CYTAMEN

Main information

  • Trade name:
  • CYTAMEN Solution for Injection 1000 Microgram/ML
  • Dosage:
  • 1000 Microgram/ML
  • Pharmaceutical form:
  • Solution for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CYTAMEN Solution for Injection 1000 Microgram/ML
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1638/003/001
  • Authorization date:
  • 21-03-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Cytamen1000micrograms/mlSolutionforInjection

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontainscyanocobalamin1000micrograms(1.0mg)

Excipients:Eachmlcontains3.5mg(0.154mmol)ofsodium.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Solutionforinjection.

Aclearredsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Addisonianperniciousanaemia.

ProphylaxisandtreatmentofothermacrocyticanaemiasassociatedwithvitaminB12deficiencyandtheSchillingtest.

InvestigationaluseintheSchillingtest.

4.2Posologyandmethodofadministration

Thefollowingdosageschemesaresuitableforadultsandchildren.

Addisonianperniciousanaemiaandothermacrocyticanaemiaswithoutneurologicalinvolvement:

Initially:250to1,000microgramsintramuscularlyonalternatedaysforoneortwoweeks,then250micrograms

weeklyuntilthebloodcountisnormal.

Maintenance:1,000microgramsmonthly.

Addisonianperniciousanaemiaandothermacrocyticanaemias,anaemiawithneurologicalcomplications:

Initially:1,000microgramsintramuscularlyonalternatedaysaslongasimprovementisoccurring.

Maintenance:1,000microgramsmonthly.

ProphylaxisofmacrocyticanaemiaassociatedwithvitaminB12deficiencyresultingfromgastrectomy,some

malabsorptionsyndromesandstrictvegetarianism:

250to1,000microgramsmonthly.

Schillingtest:

Irish Medicines Board

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Date Printed 21/03/2011 CRN 2095747 page number: 1

4.3Contraindications

Hypersensitivitytocyanocobalaminoranyotherconstituents.

CytamenshouldnotbeusedforthetreatmentofmegaloblasticanaemiaofpregnancyunlessvitaminB12deficiency

hasbeendemonstrated.

Notindicatedfortreatmentoftoxicamblyopias-useNeo-Cytamen.

4.4Specialwarningsandprecautionsforuse

Thedosageschemesgivenaboveareusuallysatisfactory,butregularexaminationofthebloodisadvisable.If

megaloblasticanaemiafailstorespondtocyanocobalamin,folatemetabolismshouldbeinvestigated.

Dosesinexcessof10microgramsdailymayproduceanincompletehaematologicalresponseinpatientswithfolate

deficiency.Indiscriminateadministrationmaymaskthetruediagnosis.Thehaematologicalandneurologicalstate

shouldbemonitoredregularlytoensureadequacyoftherapy.Cardiacarrhythmiassecondarytohypokalaemiaduring

initialtherapyhavebeenreported.Plasmapotassiumshouldthereforebemonitoredduringthisperiod.Plateletcount

shouldbemonitoredduringthefirstweeksofuseinmegaloblasticanaemiaduetothepossibleoccurrenceofreactive

thrombocytosis.

Thismedicinalproductcontainslessthan1mmolsodium(23mg)perdose,i.e.essentially'sodiumfree'.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ChloramphenicoltreatedpatientsmayrespondpoorlytoCytamen.Serumconcentrationsofcyanocobalaminmaybe

loweredbyoralcontraceptives.AntimetabolitesandmostantibioticsinvalidatevitaminB12assaysbymicrobial

techniques.

4.6Fertility,pregnancyandlactation

CytamenshouldnotbeusedforthetreatmentofmegaloblasticanaemiaofpregnancyunlessvitaminB12deficiency

hasbeendemonstrated.Cytamenissecretedintobreastmilkbutthisisunlikelytoharmtheinfant,andmaybe

beneficialifthemotherandinfantarevitaminB12deficient.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Thefollowingeffectshavebeenreportedandarelistedbelowbybodysystem:

Bloodandlymphaticsystemdisorders:

Reactivethrombocytosiscanoccurduringthefirstweeksofuseinmegaloblasticanaemia.

Disordersoftheimmunesystem:

Hypersensitivityreactionsincludingskinreactions(e.g.rash,itching)andexceptionallyanaphylaxis.

Gastrointestinaldisorders:

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Generaldisorders:

Fever,chills,hotflushing,dizziness,malaiseandinjectionsitereactionsincludinginjectionsitepain,injectionsite

indurationandinjectionsitenecrosis.

Neurologicaldisorders:

Tremor.

Skinandsubcutaneoustissuedisorders:

Acneiformandbullouseruptions.

4.9Overdose

Treatmentisunlikelytobeneededincasesofoverdosage.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

CyanocobalaminisaformofvitaminB12.

5.2Pharmacokineticproperties

Afterinjectionofcyanocobalaminalargeproportionisexcretedintheurinewithin24hours;thebodyretainsonly

55%ofa100-microgramdoseand15%ofa1000-microgramdose.VitaminB12isextensivelyboundtospecific

plasmaproteinscalledtranscobalamins;transcobalaminIIappearstobeinvolvedintherapidtransportofthe

cobalaminstotissues.VitaminB12isstoredintheliver,excretedinthebile,andundergoesextensiveenterohepatic

recycling;partofanadministereddoseisexcretedintheurine,mostofitinthefirst8hours;urinaryexcretion,

however,accountsforonlyasmallfractioninthereductionoftotalbodystoresacquiredbydietarymeans.Vitamin

B12diffusesacrosstheplacentaandalsoappearsinbreastmilk.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sodiumchloride

GlacialAceticacid(E260)

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwithothermedicinalproducts.

6.3ShelfLife

Unopened:18months

Onceopened,useimmediatelyanddiscardanyunusedcontents.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

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6.5Natureandcontentsofcontainer

Type1Glassampoulesof1mlinboxesof5.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Forsingleuseonly.Discardanyunusedcontents.

7MARKETINGAUTHORISATIONHOLDER

RPHPharmaceuticalAB

Lagervägen7

13650Haninge

Sweden

8MARKETINGAUTHORISATIONNUMBER

PA1638/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorization:06May1985

Dateoflastrenewal:06May2010

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 21/03/2011 CRN 2095747 page number: 4