natgillin/translations-raw huggingface dataset:
Consequently these indications/dosage regimens in cattle and target species pigs should be deleted from the product information.
Posledično je treba te indikacije/režime odmerjanja pri govedu in ciljni živalski vrsti prašičih izbrisati iz informacij o zdravilu.
Quality, target animal safety, user safety and environmental risk were not assessed in this referral procedure.
V tem napotitvenem postopku kakovost, varnost zdravila za ciljno živalsko vrsto, varnost zdravila za uporabnika in okoljska tveganja niso bili obravnavani.
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst in predlagateljev/imetnikov dovoljenj za promet z zdravilom v državah članicah
Efficacy issues
Vidiki učinkovitosti
Failure to follow these instructions may result in residues above the established maximum residue limit of 200 µg/kg for muscle.
Neupoštevanje teh navodil lahko povzroči, da bodo ravni ostankov nad določeno mejno vrednostjo ostankov za mišice, ki je 200 µg/kg.
Use of the product deviating from the instructions given in the product information may increase the prevalence of bacteria resistant to spiramycin.
Uporaba zdravila na način, ki odstopa od navodil v informacijah o zdravilu, lahko poveča razširjenost bakterij, odpornih proti spiramicinu.
However, in line with CVMP guideline on the conduct of bioequivalence studies in veterinary medicinal products (EMA/CVMP/016/00)3, product specific data are required to establish the residue depletion profile at the injection site.
Vendar pa so v skladu s smernicami odbora CVMP o izvajanju bioekvivalenčnih študij za zdravila za uporabo v veterinarski medicini (EMA/CVMP/016/00)3 za določitev profila izločanja ostankov z mesta injiciranja potrebni specifični podatki za posamezno zdravilo.
Ceva Sante Animale 10 avenue de la Ballastiere 33500 Libourne France
Ceva Sante Animale 10 avenue de la Ballastiere 33500 Libourne Francija
MIC of spiramycin (µg/mL) Range
MIK spiramicina (µg/ml) Razpon
• on the basis of the available data, the CVMP considered that indications as provided in Annex III
• odbor CVMP je na podlagi razpoložljivih podatkov menil, da so indikacije, kot so navedene v
Bacteria species
Bakterijska vrsta
Following intramuscular injection, spiramycin is rapidly absorbed and maximal plasma concentrations are reached within 3 hours.
Spiramicin se po intramuskularnem injiciranju hitro absorbira in doseže največjo koncentracijo v plazmi v 3 urah.
The following Minimum Inhibitory Concentrations (MIC) have been determined for spiramycin in European isolates collected from diseased animals between 2007 to 2012:
Minimalne inhibitorne koncentracije (MIK) spiramicina, določene za evropske izolate, pridobljene pri obolelih živalih med letoma 2007 in 2012, so naslednje:
Despite of several limitations, in particular the small number of animals and the short (14 days) observation period, the study was found appropriate to justify the indication ‘acute S. aureus mastitis', since results in the primary end point (bacteriological cure was reached in 7 out of 8 test cows, but in none of the 9 control cows) and some of the secondary endpoints (particularly the somatic cell count) were convincing.
Kljub nekaj omejitvam, med katerimi sta bila zlasti majhno število živali in kratko (14-dnevno) opazovalno obdobje, je bila študija ocenjena kot primerna za utemeljitev indikacije „akutni mastitis, ki ga povzroča bakterija S. aureus“, saj so bili rezultati, zabeleženi pri primarnem opazovanem dogodku (do bakteriološke ozdravitve je prišlo pri 7 od 8 preskusnih krav in pri nobeni od 9 kontrolnih krav) ter nekaterih sekundarnih opazovanih dogodkih (zlasti številu somatskih celic), prepričljivi.
If this means that the dose must be divided into two injections, then injections should be administered on opposite sides of the neck.
Če je treba zaradi tega odmerek razdeliti in ga dati z dvema injekcijama, je treba ti injekciji dati v nasprotna predela vratu.
Respiratory infections:
Okužbe dihal:
de la Ballastiere, BP 126 33500 Libourne Cedex FRANCE
de la Ballastiere, BP 126 33500 Libourne Cedex FRANCIJA
• the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products (see annex I), subject to amendments in the product information; the CVMP recommended variations of the marketing authorisations for Suanovil 20 and associated names, Captalin and associated names, and generic products thereof, in order to amend the summaries of product characteristics, labelling and package leaflets as set out in Annex III.
• odbor CVMP je menil, da je splošno razmerje med tveganji in koristmi za zdravila za uporabo v veterinarski medicini (glejte Prilogo I) pozitivno, če se upoštevajo spremembe v informacijah o zdravilu; je odbor CVMP priporočil spremembo dovoljenj za promet z zdravilom Suanovil 20 in povezanimi imeni, zdravilom Captalin in povezanimi imeni ter njunimi generičnimi zdravil, tako da se dopolni povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo, kot je določeno v Prilogi III.
Body weight should be determined as accurately as possible to avoid underdosing.
Da se prepreči premajhno odmerjanje, je treba čim natančneje določiti telesno maso.
Mannheimia haemolytica Cattle Staphylococcus aureus
Mannheimia haemolytica govedo Staphylococcus aureus govedo
Earlier and more recent in vitro susceptibility data of the target pathogens had been derived from a large number of strains collected from cattle in several EU Member States.
Starejši in novejši podatki o občutljivosti ciljnih patogenov in vitro so bili pridobljeni pri velikem številu sevov, ki so jih zbrali pri govedu v več državah članicah EU.
While for S. aureus this fraction amounted to less than 10% of the strains examined, the tri-modal MIC-distribution pattern obtained for S. uberis indicated that in addition to the susceptible fraction 10% of the strains examined had intermediate susceptibility and 20% were resistant.
Medtem ko je med pregledanimi sevi bakterije S. aureus ta delež znašal manj kot 10 %, je trimodalni vzorec porazdelitve MIK, dobljen za bakterijo S. uberis, pokazal, da je bilo poleg občutljivih sevov 10 % pregledanih sevov srednje občutljivih, 20 % pa je bilo odpornih.
La Ballastière 33500 Libourne France
La Ballastière 33500 Libourne Francija
Spiramycin levels in tissues and fluids were further increased when spiramycin was injected for a second time after 48 hours.
Koncentracije spiramicina v tkivih in tekočinah so se še povečale po drugem injiciranju spiramicina po 48 urah.
Particularly high spiramycin concentrations were determined in lung macrophages.
Posebno velike koncentracije spiramicina so ugotovili v pljučnih makrofagih.
Therefore, the benefit-risk balance is considered negative for these indications in cattle and all indications in pigs.
Zato je razmerje med tveganji in koristmi za te indikacije pri govedu in vse indikacije pri prašičih negativno.
Based on a residue depletion study performed in accordance with the current guidance2 for the determination of withdrawal periods for milk, a withdrawal period of 27 milkings (13.5 days) can be recommended for milk.
Na podlagi študije o izločanju ostankov, ki je bila izvedena v skladu s trenutnimi smernicami2 za določanje karenc za mleko, je mogoče za mleko priporočiti karenco 27 molž (13,5 dneva).
Spirovet has been shown to be bioequivalent to Suanovil 20 and consequently the time taken for residue levels in non-injection site muscle, liver, fat, kidney and milk can be assumed to be the same as for the two products.
Za zdravilo Spirovet je bilo dokazano, da je biološko enakovredno zdravilu Suanovil 20, zato se lahko predpostavi, da je čas, ki je potreben za ravni ostankov v mišicah, jetrih, maščobah, ledvicah in mleku, kamor se zdravilo ne injicira, enak pri obeh zdravilih.
Pasteurella multocida
Pasteurella multocida govedo
Mastitis caused by S. aureus should be treated once clinical signs are observed.
Mastitis, ki ga povzroča bakterija S. aureus, je treba zdraviti, ko se pojavijo klinični znaki.
Spiramycin is weakly bound to plasma proteins.
Spiramicin se šibko veže na beljakovine v plazmi.
However, as Spirovet is bioequivalent to Suanovil 20 the same withdrawal period of 27 milkings (13.5 days) can be recommended.
Vendar se lahko glede na to, da je zdravilo Spirovet biološko enakovredno zdravilu Suanovil 20, priporoči enaka karenca, tj. 27 molž (13,5 dneva).
If more than two injections are needed, a distance of at least 15 cm should be maintained between injections given on the same side of the neck.
Če sta potrebni več kot dve injekciji, mora biti med injekcijami, ki se dajo na isto stran vratu, najmanj 15 cm presledka.
Regarding bovine mastitis pathogens such as S. aureus and S. uberis, there exists already a resistant proportion of strains, as evident from recent surveillance programs.
Med patogeni, ki povzročajo mastitis pri govedu, kot sta S. aureus in S. uberis, po podatkih iz najnovejših programov spremljanja že obstaja delež odpornih sevov.
Regarding bovine respiratory pathogens like Pasteurella multocida and Mannheimia haemolytica, in vitro MIC-values of spiramycin are generally high, but their mono-modal distribution pattern does not indicate a relevant resistant fraction.
Kar zadeva goveje respiratorne patogene, kot sta Pasteurella multocida in Mannheimia haemolytica, so vrednosti MIK spiramicina in vitro običajno visoke, vendar unimodalni vzorec njihove porazdelitve ne kaže pomembnega deleža odpornih bakterij.
Milk: In case of treatment at the dose required for respiratory diseases the product is not authorised for use in animals producing milk for human consumption.
Mleko: pri zdravljenju z odmerkom, ki je potreben za bolezni dihal, uporaba zdravila ni dovoljena pri živalih, katerih mleko je namenjeno prehrani ljudi.
However since the assessment identified some deficiencies such as no surrounding injection site samples in adult cattle, it was considred necessary to use the alternative approach1 and add a 20% safety span.
Vendar pa je ocena pokazala določene pomanjkljivosti, na primer, da niso odvzeli vzorcev z okolice mesta injiciranja pri odraslem govedu, zato je bilo treba uporabiti alternativen pristop1 in dodati 20-odstotni varnostni razpon.
Captalin solution for injection contains 31.25 g spiramycin per 100 ml, corresponding to 1 000 000 IU spiramycin per ml.
Zdravilo Captalin raztopina za injiciranje vsebuje 31,25 g spiramicina na 100 ml, kar ustreza 1.000.000 i.e. spiramicina na ml.
Cattle Mannheimia haemolytica Cattle
Mannheimia haemolytica govedo
Since the study has shortcomings (no data for tissues other than injection site and in some samples residues in the surrounding injection site were higher than in the core), it was considered necessary to use the alternative approach and add a 30% safety span which resulted in a withdrawal period of 68 days for cattle meat and offal.
Ker pa je študija imela pomanjkljivosti (nobenih podatkov za tkiva, v katera se ni injiciralo zdravilo, v nekaterih vzorcih so bile vrednosti ostankov v okolici mesta injiciranja višje kot na samem mestu), je bilo treba uporabiti alternativen pristop in dodati 30-odstotni varnostni razpon, kar pomeni, da je karenca za goveje meso in organe 68 dni.
It is assumed that compared to cattle the pharmacokinetic profile of spiramycin in calves would be similar or even more favourable.
Predpostavlja se, da je farmakokinetični profil spiramicina pri teletih podoben ali še ugodnejši kot pri govedu.
The pharmacokinetic properties of spiramycin at the dose of 30 000 IU/kg body weight have been examined in one study.
Farmakokinetične lastnosti spiramicina v odmerku 30.000 i.e./kg telesne mase so proučili v eni študiji.
Lung levels determined following this treatment regime reached a multiple of the corresponding plasma levels from 4 hours after injection onwards and persisted on a high level for 32 hours after a single injection.
Koncentracije v pljučih, ki so jih določili po tem režimu zdravljenja, so 4 ure po injiciranju dosegle večkratno vrednost ustreznih plazemskih koncentracij in ostale na visoki ravni še 32 ur po enkratnem injiciranju.
The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to give its opinion on the indications, dosing regimens and withdrawal periods in cattle and pigs, in order to ensure efficacious treatment and lower the risk of development of antimicrobial resistance to spiramycin taking into account the available data and also to harmonise the withdrawal periods in cattle and pigs for the concerned products.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) so prosili, naj na podlagi razpoložljivih podatkov poda mnenje o indikacijah, režimih odmerjanja in karencah za govedo in prašiče, da bi zagotovili učinkovito zdravljenje in zmanjšali tveganje za razvoj odpornosti mikrobov proti spiramicinu ter da bi za zadevna zdravila uskladili karence za govedo in prašiče.
Rue de Bourgelat 17 69002 Lyon France
Romunija Merial Rue de Bourgelat 17 69002 Lyon Francija
The clinical data on bovine mastitis consisted primarily of an experimental S. aureus mastitis study using a challenge strain with a spiramycin MIC of 4 µg/ml.
Klinični podatki o mastitisu pri govedu izhajajo predvsem iz eksperimentalne študije o mastitisu, ki ga povzroča bakterija S. aureus, v kateri so uporabili provokacijski sev z MIK spiramicina 4 µg/ml.
Meat and offal: 75 days.
Meso in organi: 75 dni.
Meat and offal: 62 days.
Meso in organi: 62 dni.
Spiramycin is a weak base, not ionized and liposoluble which crosses easily cellular membranes by passive diffusion.
Spiramicin je šibko bazičen, neioniziran in topen v maščobah ter s pasivno difuzijo zlahka prehaja skozi celične membrane.
Therefore Suanovil 20 should not be used for treatment of respiratory infections in animals producing milk for human consumption.
Zaradi tega se zdravilo Suanovil 20 ne sme uporabljati za zdravljenje okužb dihal pri živalih, katerih mleko je namenjeno prehrani ljudi.
The maximal volume to be injected is 15 ml per injection site as this was the maximal volume administered at the residue depletion study.
Največja količina zdravila, ki se lahko injicira na eno mesto, je 15 ml, saj je bila to največja količina, ki so jo injicirali v študiji o izločanju ostankov.
One study conducted at the recommended dose showed that the injection site muscle residues were below the maximum residue limit (200 μg/kg) at Day 52.
Ena študija, ki so jo izvedli z uporabo priporočenega odmerka, je pokazala, da so bili ostanki na mestu injiciranja v mišico po 52 dneh pod mejno vrednostjo ostankov (200 μg/kg).
The veterinary medicinal products Suanovil 20 solution for injection and its generic product Spirovet are solutions for injection which contain 20 g spiramycin per 100 ml, corresponding to 600 000 IU spiramycin per ml.
Zdravilo za uporabo v veterinarski medicini Suanovil 20 raztopina za injiciranje ter njegovo generično zdravilo Spirovet sta raztopini za injiciranje, ki vsebujeta 20 g spiramicina na 100 ml, kar ustreza 600.000 i.e. spiramicina na ml.
Spiramycin is metabolised in the liver; its primary metabolite, neospiramycin, possesses antimicrobial activity.
Spiramicin se presnavlja v jetrih; njegov glavni presnovek, neospiramicin, deluje protimikrobno.
For the second dose (after 24 h or 48 h) the same practice should be followed, ensuring that a distance of at least 15 cm is maintained between all injections administered as part of the treatment.
Drugi odmerek (po 24 ali 48 urah) je treba dati po enakem postopku in prav tako zagotoviti, da bo med vsemi injekcijami, ki se dajo v okviru zdravljenja, najmanj 15 cm presledka.
Its tissue distribution is extensive, with high concentration particularly in bronchial secretions, lung parenchyma, alveolar macrophages, udders and milk.
Njegova porazdelitev v tkivih je izdatna, pri čemer so koncentracije še posebno velike v bronhialnih izločkih, pljučnem parenhimu, alveolarnih makrofagih, vimenih in mleku.
were justified;
Prilogi III, utemeljene;
Meat and offal: 68 days.
Meso in organi: 68 dni.
For the second dose (after 48 h) the same practice should be followed, ensuring that a distance of at least 15 cm is maintained between all injections administered as part of the treatment.
Drugi odmerek (po 48 urah) je treba dati po enakem postopku in prav tako zagotoviti, da bo med vsemi injekcijami, ki se dajo v okviru zdravljenja, najmanj 15 cm presledka.
Spiramycin acts on bacterial protein synthesis by binding to the 50S ribosomal subunits, inhibiting the translocation step.
Spiramicin vpliva na sintezo bakterijskih beljakovin, tako da se veže na ribosomske podenote 50S in s tem zavira translokacijo.
Spiramycin is able to reach so high tissue concentrations that it succeeds in penetrating into the cells to bind the 50S ribosomal subunits.
Spiramicin lahko v tkivih doseže tako velike koncentracije, da uspe prodreti v celice, kjer se veže na ribosomske podenote 50S.
For the treatment of bovine respiratory diseases several appropriate clinical studies from 1988 and 1989 using the dose regime of 100 000 IU/kg body weight once or twice in 48 hours interval, have been presented.
Za zdravljenje bolezni dihal pri govedu je bilo predloženih več ustreznih kliničnih študij iz leta 1988 in 1989, v katerih so uporabili režim odmerjanja 100.000 i.e./kg telesne mase enkrat ali dvakrat v razmiku 48 ur.
Scientific conclusions and grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Znanstveni zaključki in podlaga za spremembo povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo
The pharmacokinetic characteristics derived from this study demonstrate that in plasma relatively low spiramycin levels (Cmax: 1.44 IU/ml corresponding to 0.45 µg/ml) were reached with the treatment regime, whereas considerably higher spiramycin levels were reached in milk (50-fold of the plasma levels).
Farmakokinetične lastnosti, ki izhajajo iz te študije, kažejo, da se s tem režimom zdravljenja dosežejo relativno majhne koncentracije spiramicina v plazmi (Cmax: 1,44 i.e./ml, kar ustreza 0,45 µg/ml), znatno večje pa v mleku (50-krat večje od koncentracij v plazmi).
By using the pharmacodynamic and pharmacokinetic data mentioned above, a detailed PK/PDassessment was performed, which was based on two parameters: the T>MIC, which is recommended for time-dependent antibiotics like the macrolides, and the AUC/MIC, which is recommended for specific macrolides like azithromycin.
Na podlagi zgoraj omenjenih farmakodinamičnih in farmakokinetičnih podatkov je bila opravljena podrobna ocena farmakodinamike/farmakokinetike, ki je temeljila na dveh parametrih: T>MIK, ki se priporoča za časovno odvisne antibiotike, kot so makrolidi, in AUC/MIK, ki se priporoča za specifične makrolide, kot je azitromicin.
Only acute cases of mastitis caused by S. aureus with clinical signs observed for less than 24 h should be treated.
Zdravijo se lahko samo akutni primeri mastitisa, ki ga povzroča bakterija S. aureus, pri katerih se klinični znaki pojavijo za manj kot 24 ur.
The maximal volume to be injected is 20 ml per injection site as this was the maximal volume administered at the residue depletion study.
Največja količina zdravila, ki se lahko injicira na eno mesto, je 20 ml, saj je bila to največja količina, ki so jo injicirali v študiji o izločanju ostankov.
In sows has been authoresed for the treatment of mastitis at 75 000 IU/kg once or twice in 24 hour interval.
Pri svinjah pa je odobreno za zdravljenje mastitisa v odmerku 75.000 i.e./kg enkrat ali dvakrat v razmiku 24 ur.
One study was conducted at the recommended dose of 100 000 IU/kg body weight twice at 48 hours of interval, which showed that the injection site muscle residues were still above the maximum residue limit for muscle (200 μg/kg) at Day 49 post-treatment.
Izvedena je bila ena študija z uporabo priporočenega odmerka 100.000 i.e./kg telesne mase dvakrat v razmiku 48 ur, ki je pokazala, da so bili 49 dni po zdravljenju ostanki na mestu injiciranja v mišico še vedno nad mejno vrednostjo ostankov za mišico (200 μg/kg).
Spiramycin is eliminated primarily by biliary excretion.
Spiramicin se izloča predvsem z žolčem.
Using the statistical analysis1 the residues depletion at the injection sites suggested a withdrawal period of 52 days.
Statistična analiza1 je pokazala, da bi morala biti karenca glede na izločanje ostankov z mest injiciranja 52 dni.
• on the basis of the available residue depletion data in cattle, the CVMP considered that withdrawal periods should be amended to provide assurance for consumer safety;
• odbor CVMP je menil, da je treba na podlagi razpoložljivih podatkov o izločanju ostankov pri govedu spremeniti karence, tako da se zagotovi varnost potrošnikov;
Cattle (calves)
Govedo (teleta)
The pharmacokinetic characteristics derived from specific studies demonstrated that in plasma relatively low spiramycin levels (Cmax: 6-10 IU/ml corresponding to 2-3 µg/ml) were reached with the treatment regime, whereas considerably higher spiramycin levels were reached in bronchoalveolar lavage (4-5-fold of the plasma levels) and in lung tissue (100-fold of the plasma levels).
Farmakokinetične lastnosti, ugotovljene v posebnih študijah, so pokazale, da se s tem režimom zdravljenja dosežejo relativno majhne koncentracije spiramicina v plazmi (Cmax: 6-10 i.e./ml, kar ustreza 2-3 µg/ml), znatno večje pa v bronhoalveolarnem izpirku (4- do 5-krat večje od koncentracij v plazmi) in pljučnem tkivu (100-krat večje od koncentracij v plazmi).
Residue depletion studies performed at the dose of 100 000 IU/kg body weight, intramuscularly at 48 hours interval, were available in adult cattle.
Študije o izločanju ostankov, izvedene z uporabo odmerka 100.000 i.e./kg telesne mase intramuskularno v razmiku 48 ur, so bile na voljo za odraslo govedo.
Spiramycin is active against Staphylococcus aureus, Mannheimia haemolytica and Pasteurella multocida.
Spiramicin deluje proti bakterijam Staphylococcus aureus, Mannheimia haemolytica in Pasteurella multocida.
The veterinary medicinal product Suanovil 20 and its associated names has been authorised by several Member States for use in cattle for the treatment and prevention of respiratory infections and gastrointestinal infections, mastitis, metritis, omphalitis and omphalophlebitis, arthritis and interdigital abscesses at a dose of 30 000 IU/kg body weight once or twice in 24 hour interval for adult cattle and at 75 000 IU/kg body weight once or twice in 24 hour interval for calves.
Zdravilo za uporabo v veterinarski medicini Suanovil 20 in povezana imena so odobrena v več državah članicah za uporabo pri govedu za zdravljenje in preprečevanje okužb dihal in okužb prebavil, mastitisa, metritisa, omfalitisa in omfaloflebitisa, artritisa ter interdigitalnih abscesov v odmerku 30.000 i.e./kg telesne mase enkrat ali dvakrat v razmiku 24 ur za odraslo govedo in v odmerku 75.000 i.e./kg telesne mase enkrat ali dvakrat v razmiku 24 ur za teleta.
Treatment of acute clinical mastitis in lactating cows caused by Staphylococcus aureus strains sensitive to spiramycin.
Zdravljenje akutnega kliničnega mastitisa pri kravah v obdobju laktacije, ki ga povzročajo sevi bakterije Staphylococcus aureus, občutljivi za spiramicin.
The indication was substantiated by in vitro susceptibility data for Pasteurella multocida and Mannheimia haemolytica and by pharmacokinetic data of spiramycin in the target species, on the basis of which a detailed pharmacokinetic/pharmacodynamic (PK/PD) assessment has been performed.
Indikacijo podpirajo podatki o občutljivosti in vitro za bakteriji Pasteurella multocida in Mannheimia haemolytica ter farmakokinetični podatki o spiramicinu pri ciljnih živalskih vrstah, na podlagi katerih je bila opravljena podrobna ocena farmakokinetike/farmakodinamike (FK/FD).
Delete, target species pigs and any information related to these species from the product information.
Iz informacij o zdravilu izbrišite ciljno živalsko vrsto prašiče in vse informacije, povezane s to živalsko vrsto.