natgillin/translations-raw huggingface dataset:
The active substance in Fasturtec, rasburicase, is an enzyme called urate oxidase, which transforms uric acid into another chemical called allantoin, which can easily be excreted by the kidneys in the urine. 
Zdravilna učinkovina v zdravilu Fasturtec, razburikaza, je encim, imenovan urat oksidaza, ki lahko sečno kislino pretvori v drugo kemično snov, imenovano alantoin, ki jo ledvice brez težav izločijo s sečem.
What is Fasturtec used for? 
Za kaj se zdravilo Fasturtec uporablja?
The recommended dose is 0.2 mg per kilogram body weight in both children and adults, given as a daily infusion for up to seven days. 
Priporočeni odmerek pri otrocih in odraslih znaša 0,2 mg na kilogram telesne mase in se daje z infundiranjem sedem dni vsak dan. Trajanje zdravljenja se prilagodi glede na bolnikove koncentracije sečne kisline v krvi in v skladu z zdravnikovo presojo.
Fasturtec was only compared with another treatment (allopurinol, the standard treatment for reducing uric acid levels) in one of the studies, which included 52 patients. 
Zdravilo Fasturtec so v eni študiji, v katero je bilo vključenih 52 bolnikov, primerjali z drugim zdravilom (alopurinolom, običajnim zdravilom za zmanjšanje koncentracij sečne kisline).
How is Fasturtec used? 
Kako se zdravilo Fasturtec uporablja?
How has Fasturtec been studied? 
Kako je bilo zdravilo Fasturtec raziskano?
What is Fasturtec? 
Kaj je zdravilo Fasturtec?
How does Fasturtec work? 
Kako zdravilo Fasturtec deluje?
1adjuvanted by AS04C containing: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 2 
1adjuvans AS04C, ki vsebuje: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 2
1 dose (0.5 ml) contains: Hepatitis B surface antigen 1, 2, 3 
1 odmerek (0,5 ml) vsebuje: Površinski antigen virusa hepatitisa B 1, 2, 3
2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 
2adsorbiran na aluminijev fosfat (skupno 0.5 milligramov Al3+ ) 3pridobljen s tehnologijo rekombinantne DNA na celični kulturi kvasovk Saccharomyces cerevisiae
10 pre-filled syringes 
10 napolnjenih brizg
1 pre-filled syringe + 1 needle 
1 napolnjena brizga + 1 injekcijska igla
MA (EU) number (Invented) name Strength Pharmaceutical form 
Izmišljeno ime Jakost
• The Committee considered the notification of the referral triggered by the Germany under Article 29(4) of Directive 2001/83/EC; 
• Odbor je upošteval obvestilo o napotitvenem postopku, ki ga je sprožila Nemčija skladno s členom 29(4) Direktive 2001/83/ES;
Overall summary of the scientific evaluation of Nanotop and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Nanotop in povezanih imen (glejte Prilogo I)
Filters at 15 nm, 30 nm, 50 nm and 80 nm filter pore size were used. 
Uporabili so filtre z odprtinami velikosti 15 nm, 30 nm, 50 nm in 80 nm.
If the subcutaneously injected particles are too small they “run” through the lymphatic system too quickly and disappear before imaging techniques can be applied. 
Če so subkutano injicirani delci premajhni, prehitro preidejo skozi limfatični sistem in izginejo, preden se lahko uporabi slikanje.
On the other hand, if the particles are too large they would mostly remain trapped at the injection site and need too much time for transition to the lymph nodes, which is not practical. 
Če pa so delci preveliki, bodo v večini ostali ujeti na mestu injiciranja in do prehoda v bezgavke bo preteklo preveč časa, kar ni praktično.
The MAH argued that the fluctuations per se are not clinically relevant and therefore differences between such fluctuations are not likely to pose a risk to public health. 
Imetnik dovoljenja za promet z zdravilom je trdil, da sama nihanja niso klinično pomembna, zato ni verjetno, da bi razlike v teh nihanjih predstavljale tveganje za javno zdravje.
The legal basis for the submitted marketing authorisation application (MAA) was Article 10a "well established use", relying on appropriate scientific literature data of another similar product, Nanocoll. 
Pravna podlaga za predloženo vlogo za pridobitev dovoljenja za promet z zdravilom je bil člen 10a „dobro uveljavljena uporaba“, kar so podprli z ustreznimi podatki iz znanstvene literature za drugo podobno zdravilo Nanocoll.
The mutual recognition marketing authorisation application (MAA) for Nanotop 0.5 mg, kit for radiopharmaceutical preparation / lyophilisate for suspension for injection was submitted on the basis of the marketing authorisation granted by Germany on 8th December 2011. 
Vloga za pridobitev dovoljenja za promet z zdravilom po postopku z medsebojnim priznavanjem za zdravilo Nanotop 0,5 mg, komplet za pripravo radiofarmaka/liofilizat za suspenzijo za injiciranje je bila predložena na podlagi dovoljenja za promet z zdravilom, odobrenega 8. decembra 2011 v Nemčiji.
In addition the MAH has provided data on Nanocoll and Nanotop batches that were analysed on four days (six batches), and on the same day. 
Poleg tega je imetnik dovoljenja za promet z zdravilom predložil podatke o serijah zdravil Nanocoll in Nanotop, ki so jih analizirali v štirih dneh (šest serij) in v istem dnevu.
The particle size range is in this respect the crucial parameter that characterises the particular compound since small-sized colloids allow identification of a greater number of sentinel lymph nodes with a high statistical significance4. 
Zato je razpon velikosti delcev ključni parameter, ki opredeljuje neko snov, saj koloidi majhne velikosti omogočajo identifikacijo večjega števila varovalnih bezgavk z večjo statistično pomembnostjo4.
During the CMDh referral procedure that followed, no consensus could be reached as Sweden maintained their objection that the importance of the batch variability for the distribution and uptake of Nanotop in lymph nodes, as well as its clinical implications had not been adequately addressed, as even a small difference in efficacy could represent a potential serious risk to public health. 
Med posledičnim napotitvenim postopkom CMDh niso dosegli soglasja, saj je Švedska vztrajala pri svojih ugovorih, da pomembnost variabilnosti serij pri razporeditvi in privzemu zdravila Nanotop v bezgavkah ter njene klinične posledice posledice niso bile zadostno obravnavane, saj lahko tudi majhna razlika v učinkovitosti predstavlja morebitno resno tveganje za javno zdravje.
During development the MAH looked into the size distribution below 80 nm and created “particle size groups”. 
Med razvojem je imetnik dovoljenja za promet z zdravilom preučil razporeditev velikosti delcev, manjših od 80 nm, in ustvaril „skupine velikosti delcev“.
the CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion for Nanotop and associated names (see Annex I). 
je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, za katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot zadnje različice, pripravljene med postopkom usklajevalne skupine, kot je navedeno v Prilogi III tega mnenja za zdravilo Nanotop in povezana imena (glejte Prilogo I).
The data provided by the MAH support the notion that variability may decrease when batches are analysed over a shorter period of time. 
Podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom, podpirajo hipotezo, da se lahko variabilnost zmanjša, če se serije analizirajo v krajšem obdobju.
The relevant quality attributes including upper particle size limits are defined in the European core summary of product characteristics (SmPC) for Tc-99m Albumin Microcolloid (nm), in the relevant European and national Treatment Guidelines1,2,3 and in the SmPC of the approved products (e.g. Nanocoll) and have been cited by the MAH. 
Pomembne lastnosti za kakovost, vključno z zgornjimi omejitvami velikosti delcev, ki jih je navedel imetnik dovoljenja za promet z zdravilom, so opredeljene v evropskem povzetku glavnih značilnosti zdravila za mikrokoloidni albumin Tc-99m (nm), zadevnih evropskih in nacionalnih smernicah za zdravljenje1,2,3 in povzetku glavnih značilnosti odobrenih zdravil (npr. Nanocoll).
Based on this, an optimal particle size range has been established for SLN detection. 
Na podlagi tega so določili optimalen razpon velikosti delcev za zaznavanje varovalne bezgavke.
During the mutual recognition procedure (MRP), major concerns were raised by the member states Sweden and France, that considering the batch variability, it was not possible from a quality perspective to conclude about the comparability between Nanotop and Nanocoll. 
Med postopkom z medsebojnim priznavanjem (MRP) sta državi članici, Švedska in Francija, izpostavili velike pomisleke, saj zaradi variabilnosti serij ni bilo mogoče sprejeti gotovih zaključkov glede primerljivosti kakovosti med zdraviloma Nanotop in Nanocoll.
There have been no studies so far investigating the clinical effects of variability occurring within the particle size range of HSA nanocolloid (of 0 to 80 nm). 
Študij, ki bi preučevale klinične učinke variabilnosti, ki se pojavijo znotraj razpona velikosti delcev nanokoloida HSA (od 0 do 80 nm), še niso izvedli.
In addition the MAH's clinical expert states that any variability in particle size within the specified range of Nanotop (≤ 80 nm of at least 95% of the particles) is not relevant for the clinical outcome. 
Poleg tega klinični izvedenec imetnika dovoljenja za promet z zdravilom navaja, da kakršna koli variabilnost v velikosti delcev znotraj opredeljenega razpona pri zdravilu Nanotop (≤ 80 nm pri vsaj 95 % delcev) ni pomembna za klinični izid.
Nanotop is a diagnostic radiopharmaceutical kit containing denatured human serum albumin (HSA), which after radiolabelling with Sodium Pertechnetate (99mTc) solution results in Technetium (99mTc) Nanocolloid. 
Zdravilo Nanotop je diagnostični komplet za pripravo radiofarmaka, ki vsebuje denaturirani humani serumski albumin (HSA) in po radiološkem označevanju z raztopino natrijevega pertehnetata (99mTc) tvori tehnecijev (99mTc) nanokoloid.
• The Committee reviewed the bibliographic data submitted by the marketing authorisation holder to address the potential serious risk to public health with regard to the impact of the observed batch variability on the efficacy of Nanotop in comparison with Nanocoll, which is the product referred to in the submitted literature. 
• Odbor je pregledal bibliografske podatke, ki jih je imetnik dovoljenja za promet z zdravilom predložil za namene obravnave morebitnega resnega tveganja za javno zdravje zaradi vpliva opažene variabilnosti serij na učinkovitost zdravila Nanotop v primerjavi z zdravilom Nanocoll, na katerega se nanaša predložena literatura;
The MAH has discussed particle size ranges and its implication for clinical practice in general, with reference to clinical guidelines. 
Imetnik dovoljenja za promet z zdravilom je obravnaval razpone velikosti delcev in njihov splošni vpliv na klinično prakso, pri čemer je upošteval klinične smernice.
The HSA nanocolloid has the prerogative to be made up of particles smaller than other colloidal agents for SLN detection. 
Prednost nanokoloida HSA je, da je izdelan iz delcev, manjših kot pri drugih koloidnih učinkovinah za zaznavanje varovalne bezgavke.
• The Committee therefore concluded that the MAH has satisfactorily demonstrated that Nanotop is comparable to Nanocoll, and that therefore an impact on clinical efficacy is not expected. 
• Odbor je posledično sklenil, da je imetnik dovoljenja za promet z zdravilom zadovoljivo dokazal, da je zdravilo Nanotop primerljivo z zdravilom Nanocoll, in da vpliva na klinično učinkovitost ni pričakovati;
Considering the particle size and the particle size ranges range discussed above, the CHMP was of the view that Nanotop is comparable to Nanocoll - the product referred to in the submitted literature, and that therefore an impact on clinical efficacy is not expected. 
Na podlagi zgoraj omenjenih velikosti delcev in razponov velikosti delcev je odbor CHMP menil, da je zdravilo Nanotop primerljivo z zdravilom Nanocoll (zdravilom, na katerega se nanaša predložena literatura), zato se vpliv na klinično učinkovitost ne pričakuje.
The qualitative and quantitative composition of the medicinal product Nanotop was shown to be the same in comparison to the comparator product Nanocoll. 
Pokazali so, da je bila kakovostna in količinska sestava zdravila Nanotop enaka primerjalnemu zdravilu Nanocoll.
Due to different views in the interpretation of the data related to particle size distribution within the defined limits relevant for efficacy, this referral was triggered to assess the importance of the batch to batch variability for the distribution and uptake of Nanotop in lymph nodes, and whether this could have an impact on efficacy. 
Zaradi različnih pogledov na interpretacijo podatkov, povezanih z razporeditvijo velikosti delcev znotraj opredeljenih omejitev, ki veljajo za učinkovitost, je bil sprožen ta napotitveni postopek, s katerim so ocenili pomembnost variabilnosti med serijami pri razporeditvi in privzemu zdravila Nanotop v bezgavkah ter vpliv tega na učinkovitost.
The upper particle size limits for SLN detection procedures used in Europe has been established and the acceptance criterion of at least 95% of particles having a diameter ≤ 80 nm was shown to be met by all batches of Nanotop. 
V Evropi je bila določena zgornja omejitev za velikost delcev pri postopkih zaznavanja varovalne bezgavke in pokazali so, da so vse serije zdravila Nanotop izpolnile merilo sprejemljivosti, ki je vsaj 95 % delcev s premerom ≤ 80 nm.
Since the references included in this submission were studies conducted with Nanocoll, the MAH provided arguments that these data are relevant for Nanotop. 
Ker so bile kot reference za to oddajo predložene študije z zdravilom Nanocoll, je imetnik dovoljenja za promet z zdravilom predložil argumente, da se ti podatki lahko prenesejo na zdravilo Nanotop.
Technetium (99mTc) Nanocolloid is used for characterisation of the properties of the lymphatic system and in particular sentinel lymph node (SLN) detection in breast cancer and malignant melanoma. 
Tehnecijev (99mTc) nanokoloid se uporablja za karakterizacijo značilnosti limfatičnega sistema, predvsem za ugotavljanje varovalne bezgavke pri raku dojke in malignem melanomu.
This additional supportive data was considered acceptable by the CHMP to demonstrate that the particles size distribution for the studied size ranges as well as the batch variability is in the same range as for Nanocoll, the product referred to in the submitted literature. 
Odbor CHMP je menil, da so dodatni podporni podatki sprejemljivi za dokazovanje, da sta razporeditev velikosti delcev za preiskovane razpone velikosti in variabilnost serij znotraj enakega razpona kot pri zdravilu Nanocoll, na katerega se je nanašala predložena literatura.
In response to the objection that there is a difference in the data fluctuation between Nanotop and Nanocoll, the MAH has provided data to show that the fluctuations observed are comparable and that particle size group distribution is comparable between Nanotop and Nanocoll. 
Kot odziv na ugovor zaradi razlike v nihanju podatkov med zdravilom Nanotop in Nanocoll je imetnik dovoljenja za promet z zdravilom predložil podatke, s katerimi je pokazal, da so opažena nihanja in razporeditev skupin velikosti delcev pri zdravilih Nanotop ter Nanocoll primerljivi.
The particle range of Nanotop corresponds to that of Nanocoll. 
Razpon velikosti delcev pri zdravilu Nanotop je bil enak kot pri zdravilu Nanocoll.
The CMDh therefore referred the matter to the CHMP through an Art 29(4) referral procedure. 
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini je zato zadevo napotila na odbor CHMP prek napotitvenega postopka po členu 29(4).
The efficacy of a Tc-99m albumin colloid is the ability to identify the first draining SLN. Once the Tc99m albumin colloid is administered, the passage of the tracer through the lymphatic system is recorded by imaging. 
Po uporabi koloidnega albumina Tc-99m se s slikanjem posname prehod sledilca skozi limfatični sistem.
• The Committee was of the view that further analysis of the supportive data from additional batches of Nanotop and Nanocoll have demonstrated acceptably that the particles size distribution for the 
• Odbor je menil, da je dodatna analiza podpornih podatkov iz dodatnih serij zdravil Nanotop in Nanocoll pokazala sprejemljivost, kar pomeni, da sta razporeditev velikosti delcev za preučevane razpone velikosti ter variabilnost serij pri zdravilu Nanotop znotraj enakega razpona kot pri zdravilu Nanocoll;
As mentioned previously, the efficacy of a Tc-99m albumin colloid is the ability to identify the first draining SLN. Once the Tc-99m albumin colloid is administered, the passage of the tracer through the lymphatic system is recorded by imaging. 
Kot je bilo omenjeno že zgoraj, koloidni albumin Tc-99m učinkuje tako, da zazna prvo drenažno varovalno bezgavko.
(See section 4.5) 
(Glej poglavje 4.5)
Types and mechanisms of resistance 
Tipi in mehanizmi odpornosti
Always make sure that the entire dose offered has been consumed. 
Vedno se prepričajte, da je bil porabljen ves ponujen odmerek.
The results of those studies should be provided to the relevant Authorities for assessment not later than 18 months after the Commission Decision on this referral procedure. 
Rezultate teh študij je treba predložiti v oceno ustrezni organom najpozneje 18 mesecev po sklepu Komisije o tem napotitvenem postopku.
Do not use for prophylaxis. 
Ne uporabite za profilakso.
Le Carrou et al., 2006. 
Le Carrou in drugi, 2006.
Bravničarjeva 13 Ljubljana SLOVENIA 
Bravničarjeva 13 Ljubljana SLOVENIJA
The paper states that the high values for 2005-6 were due to the high level of resistance in Spain (24%), which was not included in 1999-2000. 
Članek navaja, da so bile visoke vrednosti v letih 2005-2006 posledica visoke stopnje odpornosti v Španiji (24 %), ki ni bila vključena v letih 1999-2000.
This study was conducted using two breeds of chickens, one fast growing and one slower growing, which together cover the range of chickens used for food in Europe. 
Ta študija je bila opravljena z dvema pasmama piščancev, eno hitro rastočo in eno počasneje rastočo, ki skupaj pokrivata vrste piščancev, ki se v Evropi uporabljajo za hrano.
Viale Certosa 130 I-20156 Milan ITALY 
Viale Certosa 130 I-20156 Milan ITALIJA
3641 RT Mijdrecht THE NETHERLANDS 
3641 RT Mijdrecht NIZOZEMSKA
The National Competent Authorities shall ensure that the following condition is fulfilled by the marketing authorisation holders: 
Pristojne nacionalne agencije bodo zagotovile, da bodo imetniki dovoljenj za promet izpolnili naslednji pogoj:
Not all indications were included in the product information for all Member States. 
V informacije o zdravilu za vse države članice niso vključene vse indikacije.
If no clinical improvement is achieved within 2-3 days, alternative antimicrobial therapy should be considered based on susceptibility testing. 
Če v 2 do 3 dneh ni kliničnega izboljšanja, je potrebno izbrati alternativno protimikrobno zdravljenje na podlagi testa občutljivosti.
Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms. 
Zdravljenje traja 3-5 zaporednih dni; 5 zaporednih dni pri mešanih okužbah in pri kronično progresivnih oblikah.
However evidence of widespread resistance in the European Union or lack of efficacy of the dose in the treatment of mycoplasmosis is difficult to find. 
Vendar je dokaze o razširjeni odpornosti v Evropski uniji ali pomanjkljivi učinkovitosti odmerka pri zdravljenju mikoplazmoze težko najti.
Use only fresh pre-solutions, prepared every day before start of treatment. 
Uporabite le sveže pripravljene raztopine, pripravljene vsak dan pred začetkom zdravljenja.
The hazards associated with use of the product are developmental reactions which will not become apparent at the low accidental exposure levels assumed. 
Nevarnosti, povezane z uporabo zdravila, so razvojne reakcije, ki niso očitne pri nizkih ravneh nezgodne izpostavljenosti.
This is consistent with the withdrawal period that has been in force in the majority of Member States, in which the product has been authorised for many years. 
To je v skladu s karenco, ki je v veljavi v večini držav članic, kjer je zdravilo odobreno že vrsto let.
• Residue depletion studies should be provided for any proposed new dosage regimen. 
• Za vsak nov predlagani režim odmerjanja je treba predložiti študije izločanja ostankov.
Resistance has also been reported in Mycoplasma synoviae in the EU. 
O odpornosti so poročali tudi pri Mycoplasma synoviae v EU.
Pumping systems should be checked constantly to assure proper medication. 
Črpalni sistem je potrebno nenehno preverjati, da se omogoči zadostna medikacija.
For chickens and turkeys, please refer to section 8. 
Za piščance in purane glejte poglavje 8.
4 days 
4 dni
The product shows good physical and chemical stability over a 48 month storage period, and the data support the proposed shelf life of 48 months without any special storage precautions 
Zdravilo ostane v 48 mesecih shranjevanja fizično in kemično stabilno, podatki pa podpirajo predlagani rok uporabnosti 48 mesecev brez posebnih opozoril za shranjevanje.
Calculations in broiler chickens produce the highest exposure of the environment (PECsoil 887 µg/kg). 
Izračuni pri pitovnih piščancih dajejo najvišjo izpostavljenost okolja (PECsoil 887 µg/kg).
5, does cover the main risks associated with this product, and can be used to determine user safety warnings to appear on the product information. 
5, vendar pokriva glavna tveganja, povezana s tem zdravilom, in se lahko uporabi za določitev opozoril o varnosti uporabnika, ki so del informacij o zdravilu.
Regarding the indications for P. multocida and E. coli, the marketing authorisation holders submitted challenge studies and minimal field data from studies conducted 20 years ago. 
V zvezi z indikacijami za P. multocida in E. coli so imetniki dovoljenj za promet z zdravilom predložili provokacijske študije in minimalne podatke s terena iz študij, opravljenih pred 20 leti.
Risks of use of this product have been illustrated in chickens and turkeys by two comprehensive and recent references. 
Opis tveganja pri uporabi tega zdravila pri piščancih in puranih je najti v dveh izčrpnih, nedavnih virih.
On 15 October 2010, the United Kingdom sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Baytril 10% oral solution and associated names. 
Dne 15. oktobra 2010 je Velika Britanija poslala obvestilo o napotitvi v skladu s členom 34(1) Direktive 2001/82/ES, kakor je bila nazadnje spremenjena, odboru CVMP/Evropski agenciji za zdravila za zdravilo Baytril 10 % peroralna raztopina in povezana imena.
Bayer Sante 220 Avenue De La Recherche 59120 Loos FRANCE 
Bayer Sante 220 Avenue De La Recherche 59120 Loos FRANCIJA
The marketing authorisation holders have provided a user risk assessment which, although not fully compliant with the current guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1) 
Imetniki dovoljenj za promet z zdravilom so predložili oceno tveganja za uporabnika, ki sicer ni povsem v skladu s trenutnimi smernicami o varnosti uporabnika pri farmacevtskih izdelkih za veterinarsko medicino (EMA/CVMP/543/03-Rev.1)
By limiting the use of the product, these warnings are intended to minimise the potential impact on human and animal health from antimicrobial resistance. 
Namen teh opozoril je omejiti uporabo zdravila in tako zmanjšati možni učinek na zdravje ljudi in živali zaradi protimikrobne odpornosti.
Available online at www.efsa.europa.eu/efsajournal de Jong A, Stephan B, Silley P.(2012).Fluoroquinolone resistance in E coli and Salmonella from healthy livestock and poultry in the EU. 
Na voljo na spletnem naslovu www.efsa.europa.eu/efsajournal de Jong A, Stephan B, Silley P.(2012).Fluoroquinolone resistance in E coli and Salmonella from healthy livestock and poultry in the EU.