FLOXACIN ENROFLOXACIN 10 % CONCENTRATE FOR ORAL SOLUTION

Main information

  • Trade name:
  • FLOXACIN ENROFLOXACIN 10 % CONCENTRATE FOR ORAL SOLUTION
  • Pharmaceutical form:
  • Oral solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLOXACIN ENROFLOXACIN 10 % CONCENTRATE FOR ORAL SOLUTION
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • enrofloxacin
  • Therapeutic area:
  • Chicken, Turkeys

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • PT/V/0103/001
  • Authorization date:
  • 23-02-2011
  • EU code:
  • PT/V/0103/001
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PARTICULARS TOAPPEARONTHEIMMEDIATEPACKAGE

Label-leaflet

FLOXACIN100mg/mlconcentratefororalsolutionforchickensand turkeys

Enrofloxacin

NationalissueCZ:Přípraveks indikačnímomezením

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATION

HOLDERANDOFTHEMANUFACTURINGAUTHORISATIONHOLDER

RESPONSIBLEFORBATCHRELEASE, IFDIFFERENT

Marketingauthorisation holder:

GLOBAL VETHEALTHSL

C/Capçanes

nº12-bajos

Polígono Agro-Reus

REUS 43206

Tarragona (SPAIN)

Manufacturerforthebatchrelease:

SPVETERINARIASA

Ctra ReusVinyols km4.1

Riudoms (43330)

Tarragona (SPAIN)

2. NAME OFTHEVETERINARYMEDICINALPRODUCT

FLOXACINEnrofloxacin100 mg/mlconcentrate fororalsolutionforchickens and turkeys

3. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Compositionperml:

Active substance:

Excipients:

Benzylalcohol…………..0.014ml/ml

4. PHARMACEUTICALFORM

Concentratefororalsolution.

Clearyellowsolution.

5. TARGETSPECIES

Chickens and turkeys

6. INDICATIONS

Treatmentofinfectionsinchickensandturkeysandmixandsecondaryinfectionsassociated

withvirus,causedbyMycoplasmaandgram-positiveandgram-negativebacteriasusceptibleto

enrofloxacin.

Enrofloxacinshouldbeusedwhereclinicalexperience,supportedwherepossiblebysensitivity

testingofthecausalorganism, indicatesenrofloxacin as thedrugofchoice.

Resistancedoesoccurs bymutation, particularlywithPseudomonasaeruginosa,Klebsiella,

AcinetobacterandEnterococci.

7. CONTRAINDICATIONS

Do notuse in cases ofknown hypersensitivitytotheactive substance.

Do notuse in cases ofconfirmed resistanceto quinolones, ascrossresistance mayoccur. Cross

resistance betweenfluoroquinolones iscomplete.

8. ADVERSEREACTIONS

Ifyounoticeanyseriouseffectsnotmentionedinthislabel,pleaseinformyourveterinary

surgeon

9. METHODANDROUTEOFADMINISTRATION

Concentratefororalsolution.

Therecommended dosage is 50 ppmofenrofloxacindailyindrinkingwater,for3days, which

is equivalentto 0,5mlofthe veterinarymedicinalproductperlitreofdrinkingwater.The

dosage should notbe lowerthan 10mg/kg.

For the treatmentofsalmonellosis, mix infections orchronic infections,treatmentshould be

extendedto 5 days.

10. ADVICEONCORRECTADMINISTRATION

Medicated watershould bemadeeveryday, immediatelypriortoprovision. No othersource of

watershould be available duringtreatment.

Itshould betakeninconsiderationthattheintake ofmedicated drinkingwaterdependsonthe

clinicalcondition ofthe animals and ambienttemperature.

Prudentuse.

11. WITHDRAWALPERIOD

Meatandoffal: Chickens 7 days

Turkeys 10 days

Notpermittedforuseinlayingbirds producingeggs forhuman consumption.

12. SPECIALWARNINGS, IFNECESSARY

Specialprecautionsfor use in animals

Officialand localantimicrobialpoliciesshould be taken into accountwhentheproductis used.

Whereverpossible,fluoroquinolones should be used based on susceptibilitytesting.

Fluoroquinolonesshouldbereservedforthetreatmentofclinicalconditionswhichhave

responded poorly, orare expected to respondpoorly, to otherclassesofantimicrobials.

UseoftheproductdeviatingfrominstructionsgivenintheSPCmayincreasetheprevalenceof

bacteria resistanttofluoroquinolones and may decrease the effectivenessoftreatmentwith other

quinolones duetothe potentialforcross resistance.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

productto animals

Peoplewith known hypersensitivitytofluoroquinolones should nothandle the product.

Avoid contactwithskin and eyes. In caseofcontact, rinseimmediatelywith plentyofwater.

Wearsuitable protective clothing, glovesand safetyglasses.

Whenhandlingtheproductdo noteat, drinkorsmoke.

Shouldanysymptomappearafterexposure,likeskinrash,seekmedicaladviceandshowthe

containerorlabeltothephysician.Inflammationoftheface,lipsoreyes,orbreathing

difficulties, are more serious symptoms thatrequire immediate medicalassistance.

Useduring pregnancy,lactation or lay

Do notuse in birdsinlay.

Interactionwith othermedicinalproducts and otherformsofinteraction

Whencombinedwithtetracyclinesandmacrolideantibiotics,enrofloxacinmayproducean

antagonistic effect.

Absorptionofenrofloxacinmaybereduced,whenitiscombinedwithsubstancescontaining

magnesiumoraluminium.

Overdose(symptoms, emergency procedures, antidotes), ifnecessary

Adverseeffectswerenotobservedinchickensandturkeys,respectively,treatedwithdosesup

to 10timesand6 timeshigherthanthetherapeutic dosage, for5days.

Incompatibilities

None known

13. EXPIRYDATE

Shelflifeafterdilutionaccordingtodirections:24 hours

Shelflifeafterfirstopeningthe container:3 months

Onceopened, useby…

14. SPECIALSTORAGECONDITIONS

This veterinarymedicinalproductdoesnotrequireanyspecialstorage conditions.

15. SPECIALPRECAUTIONS FORTHEDISPOSALOFUNUSEDPRODUCTS OR

WASTEMATERIALS, IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproducts shouldbe disposed ofinaccordance withlocalrequirements.

Foranimaltreatmentonly

To be suppliedonly onveterinary prescription

Keepout ofthe reach andsightofchildren

To be suppliedonly onveterinary prescription

Packsizes:1Land5L

Date onwhich the package leafletwas lastapproved:

Marketingauthorisationnumber:

Batch{number}

Nacionalissues:

CZ:“Indikačníomezení”

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

FDA - U.S. Food and Drug Administration

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

25-6-2018

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

FDA approved Epidiolex (cannabidiol) oral solution, the first drug comprised of an active ingredient derived from marijuana, to treat two rare and severe forms of epilepsy.

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

FDA - U.S. Food and Drug Administration

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency