SOLIGENTAL

Main information

  • Trade name:
  • SOLIGENTAL
  • Pharmaceutical form:
  • Eye drops
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SOLIGENTAL
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • gentamicin
  • Therapeutic area:
  • Cats, Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0111/001
  • Authorization date:
  • 30-11-2009
  • EU code:
  • FR/V/0111/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SOLIGENTAL3000IU/mleyedrops

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Gentamicin............................................................................. 3000 IU

(assulfateform)

Excipients:

Sodiummetabisulfite(E223)..................................................... 1.50 mg

Parahydroxybenzoicacid......................................................... 0.90 mg

Trometamol............................................................................ 6.00 mg

Excipient.............................................................................qs 1 ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Eyedrops.

Sterileaqueoussolution

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogsandcats.

4.2 Indicationsforuse,specifyingthetargetspecies

Indogsandcats:

Curativetreatmentofbacterialconjunctivitisandkeratoconjunctivitisduetosensitivegentamicin

bacteria,assupportedbyanantibioticsensitivityassay.

4.3 Contraindications

Donotuseinanimalwithknownforhypersensibilitytogentamicin,otheraminoglycosidesorsodium

metabisulfite.

4.4 Specialwarningsforeachtargetspecies

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Topreventanycontaminationofthesolution,stopclosethecontainerafteruse.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Peoplewithknownhypersensitivitytoaminoglycosidesorsodiumsulphiteshouldavoidcontactwiththe

product.

Washhandsafteruse.

4..6Adversereactions(frequencyandseriousness)

Rarecasesoflocalintolerance(conjunctivalinflammatoryreactions)canbeobservedattheonsetof

treatment.

Thesereactionsareveryslightandalwaystransitoryandtheydisappearspontaneouslywithoutany

specifictreatment.

4.7 Useduringpregnancy,lactationorlay

Gentamicincrossestheplacentabarrierandcan,therefore,inducetoxiceffectsinthefoetuswhen

veryhighdosagesaregiventothedams.Soligentalisanophthalmicsolutionandthesystemic

absorptionofgentamicincouldbenegligible.Therefore,theproductcouldbeusedduringpregnancy

andlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

900IUofgentamicin/dayfor8daysi.e.twodropsinstilled3timesadayfor8days.

Instilthesolutioninthelowerconjunctivalsacusingthedosingdevice.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Incaseofoverdose,theregenerationofthecorneaepitheliumcanbedelayed.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QS01AA11

Pharmacotherapeuticgroup:Ophthalmologicals,antiinfectives

5.1 Pharmacodynamicproperties

Gentamicinisabactericideantibioticbelongingtotheaminoglycosidefamily.Itsactsbyinhibiting

affectingproteinsynthesisinbacteria.ItisactiveonGram-positiveandGram-negativebacteria,

particularlyonPseudomonasandStaphylococcus.

ClinicalbreakpointswhichconcerncaninePseudomonasaeruginosatowardsgentamicinare

proposedbytheCLSIintheM31-A3guidance.Theclinicalbreakpointshavebeensetasfollows:

Methodoftesting Susceptible Intermediary Resistant

Diffusionmethodwithdiskscontaining10µgof

gentamicin >16mm 13-15mm <12mm

Dilutionmethod <2(µg/mL) 4(µg/mL) >8(µg/mL)

5.2 Pharmacokineticparticulars

Theapplicationofonedropenablesthepersistenceoftherapeuticlevelsformorethan6hours.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Trometamol

Disodiumedetate

Sodiummetabisulfite(E223)

Parahydroxybenzoicacid

Sodiumhydroxide

Sodiumchloride

Hypromellose

Povidone

Waterforinjections

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:15days.

6.4.Specialprecautionsforstorage

Donotstoreabove30

C.

6.5 Natureandcompositionofimmediatepackaging

Primarypackaging:

Colouredbrownvial,typeI

Chlorobutytldropper(blue)

ChlorobutylHigh-densitypolyethylenestopper

Presentation:

-Boxof1multidosevialof5ml

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VIRBAC

1èreavenue–2065m–L.I.D.

06516Carros

FRANCE

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFRENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

22-11-2018

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Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

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JAGUAR 30000 capsules

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Safety advisory

Therapeutic Goods Administration - Australia

28-3-2018

Public Notification: Red Zone Xtreme 3000 contains hidden drug ingredient

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The Food and Drug Administration is advising consumers not to purchase or use Red Zone Xtreme 3000, a product promoted and sold for sexual enhancement on various websites, including www.ebay.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

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