natgillin/translations-raw huggingface dataset:
The MIC50 was considered high, but the isolates presented a wild-type susceptibility pattern suggesting lack of resistance.
MIK50 je bil ocenjen kot visok, vendar so imeli izolati občutljivost divjega tipa, kar pomeni odsotnost odpornosti.
To ensure the correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Za zagotovitev pravilnega odmerka je treba čim natančneje določiti telesno maso, da ne pride do premajhnega odmerjanja.
A number of isolates in Korea and Thailand may have higher iMIC figures than previously reported in the EU and USA by Wattanaphansak et al. (2009).
Številni izolati v Koreji in na Tajskem imajo morda višje vrednosti iMIK od tistih, o katerih so iz EU in ZDA predhodno poročali Wattanaphansak idr.
People with known hypersensitivity to tiamulin should administer the veterinary medicinal product with caution.
Osebe z znano preobčutljivostjo na tiamulin naj zdravilo za uporabo v veterinarski medicini dajejo previdno.
Increased MICs against B. hyodysenteriae isolates in different European Member States give rise for concern as there are only limited antimicrobials left for the treatment of swine dysentery.
Zvišanje MIK proti izolatom B. hyodysenteriae v različnih državah članicah je zaskrbljujoče, saj je za zdravljenje prašičje dizenterije na voljo le še omejeno število protimikrobnih zdravil.
The dosage of the product to be incorporated should be established according to the following formula:
Odmerek dodanega zdravila se določi po naslednji formuli:
ALUMINIUM LAMINATE BAG
ALUMINIJASTA LAMINIRANA VREČKA
The susceptibility of B. pilosicoli towards tiamulin was investigated in three studies.
Občutljivost B. pilosicoli za tiamulin so preučevali v treh študijah.
Severe growth depression, ataxia, paralysis or death may result.
Lahko pride do hudega zaostajanja v rasti, ataksije, paralize ali pogina.
Currently further isolates have been tested from Korea (Yeh et al., 2011)6, Brazil and from Thailand (MAH proprietary data, 2016).
Testirali so še druge izolate, in sicer iz Koreje (Yeh idr., 2011)6, Brazilije in s Tajske (lastniški podatki imetnika dovoljenja za promet z zdravilom, 2016).
Based on the residue depletion data available the following withdrawal periods are recommended:
Na podlagi razpoložljivih podatkov o izločanju ostankov se priporočajo naslednje karence:
The indications in turkeys were supported by in vitro susceptibility data from the same three studies as in chickens and limited susceptibility data on M. meleagridis, a limited number of artificial infection and field studies, and a number of case reports published in the late 1970s and early 1980s.
Indikacije pri puranih podpirajo podatki o občutljivosti in vitro iz istih treh študij kot pri piščancih in omejeni podatki o občutljivosti za M. meleagridis, omejeno število študij z umetno okužbo in terenskih študij ter številna poročila o primerih, objavljena v poznih 70. in zgodnjih 80. letih 20. stoletja.
Ninety three isolates of B. pilosicoli collected in Sweden (Pringle et al. 20061), 33 isolates collected in UK, Spain and Germany (MAH proprietary data 2008) as well as 324 isolates collected in Sweden between 2002 and 2010 (Pringle et al. 20122) were tested.
Testirali so 93 izolatov B. pilosicoli, zbranih na Švedskem (Pringle idr., 20061), 33 izolatov, zbranih v Združenem kraljestvu, Španiji in Nemčiji (lastniški podatki imetnika dovoljenja za promet z zdravilom iz leta 2008) ter 324 izolatov, zbranih na Švedskem med letoma 2002 in 2010 (Pringle idr., 20122).
• Eggs: Zero days
• Jajca: Nič dni
Tiamulin MICs are high against A. pleuropneumoniae.
MIK tiamulina proti A. pleuropneumoniae so visoke.
If signs of intoxication do occur promptly remove the medicated water and replace with fresh water.
Če se pojavijo znaki zastrupitve, takoj odstranite vodo z dodanim zdravilom in jo zamenjajte s svežo vodo.
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.
Čeprav smernica VICH GL48 o študijah za vrednotenje presnove in kinetike ostankov zdravil za uporabo v veterinarski medicini pri živalih za proizvodnjo živil: študije o izločanju ostankov označevalcev za ugotavljanje karence zdravil (EMA/CVMP/VICH/463199/2009) priporoča vzorčenje jajc vsaj še 12 dni po koncu zdravljenja, podatki iz drugih dveh študij (od katerih so v eni merili tiamulinu podobno aktivnost z mikrobiološko metodo, v drugi pa skupne radioaktivne ostanke) kažejo, da je raven tiamulina v jajcih najvišja po koncu zdravljenja, zato ni skrbi, da bi se zvišane ravni tiamulina v jajcih pojavile pozneje kot ob časovnih točkah, izmerjenih v ključni študiji izločanja ostankov.
A contraindication for specific ionophores is included in the product information.
V informacije o zdravilu je vključena kontraindikacija za določene ionoforje.
The main areas of disharmony in the existing product information relate to target species, indications, posology and withdrawal periods.
Glavna področja neskladij v obstoječih informacijah o zdravilu se nanašajo na ciljne živalske vrste, indikacije, odmerjanje in karenco.
The tiamulin MIC data determined for the available EU Lawsonia strains are all below the estimated ileal tiamulin contents of 0.63 μg/ml.
Podatki o MIK za tiamulin, ugotovljeni za razpoložljive seve rodu Lawsonia v EU, so vsi pod ocenjeno vsebnostjo tiamulina v ileumu, ki je 0,63 μg/ml.
It distributes widely through the body and has been shown to concentrate in the liver and kidney (sites of excretion) and in the lung (30 times serum level).
Porazdeli se po vsem telesu in se dokazano koncentrira v jetrih in ledvicah (mesti izločanja) ter v pljučih (30-kratna serumska koncentracija).
Dose (mg product per kg body weight per day)
odmerek (mg zdravila na kg telesne mase na dan)
4.7 Use during pregnancy, lactation or lay
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Brejost in laktacija:
Overall, the benefit-risk balance of Denagard 45% is considered positive subject to the recommended changes in the product information (see Annex III).
Splošno razmerje med tveganji in koristmi za zdravilo Denagard 45% je bilo ocenjeno kot pozitivno, pod pogojem, da se upoštevajo priporočene spremembe informacij o zdravilu (glejte Prilogo III).
On very rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin.
Zelo redko se lahko pojavita eritem ali blag edem kože pri prašičih po uporabi tiamulina.
The situation is transient and recovery normally occurs within 35 days following withdrawal of tiamulin treatment.
Gre za prehodno stanje in v 3-5 dneh po prenehanju zdravljenja s tiamulinom običajno pride do okrevanja.
Manufacturer's batch number <Batch> <Lot> {number}
Proizvajalčeva številka serije Serija: {številka}
administered in the drinking water gave a mycoplasmacidal effect at MIC90, reduced lung lesions and eliminated the organism in some cases.
Večji odmerki, dani v pitno vodo, so imeli mikoplazmaciden učinek pri MIK90, zmanjšali so pljučne lezije in v nekaterih primerih odstranili mikroorganizme.
Tiamulin hydrogen fumarate is well absorbed in the pig (over 90%) following oral administration and widely distributed through the body.
Tiamulinijev hidrogenfumarat se pri prašičih po peroralnem vnosu dobro absorbira (več kot 90 %) in se porazdeli po vsem telesu.
Denagard 45% is also effective in the treatment of Pleuropneumonia caused by A. pleuropneumoniae in pigs.
Zdravilo Denagard 45% je učinkovito tudi pri zdravljenju plevropneumonije pri prašičih, ki jo povzroča A. pleuropneumoniae.
The feed should be removed and replaced with fresh feed not containing the anticoccidials monensin, salinomycin or narasin.
Krmo je treba odstraniti in jo zamenjati s svežo krmo, ki ne vsebuje kokcidiostatikov monenzina, salinomicina in narazina.
Tiamulin hydrogen fumarate is well absorbed in chickens (70-95%) after oral administration and reaches peak concentrations in 2-4 hours (Tmax 2.85 hours).
Piščanci Tiamulinijev hidrogenfumarat se pri piščancih po peroralnem vnosu dobro absorbira (70-95 %) in doseže največje koncentracije po 2-4 urah (tmax 2,85 h).
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.
Klinična poročila kažejo, da so v francoski študiji uspešno zdravili M. synoviae, v madžarski in britanski študiji pa so uspešno zdravili tudi M. meleagridis, saj je prišlo do zmanjšanja kliničnih znakov, vnetja zračnih vrečk in sinusitisa.
During this referral and considering the scope of the procedure, adequate data have been submitted to support the following posology:
V tej napotitvi in glede na namen napotitve so bili predloženi ustrezni podatki v podporo naslednjemu odmerjanju:
The animals treated showed significant improvements in clinical endpoints such as diarrhoea score, feed conversion efficiency, average daily gain, and bacterial shedding was completely stopped (not examined in all studies).
Pri zdravljenih živalih je prišlo do pomembnega izboljšanja kliničnih opazovanih dogodkov, kot so resnost driske, učinkovitost presnavljanja krme, povprečni dnevni prirast telesne mase, izločanje bakterij iz telesa pa se je popolnoma ustavilo (česar niso preučevali v vseh študijah).
At higher doses (40 mg) no deaths, significantly reduced lung lesion scores, as well as no A. pleuropneumoniae re-isolation, indicating a strong bactericidal effect, were observed.
Pri večjem odmerku (40 mg) niso opazili nobene smrti, pomembno zmanjšan izid pljučnih lezij in nobene ponovne izolacije A. pleuropneumoniae, kar kaže na močan baktericidni učinek.
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.
Nadaljnje študije so pokazale zmanjšanje lezij za 95 % pri preprečevanju in za 74 % pri zdravljenju s približno predlaganim odmerkom 40 mg tiamulinijevega hidrogenfumarata/kg telesne mase, danega s pitno vodo.
The LD5 is 1090 mg/kg body weight for chickens and 840 mg/kg body weight for turkeys.
LD5 je 1090 mg/kg telesne mase pri piščancih in 840 mg/kg telesne mase pri puranih.
Appropriate guidance has been included in the product information to mitigate the risk.
V informacije o zdravilu so dodana ustrezna navodila za zmanjševanje tveganja.
(equivalent to tiamulin 365 mg/g) Excipients:
(kar ustreza 365 mg tiamulina na g) Pomožne snovi:
In order to avoid interactions between the ionophores and tiamulin, the veterinarian and farmer should check that the feed label does not state that it contains salinomycin, monensin and narasin.
Da bi se izognili medsebojnemu delovanju med ionoforji in tiamulinom, morata veterinar in kmet preveriti nalepko na krmi, da le-ta ne vsebuje salinomicina, monenzina in narazina.
The clinical signs of acute toxicity in chickens are - vocalisation, clonic cramps and lying in a lateral position, and in turkeys - clonic cramps, lateral or dorsal position, salivation and ptosis.
Klinični znaki akutne toksičnosti pri piščancih so vokalizacija, klonični krči in ležanje na strani, pri puranih pa klonični krči, ležanje na strani ali hrbtu, slinjenje in ptoza.
Target animal safety can be compromised in case of inadvertent coadministration of ionophores such as monensin, salinomycin, and narasin.
Varnost ciljnih živali je lahko ogrožena v primeru nenamerne sočasne uporabe ionoforjev, kot so monenzin, salinomicin in narazin.
At 0, 24, 36 and 48 hours after the last treatment, animals were necropsied and the entire liver was analysed for 8-α-hydroxymutilin based on a GC analytical method.
Po 0, 24, 36 in 48 urah po zadnjem zdravljenju so na živalih opravili obdukcijo in s plinsko kromatografijo analizirali 8-α-hidroksimutilin v celotnih jetrih.
Shelf life after first opening the immediate packaging: 3 months.
Rok uporabnosti po prvem odpiranju stične ovojnine: 3 mesece.
Field exposure to tiamulin at around the proposed dose rate of 25 mg/kg body weight yielded a 100% microbiological response.
Terenska izpostavljenost tiamulinu v približno predlaganem odmerku 25 mg/kg telesne mase je povzročila 100-odstoten mikrobiološki odziv.
Three artificial infection studies already discussed for chickens and two field trials supported the claims treatment and metaphylaxis of Infectious Sinusitis and Airsacculitis.
Tri študije z umetno okužbo, že obravnavane pri piščancih, in dve terenski preskušanji podpirajo trditve o zdravljenju in metafilaksi infekcijskega sinusitisa in vnetju zračnih vrečk.
There was some variation in the clinical results and there was a reported reduction in water intake with tiamulin in the drinking water.
Klinični rezultati se nekoliko razlikujejo, ob prisotnosti tiamulina v pitni vodi pa so poročali tudi o manjšem vnosu vode.
Water intake may be depressed in chickens and turkeys during the administration of tiamulin in drinking water and an inclusion rate of 250 ppm must not be exceeded.
Pri piščancih in puranih lahko med dajanjem tiamulina s pitno vodo pride do zmanjšanega vnosa vode; vsebnost 250 ppm se ne sme preseči.
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.
Pri puranih je pojav izrazitejši - vnos se zmanjša za približno 20 %, zato je priporočljivo, da ne presežete odmerka 500 mg tiamulinijevega hidrogenfumarata v 2 litrih vode za pitje.
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.
Pri perutnini velja, da ima tiamulinijev hidrogenfumarat sorazmerno visok terapevtski indeks in preveliko odmerjanje ni verjetno, zlasti, ker se pri nenormalno visokih koncentracijah zmanjša vnos vode in s tem tudi tiamulinijevega hidrogenfumarata.
In case of accidental ingestion, seek medical advice immediately and show the label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite ovojnino.
Do not use in pigs and birds that could receive products containing monensin, narasin or salinomycin during or for at least seven days before or after treatment with tiamulin.
Ne uporabite pri prašičih in pticah, ki bi lahko med zdravljenjem s tiamulinom ali vsaj sedem dni pred njim ali po njem prejemali zdravila, ki vsebujejo monenzin, narazin ali salinomicin.
The product has been shown to be efficacious in the treatment of Swine Dysentery caused by B. hyodysenteriae, Porcine Colonic Spirochaetosis (colitis) caused by B. pilosicoli and Porcine Proliferative Enteropathy (ileitis) caused by L. intracellularis.
Zdravilo je dokazano učinkovito pri zdravljenju prašičje dizenterije, ki jo povzroča B. hyodysenteriae, spirohetoze debelega črevesa (kolitisa), ki jo povzroča B. pilosicoli, in prašičje proliferativne enteropatije (ileitisa), ki jo povzroča L. intracellularis.
The susceptibility (MIC data) of M. gallisepticum and M. synoviae from turkey to tiamulin is summarised above with the in vitro susceptibility data in chickens.
Občutljivost (podatki o MIK) M. gallisepticum in M. synoviae iz puranov za tiamulin je povzeta zgoraj, skupaj s podatki o občutljivosti in vitro pri piščancih.
McOrist and Gebhart (1995)4 found an intracellular minimum bactericidal concentration (iMBC) of <2 µg/ml in another strain.
McOrist in Gebhart (1995)4 sta pri drugem sevu ugotovila, da je minimalna znotrajcelična baktericidna koncentracija (iMBK) < 2 µg/ml.
Serum protein binding is approximately 30%.
Stopnja vezave na serumske beljakovine je približno 30 %.
Denagard 45% is generally well tolerated in the target species and appropriate information is included in the product information.
Ciljne vrste zdravilo Denagard 45% na splošno dobro prenašajo in informacije o zdravilu vsebujejo ustrezne informacije.
Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to tiamulin.
Neustrezna uporaba zdravila za uporabo v veterinarski medicini lahko poveča pojavnost bakterij,
Personal protective equipment consisting of safety glasses or goggles and gloves should be worn when handling the veterinary medicinal product in order to avoid contamination of the user's eyes and topical exposure of skin.
Pri ravnanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz zaščitnih očal in rokavic, da ne pride do kontaminacije uporabnikovih oči in topikalne izpostavljenosti kože.
- very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- pogosti (pri več kot 1, toda manj kot 10 živalih od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
Doses as low as 10 mg tiamulin hydrogen fumarate/kg body weight by gavage gave excellent microbiological results when used for prevention/metaphylaxis but much higher doses were required for treatment.
Tudi tako majhni odmerki, kot je 10 mg tiamulinijevega hidrogenfumarata/kg telesne mase, ki so jih dajali z gavažo, so dali odlične mikrobiološke rezultate, ko so jih uporabili za preprečevanje/metafilakso, za zdravljenje pa so bili potrebni precej večji odmerki.
At 150 mg tiamulin hydrogen fumarate/kg body weight no central nervous system effects were noted except for tranquillisation.
Pri odmerku 150 mg tiamulinijevega hidrogenfumarata/kg telesne mase razen pomirjevalnega učinka niso opazili drugih učinkov na centralni živčni sistem.
For five French isolates of M. meleagridis the MIC ranged from 0.03 - 0.06 µg/ml.
Pri petih francoskih izolatih M. meleagridis je bila MIK v razponu med 0,03 in 0,06 µg/ml.
Corresponding wordings is added in the product information.
V informacije o zdravilu je dodano ustrezno besedilo.
In case of accidental spillage into the eye, the open eye should be flushed with water.
V primeru nenamernega razlitja v oči odprto oko sperite z vodo.
Concomitant use of tiamulin and the divalent ionophore anticoccidials lasalocid and semduramicin do not appear to cause any interaction, however the concomitant use of maduramicin may lead to a mild to moderate growth depression in chickens.
Ni videti, da bi sočasna uporaba tiamulina in divalentnih kokcidiostatičnih ionoforjev lasalocida in semduramicina povzročala kakršno koli medsebojno delovanje, medtem ko sočasna uporaba z maduramicinom pri piščancih lahko privede do blagega ali zmernega zaostajanja v rasti.
Animals were treated at the intended dose (40 mg tiamulin hydrogen fumarate/kg body weight administered daily for 5 days) and sacrificed at 0 hours, 8 hours, 1 day, 2 days and 3 days post treatment and samples from skeletal muscle, skin and underlying fat as well as liver were taken.
Živali so zdravili s predvidenim odmerkom (40 mg tiamulinijevega hidrogenfumarata/kg telesne mase, ki so ga dajali vsakodnevno v obdobju 5 dni), jih žrtvovali po 0 urah, 8 urah, 1 dnevu, 2 dnevih in 3 dnevih po zdravljenju ter odvzeli vzorce skeletnih mišic, kože in podkožne maščobe ter jeter.
For chickens and turkeys, in order to avoid interactions between the incompatible ionophores monensin, narasin and salinomycin and tiamulin, the feed mill supplying the birds feed should be notified that tiamulin will be used and that these anticoccidials should not be included in the feed or contaminate the feed.
Da bi se izognili medsebojnemu delovanju med nezdružljivimi ionoforji monenzinom, narazinom in salinomicinom ter tiamulinom pri piščancih in puranih, morajo biti obrati za pripravo ptičje krme obveščeni, da bo uporabljen tiamulin in da zato ti antikokcidiki ne smejo biti vključeni v krmo ali jo kontaminirati.
Administered for five days these doses caused significant improvements in clinical endpoints (e.g. feed conversion efficiency, average daily gain, diarrhoea score) and pathological signs though complete elimination of L. intracellularis could not be achieved.
Ti odmerki, dani v obdobju petih dni, so povzročili pomembna izboljšanja kliničnih opazovanih dogodkov (npr. učinkovitosti presnavljanja krme, povprečnega dnevnega prirasta telesne mase, resnosti driske) in bolezenskih znakov, a popolne odstranitve L. intracellularis ni bilo mogoče doseči.
In case of exposure or accidental spillage onto skin the affected area should be washed with soap and water.
V primeru izpostavljenosti ali nenamernega razlitja po koži prizadeti predel sperite z milom in vodo.
There is little evidence for serious adverse reactions, except when it is used with the incompatible coccidiostatic ionophores monensin, salinomycin, and narasin.
Dokazov o resnih neželenih učinkih je le malo, razen kadar se zdravilo uporablja z nezdružljivimi kokcidiostatičnimi ionoforji monenzinom, salinomicinom in narazinom.
In order to obtain the correct dosage the concentration of tiamulin has to be adjusted accordingly.
Koncentracijo tiamulina je treba ustrezno prilagoditi, da bo odmerek pravilen.
It has been noted that Denagard 45% and its associated names do not have the same product information across the Member States with respect to e.g. target species, indications, posology and withdrawal periods
Ugotovljeno je bilo, da se informacije o zdravilu za zdravilo Denagard 45% in povezana imena med državami članicami razlikujejo, in sicer v zvezi z npr. ciljnimi vrstami, indikacijami, odmerjanjem in karenco.
Tiamulin hydrogen fumarate is considered to have an adequate therapeutic index in the pig and a minimum lethal dose has not been established.
Terapevtski indeks tiamulinijevega hidrogenfumarata pri prašičih velja za ustreznega in minimalni smrtni odmerek ni bil ugotovljen.
It has been shown to concentrate in the lung, polymorphonuclear leucocytes and also in liver, where it is metabolised and excreted (70-85%) in the bile, the remainder is excreted via the kidney (15-30%).
Dokazano se koncentrira v pljučih, polimorfonuklearnih levkocitih in tudi v jetrih, kjer se presnovi in izloči (70-85 %) z žolčem,
The indications in chickens were supported by in vitro susceptibility data from three studies, and various artificial infection and field studies.
Indikacije pri piščancih podpirajo podatki o občutljivosti in vitro iz treh študij ter različne študije z umetno okužbo in terenske študije.
Tiamulin has shown a high level of in vitro activity against porcine and avian Mycoplasma species as well as gram-positive aerobes (streptococci and staphylococci), anaerobes (clostridia), gram-negative anaerobes (Brachyspira hyodysenteriae, Brachyspira pilosicoli), and gram-negative aerobes (Actinobacillus pleuropneumoniae and Pasteurella multocida).
Tiamulin ima visoko aktivnost in vitro proti prašičjim in ptičjim Mycoplasma vrstam, po Gramu pozitivnim aerobom (streptokokom in stafilokokom), anaerobom (klostridijem), po Gramu negativnim anaerobom (Brachyspira hyodysenteriae, Brachyspira pilosicoli) in po Gramu negativnim aerobom (Actinobacillus pleuropneumoniae in Pasteurella multocida).
Serum protein-binding was approximately 45%.
Stopnja vezave na serumske beljakovine je bila približno 45 %.