
system
disorders
Vascular
disorders
Gastrointest
inal
disorders

Heptobiliar
y disorders

Common Unc
Candidiasis
Eosinophilia
Thrombocytosis

ommon Ver
(including vaginitis
and oral thrush)
Neutropenia
Leucopenia
Thrombocytopenia

y rare Unknown

Agranuloc

Headache
Dizziness
Phlebitis or
thrombophlebitis
with intravenous
administration
Diarrhoea Ant

Transient
elevations in one
or more hepatic
enzymes3
Skin and
Maculopapular or
subcutaneou urticarial rash
s tissue
disorders

Neurolo

ibacterial
agent-associated
diarrhoea and
colitis2 (see section
4.4)
Abdominal pain
Nausea
Vomiting

Bad

Pruritus

ytosis
Haemolytic
anaemia
Lymphocytosis
Anaphylaxis
(including
bronchospasm
and/or
hypotension)
(see section 4.4)
gical
sequelae1
Paraesthesia

taste

Jaundice

Toxic epidermal
necrolysis
Stevens-Johnson
syndrome
Erythema

multiforme
Angioedema
Drug Reaction
with
Eosinophilia and
Systemic
Symptoms
(DRESS)4
Renal and
urinary
disorders

1

Transi

General
disorders
and
administrati
on site
conditions
Investigatio
ns

Pain and/or
inflammation
after
intramuscular
injection

ent
elevations of blood
urea, blood urea
nitrogen and/or
serum creatinine
Fever

Interstitial
nephritis
Acute
renal
failure

Positive Coombs’
test5

There have been reports of neurological sequelae including tremor, myoclonia, convulsions,
encephalopathy and coma in patients with renal impairment in whom the dose of Fortum has not been
appropriately reduced.
2
Diarrhoea and colitis may be associated with Clostridium difficile and may present as
pseudomembranous colitis.
3
ALT (SGPT), AST (SOGT), LHD, GGT, alkaline phosphatase.
4
There have been rare reports where DRESS has been associated with ceftazidime.
5
A positive Coombs test develops in about 5% of patients and may interfere with blood cross matching.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Overdose can lead to neurological sequelae including encephalopathy,
convulsions and coma.
Symptoms of overdose can occur if the dose is not reduced appropriately in
patients with renal impairment (see sections 4.2 and 4.4).
Serum levels of ceftazidime can be reduced by haemodialysis or peritoneal
dialysis.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-bacterials for systemic use.
Third-generation cephalosporins ATC code: J01DD02
Mechanism of action
Ceftazidime inhibits bacterial cell wall synthesis following attachment to penicillin binding
proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis,
which leads to bacterial cell lysis and death.
PK/PD relationship
For cephalosporins, the most important pharmacokinetic-pharmacodynamic index correlating
with in vivo efficacy has been shown to be the percentage of the dosing interval that the
unbound concentration remains above the minimum inhibitory concentration (MIC) of
ceftazidime for individual target species (i.e. %T>MIC).
Mechanism of Resistance
Bacterial resistance to ceftazidime may be due to one or more of the following mechanisms:


hydrolysis by beta-lactamases. Ceftazidime may be efficiently hydrolysed by extendedspectrum beta-lactamases (ESBLs), including the SHV family of ESBLs and AmpC
enzymes that may be induced or stably derepressed in certain aerobic Gram-negative
bacterial species



reduced affinity of penicillin-binding proteins for ceftazidime



outer membrane impermeability, which restricts access of ceftazidime to penicillin
binding proteins in Gram-negative organisms



bacterial efflux pumps.

Breakpoints
Minimum inhibitory concentration (MIC) breakpoints established by the European
Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Organism B

reakpoints (mg/L)

S

48



Non-species related
breakpoints2

1

8



Pseudomonas
aeruginosa

1 2-



Enterobacteriaceae

I

S=Susceptible, I=Intermediate, R=Resistant
1

The breakpoints relate to high dose therapy (2 g x 3).

R

4

>4

->

8
>8

2

Non-species related breakpoints have been determined mainly on the basis of PK/PD data and are
independent of MIC distributions of specific species. They are for use only for species not mentioned
in the table or footnotes.

Microbiological Susceptibility
The prevalence of acquired resistance may vary geographically and with time for selected
species and local information on resistance is desirable, particularly when treating severe
infections. As necessary, expert advice should be sought when the local prevalence of
resistance is such that the utility of ceftazidime in at least some types of infections is
questionable.

Commonly Susceptible Species
Gram-positive aerobes:
Streptococcus pyogenes
Streptococcus agalactiae
Gram-negative aerobes:
Citrobacter koseri
Haemophilus influenzae
Moraxella catarrhalis
Neisseria menigitidis
Pasteurella multocida
Proteus mirabilis
Proteus spp (other)
Providencia spp.
Species for which acquired resistance may be a problem
Gram-negative aerobes:
Acinetobacter baumannii+
Burkholderia cepacia
Citrobacter freundii
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli
Klebsiella pneumoniae
Klebsiella spp (other)
Pseudomonas aeruginosa
Serratia spp
Morganella morganii
Gram-positive aerobes:
Staphylococcus aureus£
Staphylococcus pneumoniae££
Viridans group streptococcus
Gram-positive anaerobes:
Clostridium perfringens
Peptostreptococcus spp.
Gram-negative anaerobes
Fusobacterium spp.

Inherently resistant organisms
Gram-positive aerobes:
Enterococcus spp including Enterococcus faecalis and Enterococcus faecium
Listeria spp
Gram-positive anaerobes:
Clostridium difficile
Gram-negative anaerobes
Bacteroides spp. (many strains of Bacteroides fragilis are resistant).
Others:
Chlamydia spp
Mycoplasma spp
Legionella spp
£

S.aureus that is methicillin susceptible are considered to have inherent low susceptibility to
ceftazidime.All methicillin-resistance S. Aureus are resistant to ceftazidime.
££

S.pneumoniae that demonstrate intermediate susceptibility or are resistant to penicillin can be
expected to demonstrate at least reduced susceptibility to ceftazidime.
+High rates of resistance have been observed in one or more areas/countries/regions within the
EU.

5.2

Pharmacokinetic properties
Absorption
After intramuscular administration of 500 mg and 1 g of ceftazidime, peak
plasma levels of 18 and 37 mg/l, respectively are achieved rapidly. Five
minutes after intravenous bolus injection of 500 mg, 1 g or 2 g, plasma levels
are 46, 87 and 170 mg/l, respectively. The kinetics of ceftazidime are linear
within the single dose range of 0.5 to 2 g following intravenous or
intramuscular dosing.
Distribution
The serum protein binding of ceftazidime is low at about 10%. Concentrations
in excess of the MIC for common pathogens can be achieved in tissues such as
bone, heart, bile, sputum, aqueous humour, synovial, pleural and peritoneal
fluids. Ceftazidime crosses the placenta readily, and is excreted in the breast
milk. Penetration of the intact blood-brain barrier is poor, resulting in low
levels of ceftazidime in the CSF in the absence of inflammation. However,
concentrations of 4 to 20 mg/l or more are achieved in the CSF when the
meninges are inflamed.
Biotransformation
Ceftazidime is not metabolised.
Elimination
After parenteral administration plasma levels decrease with a half-life of about
2 h. Ceftazidime is excreted unchanged into the urine by glomerular filtration;

approximately 80 to 90 % of the dose is recovered in the urine within 24 h.
Less than 1 % is excreted via the bile.
Special patient populations
Renal impairment
Elimination of ceftazidime is decreased in patients with impaired renal
function and the dose should be reduced (see section 4.2).
Hepatic impairment
The presence of mild to moderate hepatic dysfunction had no effect on the
pharmacokinetics of ceftazidime in individuals administered 2 g intravenously
every 8 hours for 5 days, provided renal function was not impaired (see section
4.2).
Elderly
The reduced clearance observed in elderly patients was primarily due to agerelated decrease in renal clearance of ceftazidime. The mean elimination halflife ranged from 3.5 to 4 hours following single or 7 days repeat BID dosing of
2 g IV bolus injections in elderly patients 80 years or older.
Paediatric population
The half-life of ceftazidime is prolonged in preterm and term neonates by 4.5
to 7.5 hours after doses of 25 to 30 mg/kg. However, by the age of 2 months
the half-life is within the range for adults.
5.3

Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of
safety pharmacology, repeat dose toxicity, genotoxicity, toxicity to
reproduction. Carcinogenicity studies have not been performed with
ceftazidime.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium carbonate (anhydrous sterile)

6.2

Incompatibilities
Ceftazidime is less sta ble in Sodi um B icarbonate Injection than o ther
intravenous fluids. It is not recommended as a diluent.
Ceftazidime and aminog lycosides should not be mixed in the same g iving set
or syringe.
Precipitation has been reported when
vanco mycin has been add ed to
ceftazidime in solution. I t is r ecommended that giving sets and intr avenous
lines are flushed been administration of these two agents.

6.3

Shelf life

Fortum Monovial - T wo years for the unconstituted produc t and 24 hours for
the constituted product when stored below 30ºC and protected from light.
Three years when stored below 25ºC and protected from light.
6.4

Special precautions for storage
The unconstituted product should be stor ed belo w 25ºC and protected from
light.
Constituted solutions ma y be stored in the refrigerator (2 – 8ºC) for up to 24
hours.

6.5

Nature and contents of container

Individually cartoned vials containing 3g ceftazidime (as pentahydrate) for
intravenous and intravenous infusion use.
Not all pack sizes may be marketed.
6.6.

Special precautions for disposal and other handling

All sizes of vials of Fortum are supplied under reduced pressure. As the product
dissolves, carbon dioxide is released and a positive pressure develops. Small bubbles
of carbon dioxide in the constituted solution may be ignored.
Instructions for constitution
See table for addition volumes and solution concentrations, which may be useful
when fractional doses are required.
Vial size

Amount of diluent
to be added (ml)
250 mg powder for solution for injection
250 mg
Intramuscular
1.0 ml
Intravenous bolus
2.5 ml
500 mg powder for solution for injection
500mg
Intramuscular
1.5 ml
Intravenous bolus
5 ml
1 g powder for solution for injection or infusion
1g
Intramuscular
3 ml
Intravenous bolus
10 ml
Intravenous infusion 50 ml*
2 g powder for solution for injection or infusion
2g
Intravenous bolus
10 ml
Intravenous infusion 50 ml*
3 g powder for solution for injection or infusion
3g
Intravenous bolus
15 ml
Intravenous infusion 75 ml*

*Note: Addition should be in two stages.

Approximate
concentration (mg/ml)
210
90
260
90
260
90
20
170
40
170
40

Solutions range in colour from light yellow to amber depending on concentration,
diluents and storage conditions used. Within the stated recommendations, product
potency is not adversely affected by such colour variations.
Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with:














sodium chloride 9 mg/ml (0.9%) solution for injection
M/6 sodium lactate injection
compound sodium lactate injection (Hartmann's solution)
5% dextrose injection
0.225% sodium chloride and 5% dextrose injection
0.45% sodium chloride and 5% dextrose injection
0.9% sodium chloride and 5% dextrose injection
0.18% sodium chloride and 4% dextrose injection
10% dextrose injection
Dextran 40 injection 10% in 0.9% sodium chloride injection
Dextran 40 injection 10% in 5% dextrose injection
Dextran 70 injection 6% in 0.9% sodium chloride injection
Dextran 70 injection 6% in 5% dextrose injection

Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with
Intra-peritoneal Dialysis Fluid (Lactate).
Ceftazidime may be constituted for intramuscular use with 0.5% or 1% Lidocaine
Hydrochloride Injection.
Preparation of solution for bolus injection
1. Insert the syringe needle through the vial closure and inject the recommended
volume of diluent. The vacuum may assist entry of the diluent. Remove the
syringe needle.
2. Shake to dissolve: carbon dioxide is released and a clear solution will be obtained
in about 1 to 2 minutes.
3. Invert the vial. With the syringe plunger fully depressed, insert the needle through
the vial closure and withdraw the total volume of solution into the syringe (the
pressure in the vial may aid withdrawal). Ensure that the needle remains within
the solution and does not enter the head space. The withdrawn solution may
contain small bubbles of carbon dioxide; they may be disregarded.
These solutions may be given directly into the vein or introduced into the tubing of a
giving set if the patient is receiving parenteral fluids. Ceftazidime is compatible with
the most commonly used intravenous fluids.
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER

Glaxo Operations UK Ltd
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as
GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT

8

MARKETING AUTHORISATION NUMBER(S)
PL 00004/0294

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/01/2011

10

DATE OF REVISION OF THE TEXT
10/08/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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