Ceftazidime Sandoz

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Ceftazidime pentahydrate 582.4 mg equivalent to 500 mg ceftazidime
Available from:
Novartis New Zealand Ltd
INN (International Name):
Ceftazidime pentahydrate 582.4 mg (equivalent to 500 mg ceftazidime)
Dosage:
500 mg
Pharmaceutical form:
Powder for injection
Composition:
Active: Ceftazidime pentahydrate 582.4 mg equivalent to 500 mg ceftazidime Excipient: Nitrogen Sodium carbonate
Units in package:
Vial, glass, single dose, 15 mL
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Sandoz GmbH
Therapeutic indications:
Ceftazidime Sandoz is indicated for the 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 beta-lactam antibiotics. May be used with an antibiotic against anaerobes when the presence of Bacteroides fragilis is suspected. 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; 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).
Product summary:
Package - Contents - Shelf Life: Vial, glass, single dose, - 15 mL - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
Authorization number:
TT50-6867a
Authorization date:
2002-03-07

Ceftazidime Sandoz

Ceftazidime Ph Eur, powder for injection, 250 mg, 500 mg, 1 g and 2 g (as

ceftazidime)

Presentation

CeftazidimeSandoz powder for injection is a whitetocream coloured powderaseptically filledinto

single dose glass vials.

CeftazidimeSandoz 250mg contains ina 15 ml vial, sterile ceftazidime pentahydrate equivalent to

ceftazidime 250 mg.

CeftazidimeSandoz 500mg contains ina 15 ml vial, sterile ceftazidime pentahydrate equivalent to

ceftazidime 500 mg.

CeftazidimeSandoz 1 g containsin 20ml or 50 mlvials, sterile ceftazidime pentahydrate equivalent

to ceftazidime 1 g.

CeftazidimeSandoz 2 g containsin 50ml or 100 mlvials, sterileceftazidime pentahydrate equivalent

to ceftazidime 2 g.

Uses

Actions

Pharmacotherapeutic group

J01DD02 – Third generationcephalosporins,ceftazidime.

Mechanism of action

Beta-lactam antibiotic.

Pharmacodynamic effects

Inhibition of bacterial cellwall synthesis.

Antibiotic class

Third generation cephalosporin.

Antibiotic nature and mode of action

Ceftazidime isbactericidalin action, exerting its effecton target cell wall proteinsand causing

inhibition of cell wall synthesis. A wide range ofpathogenic strainsand isolatesare susceptiblein vitro

includingstrains resistant to gentamicinand other aminoglycosides.Ceftazidimeis stable to most

beta-lactamasesproducedby Gram-positive andGram-negative organisms andconsequently is

active againstmany ampicillin and cephalothin resistant strains (but not methicillin resistantstrains).

In vitro, the activities of ceftazidime andaminoglycoside antibioticsin combination have been shown

to be at least additive; there is evidenceof synergy insomestrainstested. Thisproperty may be

important in the treatment of febrile neutropenic patients.

Susceptibilitydata

Dilution ordiffusiontechniques – either quantitative (MIC) or breakpoint, should beusedfollowing a

regularly updated, recognised and standardisedmethod (e.g. NCCLS). Standardised susceptibility

test procedures require theuse of laboratory control microorganisms to control the technical aspects

of the laboratory procedures. For laboratory tests associatedwith ceftazidime administration,

ceftazidime pentahydrate should beused.

A report of "Susceptible" indicates that the pathogen islikely to be inhibited if theantimicrobial

compound in the blood reaches the concentrations usually achievable. A report of "Intermediate"

indicates thatthe result should beconsideredequivocal, and if themicroorganism is not fully

susceptible toalternative, clinically feasible drugs,thetest should berepeated. This category implies

possible clinical applicability in body sites where the drug is physiologically concentrated orin

situationswhere highdosage of drugcan be used.This category also providesabuffer zone, which

prevents small uncontrolled technical factors fromcausing major discrepancies in interpretation.

Ceftazidime has been shown to havein vitroactivityagainst the followingorganisms.

Gram-negative:Pseudomonas aeruginosa;Pseudomonasspp. (includingPseudomonas

pseudomallei);Escherichiacoli;Klebsiellaspp. (includingKlebsiellapneumoniae);Proteus mirabilis;

Proteus vulgaris;Morganellamorganii(formerlyProteusmorganii);Proteus rettgeri;Providenciaspp.;

Enterobacterspp.;Citrobacterspp.;Serratiaspp.;Salmonellaspp.;Shigellaspp.;Yersinia

enterocolitica;Pasteurellamultocida;Acinetobacterspp.;Neisseriagonorrhoeae;Neisseria

meningitidis;Haemophilus influenzae(including ampicillin resistantstrains);Haemophilus

parainfluenzae(including ampicillinresistant strains).

Gram-positive:Staphylococcus aureus(methicillin-sensitivestrains);Staphylococcus epidermidis

(methicillin-sensitive strains);Micrococcusspp.;Streptococcus pyogenes(GroupA beta-haemolytic

streptococci);StreptococcusGroup B (Streptococcus agalactiae);Streptococcus pneumoniae;

Streptococcus mitis;Streptococcusspp. (excludingEnterococcus(Streptococcus)faecalis).

Anaerobic strains:Peptococcusspp.;Peptostreptococcusspp.;Streptococcusspp.;

Propionibacteriumspp.;Clostridiumperfringens;Fusobacteriumspp.;Bacteroidesspp (manystrains

ofBacteroides fragilisresistant).

Resistance

A report of "Resistant" indicates that the pathogen isnot likely to be inhibited if the antimicrobial

compound in the blood reaches the concentrations usually achievable, other therapy should be

selected. Note: the prevalence of resistance may varygeographically for selectedspecies and local

information onresistance isdesirable, particularly when treatingsevere infections.

Ceftazidime isnot activein vitroagainstthe followingorganisms: methicillin-resistant staphylococci;

Enterococcus(Streptococcus)faecalisand many other enterococci;Clostridium difficile;Listeria

monocytogenes;Campylobacterspp.

Clinicallyrelevant MIC ranges

Ceftazidime hashigh intrinsicactivityin vitroand actswithin a narrow MIC range for most generawith

minimal changes in MIC atvaried inoculum levels.

Pharmacokinetics

The pharmacokinetics of ceftazidime are similar whether it is administered by a single or by repeat

dosage. Concurrent oral administrationof probeneciddid not affect the serum levels or urinary

recoveries ofceftazidime. The pharmacokinetics ofceftazidimewere not affected when administered

intramuscularly with 0.5% lignocaine.

Absorption

Absorption ofceftazidimeafter oral administration is negligible, therefore Ceftazidime Sandoz is

intended for parenteral useonly. In humans, after a single IM administration of 500 mg and 1 g,mean

peak serum levels of 18 and 37 mg/l respectively areachievedat 1 hour, fallingto 8 and 2 mg/l and

20 and 5 mg/lat four and eight hours respectively for the two doses. Five minutes after an IV bolus

injection of 500 mg, 1 g and 2 g, mean serum levelsare respectively46, 87 and 170 mg/l, falling to 17

and 6 mg/l, 32 and 10 mg/land 85 and 15mg/l at one and four hours respectively with the three

doses.

Distribution

Therapeutically effective concentrationsare still present in the serum8 to 12 hours after either IV or

IM administration. Serum protein bindingis low atabout 10%. Concentrationsinexcess oftheMIC for

common pathogens can beachievedin tissues such asbone, heart,bile, sputum,aqueous humour,

synovial, pleural and peritoneal fluids. Ceftazidimecrosses the placenta readily,and is excreted in the

breast milk. Penetrationof the intact blood-brain barrier is poor resulting in low levels of ceftazidime in

the CSF in the absence of inflammation.However,therapeutic levels of 4 to 20 mg/l or more are

achieved in the CSF whenthe meninges are inflamed.

Biotransformation

Ceftazidime isnot metabolisedin vivoand is excretedunchangedin the active form into the urine by

glomerularfiltration. In the presence of normalrenal function approximately 80 to 90% of the dose is

recovered in the urine within24 hours.Less than 1% is excreted via the bile.

Elimination

The serum half-life in adults with normalrenal functionis about 1.8 hours (1.2 to2.9 hours). This may

be prolongedto 20 to 35 hours in anuricpatients. In neonates, the serum half-life of ceftazidime can

be three to four times greater than thatmeasured inadults. Elimination of ceftazidime isdecreased in

patientswith impaired renalfunction and thedose should be reduced (refer to Dosageand

administration - renal impairment).

Indications

Treatment of single or multiple infections caused by susceptibleorganisms. May be used alone as

first choice medicine before the resultsof sensitivity tests are available. May be usedin combination

with an aminoglycoside or most other beta-lactamantibiotics. Maybe used withan antibiotic against

anaerobeswhen the presence ofBacteroides fragilisis suspected.

Indications include: severeinfectionse.g. septicaemia, bacteraemia, peritonitis,meningitis; infections

in immunosuppressed patients; infections in patientsin intensive care, e.g. infected burns; respiratory

tract infectionsincludinglung infections incysticfibrosis; ear, noseand throat infections; urinary tract

infections; skinand soft tissue infections; gastrointestinal, biliary and abdominal infections; bone and

joint infections; infectionsassociated withhaemo-and peritoneal dialysis and with continuous

ambulatory peritoneal dialysis (CAPD).

Dosage and administration

Dosage

Dosagedepends upon theseverity, sensitivity, site and type of infection and upon the age andrenal

function of the patient.

Adults

1 to 6 g daily in two or three divided doses by IVor IM injection. Urinary tract and less severe

infections- 500 mg or 1 gevery 12 hours. Most infections - 1g every 8 hours or2g every 12 hours.

Very severe infectionsparticularly in immunocompromised patients includingthosewith neutropenia -

2 g every 8 or 12 hours, or3 g every 12 hours. Fibrocystic adultswith pseudomonal lung infections

100 to 150 mg/kg/day in three divided doses. In adultswith normalrenal function9 g daily has been

used without ill effect.

Infants andchildren older than 2 months

30 to 100 mg/kg daily in two or three divided doses. Doses up to 150 mg/kg daily(maximum 6g daily)

in three divided doses may be given to infected immunocompromised orfibrocystic children or

children withmeningitis.

Neonatesaged 0 to 2 months

25 to 60 mg/kg daily in two divided doses. In neonatesthe serum half life of ceftazidime can be three

to four times that in adults.

Use in the elderly

In view of the reducedclearance of ceftazidime inacutely ill elderly patients, thedaily dosageshould

not normally exceed3 g, especiallyin those over80 years of age.

Renal impairment

Ceftazidime isexcreted unchanged by the kidneys.Therefore in patients with impaired renalfunction

the dosageshould bereduced. An initialloading doseof 1 g shouldbe given. Maintenance doses

shouldbebasedonGFR.

Recommended maintenance doses of ceftazidime inrenal insufficiency

Creatinine

clearance (ml/min) Approximate serumcreatinine

in micromol/l (mg/dl) Recommended unit doseof

ceftazidime (g) Frequency of

dosing (hourly)

>50 <150(<1.7) Normal dosage

50-31150-200 (1.7-2.3) 1.0 12

30-16200-350 (2.3-4.0) 1.0 24

15-6350-500 (4.0-5.6) 0.524

<5>500 (>5.6) 0.548

In patients withsevere infectionsthe unit doseshouldbe increasedby 50% or the dosing frequency

increased. In such patients the ceftazidime serum levels should bemonitored and trough levels

should not exceed40 mg/l.

In children the creatinineclearance should be adjusted for body surface area orlean body mass.

Haemodialysis

The serum half-life duringhaemodialysis rangesfrom3 to 5 hours. Following each haemodialysis

period the maintenance dose of ceftazidime recommended in the above table should be repeated.

Peritoneal dialysis

Ceftazidimemay be usedin peritonealdialysisandcontinuous ambulatory peritoneal dialysis (CAPD).

In addition to intravenous use, ceftazidimecan beincorporated intothe dialysisfluid (usually 125 to

250 mg for 2 litres of dialysissolution).

For patients inrenal failureon continuous arteriovenous haemodialysis orhigh-flux haemofiltration in

intensive therapy units; 1 gdaily either asa single dose or in divided doses. For low-flux

haemofiltrationfollow the dosage recommended underimpaired renal function.

For patients onvenovenoushaemofiltration andvenovenous haemodialysis, follow the dosage

recommendations in the tables below:

Continuous venovenous haemofiltrationdosage guidelinesfor ceftazidime

Residual renal function (creatinine

clearance inml/min) Maintenance dose (mg)administered every 12 h for a

ultrafiltration rate (ml/min) of

16.7 33.350

0 250 250 500 500

5 250 250 500 500

10250 500 500 750

15250 500 500 750

20500 500 500 750

Ceftazidime dosage guidelines duringcontinuous venovenous haemodialysis

Residual renal function (creatinine

clearance inml/min) Maintenance dose (mg)administered every 12 h for a

dialysate inflowrate of:

1.0 litres/h 2.0 litres/h

Ultrafiltration rate (litres/h) Ultrafiltration rate (litres/h)

0.5 1.0 2.0

0 500 500 500 500 500 750

5 500 500 750 500 500 750

10500 500 750 500 750 1000

15500 750 750 750 750 1000

20750 750 1000 750 750 1000

Administration

Use Ceftazidime Sandoz injection intravenously orbydeep intramuscular injection. Recommended IM

injection sites are the upperouter quadrant of the gluteus maximus or lateral part of the thigh.

Ceftazidime solutions may be given directly into the vein or introduced into the tubing of a giving set if

the patient isreceiving parenteral fluids.

Contraindications

Patients withknown hypersensitivity tocephalosporin antibiotics, ceftazidime pentahydrate orto any

of the excipients.

History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam

antibacterial agent(penicillins,monobactams andcarbapenems).

Warnings and precautions

Ceftazidime should not ordinarily be given to those allergicto cephalosporins orto penicillins,

especially where an allergic or urticarialreactionhasoccurred. Before beginningtreatment establish

whether the patient has a history of hypersensitivity reactions to ceftazidime, cephalosporins,

penicillins orother medicines. Special care is indicated in patients who have experienced anallergic

reaction to penicillins or other beta-lactams. If an allergic reactionto ceftazidimeoccurs discontinue

the medicine.Serious hypersensitivity reactions may require epinephrine(adrenaline),

hydrocortisone, antihistamine or other emergency measures.

Ceftazidime has a limited spectrum of antibacterial activity. It is not suitable for use as a singleagent

for the treatment of some types of infectionsunless the pathogen is already documented and known

to be susceptible or there isa very highsuspicion thatthe most likely pathogen(s) would besuitable

for treatment with ceftazidime. This particularly applies when considering the treatment of patients

with bacteraemia and whentreating bacterial meningitis, skin and soft tissue infectionsand bone and

joint infections. In addition,ceftazidimeis susceptibleto hydrolysisby several ofthe extended

spectrum beta lactamases (ESBLs). Therefore information on the prevalenceof ESBL producing

organismsshould be takeninto accountwhenselecting ceftazidimefor treatment.

Antibacterialagent-associated colitisand pseudo-membranous colitis have been reportedwith nearly

all anti-bacterial agents, includingceftazidime, and mayrange in severity from mild to life-threatening.

Therefore, it is important to considerthis diagnosis in patientswhopresent withdiarrhoea during or

subsequent to the administration of ceftazidime .Discontinuationof therapy withceftazidimeand the

administration of specific treatment forClostridiumdifficileshouldbe considered. Medicinal products

that inhibit peristalsisshouldnot be given.

Concurrent treatment withhigh doses ofcephalosporins and nephrotoxic medicinessuch as

aminoglycosides orpotentdiuretics(e.g.furosemide) may adverselyaffect renalfunction. Clinical

experience has shown thatthis is not likely to be a problem withceftazidime at the recommended

dose levels.There is no evidence that ceftazidime adversely affects renal function at normal

therapeutic doses.

Ceftazidime iseliminatedvia the kidneys, therefore the dosageshould be reduced according tothe

degree of renal impairment. Neurologicalsequelae have occasionally been reported when thedose

has not beenreduced appropriately (referto Dosage and administration - Renal impairment and

Adverse Effects).

As with other broad spectrumantibiotics, prolonged use may result in the overgrowth of non-

susceptible organisms (e.g.Candida, enterococci)which may require interruptionof treatment or

appropriate measures.Repeatedevaluation of the patient'scondition is essential.

As with other extended-spectrumcephalosporinsandpenicillins, someinitiallysusceptible strainsof

Enterobacterspp. and Serratia spp. maydevelopresistance duringceftazidimetherapy. When

clinically appropriate during therapy of such infections, periodicsusceptibility testing should be

considered.

Pregnancy and lactation

Use in pregnancy

AssignedCategory B1 by the AustralianDrugEvaluation Committee. This category includes

medicines which have beentaken by only alimited number of pregnant womenand women of

childbearingage, without an increase inthe frequency of malformation or other direct orindirect

harmful effects on the human foetus having been observed. Studiesin animalshave not shown

evidence of anincreased occurrence of foetaldamage.There is noexperimentalevidence of

embryopathic or teratogenic effects, butas with all medicines, ceftazidimeshouldbe administered

with caution during the early monthsof pregnancy andearly infancy.

Use in lactation

Ceftazidime isexcreted inhuman milkinsmall quantities andshould be usedwith caution innursing

mothers.

Effects on abilityto drive and use machines

Thismedicine ispresumed to be safeor unlikely to producean effect.

Adverse effects

Data from large clinical trials (internal andpublished)were used to determine thefrequency of very

common to uncommon undesirable effects. The frequencies assigned to all other undesirableeffects

were mainlydetermined using post-marketing data and refer to a reportingrateratherthan atrue

frequency.

Clinical trial data

Common - incidence between1/100 and 1/10

Blood and lymphatic systemdisorders

Eosinophilia andthrombocytosis.

Gastrointestinal disorders

Diarrhoea.

General disorders and administrationsiteconditions

Pain and/orinflammationafter IM injection.

Hepatobiliary disorders

Transient elevations in one or more of the hepatic enzymes, ALT (SGPT), AST (SOGT), LDH, GGT

and alkalinephosphatase.

Investigations

Positive Coombs' test. A positive Coombs' test develops in about5% of patients and may interfere

with blood cross-matching.

Skin andsubcutaneous tissue disorders

Maculopapular or urticarialrash.

Vasculardisorders

Phlebitis orthrombophlebitis with IV administration.

Uncommon- incidence between1/1000 and 1/100

Blood and lymphatic systemdisorders

Leucopenia,neutropenia, and thrombocytopenia.

Gastrointestinal disorders

Nausea, vomiting, abdominal pain, andcolitis. As withother cephalosporins, colitismay be associated

withClostridium difficileand may present as pseudomembranouscolitis.

General disorders and administrationsiteconditions

Fever.

Infectionsand infestations

Candidiasis including vaginitis and oralthrush.

Investigations

As with someother cephalosporins, transient elevations of blood urea, blood ureanitrogen and/or

serum creatinine have beenobserved.

Nervous systemdisorders

Headacheanddizziness.

Skin andsubcutaneous tissue disorders

Pruritus.

Post-marketing pharmacovigilance data

Veryrare - incidence lower than 1/10,000

Blood and lymphatic systemdisorders

Lymphocytosis, haemolyticanaemia, andagranulocytosis.

Gastrointestinal disorders

Bad taste.

Hepatobiliary disorders

Jaundice.

Immune systemdisorders

Anaphylaxis(including bronchospasm and/or hypotension).

Nervous systemdisorders

Paraesthesia.There have been reportsof neurological sequelae including tremor, myoclonia,

convulsions,encephalopathy, and comain patientswith renal impairment in whomthe dose of

ceftazidime has not been appropriately reduced.

Skin andsubcutaneous tissue disorders

Angioedema,erythema multiforme, Stevens-Johnson syndrome, andtoxic epidermal necrolysis.

Interactions

Interactionswithother medicines

Concurrent use of high doseswith nephrotoxic medicines may adversely affect renal function(refer to

Warningsand precautions).

Chloramphenicol is antagonisticin vitrowith ceftazidime and other cephalosporins. Theclinical

relevance of this findingisunknown, butifconcurrent administration of ceftazidime with

chloramphenicol is proposed, the possibility of antagonismshouldbe considered.

In common with other antibiotics, ceftazidime may affect the gut flora, leadingto lower oestrogen

reabsorptionand reducedefficacyof combined oralcontraceptives.

Effects on laboratory tests

Ceftazidime does not interfere with enzyme-based tests for glycosuria but slight interferencemay

occurwith copper(II) reduction methods(Benedict'sand Fehling's solutions, Clinitest).

Ceftazidime does not interfere in the alkaline picrateassay for creatinine.

Overdosage

Signs and symptoms

Overdosagecan lead to neurological sequelae including encephalopathy, convulsions and coma.

Management

Serum levelsof ceftazidimecan bereduced by haemodialysisor peritoneal dialysis.

Pharmaceutical precautions

Instructions for use/handling

On additionofwater for injections, Ceftazidime Sandoz dissolves with effervescence to produce a

solutionfor use by injection only. Solutions range fromlight yellow to amber depending on

concentration,diluent andstorage conditions used.Within the statedrecommendations, product

potency is not adversely affected by such colour variations.

Solutions ofCeftazidimeSandoz injection reconstituted in water for injectionsretain satisfactory

potency for 24 hours if refrigeratedat 2 to 8°C. Ceftazidime Sandoz 1 g injectionmay be reconstituted

for intramuscular administration using 0.5% Lignocaine Hydrochloride Injection BP; the resultant

solutions maybe stored for 24 hours under refrigeration (2 to 8°C). Solutions ofCeftazidimeSandoz 1

g injection reconstituted in1.0% lignocaine solution retain satisfactory potency for 24 hours if

refrigerated (2 to 8°C).Some increase inthe colour ofpreparedsolutions of ceftazidimefor injection

may occur onstorage. It is, however, advisable to usethe reconstituted product as soon aspossible.

CeftazidimeSandoz 2 g injection iscompatiblewith 0.9% sodiumchloride, 5% glucose, 5%

glucose/0.9% sodiumchloride (1:1, v/v) and Ringer'sLactate Solution. Solutionsat concentrations of

50 mg/ml in these infusionfluids may be storedfor upto 24 hoursif refrigerated(2 to 8°C).

CeftazidimeSandoz 2 g injection may bestoredfor upto 24 hoursunder refrigeration (2 to 8°C) at

concentrationsbetween 0.05 mg/ml and0.25 mg/ml in Intraperitoneal Dialysis Fluid (Lactate) BPC

1973.

CeftazidimeSandoz 2 g injection has been found compatible for 24hours under refrigeration(2 to

8°C) when admixed at 4 mg/ml with potassiumchloride 10 mEq/l or 40 mEq/l in 0.9% Sodium

Chloride Injection BP, or heparin(10 and50 units/ml) in0.9% sodiumchloride.

CeftazidimeSandoz 2 g injection (4 mg/ml) has been found compatible for 24 hourswhenrefrigerated

(2 to 8°C, do not freeze)when admixedwith cloxacillin.

CeftazidimeSandoz injection 500 mg, reconstitutedwith 1.5 ml Water for Injections, may beadded to

metronidazoleinfusion(500mg in 100ml) and both antibiotics retain their activity. Ceftazidime

Sandoz 2 g injection (5 mg/ml) is compatible for 24hourswhenrefrigerated(2 to8°C, do not freeze)

whenadmixedwith metronidazole.

All vial presentations of Ceftazidime Sandoz injectionare packaged under reduced pressure. As the

product dissolves, carbondioxide is releasedand a positive pressure develops.For ease of use, it is

recommended that the followingtechniques of reconstitution are adopted.

Preparationof solutions for IM or IV bolus injection

Insertsyringeneedle through vial closure and inject recommendedvolume of diluent. The vacuum

may assist entry of the diluent. Removesyringe needle. Shake to dissolve; carbondioxide is released

and a clearsolution obtained in about one to two minutes. Invert the vial. With the syringe plunger

fully depressed, insert the needle throughvial closureand withdrawthe total volume of solutioninto

the syringe (the pressure inthe vial may aid withdrawal). Ensure that the needle remainswithin the

solutionanddoes not enterthe headspace. Thewithdrawn solutionmay containsmall bubblesof

carbon dioxide which should be expelledfrom the syringe before injection.

Preparationof solutions for IV infusionin a mini-bag or burette-type set

CeftazidimeSandoz injection 1 g or 2 gvials may be reconstituted for short intravenous infusion (e.g.

up to 30 minutes) using a total of 50 ml of compatiblediluent, added in two stages asfollows.Insert

syringe needle through thevial closure and inject 10ml of diluent. The vacuummay assist entry of the

diluent. Remove the syringe needle. Shake to dissolve; carbondioxide is released and a clear

solutionis obtained in about one to two minutes.When, and not before, the product has dissolved,

insert a gasrelief needle through vial closure to relieve internal pressure and,with gas reliefin

position, adda further 40ml of diluent. Removethegas relief needle andsyringe needle; shake the

vial and set upfor infusionuse in the normal way. Additional pressure that may develop in thevial

especially after storage, should be relieved prior to administration to the patient. Note: to preserve

product sterility, it is important that a gas relief needle isnotinsertedthrough thevial closure before

the product has dissolved.

Incompatibilities

CeftazidimeSandoz injection is compatible withmost commonly used intravenous fluids. However,

since Ceftazidime Sandozis less stablein Sodium Bicarbonate Injection than inother intravenous

fluids it is not recommended as a diluent.

Ceftazidime and aminoglycosidesshouldnot be mixed in the samegiving set orsyringe.

Precipitationhas been reported when vancomycin has been added to ceftazidime in solution.

Therefore, it would be prudent to flushgiving setsand intravenous lines betweenadministration of

these two agents.

Special precautions for storage

Store at or below 25°C. Protect from lightand moisture. Store the reconstituted medicine between 2

to 8°C and use within 24 hours.Refrigerate, do not freeze.

CeftazidimeSandoz contains no antimicrobial agent. To reduce microbiological hazard, use assoon

as practicable after dilution. Discard any residue.

Medicine classification

Prescription Medicine.

Package quantities

Single vial packs. Not all pack sizes and/or strengthsmay be currently marketed.

Further information

Displacement volumes

250 mg vial

CeftazidimeSandoz injection 250 mg ispackaged ina 15 ml vial.Reconstitutionwith 1 ml diluent

results in a final volume ofapproximately 1.2 ml. Reconstitutionwith 2.5 ml diluent results in afinal

volume of approximately 2.8 ml.

500 mg vial

CeftazidimeSandoz injection 500 mg ispackaged ina 15 ml vial.Reconstitutionwith 1.5 ml diluent

results in a final volume ofapproximately 2.1 ml. Reconstitutionwith 5 ml diluentresults in a final

volume of approximately 5.5 ml.

1 gvial

CeftazidimeSandoz injection 1 g is packaged in 20ml and 50 mlvials. Reconstitution with 3 ml

diluent results in a final volume of approximately 3.8ml. Reconstitution with 10ml diluent results in a

final volume of approximately 11.0 ml. Reconstitutionwith 40 ml diluent results ina final volume of

approximately 41.0 ml.

2 gvial

CeftazidimeSandoz injection 2 g is packaged in 50ml and 100 mlvials. Reconstitution with10 ml

diluent results in a final volume of approximately 11.5 ml. Reconstitution with 40ml diluent results in a

final volume of approximately 42.0 ml.

List of excipients

Sodium carbonate anhydrous. Totalsodium content of the mixture is approximately 54 mg/g.

Name and address

NovartisNew Zealand Limited

Private Bag 65904 MairangiBay

AUCKLAND 0754

Telephone: (09) 361 8100

Date of preparation

31 st January2012

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