Fenflor 300 mg/ml Solution for Injection for Cattle

Main information

  • Trade name:
  • Fenflor 300 mg/ml Solution for Injection for Cattle
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Fenflor 300 mg/ml Solution for Injection for Cattle
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • florfenicol
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0292/002
  • Authorization date:
  • 02-03-2012
  • EU code:
  • UK/V/0292/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

RevisedMarch2013

AN:01145/2012

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Fenflor300mg/mlsolutionforinjectionforcattle

Florfenicol

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activesubstance:

Florfenicol 300mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Alightyellowtoyellow,clear,viscousliquid.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle.

4.2Indicationsforuse,specifyingthetargetspecies

Diseasescausedbyflorfenicolsusceptiblebacteria.

Preventiveandtherapeutictreatmentofrespiratorytractinfectionsincattle

duetoMannheimiahaemolytica,PasteurellamultocidaandHistophilussomni.

Thepresenceofthediseaseintheherdshouldbeestablishedbefore

preventivetreatment.

4.3Contraindications

Donotuseinadultbullsintendedforbreedingpurposes.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Seealsosection4.7.

Donotuseincaseofresistancetotheactivesubstance.

4.4Specialwarningsforeachtargetspecies

None.

RevisedMarch2013

AN:01145/2012

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

Swabseptumbeforeremovingeachdose.Useadry,sterilesyringe

andneedle.

Theproductshouldbeusedinconjunctionwithsusceptibilitytesting

andtakeintoaccountofficialandlocalantimicrobialpolicies.

ii. Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Careshouldbetakentoavoidaccidentalself-injection.

Incaseofaccidentalselfinjection,seekmedicaladviceandshowthe

labeltothedoctor.

Donotusetheproductinknowncasesofsensitivitytopropyleneglycol.

4.6Adversereactions(frequencyandseriousness)

Adecreaseinfoodconsumptionandtransientsofteningofthefaecesmay

occurduringthetreatmentperiod.Thetreatedanimalsrecoverquicklyand

completelyuponterminationoftreatment.

Administrationoftheproductbytheintramuscularroutemaycauseswellingat

theinjectionsitewhichmaypersistfor14days.Inflammationattheinjection

sitemaypersistupto32daysafteradministration.

Administrationoftheproductbythesubcutaneousroutemaycauseswelling

andinflammationattheinjectionsitewhichmaypersistatleastfor41days.

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotrevealedanyevidenceofembryo-or

foetotoxicpotentialforflorfenicol.

However,theeffectofflorfenicolonbovinereproductiveperformanceand

pregnancyhasnotbeenassessed.Useonlyaccordinglytothebenefit/risk

assessmentbytheresponsibleveterinarian.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amountstobeadministeredandadministrationroute

Fortreatment:

IMroute:20mg/kgbodyweight(1ml/15kg)tobeadministeredtwice48hours

apartusinga16gaugeneedle.

SCroute:40mg/kgbodyweight(2ml/15kg)tobeadministeredonceonly

usinga16gaugeneedle.

RevisedMarch2013

AN:01145/2012

Forprevention:

SCroute:40mg/kgbodyweight(2ml/15kg)tobeadministeredonceonly

usinga16gaugeneedle.

Thedosevolumegivenatanyoneinjectionsiteshouldnotexceed10ml.

Theinjectionshouldonlybegivenintheneck.

Toensureacorrectdosagebodyweightshouldbedeterminedasaccurately

aspossibletoavoidunderdosing.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

None.

4.11Withdrawalperiods

Meatandoffal:byIM(at20mg/kgbodyweight,twice): 30days

bySC(at40mg/kgbodyweight,once): 44days

Milk:Notpermittedforuseinlactatinganimalsproducingmilkforhuman

consumption.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse

ATCVetcode:QJ01BA90

5.1Pharmacodynamicproperties

Florfenicolisasyntheticbroadspectrumantibioticeffectiveagainstmost

Gram-positiveandGram-negativebacteriaisolatedfromdomesticanimals.

Florfenicolactsbyinhibitingproteinsynthesisattheribosomallevelandis

bacteriostatic.Laboratorytestshaveshownthatflorfenicolisactiveagainstthe

mostcommonlyisolatedbacterialpathogensinvolvedinbovinerespiratory

diseasewhichincludeMannheimiahaemolytica,Pasteurellamultocida

andHistophilussomni.

Florfenicolisconsideredtobeabacteriostaticagent,butinvitrostudiesof

florfenicoldemonstratedbactericidalactivityagainstMannheimiahaemolytica,

PasteurellamultocidaandHistophilussomni.

Acquiredresistancetoflorfenicolismediatedbyeffluxpumpresistance

associatedwithafloRgene.Suchresistancehasnotyetbeenidentifiedinthe

targetpathogensexceptforPasteurellamultocida.Crossresistancewith

chloramphenicolcanoccur.Resistancetoflorfenicolandotherantimicrobials

hasbeenidentifiedinthefood-bornepathogenSalmonellatyphimurium.

5.2 Pharmacokineticparticulars

Intramuscularadministrationattherecommendeddoseof20mg/kgmaintains

efficaciousbloodlevelsincattlefor48hours.Maximummeanplasma

RevisedMarch2013

AN:01145/2012

concentrat ion(Cmax)of3.86μg/mloccursat5hours(Tmax),afterdosing.

Themeanplasmaconcentration24hoursafterdosingwas1.56μg/ml.

Theharmonicmeaneliminationhalflifewas18.8hours.

Aftersubcutaneousadministrationoftherecommendeddoseof40mg

florfenicol/kgb.w.,maximumplasmaconcentration(Cmax)ofapproximately

3.5μg/mloccursapproximately7.0hours(Tmax)afterdosing.Themean

plasmaconcentration24hoursafterdosingisapproximately 2μg/ml.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Dimethylsulfoxide

Propyleneglycol

Macrogol400

6.2Incompatibilities

Intheabsenceofincompatibilitystudies,thisveterinarymedicinalproduct

shouldnotbemixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatecontainer:28days

6.4Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorage

conditions.

6.5Natureandcompositionofimmediatepackaging

50,100and250mlTypeIamberglassbottleclosedwithabromobutylrubber

stopperandaluminiumseal.

1bottle(50ml)incardboardbox.

1bottle(100ml)incardboardbox.

1bottle(250ml)incardboardbox.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

RevisedMarch2013

AN:01145/2012

7. MARKETINGAUTHORISATIONHOLDER

KRKA,d.d.,Novomesto

Šmarješkacesta6

8501Novomesto

Slovenia

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 01656/4026

9. DATEOFFIRSTAUTHORISATION

Date:4July2007

10.DATEOFREVISIONOFTHETEXT

Date:March2013

APPROVED 22/03/2013

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

12-9-2018

FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access

FDA - U.S. Food and Drug Administration

19-7-2018

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Openfoodtox: over 300 substances added to EFSA chemical hazards database

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

17-3-2017

Withdrawal of a batch of EpiPen® 300 micrograms

Withdrawal of a batch of EpiPen® 300 micrograms

MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.

Danish Medicines Agency

21-2-2017

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.

Danish Medicines Agency

There are no news related to this product.