CRINONE 4% PROGESTERONE

Main information

  • Trade name:
  • CRINONE 4% PROGESTERONE
  • Dosage:
  • 4 %w/w
  • Pharmaceutical form:
  • Vaginal Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CRINONE 4% PROGESTERONE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0285/013/001
  • Authorization date:
  • 25-07-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Crinone4%w/wprogesteronevaginalgel

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipientsseesection6.1.

3PHARMACEUTICALFORM

Vaginalgel

Whitetooffwhitegelcontainedwithinawhiteplasticapplicator.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Menopausaldisposal(incombinationwithoestrogentherapy).

4.2Posologyandmethodofadministration

Intravaginalapplication.

Treatmentofmenopausaldisorders:

Oneapplication(1.125g4%gel)everyotherdayforthelast12daysofeachoestrogenicsequence.

Children:notapplicable.

4.3Contraindications

Crinoneshouldnotbeusedinindividualswithanyofthefollowingconditions:

4.4Specialwarningsandprecautionsforuse

Crinone4%ProgesteroneVaginalGelcanbeprescribedwithanoestrogenproductasHRT.Epidemiologicalevidence

suggeststhattheuseofHRTisassociatedwithanincreasedriskofdevelopingdeepveinthrombosis(DVT)or

ActiveIngredient 4%gel

Mg/dose %w/w

Progesterone 45 4.0

1.KnownsensitivitytoCrinone(progesteroneoranyoftheotheringredients).

2.Undiagnosedvaginalbleeding.

3.Knownorsuspectedmalignancyofthebreastorgenitalorgans.

4.Acuteporphyria.

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studies.

However,whenCrinoneisco-prescribedasHRTtheprescribinginformationfortheoestrogenproductshouldbe

referredto.

Incasesofbreakthroughbleeding,asinallcasesofirregularvaginalbleeding,non-functionalcausesshouldbe

considered.Incasesofundiagnosedvaginalbleeding,adequatediagnosticmeasuresshouldbeundertaken.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Althoughnointeractionwithotherdrugshavebeenreported.Crinoneisnotrecommendedforusewithothervaginal

preparations.

4.6Pregnancyandlactation

Notapplicable.

4.7Effectsonabilitytodriveandusemachines

Driversandusersofmachinesarewarnedthatriskofsomnolencemayoccur.

4.8Undesirableeffects

Headache,somnolence,breasttenderness,intermenstrualbleeding(spotting),vaginalirritationandothermild

applicationsitereactions.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Thoseofthenaturallyoccurringprogesteronewithinductionofafullsecretoryendometrium.

5.2Pharmacokineticproperties

Theprogesteronevaginalgelisbasedonapolycarbophildeliverysystemwhichattachestothevaginalmucosaand

providesaprolongedreleaseofprogesteroneforatleastthreedays.

5.3Preclinicalsafetydata

Inrabbits,CrinonewasaneyeirritantcategorisedclassIV(minimaleffectsclearinginlessthan24hours),butnota

dermalirritant.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerin

LightLiquidParaffin

HydrogenatedPalmOilGlycerides

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Sorbicacid

Polycarbophil

Sodiumhydroxide

Purifiedwater

6.2Incompatibilities

Noincompatibilitieswerefoundwiththeusualcontraceptivedevices.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Asingleuse,onepiece,whitepolyethyleneapplicatorwithatwist-offtop,designedforintravaginalapplication.

Eachapplicatorcontains2.6gofgelanddelivers1.125ofgel.Eachoneiswrappedupandsealedina

paper/aluminium/polyethylenefoiloverwrap.

Theapplicatorsarepackedincardboardboxescontaining6unitsofCrinone4%progesteronevaginalgel.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

None.

7MARKETINGAUTHORISATIONHOLDER

SeronoLimited

BedfontCross

StanwellRoad

Feltham

MiddlesexTW148NX

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA285/13/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25July1997

Dateoflastrenewal:25July2002

10DATEOFREVISIONOFTHETEXT

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