SANDOGLOBULINE I.V 6 G

Israel - English - Ministry of Health

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Active ingredient:
IMMUNOGLOBULIN NORMAL HUMAN 6 G/VIAL
Available from:
MEDILINE LTD.
ATC code:
J06BA02
Pharmaceutical form:
POWDER FOR SOLUTION FOR INJECTION
Administration route:
I.V
Manufactured by:
CSL BEHRING AG, SWITZERLAND
Therapeutic group:
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASCULAR ADM.
Therapeutic indications:
Primary immunodeficiency (patients with primary defective antibody synthesis such as agammaglobulinaemia or hypogammaglobulinaemia). Idiopathic thrombocytopenic purpura (ITP).
Authorization number:
045382292300
Authorization date:
2010-05-01

1. NAME OF THE MEDICINALPRODUCT

Sandoglobulin ® I.V1 G

Sandoglobulin ® I.V3 G

Sandoglobulin ® I.V6 G

2. QUALITATIVEAND QUANTITATIVE COMPOSITION

Human normal immunoglobulin for intravenous administration (IVIg).

Supplied in presentations of 1 g, 3 g and 6 g.

Atleast96%ofthetotalproteinisIgGofwhichatleast90%ofitasmonomersordimers.TheremainderconsistsofIgG

fragments, albumin, small amounts of IgA(maximum 40mg/g protein), polymeric IgG and traces of IgM.

The typical distribution of the IgG subclasses closely resembles that in normal human plasma:

: 57.7%

: 35.1%

: 3.1%

: 4.1%

Sucroseisaddedasastabilizer,andthepreparationalsocontainstracesofsodiumchloride(Forafulllistofexcipients,

see section 6.1).

3. PHARMACEUTICALFORM

Powder for solution for infusion (intravenous administration).

Alyophilised, fine-grained powder which is either white or slightly yellow.

4. CLINICALPARTICULARS

4.1Therapeutic indications

1.Primaryimmunodeficiency(patientswithprimarydefectiveantibodysynthesissuchasagammaglobulinemiaor

hypogammaglobulinaemia).

2.Idiopathic thrombocytopenic purpura (ITP).

4.2 Posology and method of administration

PosologySandoglobulin ® is administeredas an intravenous infusion.

The dose and dosage regimen to be used depend on the indication.

Inreplacementtherapythedosagemayneedtobeindividualisedforeachpatientdependentonthepharmacokineticand

clinical response.The following dosage regimens are given as a guideline.

Replacementtherapyinprimaryimmunodeficiencysyndromes:

The recommended starting dose is 0.4-0.8 g/kg body weight (b.w.), followed by at least 0.2g/kg b.w. every three weeks.

ThedoseanddosageintervalshouldbeadjustedtomaintainatroughplasmaconcentrationofIgG(measuredbeforethe

next infusion) of at least 4-6g/L.Threeto 6 monthsarerequiredafter the initiationof therapyfor equilibrationto occur.The

doserequiredtoreachatroughlevelof6g/Lisoftheorderof0.2-0.8g/kgbodyweight/month.Thedosageintervalwhen

steady state has been reached varies from 2 to 4 weeks.

Trough levels should be measured in order to adjust the dose and dosage interval.

Idiopathic(immune)thrombocytopenicpurpura(ITP):

Forthetreatmentofanacuteepisode,0.8to1g/kgb.w.ondayone,whichmayberepeatedoncewithin3days,or0.4g/

kg b.w. daily for two to five days.The treatment can be repeated if relapse occurs.

The dosage recommendations are summarised in the followingTable1:

Indication Dose Frequency of injections

Replacementtherapyin

Primary immunodeficiency starting dose:

0.4–0.8g/kgb.w.

thereafter:

0.2–0.8g/kgb.w. every 2–4weeks to obtain IgG trough level of at

least 4–6g/l

Immunomodulation

Idiopathic thrombocytopenic

purpura 0.8–1g/kgb.w.

0.4g/kgb.w./d

0.4g/kgb.w./d on day1, possibly repeated once within 3days

for 2–5days

for 3–7days

Method of administration

Dependingonthepatient’srequirements,thelyophilizedpowdercanbereconstitutedwith0.9%sodiumchloride,water

forinjection,or5%dextrose.TheconcentrationofSandoglobulin ® inanyofthesesolutionsfori.vinfusionmayrangefrom

3%to12%dependingonthevolumeused.ThevolumeofsolventrequiredforadesiredconcentrationisgiveninTable2.

Instructions for reconstitution see section 6.6.

Table2:Volume of solvent required for a desired concentration

Vial size Volume of solvent required [ml] for a desired concentration [%]

3% 6% 9% 12%

1g 33 16.5 11 8.3

3g 100 50 33 25

6g 200 100 66 50

* container not large enough to allow the preparation of a 3% solution.

Itshouldbenotedthatwhenreconstitutedwithwaterforinjectionsa3%solutionofSandoglobulin®ishypotonic(192

mOsm/kg).

Sandoglobulin should be infused intravenously at an initial rate of 30 mg/kg/hr for the first 30 minutes.

Ifwelltolerated,therateofadministrationmaygraduallybeincreasedtoamaximumof180mg/kg/hr.Foraconversionof

the infusion rates from weight to volume for the different Sandoglobulin concentrations please refer toTable 3.

Table3:Conversion of infusion rates for Sandoglobulin concentrations

Concentration Initial infusion rate:

30 mg/kg/hr

60 mg/kg/hr 120 mg/kg/hr Maximum Infusion

Rate:

180 mg/kg/hr

(mg/ml)

30 mg/ml 1 ml/kg/hr 2 ml/kg/hr 4 ml/kg/hr 6 ml/kg/hr

60 mg/ml 0.5 ml/kg/hr 1 ml/kg/hr 2 ml/kg/hr 3 ml/kg/hr

90 mg/ml 0.33 ml/kg/hr 0.66 ml/kg/hr 1.33 ml/kg/hr 2 ml/kg/hr

120 mg/ml 0.25 ml/kg/hr 0.5 ml/kg/hr 1 ml/kg/hr 1.5 ml/kg/hr

beused,buttheinfusionshouldalwaysstartatalowrate,andclosemonitoringofthepatientisrequiredwhentherateis

gradually increased.

4.3 Contraindications

Hypersensitivity to any of the components.

Hypersensitivitytohumanimmunoglobulins,especiallyinpatientswiththeveryrarecasesofIgAdeficiencywhenthe

patient has antibodies against IgA.

4.4 Special warnings and precautions for use

Thrombotic Events

Thromboticevents,includingmyocardialinfarction,cerebralvascularaccident,deepveinthrombosis,andpulmonary

embolismhavebeenreportedinassociationwithintravenoususeofIVIG(seeADVERSEREACTIONS[6]).Thrombotic

eventshavealsobeenreportedwithsubcutaneousadministrationofimmuneglobulin.Patientsatriskforthromboticevents

includethosewithahistoryofatherosclerosis,multiplecardiovascularriskfactors,advancedage,impairedcardiacoutput,

coagulationdisorders,prolongedperiodsofimmobilization,obesity,diabetesmellitus,acquiredorinheritedthrombophilic

disorder, a history of vascular disease, or a history of a previous thrombotic or thromboembolic event.

Considerbaselineassessmentofbloodviscosityinpatientsatriskforhyperviscosity,includingthosewithcryoglobulins,

fastingchylomicronemia/markedlyhightriacylglycerols(triglycerides),ormonoclonalgammopathies(seeWARNING AND

PRECAUTIONS[5.9]).Forpatientsjudgedtobeatriskofdevelopingthromboticevents,administerIVIG,intravenously

attheminimumrateofinfusionpracticable,notexceeding3.3milligramIgG/kg/min(<2mL/kg/hr)(seeDOSAGEAND

ADMINISTRATION[2.3]).Whenadministeringsubcutaneouslymonitorthepatientsforsignsandsymptomsofthrombotic

events.

Hemolysis

IVIG,containsbloodgroupantibodiesthatmayactashemolysinsandinduceinvivocoatingofredbloodcells(RBC)with

immuneglobulin.Thismaycauseapositivedirectantiglobulintest[DAT(Coomb’stest)]6-7.Delayedhemolyticanemiacan

developsubsequenttoGAMMAGARDLIQUIDtherapyduetoenhancedRBCsequestration;acutehemolysis,consistent

with intravascular hemolysis, has been reported (seeADVERSE REACTIONS [6])5-8.

Thefollowingriskfactorsmayberelatedtothedevelopmentofhemolysis:highdoses(e.g.,≥2grams/kg,singleadministration

ordividedoverseveraldays)andnon-Obloodgroup.5Underlying inflammatorystateinanindividual patientmayincrease

the risk of hemolysis5 but its role is uncertain 8.

Monitorpatientsforclinicalsignsandsymptomsofhemolysis(seeWARNINGSANDPRECAUTIONS[5.9]),particularly

patientswithriskfactorsnotedabove.Considerappropriatelaboratorytestinginhigherriskpatients,includingmeasurement

ofhemoglobinorhematocritpriortoinfusionandwithinapproximately36to96hourspostinfusion.Ifclinicalsigns

andsymptomsofhemolysisorasignificantdropinhemoglobinorhematocrithavebeenobserved,performadditional

confirmatorylaboratorytesting.Iftransfusionisindicatedforpatientswhodevelophemolysiswithclinicallycompromising

anemia after receiving IGIV, perform adequate cross-matching to avoid exacerbating on-going hemolysis.

Certainsevereadversedrugreactionsmayberelatedtotherateofinfusion.Therecommendedinfusionrategivenunder

“4.2Methodofadministration”mustbecloselyfollowed.Patientsmustbecloselymonitoredandcarefullyobservedforany

symptoms throughout the infusion period.

Certain adverse reactions may occur more frequently

–in case of high rate of infusion,

–in patients with hypo- or agammaglobulinaemia with or without IgAdeficiency,

–inpatientswhoreceivehumannormalimmunoglobulinforthefirsttimeor,inrarecases,whenthehumannormal

immunoglobulin product is switched or when there has been a long interval since the previous infusion.

True hypersensitivity reactions are rare.They can occur in the very rare cases of IgAdeficiency with anti-IgAantibodies.

Rarely,humannormalimmunoglobulincaninduceafallinbloodpressureassociatedwithanaphylacticreaction,evenin

patients who had tolerated previous treatment with human normal immunoglobulin.

Potential complications can often be avoided by ensuring:

–that patients are not sensitive to human normal immunoglobulin by initially injecting the product slowly (30 mg/kg/hr);

–thatpatientsarecarefullymonitoredforanysymptomsthroughouttheinfusionperiod.Inparticular,patientsnaiveto

humannormalimmunoglobulin,patientsswitchedfromanalternativeIVIgproductorwhentherehasbeenalonginterval

sincethepreviousinfusionshouldbemonitoredduringthefirstinfusionandforthefirsthourafterthefirstinfusion,inorder

to detect potential adverse signs.All other patients should be observed for at least 20minutes after administration.

ThereisclinicalevidenceofanassociationbetweenIVIgadministrationandthromboemboliceventssuchasmyocardial

infarction,stroke,pulmonaryembolismanddeepveinthromboseswhichisassumedtoberelatedtoarelativeincreasein

bloodviscositythroughthehighinfluxofimmunoglobulininat-riskpatients.Cautionshouldbeexercisedinprescribingand

infusingIVIginobesepatientsandinpatientswithpre-existingriskfactorsforthromboticevents(suchasadvancedage,

hypertension,diabetesmellitusandahistoryofvasculardiseaseorthromboticepisodes,patientswithacquiredorinherited

thrombophilicdisorders,patientswithprolongedperiodsofimmobilisation,severelyhypovolaemicpatients,patientswith

diseases which increase blood viscosity).

CasesofacuterenalfailurehavebeenreportedinpatientsreceivingIVIgtherapy.Inmostcases,riskfactorshavebeen

identified,suchaspre-existingrenalinsufficiency,diabetesmellitus,hypovolaemia,overweight,concomitantnephrotoxic

medicinal products or age over 65.

In case of renal impairment, IVIg discontinuation should be considered.

Whilethesereportsofrenaldysfunctionandacuterenalfailurehavebeenassociatedwiththeuseofmanyofthelicensed

IVIgproducts,thosecontainingsucroseasastabiliseraccountedforadisproportionateshareofthetotalnumber.Inpatients

at risk, the use of IVIg products that do not contain sucrose may be considered.

Inpatientsatriskforacuterenalfailureorthromboembolicadversereactions,IVIgproductsshouldbeadministeredatthe

minimum rate of infusion and dose practicable.

In all patients, IVIg administration requires:

–adequate hydration prior to the initiation of the infusion of IVIg,

–monitoring of urine output,

–monitoring of serum creatinine levels,

–avoidance of concomitant use of loop diuretics.

Incaseofadversereaction,eithertherateofadministrationmustbereducedortheinfusionstopped.Thetreatment

required depends on the nature and severity of the side effect.

In case of shock, standard medical treatment for shock should be implemented.

Information for diabetics

Afterintravenousadministration,sucroseisnotmetabolisedinthebody,butexcretedunchangedviathekidneys(inthe

urine).Thus,theamountofsucroseadministeredwithintravenousSandoglobulintreatmentdoesnotinfluencetheglucose

metabolicstate,sothatadaptationoftheindividualdiabetestherapy(diet,dosesoforalantidiabeticsand/orinsulin)isnot

indicated.

Information on safety with respect to transmissible agents

Standardmeasurestopreventinfectionsresultingfromtheuseofmedicinalproductspreparedfromhumanbloodorplasma

includeselectionofdonors,screeningofindividualdonationsandplasmapoolsforspecificmarkersofinfection,andthe

inclusionofeffectivemanufacturingstepsfortheinactivation/removalofviruses.Inactivation/removalfactorsforvirusesby

individual manufacturing steps of Sandoglobulin and the cumulative reduction factors are shown inTable3.

Table3:Removal/inactivation factors for viruses (expressed as LRFs = log

10 of reduction factors)

HIV PRV SFV SIN BVDV BEV

Removal by fractionation/

filtration 15.5 16.0 ≥9.3 12.4 n.d. 14.1

Inactivation (pH4/pepsin) 6.1 ≥5.3 ≥6.8 n.d. ≥4.4 <1

Removal by nanofiltration ≥4.9 ≥4.4 n.d. ≥7.5 ≥4.5 ≥5.1

Cumulative reduction factors >26 >25 >16 >19 >8 >19

HIVHuman immunodeficiency virus;PRVPseudorabies virus;SFVSemliki-Forest virus;SINSindbis virus;BVDVBovine

viral diarrhoea virus; BEVBovine enterovirus;n.d.not determined.

SFV, SIN and BVDV are model viruses for Hepatitis C virus.

ThemeasurestakenareconsideredeffectiveforenvelopedvirusessuchasHIV,HBV,andHCV.Theymaybeoflimited

value against non-enveloped viruses such as HAV and B19 virus.

Additionally,themanufacturingprocesswasinvestigatedforitscapacitytodecreasetheinfectivityofanexperimentalagent

oftransmissiblespongiformencephalopathy(TSE),consideredasamodelforthevCJDandCJDagents.Severalofthe

individualproductionstepsintheSandoglobulinmanufacturingprocesshavebeenshowntodecreaseTSEinfectivityofthis

experimentalmodelagent.TSEreductionstepsincludeprecipitation(3.5log

),depthfiltrations(7.3log

),andnanofiltration

(4.4log

).ThesestudiesprovidereasonableassurancethatlowlevelsofvCJD/CJDagentinfectivity,ifpresentinthe

starting material, would be removed.

Despitethis,whenmedicinalproductspreparedfromhumanbloodorplasmaareadministered,thepossibilityoftransmitting

infective agents cannot be totally excluded.This also applies to unknown or emerging viruses and other pathogens.

ThereisreassuringclinicalexperienceregardingthelackofhepatitisAorB19virustransmissionwithimmunoglobulinsand

it is also assumed that the antibody content makes an important contribution to the viral safety.

ItisstronglyrecommendedthateverytimethatSandoglobulinisadministeredtoapatient,thenameandbatchnumberof

the product are recorded in order to maintain a link between the patient and the batch of the product.

4.5 Interactions with other medicinal products and other forms of Interaction

Sandoglobulin ® should not be mixedwith any other drug and should always be given through a separate infusion line.

Live attenuated virus vaccines

Immunoglobulinadministrationmayimpairtheefficacyofliveattenuatedvirusvaccinessuchasmeasles,mumps,rubella

andvaricellaforaperiodofatleast6weeksandupto3months.Afteradministrationofthisproduct,anintervalof3months

shouldelapsebeforevaccinationwithliveattenuatedvirusvaccines.Inthecaseofmeasles,thisimpairmentmaypersistfor

up to 1year.Therefore patients receiving measles vaccine should have their antibody status checked.

Interference with serological testing

Afterinjectionofimmunoglobulinthetransitoryriseofthevariouspassivelytransferredantibodiesinthepatient’sbloodmay

result in misleading positive results in serological testing.

Passivetransmissionofantibodiestoerythrocyteantigens,e.g.A,BDmayinterferewithsomeserologicaltestsforredcell

allo-antibodies (e.g. Coombs test).

4.6 Pregnancy and lactation

Thesafetyofthismedicinalproductforuseinhumanpregnancyhasnotbeenestablishedincontrolledclinicaltrials

andthereforeshouldonlybegivenwithcautiontopregnantwomenandbreast-feedingmothers.Clinicalexperiencewith

immunoglobulinssuggeststhatnoharmfuleffectsonthecourseofpregnancy,oronthefoetusandtheneonatearetobe

expected.

Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.

4.7 Effects on ability to drive and use machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable effects

Thefollowingadversereactionsarecommon(>1/100,<1/10)::headache,nausea,vomiting,diarrhoea,fatigue,malaise,

dizziness,chills,sweating,fever(hyperthermia),flushing,allergicreactions,myalgia,arthralgia,lowbloodpressureand

moderate low back pain may occur occasionally.

Uncommon(>1/1,000,<1/100)adversereactionsare:abdominalpain,cyanosis,dyspnea,feelingoftightnessorpainin

thechest,rigor,pallor,hypertension, hypotension, tachycardia. Mostofthese effectsare related totherateofinfusion, and

may be relieved by reducing the rate or temporarily stopping the infusion.

Rarely(>1/10,000,<1/1,000)humannormalimmunoglobulinsmaycauseasuddenfallinbloodpressureand,inisolated

cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.

Casesofreversibleasepticmeningitis,isolatedcasesofreversiblehaemolyticanaemia/haemolysisandrarecasesof

transient cutaneous reactions, have been observed with human normal immunoglobulin.

Increase in serum creatinine level and/or acute renal failure have been observed.

Veryrare(<1/10,000):Thromboembolicreactionssuchasmyocardialinfarction,stroke,pulmonaryembolism,deepvein

thromboses.

For safety with respect to transmissible agents, see section 4.4.

4.9 Overdose

Overdose may lead to fluid overload and hyperviscosity,particularlyin patients at risk,includingelderly patients or patients

with renal impairment.

5. Pharmacological Properties

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:immuneseraandimmunoglobulins:immunoglobulins,normalhuman,forintravascular

administration, (ATCcode:JO6B-A02).

HumannormalimmunoglobulincontainsmainlyimmunoglobulinG(IgG)withabroadspectrumofantibodiesagainst

infectious agents.

HumannormalimmunoglobulincontainstheIgGantibodiespresentinthenormalpopulation.Itisusuallypreparedfrom

pooledplasmafromnotfewerthan1,000donors.IthasadistributionofimmunoglobulinGsubclassescloselyproportional

tothatinnativehumanplasma.AdequatedosesofthismedicinalproductmayrestoreabnormallylowimmunoglobulinG

levels to the normal range.

Themechanismofactioninindicationsotherthanreplacementtherapyisnotfullyelucidated,butincludesimmunomodulatory

effects.

5.2PharmacokineticProperties

Humannormalimmunoglobulinisimmediatelyandcompletelybioavailableintherecipient’scirculationafterintravenous

administration.Itisdistributedrelativelyrapidlybetweenplasmaandextravascularfluid,afterapproximately3to5days

equilibrium is reached between the intra- and extravascular compartments.

TheantibodiespresentinSandoglobulinpossessthesamepharmacokineticcharacteristicsasthoseofendogenous

IgG.Thebiologicalhalf-lifeofSandoglobulinis21daysonaverageinsubjectswithnormalIgGserumlevels,whereasit

wasfoundtobe32daysinpatientswithprimaryhypogammaglobulinaemiaoragammaglobulinaemiawhentreatedwith

Sandoglobulin.This half-life may vary from patient to patient, in particular in primary immunodeficiency.

IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

5.3 Preclinical safety data

Sandoglobulin®givenbyi.vinfusiontolaboratoryanimalsindosesseveraltimesthetherapeuticdosesinmandidnotexert

any toxic effects. However, toxicological testing in animals is of little predictive value for human use since

(a) the fluid volume associated with single administration of a high dose results in circulatory overloading, and

(b)repeatedadministrationisimpracticablebecauseoftheformationofantibodiesagainsttheheterologous(human)

Beingnormalconstituentsofthehumanbody,theproteinscontainedinSandoglobulinpreparationscanbeconsideredtobe

non-toxicinman.ThebroadclinicaluseofIVIgpreparationsovermorethan20yearshasnotrevealedanytoxic,mutagenic,

or tumorigenic potential.

6. PHARMACEUTICALPARTICULARS

6.1 List of Excipients

Sucrose 1.67 g per 1g protein

Sodium Chloride ≤20 mg per 1g protein

Sandoglobulin ® contains no preservatives.

Solvent: sodium chloride, water for injection

6.2 Incompatibilities

Sandoglobulin ® shouldnotbemixedwithanyotherpharmaceuticalproductotherthantherecommendedsolvents(see

section 4.2).

6.3 Shelf life

3 years

Chemical and physical in-use stability has been demonstrated for 24 hours at +4 °C and then 12 hours at +30 °C.To avoid

microbiological contamination, Sandoglobulin should be used immediately.

In-use storage prior to use should not exceed 24 hours at +2 °C to +8 °C.

6.4 Special precautions for storage

Keep in the original pack (protect from light). Do not store above 25 ºC. Do not freeze.

Do not use after the expiry date.

Keep out of the reach and sight of children.

6.5 Nature and content of container

Sandoglobulin ® is presented in infusion bottles (glass type II, surface treated).

Sandoglobulin ® 1 g 50 mLbottle

3 g 100 mLbottle

6 g 250 mLbottle

6.6 Special precautions for disposal and otherhandling

Each pack contains detailed instruction for handling (see attached) describing dissolution of the lyophilized powder.

The product should be brought to room or body temperature before use.

Total reconstitution should be obtained within 20minutes.

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.

Reconstituted products should be inspected visually for particulate matter and discoloration prior to administration.

Any unused product or waste material should be disposed of in accordance with local requirements.

Reconstitution using the transfer set and solvent bottle (where provided)

Notethatthelyophilisatebottleispartiallyevacuatedtofacilitatereconstitution.Ifonlyapartofthesolventprovidedistobe

transferred,removetheexcessamountofsolventusingasterilesyringebeforetransferringtheremainingsolventintothe

lyophilisate bottle.Table2 (see section 4.2) indicates the volume of sterile solvent required for a desired concentration.

Transfer the solvent from the bottle according to the following instruction (see also figures1 to 4):

1 Removetheprotectiveplasticcapsfromthelyophilisate(“LYO”)andsolventbottles,disinfectbothrubber

stoppersandallowtodry.Removetheprotectivecoverfromtheendofthetransfersetwiththeshorter

needleandinserttheexposedneedlethroughthecenteroftherubberstopperintothebottlecontainingthe

solvent.

2a and b Removethesecondprotectivecoverfromtheotherendofthetransferset.Graspbothbottlesasshown

infigure2aandaimwiththeexposedneedleforthecenteroftherubberstopperofthelyophilisatebottle.

Quicklyplungethesolventbottleontothelyophilisatebottleandatthesametimebringthebottlesinto

anuprightposition(figure2b).Onlyifthisisdonequicklyandthebottlesareimmediatelybroughtintoan

uprightpositioncanthevacuuminthelyophilisatebottlebemaintained,thusspeedingupreconstitutionand

facilitating the transfer.Allow the solvent to flow into the lyophilisate bottle.

3 Oncethesolventistransferred,liftthesolventbottleoffthespiketoreleasethevacuum(seefigure3).This

will reduce foaming and facilitate reconstitution. Remove the spike.

4 Swirlvigorouslybut donotshake,otherwisefoamcouldformwhichisveryslowtosubside.Thelyophilisate

should reconstitute within 20minutes.

General reconstitution

Toreconstitutetheproductusingothersolventsorwhennosolventortransfersetisprovided,Table2(seesection4.2)

indicatesthevolumeofsterilesolventrequiredforadesiredconcentration.Observingaseptictechnique,thisvolumeshould

bedrawnintoasterilesyringe.Thesolventistheninjectedintothelyophilisatebottle,usinganewsterileneedle.Swirl

vigorouslybutdonotshake,otherwisefoamcouldformwhichisveryslowtosubside.Thelyophilisateshouldreconstitute

within 20minutes.

7. Manufacturer

CSLBehringAG, Bern, Switzerland

8. License Holder

Mediline Ltd.

22 Ben-Gurion St., Herzlia

9. License Numbers

SANDOGLOBULINE I.V 1 G 045 37 22921

SANDOGLOBULINE I.V 3 G 045 44 22922

SANDOGLOBULINE I.V 6 G 045 38 22923

The format of this leaflet was defined by the MOH and its content was checked and approved in May 2013.

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