qanastek/EMEA-V3 huggingface dataset:
Therefore, it may be necessary to combine Advocate treatment with treatments aimed at breaking the flea life cycle in the surroundings.
Għalhekk jista´jkun neċessarju illi barra t- trattament ta´ l- Advocate ikun hemm ukoll trattament fuq l- ambjent sabiex jinqered iċ- ċiklu ta´ ħajja tal- briegħed fl- inħawi.
This can result in more rapid reductions in the household flea population.
Dan jista´jwassal għal tnaqqis aktar mgħaġġel tan- numru ta´ briegħed fid- dar.
Treatment of ear mite infestation (Otodectes cynotis)
Trattament ta` l - infezzjoni tad- dudu tal- widna (Otodectes cynotis)
A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Eżami ieħor minn veterinarju huwa rrikmandat peress li biċċa mill -- annimali jirrikjedu t- tieni trattament.
Cats in endemic areas, or those which have travelled to endemic areas, may be infected with adult heartworms.
Qtates li jgħixu jew li jiġu meħuda f´postijiet fejn jgħix id- dudu tal- qalb, jistgħu jkunu nfettati bid- dud tal- qalb adulti.
Therefore prior to treatment with Advocate, the advice provided in the section “ SPECIAL WARNING(S )” should be considered.
Għalhekk qabel il- kura tal- Advocate, l- avviż li huwa taħt is- sezzjoni „ TWISSIJIET SPEĊJALI ” għandu jiġi kkunsidrat.
Therefore they can be treated without special considerations.
Għalhekk għandhom jiġu trattati mingħajr prewkawzjonijiet speċjali.
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworms and hookworms.
F´postijiet fejn jgħix id- dudu tal- qalb, trattament ta´ kull xahar inaqqas ir- riskju li jerġa jkun hemm infezzjoni kkaġunata speċjalment mill- ħniex.
Then hold the pipette in an upright position, and twist and pull off cap.
Żomm il- pipetta tħares il- fuq, issa ilwi u iġbed il- għatu ´l barra.
Part the fur on the cat's neck at the base of the skull until the skin is visible.
54 Ofroq il- pil fuq l- għonq tal- qattus fit- tarf tal- kranju sakemm tidher il- ġilda.
54 Application at the base of the skull will minimise the opportunity for the cat to lick the product.
Applikjazzjoni fit- tarf tal- kranju tnaqqas l- opportunita` ´l qattus biex jilgħaq il- prodott.
Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal żgħar.
Do not store above 30°C.
Taħżinx f' temperatura 'l- fuq minn 30°C.
Do not use after the expiry date stated on the label and carton.
Tużax wara d- data tal- iskadenza fuq it- tikketta u fuq il- pakkett.
Care should be taken that the contents of the pipette do not come into contact with the eyes or mouth of the recipient and/ or other animals.
Għandha tingħata attenzjoni biex il- kontenut tal- pipetta jew id- doża applikata ma tiġix f´kuntatt ma´ l - għajnejn jew ma´ ħalq l- annimal li jiġi trattat jew annimali oħra.
It is recommended that cats living in, or travelling to, areas endemic for heartworm are treated monthly with the product to protect them from heartworm disease.
Huwa rrikommandat illi qtates li jgħixu jew li jiġu meħuda f´postijiet fejn jgħix id- dudu tal- qalb, jiġu trattati kull xahar bil- prodott ħalli jiġu pproteġuti mill- marda tad- dudu tal- qalb.
Whilst the accuracy of diagnosis of feline heartworm infection is limited, it is recommended that attempts be made to check the heartworm status of any cat aged over 6 months, prior to beginning of prophylactic treatment, as use of the product on cats which have adult heartworm may cause serious adverse effects, including death.
Minħabba l- fatt li l - akkuratezza tad- dijanjosi tal- infezzjoni tad- dudu tal- qalb fil- qtates hija limitata, huwa rrikommandat illi jsiru provi biex isir l- eżami fuq l- istat tad- dudu tal- qalb fuq qtates li għandhom il- fuq minn 6 xhur qabel ma jintbeda t- trattament profilaktiku, għaliex meta jintuża l- prodott fuq il- qtates li għandhom dudu tal- qalb adult jista´ jikkawża effetti avversarji serji, inkluż il- mewt.
Treatment of animals weighing less than 1 kg should be based on a risk-benefit assessment.
Trattamenti fuq annimali li jiżnu inqas minn 1 kg għandhom jiġu bbazati fuq valutazzjoni tar- riskju u benefiċċju.
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product.
55 Kuntatt qasir ta´l- annimal ma´l- ilma, f´okkażżjoni waħda jew tnejn, bejn it- trattamenti ta´ kull xahar m´huwiex mistenni li jnaqqas sinifikament l- effiċjenza tal- prodott.
Avoid contact with skin, eyes or mouth.
Għall- persuni li jamministraw l- Advocate fuq l- annimali Evita kuntatt mal- ġilda, għajnejn jew ħalq.
55 Wash hands thoroughly after use.
Aħsel idejk sew wara li tuża.
After application do not stroke or groom animals until the application site is dry.
Tmellisx jew tippetna l- annimal wara l- applikazzjoni qabel ma ’ tinxef il- parti fejn tapplika Nies li għandhom sensittivita kbira kemm għall- benzyl alcohol Imidakloprid u Moksidektin għandhom jamministraw il- prodott b´kawtela.
In case of accidental spillage onto skin, wash off immediately with soap and water.
F´okkażżjonijiet rari ħafna sensittivita` tal- ġilda jew rejazzjonijiet tal- ġilda li jgħaddu (eż. allerġija, irritazzjoni, tniggis) jistgħu jinħassu meta jiġi wżat il- prodott.
People with a known hypersensitivity to either benzyl alcohol, imidacloprid or moxidectin should administer the product with caution.
Jekk aċċidentalment il- prodott jixxerred fuq il- ġilda, aħsel malajr bl- ilma u s- sapun.
In very rare cases the product may cause skin sensitisation or transient skin reactions (for example allergy, irritation or tingling).
F´ okkażżjonijiet rari ħafna rejazzjonijiet tal- ġilda individwali (eż. allerġija, irritazzjoni, tniggis) jista´jinħass meta jiġi wżat il- prodott.
If the product accidentally gets into eyes, they should be thoroughly flushed with water.
Nies li għandhom sensittivita kbira għall- Imidakloprid u Moksidektin għandhom jamministraw il - prodott b´kawtela Jekk aċcidentalment il- prodott imiss ma´ l- għajnejn, dawn għandhom jiġi mlaħalħin sewwa bl- ilma.
If skin or eye symptoms persist, or the product is accidentally swallowed, seek medical attention and show the package insert to the physician.
Jekk sintomi ta´ l- għajnejn jew ġilda ma jmorrux, jew il- prodott jiġi aċċidentalment miblugħ, fittex tabib mall- ewwel u qis li turih il- pakkett jew il- fuljett t 'informazzjoni li jkun fih ġewwa.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA 'PRODOTT MHUX UŻATA JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Medicines should not be disposed of via wastewater or household waste.
Il- mediċina m’ għandiex tiġi mormija fl- ilma.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Saqsi lil- veterinarju tiegħek kif tista’ tarmi mediċina li ma baqagħlekx bzonn.
These measures should help to protect the environment.
Dawn il- miżuri għandhom igħinu biex nipproteġu l- ambjent.
Imidacloprid is effective against larval flea stages and adult fleas.
Imidakloprid huwa effettiv kontra l- istadju tal- larva tal- bergħud u briegħed adulti.
Flea larvae in the pet’ s surroundings are killed after contact with a pet treated with the product.
Briegħed fi stat ta´ larva, li jkunu fl- inħawi fejn ikun qiegħed l- annimal, jiġu meqruda wara li jiġu f´kuntatt ma´l- annimal li jkun itrattat bil- prodott.
0.4 ml and 0.8 ml per pipette; blister packs containing 3, 4, 6, 21 or 42 unit dose pipettes.
0. 4 ml, u 0. 8 ml kull pipetta Strixxi li għandhom 3, 4, 6, 21 jew 42 pipetta ta’ doża waħhda
Not all pack sizes may be marketed.
Mhux id- daqs tal- pakketti kollha jistgħu qegħdin fis- suq.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- sid tal- awtorizzazzjoni tal- kummerċ.
España Química Farmacéutica Bayer, S. L.
57 España Química Farmacéutica Bayer, S. L.
Τ .Θ.
Sverige Κύπρος PHARMACARE Ltd.
58 PACKAGE LEAFLET Advocate spot-on solution for dogs
58 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Advocate għal klieb
Benzyl alcohol, 1 mg/ ml butylhydroxytoluene (E 321; as antioxidant)
Benzyl alchhol 1 mg/ ml butylhydroxytoluene (E321; bħala antiossidant)
59 Do not use in puppies under 7 weeks of age.
Tużax fuq klieb li huma iżgħar minn 7 ġimgħat.
Laboratory studies with either imidacloprid or moxidectin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Studji fil- laboratorju bl- użu t´Imidakloprid u Moksidektin fuq il- far u l- fniek ma pprovdewx evidenza ta 'periklu fit- tqala, ħsara lill- fetu jew ħsara lill- omm.
For cats, the corresponding “ Advocate for cat” product, which contains 100 mg/ ml imidacloprid and 10 mg/ ml moxidectin, must be used.
Għall - qtates għandu jintuża il- prodott apposta għalihom “ Advocate għall- qtates ”, li fih 100 mg/ ml Imidakloprid u 10 mg/ ml Moksidektin.
If the animal licks the application site after treatment, transient neurological signs, such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting, may occur infrequently.
Il- prodott jista` f’ każijijiet rari, jikkawża reazzjonijiet lokali sensittivi ħafna. Jekk l- annimal jilgħaq il- post ta´l- applikazzjoni wara t- trattament, sintomi newroloġici li jgħaddu bħal għejja, tregħid ma´kullimkien, sinjali fl- għajnejn (twessiegħ fit- toqba tal- mamma tal- għajn, ftit akkomodazzjoni ta´l - għajn, oxxillazzjoni kontinwa waħda ġo l- oħra tal- boċċi tal- għajnejn), respirazzjoni li mhix normali, tbeżżieq u rriġettar jistgħu jsiru, kultant
This is not a sign of intoxication and disappears within some minutes without treatment.
Dan m´huwiex sinjal t’ intossikazzjoni u tisparixxi fi ftit minuti mingħajr xi trattament.
Correct application will minimise licking of the application sites.
Jekk il- prodott jiġi applikat tajjeb, inqas jilgħaq l- annimal il- post t´applikazzjoni.
In case of accidental oral uptake, symptomatic treatment should be administered by a veterinary surgeon.
F´każ li l- prodott jittieħed aċċidentalment orali, trattament simptomatiċi għandu jiġi meħud. minn tabib veterinarju.
There is no known specific antidote.
M´hemm l- ebda antidot speċifiku maghruf.
Apply topically to the skin between the shoulder blades.
Applika topikali fuq il- ġilda bejn l- għadam ta´l- ispallel.
Dosage schedule
60 Skeda tad- doża Id- dożi minimi rrikkmandati huma ta´10 mg Imidakloprid għal kull kg użin tal- ġisem. u 2. 5 mg Moksidektin għal kull kg użin tal- ġisem, li jiġu ekwivalenti għal 0. 1 ml Advocate għall- klieb, għal kull kg użin tal- ġisem.
The recommended minimum doses are 10 mg/ kg bodyweight imidacloprid and 2.5 mg/ kg bodyweight moxidectin, equivalent to 0.1 ml/ kg bodyweight Advocate for dogs.
L- iskeda ta´ trattament għandha tiġi bbażata fuq il- sitwazzjoni epidemjoloġika lokali.
The treatment schedule should be based on the local epidemiological situation.
Qies tal- pipetta għall- użu
60
Volum
Pipette size to be used
[ml]
minimum of 2.5
Minimu ta´ 2. 5
> 4 – 10 kg
> 4- 10 kg
Advocate for medium dogs
Advocate għall- klieb ta´qies medju
10 - 25
10- 25
10 - 25
2. 5- 6. 25
2.5 – 6.25
> >
> 25 – 40 kg
10- 25 kg 25- 40 kg
Advocate for extra-large dogs
Advocate ghall- klieb kbar Advocate għall- klieb kbar ħafna
4.0
2. 5 4. 0
10 - 16
10- 25 10- 16
2.5 - 4
2. 5- 6. 25 2. 5- 4
treatment and prevention
Trattament u prevenjoni tal- briegħed
Treatment of demodicosis (caused by Demodex canis)
Trattament ta ’ domodicosis (ikkawżata minn Demodex canis)
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Billi demodikosis hija marda b’ ħafna fatturi, huwa rrikmandat fejn possibli, li titratta wkoll xi marda li hija konnessa, kif jeħtieġ.
Therefore before treatment with Advocate, the advice provided in the section ” SPECIAL WARNING(S )“ should be considered.
Għalhekk qabel il- kura tal- Advocate, l- avviż li huwa taħt is- sezzjoni „ TWISSIJIET SPEĊJALI ” għandu jiġi kkunsidrat.
For prevention of heartworm disease, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present.
61 Għall- prevenzjoni tal- marda tad- dudu tal- qalb, il- prodott għandu jiġi applikat regularment f´intervalli ta´xahar waqt iż- żmien tas- sena meta n- nemus (li permezz tagħhom jinġarru u jinfirxu l- larva tad- dud tal- qalb) huma preżenti.
In non-endemic areas there should be no risk of dogs having heartworm.
F´postijiet li mhumiex endemiċi m´għandux ikun hemm riskju ta´qtates li jieħdu d- dudu tal- qalb.
61 Treatment of Angiostrongylus vasorum
Trattament ta ’ Angiostrogylus vasorum
In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective roundworm, hookworms and whipworms.
F´postijiet fejn jgħix id- dudu tal- qalb, trattament ta´ kull xahar inaqqas ir- riskju li jerġa jkun hemm infezzjoni kkaġunata speċjalment mill- ħniex.
Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.
Studji wrew illi t- trattament tal- klieb ta´kull xahar jippreveni nfezzjonijiet ikkaġunati minn Uncinaria stenocephala
Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin.
Jekk possibli applika fuq ġilda ntatta Poġġi t- tarf tal- pipetta fuq il- ġilda u għafas il- pipetta bis- sħiħ kemm il- darba biex tbattal il- kontenut direttament fuq il- ġilda..
For dogs of more than 25 kg:
62 Għall- klieb li jiżnu aktar minn 25 kg:
At each spot part the coat until the skin is visible.
Fuq kull parti, ofroq il- pil sakemm tidher il- ġilda.
Wherever possible apply to undamaged skin.
Jekk possibli applika fuq ġilda ntatta.
Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin.
Poġġi t- tarf tal- pipetta fuq il- ġilda u għafas bil- mod il- pipetta biex toħroġ ftit mill - kontenut direttament fuq il- ġilda.
Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal's side.
Tapplikax ammont eċċessiv tat- taħlita fuq parti waħda tal- ġisem, għaliex hekk it- taħlita tista´ ċċarċar mal- ġnub.
Do not store above 30°C.
Taħżinx f' temperatura 'l- fuq minn 30 °C.
When the product is applied in 3 to 4 separate spots, specific care should be taken to prevent the animal licking the application sites.
Meta l- prodott jiġi applikat fuq 3 jew 4 partijiet differenti, għandha tingħata attenzjoni speċjali biex tevita li l- annimal jilgħaq il- partijiet t´applikazzjoni.
This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described under the section “ ADVICE ON CORRECT ADMINISTRATION”; in particular, oral uptake by the recipient and/ or other animals in close contact should be prevented.
Dan il- prodott fih il- moksidektin (laktonju makroċikliku), għalhekk, għandha tingħata attenzjoni speċjali fuq klieb tar- razza Collies, Old English Sheepdogs u razzez simili jew taħlit ta´razzez simili; biex il- prodott jiġi amministrat kif spjegat fis- sezzjoni „ TAGĦRIF FUQ APPLIKAZZJONI KORRETTA” ¸ partikularment għandu jiġi evitat li annimali trattati / jew annimali oħra li jiġu f ’ kuntatt magħhom, jilgħaqu l- mediċina.
Although the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic efficacy against adult Dirofilaria immitis.
Għalkemm il- prodott jista´jiġi użat mingħajr periklu fuq klieb li huma nfettati bil- marda tad- dudu tal - qalb adult, dan m´għandux effet terapewtiku kontra Dirofilaria immitis adulti.
It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product.
Huwa għalhekk rikommandat illi l- klieb li għandhom minn 6 xhur l´fuq, u li joqgħodu f´postijiet fejn jgħix id- dud tal - qalb, jiġu eżaminati għall- infezzjoni tad- dud tal- qalb adulti qabel jigu trattati bil- prodott.
Brief contact of the animal with water on one or two occasions between monthly treatments is unlikely to significantly reduce the efficacy of the product.
63 Kuntatt qasir ta´l- annimal ma´l- ilma, f´okkażżjoni waħda jew tnejn, bejn it- trattamenti ta´ kull xahar m´huwiex mistenni li jnaqqas sinifikament l- effiċjenza tal- prodott.
For persons administering Advocate to animals:
Għall- persuni li jamministraw l- Advocate fuq l- annimali:
63 Do not eat, drink or smoke during application.
Tiekolx, tixrobx u tpejjipx waqt l- applikazzjoni.
People with a known hypersensitivity to either benzyl alcohol, imidacloprid or moxidectin should administer the product with caution.
Tmellisx jew tippetna l- annimal wara l- applikazzjoni qabel ma ’ tinxef il- parti fejn tapplika Nies li għandhom sensittivita kbira kemm għall - Benzyl alcohol Imidakloprid u Moksidektin għandhom jamministraw il- prodott b´kawtela.
In very rare cases the product may cause skin sensitisation or transient skin reactions (for example allergy, irritation or tingling).
F´okkażżjonijiet rari ħafna sensittivita` tal- ġilda jew rejazzjonijiet tal- ġilda li jgħaddu (eż. allerġija, irritazzjoni, tniggis) jistgħu jinħassu meta jiġi wżat il - prodott.
Imidacloprid is effective against larval flea stages and adult fleas.
midakloprid huwa effettiv kontra l- istadju tal- larva tal- bergħud u briegħed adulti.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Resistenza tal- parassita għal xi klassi partikulari ta´sustanza kontra d- dud tista´tiżviluppa wara li jsir użu frekwenti u repetut ta´din is- sustanza ta´din il- klassi
0.4 ml, 1.0 ml, 2.5 ml and 4.0 ml per pipette; blister packs containing 3, 4, 6, 21 or 42 unit dose pipettes.
0. 4 ml, u 0. 8 ml kull pipetta Strixxi li għandhom 3, 4, 6, 21 jew 42 pipetta ta’ doża waħhda
España Química Farmacéutica Bayer, S. L.
65 España Química Farmacéutica Bayer, S. L.
Invented name
Isem kummer ċjali
Target Route of species administration
Speċi li fuqhom Mod ta ’ għandu jintuża Amministrazzj l- prodott oni
Content (concentration)
Kontenut
Premix for medicated feeding stuff
Ikel imħallat mal - Ħnieżer mediċina għal- lest
In-feed use
Użu ta ’ mediċina mħallta ma ’ l- ikel
aluminium 42.5 mg/ g foil/ polyester laminated bag
borża laminata 42. 5 mg/ g tal- polyester magħmula minn fojl tal- aluminju
2 days
Jumejn
Pigs
Ikel imħallat mal - Ħnieżer mediċina għal- lest
Polyethylene 8.5 mg/ g lined paper bags
Boroż tal- karti 8. 5 mg/ g infurrati bil- polyethylene
Pigs
Trab orali Ħnieżer
Chicken
Granuli għal użu Tiġieġ fl- ilma tax- xorb
In drinking water use
Jittieħed ma ’ l- ilma tax- xorb
Aluminium foil 625 mg/ g laminated sachet
Qratas laminati 625 mg/ g b’ fojl ta ’ l- aluminju
2 days Not authorised for laying birds
Jumejn Mhux awtorizzat għal tjur li jbid
Aivlosin 42.5 mg/ g Premix for medicated feeding stuff for pigs.
Aivlosin 42. 5 mg/ g Taħlita mediċinali għal ikel medikat għall- qżieqeż
Active substance:
Sustanza Attiva:
For a full list of excipients see section 6.1
(bħala Tylvalosin tartrate)
Premix for medicated feeding stuff A beige granular powder
Taħlita mediċinali lesta minn qabel għal ikel medikat Trab granulari beiġġ
Pigs
Qżieqeż
4.2 Indications for use
4. 2 Indikazzjonijiet għall- użu
Treatment and prevention of Swine Enzootic Pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae in pigs.
Trattament u prevenzjoni ta ’ Pnewmonja Enżootika tal- Qżieqeż ikkawżata minn strejns suxxetibbli ta ’ Mycoplasma hyopneumoniae fil- qżieqeż.
At the recommended dose, lung lesions and weight loss are reduced but infection with Mycoplasma hyopneumoniae is not eliminated.
Fid- doża rrakkomandata, is- selħiet fil- pulmuni u t- telf fil- piż jitnaqqsu iżda l- infezzjoni bil- Mycoplasma hyopneumoniae ma tkunx eliminata.
Treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis in herds where there is a diagnosis based on clinical history, post-mortem findings and clinical pathology results.
Trattament ta ’ l- Enteropatija Proliferattiva tal- Qżieqeż (iljite) kkawżata minn Lawsonia intracellularis f’ merħliet fejn hemm dijanjosi bbażata fuq l- istorja klinika, sejbiet li jsiru wara l- mewt u riżultati patoloġiċi kliniċi.
Treatment of clinical outbreaks of Swine Dysentery, caused by Brachyspira hyodysenteriae in herds where the disease has been diagnosed and prevention of further clinical cases.
Trattament ta ’ mard kliniku mifrux ta ’ disinterija tal- qżieqeż fil- merħliet, ikkawżat minn Brachyspira hyodysenteriae, fejn il- marda kienet stabbilita, u għal prevenzjoni ta ’ każijiet kliniċi ulterjuri.
4.4 Special warnings
4. 4 Twissijiet speċjali
Acute cases and severely diseased pigs with reduced food or water intake should be treated with a suitable injectable product.
Qżieqeż b’ każijiet ta ’ infezzjonijiet akuti u qżieqeż morda serjament li naqqsu mill- ikel jew l- ilma għandhom jiġu kkurati bi prodott adattat, li jista jiġi injettat.
Generally, strains of B. hyodysenteriae have higher MIC values in cases of resistance against other macrolides, such as tylosin.
Ġeneralment, strejns ta ’ B. hyodysenteriae għandhom valuri tal- MIC ogħla f’ każijiet ta ’ reżistenza kontra makrolidi oħrajn, bħal tilosin.
The clinical relevance of this reduced susceptibility is not fully explored.
Ir- rilevanza klinika ta ’ din is- suxxettibilità mnaqqsa mhix esplorata b’ mod sħiħ.
Cross-resistance between tylvalosin and other macrolides cannot be excluded.
Ir- reżistenza inkroċjata bejn tylvalosin u makrolidi oħrajn ma tistax tiġi eskluża.
2 4.5 Special precautions for use
2 4. 5 Prekawzjonijiet Specjali għall- Użu
It is sound clinical practice to base treatment on susceptibility testing.
Hija prattika klinika tajba li tibbaża t- trattament fuq l- ittestjar tas- suxxetibilità
Because Aivlosin has been shown to cause hypersensitivity reactions in laboratory animals, people with known hypersensitivity to tylvalosin tartrate should avoid any contact with the product.
Minħabba li Aivlosin intwera li jista ’ jikkaġuna sensittività eċċessiva f’ annimali tal- laboratorju, nies li hu magħruf li għandhom sensittività eċċessiva għal tylvalosin tartrate għandhom jevitaw kull kuntatt mal- prodott.
When mixing the veterinary medicinal product and handling the medicated feed, direct contact with eyes, skin and mucous membranes should be avoided.
Waqt it- taħlit tal- prodott veterinarju mediċinali u l- immaniġġjar ta ’ l- ikel medikat, kuntatt dirett ma ’ l- għajnejn, ġilda u membrani mukużi għandu jkun evitat.
Personal protective equipment should be worn when mixing the veterinary medicinal product or handling the medicated feed: overalls, impervious gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter to European Standard EN 143.
Tagħmir personali protettiv għandu jintlibes meta tħallat il- prodott mediċinali veterinarju u waqt l- imaniġġjar ta ’ l- ikel medikat: agħta, ingwanti impermeabbli u / jew respiratur ta ’ nofs maskla li jikkonforma ma ’ l- Istandard Ewropew EN 149 li tużah u tarmih, jew respiratur mhux li tużah u tarmih iżda li jikkonforma ma ’ l- Istandard Ewropew EN 140, b’ filtru skond EN 143.
Wash contaminated skin.
Aħsel il- ġilda kkontaminata.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
F’ każ li tibla ’ b’ mod aċċidentali fittex parir mediku immedjatament u uri t- tikketta lit- tabib.
None known
Xejn li hu magħruf.
4.7 Use during pregnancy and lactation
4. 7 Użu waqt it- tqala u fi żmien il- ħalib
The safety of Aivlosin during pregnancy and lactation has not been established in pigs.
Is- sigurtà ta ’ aivlosin waqt it- tqala u fi żmien il- ħalib ma ġietx stabbilita fil- qżieqeż.
Use only in accordance with risk/benefit assessment by the responsible veterinarian.
Uża biss skond l- istima tar- riskju/ benefiċċju mill- veterinarju responsabbli.
Studies in laboratory animals have not produced any evidence of teratogenicity.
Studji fuq annimali fil- laboratorju ma pproduċew l- ebda evidenza ta ’ teratoġeniċità.
Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above.
Tossiċità materna f’ annimali rodenti kienet osservata f’ dożi ta ’ 400 mg/ kg u aktar ta ’ tylvalosin għal kull kilogramm ta ’ piż tal- ġisem.
In mice, a slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.
Fil- ġrieden, tnaqqis żgħir fil- piż tal- ġisem tal- fetu kien innutat f’ dożi li jikkawżaw tossiċità materna.
None known
Xejn li hu magħruf
In-feed use.
Biex jintuża ma ’ l- ikel.
For incorporation into dry feed only.
Biex jiġi inkorporat ma ’ għalf xott biss.
For treatment and prevention of Swine Enzootic Pneumonia The dosage is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days.
Għall- kura u l- prevenzjoni tal- Pnewmonja Enżootika tal- Qżieqeż Id- dożaġġ hu ta ’ 2. 125 mg ta ’ tylvalosin għal kull kilogramm ta ’ piż tal- ġisem kuljum ma ’ l- ikel għal 7 t’ ijiem konsekuttivi.
Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific medication.
Infezzjoni sekondarja b’ organiżmi bħal Pasteurella multocida u Actinobacillus pleuropneumoniae jistgħu jikkomplikaw il- pnewmonja enżootika u jeħtieġu medikazzjoni speċifika.
For treatment of Porcine Proliferative Enteropathy (ileitis) The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
Għall- kura ta ’ l- Enteropatija Proliferattiva tal- Qżieqeż (EPQ) (ileite) Id- dożaġġ hu ta ’ 4. 25 mg ta ’ tylvalosin għal kull kilogramm ta ’ piż tal- ġisem, mogħti ma ’ l- ikel għal 10 ijiem konsekuttivi.
For treatment and prevention of Swine Dysentery The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
3 Għall- kura u l- prevenzjoni tad- Disinterija tal- Qżieqeż Id- dożaġġ hu ta ’ 4. 25 mg ta ’ tylvalosin għal kull kilogramm ta ’ piż tal- ġisem, mogħti ma ’ l- ikel għal 10 ijiem konsekuttivi.
In dication
Indikazzjoni
Dose of active
Doża
Duration of
tas - Tul tal -
In feed inclusion rate
Rata ta ’ inklużjoni ma ’ l- ikel
ingredient
sustanza attiva kura
Aivlosin 42.5 mg/g Premix
Aivlosin 42. 5 mg/ g Ikel imħallat minn qabel
Treatment and prevention of swine enzootic pneumonia
Għall- kura u l- prevenzjoni tal- pnewmonja enżootika tal- qżieqeż
2.125 mg/kg bodyweight/day
2. 125 mg/ kg ta ’ 7 ijiem piż tal- ġisem / kuljum
1 kg/tonne*
1 kg/ tunnellata *
Treatment of PPE (ileitis)
Kura tal- EPQ (ileite)
4.25 mg/kg bodyweight/day
4. 25 mg/ ta ’ piż 10 ijiem tal- ġisem / kuljum
2 kg/tonne*
2 kg/ tunnellata *
Treatment and prevention of swine dysentery
Għall- kura u l- prevenzjoni tad- disinterija tal- qżieqeż
* Important: these inclusion rates are assumes a pig eats equivalent of 5% bodyweight per day.
* Importanti: dawn ir- rati ta ’ inklużjoni jassumu li qażquż jiekol l- ekwivalenti ta ’ 5% tal- piż tal- ġisem tiegħu f’ ikel kuljum.
In older pigs, or in pigs with reduced appetite, or on restricted feed intake, inclusion levels may need to be increased to achieve target dosage.
Fi ħnieżer aktar xjuħ, jew fi qżieqeż b’ nuqqas ta ’ aptit, jew li qed jieħdu razzjon ta ’ ikel ristrett, il- livelli ta ’ inklużjoni jista ’ jkollhom bżonn jiżdiedu sabiex tintlaħaq il- mira tad- dożaġġ.
Where feed intake is reduced, use the following formula:
Fejn it- teħid ta ’ ikel ikun mnaqqas, uża l- formula li ġejja:
Dose rate (mg/kg bodyweight) x bodyweight (kg)
Rata tad- doża (mg/ kg piż tal- ġisem) x piż tal- ġisem (kg) Kg ta ’ Ikel imħallat minn qabel/ tunnellata ta ’ ikel
Daily feed intake (kg) x Premix strength (mg/g)
Razzjon ta ’ ikel kuljum (kg) x Qawwa ta ’ l- Ikel imħallat minn qabel (mg/ g)
As an adjunct to medication, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the build up of resistance.
Flimkien mal- mediċina, immaniġġjar tajjeb u prattiċi ta ’ l- iġjene tajbin għandhom jiġu introdotti sabiex inaqqsu r- riskju ta ’ l- infezzjoni u biex jikkontrollaw l- iżvilupp tar- reżistenza.
A horizontal ribbon mixer should be used to incorporate the product into the feeding stuff.
Għandu jintuża makkinarju tat- taħlit b’ ċinga orizzontali sabiex jinkorpora l- prodott ma ’ l- għalf.
It is recommended that Aivlosin is first mixed into 10 kg of the feeding stuff, followed by the rest of the feeding stuff and mixed well.
Huwa rrakkomandat li Aivlosin l- ewwel jitħallat ma ’ 10 kg ta ’ għalf, segwit mill- kumplament ta ’ l- għalf u mħallat sew.
Medicated feed may then be pelleted.
L- ikel medikat jista mbagħad ikun magħmul f’ pellits.
Pelleting conditions involve a single pre-conditioning step with steam for 5 minutes and pelleting at not more than 70°C under normal conditions.
Il- kondizzjonijiet sabiex isiru l- pellits jinvolvu pass wieħed li jikkonsisti fi provizjoni minn qabel ta ’ fwar għal 5 minuti, u imbagħad isiru l- pellits f’ temperatura ta ’ mhux aktar minn 70°C f’ kondizzjonijiet normali.
No signs of intolerance have been observed in growing pigs at up to 10 times the recommended dosage.
4. 10 Doża eċċessiva
4.11 Withdrawal period(s)
4. 11 Perijodu/ i ta ’ tiżmim
Meat and offal:
Laħam u l- ġewwieni ta ’ l- annimal:
Macrolide antibiotic, ATC vet code:
Grupp farmako- terapewtiku: antibijotiku makrolid, Kodici veterinarja ta ’ l- ATC:
5.1 Pharmacodynamic properties
5. 1 Kwalitajiet farmakodinamiċi
Tylvalosin tartrate is a macrolide antibiotic that has antibacterial activity against Gram-positive, some Gram-negative organisms and mycoplasma.
Tylvalosin tartrate huwa antibijotiku makrolid li għandu attività anti- batterika kontra organiżmi Gram - pożittivi u mikoplażma.
It acts by inhibiting protein synthesis in the bacteria cell.
Hu jaġixxi billi jinibixxi s- sintesi tal- proteina fil- ċellula tal- batterju.
Macrolide antibiotics are the metabolites or semi-synthetic derivatives of metabolites of soil organisms obtained by fermentation.
4 L- antibijotiċi ta ’ makrolid huma metaboliti jew derivattivi semi- sintetiċi ta ’ metaboliti ta ’ organiżmi li jinsabu fil- ħamrija li jinkisbu permezz tal- fermentazzjoni.
They have different sized lactone rings and due to the dimethylamino group, are basic.
Għandhom ċrieki ta ’ daqsijiet differenti, u minħabba l- grupp dimethylamino, il- makrolidi huma bażiċi.
Tylvalosin has a sixteen membered ring.
Tylvalosin għandu ċirku ta ’ 16- membru.
Macrolides interfere with protein synthesis by reversibly binding to the 50S ribosome subunit.
Il- makrolidi jinterferixxu mas- sintesi tal- proteina billi jeħlu b’ mod riversibbli mas- sottounità tar- ribosoma 50S.
They bind to the donor site and prevent the translocation necessary for keeping the peptide chain growing.
Huma jeħlu mas- sit tad- donatur u jimpedixxu t- traslokazzjoni meħtieġa biex iżommu l- katina tal- peptid tikber.
Their effect is essentially confined to rapidly dividing organisms.
L- effett tagħhom ġeneralment huwa limitat f’ organiżmi li jinqasmu malajr.
Macrolides are generally considered bacteriostatic and mycoplasmastatic.
Il- makrolidi ġeneralment huma kkunsidrati bħala batterjostatiċi u mikoplażmatiċi.
4 It is considered that there are multiple mechanisms responsible for resistance development to macrolide compounds: namely alteration of the ribosomal target site, utilisation of active efflux mechanism and production of inactivating enzymes.
Huwa kkunsidrat li hemm bosta mekkaniżmi responsabbli għall- iżvilupp tar- reżistenza għal- komposti ta ’ makrolid: dawn huma (i) tibdil fil- lok tat- targit tar- ribosoma, użu ta ’ mekkaniżmu ta’ tneħħija attiv u l- produzzjoni ta ’ enżimi li jagħmluh inattiv.
Resistance to tylvalosin by Mycoplasma hyopneumoniae and Lawsonia intracellularis has not been reported or found in the field to date.
Ir- reżistenza għal tylvalosin minn Mycoplasma hyopneumoniae u Lawsonia intracellularis għadha ma kinetx irrappurtata u lanqas għadha ma nstabet fil- beraħ sal- lum.
No breakpoint for Brachyspira hyodysenteriae has been established.
L- ebda breakpoint għal Brachyspira hyodysenteriae ma ġie stabbilit.
Generally strains of B. hyodysenteriae have higher MIC values in cases of resistance against other macrolides, such as tylosin.
Ġeneralment, strejns ta ’ B. hyodysenteriae għandhom valuri tal- MIC ogħla f’ każijiet ta ’ reżistenza kontra makrolidi oħrajn, bħal tilosin.
Cross-resistance between tylvalosin and other macrolide antibiotics cannot be excluded.
Ir- reżistenza inkroċjata bejn tylvalosin u antibijotiċi makrolidi oħrajn ma tistax tiġi eskluża.
Tylvalosin tartrate is rapidly absorbed after oral administration of Aivlosin.
Tylvalosin tartrate huwa assorbit malajr wara l- għoti mill- ħalq ta ’ Aivlosin.
After administration of the recommended dose lung concentrations of 0.060 – 0.066 µg/ml were found at 2 and 12 hours post-treatment.
Wara l- għoti tad- doża rrakkomandata, madankollu, konċentrazzjonijiet ta ’ 0. 060- 0. 066µg/ ml instabu fil- pulmun sagħtejn u 12- il siegħa wara t- trattament.
The parent compound is widely distributed in the tissues with the highest concentrations found in the lungs, bile, intestinal mucosa, spleen, kidney and liver.
Il- kompost prinċipali hu distribwiti b’ mod qawwi fit- tessuti, bl- ogħla konċentrazzjonijiet li nstabu fil- pulmuni, bili, fil- mukuża ta ’ l- imsaren, milsa, kliewi u fwied.
There is evidence that the concentration of macrolides is higher at the site of infection than in plasma, in particular in neutrophils, alveolar macrophages and alveolar epithelial cells.
Hemm evidenza li l- konċentrazzjoni tal- makrolidi hi ogħla fis- sit ta 'l- infezzjoni milli fil- plażma, b’ mod partikulari fin- newtrofili, makrofaġi alveolari u ċelluli epiteljali alveolari.
In vitro metabolism studies have confirmed that the parent compound is rapidly metabolised to 3-O- acetyltylosin.
Studji in vitro tal- metaboliżmu ikkonfermaw li l- kompost prinċipali huwa metabolizzat malajr għal 3 - O- acetyltylosin.
In a trial with 14C aivlosin administered at 2.125 mg/kg to pigs for 7 days over 70% of the dose was excreted in the faeces, with urinary excretion accounting for 3 to 4% of the dose.
Fi prova bis- 14C aivlosin mogħti f’ 2. 125 mg/ kg lill- qżieqeż fuq perijodu ta ’ 7 ijiem, aktar minn 70% tad- doża kienet eliminata fil- ħmieġ, bit- tneħħija fl- awrina tammonta għal 3 sa 4% tad- doża.
Magnesium trisilicate (sepiolite) (declared on labelling as carrier) Wheat feed flour Hydroxypropyl cellulose Non-fat soyabean powder
Trisilikat tal- Magnesju (sepiolite) Dqiq tal- qamħ tat- tmiegħ Hydroxypropyl cellulose Trab mhux xaħmi tal- fula tas- soja
(declared on labelling as carrier)
(dikjarat fuq it- tikketta bħala karrjer) (dikjarat fuq it- tikketta bħala karrjer)
6.2 Incompatibilities
6. 2 Inkompatibilitajiet maġġuri
6.3 Shelf life
5 6. 3 Żmien ta ’ kemm il- prodott idum tajjeb
Shelf-life of the veterinary medicinal product as packaged for sale:
Żmien kemm idum tajjeb il- prodott mediċinali veterinarju kif ippakkjat għall- bejgħ:
1 month in meal or pellets
Żmien kemm idum tajjeb wara li jkun inkorporat fl- ikel: xahar fil- maxx jew pellits
6.4 Special precautions for storage
6. 4 Tagħrif speċjali dwar kif għandu jinħazen
Do not store above 25°C Keep the container tightly closed.
Taħżinx f’ temperatura ta ’ aktar minn 25°C.
Store in the original container.
Aħzen fil- kontenitur oriġinali.
5 6.5 Nature and contents of container
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
One aluminium foil/polyester laminated bag containing 5 or 20 kg.
Borża waħda laminata tal- polyester magħmula minn fojl tal- aluminju li fiha 5 jew 20 kg.
Not all pack sizes might be marketed.
Mhux id- daqs tal- pakki kollha jistgħu qegħdin fis- suq.
6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Kull prodott mhux użat li fih medicina veterinarja jew materjal għar- rimi li jiġi minn prodotti bħal dawn li fihom medicina veterinarja għandhom jintremew skond il- liġijiet lokali.
ECO Animal Health Limited 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom
ECO Animal Health Limited 78 Coombe Road New Malden Surrey KT3 4QS Renju Unit
MARKETING AUTHORISATION NUMBER
NUMRU( I) TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
9 September 2004
9 ta ’ Settembru 2004
18.03.2009
< Data tad- Deċiżjoni tal- Kummissjoni >
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Informazzjoni dettaljata dwar dan il- prodott mediċinali veterinarju tinsab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /
PROHIBITION OF SALE, SUPPLY AND/OR USE
PROJBIZZJONI TA ’ BEJGĦ, PROVVISTA U / JEW UŻU
Consideration should be given to official guidance on the incorporation of medicated premixes in final feed.
Konsiderazzjoni għandha tingħata lill- gwida uffiċċjali fuq l- inkorporazzjoni ta ’ taħlita medikata fl- għalf finali.
Aivlosin 8.5 mg/g Premix for medicated feeding stuff for pigs.
Aivlosin 8. 5 mg/ g Taħlita mediċinali għal ikel medikat għall- qżieqeż
8.5 mg/g
8. 5 mg/ g
Premix for medicated feeding stuff A light yellow or light brown-yellow powder
Taħlita mediċinali lesta minn qabel għal ikel medikat Trab isfar ċar jew kannella safrani ċar
4.5 Special warnings
4. 4 Twissijiet speċjali
7 4.5 Special precautions for use
7 4. 5 Prekawzjonijiet Specjali għall- Użu
For treatment and prevention of Swine Dysentery The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
8 Għall- kura u l- prevenzjoni tad- Disinterija tal- Qżieqeż Id- dożaġġ hu ta ’ 4. 25 mg ta ’ tylvalosin għal kull kilogramm ta ’ piż tal- ġisem, mogħti ma ’ l- ikel għal 10 ijiem konsekuttivi.
8
Doża
Indication
tas - Tul tal -
Dose of active ingredient
Rata ta ’ inklużjoni ma ’ l- ikel
Duration of treatment
sustanza attiva kura
In feed inclusion rate Aivlosin 8.5 mg/g Premix
Aivlosin 8. 5 mg/ g Ikel imħallat minn qabel
Treatment and prevention of swine enzootic pneumonia
Għall- kura u l - prevenzjoni tal - pnewmonja enżootika tal- qżieqeż
5 kg/tonne*
5 kg/ tunnellata *
10 days
10 kg/ tunnellata *
10
4. 25 mg/ ta ’ piż 10 ijiem
10
10 kg/ tunnellata *
kg/tonne*
prevenzjoni
* Important: these inclusion rates are assumes a pig eats equivalent of 5% bodyweight per day.
disinterija tal- qżieqeż kuljum * Importanti: dawn ir- rati ta ’ inklużjoni jassumu li qażquż jiekol l- ekwivalenti ta ’ 5% tal- piż tal- ġisem tiegħu f’ ikel kuljum.
Macrolide antibiotics are the metabolites or semi-synthetic derivatives of metabolites of soil organisms obtained by fermentation.
9 L- antibijotiċi ta ’ makrolid huma metaboliti jew derivattivi semi- sintetiċi ta ’ metaboliti ta ’ organiżmi li jinsabu fil- ħamrija li jinkisbu permezz tal- fermentazzjoni.
The ir effect is essentially confined to rapidly dividing organisms.
L- effett tagħhom ġeneralment huwa limitat f’ organiżmi li jinqasmu malajr.
9 It is considered that there are multiple mechanisms responsible for resistance development to macrolide compounds: namely alteration of the ribosomal target site, utilisation of active efflux mechanism and production of inactivating enzymes.
Huwa kkunsidrat li hemm bosta mekkaniżmi responsabbli għall- iżvilupp tar- reżistenza għal- komposti ta ’ makrolid: dawn huma (i) tibdil fil- lok tat- targit tar- ribosoma, użu ta ’ mekkaniżmu ta’ tneħħija attiv u l- produzzjoni ta ’ enżimi li jagħmluh inattiv.
6.2 List of excipients
6. 1 Lista ta ’ ingredjenti
Magnesium trisilicate (sepiolite) (declared on labelling as carrier) Wheat feed flour Hydroxypropyl cellulose Non-fat soyabean powder Paraffin light liquid
Trisilikat tal- Magnesju (sepiolite) Dqiq tal- qamħ tat- tmiegħ Hydroxypropyl cellulose Trab mhux xaħmi tal- fula tas- soja Paraffina ħafifa likwida
6.3 Shelf life
10 6. 3 Żmien ta ’ kemm il- prodott idum tajjeb
Shelf-life after incorporation into feed:
Żmien kemm idum tajjeb wara li jkun inkorporat fl- ikel:
1 month meal, 2 weeks in pellets
Imħallat minn qabel: xahar fil- maxx, ġimagħtejn fil- pellits
10 6.7 Nature and contents of container
6. 5 In- natura tal- materjal tal- kontenitur u ta ’ dak li hemm ġo fih
One polyethylene lined paper bag containing 5 or 20 kg.
Borża waħda tal- karti b’ inforra tal- polietilina li fiha 5 jew 20 kg.
6.8 Special precautions for the disposal of unused medicinal product or waste materials, if any
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Aivlosin 8.5 mg/g Oral Powder for pigs
Aivlosin 8. 5 mg/ g Trab li jittieħed mill- ħalq għal qżieqeż
Tylvalosin (as Tylvalosin tartrate)
Tylvalosin (bħala Tylvalosin tartrate)
For a full list of excipients see section 6.1.
Għal- lista sħiħa ta ’ sustanzi mhux attivi are sezzjoni 6. 1.
A light yellow or light brown-yellow powder.
Trab li jittieħed mill- ħalq Trab isfar ċar jew kannella- isfar ċar.
Treatment and prevention of Swine Enzootic Pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae in pigs.
Trattament u prevenzjoni ta ’ Pnewmonja Enżootika tal- Qżieqeż ikkawżata minn razez (strejns) suxxetibbli ta ’ Mycoplasma hyopneumoniae fil- qżieqeż.
At the recommended dose, lung lesions and weight loss are reduced but infection with Mycoplasma hyopneumoniae is not eliminated.
Fid- doża rrakkomandata, is- slieħ fil- pulmuni u t- telf fil- piż jitnaqqsu iżda l- infezzjoni bil- Mycoplasma hyopneumoniae ma tkunx eliminata.
Treatment of Porcine Proliferative Enteropathy caused by Lawsonia intracellularis in herds where there is a diagnosis based on clinical history, post-mortem findings and clinical pathology results.
Trattament ta ’ Enteropatija Proliferattiva tal- Qżieqeż (ileite) ikkawżata minn Lawsonia intracellularis f’ merħliet fejn hemm dijanjosi bbażata fuq l- istorja klinika, sejbiet li jsiru wara l- mewt u riżultati patoloġiċi kliniċi.
Treatment of clinical outbreaks of swine dysentery, caused by Brachyspira hyodysenteriae in herds where the disease has been diagnosed and prevention of further clinical cases.
Trattament ta ’ mard mifrux ta ’ disinterija tal- qżieqeż, ikkawżat minn Brachyspira hyodysenteriae f’ merħliet fejn il- marda kienet stabbilita, u għal prevenzjoni ta ’ każijiet kliniċi ulterjuri.
Acute cases and severely diseased pigs with reduced food and water intake should be treated with a suitable injectable product.
Qżieqeż b’ każijiet ta ’ infezzjonijiet akuti u qżieqeż morda serjament li naqqsu mill- ikel jew l- ilma għandhom jiġu kkurati bi prodott adattat li jista jiġi injettat.
Generally, strains of B. hyodysenteriae have higher MIC values in cases of resistance against other macrolides such as tylosin.
Ġeneralment, strejns ta ’ B. hyodysenteriae għandhom valuri tal- MIC ogħla f’ każijiet ta ’ reżistenza kontra makrolidi oħrajn, bħal tilosin.
4.5 Special precautions for use
12 4. 5 Prekawzjonijiet specjali għall- użu
It is sound clinical practice to base treatment on susceptibility testing.
Hija prattika klinika tajba li tibbaża t- trattament fuq l- ittestjar tas- suxxetibilità.
12 Special precautions to be taken by the person administering the medicinal product to the animals
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
When adding the veterinary medicinal product to the individual feed ration and when handling this medicated feed, direct contact with eyes, skin and mucous membranes should be avoided.
Meta tkun qed iżżid il- prodott mediċinali veterinarju mar- razzjon ta ’ l- għalf individwali u meta tkun qed iġġorr dan il- għalf, kuntatt dirett ma ’ l- għajnejn, ġilda u riti mukużi għandu jkun evitat.
Personal protective equipment should be worn when handling the veterinary medicinal product or the feed with product added: overalls, impervious gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter to European Standard EN 143.
Għandu jintlibes tagħmir personali protettiv meta tkun qed iġġorr il- prodott mediċinali veterinarju jew l- għalf bil- prodott miżjud: għata, ingwanti impermeabbli u jew respiratur ta ’ nofs maskla li jikkonforma ma ’ l- Istandard Ewropew EN 149 li tużah u tarmih, jew respiratur, (mhux li tuża u tarmi) li jikkonforma ma ’ l- Istandard Ewropew EN 140, b’ filtru skond EN 143.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
F’ każ li aċċidentalment tibla ’, fittex parir mediku immedjatament u uri t- tikketta lit- tabib.
4.6 Adverse Reactions (frequency and seriousness)
4. 6 Effetti mhux mixtieqa (frekwenza u gravità)
None known.
Xejn li hu magħruf.
The safety of Aivlosin during pregnancy and lactation has not been established in pigs.
Is- sigurtà ta ’ aivlosin waqt it- tqala u fi żmien il- ħalib ma kinetx stabbilita fil- qżieqeż.
Studies in laboratory animals have not produced any evidence of teratogenicity.
Studji fuq annimali tal- laboratorju ma pproduċew l- ebda evidenza ta ’ teratoġeniċità.
Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above.
Tossiċità materna f’ annimali rodenti kienet osservata f’ dożi ta ’ 400 mg/ kg ta ’ tylvalosin għal kull kilogramm ta ’ piż tal- ġisem u aktar.
For use in individual pigs on farms where only a small number of pigs are to receive the medicine.
Għall- użu fuq qżieqeż individwali fejn numru żgħir ta ’ qżieqeż jkunu ser jirċievu l- mediċina.
Larger groups should be treated with medicated feeding stuff containing the premix.
Gruppi akbar għandhom jiġu ttrattati b’ għalf medikat li jkun fih it- taħlita medikata lesta.
For treatment and prevention of Enzootic Pneumonia The dosage is 2.125 mg tylvalosin per kg bodyweight per day for 7 consecutive days.
Għall- kura u l- Prevenzjoni ta ’ Pnewmonja Enżootika Id- dożaġġ hu ta ’ 2. 125 mg tylvalosin kuljum għal kull kilogramm ta ’ piż tal- ġisem għal 7 t’ ijiem konsekuttivi.
For treatment of Porcine Proliferative Enteropathy (ileitis) The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
Għall- kura ta ’ l- Enteropatija Proliferattiva tal- Qżieqeż (EPQ) (ileite) Id- dożaġġ hu ta ’ 4. 25 mg ta ’ tylvalosin għal kull kilogramm ta ’ piż tal- ġisem, għal 10 ijiem konsekuttivi.
For treatment and prevention of Swine Dysentery The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
13 Għall- kura u l- prevenzjoni tad- Disinterija tal- Qżieqeż Id- dożaġġ hu ta ’ 4. 25 mg ta ’ tylvalosin għal kull kilogramm ta ’ piż tal- ġisem, għal 10 ijiem konsekuttivi.
This is achieved by thoroughly mixing Aivlosin 8.5 mg/g Oral Powder into the daily ration for each individual pig.
Dan jinkiseb billi tħallat tajjeb Aivlosin 8. 5 mg/ g Trab li Jittieħed mill- Ħalq fir- razzjon ta ’ l- għalf ta ’ kuljum għal kull qażquż individwali.
Scoops of 3 sizes are provided for measuring the correct amount of Aivlosin 8. 5 mg/g Oral Powder for mixing with the daily ration, according to the schedule below.
Mgħaref ta ’ 3 daqsijiet huma pprovduti biex jitkejjel l- ammont korrett ta ’ Aivlosin 8. 5 mg/ g Trab li Jittieħed mill- Ħalq sabiex jitħallat mar- razzjon ta ’ kuljum, skond l- iskeda t’ hawn taħt.
The feed containing the oral powder should be provided as the sole ration for the periods recommended above.
L- ikel li jkun fih it- trab li jittieħed mill- ħalq għandu jkun ipprovdut bħala l- uniku razzjon għall- perjodi rakkomandati hawn fuq.