Quiflor 20 mg/ml solution for injection

Main information

  • Trade name:
  • Quiflor 20 mg/ml solution
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Quiflor 20 mg/ml solution
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • marbofloxacin
  • Therapeutic area:
  • Cattle, Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0365/001
  • Authorization date:
  • 23-03-2011
  • EU code:
  • UK/V/0365/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:January2013

AN:01322/2012

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Quiflor20mg/mlSolutionforInjectionforCattleandPigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlofsolutionforinjectioncontains:

Activesubstance:

Marbofloxacin20mg

Excipients:

Metacresol 2mg

Disodiumedetate0.10mg

Monothioglycerol 0.50mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clear,greenishyellowtobrownishyellowsolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle(pre-ruminantcalvesupto100kgb.w).

Pigs.

4.2Indicationsforuse,specifyingthetargetspecies

Cattle(pre-ruminantcalvesupto100kgb.w)

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofPasteurella

multocida,MannheimiahaemolyticaandMycoplasmabovis.

Fatteningpigs

TreatmentofrespiratoryinfectionscausedbysensitivestrainsofActinobacillus

pleuropneumoniae,Mycoplasmahyopneumoniae,Pasteurellamultocida.

Theveterinarymedicinalproductshouldonlybeusedbasedonsusceptibility

testing.

4.3Contraindications

Donotadministerinanimalswithknownhypersensitivitytomarbofloxacinor

anyotherquinoloneortoanyoftheexcipients.

Revised:January2013

AN:01322/2012

Page2of5

Donotuseincaseswherethepathogeninvolvedisresistanttoother

fluoroquinolones(crossresistance).

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

i.Specialprecautionsforuseinanimals

Officialandlocalantimicrobialpoliciesshouldbetakenintoaccountwhen

theproductisused.Fluoroquinolesshouldbereservedforthetreatment

ofclinicalconditionswhichhaverespondedpoorly,orareexpectedto

respondpoorly,tootherclassesofantimicrobials.Wheneverpossible,

fluoroquinolonesshouldonlybeusedbasedonsusceptibilitytesting.Use

oftheproductdeviatingfromtheinstructionsgivenintheSPCmay

increasetheprevalenceofbacteriaresistanttothefluoroquinolonesand

maydecreasetheeffectivenessoftreatmentwithotherquinolonesdueto

thepotentialforcrossresistance

ii. Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Peoplewithknownhypersensitivityto(fluoro)quinolonesshouldavoid

contactwiththeproduct.

Incaseofcontactwithskinoreyes,rinsewithplentyofwater.

Careshouldbetakentoavoidaccidentalselfinjection.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthe

labeltothedoctor.

Accidentalself-injectioncaninduceaslightirritation.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Administrationbysubcutaneousandintramuscularroutemayinducetransitory

oedema.Administrationbytheintramuscularroutemaycausepainreactionand

inflammatorylesionsatthesiteofinjection.Inflammatorylesionspersist6days

inpigsand12daysincalves.

4.7Useduringpregnancy,lactationorlay

Maybeusedinpregnantandlactatingcowsandsows.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Revised:January2013

AN:01322/2012

Page3of5

4.9Amountstobeadministeredandadministrationroute

Therecommendeddosageis2mg/kg/day(1ml/10kg)inasingledailyinjection

bysubcutaneousorintramuscularroutesincattle(thefirstinjectionmayalsobe

givenbyintravenousroute),andbyintramuscularrouteinpigs.

Treatmentdurationisasfollows:

- cattle,IM,SCroute:3to5days

- pigs,IMroute:3to5days

Toensureadministrationofacorrectdose,bodyweightshouldbedetermined

asaccuratelyaspossible,toavoidunderdosing.

Thedosevolumegivenatoneinjectionsiteshouldnotexceed6mlincalves

and3mlinpigs.

Inordertoreducetheriskofparticulatecontaminationoftheproduct,itis

recommendedthatadraw-offneedlebeusedtoreducethenumberoftimesthe

septumispunctured.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosignofoverdosehasbeenobservedafteradministrationof3timesthe

recommendeddose.

Overdosemaycauseacutesignsintheformofneurologicaldisorderswhich

shouldbetreatedsymptomatically.

4.11Withdrawalperiod(s)

Meatandoffal

Preruminatingcalves(up

to100kgbodyweight 6days

Pigs 4days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,

Fluoroquinolones.

ATCvetcode:QJ01MA93

5.1Pharmacodynamicproperties

Marbofloxacinisasynthetic,bactericidalantimicrobial,belongingtothe

fluoroquinolonegroupwhichactsbyinhibitionofDNAgyrase.Itiseffective

againstawiderangeofGrampositivebacteria(inparticularStaphylococci)and

Gramnegativebacteria(Escherichiacoli,Salmonellatyphymurium,

Campylobacterjejuni,Citrobacter,Enterobacter,Proteusspp.,Klebsiellaspp.,

Actinobacilluspleuropneumoniae,Bordetellabronchiseptica,Mannheimia

haemolytica,Pasteurellamultocida,Histophilusspp.,Moraxellaspp.,

Revised:January2013

AN:01322/2012

Page4of5

Pseudomonasaeruginosa)aswellasMycoplasma(Mycoplasmabovis,

Mycoplasmadispar,Mycoplasmahyopneumoniae).

ResistanceinStreptococcusmayoccur.

Resistancetofluoroquinolonesoccursbychromosomalmutationwiththree

mechanisms:decreaseofthebacterialwallpermeability,expressionofefflux

pumpormutationofenzymesresponsibleformoleculebinding.

5.2Pharmacokineticparticulars

Aftersubcutaneousadministrationincattleandpigsattherecommendeddose

of2mg/kg,marbofloxacinisreadilyabsorbedanditsbioavailabilityiscloseto

100%.Itisweaklyboundtoplasmaproteins(lessthan10%inpigsand30%in

cattle),extensivelydistributedandinmosttissues(liver,kidney,skin,lung,

bladder,uterus,digestivetract)itachieveshigherconcentrationsthanin

plasma.

Incattle,marbofloxaciniseliminatedslowlyinpre-ruminatingcalves(t

1/2 β=5-9

h)predominantlyintheactiveforminurine(3/4)andfaeces(1/4).

Inpigs,marbofloxaciniseliminatedslowly(t

1/2 β=8-10h)predominantlyinthe

activeforminurine(2/3)andfaeces(1/3).

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Gluconolactone

Disodiumedetate

Mannitol

Metacresol

Monothioglycerol

Waterforinjections

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmust

notbemixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days.

6.4.Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfromlight.

Donotfreeze.

Revised:January2013

AN:01322/2012

Page5of5

6.5Natureandcompositionofimmediatepackaging

Bottle(amberglassPh.Eur.typeII),bromobutylrubberstopper,aluminium

closure:50mlsolutionforinjection,inabox.

Bottle(amberglassPh.Eur.typeII),bromobutylrubberstopper,aluminium

closure:100mlsolutionforinjection,inabox.

Bottle(amberglassPh.Eur.typeII),bromobutylrubberstopper,aluminium

closure:250mlsolutionforinjection,inabox.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Krka,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER

Vm 01656/4060

9. DATEOFFIRSTAUTHORISATION

Date:19December2011

10.DATEOFREVISIONOFTHETEXT

Date:January2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Veterinaryprescription.

Approved:

23/01/13

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20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

23-8-2018

 Minutes of the CAT meeting 18-20 April 2018

Minutes of the CAT meeting 18-20 April 2018

Europe - EMA - European Medicines Agency