ANABACT

Main information

  • Trade name:
  • ANABACT Cutaneous Gel 0.75%w/ w %w/ w
  • Dosage:
  • 0.75%w/ w %w/ w
  • Pharmaceutical form:
  • Cutaneous Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANABACT Cutaneous Gel 0.75%w/w %w/w
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0980/003/001
  • Authorization date:
  • 13-11-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Anabact

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Metronidazole0.75%w/w

Forexcipientssee6.1.

3PHARMACEUTICALFORM

Gel.

Paleyellowcleargel.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthedeodorisation ofmalodorousfungating tumours.

4.2Posologyandmethodofadminstration

Adultsand Elderly:

Clean thewound thoroughly. Apply thegeloverthecompleteareawith anon-adherentdressing. Useonceortwiceas

necessary.

Children:

Notrecommended

4.3Contraindications

In patientsknown to besensitiveto metronidazole, Bronopol, hydroxybenzoicacid esters, hydroxyethylcellulose,

propyleneglycolorphosphoricacid.

Usein patientswith diseaseoftheperipheralnervoussystem.

4.4Special warningsandspecialprecautionsforuse

Strong sunlightshould beavoided becausemetronidazoleisunstableunderultra-violetlight. Contactwith theeyes

should beavoided. Ifcontactwith theeyesoccurs, thegelshould becarefully washed outwith water.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Adisulfiram-likereaction hasbeen reported in asmallnumberofpatientstaking oralmetronidazoleand alcohol

concomitantly. Anticoagulantsand antiepilepticsmay alsointeract. Concurrentusewith keratolyticsisnot

Irish Medicines Board

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Date Issued 03/08/2005 CRN 2012710 page number: 1

4.6Pregnancyandlactation

Thesafety ofmetronidazolein pregnancy and lactationhasnotbeen adequately established. Thegelshould not

thereforebeused in thesecircumstancesunlessthephysician considersitessential. Medication should bestopped if

pregnancy occurs.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

May causelocaldrynessoftheskin, itching and peeling.

4.9Overdose

Overdoseisextremely unlikely. Ifnecessary, medication should beremoved by washing with warmwater.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Metronidazoleisan established antibacterialagent. Itiseffectiveagainstavariety oforganismsincluding anaerobic

bacteriawhich areresponsibleforthedistressing symptomsofmalodorousfullthicknesswounds.

5.2Pharmacokineticproperties

Thesystemicconcentration ofMetronidazolefollowing thetopicaladministration of1g ofa0.75%Metronidazolegel

hasbeen demonstratedto rangefrom25ng/ml(limitofdetection)to 66ng/ml, with amean c/max of40.6ng/ml.

Thecorresponding mean c/max following theoraladministration ofasolution containing 30mg ofMetronidazolewas

850ng/ml(equivalentto 212ng/mlifdosecorrected). Themean Tmax forthetopicalformulation was6.0 hours

compared to 0.97 hoursfortheoralsolution. Theselevelsfollowing topicaladministration areclinically insignificant.

5.3Preclinical safetydata

No published dataareavailableontheirritancyand toleranceoftopicalmetronidazolein animals.

Itwas, therefore, considered moreappropriateto investigatethepotentialirritancy and toleranceoftopicalapplication

oftheproposed marketing formulation ofmetronidazole0.75%gelin human volunteers.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Bronopol

Hydroxybenzoicacid esters

Hydroxyethylcellulose

Propyleneglycol

Phosphoricacid

Irish Medicines Board

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Date Issued 03/08/2005 CRN 2012710 page number: 2

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2 years.

6.4Special precautionsforstorage

Do notstoreabove25°C. Keep containerin outercarton.

6.5Natureandcontentsofcontainer

Internally lacquered membranesealed aluminiumtubeseach fitted with alowdensity polyethylenecap. Theproductis

availablein packsof5g, (professionalsample)10g, 15g, 25g, 30g and 40g, though theavailability ofcertain pack sizes

may belimited.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

CambridgeHealthcareSuppliesLimited

14DWendoverRoad

Rackheath IndustrialEstate

Norwich

NR136LH

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

PA980/3/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 13 th

November1998

Dateoflastrenewal: 13 th

November2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 03/08/2005 CRN 2012710 page number: 3