DERBAC-M LIQUID

Main information

  • Trade name:
  • DERBAC-M LIQUID
  • Dosage:
  • 0.5%w/v %w/v
  • Pharmaceutical form:
  • Cutaneous Emulsion
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DERBAC-M LIQUID
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0618/014/001
  • Authorization date:
  • 13-07-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DerbacMLiquid0.5%w/wCutaneousemulsion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Theliquidcontains0.5%w/wMalathion.

Alsocontainsmethylparahydroxybenzoate(E218)0.20%w/wandpropylparahydroxybenzoate(E216)0.08%w/w.

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

CutaneousEmulsion.

Creamywhiteperfumedemulsion.

4CLINICALPARTICULARS

4.1TherapeuticIndications

1.Forthetreatmentofsevereinfestationofthescalporpubicwithlice(T.Pediculosis).

2.Forthetreatmentofscabies.

4.2Posologyandmethodofadministration

Topical.

Adultsincludingtheelderlyandchildrenover6monthsofage:

1.Applythoroughlytoallpartsofthehairandscalporthehairoftheaffectedareas.Leaveforatleastonehouron

bodyorpreferablyovernightonscalpandbeforebathing.Treatmentshouldberepeatedafter7days.

2.Applyliquidtoentirebodysurfaceexceptscalp.Childrenundertheageoftwoyearsshouldhaveathinfilmof

theliquidappliedtothescalp,faceandears,avoidingtheeyesandmouth.Treatmentshouldberepeatedafter7

days.

Thisproductshouldnotbeusedoninfantslessthan6monthsofageexceptundermedicalsupervision.

4.3Contraindications

Knownhypersensitivitytoactiveconstituents.

Nottobeusedoninfantslessthansixmonthsoldexceptonmedicaladvice.

4.4Specialwarningsandprecautionsforuse

Theeyesshouldbewellprotectedduringtheapplicationandwashingofhair.

Personsapplyingthisproductshouldwearrubberglovessothattheircontinueddirectcontactisavoided.

Irish Medicines Board

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Date Printed 25/03/2011 CRN 2092334 page number: 1

Thesourceofinfestationshouldbesoughtandtreated.

Thisproductispoisonousifingested.Ifaccidentallyswallowed,contactyourlocaldoctororhospitalimmediately.

Prolongedcontinuedapplicationshouldbeavoided.Itshouldnotbeusedmorethanonceaweekandfornotmore

thanthreeconsecutiveweeks.

Keepoutofreachofchildren.

Childrenundertheageof6monthsshouldonlybetreatedundermedicalsupervision.

Thelotionshouldnotbeappliedtodamagedskinexceptaftermedicalconsultation.

Thisproductcontainsmethylparahydroxybenzoate(E218)andpropylparahydroxybenzoate(E216)which

maycauseallergicreactions(possiblydelayed).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Fertility,pregnancyandlactation

Noknoweffectsinpregnancyandlactation.However,aswithallmedicines,usewithcaution.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Veryrarelyskinirritationhasbeenreportedwithmalathionproducts.

4.9Overdose

ItismostunlikelythatatoxicdoseofMalathionwillbeingested.Treatmentconsistsofgastriclavage,assisted

respirationand,ifnecessaryintheeventofmassiveingestion,administrationofatropinetogetherwithpralidoxime.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Malathion,ATCcode:P03AX03.

DerbacMLiquidcontainsmalathion,awidelyusedorganophosphorousinsecticidewhichisactivebycholinesterase

inhibition.Itiseffectiveagainstawiderangeofinsectsbutisoneoftheleasttoxicorganophosphorousinsecticidessinceit

israpidlydetoxifiedbyplasmacarboxylesterases.

5.2Pharmacokineticproperties

Derbac-MLiquidisappliedtopicallytotheaffectedarea.

5.3Preclinicalsafetydata

Irish Medicines Board

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Date Printed 25/03/2011 CRN 2092334 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Emulsifyingwax

PotassiumCitrate

CitricAcid

PerfumeHT52

Purifiedwater

6.2Incompatibilities

30months.

6.3ShelfLife

Twoandahalfyears.

6.4Specialprecautionsforstorage

Donotstoreabove25 o

Storethebottleintheoutercartoninordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Cartoned,clearoramberglass(Ph.Eur.TypeIII)bottleswithpolyethylenecapsandpolypropylenefacedwads

containingeither50,55,160,200or210mlofproduct.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

SetonProductsLimited

TubitonHouse

Oldham

OL13HS

England

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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Date Printed 25/03/2011 CRN 2092334 page number: 3

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13July1993

Dateoflastrenewal:13July2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 25/03/2011 CRN 2092334 page number: 4