ACI-JEL THERAPEUTIC VAGINAL JELLY

Main information

  • Trade name:
  • ACI-JEL THERAPEUTIC VAGINAL JELLY
  • Dosage:
  • 0.93865%w/ %w/w
  • Pharmaceutical form:
  • Vaginal Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACI-JEL THERAPEUTIC VAGINAL JELLY
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0748/019/001
  • Authorization date:
  • 01-04-1994
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Aci-JelTherapeuticVaginalJelly

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Thegelcontains0.9386 %w/wGlacialAceticAcid in abuffered formulation (asdescribed in theapplication).

Forexcipients, seesection 6.1

3PHARMACEUTICALFORM

Vaginalgel.

Whitemobilegelofcharacteristicodour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

To restoreand maintain vaginalacidity, to reducerecurrenceand severity oftrichomonasinfection orin the

managementofnon-specificvaginitisorcervicitis.

4.2Posologyandmethodofadminstration

RouteofAdministration

Vaginaluse

Recommended Dose

Oneapplicatorfulintravaginally onceortwicedaily forup to 2 weeksorasprescribed.

4.3Contraindications

Noneknown.

4.4Special warningsandspecialprecautionsforuse

Ifthereisno improvementorthecondition isaggravated, consultthedoctor.

Do notusein conjunction with barriermethodsofcontraception.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

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Date Issued 21/10/2005 CRN 2015877 page number: 1

4.6Pregnancyandlactation

Forglacialaceticacid no clinicaldataon exposed pregnanciesareavailable.

Animalstudiesdo notindicatedirectorindirectharmfuleffectswith respectto pregnancy, embryonal/foetal

development, parturition orpostnataldevelopment(seesection 5.3).

Caution should beexercised when prescribing to pregnantwomen.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Rarely, localirritationand inflammation.

4.9Overdose

Aci-JelTherapeuticVaginalJelly isintended forintravaginaluse.Ifaccidentalingestion occurs, an appropriate

method ofgastricemptying may beused.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Aci-JelTherapeuticVaginalJelly helpsrestorevaginalpH.Aceticacid isalso bactericidalorbacteriostaticto many

typesoforganism.

5.2Pharmacokineticproperties

Therehavebeen no pharmacokineticstudiesofabsorption oftheexcipientsused in Aci-JelVaginalJelly.Itisunlikely

thatthereisany systemicabsorption ofany oftheingredientsoftheproduct.

5.3Preclinical safetydata

No relevantinformation additionalto thatcontained elsewherein theSummary ofProductCharacteristics.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerin

Castoroil

Propylhydroxybenzoate

Tragacanth

Acacia

Egg albumin impalpablepowder

Perfumelavendercompound 13091

Potassiumhydroxidepellets

Potassiumbitartrate

Irish Medicines Board

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Date Issued 21/10/2005 CRN 2015877 page number: 2

6.2Incompatibilities

Noneknown.

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.

6.5Natureandcontentsofcontainer

Epoxy resin lined, blind end aluminiumtubeswith polyethylenecaps.

Each tubecontains85g ofjelly.Aplasticvaginalapplicatorissupplied with each pack.

6.6Instructionsforuseandhandling

Notapplicable.

7MARKETINGAUTHORISATIONHOLDER

Janssen-Cilag Limited

Saunderton

High Wycombe

Buckinghamshire

HP14 4HJ

8MARKETINGAUTHORISATIONNUMBER

PA748/19/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisationl: 1 st

April1984

Dateoflastrenewal: 1 st

April, 2004

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 21/10/2005 CRN 2015877 page number: 3