Kevzara(sarilumab，萨瑞鲁单抗)的产品信息.pdfVIP

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

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1.NAMEOFTHEMEDICINALPRODUCT

Kevzara150mgsolutionforinjectioninpre-filledsyringe

Kevzara150mgsolutionforinjectioninpre-filledpen

Kevzara200mgsolutionforinjectioninpre-filledsyringe

Kevzara200mgsolutionforinjectioninpre-filledpen

2.QUALITATIVEANDQUANTITATIVECOMPOSITION

Kevzara150mgsolutionforinjectioninpre-filledsyringe

Eachpre-filledsyringecontains150mgsarilumabin1.14mlsolution(131.6mg/ml).

Kevzara150mgsolutionforinjectioninpre-filledpen

Eachpre-filledpencontains150mgsarilumabin1.14mlsolution(131.6mg/ml).

Kevzara200mgsolutionforinjectioninpre-filledsyringe

Eachpre-filledsyringecontains200mgsarilumabin1.14mlsolution(175mg/ml).

Kevzara200mgsolutionforinjectioninpre-filledpen

Eachpre-filledpencontains200mgsarilumabin1.14mlsolution(175mg/ml).

SarilumabisahumanmonoclonalantibodyproducedinChineseHamsterOvarycellsbyrecombinant

DNAtechnology.

Forthefulllistofexcipientsseesection6.1.

3.PHARMACEUTICALFORM

Solutionforinjection(injection)

Clear,colourlesstopaleyellowsterilesolutionofapproximatelypH6.0.

Kevzara150mgsolutionforinjection

298-346mmol/kg

Kevzara200mgsolutionforinjection

306-371mmol/kg

4.CLINICALPARTICULARS

4.1Therapeuticindications

Rheumatoidarthritis

Kevzaraincombinationwithmethotrexate(MTX)isindicatedforthetreatmentofmoderatelyto

severelyactiverheumatoidarthritis(RA)inadultpatientswhohaverespondedinadequatelyto,orwho

areintoleranttooneormorediseasemodifyingantirheumaticdrugs(DMARDs).Kevzaracanbe

givenasmonotherapyincaseofintolerancetoMTXorwhentreatmentwithMTXisinappropriate

(seesection5.1).

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Polymyalgiarheumatica