SUMMARYOFPRODUCT CHARACTERISTICS

BaytrilDirect100 mg/mlInjektionslösungfürSchweine [AT]

Baytril1nject 100 mg/mlsolution forinjection forpigs [BE, LU, NL] BaytrilInject– Soluzione iniettabile 100mg/mlpersuini[IT]

BaytrilMax 100 mg/mlsolution forinjection forpigs [IE, UK]

1 mlcontains:

Active substance:

Enrofloxacin 100 mg

Excipient(s):

n-Butanol 30 mg

Benzylalcohol (E1519)20 mg

For the fulllistofexcipients, see section 6.1.

Solution forinjection Clear, yellowsolution

Pig

Forthe treatmentofbacterialbronchopneumonia caused byenrofloxacin-sensitive Actinobacillus pleuropneumoniae, Pasteurella multocida and complicated byHaemophilus parasuisas secondary pathogen in pigs.

Do notuse in case ofhypersensitivityto the active substance orto anyofthe excipients. Do notuse in case ofresistance againstotherfluoroquinolone due to the potentialforcross-resistance.

Do notuse in animals with centralnervous system-associated seizure disorders. Do notuse in the presence ofexistingdisorders ofcartilage developmentormusculoskeletaldamage around functionallysignificantorweight-bearingjoints. Do notuse for prophylaxis.

None.

Special precautions for use in animals

Repeated injections should be administered atdifferentsites.

Official, nationaland regionalantimicrobialpolicies should be taken into accountwhen the productis used.

Fluoroquinolones should be reserved forthe treatmentofclinicalconditions which have responded

poorly, orare expected to respond poorly, to otherclasses ofantimicrobials.

Wheneverpossible, fluoroquinolones should onlybe used based on susceptibilitytesting.

Use ofthe productdeviatingfromthe instructions given in the SPCmayincrease the prevalence of bacteria resistantto the fluoroquinolones and maydecrease the effectiveness oftreatmentwith other quinolones due to the potentialforcross resistance.

Enrofloxacin is eliminated renally. As with allfluoroquinolones, delayed excretion can therefore be expected in the presence ofexistingrenaldamage.

Specialprecautions to be taken bythe person administeringthe veterinarymedicinalproducttoanimals

People with known hypersensitivityto (fluoro)quinolones should avoid contactwith the veterinary medicinalproduct.

Directcontact with the skin should be avoided due to sensitisation, contactdermatitis and possible hypersensitivityreactions.

Wash anysplashes fromskin oreyes immediatelywith water. Do noteat, drinkorsmoke while handlingthe product.

Take care to avoid accidentalself-injection. In case ofaccidentalself-injection, seekmedicaladvice immediatelyand showthe package leafletorlabelto the physician.

In rare cases, transitoryinflammatoryreactions (swelling, redness)can occuratthe injection site. These regress within a fewdays withoutfurthertherapeutic measures.

The frequencyofadverse reactions is defined usingthe followingconvention:

• very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

• common (more than 1 but less than 10 animals in 100 animals)

• uncommon (more than 1 but less than 10 animals in 1,000 animals)

• rare (more than 1 but less than 10 animals in 10,000 animals)

• very rare (less than 1 animal in 10,000 animals, including isolated reports)

Maybe used duringpregnancyand lactation.

Antagonisteffectsduetoconcurrentadministrationofbacteriostaticantimicrobialagentssuchas macrolides ortetracyclines and phenicols macrolides and tetracyclines mayoccur.

Enrofloxacin mayinterfere with the metabolismoftheophylline, decreasingtheophylline clearance resultingin increased plasma levels oftheophylline

The dosage forrespiratorytractinfections is 7.5mgenrofloxacin perkgbodyweightfora single administration.

This corresponds to

0.75 ml Baytril 1nject solution for injection per 10 kg body weight per day

No more than 7.5 mlshould be administered atanyone injection site. In cases ofsevere orchronic respiratorytractinfections, a second injection maybe required after48 hours.

Methodofadministration:

The intramuscularinjection should be made into the neckatthe earbase. Repeated injections should be made atdifferentinjection sites.

To ensure administration ofthe correctdosage, bodyweightshould be determined as accuratelyas possible to avoid underdosing. The stoppermaybe safelypunctured up to 20 times.

Doses ofaround 25 mgactive ingredientperkgbodyweightand above maycause lethargy, loss of appetite and ataxia.No information is available on the tolerabilityofdoses severaltimes higherthan the therapeutic dose (overthe recommended ora prolonged treatmentperiod).

Do notexceed the recommended dose. In accidentaloverdose there is no antidote and treatment

should be symptomatic.

Meatand offal: 12 days

Pharmacotherapeutic group: antibacterials forsystemic use,Fluoroquinolones, ATCvetcode:QJ01MA90

Enrofloxacin has a spectrumofactivitywhich includesActinobacillus pleuropneumoniae, Pasteurella multocida and Haemophilus parasuis.

Enrofloxacin belongs to the fluoroquinolone group ofantibiotics. The substance has bactericidal activitywhich is mediated bybindingto subunitAofDNAgyrase and the resultingselective inhibition ofthis enzyme.

DNAgyrase is a topoisomerase. These enzymes are involved in the replication, transcriptionand recombination ofbacterialDNA. Fluoroquinolones also influence bacteria in the stationaryphase by alteringcellwallpermeability.

Resistance to fluoroquinolones has been reported to arise fromfive sources, (i)pointmutations in the

genes encodingforDNAgyrase and/ortopoisomerase IVleadingto alterations ofthe respective enzyme, (ii)alterations ofdrugpermeabilityin Gram-negative bacteria, (iii)efflux mechanisms, (iv) plasmid mediated resistance and (v)gyrase protectingproteins. Allmechanisms lead to a reduced susceptibilityofthe bacteria to fluoroquinolones. Cross-resistance within the fluoroquinolone class of antimicrobials is common.

The inhibitoryand bactericidalconcentrations ofenrofloxacin are veryclose, beingeitheridenticalor differingbyno more than 1-2 dilution steps.

Followingintramuscularadministration in pigs, the active ingredientenrofloxacin is absorbed very rapidlyand almostcompletely(high bioavailability). Peakserumconcentrations ofthe active ingredientare reached after1-2 hours.

Therapeutic concentrations are maintained fora period ofatleast48 hours.

Enrofloxacin has a high volume ofdistribution. The concentrations in the tissues and organs mostly significantlyexceed serumlevels. Organs in which high concentrations can be expected include the lungs, liver, kidneys, gutand muscle tissue.

Enrofloxacin is eliminated renally.

Arginine n-Butanol

Benzylalcohol (E1519) Waterforinjection

In the absence ofcompatibilitystudies, this veterinarymedicinalproductmustnotbe mixed with otherveterinarymedicinalproducts.

Shelflife ofthe veterinarymedicinalproductin theunopened container:3 years Shelflife afterfirstopeningofthe container:28 days

6.4 Specialprecautions for storage

Protectfromfrost.

Carton box containingone 100 mlbrown glass (Type 1)bottle with chlorobutylrubberstopper secured byan aluminiumcrimp cap.

Anyunused veterinarymedicinalproductorwaste materials derived fromsuch veterinarymedicinal products should be disposed ofin accordance with localrequirements.

7. MARKETING AUTHORISATION HOLDER

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

8. MARKETING AUTHORISATION NUMBER

Vm 00010/4172

9. DATE OF FIRST AUTHORISATION

05 September 2011

10. DATE OF REVISION OF THE TEXT

July 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Prescription- and pharmacy-only medicine, repeat dispensing prohibited.

22 July 2016