GEREF 50

Main information

  • Trade name:
  • GEREF 50
  • Dosage:
  • 50 Microgram
  • Pharmaceutical form:
  • Pdr+Solv for Soln for Inj
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GEREF 50
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0285/006/001
  • Authorization date:
  • 26-07-1991
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

GEREF®50

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachampouleofpowdercontainssermorelinacetateequivalentto50microgramsofsermorelin.

EachampouleofGerefisaccompaniedbyasolventampoulecontaining0.9%SodiumChlorideInjectionBP.

3PHARMACEUTICALFORM

Powderandsolventforsolutionforinjection

Awhite,sterile,pyrogen-free,crystallinepowderforsolutionforinjectioninaclear,TypeIglassampoule

accompaniedbyaclear,Type1glassampoulecontainingaclearcolourless,sterilesolutionforreconstitution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Fortheevaluationofthefunctionalcapacityandresponseofthesomatotrophsoftheanteriorpituitary.

4.2Posologyandmethodofadministration

Recommendedprocedure:Asingleintravenousinjectionof1.0microgram/kgbodyweightinthemorningfollowing

anovernightfast.

Gerefshouldbereconstitutedimmediatelybeforeusewithaminimumof0.5mloftheaccompanyingsterilesolvent.

Venousbloodsamplesshouldbedrawn15minutesbeforeandimmediatelypriortoGerefadministration.Venous

bloodsamplesarethendrawnat15,30,45and60minutesfollowingGerefinjection.Samplesat90and120minutes

areoptional,sinceinthemajorityofpatientstheydonotgiveadditionalinformation.

4.3Contraindications

UseinpatientsknowntobehypersensitivetosermorelinacetateoranyoftheexcipientsofGeref.

Useduringpregnancyorlactation.

4.4Specialwarningsandprecautionsforuse

Thetestshouldonlybecarriedoutandinterpretedunderspecialistsupervision.

Patientsalreadyongrowthhormonetherapyshouldhavetherapydiscontinuedonetotwoweekspre-test.

Thetestshouldbecarriedoutwithparticularcautioninpatientswithdiabetesmellitusorepilepsy.

Untreatedhypothyroidismoruseofanti-thyroidmedicationssuchaspropylthiouracilorhighlevelsofsomatostatin

Irish Medicines Board

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Date Printed 13/07/2006 CRN 2025520 page number: 1

Obesity,hyperglycaemiaandelevatedplasmafattyacidsaregenerallyassociatedwithpoorGHresponsestoGeref.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

TheGereftestshouldbeconductedintheabsenceofdrugswhichaffectdirectlythepituitarysecretionof

somatotrophin.Thesewouldincludepreparationswhichcontainorinducethereleaseofsomatostatin,insulin,or

glucocorticoids,andcyclo-oxygenaseinhibitorssuchasaspirinandindomethacin.

Thesomatotrophinlevelsmaybetransientlyelevatedbyclonidine,levodopaorinsulin-inducedhypoglycaemia.The

responsetoGerefmayalsobereducedbyanti-muscarinicagentssuchasatropine.

ItispossiblethatbetaadrenoceptoragonistsandblockersmayaffectresponsestoGeref.

4.6Pregnancyandlactation

Theproductshouldnotbeusedduringpregnancyorlactation.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Facialheat,facialflushandinjectionsitepainoccasionallyoccurandusuallydisappearwithinafewminutes.

4.9Overdose

Nodatarelatingtoacuteoverdosageareavailable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Sermorelinisasyntheticpeptideconsistingofthe1-29aminoacidsequenceofnaturalGHRF(GrowthHormone

ReleasingFactor).

5.2Pharmacokineticproperties

Sermorelinhasaplasmahalflifeof6-7minutesafterintravenousadministration.Peakresponseisreached

approximately30minutes(15-60)postdoseandlasts2-3hours.

5.3Preclinicalsafetydata

Toxicitystudiesdemonstratethegoodtoleranceoftheproduct,noclinicallyrelevantaffectswerefoundatdosesup

to100timestherecommendedhumandose.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Mannitol

Sodiumhydrogenphosphatedihydrate

Irish Medicines Board

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6.2Incompatibilities

Noknownchemicalincompatibilities.

6.3ShelfLife

2years.

6.4Specialprecautionsforstorage

Storeat2 °

Cto8 °

Protectfromlight.

6.5Natureandcontentsofcontainer

The3mlampouleofGeref50andthe2mlampoulecontaining1mlofthesolventareofcolourlessneutralglass.

Geref50isavailableinthefollowingpacksizes:1ampouleofGeref50and1ampouleofsolvent.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Theinjectionshouldbereconstitutedimmediatelypriortousewiththesolventprovided.Discardanyproduct

remainingafteruse.

7MARKETINGAUTHORISATIONHOLDER

SeronoLimited

BedfontCross

StanwellRoad

FelthamTW148NX

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA285/6/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26July1991

Dateoflastrenewal:26July2001

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 13/07/2006 CRN 2025520 page number: 3