FrancophonIA/ELRC3.0 huggingface dataset:
English: The epidemiological cut-off value or wild-type MIC was approximately ≤0.25 µg/ml while resistance MICs appeared to begin at 0.5 µg/ml (first-step mutant) and 4.0 µg/ml (second-step mutant) (MAH proprietary data 2008).
Maltese: Il-valur ta' limitu epidemjoloġiku jew l-MIC tat-tip selvaġġ kien/et madwar ≤0.25 µg/ml waqt li MICs ta' reżistenza dehru li bdew b'0.5 µg/ml (mutant tal-ewwel stadju) u b'4.0 µg/ml (mutant tat-tieni stadju) (data riżervata tal-MAH 2008).
English: iii) For the treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis.
Maltese: iii) Għat-trattament ta'Enteropatija Proliferattiva tal-Qżieqeż (ileite) ikkawżata minn Lawsonia intracellularis.
English: Due to technical constraints the susceptibility of Lawsonia intracellularis is difficult to test in vitro.
Maltese: Minħabba restrizzjonijiet tekniċi, is-suxxettibilita ta' Lawsonia intracellularis huwa diffiċli li jiġi ttestjat in vitro.
English: McOrist et al. (1995)3 examined three strains of L. intracellularis to find intracellular MIC (iMIC) and extracellular MIC (eMIC)
Maltese: (1995)3 eżamina tliet razez ta' L. intracellularis biex sab li l-MIC intraċellulari (iMIC) u ekstraċellulari (eMIC) ta' tiamulin hija 4 µg/ml.
English: On 25 August 2015 Germany submitted a referral notification in accordance with Article 34(1) of Directive 2001/82/EC, to the CVMP/European Medicines Agency for Denagard 45% and its associated names (thereafter called Denagard 45%).
Maltese: Fil-25 ta' Awwissu 2015, il-Ġermanja ppreżentat notifika ta' riferiment skont l-Artikolu 34(1) tadDirettiva 2001/82/KE, lis-CVMP/lill-Aġenzija Ewropea għall-Mediċini għal Denagard 45 % u lismijiet assoċjati tiegħu (minn hawn ‘il quddiem imsejjaħ Denagard 45 %).
English: Granules
Maltese: Tiġieġ
English: In European isolates collected between 2009 and 2012 as part of the VetPath III project the following MICs of tiamulin were obtained: MIC50 of 8.0 µg/ml, MIC90 of 16 µg/ml, MIC range of 2.0-16 µg/ml.
Maltese: F'iżolati Ewropej miġbura bejn l-2009 u l-2012 bħala parti mill-proġett VetPath III, inkisbu l-MICs li ġejjin ta' tiamulin: MIC50 ta' 8.0 µg/ml, MIC90 ta' 16 µg/ml, medda ta' MIC ta' 2.0-16 µg/ml.
English: In the newer European strains and the older global isolates MIC ranges were similar for M. gallisepticum ranging from 0.001 - 0.037 µg/ml with MIC50s of 0,001 and 0.008 µg/ml and MIC90s of 0.025 and 0.031 µg/ml.
Maltese: Fir-razez Ewropej aktar ġodda u fl-iżolati globali aktar antiki, il-meded ta' MIC kienu simili għal M. gallisepticum li varjaw minn 0.001 - 0.037 µg/ml b'MIC50s ta' 0,001 u 0.008 µg/ml u MIC90s ta' 0.025 u 0.031 µg/ml.
English: McOrist, S. and Gebhart, C.J. (1995) In vitro testing of antimicrobial agents for Proliferative Enteropathy (ileitis).
Maltese: In vitro testing of antimicrobial agents for Proliferative Enteropathy (ileitis).
English: In drinking water the 250 ppm (0.025%) tiamulin hydrogen fumarate concentration provided a rolling serum level over a 48 hour medication period of 0.78 µg/ml (range 1.40.45 µg/ml) and at 125 ppm (0.0125%), 0.38 µg/ml (range 0.65-0.2 µg/ml) in eight-week old chickens.
Maltese: Fl-ilma tax-xorb il konċentrazzjoni ta'250 ppm (0.025%) ta' tiamulin hydrogen fumarate, ipprovdiet livell rolling fisserum fuq perjodu ta'medikazzjoni ta'48 siegħa ta'0.78 µg/ml (medda ta'1.4-0.45 μg/ml) u ta'125 ppm
English: Denagard 45% is also effective in the treatment of Pleuropneumonia caused by A. pleuropneumoniae in pigs.
Maltese: Denagard 45 % huwa wkoll effettiv filkura ta' Plewropulmonite kkawżata minn A. pleuropneumoniae fil-ħnieżer.
English: Marketing authorisation holder:
Maltese: Sustanza Attiva:
English: ii) Treatment of Porcine Colonic Spirochaetosis (colitis) caused by Brachyspira pilosicoli susceptible to tiamulin.
Maltese: ii) Trattament ta' Spiroċetożi Kolonika tal-Qżieqeż (kolite) ikkawżata minn Brachyspira pilosicoli suxxettibbli għal tiamulin.
English: Nine older artificial infection studies and three old field studies were presented to support the indication ‘treatment and metaphylaxis of Chronic Respiratory Disease caused by M. gallisepticum'.
Maltese: Ġew ippreżentati disa' studji aktar antiki dwar infezzjoni artifiċjali u tliet studji antiki fuq il-post sabiex jappoġġjaw l-indikazzjoni “kura u metafilassi ta' Marda Respiratorja Kronika kkawżata minn M. gallisepticum”.
English: Further studies showed a 95% lesion reduction for prevention and 74% during treatment at around the proposed dose of 40 mg tiamulin hydrogen fumarate/kg body weight given in the drinking water.
Maltese: Aktar studji wrew tnaqqis ta' leżjonijiet ta' 95 % għall-prevenzjoni u 74 % waqt ilkura b'madwar id-doża proposta ta' 40 mg tiamulin hydrogen fumarate/kg piż tal-ġisem li ngħata fl-ilma tax-xorb.
English: Artificial challenge studies were carried out using tiamulin inclusion rates in drinking water ranging from 120 to 180 ppm equivalent to doses of 20 to 40 mg tiamulin hydrogen fumarate/kg body weight.
Maltese: Saru studji dwar sfida artifiċjali bl-użu ta' rati ta' inklużjoni ta' tiamulin fl-ilma tax-xorb li varjaw minn 120 sa 180 ppm ekwivalenti għal dożi ta' 20 sa 40 mg tiamulin hydrogen fumarate/kg piż talġisem.
English: • Chronic Respiratory Disease caused by M. gallisepticum and Airsacculitis and Infectious Synovitis caused by M. synoviae: 25 mg tiamulin hydrogen fumarate (equivalent to 55.6 mg of product)/kg body weight administered daily for the period of 3 to 5 consecutive days.
Maltese: Marda Respiratorja Kronika kkawżata minn M. gallisepticum u Airsacculitis u Sinovite Infettiva kkawżati minn M. synoviae: 25 mg taimulin hydrogen fumarate (ekwivalenti għal 55.6 mg ta' prodott)/kg piż tal-ġisem mogħti kuljum għal perjodu ta' 3 sa 5 ijiem konsekuttivi.
English: From these data the CVMP concluded that Denagard 45% at a dose of 40 mg tiamulin hydrogen fumarate (equivalent to 88.9 mg of product)/kg body weight for three to five consecutive days would be efficacious in the treatment and metaphylaxis of Infectious Sinusitis and Airsacculitis caused by Mycoplasma gallisepticum, Mycoplasma synoviae and Mycoplasma meleagridis susceptible to tiamulin.
Maltese: Minn din id-data, is-CVMP ikkonkluda li Denagard 45 % f'doża ta' 40 mg tiamulin hydrogen fumarate (ekwivalenti għal 88.9 mg ta' prodott)/kg piż tal-ġisem għal tlitt sa ħamest ijiem konsekuttivi jkun effikaċi fil-kura u l-metafilassi ta' Sinusite Infettiva u Airsacculitis kkawżati minn Mycoplasma gallisepticum, Mycoplasma synoviae u Mycoplasma meleagridis suxxettibbli għal tiamulin.
English: Tiamulin hydrogen fumarate is a bacteriostatic semi-synthetic antibiotic belonging to the pleuromutilin group of antibiotics and acts at the ribosomal level to inhibit bacterial protein synthesis.
Maltese: Tiamulin hydrogen fumarate huwa antibijotiku semisintetiku batterjostatiku li jappartjeni għall-grupp pleuromutilin ta' antibijotiċi u jaġixxi fil-livell ta' ribożomi sabiex jinibixxi s-sinteżi tal-proteina batterika.
English: In European isolates tiamulin was highly active against M. hyopneumoniae, with MIC50 of 0.016 µg/ml, MIC90 of 0.062 µg/ml, and a MIC range of 0.002-0.125 µg/ml (MycoPath I project, 2014).
Maltese: F'iżolati Ewropej tiamulin kien attiv ħafna kontra M. hyopneumoniae, b'MIC50 ta' 0.016 µg/ml, MIC90 ta' 0.062 µg/ml, u medda ta' MIC ta' 0.
English: Manufacturer's batch number <Batch> <Lot> {number}
Maltese: Numru tal-lott tal-manifattur Lott {numru}
English: For M. synoviae MICs ranged from 0.05 to 0.5 µg/ml with MIC50s of 0.1 µg/ml and a MIC90 of 0.25 µg/ml.
Maltese: Għal M. synoviae l-MICs varjaw minn 0.05 sa 0.5 µg/ml b'MIC50s ta' 0.1 µg/ml u MIC90 ta' 0.25 µg/ml.
English: Aluminium foil sachets of 55.6 g and 111.2 g
Maltese: 55.6 g 111.
English: Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to tiamulin.
Maltese: Użu ħażin tal-prodott mediċinali veterinarju jista jżid il-prevalenza ta' batteri reżistenti għal tiamulin.
English: Clinical case reports did suggest that M. synoviae was treated effectively in a French study, and Hungarian and UK studies showed that M. meleagridis was also effectively treated causing reductions in clinical signs, airsacculitis and sinusitis.
Maltese: Ir-rapporti kliniċi ssuġġerixxew li M. synoviae ġiet ikkurata b'mod effettiv fi studju Franċiż, u studji Ungeriżi u tar-Renju Unit urew li M. meleagridis ukoll ġiet ikkurata b'mod effettiv waqt li kkawżat tnaqqis fi studji kliniċi, airsacculitis u sinusite.
English: Following a 50 mg tiamulin hydrogen fumarate/kg body weight single dose the Cmax was 4.02 µg/ml in serum by microbiological assay and after a 25 mg/kg dose it was 1.86 µg/ml.
Maltese: Wara doża waħda ta'50 mg ta'tiamulin hydrogen fumarate/kg ta'piż tal-ġisem, is-Cmax kien ta'4.02 μg/ml fis-serum permezz ta'assaġġ mikrobijoloġiku, u wara doża ta'25 mg/kg kien ta'1.86 μg/ml.
English: When administered in the drinking water at 125, 250, or 500 ppm the estimated dose rates ranged from as low as 22 mg tiamulin hydrogen fumarate/kg body weight to a maximum of 102 mg tiamulin hydrogen fumarate/kg body weight.
Maltese: Meta ngħata fl-ilma tax-xorb f'125, 250, jew 500 ppm, ir-rati tad-dożi stmati varjaw minn baxxi sa 22 mg tiamulin hydrogen fumarate/kg piż tal-ġisem għal massimu ta' 102 mg tiamulin hydrogen fumarate/kg piż tal-ġisem.
English: The liver residue data were subjected to log-linear regression using the WT1.4 calculation program and the resulting withdrawal period was 42 hours, rounded up to two days.
Maltese: Id-data dwar ir-residwi tal-fwied ġiet soġġetta għal rigressjoni loglineari bl-użu tal-programm ta' kalkolu WT1.4 u l-perjodu tal-irtirar li rriżulta kien ta' 42 siegħa, li tqarreb għal jumejn.
English: - Dosage: 25 mg tiamulin hydrogen fumarate (equivalent to 55.6 mg of product)/kg body weight administered daily for 3 to 5 consecutive days.
Maltese: - Dożaġġ: 25 mg tiamulin hydrogen fumarate (ekwivalenti għal 55.6 mg ta' prodott)/kg piż tal-ġisem mogħti kuljum għal 3 sa 5 ijiem konsekuttivi.
English: Regarding poultry, there is a relatively high therapeutic index with tiamulin hydrogen fumarate and the likelihood of an overdose is considered remote especially as water intake and hence tiamulin hydrogen fumarate intake is reduced if abnormally high concentrations are given.
Maltese: Fit-tjur hemm indiċi terapewtiku relattivament għoli b'tiamulin hydrogen fumarate, u l-probabbiltà ta'doża eċċessiva hi kkunsidrata li hi remota, speċjalment billi t-teħid tal-ilma, u għaldaqstant it-teħid ta'tiamulin hydrogen fumarate, jitnaqqas jekk jingħataw konċentrazzjonijiet għoljin b'mod anormali.
English: Although VICH guideline GL48 on Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009) recommends sampling eggs until at least 12 days after the end of treatment, data from two other studies (one of which measured tiamulin-like activity using a microbiological method and the other of which measured total radioactive residues) indicate that tiamulin levels in eggs peak immediately after the end of treatment and consequently there is no concern that increased tiamulin levels in eggs will occur at time points beyond those measured in the pivotal residue depletion study.
Maltese: Għalkemm il-linja gwida GL48 ta' VICH dwar Studji sabiex jiġu vvalutati l-metaboliżmu u l-kinetiċi tar-residwi ta' mediċini veterinarji f'annimali li jipproduċu l-ikel: studji dwar it-tnaqqis tar-residwi mmarkati sabiex jiġu stabbiliti perjodi tal-irtirar tal-prodotti (EMA/CVMP/VICH/463199/2009) tirrakkomanda l-kampjunar tal-bajd tal-inqas 12-il jum wara tmiem il-kura, data minn żewġ studji oħra (wieħed li kejjel l-attività bħal ta' tiamulin bl-użu ta' metodu mikrobijoloġiku u l-ieħor li kejjel r-residwi radjuattivi totali) tindika li l-livelli ta' tiamulin fil-bajd jilħqu l-milja tagħhom immedjatament wara tmiem il-kura u konsegwentement m'hemm l-ebda tħassib li se jkun hemm livelli ta' tiamulin miżjuda fil-bajd fil-punti ta' żmien wara dawk imkejla fl-istudju dwar it-tnaqqis tar-residwi pivotali.
English: At 250 ppm tiamulin hydrogen fumarate administered for three days significant improvements in clinical endpoints, pathological signs and elimination of M. gallisepticum were shown.
Maltese: B'250 ppm tiamulin hydrogen fumarate li ngħata għal tlitt ijiem, intwera titjib kbir f'punti finali klinċi, f'sinjali patoloġiċi u ntweriet l-eliminazzjoni ta' M. gallisepticum.
English: It appears to inhibit microbial protein production by producing biochemically inactive initiation complexes, which prevent elongation of the polypeptide chain.
Maltese: Jidher li jinibixxi l-produzzjoni ta' proteini mikrobjali billi jipproduċi kumplessi talinizjazzjoni bijokimikament inattivi, li jipprevjenu t-titwil tal-katina tal-polypeptide.
English: Artificial challenge studies were carried out using tiamulin inclusion rates in drinking water ranging from 60 to 250 ppm or estimated doses from 10 to 64.2 mg tiamulin hydrogen fumarate/kg body weight.
Maltese: Saru studji dwar sfida artifiċjali bl-użu ta' rati ta' inklużjoni ta' tiamulin fl-ilma tax-xorb li varjaw minn 60 sa 250 ppm jew b'dożi stmati minn 10 sa 64.2 mg tiamulin hydrogen fumarate/kg piż talġisem.
English: For the higher dosage (20 mg tiamulin hydrogen fumarate per kg body weight for up to five days) a GLP-compliant residue depletion study using a bioequivalent product containing 125 mg tiamulin hydrogen fumarate per ml (Tiamutin 12.5 % Solution) was provided.
Maltese: Għad-dożaġġ ogħla (20 mg tiamulin hydrogen fumarate għal kull kg piż tal-ġisem sa ħamest ijiem), ġie pprovdut studju dwar it-tnaqqis tar-residwi konformi mal-GLP bl-użu ta' prodott bijoekwivalenti li fih 125 mg tiamulin hydrogen fumarate għal kull ml (Tiamutin 12.5 % Soluzzjoni).
English: Tiamulin at inclusion rates of 100 ppm (equivalent to 5 mg tiamulin hydrogen fumarate/kg body weight) and doses of 8 mg tiamulin hydrogen fumarate/kg body weight was administered for five to ten days.
Maltese: Tiamulin b'rati ta' inklużjoni ta' 100 ppm (ekwivalenti għal 5 mg tiamulin hydrogen fumarate/kg piż tal-ġisem) u f'dożi ta' 8 mg tiamulin hydrogen fumarate/kg piż tal-ġisem ingħata għal ħamest sa għaxart ijiem.
English: From each individual pig, specimens from liver and muscle were collected and analysed for 8-α-hydroxymutilin using a validated LCMS-MS analytical method.
Maltese: Għal kull ħanżir individwali, inġabru kampjuni mill-fwied u mill-muskolu u ġew analizzati għal 8-α-hydroxymutilin bl-użu ta' metodu analitiku LCMS-MS validat.
English: In breeders on 0.025% tiamulin hydrogen fumarate the average serum level was 0.36 µg/ml (range 0.22-0.5 µg/ml).
Maltese: F'dundjani tat-tgħammirli kienu fuq 0.025% tiamulin hydrogen fumarate, il-medja tal-livell fis-serum kienet ta'0.36 μg/ml (medda ta'0.22-0.5 µg/ml).
English: Colon contents concentrations of tiamulin have been estimated at 3.41 µg/ml following administration of tiamulin hydrogen fumarate at 8.8 mg/kg body weight.
Maltese: Il-kontenut ta'konċentrazzjonijiet ta'tiamulin fil-kolon ġew stmati li huma 3.41µg/ml wara l-għoti ta' tiamulin hydrogen fumarate f'dożaġġ ta'8.8 mg/kg ta' piż tal-ġisem.
English: The susceptibility of B. pilosicoli towards tiamulin was investigated in three studies.
Maltese: Is-suxxettibbiltà ta' B. pilosicoli lejn tiamulin ġiet investigata fi tliet studji.
English: At 150 mg tiamulin hydrogen fumarate/kg body weight no central nervous system effects were noted except for tranquillisation.
Maltese: F'dożaġġ ta' 150 mg ta' tiamulin hydrogen fumarate/kg ta' piż tal-ġisem, ma ġew osservati l-ebda effetti fis-sistema nervuża ċentrali ħlief għal trankwillizzazzjoni.
English: Following a single oral dose of 10 mg and 25 mg tiamulin hydrogen fumarate/kg body weight the Cmax was 1.03 µg/ml and 1.82 µg/ml in serum respectively by microbiological assay and the Tmax was 2 hours for both.
Maltese: Wara doża orali waħda ta'10 mg u 25 mg ta'tiamulin hydrogen fumarate/kg ta' piż tal-ġisem, is-Cmax kienet ta'1.03µg/ml u 1.82 μg/ml fis-serum rispettivament skont analiżi mikrobijoloġika, u t-Tmax kien ta'sagħtejn għat-tnejn.
English: For M. synoviae MICs ranged from 0.004 to 0.5 µg/ml with a MIC50 of 0,125 µg/ml and a MIC90 of 0.25 µg/ml.
Maltese: Għal M. synoviae l-MICs varjaw minn 0.004 sa 0.5 µg/ml b'MIC50 ta' 0,125 µg/ml u MIC90 ta' 0.25 µg/ml.
English: The CVMP agreed that although there is limited data for M. synoviae in comparison with M. gallisepticum, the available information from the studies provided is sufficient to support the conclusion that Denagard 45% at a dose of 25 mg tiamulin hydrogen fumarate (equivalent to 55.6 mg of product)/kg body weight for three to five consecutive days would be efficacious in the treatment and metaphylaxis of Airsacculitis and Infectious Synovitis caused by M. synoviae.
Maltese: Is-CVMP qabel li għalkemm hemm data limitata għal M. synoviae meta mqabbla ma' M. gallisepticum, l-informazzjoni disponibbli mill-istudji pprovduti hija biżżejjed biex tappoġġja lkonklużjoni li Denagard 45 % f'doża ta' 25 mg tiamulin hydrogen fumarate (ekwivalenti għal 55.6 mg ta' prodott)/kg piż tal-ġisem għal tlitt sa ħamest ijiem konsekuttivi jkun effikaċi fil-kura u l-metafilassi ta' Airsacculitis u Sinovite Infettiva kkawżati minn M. synoviae.
English: For the treatment and metaphylaxis of Infectious Sinusitis and Airsacculitis caused by Mycoplasma gallisepticum, Mycoplasma synoviae and Mycoplasma meleagridis.
Maltese: Għat-trattament u l-metafilassi ta' Sinusite Infettiva u Airsakkulite kkawżati minn Mycoplasma gallisepticum, Mycoplasma synoviae u Mycoplasma meleagridis.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group:
Maltese: KWALITAJIET FARMAKOLOĠIĊI
English: Field exposure to tiamulin at around the proposed dose rate of 25 mg/kg body weight yielded a 100% microbiological response.
Maltese: Esponiment fuq il-post għal tiamulin f'madwar ir-rata ta' doża proposta ta' 25 mg/kg piż tal-ġisem kisbet rispons mikrobijoloġiku ta' 100 %.
English: Indication(s)
Maltese: Indikazzjoni(jiet)
English: DENAGARD 45% W.S.G.
Maltese: DENAGARD 45% W.S.G. voor varkens en kippen
English: Tiamulin was administered for three days by gavage at 20-30 mg tiamulin hydrogen fumarate/kg body weight or in the drinking water.
Maltese: Tiamulin ingħata għal tlitt ijiem bi tmigħ sfurzat f'20-30 mg tiamulin hydrogen fumarate/kg piż tal-ġisem jew fl-ilma tax-xorb.
English: From these data the CVMP concluded that Denagard 45% at a dose of 20 mg tiamulin hydrogen fumarate (equivalent to 44.4 mg of product)/kg body weight for five consecutive days would be efficacious in the treatment and metaphylaxis of Enzootic Pneumonia caused by M. hyopneumoniae, including infections complicated by P. multocida.
Maltese: Minn din id-data, is-CVMP ikkonkluda li Denagard 45 % f'doża ta' 20 mg tiamulin hydrogen fumarate (ekwivalenti għal 44.4 mg ta' prodott)/kg piż tal-ġisem għal ħamest ijiem konsekuttivi jkun effikaċi fil-kura ta' Pulmonite Enzootika kkawżata minn M. hyopneumoniae, inkluż infezzjonijiet ikkumplikati minn P. multocida.
English: - Dosage: 40 mg tiamulin hydrogen fumarate (equivalent to 88.9 mg of product)/kg body weight administered daily for 3 to 5 consecutive days.
Maltese: - Dożaġġ: 40 mg tiamulin hydrogen fumarate (ekwivalenti għal 88.9 mg ta' prodott)/kg piż tal-ġisem mogħti kuljum għal 3 sa 5 ijiem konsekuttivi.
English: - Treatment of Porcine Proliferative Enteropathy (ileitis) caused by Lawsonia intracellularis susceptible to tiamulin.
Maltese: - Trattament ta' Enteropatija Proliferattiva tal-Qżieqeż (ileite) ikkawżata minn Lawsonia intracellularis suxxettibli għal tiamulin.
English: Lactose
Maltese: FARMAĊEWTIKU
English: Three distinct multi-resistant strains were isolated.
Maltese: Ġew iżolati tliet razez multireżistenti distinti.
English: As long as combined use with these ionophores is avoided, especially in broilers, Denagard 45% has proven to be safe and effective in the treatment of airsacculitis, synovitis and sinusitis caused by M. gallisepticum, M. synoviae and/or M meleagridis in chickens and turkeys.
Maltese: Sakemm jiġi evitat l-użu kkombinat ma' dawn lionofori, speċjalment fit-tiġieġ tas-simna, Denagard 45 % wera li huwa sigur u effettiv fil-kura ta' airsacculitis, sinovite u sinusite kkawżati minn M. gallisepticum, M. synoviae u/jew M meleagridis fit-tiġieġ u fid-dundjani.
English: The indication Porcine Colonic Spirochaetosis (colitis) caused by B. pilosicoli was supported by in vitro susceptibility data and field studies.
Maltese: L-indikazzjoni Spiroketożi Konolika tal-Ħnieżer (kollite) ikkawżata minn B. pilosicoli ġiet appoġġjata minn data dwar suxxettibbiltà in vitro u minn studji fuq il-post.
English: - Dosage: 20 mg tiamulin hydrogen fumarate (equivalent to 44.4 mg of product)/kg body weight administered daily for 5 consecutive days.
Maltese: - Dożaġġ: 20 mg tiamulin hydrogen fumarate (ekwivalenti għal 44.4 mg ta' prodott)/kg piż tal-ġisem mogħti kuljum għal 5 ijiem konsekuttivi.
English: iv) Treatment and metaphylaxis of Enzootic Pneumonia caused by Mycoplasma hyopneumoniae, including infections complicated by Pasteurella multocida susceptible to tiamulin.
Maltese: iv) Għat-trattament u l-metafilassi ta' Pnewmonja Enzootika kkawżata minn Mycoplasma hyopneumoniae, inklużi infezzjonijiet ikkumplikati minn Pasteurella multocida, suxxettibli għal tiamulin.
English: In turkeys serum levels of tiamulin hydrogen fumarate are lower with a 50 mg tiamulin hydrogen fumarate/kg body weight single dose giving a Cmax of 3.02 µg/ml in serum, and 25 mg/kg giving 1.46 µg/ml.
Maltese: Fid-dundjani, il-livelli ta'tiamulin fis-serum ta'tiamulin hydrogen fumarate, huma aktar baxxi b'doża waħda ta'50 mg ta'tiamulin hydrogen fumarate/kg ta'piż tal-ġisem, li jagħtu Cmax ta'3.02 μg/ml fis serum, u 25 mg/kg li jagħtu 1.46 μg/ml.
English: For edible tissues and based on residue concentrations in liver, a withdrawal period of 26.2 hours was calculated using the WT1.4 calculation program, rounded up to 2 days.).
Maltese: Għal tessuti li jistgħu jittieklu u abbażi ta' konċentrazzjonijiet tar-residwi filfwied, ġie kkalkulat perjodu tal-irtirar ta' 26.2 sigħat permezz tal-programm ta' kalkolu WT1.4, li tqarreb għal jumejn.).
English: The indication for treatment and metaphylaxis of Enzootic Pneumonia caused by M. hyopneumoniae, including infections complicated by P. multocida was supported by in vitro susceptibility data from the European MycoPath I project, proprietary clinical studies and literature.
Maltese: L-indikazzjoni għall-kura u l-metafilassi ta' Pulmonite Enzootika kkawżata minn Mycoplasma hyopneumoniae, inkluż infezzjonijiet ikkumplikati minn P. multocida ġiet appoġġjata minn data dwar suxxettibbiltà in vitro mill-proġett Ewropew MycoPath I, minn studji kliniċi riżervati u milletteratura.
English: This includes the specification of target pathogens, replacement of the prevention claim by metaphylaxis and clear dose recommendations based on mg tiamulin hydrogen fumarate/kg body weight for each target species and indication as well as prudent use recommendations for antimicrobial veterinary medicinal products authorised in the EU.
Maltese: Din tinkludi l-ispeċifikazzjoni tal-patoġeni fil-mira, sostituzzjoni tad-dikjarazzjoni tal-prevenzjoni mill-metafilassi u rakkomandazzjonijiet tad-doża ċari abbażi ta' mg tiamulin hydrogen fumarate/kg piż tal-ġisem għal kull speċi fil-mira u indikazzjoni kif ukoll rakkomandazzjonijiet ta' użu prudenti għal prodotti mediċinali veterinarji antimikrobiċi awtorizzati fl-UE.
English: In turkeys, it is more marked, with approximately 20% reduction and therefore it is recommended not to exceed a concentration of 500 mg tiamulin hydrogen fumarate in 2 litres of the drinking water.
Maltese: Fid-dundjani, ikun aktar notevoli, bi tnaqqis ta' madwar 20%, u għalhekk hu rrakkomandat li ma teċċedix konċentrazzjoni ta' 500 mg ta'tiamulin hydrogen fumarate f '2 litriilma tax-xorb.
English: Lee, H.R. Yeh, A. Kim, J.Y.
Maltese: Lee, J.M. Hwang, B.K. Kang, J.M. 783 Kim, I.S. Choi, and J.B. Lee. 2011.