qanastek/EMEA-V3 huggingface dataset:
The pig to be treated should be weighed and the amount of feed that the pig is likely to consume should be estimated, based on a daily feed intake equivalent to 5% of bodyweight.
Il- qażquż li jkun ser jiġi ttrattat għandu jintiżen, u l- ammont ta ’ l- għalf li l- qażquż x’ aktarx li jkun ser jiekol għandu jiġi stmat, ibbażat fuq konsum ta ’ ikel ta ’ kuljum ekwivalenti għal 5% tal- piż tal- ġisem.
Consideration must be given to pigs whose daily feed intake is reduced or restricted.
Għandha tingħata konsiderazzjoni lil qżieqeż li l- konsum ta 'l- ikel ta ’ kuljum tagħhom hu mnaqqas jew ristrett.
The correct quantity of Aivlosin 8.5 mg/g Oral Powder should be added to the estimated quantity of daily ration for each pig, in a bucket or similar receptacle, and thoroughly mixed.
Il- kwantità korretta ta ’ Aivlosin 8. 5 mg/ g Trab li Jittieħed mill- Ħalq għandha tiżdied mal- kwantità stmata tar- razzjon ta ’ kuljum għal kull qażquż, f’ barmil jew f’ xi reċipjent simili, u mħallta sew.
13 The product should only be added to dry non-pelleted feed.
Il- prodott għandu jkun miżjud ma ’ għalf xott u li mhux f’ forma ta ’ pellits.
Swine Enzootic Pneumonia 2. 125 mg/kg bodyweight
Pnewmonja Enżootika tal- Qżieqeż 2. 125 mg/ kg ta ’ piż tal- ġisem
PPE (ileitis) & Swine Dysentery 4.25 mg/kg bodyweight
EPQ (ileite) u Disinterija tal- Qżieqeż 4. 25 mg/ kg ta ’ piż tal- ġisem
Number of Bodyweight scoops range (kg) 1 6.5-12 13-24
13 – 24
Number of scoops 1 2
73 – 96
13 - 2 4 2 5 - 48 49 - 72 73 - 9 6
49 - 72 73 - 96
NB:
6 7 8
A level scoop of the product should be measured
116 – 145 146 – 175 176 – 200
A level scoop of the product should be measured
Mgħarfa għandha titkejjel
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 potential build up of resistance.
mimlija
4.10 Overdose
bil- prodott
Two days
Jumejn
It acts by inhibiting protein synthesis in the bacteria cell.
Hu jaġixxi billi jinibixxi s- sintesi tal- proteina fiċ- ċellula tal- batterju.
Macrolide antibiotics are the metabolites or semi-synthetic derivatives of metabolites of soil organisms obtained by fermentation.
L- antibijotiċi makrolidi huma metaboliti jew derivattivi semi- sintetiċi ta ’ metaboliti ta ’ organiżmi li jinsabu fil- ħamrija li jinkisbu permess tal- fermentazzjoni.
They have different sized lactone rings and due to the dimethylamino group, are basic.
Għandhom ċrieki lattoniċi ta ’ daqsijiet differenti, u minħabba l- grupp dimethylamino, il- makrolidi għandhom xeħta alkalina.
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- peptidi tikber.
Their effect is essentially confined to rapidly dividing organisms.
L- effett tagħhom ġeneralment huwa limitat għal dawk l- organiżmi li jirreplikaw malajr.
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 diversi mekkaniżmi responsabbli għall- iżvilupp tar- reżistenza għal- komposti ta ’ makrolid: dawn huma tibdil fil- lok tal- mira tar- ribosoma, użu ta ’ mekkaniżmu effluss 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 ma nstabet f’ dal- qasam sal- lum.
No breakpoint for Brachyspira hyodysenteriae has been
L- ebda valur ta ’ MIC għal Brachyspira hyodysenteriae għadu 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 makrolidi antibijotiċi oħrajn ma tistax tiġi eskluża.
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, instabu 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 distribwit b’ mod qawwi fit- tessuti, bl- ogħla konċentrazzjonijiet li nstabu fil- pulmuni, bila, fil- mukuża ta ’ l- imsaren, milsa, kliewi u fwied.
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 bil- 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 li kienet tammonta għal 3 sa 4% tad- doża.
Magnesium trisilicate (sepiolite) Wheat feed flour Hydroxypropyl cellulose Non-fat soyabean powder Paraffin light liquid
Trisilikat tal- Magnesju (sepjolit) Dqiq tal- qamħ tat- tmiegħ Hydroxypropyl cellulose Trab mhux xaħmi tal- fula tas- soja Paraffina likwida ħafifa
6.2 Incompatibilities
15 6. 2 Inkompatibilitajiet maġġuri
6.3 Shelf life
6. 3 Żmien ta ’ kemm il- prodott idum tajjeb
Shelf-life of the veterinary medicinal product as packaged for sale:
Żmien kemm idum tajjeb tal- prodott mediċinali veterinarju kif ippakkjat għall- bejgħ:
3 years Feed to which the oral powder has been added should be replaced if not consumed within 24 hours.
3 snin Għalf li miegħu jkun żdied it- trab li jittieħed mill- ħalq għandu jinbidel jekk ma jkunx ikkunsmat fi żmien 24 siegħa.
6.4 Special precautions for storage
Tagħrif speċjali dwar kif għandu jinħazen
One polyethylene lined paper bag containing 1 or 3 kg.
Borża waħda tal- karti b’ inforra tal- polietilina li fiha 1 kg jew 3 kg.
Scoops of 5 ml, 10 ml and 25 ml are attached.
Mgħaref ta ’ 5 ml, 10 ml u 25 ml huma mwaħħla magħha.
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 materjali għar- rimi li jiġu minn prodotti bħal dawn li fihom medicina veterinarja għandhom jintremew skond il- liġijiet lokali.
DATE OF FIRST AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TAL- AWTORIZZAZZJONI
9 September 2004
9 ta ’ Settembru, 2004
PROHIBITION OF SALE, SUPPLY AND/OR USE
16 PROJBIZZJONI TA ’ BEJGĦ, PROVVISTA U / JEW UŻU
Aivlosin 625 mg/g Granules for use in drinking water for chickens
Aivlosin 625 mg/ g Granuli għal użu fl- ilma tax- xorb għat- tiġieġ
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, ara sezzjoni 6. 1.
Granules for use in drinking water, White granules.
Granuli għal użu fl- ilma tax- xorb Granuli bojod.
Chickens
Flieles
4.2 Indications for use, specifying the target species
4. 2 Indikazzjonijiet għal użu tal- prodott li jispeċifikaw l- ispeċi li fuqhom se jintuża l - prodott.
Treatment and prevention of respiratory disease associated with Mycoplasma gallisepticum in chickens.
Kura u prevenzjoni ta ’ mard respiratorju marbut ma ’ Mycoplasma gallisepticum fit- tiġieġ.
As an aid in the prevention strategy to reduce the clinical signs and mortality from respiratory disease in flocks, where infection in ovum with Mycoplasma gallisepticum is likely because the disease is known to exist in the parent generation.
Bħala għajnuna fi strateġija ta ’ prevenzjoni sabiex jitnaqqsu s- sinjali kliniċi u l- mortalità mill- mard respiratorju fi qtajja ta ’ tjur, meta infezzjoni fl- ovum b’ Mycoplasma gallisepticum hija probabbli peress li l- marda hi magħrufa li teżisti fil- ġenerazzjoni tal- ġenituri.
The prevention strategy should include efforts to eliminate the infection from the parent generation.
L- istrateġija ta ’ prevenzjoni għandha tinkludi sforzi sabiex l- infezzjoni tiġi eliminata mill- ġenerazzjoni tal- ġenituri
Good management and hygiene practices should be introduced to reduce the risk of re-infection.
Immaniġġjar u prattiċi tajbin ta ’ l- iġjene għandhom jiġu introdotti biex jitnaqqas ir- riskju ta ’ infezzjoni mill- ġdid.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
18 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
Tylvalosin has been shown to cause hypersensitivity reactions in laboratory animals; therefore, people with known hypersensitivity to tylvalosin tartrate should avoid contact with the veterinary medicinal product.
Tylvalosin intwera li jista ’ jikkawża reazzjonijiet ta ’ sensittività eċċessiva f’ annimali tal- laboratorju; għalhekk persuni li hu magħruf li għandhom sensittività eċċessiva għal tylvalosin tartrate għandhom jevitaw il- kuntatt mal- prodott mediċinali veterinarju.
17 When mixing the veterinary medicinal product and handling the medicated water, direct contact, with eyes, skin and mucous membranes should be avoided.
Meta tkun qed tħallat il- prodott mediċinali veterinarju u ġġorr l- ilma bil- mediċina, għandek tevita kuntatt dirett ma ’ l- għajnejn, il- ġilda u l- membrani mukużi.
Personal protective equipment consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a non- disposable respirator conforming to European Standard EN 140, with a filter conforming to European Standard EN 143 should be worn when mixing the veterinary medicinal product.
Tagħmir protettiv personali, li jikkonsisti minn ingwanti li ma jgħaddix ilma minnhom u respiratur ta ’ nofs maskla li hu konformi ma ’ l - Istandard Ewropew EN 149 jew respiratur li jista ’ jerġa ’ jintuża li hu konformi ma ’ l- Istandard Ewropew EN 140, flimkien ma ’ filtru konformi ma ’ l- Istandard Ewropew EN 143 għandu jintlibes meta jitħallat il- prodott mediċinali veterinarju.
Wash contaminated skin.
Aħsel ġilda kontaminata.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ li tibla ’ l- prodott b’ mod aċċidentali, fittex tabib mill- ewwel u qis li turih il- pakkett jew il- fuljett ta ’ informazzjoni li jkun fih ġewwa.
The safety of the veterinary medicinal product has not been established during lay.
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita fi żmien il- bajd.
For use in drinking water.
Għal użu fl- ilma tax- xorb.
For treatment of respiratory disease associated with Mycoplasma gallisepticum:
Għal kura ta ’ mard respiraturju marbut ma ’ Mycoplasma gallisepticum
The dosage is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days.
Id- dożaġġ hu ta ’ 25 mg ta ’ tylvalosin għal kull kg ta ’ piż tal- ġisem, kuljum fl- ilma tax- xorb għal 3 ijiem konsekuttivi.
When used as an aid in the prevention strategy (where infection in ovum with Mycoplasma gallisepticum is likely):
Meta użata bħala għajnuna fl- istrateġija ta ’ prevenzjoni (meta infezzjoni fil- bajda ta ’ l- omm b’ Mycoplasma gallisepticum huwa probabbli):
The dosage is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at 1 day old.
Id- dożaġġ hu ta ’ 25 mg ta ’ tylvalosin għal kull kg ta ’ piż tal- ġisem, kuljum fl- ilma tax- xorb għal 3 ijiem konsekuttivi minn meta jkollhom jum.
This is followed by a second treatment with 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at the period of risk, i.e. at times of management stress such as administration of vaccines (typically when birds are 2-3 weeks old).
Dan ikun segwit bit- tieni trattament ta ’ 25 mg tylvalosin għal kull kg ta ’ piż tal- ġisem kuljum fl- ilma tax- xorb għal 3 ijiem konsekuttivi fil- perjodu tar- riskju, i. e fi żmien ta ’ stress fit- tmexxija, bħall- amministrazzjoni ta ’ vaċċini (tipikament meta tjur ikollhom 2 - 3 ġimgħat).
Determine the combined bodyweight (in kg) of all the chickens to be treated.
Iddetermina l- piż kollu tal- ġisem (f’ kg) tat- tiġieġ li jkunu se jiġu trattatti.
Select the correct number of sachets according to the amount of product required.
Agħżel l- għadd korrett ta ’ qratas skond l- ammont tal- prodott meħtieġ.
One sachet of 40 g is sufficient to treat a total of 1000 kg of chickens (e.g.
Qartas wieħed ta ’ 40g huwa biżżejjed biex jittratta 1000 kg ta ’ tiġieġ (e. g.
20 000 birds with an average bodyweight of 50 g).
20, 000 tajra b’ piż tal- ġisem medju ta ’ 50 g).
One sachet of 400 g is sufficient to treat a total of 10 000 kg of chickens (e.g.
Qartas wieħed ta ’ 400 mg huwa biżżejjed biex jittratta 10, 000 kg ta ’ tiġieġ (e. g.
20 000 birds with an average bodyweight of 500 g).
20, 000 tajra b’ piż tal - ġisem medju ta ’ 500 g).
In order to achieve a correct dose, the preparation of a concentrated (stock) solution might be required (e.g. to treat a total of 500 kg total bird weight, only 50% of the prepared stock solution prepared from the 40 g sachet should be used).
19 Sabiex tikseb id- doża korretta, għandu mnejn ikun meħtieġ il- preparazzjoni ta ’ soluzzjoni konċentrata (stokk) (eż. biex tittratta total ta ’ 500 kg bħala total tal- piż tal- ġisem tat- tjur, 50% biss tas- soluzzjoni stokk magħmula mill- qartas ta ’ 40 g għandha tintuża).
The product should be added to a volume of water that the chickens will consume in one day.
Il- prodott għandu jiġi miżjud mal- volum ta ’ ilma li t- tiġieġ ikunu ser jikkonsmaw f’ jum wieħed.
No other source of drinking water should be available during the medication period.
L - ebda sors ieħor ta ’ ilma għax- xorb m’ għandu jkun disponibbli waqt il- perjodu li tkun qed tingħata l - mediċina
18 Mixing instructions:
Struzzjonijiet għat- taħlit:
The product may be mixed directly into the drinking water system or first mixed as a stock solution into a smaller amount of water, which is then added into the drinking water system.
Il- prodott jista ’ jitħallat direttament mas- sistema ta ’ l- ilma għax- xorb jew jista ’ l- ewwel jitħallat bħala soluzzjoni stokk f’ ammont iżgħar ta ’ ilma, li mbagħad jiġi miżjud ma ’ l- ilma għax- xorb.
When mixing the product directly into the drinking water system, the contents of the sachet should be sprinkled onto the surface of the water and mixed thoroughly until a clear solution is produced (usually within 3 minutes).
Meta l- prodott jiġi mħallat direttament fis- sistema ta ’ l- ilma għax- xorb, il- kontenut tal- qartas għandu jiġi mraxxax fuq il- wiċċ ta ’ l- ilma u mħallat sew sakemm is- soluzzjoni tkun ċara (ġeneralment fi żmien 3 minuti),
When preparing a stock solution the maximum concentration should be 40 g per 1500 ml or 400 g of product per 15 litres and it is necessary to mix the solution for 10 minutes.
Meta tipprepara s- soluzzjoni stokk il- konċentrazzjoni massima għandha tkun 40 g għal kull 1500 ml jew 400 g ta ’ prodott għal 15- il litru u hu meħtieġ li tħallat is- soluzzjoni għal 10 minuti.
After this time, any remaining cloudiness will not affect efficacy of the product.
Wara dan il- ħin, is- soluzzjoni mdardra li tibqa ’ m’ għandiex taffettwa l- effikaċja tal- prodott.
No signs of intolerance have been observed in chickens at up to 150 mg tylvalosin per kg bodyweight per day for 5 days.
L- ebda sinjali ta ’ intolleranza ma kienu osservati fit- tiġieġ meta ngħataw sa 150 mg ta ’ tylvalosin għal kull kg ta ’ piż tal- ġisem kuljum għal 5 ijiem.
2 days Not authorised for use in laying birds producing eggs for human consumption.
Jumejn Mhux awtorizzat sabiex jintuża fi tjur li jipproduċu bajd għall- konsum tan- nies.
Do not use within 14 days of onset of the laying.
M’ għandekx tuża fi żmien 14- il jum minn meta se jibdew ibidu.
Pharmacotherapeutic group:
Grupp Farmako- terapewtiku:
Macrolide antibiotic, ATC vet code:
Antibijotikumakrolid, Kodici ATĊ veterinarja:
Tylvalosin is a macrolide antibiotic.
Tylvalosin hu antibijotiku makrolid.
Macrolides are metabolites or derivatives of metabolites of soil organisms obtained by fermentation.
Il- makrolidi huma metaboliti jew derivati ta ’ metaboliti ta ’ organiżmi tal- ħamrija miksuba mill- fermentazzjoni.
They interfere with protein synthesis by reversibly binding to the 50S ribosome subunit.
Dawn jinterferixxu mas- sintesi tal- proteini billi jeħlu b’ mod riversibbli mal- 50S ribosome subunit.
They are generally considered bacteriostatic.
Huma ġeneralment ikkunsidrati bħala batterjostatiċi.
Tylvalosin has activity against pathogenic organisms isolated from a range of animal species - mainly gram positive organisms and mycoplasma but also some gram negative organisms.
Tylvalosin għandu attività kontra organiżmi patoġeniċi iżolati minn medda ta ’ speċi ta ’ annimali - primarjament organiżmi gram pożittivi u mikoplasma iżda wkoll xi organiżmi gram negattivi.
Tylvalosin has activity against the following mycoplasma species found in chickens:
Tylvalosin għandu attività kontra l- ispeċi ta ’ mikoplasma li ġejjin li jinsabu fit- tiġieġ:
The Minimum Inhibitory Concentration of tylvalosin for M gallisepticum ranges from 0.007 to 0.25 µg/ml.
Il- Konċentrazzjoni Inibitorja Minima ta ’ tylvalosin għal M. gallispticum tvarja minn 0. 007 sa 0. 25 µg/ ml.
Macrolides (including tylvalosin) have been shown to have effects on the innate immune system, which may augment the direct effects of the antibiotic on the pathogen and aid the clinical situation.
Makrolidi (li jinkludu tylvalosin) intwerew li kellhom effetti fuq is- sistema immunoloġika mit- twelid, u dan jista ’ jżid l- effetti diretti ta ’ l- antibijotiku fuq il- patoġenu u jgħin lis- sitwazzjoni klinika.
Bacteria can develop resistance to antimicrobial substances.
Il- batterja tista ’ tiżviluppa reżistenza għal sustanzi li jaħdmu kontra l- mikrobi.
The re are multiple mechanisms responsible for resistance development to macrolide compounds.
Hemm mekkaniżmi multipli li huma responsabbli għall- iżvilupp tar- reżistenza għall- komposti makrolidi.
Cross-resistance within the macrolide group of antibiotics cannot be excluded.
20 Reżistenza inkroċjata fi ħdan il- grupp makrolidu ta ’ l- antibijotiċi ma tistax tiġi eskluża.
Reduced susceptibility for tylvalosin was generally noted in tylosin resistant strains.
Suxxetibilità mnaqqsa għal tylvalosin kienet ġeneralment innotata f’ razez reżistenti għal tylosin.
Tylvalosin tartrate is rapidly absorbed after oral administration of the product.
Tylvalosin tartrejt jiġi assorbit malajr wara l- għoti mill- ħalq tal- prodott.
Tylvalosin is widely distributed in tissues with the highest concentrations found in the respiratory tissues, bile, intestinal mucosa, spleen, kidney and liver.
Tylvalosin jitqassam tajjeb ħafna fittessuti bl- ogħla konċentrazzjonijiet jinstabu fit- tessut respiratorju, fil- bila, fil- mukuża intestinali, fil- milsa, fil- kliewi u fl- fwied.
19 Tylvalosin has been shown to concentrate in phagocytic cells and gut epithelial cells.
Intwera li tylvalosin jikkonċentra ruħu fiċ- ċelluli fagoċitiċi u fċ- ċelluli epiteljali ta ’ l- imsaren.
Concentrations (up to 12x) were achieved in the cells (intracellular), compared to the extracellular concentration.
Konċentrazzjonijiet (sa 12x) instabu ġoċ- ċelloli (intraċellulari), meta mqabbla ma ’ konċentrazzjoni estraċellulari.
In vivo studies have shown tylvalosin to be present in higher concentrations in the mucous lining of the respiratory and gut tissues compared to the plasma.
Studji in vivo wrew li tylvalosin ikun preżenti f’ konċentrazzjonijiet ogħla fil- kisja mukuża tat- tessut respiratorju u dak ta ’ l- imsaren, meta mqabbel mal- plażma.
The major metabolite of tylvalosin is 3-acetyltylosin (3-AT), which is also microbiologically active.
Il- metabolit prinċipali ta ’ tylvalosin hu 3- acetyltylosin (3AT), li hu wkoll attiv b’ mod mikrobijoloġiku.
The terminal half-lifes for the elimination of tylvalosin and its active metabolite 3-AT range from 1 to 1.45 hours.
Il- half- lifes terminali għall- eliminazzjoni ta ’ tylvalosin u l- metabolit attiv tiegħu 3- AT ivarjaw minn 1 sa 1. 45 sigħat.
Six hours after treatment, the concentration of tylvalosin in the gastrointestinal tract mucosa has a mean concentration of 133 ng/g and in the gastrointestinal contents of 1040 ng/g.
Sitt sigħat wara t- trattament, il- konċentrazzjoni ta ’ tylvalosin fil- mukosa tal- passaġġ gastro- intestinali għandha konċentrazzjoni medja ta ’ 133 ng/ g u 1040 ng/ g fil- kontenut gastro - intestinali.
The active metabolite 3-AT has a mean concentration of 57.9 ng/g and 441 ng/g, respectively.
Il- metabolit attiv 3- AT għandu konċentrazzjoni medja ta ’ 57. 9 ng/ g u 441 ng/ g rispettivament.
None known
M' hemm xejn magħruf.
3 years Shelf-life of the medicated drinking water:
Sentejn Iż- żmien kemm idum tajjeb wara li jitħallat ma ’ l- ilma:
Only a sufficient amount of medicated drinking water should be prepared to cover the daily requirements.
Għandu jiġi ppreparat biss ammont suffiċjenti ta ’ ilma medikat għax- xorb sabiex ikopri l- ħtiġijiet ta ’ kuljum.
Medicated drinking water should be replaced every 24 hours.
Ilma medikat għax- xorb għandu jiġi mibdul kull 24 siegħa.
Opened sachets should not be stored.
Taħżinx f’ temperatura ogħla minn 25°C Qratas miftuħin m’ għandhomx jinżammu.
Aluminium foil laminated sachet containing 40 g or 400 g.
Qartas miksi b’ folja tal- aluminjum li fih 40 g jew 400 g.
Not all pack sizes might be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu jitpoġġew fis- suq.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
21 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
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 Ir- Renju Unit
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TA ’ L - AWTORIZZAZZJONI
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 mediku veterinarju tinstab 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, PROVISTA, U/ JEW UŻU
21 ANNEX II
22 ANNESS II
CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING RESTRICTIONS REGARDING SUPPLY AND USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVVISTA U L- UŻU
PROHIBITION OF SALE, SUPPLY AND/OR USE
PROJBIZZJONI TAL- BEJGĦ, PROVVISTA U L- UŻU
Gallows Green Services Limited Cod Beck Blenders, Cod Beck Estate Dalton Lane, Dalton Thirsk, North Yorkshire YO7 3HR United Kingdom
Gallows Green Services Limited Cod Beck Blenders, Cod Beck Estate Dalton Lane, Dalton Thirsk, North Yorkshire YO7 3HR Renju Unit
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVVISTA U L- UŻU
To be supplied only on veterinary prescription.
Prodott mediċinali veterinarju suġġett għal riċetta.
OTHER CONDITIONS:
KONDIZZJONIJIET OĦRA:
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 lesta għal ma l- ikel, fl- għalf finali.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
PROJBIZZJONI TAL- BEJGĦ, PROVVISTA U L- UŻU
2377/90 in accordance with the following table:
MRLs għal tylvalosin kienu inklużi f’ Anness I tar- Regolazzjoni tal- Kunsill (EEC) Nru.
Pharmacologically
2377/ 90 kif ġej:
Marker
Sustanza( i) attiva( i) Residwu tal - farmakologikament markatur
Animal
Speċi ta ’ Annimal
Target tissues
Tessuti fil- mira
active substance(s)
Proveddimenti oħrajn
Sum of tylvalosin and 3-O- acetyltylosin
Tylvalosin Ammont ta ’ tylvalosin u 3- O - acetyltylosin
Porcine
Qażquż
Muscle Skin and fat Liver Kidney
Muskolu Ġilda u xaħam Fwied Kilwa
Sum of tylvalosin and 3-O- acetyltylosin
Total ta ’ tylvalosin u 3- O -
Poultry
Flieles
Not for use in animals from which eggs are produced for human consumption
Ġilda u xaħam Mhux għall- użu Fwied fl- annimali li
23 ANNEX III
50 µg/ kg
LABELLING AND PACKAGE LEAFLET
2377/ 90 b’ konformità mat- tabella li ġejja.
24 A.
24 Sustanza( i) farmakoloġikament attiva
LABELLING
Speċi ta ’ annimal
25 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
25 ANNESS III
Aivlosin 8.5 mg/g premix for medicated feeding stuff for pigs.
Aivlosin 42. 5 mg/ g taħlita mediċinali lesta minn qabel għal ikel medikat għall- qżieqeż Aivlosin 8. 5 mg/ g taħlita mediċinali lesta minn qabel għal ikel medikat għall- qżieqeż
Tylvalosin Tylvalosin (as Tylvalosin tartrate)
Sustanza attiva Tylvalosin Tylvalosin
42.5 mg/g 8.5 mg/g
42. 5 mg/ g 8. 5 mg/ g
Carrier:
(bħala Tylvalosin tartrate)
Magnesium trisilicate, wheat feed flour
Trisilikat tal- magnesjum, Dqiq tal- qamħ tal- ikel
PHARMACEUTICAL FORM:
GĦAMLA FARMAĊEWTIKA
Premix for medicated feeding stuff
Taħlita mediċinali lesta minn qabel għal ikel medikat
20 kg 5 kg
20kg 5 kg
TARGET SPECIES
SPEĊI LI GĦALIHA HUWA INDIKAT IL- PRODOTT
INDICATIONS
INDIKAZZJONIJIET
Treatment and prevention of Swine Enzootic Pneumonia.
Trattament u prevenzjoni ta ’ Pnewmonja Enżootika tal- Qżieqeż.
Treatment of Porcine proliferative Enteropathy (ileitis).
Trattament ta ’ Enteropatija proliferattiva tal- Qżieqeż (ileite).
Treatment of clinical outbreaks of Swine Dysentery in herds where the disease has been diagnosed, and prevention of further clinical cases.
Trattament ta ’ mard kliniku mifrux ta ’ Disinterija tal- Qżieqeż f’ merħliet fejn il- marda kienet stabbilita, u għal prevenzjoni ta ’ każijiet kliniċi ulterjuri.
METHOD AND ROUTE OF ADMINISTRATION
METODU U MOD TA 'AMMINISTRAZZJONI
In-feed use.
Uża ma ’ l- ikel.
For incorporation into dry feed only.
Biex jitħallat ma ’ ikel xott biss.
A horizontal ribbon mixer should be used to incorporate the product into feeding stuff.
Struzzjonijiet għat- Taħlit Għandu jintuża makkinarju tat- taħlit b’ ċinga orizzontali biex jinkorpora l- prodott ma ’ l- ikel.
It is recommended that Aivlosin is first mixed with 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 bil- medikazzjoni jista ’ mbagħad isir 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.
Kondizzjonijiet sabiex isru l- pellits jinvolvu pass wieħed li jikkonsisti billi tfawwar għal 5 minuti u mbagħad isiru il- pellits f’ temperatura ta ’ mhux aktar minn 70°C taħt kondizzjonijiet normali.
No known incompatibilities.
28 M’ hemm l- ebda inkompatibilità magħrufa.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif li jinstab fil- pakkett qabel l- użu
Withdrawal period:
Żmien ta ’ tiżmim:
Meat and offal:
Laħam u l- ġewwieni:
SPECIAL WARNING(S)
TWISSIJIET SPEĊJALI OĦRA
People with known hypersensitivity to tylvalosin tartrate should avoid any contact with the product.
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 mediċinali veterinarju u t- tqandil ta ’ l- għalf medikat, kuntatt dirett ma ’ l- għajnejn, ġilda u riti 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 jew tqandel l- għalf medikat: agħta, ingwanti impermeabbli u jew respiratur ta ’ nofs maskla li jikkonforma ma ’ l- Istandard Ewropew EN 149 li tuża u tarmi jew respiratur, li mhux minn dawk li tuża u tarmi iżda 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.
Fil- każ li tibla ’ b’ mod aċċidentali fittex parir mediku immedjatament u uri t- tikketta lit- tabib.
EXP **/****
JIS ** / ****
Keep the container tightly closed.
Taħżinx f’ temperatura ta ’ aktar minn 25°C Żomm il- kontenitur magħluq sew.
Do not use after the expiry date stated on the label.
Tużax wara d- data ta ’ skadenza li hemm fuq it- tikketta
2 weeks (Aivlosin 8.5 mg/g)
Żmien kemm idum tajjeb wara li jkun inkorporat fil- maxx jew f’ pellits: xahar (Aivlosin 42. 5 mg/ g) Żmien kemm idum tajjeb wara li jkun inkorporat fil- maxx jew f’ pellits: ġimagħtejn (Aivlosin 8. 5 mg/ g)
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS, IF ANY
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI VETERINARJI MHUX UŻATI, JEKK IKUN HEMM
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Kwalunkwe prodott medicinali veterinarju li ma jintużax jew prodotti oħra għar- rimi li jiġu minn prodotti mediċinali veterinarji bħal dawn għandhom jintremew skond il- liġijiet lokali.
THE WORDS “FOR ANIMAL TREATMENT ONLY“ AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAT- TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UŻU, jekk applikabbli
For animal treatment only – to be supplied only on veterinary prescription
Għat- trattament ta ’ l- annimali biss jingħata biss b’ riċetta veterinarja
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 mediċinali lesta minn qabel għal ikel medikat, fl- għalf finali.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ”
Marketing Authorisation Holder:
Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ:
(Aivlosin 42.5 mg/g – 20 kg) (Aivlosin 42.5 mg/g – 5 kg) (Aivlosin 8.5 mg/ g – 20 kg) (Aivlosin 8.5 mg/g – 5 kg)
(Aivlosin 42, 5mg/ g – 20 kg) (Aivlosin 42, 5mg/ g – 5 kg) (Aivlosin 8, 5mg/ g – 20 kg) (Aivlosin 8, 5mg/ g – 5 kg)
Batch No:
Lott nru.
28 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
30 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Aivlosin 8.5 mg/g Oral Powder for pigs.
Aivlosin 8. 5 mg/ g Trab li Jittieħed mill- Ħalq għal qżieqeż
Active substance Tylvalosin (as Tylvalosin tartrate)
Sustanza attiva Tylvalosin (bħala Tylvalosin tartrate)
Oral powder.
Trab li jittieħed mill- ħalq.
Treatment of Porcine Proliferative Enteropathy (ileitis).
Trattament ta ’ l- Enteropatija Proliferattiva tal- Qżieqeż (ileite).
Treatment and prevention of Swine Dysentery.
Trattament u prevenzjoni tad- Disinterija tal- Qżieqeż.
Only to be added to dry food.
Biex jiżdied ma ’ ikel xott biss.
Direct contact with the eyes, skin and mucous membranes should be avoided and personal protective equipment should be worn.
Kuntatt dirett ma ’ l- għajnejn u mar- riti mukużi tal- ġilda għandu jkun evitat u għandu jintlibes tagħmir protettiv personali.
In case of accidental ingestion seek medical advice immediately and show label to physician.
F’ każ li tibla ’ b’ mod aċċidentali, fittex parir mediku minnufih u uri t- tikketta lit- tabib.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif li tinstab fil- pakkett qabel l- użu.
Do not use after the expiry date stated on the label.
Tużax wara d- data ta ’ li jiskadi li hemm fuq it- tikketta
Feed to which the oral powder has been added should be replaced if not consumed within 24 hours.
Għalf li miegħu jkun żdied it- trab li jittieħed mill- ħalq għandu jinbidel jekk ma jkunx ikkunsmat fi żmien 24 siegħa.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH VETERINARY MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI VETERINARJI MHUX UŻATI, JEKK IKUN HEMM
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Kwalunkwe prodott mediċinali veterinarju li ma jintużax jew prodotti oħra għar- rimi li jiġu minn prodotti mediċinali veterinarji bħal dawn għandhom jintremew skond il- liġijiet lokali.
THE WORDS “FOR ANIMAL TREATMENT ONLY“ AND CONDITIONS OR RESTRICTIONS REGARDING SALE AND SUPPLY, if any
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
For animal treatment only – to be supplied only on veterinary prescription
Għat- trattament ta ’ l- annimali biss – għandu jingħata biss bi preskrizzjoni veterinarja
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN“
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ”
MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
NUMRU/ I TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
31 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
33 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Granules for use in drinking water for chickens (40 g sachet)
Granuli għal użu fl- ilma tax- xorb għat- tiġieġ (qartas ta ’ 40 g)
Aivlosin 625 mg/g Granules for use in drinking water for chickens Tylvalosin (as tylvalosin tartrate)
Aivolsin 625 mg/ g Granuli għal użu fl- ilma tax- xorb għat- tiġieġ Tylvalosin (bħala tylvalosin tartrate)
ROUTE(S) OF ADMINISTRATION
METODU U MOD( I) TA 'AMMINISTRAZZJONI
In drinking water use
Biex jintuża fl- ilma tax- xorb
2 days Not for laying birds
Laħam u ġewwieni: jumejn Mhux għal tjur tal- bajd
EXP {month/year} Medicated drinking water should be replaced every 24 hours
Jiskadi {xahar/ sena} Ilma tax- xorb medikat għandu jiġi mibdul kull 24 siegħa
Opened sachets should not be stored.
Taħżinx f' temperatura ’ l fuq minn 30°C Qratas miftuħa m’ għandhomx jinżammu.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
For animal treatment only - to be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss - għandu jingħata biss bi preskrizzjoni veterinarja.
11 MARKETING AUTHORISATION NUMBER(S)
NUMRU/ I TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
33 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
35 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
Granules for use in drinking water for chickens (400 g sachet)
Granuli għal użu fl- ilma tax- xorb għat- tiġieġ (qartas ta ’ 400 g)
Granules for use in drinking water
Granuli għal użu fl- ilma tax- xorb
400 g
400g
Chicken
Tiġieġ
EXP {month/year} Medicated drinking water should be replaced every 24 hours
Jiskadi {xahar / sena} Ilma tax- xorb medikat għandu jinbidel kull 24 siegħa
Opened sachets should not be stored.
Taħżinx f' temperatura ’ l fuq minn 30°C Qratas miftuħin m’ għandhomx jinżammu.
Dispose of in accordance with local requirements.
Armi b’ mod konformi mal- ħtiġijiet lokali
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
For animal treatment only - to be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss - għandu jingħata biss bi preskrizzjoni medika.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
IL- KLIEM "GĦAL TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVISTA U L- UŻU, jekk applikabbli
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IL- KLIEM “ ŻOMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ”
15 MARKETING AUTHORISATION NUMBER(S)
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
MANUFACTURER’S BATCH NUMBER
NUMRU/ I TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
36 PACKAGE LEAFLET Aivlosin 42.5 mg/g Premix for medicated feeding stuff
38 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Aivlosin 42. 5 mg/ g Ikel imħallat mal- mediċina minn qabel bil- lest
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
L- ISEM U INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ U TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦAD- DISTRIBUZZJONI TAL- LOTT FIŻ- ŻEE, JEKK HUWA DIFFERENTI
Marketing Authorisation Holder:
Sid ta ’ l- Awtorizzazzjoni tal- Kummerċ
Manufacturer responsible for Batch Release:
Manifattur responsabbli għall- Ħruġ tal- Lott
Gallows Green Services Limited Cod Beck Blenders, Cod Beck Mill Dalton, Thirsk, North Yorkshire YO7 3HR United Kingdom
Gallows Green Services Limited Cod Beck Blenders, Cod Beck Mill Dalton, Thirsk, North Yorkshire YO7 3HR Renju Unit
Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs.
Aivlosin 42. 5 mg/ g Taħlita mediċinali lesta minn qabel għal ikel medikat għall- qżieqeż.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
DIKJARAZZJONI TAS- SUSTANZA ATTIVA U INGREDJENTI OĦRA
Active substance Tylvalosin (as Tylvalosin tartrate)
Sustanza attiva Tylvalosin
42.5 mg/g
42. 5 mg/ g
Magnesium trisilicate, wheat feed
Trisilikat tal- magnesjum, dqiq tal- qamħ tal- ikel
Treatment and prevention of Swine Enzootic Pneumonia caused by susceptible strains of Mycoplasma hyopneumoniae.
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, il- feriti fil- pulmuni u t- tnaqqis fil- piż jitnaqqsu iżda l- infezzjoni b’ 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 (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 in herds, caused by Brachyspira hyodysenteriae, where the disease has been diagnosed, and prevention of further clinical cases.
Trattament ta ’ mard kliniku mifrux ta ’ Disinterija tal- Qżieqeż, ikkawżat minn Brachyspira hyodysenteriae f’ merħliet fejn il- marda kienet iddijanjostikata, u għal prevenzjoni ta ’ każijiet kliniċi ulterjuri.
37 5.
39 5.
CONTRAINDICATIONS
KONTRAINDIKAZZJONIJIET
ADVERSE REACTIONS
EFFETTI MĦUX MIXTIEQA
None known.
L- ebda effetti mhux mixtieqa mhuma magħrufa.
If you notice any serious effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit- tabib veterinarju tiegħek.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊI, METODU U MOD TA 'AMMINISTRAZZJONI
For incorporation into dry feed only.
Jittieħed ma ’ l- ikel Biex jiżdied ma ’ ikel 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 ta ’ Pnewmonja Enżootika tal- Qżieqeż Id- dożaġġ hu ta ’ 2. 125 mg 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 tista ’ tikkomplika l- pnewmonja enżootika u tkun teħtieġ medikazzjoni speċifika.
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.
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.
Dose of active ingredient
Doża tas- sustanza attiva
In feed inclusion rate Aivlosin 42.5 mg/g Premix
Tul tal - Rata ta ’ inklużjoni ma ’ l- ikel kura Aivlosin 42. 5 mg/ g Ikel imħallat minn qabel
2.125 mg/kg bodyweight/day
2. 125 mg/ kg ta ’ 7 piż tal- ġisem / kuljum
1 kg/tonne*
ijiem 1 kg/ tunnellata *
kg/tonne*
2 kg/ tunnellata *
10 days
2 kg/ tunnellata *
kg/tonne*
* Importanti: dawn ir- rati tal- ġisem tiegħu f’ ikel kuljum.
* Important: these inclusion rates are assumes a pig eats equivalent of 5% bodyweight per day.
ta ’ inklużjoni jassumu li qażquż jiekol l- ekwivalenti ta ’ 5% tal- piż
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 qżieqeż 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.
Dose rate (mg/kg bodyweight) x bodyweight (kg)
40 Rata tad- doża (mg/ kg piż tal- ġisem) x piż tal- ġisem (kg) Kg ta ’ Ikel imħallat minn qabel/ tunnellata ta ’ ikel
38 Acute cases and severely diseased pigs with reduced food and water intake should be treated with a suitable injectable product.
Każijiet akuti u qżieqeż morda serjament b’ ikel jew teħid ta ’ l- ilma mnaqqas għandhom ikunu ttrattati bi prodott xieraq li jista ’ jkun injettat.
In addition to medical treatment, good management and hygiene practices should be established on the farm 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.
The medicated feed should be fed as the sole ration.
Dan l- ikel bil- mediċina għandu jkun l- uniku razzjon ta ’ ikel.
Mixing Instructions
Struzzjonijiet għat- taħlit
A horizontal ribbon mixer should be used to incorporate the product into feeding stuff.
Mikser tat- tip ribbon orizzontali għandu jintuża biex jinkorpora l- prodott ma ’ l- oġġetti ta ’ l- ikel.
Pelleting conditions involve a single pre-conditioning step with steam for 5 minutes and pelleting at not more than 70°C under normal conditions.
Kondizzjonijiet għal pellits jinvolvu pass wieħed li jikkondizzjona minn qabel bil- fwar għal 5 minuti u mbagħad isiru il- pellits f’ temperatura ta ’ mhux aktar minn 70°C taħt kondizzjonijiet normali.
No known incompatibilities.
M’ hemm l- ebda inkompatibilità magħrufa.
WITHDRAWAL PERIOD
PERIJODU TA 'TIŻMIM
SPECIAL STORAGE CONDITIONS
TAGĦRIF SPEĊJALI DWAR KIF GĦANDU JINĦAŻEN
Keep out of the reach and sight of children Do not store above 25°C Keep the container tightly closed.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal Taħżinx f’ temperatura ta ’ aktar minn 25°C Żomm il- kontenitur magħluq sew.
Shelf life after incorporation into feed:
Żmien kemm idum tajjeb wara li jkun inkorporat fl- ikel:
Meal and Pellets:
Għalf u pellits:
1 month
Xahar
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.
Billi Aivlosin intwera li jikkawża reazzjonijiet ta ’ sensittività eċċessiva f’ annimali tal- laboratorju, nies li hu magħruf li għandhom sensittività eċċessiva għal tylvalosin tartrate għandhom jevitaw kull kuntatt mal- prodott.
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 EN 143.
Tagħmir personali protettiv għandu jintlibes meta tħallat il- prodott mediċinali veterinarju jew tqandel l- għalf medikat: owveralls, ingwanti impermeabbli u jew respiratur ta ’ nofs maskla li jikkonforma ma ’ l- Istandard Ewropew EN 149 li tuża u tarmi 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.
41 Fil- każ ta ’ bligħ aċċidentali fittex parir mediku immedjatament u uri it- tikketta lit- tabib.
39 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.
Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above.
Tossiċità materna f’ annimali gerriema kienet osservata f’ dożi ta ’ 400 mg/ kg ta ’ tylvalosin għal kull kilogramm ta ’ piż tal- ġisem u aktar.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS, IF ANY
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Kwalunkwe prodott medicinali veterinarju li ma jintużax jew prodotti oħra għar- rimi li jiġu minn prodott medicinali veterinarju bħal dawn għandhom jintremew skond il- liġijiet lokali.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DATA META ĠIE APPROVAT L- AĦĦAR IL- FULJETT FIL- PAKKETT INFORMATTIV
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: // emea. europa. eu /.
Not all pack sizes might be marketed.
Mhux id- daqsijiet tal- pakkett kollha jistgħu jkunu għall- bejgħ.
Consideration should be given to official guidance on the incorporation of medicated premixes in final feed.
Konsiderazzjoni għandha tingħata lill- gwida uffiċjali fuq l- inkorporazzjoni ta ’ ikel imħallat minn qabel fl- għalf finali.
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.
40 Česká republika Cymedica spol. sr.o., Pod Nádražím 853, 268 01 Hořovice, ČESKÁ REPUBLIKA.
42 Česká republika Cymedica spol. sr. o., Pod Nádražím 853, 268 01 Hořovice, ČESKÁ REPUBLIKA.
France ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Royaume-Uni Tel: +44 (0) 20 8447 8899 Email: sales@ecoanimalhealth.com
France ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Royaume- Uni Tel: +44 (0) 20 8447 8899
41 Ireland ECO Animal Health Ltd, The Grange, 100 The High Street, London, N14 6BN, UNITED KINGDOM.
43 Ireland ECO Animal Health Ltd, The Grange, 100 The High Street, London, N14 6BN, UNITED KINGDOM.