CRINONE 8% W/W PROGESTERONE

Main information

  • Trade name:
  • CRINONE 8% W/W PROGESTERONE
  • Dosage:
  • 8 %w/w
  • Pharmaceutical form:
  • Vaginal Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CRINONE 8% W/W PROGESTERONE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0285/013/002
  • Authorization date:
  • 25-07-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Crinone8%w/wprogesteronevaginalgel

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Excipients:Containssorbicacid0.08%w/w(0.9mg/1.125gdose)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Vaginalgel

Whitetooffwhitegelcontainedinawhiteplasticapplicator.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Infertilityduetoinadequatelutealphase.

4.2Posologyandmethodofadministration

Intravaginalapplication.

Treatmentofinfertilityduetoinadequatelutealphase:

Oneapplication(1.125g8%gel)everyday,startingafterdocumentedovulationorarbitrarilyonthe18th-21stdayof

thecycle.

Children:notapplicable.

4.3Contraindications

ActiveIngredient

Mg/dose%w/w

Progesterone 90 8.0

1.KnownhypersensitivitytoprogesteroneortoanyoftheotherexcipientsofCrinone.

2.Undiagnosedvaginalbleeding.

3.Knownorsuspectedmalignancyofthebreastorgenitalorgans.

4.Acuteporphyria.

5.Thrombophlebitis,thromboembolicdisorder,cerebralapoplexy,orpatientswithahistoryoftheseconditions.

Irish Medicines Board

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Date Printed 29/11/2010 CRN 2091414 page number: 1

4.4Specialwarningsandprecautionsforuse

Incasesofbreakthroughbleeding,asinallcasesofirregularvaginalbleeding,non-functionalcausesshouldbe

considered.Incasesofundiagnosedvaginalbleeding,adequatediagnosticmeasuresshouldbeundertaken.

Sorbicacidmaycauselocalskinreactions,(e.g.contactdermatitis).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Althoughnointeractionwithotherdrugshavebeenreported.Crinoneisnotrecommendedforuseconcurrentlywith

othervaginalpreparations.

4.6Fertility,pregnancyandlactation

Incaseofcorpusluteumdeficiency,CRINONEcanbeusedduringthefirstmonthofpregnancy.

Donotuseduringlactation.

4.7Effectsonabilitytodriveandusemachines

Driversandusersofmachinesarewarnedthatriskofsomnolencemayoccur.

4.8Undesirableeffects

Inaddition,intermenstrualbleeding(spotting),vaginalirritation,hypersensitivityreactionsusuallymanifestingasskin

rash,andothermildapplicationsitereactionshavebeenreportedpost-marketing.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Thoseofthenaturallyoccurringprogesteronewithinductionofafullsecretoryendometrium.

5.2Pharmacokineticproperties

Theprogesteronevaginalgelisbasedonapolycarbophildeliverysystemwhichattachestothevaginalmucosaand

providesaprolongedreleaseofprogesteroneforatleastthreedays.

5.3Preclinicalsafetydata

Inrabbits,CrinonewasaneyeirritantcategorisedclassIV(minimaleffectsclearinginlessthan24hours),butnota

dermalirritant.

SystemOrganClass Common

Nervoussystemdisorders Headache

Reproductivesystemandbreastdisorders Breasttenderness

Irish Medicines Board

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Date Printed 29/11/2010 CRN 2091414 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerin

LightLiquidParaffin

HydrogenatedPalmOilGlycerides

Carbomer974P

Sorbicacid

Polycarbophil

Sodiumhydroxide

Purifiedwater

6.2Incompatibilities

Noincompatibilitieswerefoundwiththeusualcontraceptivedevices.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Asingleuse,onepiece,whitepolyethyleneapplicatorwithatwist-offtop,designedforintravaginalapplication.

Eachapplicatorcontains2.6gofgelanddelivers1.125gofgel.Eachoneiswrappedupandsealedina

paper/aluminium/polyethylenefoiloverwrap.

Theapplicatorsarepackedincardboardboxescontaining6unitsofCrinone8%progesteronevaginalgel,and15units

ofCrinone8%progesteronevaginalgel.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

SeronoLimited

BedfontCross

StanwellRoad

Feltham

MiddlesexTW148NX

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25July1997

Dateofrenewal:25July2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 29/11/2010 CRN 2091414 page number: 4