natgillin/translations-raw huggingface dataset:
Wash hands and any exposed skin with soap and water immediately after use.
Takoj po uporabi si z milom in vodo umijte roke in izpostavljene dele kože.
On the basis of in vitro tests, it has been hypothesised that a metabolite or degradation product of spectinomycin was produced in the gut and was able to reach the infection site and interfere with E. coli adherence to the respiratory mucosa, but this has not been validated (Goren et al., 1988)2.
Na podlagi preiskav in vitro je bila postavljena hipoteza, da se v črevesu tvori presnovek ali produkt razgradnje spektinomicina, ki doseže mesto okužbe in ovira priraščanje E. coli na sluznico dihal, vendar to ni bilo validirano (Goren in sod.
Shelf life of the veterinary medicinal product as packaged for sale: “to be completed nationally”.
Rok uporabnosti zdravila v pakiranju za prodajo: “podatke je treba dopolniti v posameznih državah”.
The proposed withdrawal time of 0 days was well supported by a residue study where pigs were treated using the proposed harmonised dosing regimen 10 mg/kg bw/day for 7 days, and is considered acceptable by the CVMP.
Predlagana karenca 0 dni je bila dobro podprta s študijami ostankov, v katerih so se prašiči zdravili s predlaganim usklajenim režimom odmerjanja 10 mg/kg telesne mase/dan 7 dni, kar je sprejemljivo za odbor CVMP.
The repeated or prolonged use should be avoided, by improving the farm management and disinfection practices.
Z izboljšanim upravljanjem kmetije in z izboljšanjem navad glede dezinfekcije se je treba izogniti ponavljajoči in podaljšani uporabi zdravila.
A single oral administration of lincomycin hydrochloride, at dose levels of approximately 22, 55 and 100 mg/kg body weight in pigs, resulted in dose related lincomycin serum levels, detected for 24-36 hours after administration.
Po enkratnem peroralnem dajanju linkomicinijevega klorida v odmerkih po približno 22, 55 in100 mg/kg/telesne teže prašičem, so v serumu še 24-36 ur po dajanju izmerili vrednosti linkomicina, ki so bile odvisne od velikosti odmerka.
In Brachyspira hyodysenteriae nearly all isolates are resistant at least regarding the wild-type in vitro susceptibility.
Pri Brachyspira hyodysenteriae so bili skoraj vsi izolati odporni, predvsem glede občutljivosti divjih tipov in vitro.
Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis, it has bacteriostatic activity and is active against Mycoplasma spp.
Spektinomicin spada med aminociklitole in je proizvod bakterije Streptomyces spectabilis, deluje bakteriostatično, deluje proti Mycoplasma spp.
Use of the product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria resistant to lincomycin and spectinomycin and may decrease the effectiveness of treatment with other antimicrobials of the same or related classes, due to the potential for cross resistance.
Uporaba zdravila, ki ni v skladu z navodili v povzetku glavnih značilnosti zdravila, lahko poveča tveganje za razvoj in selekcijo odpornih bakterij in zmanjša učinkovitost zdravljenja z drugimi protimikrobnimi zdravili iz istega ali sorodnega razreda zaradi možnosti nastanka navzkrižne odpornosti.
There is no established clinical breakpoint.
Klinična mejna vrednost ni določena.
For those reasons, despite that the available data show no negative evolution over time, it could not be excluded that the results obtained in the old clinical studies conducted at the time of product development do not reflect clinical efficacy in modern outbreaks of swine dysentery.
Čeprav razpoložljivi podatki ne kažejo negativne evolucije v času, pa zaradi zgornjih razlogov ni mogoče izključiti, da rezultati iz starih kliničnih študij, izvedenih v času razvoja zdravila, ne odražajo klinične učinkovitosti pri sodobnih izbruhih prašičje dizenterije.
Pigs: 3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day, for 7 days.
Prašiči: 3,33 mg linkomicina in 6,67 mg spektinomicina/kg telesne teže/dan, za čas zdravljenja 7 dni.
For E. coli, a newly conducted pan-European MIC survey, involving 67 chicken isolates and 33 turkey isolates, showed a wide MIC range (from 2:4 to ≥256:512 µg/ml), a high spectinomycin MIC90 (256 µg/ml) and a bimodal distribution.
Nova panevropska raziskava MIK za E. coli, ki je vključila 67 izolatov iz piščancev in 33 izolatov iz puranov, je pokazala širok razpon MIK (od 2 : 4 do ≥ 256 : 512 µg/ml), veliko vrednost MIK90 za spektinomicin (256 µg/ml) in bimodalno porazdelitev.
In general mixture with other medicines should be avoided.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Mešanju z drugimi zdravili se je treba praviloma izogibati.
This could be due to combined intra- and extracellular action of lincomycin and spectinomycin, respectively.
To je lahko posledica kombiniranega znotrajin zunajceličnega delovanja linkomicina oziroma spektinomicina.
Spectinomycin is classified as an aminocyclitol antibiotic, close to aminoglycosides; it inhibits protein synthesis by binding to the 30S ribosomal subunit.
Spektinomicin je razvrščen kot aminociklitolni antibiotik, soroden aminoglikozidom; zavira sintezo beljakovin, tako da se veže na ribosomsko podenoto 30S.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
Pigs and chickens.
Prašiči in piščanci.
In a GCP-compliant, multicentre field study, pigs were treated as recommended and medication with Linco-Spectin 100 for 7 and 14 days was efficacious for the treatment of ileitis in pigs; there was no benefit of treating pigs suffering from ileitis longer than 7 days.
Zdravljenje z zdravilom Linco-Spectin 100, ki je trajalo 7 in 14 dni, je bilo učinkovito proti ileitisu pri prašičih; zdravljenje prašičev z ileitisom več kot 7 dni ni bilo koristno.
Due to technical constraints the susceptibility of Lawsonia intracellularis is difficult to test in vitro, and data about the resistance status in that species are lacking.
Zaradi tehničnih omejitev je občutljivost Lawsonia intracellularis težko preskušati in vitro in podatki o odpornosti pri teh vrstah so pomanjkljivi.
Spectinomycin is poorly absorbed by the gastro-intestinal tract and does not easily cross membranes.
Spektinomicin se slabo absorbira v prebavilih in slabo prehaja skozi membrane.
Do not use in birds in lay.
Ne uporabite pri pticah v obdobju nesnosti.
In chickens, in order to reflect the fact that in the only study formally demonstrating efficacy of the 50 mg/kg dose against CRD clinical signs and lesions, the challenge was mild to moderate with no mortality recorded, it is proposed to amend the indication as follows:
Ker je bila v edini študiji na piščancih, ki je uradno dokazala učinkovitost odmerka 50 mg/kg proti kliničnim znakom in lezijam KRB, provokacija blaga do zmerna in brez umrljivosti, je odbor predlagal naslednjo spremembo indikacije:
Among in vitro susceptibility data for M. gallisepticum, a new MIC survey of lincomycin-spectinomycin (1:2 ratio) was carried out on 60 isolates, and showed a MIC range of [0.25:0.5 - 8:16 µg/ml], and MIC50/MIC90 values of 0.5:1 and 2:4 µg/ml, respectively.
Glede podatkov o občutljivosti in vitro za M. gallisepticum se je izvedla nova raziskava MIK za linkomicin-spektinomicin (v razmerju 1 : 2) s 60 izolati, ki je pokazala razpon MIK [0,25 : 0,58 : 16 µg/ml] in vrednosti MIC50 0,5 : 1 ter MIC90 2 : 4 µg/ml.
June http://www.who.int/foodsafety/foodborne_disease/AGISAR_2009_report_final.pdf?ua=1
3 Poročilo Report of the first meeting of the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR), 15-19 June 2009. http://www.who.int/foodsafety/foodborne_disease/AGISAR_2009_report_final.pdf?ua=1
For the treatment and prevention of dysentery caused by Brachyspira hyodysenteria and for the treatment and prevention of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis, and associated enteric pathogens (Escherichia coli).
Za zdravljenje in preprečevanje prašičje dizenterije, ki jo povzroča Brachyspira hyodysenteriae, za zdravljenje in preprečevanje prašiščje proliferativne enteropatije (ileitisa), ki ga povzroča Lawsonia intracellularis in povezanih črevesnih patogenov (Escherichia coli).
4.8 Interaction with other medicinal products and other forms of interaction
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Mešanju z drugimi zdravili se je treba praviloma izogibati.
It was the only available trial where the 50 mg/kg bw dose was firmly shown to be beneficial in a treatment context, although the challenge was rather mild (e.g. no mortality was recorded);
To je bilo edino razpoložljivo preskušanje, v katerem so jasno pokazali, da je odmerek 50 mg/kg telesne mase koristen v sklopu zdravljenja, čeprav je bila provokacija precej blaga (npr. zabeležili niso nobenega primera umrljivosti).
* A detrimental shift to the use of other molecules considered as more important to public health (e.g. fluoroquinolones) might occur in case the product is withdrawn in chickens.
• Če se zdravilo za uporabo pri piščancih ukine, lahko pride do škodljivega prehoda na uporabo drugih molekul, za katere menijo, da so pomembnejše za javno zdravje (npr. fluorokinoloni).
The combination was superior to lincomycin alone.
Kombinacija je bila boljša kot samostojni linkomicin.
Chickens: 16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw/day, for 7 days.
Piščanci: 16,65 mg linkomicina in 33,35 mg spektinomicina/kg telesne teže/dan, za čas zdravljenja 7 dni.
Excipients: Sodium benzoate, lactose.
Pomožne snovi: Natrijev benzoat, laktoza monohidrat.
Poultry (broilers)
Piščanci (brojlerji)
Lincomycin resistance is widespread in B. hyodysenteriae and may lead to clinical treatment failure.
Razširjena odpornost na linkomicin pri B. Hyodysenteriae ima lahko za posledico neuspešno klinično zdravljenje.
It is mainly active against Gram-positive bacteria and obligate anaerobes, and against mycoplasmas.
Navadno učinkuje proti grampozitivnim bakterijam, obligatnim anaerobom in mikoplazmam.
Personal protective equipment consisting of approved dust masks (either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to European Standard EN 140 with a filter EN 143), gloves and safety glasses should be worn when handling and mixing the product.
Ob ravnanju in mešanju izdelka je treba nositi osebno zaščitno opremo, ki sestoji iz priporočenih mask za prah (ali dihalno polmasko za enkratno uporabo, ki ustreza evropskemu standardu EN149 ali dihalno masko za veečkratno uporabo, ki ustreza evropskemu standardu EN140 s filtrom EN143), rokavic in zaščitnih očal.
NAME OF THE VETERINARY MEDICINAL PRODUCT <Invented name> 222 mg/g + 444.7 mg/g powder for use in drinking water lincomycin (as lincomycin hydrochloride)/spectinomycin (as spectinomycin sulphate).
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI <Izmišljeno ime> 222 mg/g + 444,7 mg/g prašek za dajanje v vodo za pitje linkomicin (kot linkomicinijev klorid)/spektinomicin (kot spektinomicinijev sulfat)
Double LDPE bag containing 4.5 kg powder inside a tamper evident polypropylene tub with a polypropylene lid.
Dvojna LDPE vreča v vedru iz polipropilena z zaščitnim pokrovom iz polipropilena vsebuje 4,5 kg praška.
Also, information as to widespread decreased susceptibility in B. hyodysenteriae and as to the bimodal distribution in E. coli should be added to section 5.1.
Prav tako je treba v poglavje 5.1 Farmakodinamične lastnosti dodati informacije o široko razširjeni zmanjšani občutljivosti B. hyodysenteriae in bimodalni porazdelitvi E. coli.
Chickens: Meat and offal: 5 days.
Piščanci: Meso in organi: 5 dni.
In pigs, lincomycin is rapidly absorbed following oral administration.
Po peroralnem dajanju se linkomicin pri prašičih hitro absorbira.
Whereas * the CVMP considered the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet; * the CVMP reviewed the summary of product characteristics, labelling and package leaflet proposed by the marketing authorisation holders and considered all the overall submitted data;
• CVMP je pregledal povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih predlagajo imetniki dovoljenj za promet, in upošteval vse predložene podatke;
Poultry: For dosing via the drinking water.
Perutnina: za odmerjanje v vodo za pitje.
Pigs and poultry (nonlayers)
Prašiči in perutnina (nenesnice)
10,000 x [daily water consumption per animal (L)] average body weight of one pig (kg) In pigs 150 g of the veterinary medicinal product corresponds to the dose for 10,000 kg of body weight per day.
povprečna telesna teža enega prašiča (kg) Pri prašičih 150 g zdravila za uporabo v veterinarski medicini ustreza odmerku za 10000 kg telesne teže na dan.
In E. coli, a significant part of the strains show high MIC values (minimum inhibitory concentrations) against the lincomycin-spectinomycin combination and may be clinically resistant, although no breakpoint is defined.
Velik del sevov E. coli kaže visoke vrednosti MIK (minimalne inhibitorne koncentracije) proti kombinaciji linkomicin - spektinomicin in je lahko klinično odporen, čeprav mejna vrednost ni določena.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For use in drinking water.
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
Lithuania Zoetis Belgium SA Rue Laid Burniat 1
Luksemburg Zoetis Belgium SA Rue Laid Burniat 1
Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Razlogi za spremembo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Podatke je treba dopolniti v posameznih državah
For the treatment and prevention of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli, and associated with a low mortality rate.
Za zdravljenje in preprečevanje kronične respiratorne bolezni (CRD), ki ju povzročata Mycoplasma gallisepticum in Escherichia coli in je povezana z nizko stopnjo umrljivosti.
In a newly provided GCP challenge study the product used at 50 mg/kg bw/day for 7 days was shown to be effective in reducing clinical signs, lesions and bacteriological re-isolation associated to E. coli and/or M. gallisepticum experimental infection in chickens, although the bacterial re-isolation rate was high, with a non-statistically significant reduction for E. coli, and the MIC of the infective strains was low when compared to most field strains.
V novo predloženi, z DKP skladni provokacijski študiji zdravljenja z zdravilom v odmerku 50 mg/kg telesne mase/dan, ki je trajalo 7 dni, so pokazali, da je učinkovito pri zmanjševanju kliničnih znakov, lezij in ponovne bakteriološke izolacije, povezanih z eksperimentalnimi okužbami z E. coli in/ali M. gallisepticum pri piščancih; čeprav je bil delež ponovne izolacije bakterij velik, zmanjšanje pri E. coli ni bilo statistično pomembno, vrednosti MIK za kužne seve pa so bile v primerjavi z večino sevov na terenu majhne.
Resistance to lincomycin can readily develop in B. hyodysenteriae and most of the isolates studied show decreased susceptibility in vitro.
Odpornost na linkomicin se lahko pri B. Hyodysenteriae razvije hitro in večina preučevanih izolatov kaže in vitro zmanjšano občutljivost.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Podatke je treba dopolniti v posameznih državah.
Repeated dosing of pigs with daily oral doses of 22 mg lincomycin/kg body weight for 3 days indicated no accumulation of lincomycin in the species, with no detectable serum levels of antibiotic after 24 hours post administration.
Večkratno odmerjanje z dnevnimi odmerki 22 mg linkomicina/kg telesne teže prašičem 3 dni, je pokazalo da se linkomicin pri živalih ne kopiči; koncentracij antibitoka v serumu ni bilo mogoče izmeriti po 24 urah, po dajanju.
Meat and offal: 5 days.
Meso in organi: 5 dni.
Co. Cork
Ringaskiddy, Co. Cork,
In E. coli and Salmonella spp.
Kaže, da je porazdelitev minimalnih inhibitornih koncentracij (MIK) pri E. coli in Salmonella spp.
“For the treatment and prevention of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli, and associated with a low mortality rate.
„Za zdravljenje in preprečevanje kronične respiratorne bolezni (KRB), ki jo povzročata Mycoplasma gallisepticum ter Escherichia coli in je povezana z majhnim deležem umrljivosti.
Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis which inhibits protein synthesis.
Linkomicin je antibiotik iz skupine linkozamidov in je proizvod bakterije Streptomyces lincolnensis, ki zavira sintezo breljakovin.
White HDPE bottle containing 150 g or 1.5 kg powder for oral solution with a white tamper evident LDPE lid.
Bela HDPE plastenka z zaščitnim belim LDPE pokrovom vsebuje 150 g ali 1,5 kg praška za peroralno raztopino.
2,000 x [daily water consumption per bird (L)] average body weight of one bird (kg)
2000 x [dnevno popita voda na žival (L)]
Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria (such as Brachyspira hyodysenteriae) and mycoplasmas.
Linkomicin deluje proti grampozitivnim bakterijam (kot je Brachyspira hyodysenteriae) in mikoplazmam.
MARKETING AUTHORISATION NUMBER(S) To be completed nationally
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET Podatke je treba dopolniti v posameznih državah
In a newly provided GCP-compliant challenge study the product used at 50 mg/kg/day for 7 days was shown to be effective in reducing clinical signs and lesions associated with E. coli and/or M. gallisepticum experimental infection in chickens, although the bacterial re-isolation rate was high - and its reduction was non statistically significant for E. coli - and the MIC values of the infective strains were at the very lower end of the range determined in the MIC surveys.
V novo predloženi, z DKP skladni provokacijski študiji zdravljenja z zdravilom v odmerku 50 mg/kg telesne mase/dan, ki je trajalo 7 dni, so pokazali, da je učinkovito pri zmanjševanju kliničnih znakov in lezij, povezanih z eksperimentalnimi okužbami z E. coli in/ali M. gallisepticum pri piščancih, čeprav je bil delež ponovne izolacije bakterije velik (zmanjšanje pri E. coli ni bilo statistično pomembno), vrednosti MIK za kužne seve pa so bile povsem na spodnji meji razpona, določenega v raziskavah MIK.
SPECIAL WARNING(S)
POSEBN(O)A OPOZORIL(O)A
Due to technical constraints the susceptibility of L. intracellularis is difficult to test in vitro, and data about the lincomycin-spectinomycin resistance status in that species are lacking.
Zaradi tehničnih omejitev je občutljivost L. Intracellularis težko preskušati in vitro in zato so podatki o odpornosti na kombinacijo linkomicin - spektinomicin pri teh živalskih vrstah pomanjkljivi.
Pigs Poultry
Prašiči Perutnina
In the new MIC survey using 25 isolates from Belgium, a lincomycinspectinomycin MIC range of 1:2 to 32:64 µg/ml was obtained, with a MIC50 of 16:32 and a MIC90 of 32:64 µg/ml.
V novi raziskavi MIK, v kateri so uporabili 25 izolatov iz Belgije, so ugotovili razpon MIK linkomicina-spektinomicina od 1 : 2 do 32 : 64 µg/ml, pri čemer sta bili vrednosti MIK50
Lay:
Serija:
Cases of diarrhoea or soft faeces and/or perianal region inflammation have been encountered in healthy pigs at the start of treatment.
NEŽELENI UČINKI Pri zdravih prašičih se lahko na začetku zdravljenja pojavi prehodna driska ali mehko blato in/ali edem v perianalnem predelu.
PHARMACEUTICAL FORM Powder for use in drinking water.
FARMACEVTSKA OBLIKA Prašek za uporabo v pitni vodi.
In chickens treated at several times the recommended dose, enlargement of the caecum and abnormal caecum content was observed.
Pri piščancih so ob dajanju nekajkrat večjih odmerkov od priporočenih opazili nenavadno vsebino v cekumu in njegovo povečanje.
The presence of the disease in the flock must be established before the product is used.”
Pred uporabo zdravila je treba potrditi prisotnost bolezni v jati.«
This study is the only formal demonstration of the benefit of the 50 mg/kg bw dose, and the obtained challenge was only mild to moderate, with no observed mortality.
Ta študija je edini uradni dokaz za korist odmerka 50 mg/kg telesne mase, posledična provokacija pa je bila samo od blaga do zmerna, brez opažene umrljivosti.
This study was the only formal demonstration of the benefit of the 50 mg/kg bw dose, and the obtained challenge was only mild to moderate, with no observed mortality.
Ta študija je bila edini uradni dokaz za korist odmerka 50 mg/kg telesne mase, posledična provokacija pa je bila samo od blaga do zmerna, brez opažene umrljivosti.
Likewise, information about the lack of data on the development of resistance in L. intracellularis should be included in the above mentioned sections of the SPC.
V zgornji poglavji povzetka glavnih značilnosti zdravila je treba vključiti tudi informacije o pomanjkljivih podatkih o razvoju odpornosti L. intracellularis.
Zoetis Portugal, Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal
Portugalska Zoetis Portugal, Lda Lagoas Park, Edifício 10
PHARMACEUTICAL FORM Powder for use in drinking water
FARMACEVTSKA OBLIKA Prašek za uporabo v vodi za pitje
Slovenia Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgija
Germany Zoetis Deutschland GmbH Schellingstraße 1,
Zoetis Deutschland GmbH Schellingstraße 1, D-10785 Berlin Nemčija
As an indication, standard water intake varies around 0.15 L/kg bw/day.
Običajna količina dnevno popite vode se giblje okrog 0,15 L/kg telesne teže/dan.
INDICATION(S)
INDIKACIJ(A)E
Nevertheless, a clear warning as to the possibility of treatment failure due to clinically resistant strains in B. hyodysenteriae and associated Enterobacteriaceae (E. coli) should be included in section 4.4.
Vendar je treba v poglavje 4.4 Posebna opozorila za vsako ciljno živalsko vrsto v povzetku glavnih značilnosti zdravila vključiti jasno opozorilo glede morebitno neuspešnega zdravljenja zaradi klinično odpornih sevov B. hyodysenteriae in sorodnih enterobakterij (E. coli).
PACKAGE LEAFLET FOR: <Invented name> 222 mg/g + 444.7 mg/g powder for use in drinking water for pigs and chickens
<Izmišljeno ime> 222 mg/g + 444,7 mg/g prašek za dajanje v vodo za pitje za prašiče in piščance
Pigs: Meat and offal: Zero days.
Prašiči: Meso in organi: nič dni.
It has little or no action against gram-negative bacteria such as Escherichia coli.
Na gramnegativne bakterije kot je Escherichia coli deluje šibko ali nič.
The veterinary medicinal product should be used based on antimicrobial susceptibility testing.
Uporaba zdravila mora temeljiti na preskušanju občutljivosti bakterij, ki se jih izolira iz živali.
The combination was shown to be superior to lincomycin alone.
Pokazali so, da je kombinacija boljša kot monoterapija z linkomicinom.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally.
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podatke je treba dopolniti v posameznih državah.
This benefit-risk evaluation is performed in the context of Article 34 of Directive 2001/82/EC, which in the present procedure has the purpose of obtaining harmonisation within the EU of the conditions of authorisation for the product Linco-Spectin 100 (and associated names).
Njen namen v sklopu trenutnega postopka je uskladitev pogojev dovoljenj za promet z zdravilom LincoSpectin 100 (in povezanimi imeni) znotraj EU.