בליאומיצין PFI

ישראל - עברית - Ministry of Health

קנה את זה

עלון מידע עלון מידע (PIL)

29-11-2020

מרכיב פעיל:
BLEOMYCIN SULFATE
זמין מ:
MEGAPHARM LTD
קוד ATC:
L01DC01
טופס פרצבטיות:
אבקה להכנת תמיסה לזריקה
הרכב:
BLEOMYCIN SULFATE 15000 IU/VIAL
מסלול נתינה (של תרופות):
לתוך קרום הריאה, תוך-עורקי, תוך-ורידי, תת-עורי, תוך-שרירי, לתוך בקע
סוג מרשם:
מרשם נדרש
תוצרת:
BAXTER ONCOLOGY GmbH, GERMANY
קבוצה תרפויטית:
BLEOMYCIN
איזור תרפויטי:
BLEOMYCIN
סממני תרפויטית:
Bleomycin is useful in the management of the following neoplasms: Squamous cell carcinoma affecting the mouth, nasopharynx and paranasal sinuses, larynx, oesaphagus, cervix, vagina, penis and skin. Well differentiated tumors usually respond better than anaplastic ones.Hodgkin's disease and other malignant lymphomas, including mycosis fungoides. Testicular carcinoma (seminoma and no seminoma) .Malignant effusions of serous cavities (intrapleural and intraperitoneal).Secondary indications in which bleomycin has been shown to be of some value include metastatic malignant melanoma, carcinoma of the thyroid lung and bladder. Local treatment of refractory warts. Bleomycin can be used as a single agent, but is generally used in combination with other cytotoxics and/or with radiation therapy.
מספר אישור:
133 57 25199 00
תאריך אישור:
2020-09-30

מסמכים בשפות אחרות

עלון מידע עלון מידע - אנגלית

29-11-2020

מאפייני מוצר מאפייני מוצר - אנגלית

18-08-2016

עלון מידע עלון מידע - ערבית

29-11-2020

Bleomycin

– Summary of Product Characteristics

Warning:

ItisrecommendedthatBleomycinbeadministeredunderthesupervisionofa

qualifiedphysicianexperiencedintheuseofcancerchemotherapeuticagents.

Appropriatemanagementoftherapyandcomplicationsispossibleonlywhen

adequatediagnosticandtreatmentfacilitiesarereadilyavailable.Pulmonary

fibrosisisthemostseveretoxicityassociatedwithBleomycin.Themost

frequentpresentationispneumonitisoccasionallyprogressingtopulmonary

fibrosis.Itsoccurrenceishigherinelderlypatientsandthosereceivinggreater

than400unitstotaldose,butpulmonarytoxicityhasbeenobservedinyoung

patients and those treated with low doses.

Asevereidiosyncraticreactionconsistingofhypotension,mentalconfusion,

fever,chillsandwheezinghasbeenreportedinapproximately1%oflymphoma

patients treated withBleomycin.

1. NAME OF THE MEDICINALPRODUCT

BleomycinPFI

2. QUALITATIVEAND QUANTITATIVE COMPOSITION

OnevialcontainsBleomycinsulphateequivalentto15units(USP)or15000

InternationalUnits(I.U)Bleomycin.1unit(USP)(correspondingto1000I.U.)

correspondsto1mgpotency.Note1mgpotencyisdefinedbybioassayand,

therefore,isnotidenticalto1mgdryweight(1mgdryweightaccordingUSP

corresponds to 1.5 to 2.0 mg potency).

3. PHARMACEUTICALFORM

Powder for solution for infusion, injection or instillation.

4. CLINICALPARTICULARS

4.1 Therapeutic indications

Bleomycinis useful in the management of the following neoplasms:

1)Squamouscellcarcinomaaffectingthemouth,nasopharynxandparanasal

sinuses,larynx,esophagus,cervix,vagina,penisandskin.Well-differentiated

tumors usually respond better than anaplastic ones.

2)Hodgkin’sdiseaseandothermalignantlymphomas,includingmycosis

fungoides.

3)Testicular carcinoma (seminoma and non-seminomas).

4)Malignant effusions of serouscavities (pleura and peritoneum).

5)AdditionalindicationsinwhichBleomycinhasbeenshowntobeofsome

valueincludemetastaticmalignantmelanoma,carcinomaofthethyroid,lung

and bladder.

Local treatment of refractory warts.

Bleomycincanbeusedasasingleagent,butisgenerallyusedincombination

with other cytotoxics and/or with radiation therapy.

4.2 Posology and method of administration

Bleomycinisadministeredparenterallyasintramuscularinjection,intravenous

injection/infusion,intraarterialinjection/infusion,subcutaneousinjection,

intratumoral injection or intracavitary instillation.

Posology

Adults

1.)Squamouscellcarcinoma

Intramuscularorintravenousinjectionof10-15units(USP)/m².Intravenous

infusionfor6-24hoursof10-15units(USP)/m²/dayin4to7consecutivedays

every3-4weeks.

2.)Hodgkin’slymphomaandnon-Hodgkin’slymphoma

Intramuscularorintravenousinjectionof5-10units(USP)/m²onceortwice

aweek.Becauseofthepossibilityofananaphylactoidreaction,lymphoma

patientsshouldbetreatedwith1-2units(USP)/doseforthefirsttwodoses.Ifno

acutereactionsoccur,theregulardosageregimencanbeadministered.

3.)Testicularcarcinoma

Intramuscularorintravenousinjectionof10-15units(USP)/m²onceortwicea

week.Intravenousinfusionfor6-24hoursof15-20units(USP)/m²/dayfor5-6

4.)Malignanteffusions

60units(USP)in100mlphysiologicalsalineintrapleurallyorintraperitoneally

asasingledoseandrepeated,ifnecessary.

5.)Refractorywarts

IntralesionallyinjectionofBleomycinhasbeengivenasa0.1%solution,

usuallyasa0.1mlinjection.

ImprovementofHodgkin’sdiseaseandtesticulartumorsispromptandnoted

withintwoweeks.Ifnoimprovementisseenbythistime,improvementis

unlikely.Squamouscellcancersrespondmoreslowly,sometimesrequiringas

long as 3 weeks before any improvement is noted.

Age in years Total dose Dose per week

80 and over 100 units (USP) 15 units (USP)

70-79 150-200 units (USP) 30 units (USP)

60-69 200-300 units (USP) 30-60 units (USP)

Under 60 400 units (USP) 30-60 units (USP)

TotaldosesofBleomycininpatientsnotolderthan60yearsshouldnot

exceed400units(USP)(approximately225units/m²bodysurface),unlessan

examinationofthelungfunctionhasensuredcontinuedadministration.Doses

mayneedtobeadjustedwhengivenincombinationwithotherantineoplastic

agents or with radiotherapy, and in patients older than 60 years (see below).

Elderly patients

The total dose should be reduced as indicated below

Children

IfadministrationofBleomycintochildrenisindicated,thedosageshouldbe

based on that recommended for adults and adjusted to body surface area.

Reduced renal function

Inpatientswithreducedkidneyfunction,dosesshouldbereduced.Ifcreatinine

clearance decreases to 20 ml/min, 50% ofBleomycindose should be given.

Combination therapy

InconjunctionwithradiotherapytheBleomycindosageshouldbereduced.The

dosemayneedtobeadjustedwhenBleomycinisusedincombinationwith

other cytotoxic drugs.

Methodofadministration/preparationofsolutions

Note:Forpreparationofthesolutiondissolvethewholecontentofavial(15

units)intheappropriateamountofsolvent.Fromthissolutionuseanaliquot

accordingtotheunitsneededfortreatment.Example:requireddosage8.5units

(5units/m 2

x1.7m 2

);dissolvethecontentofavial(15units)in5mlsolvent;

take out 2.83 ml (8.5 units) for application.

Intramuscular injection

Dissolvethecontentsofavialin1-5mlphysiologicalsalinesolvent.Since

repeatedi.m.injectionsatthesamesitemaycauselocaldiscomfort,itis

advisabletochangetheinjectionsite.Incaseofunduelocaldiscomfort,alocal

anaestheticsuchas1½-2ml1%lidocainehydrochloridecanbeaddedtothe

injection solution.

Intravenous injection

Dissolvethecontentsofavialin5-10mlofphysiologicalsalinesolventand

administeroveraperiodof5-10minutes.Avoidafastbolusinjection,whichwill

giveahighbloodconcentrationpassingthroughthelungs,increasingtherisk

of damage to the lungs.

Intravenous infusion

DissolveBleomycinin 200-1000 ml of physiological saline.

Intra-arterial injection

DissolvethecontentsofavialofBleomycinin5mlormoreofphysiological

saline and administer over a period of 5-10 minutes.

Intra-arterial infusion

DissolveBleomycinin200-1000mlofphysiologicalsaline.Theinfusionmay

begivenoverafewhourstoseveraldays.Topreventthrombosisattheinjection

siteheparincanbeadministered,especiallyifaninfusionisgivenoveralong

period of time.

Injection/infusionintothearterysupplyingthetumorshowsatendencyfor

higherefficacythanotherroutesofsystemicadministration.Thetoxiceffects

are as with i.v. injection/infusion.

Subcutaneous injection

Absorptionaftersubcutaneousinjectionisdelayedandmayimitateslowi.v.

infusion;thisformofadministrationisnotusedsooften.Caremustbetakento

Intratumoral injection

Bleomycinisdissolvedinphysiologicalsalinetomakea1-3units(USP)/ml

solutionwhichisinjectedintothetumoranditssurroundingtissues.Thisform

of application is rarely used.

Intracavitary instillation

Followingaspirationofthepleuralorperitonealcavity,Bleomycindissolvedin

physiologicalsalineisinstilledviatheneedleorcatheterusedforaspiration.The

needleorcatheteristhenremoved.Inordertoensuretheuniformdispersion

ofBleomycinwithintheserouscavitythepatient’spostureshouldbechanged

every 5 minutes, for 20 minutes.

ExtravasaladministrationofBleomycindoesnotusuallydemandextraordinary

precautions.Incaseofdoubt(concentratedsolution,sclerotictissue,etc.)

perfusion with physiological saline may be performed.

4.3 Contra-indications

Bleomyciniscontra-indicatedinpatientswithacutepulmonaryinfection,

severelyimpairedlungfunctionorcirculatorydisturbancesinthelungsandin

patientswhohavedemonstratedahypersensitiveoranidiosyncraticreactionto

the drug(Pregnancy and lactation: see item 4.6).

4.4 Special warnings and special precautions for use

PatientsreceivingBleomycinchemotherapyshouldbecarefullymonitoredby

experienced oncologists.

BecauseofthepossibleteratogeniceffectofBleomycinonmaleandfemale

germcellsadequateconceptioncontrolshouldbeestablishedduring,andfora

period of 6 months after treatment.

PulmonaryReactions

PatientsundergoingtreatmentwithBleomycinshouldbecarefullymonitored

foranysignoflungdysfunction.Pulmonaryreactionsarethemostseriousside

effects,occurringinapproximately10%oftreatedpatientsduring,oroccasionally

afteracourseoftreatment.Themostfrequentformisinterstitialpneumonitis.

Ifnotdiagnosedandtreatedimmediatelythisconditionmayprogressto

pulmonaryfibrosis.Approximately1%ofpatientstreateddiedbecauseof

pulmonaryfibrosis.FrequentchestX-rays(preferablyweekly)areadvisableand

shouldbecontinuedforupto4weeksaftercompletionofacourseoftreatment.

PulmonarytoxicityofBleomycinisbothdose-relatedandage-relatedwhen

thetotaldoseexceeds400units(USP)(approximately225units/m²body

surface)thismayalsooccurwhenlowerdosesareadministered,especiallyin

elderlypatients(over70yearsofage),patientswithreducedkidneyfunction,

pre-existinglungdisease,previousorconcurrentradiotherapytothechestand

inpatientswhoneedadministrationofoxygen.Itissignificantlyenhancedby

thoracicradiationandbyhyperoxiausedduringsurgicalanesthesia.Pulmonary

toxicityisunpredictableandhasbeenseenoccasionallyinyoungpatients

receivinglowdoses.Vascularchangesoccurinthelung,partlydestroying

theelasticityofthewallsofthevessel.Theearliestsymptomassociatedwith

pulmonarytoxicityofBleomycinisdyspnea.Fineralesaretheearliestsign.

Ifpulmonarychangesarenoted,treatmentshouldbediscontinueduntilitcan

bedeterminediftheyaredrugrelated.Patientsshouldbetreatedwithbroad

spectrum antibiotics and corticosteroids.

Bleomycinsensitivityincreasesinoldage.Ifbreathlessnessorlunginfiltrates

appear,notobviouslyattributabletotumorortoco-existentlungdisease,

administrationofthedrugmustbestoppedimmediatelyandpatientsshouldbe

treated with corticosteroid and broad-spectrum antibiotics.

Pyrexia

Likemost cytotoxic agentsBleomycincancauseimmediateanddelayedtoxic

effects.Themostimmediateeffectisfeveronthedayofinjection.Itsometimes

occurs2to6hoursafterthefirstinjectionofBleomycin.Incasesofpersistent

severepyrexiaitmaybenecessarytogiveantipyretics.Theincidenceofpyrexia

decreases with subsequent injections.

Skinandmucouschanges

IntheeventofcutaneoussideeffectsinpatientswithAIDS,Bleomycin

treatment should be stopped and should not be resumed.

Induration,edema,hyperkeratosis,nailchanges,bullaformationoverpressure

pointssuchaselbows,alopeciaandstomatitismayoccurduringtreatmentwith

Bleomycin.

Thesesideeffectsarerarelyseriousandusuallydisappearaftercompletion

oftreatment.MucosalulcerationseemstobeaggravatedwhenBleomycin

iscombinedwithirradiationorotherdrugstoxictomucousmembranes.Skin

toxicityisarelativelylatemanifestationcorrelatingwiththecumulativedoses,

usuallydevelopinginthe2ndand3rdweekoftreatmentafteradministrationof

150 to 200 units (USP) ofBleomycin.

Idiosyncraticreactions

Anidiosyncraticreaction,clinicallysimilartoanaphylaxis,hasbeenreported

inapproximately1%ofthelymphomapatientstreatedwithBleomycin.The

reactionmaybeimmediateordelayedforseveralhours,andusuallyoccurs

afterthefirstorseconddose.Itconsistsofhypotension,mentalconfusion,fever,

chills,andwheezing.Treatmentissymptomatic,includingvolumeexpansion,

pressor agents, antihistamines, and corticosteroids.

Hypersensitivity

Becauseofthepossibilityofananaphylactoidreaction(reportedin1%of

lymphomapatients)patientsshouldreceiveinitiallyatestdoseof1-2units

(USP)intotal.Ifnoacutereactionoccurstheregulardosageregimencanbe

administered.

Gastrointestinal

Gastrointestinalsideeffectssuchasnauseaandvomitingmayoccurbutare

moreoftenseeninhigh-doseschedules.Antiemeticdrugsmaybeofhelp.

Anorexiaandweightlossarecommonandmaypersistforalongtimeafter

termination of the treatment.

Others

Vascular toxicities have been reported rarely.The events are clinically

heterogeneous and may include myocardial infarction, cerebrovascular

accident, thrombotic microangiopathies like hemolytic-uremic-syndrome and

cerebral arteritis.

Likeothercytotoxicagents,Bleomycinmayinducetumorlysissyndrome

inpatientswithrapidlygrowingtumors.Adequatesupportingtreatmentand

pharmacological measures may prevent or relieve such complications.

4.5Interactionswithothermedicinalproductsandotherformsof

interaction

WhenBleomycinisusedasoneofthedrugsinmultiplechemotherapy

regimensthetoxicityofBleomycinshouldbeborneinmindintheselection

and dosage of drugs with a similar toxic potential.

Anincreasedriskofpulmonarytoxicityhasbeendescribedwithconcomitant

useofBCNU,mitomycin-C,cyclophosphamide,methotrexateandgemcitabine.

Previousorconcurrentradiotherapytothechestisanimportantfactorin

increasing the incidence and severity of lung toxicity.

BecauseofthepotentialofBleomycintosensitizethelungtissue,therisk

ofdevelopingpulmonarytoxicityisincreasedinpatientswhohavereceived

Bleomycinwhenoxygenisbeingadministeredatsurgery.Areductionininspired

oxygen during operation and postoperatively is therefore recommended.

InpatientstreatedfortesticularcancerwithacombinationofBleomycin

andvincaalkaloidsasyndromehasbeenreportedcorrespondingtomorbus

Raynaud,ischemiawhichmayleadtonecrosisoftheperipheralpartsofthe

body (fingers, toes, nose tip).

Inpatientstreatedwithatriplecombinationregimenofcisplatin,vinblastine

andBleomycin,apositivecorrelationbetweenGFR(glomerularfiltrationrate)

andpulmonaryfunctionwasobserved.Therefore,Bleomycinshouldbeused

cautiouslyinpatientswithseverelyimpairedrenalfunction.Anotherstudy

showedthatanincreaseofthecisplatindosewasassociatedwithadecrease

of the creatinine clearance and theBleomycinelimination.

Theincreaseinneutrophilcountsandthestimulationoftheabilitytoproduce

superoxideradicalsaftertheuseofgranulocyte-colonystimulatingfactormay

potentiate lung injury.

Therateandextentofabsorptionoforalacetyldigoxinandofphenytoincould

be reduced byBleomycintreatments.

4.6 Use during pregnancy and lactation

AnimalexperimentshaverevealedthatBleomycinhasteratogenicand

carcinogenic potential.

TheuseofBleomycinshouldbeavoidedwheneverpossibleduringpregnancy

particularly during the first trimester.

Inavitalindicationduringthefirsttrimesterofpregnancyamedicalconsultation

regarding abortion is absolutely necessary.

Afterthefirsttrimesterofpregnancy,iftherapycannotbedelayedandthepatient

wishestocontinuewithherpregnancy,chemotherapymaybeundertakenafter

informing the patient of the minor but possible risk of teratogenic effects.

Bleomycinshould not be given to mothers who are breast feeding.

Contraceptive measures:

Bleomycincancausecongenitalanomalities.Conceptionduring

andsixmonthsaftertreatmentisnotadvisable.Womenshould

notbecomepregnantduringandsixmonthsaftertreatment.

4.7 Effects on ability to drive and use machines

PotentialsideeffectsofthechemotherapywithBleomycin,likenauseaand

4.8 Undesirable Effects

NEOPLASMS,BENIGNANDMALIGNANTANDUNSPECIFIED(INCLUDING

CYSTSAND POLYPS):Tumor pain,Tumor lysis syndrome

BLOODAND LYMPHATIC SYSTEM DISORDERS:

Febrileneutropenia,Neutropenia,Thrombocytopenia,Hemolyticuremic

syndrome,Thrombotic microangiopathy, Granulocytopenia, Leukopenia

METABOLISMAND NUTRITION DISORDERS:

Anorexia

PSYCHIATRIC DISORDERS:

Confusional state

NERVOUS SYSTEM DISORDERS:

Cerebral arteritis, Cerebrovascular accident

CARDIAC DISORDERS:

Myocardial infarction, Pericarditis

VASCULAR DISORDERS:

Hypotension,Phlebitis,Raynaud’sphenomenon,Thrombophlebitis,Arterial

thrombosis, deep vein thrombosis.

RESPIRATORY,THORACICAND MEDIASTINALDISORDERS:

Respiratoryfailure,pulmonaryembolism,Dyspnoea,Interstitiallungdisease,

Pulmonaryfibrosis,Pulmonarytoxicity,Rales,Wheezing,Acuterespiratory

distress syndrome.

GASTROINTESTINALDISORDERS:

Nausea, Stomatitis, Vomiting

SKINANDSUBCUTANEOUSTISSUEDISORDERS:Alopecia,Blister,

Erythema,Hyperkeratosis,Naildisorder,Pruritis,Rash,Rashvesicular,Skin

hyperpigmentation, Skin striae, Skin toxicity, Dermatitis, Drug eruption.

MUSCULOSKELETALAND CONNECTIVETISSUE DISORDERS:

Arthralgia, Myalgia, Scleroderma

GENERALDISORDERSANDADMINISTRATIVE SITE CONDITIONS:

Chestpain,Chills,Induration,Injectionsitepain,Localreaction,Mucosal

inflammation,Mucosalulceration,Oedema,Oedemaperipheral,Pyrexia,

Tenderness, Idiosyncratic drug reaction

4.9 Overdose

ObservationsindicatethatitisdifficulttoeliminateBleomycinfromthebody

bydialysis.TheacutereactionfollowinganoverdosageofBleomycinwould

probablyincludehypotension,fever,rapidpulseandgeneralsymptomsof

shock.Treatmentispurelysymptomatic.Intheeventofrespiratoryproblemsthe

patient should be treated with a corticosteroid and a broad-spectrum antibiotic.

5. PHARMACOLOGICALPROPERTIES

5.1 Pharmacodynamic properties

ATC-code: L01 DC 01

Bleomycinisamixtureofbasic,water-solubleglucopeptide-antibioticswith

cytotoxicactivity.Bleomycinactsbyintercalatingwithbothsingleanddouble-

strandedDNA(deoxyribonucleicacid)resultinginbothsingleanddouble-strand

scission,leadingtoinhibitionofcelldivision,ofgrowthandofDNAsynthesis;to

alesserdegreeBleomycinmayinfluenceRNA(ribonucleicacid)andprotein

synthesis.

ThemostimportantfactorinthetissueselectivityofBleomycinisthedifference

inintracellularinactivation.Squamouscells,withtheirlowcontentofBleomycin

hydrolase,haveahighsusceptibilityforBleomycin.Insensitivetissues,both

normalandneoplastic,chromosomeaberrationssuchasfragmentation,

chromatide breaks, and translocations appear to be regularly produced.

Bleomycinis pyrogenic.

Bleomycincauseslittleornobone-marrowtoxicityandnoimmunosuppression.

Bleomycincanbeusedalone,incombinationwithradiotherapyandtogether

with other cytotoxic drugs.

5.2 Pharmacokinetic properties

Absorption

Bleomycinisadministeredparenterally.Afterintravenousadministrationofa

bolusdoseof15units(USP)/m²bodysurfacepeakconcentrationsof1to10mU/

mlareachievedinplasma.Followingthei.m.injectionof15unitspeakplasma

concentrationsofabout1mU/mlareachievedafter30minutes.Continuous

infusionof30units(USP)ofBleomycindailyfor4to5daysresultedinan

Distribution

Bleomycinisrapidlydistributedtobodytissueswithhighestconcentrationsin

skin,lungs,peritoneumandlymphatictissue.Lowconcentrationsareseenin

the bone marrow.

Bleomycincouldnotbedetectedincerebrospinalfluidafterintravenous

injection.Bleomycinappearstocrosstheplacentalbarrier.Theapparent

volumeofdistribution(Vd)ßisabout0.27+0.09L/kg.Bleomycinisboundto

plasma proteins only to a slight extent.

Biotransformation

ThebiotransformationofBleomycinisnotfullymappedout.Inactivationtakes

placeduringenzymaticbreakdownbyBleomycinhydrolasewhichislocalized

primarilyinplasma,liver,spleen,intestineandbonemarrowandtoamuch

lesser extent in skin and lungs.

Elimination

Theeliminationhalf-life(T½ß)ofBleomycinisabout3hours.Aftercontinuous

i.v.infusiontheeliminationhalf-lifemaybeincreasedtoabout9hours.The

systemicplasmaclearance(Cls)isabout1.1ml/minxkg.Abouttwothirdsofthe

administereddrugisexcretedunchangedintheurine,probablybyglomerular

filtration.Approximately50%isrecoveredintheurinein24hoursafterani.v.

ori.m.injection.Therefore,therateofexcretionishighlyinfluencedbyrenal

function;concentrationsinplasmaaresignificantlyelevatedifusualdosesare

giventopatientswithrenalimpairmentwithonlyupto20%excretedin24

hours.ObservationsindicatethatitisdifficulttoeliminateBleomycinfromthe

body by dialysis.

5.3 Preclinical safety data

AnimalexperienceshaverevealedthatBleomycinhasteratogenicand

carcinogenic potential.

6. PHARMACEUTICALPARTICULARS

6.1 List of excipients

None.

6.2 Incompatibilities

Bleomycinsolutionshouldnotbemixedwithsolutionsofessentialamino

acids,aminophylline,ascorbicacid,benzylpenicilline,carbenicilline,cefalotine,

cefalozine,dexamethasone,diazepam,glutathione,hydrogensuperoxide,

hydrocortisone-Na-succinate,methotrexate,mitomycin,nafcilline,penicilline

G, riboflavin, substances containing sulfhydryl groups, terbutaline, or thiols.

6.3 Shelf life

42 months (3,5 years).

6.4 Special precautions for storage

Store at 2 -8°C. Keep in the carton.

6.5 Nature and contents of container

Packswith1or10vialseachcontainingBleomycinsulphateequivalentto15

units (USP).

6.6 Instructions for use/handling

Thegeneralguidelinesforsafehandlingofcytotoxicdrugsshouldbefollowed.

Precautionsshouldbetakentoavoidcontactwithskin,mucousmembranes

oreyes.Intheeventofcontaminationtheaffectedpartsshouldbewashed

thoroughlywithwater.Urineproducedforupto72hoursafteradoseof

Bleomycinshould be handled by wearing protective clothing

7. DATE OF (PARTIAL) REVISION OF THE TEXT June 2010

8. MANUFACTURER

Baxter Oncology GmbH, Germany

9. REGISTRATION HOLDER

MegaPharm Ltd., P.O. Box 519, Hod Ha`Sharon 45105

The format of this leaflet was determined by the Ministry of Health and its

content was checked and approved in February 2011

BLESPC 112010P.2

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