natgillin/translations-raw huggingface dataset:
Scientific conclusions and grounds for the variation to the terms of the marketing authorisations presented by the EMA
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom, ki jih je predstavila Evropska agencija za zdravila
This will be an intensive period of monitoring to establish that the site is performing to acceptable standards.
To bo obdobje intenzivnega spremljanja, da se ugotovi, ali obrat deluje v skladu s sprejemljivimi standardi.
Grounds for variation of the marketing authorisations
Podlaga za spremembo dovoljenj za promet z zdravilom
To meet supply demands, the unprecedented importation of PD solutions from Canada, Turkey and USA increased.
Za zadovoljitev povpraševanja se je uvoz raztopin za PD iz Kanade, Turčije in ZDA povečal na raven brez primere.
Focus should be given to the timeliness of communication of safety signals to healthcare professionals and competent authorities, and the accuracy and consistency of the systems in place to collect safety information and provide it to the regulatory networks.
Poseben poudarek je treba nameniti pravočasnemu obveščanju zdravstvenih delavcev in pristojnih organov o varnostnih znakih ter natančnosti in doslednosti uvedenih sistemov pri zbiranju varnostnih podatkov in njihovem posredovanju regulativnim omrežjem.
Further to the replacement of the product from Castlebar, mostly completed in April 2011, a decline in the number of aseptic peritonitis cases reported was observed.
Opaženo je bilo, da je po zamenjavi zdravil, proizvedenih v Castlebaru, ki je bila večinoma izvedena aprila 2011, število primerov aseptičnega peritonitisa, o katerih so poročali, upadlo.
• The Committee agreed with the change management plan for development of the global corrective and preventive actions (CAPA) at Castlebar.
• Odbor je potrdil načrt upravljanja sprememb za oblikovanje celovitih korektivnih in preventivnih ukrepov v Castlebaru.
Following continued review until September 2011, the CHMP now considers that weekly reports can cease, and the MAH should promptly inform the appropriate national competent authorities of any data suggestive of a signal with the dialysis solutions on the market.
Po nadaljnjih pregledih, ki so potekali do septembra 2011, je CHMP menil, da tedenska poročila niso več potrebna, imetnik dovoljenja za promet z zdravilom pa mora pristojne nacionalne organe nemudoma obvestiti o kakršnih koli podatkih, ki bi kazali na opozorila v zvezi z dializnimi raztopinami na trgu.
Modern rapid microbial methods should be applied on site to raw materials, excipients and finished product, to reduce variability, improve turn around time and improve the quality of information.
V obratih je treba za surovine, pomožne snovi in končna zdravila uvesti sodobne hitre mikrobiološke metode, da bi se zmanjšala variabilnost, skrajšal čas obtoka in izboljšala kakovost informacij.
• The Committee considered all data submitted by the MAH, in writing and at oral explanations, including the overall root cause investigation report, and concludes that the MAH has performed a comprehensive investigation of the root cause leading to the out-of-specifications for endotoxins in dialysis solutions produced at particular lines of manufacture in Castlebar.
• Odbor je upošteval vse podatke imetnika dovoljenja za promet z zdravilom, ki jih je ta predložil v pisni obliki in med ustnimi pojasnili, vključno s celotnim poročilom za preučitev glavnega vzroka, in sklenil, da je imetnik dovoljenja za promet z zdravilom izvedel celovito preiskavo glavnega vzroka, ki je povzročal rezultate zunaj specifikacijskih meja za endotoksine v dializnih raztopinah, proizvedenih na določenih proizvodnih linijah v Castlebaru.
During the article 31, several measures were put in place in order to monitor the risk of developing aseptic peritonitis, identified as the primary risk following the use of dialysis solutions manufactured at the affected manufacturing lines in Castlebar.
Med postopkom v skladu s členom 31 je bilo vzpostavljenih več ukrepov za spremljanje tveganja za razvoj aseptičnega peritonitisa, za katerega so ugotovili, da je primarno tveganje po uporabi dializnih raztopin, proizvedenih na okuženih proizvodnih linijah v Castlebaru.
Overall summary of the scientific evaluation of dialysis solutions from Baxter group of companies and associated companies produced at Castlebar (see Annex I)
Splošni povzetek znanstvenega vrednotenja dializnih raztopin, ki jih proizvaja skupina družb in povezanih družb Baxter v obratu Castlebar (glejte Prilogo I)
Considering the global implications of the findings at Castlebar, and proposed improvements at this manufacturing site, global corrective and preventive actions (CAPA) should be drawn up and used to audit other sites producing dialysis solutions, including those authorised in the framework of this procedure at the time of the first and second opinions.
Ob upoštevanju celovitih posledic ugotovitev v Castlebaru in predlaganih izboljšav tega proizvodnega obrata je treba oblikovati celovite korektivne in preventivne ukrepe ter jih uporabiti tudi za pregled drugih proizvodnih obratov, v katerih se proizvajajo dializne raztopine, vključno s tistimi, ki so bili odobreni v okviru tega postopka v prvem in drugem izdanem mnenju.
Whilst all data to finalise the article 31 was not available, a stepwise approach was followed for the assessment, resulting in subsequent opinions being adopted by the CHMP.
Dokler niso bili na voljo vsi podatki za dokončanje postopka po členu 31, je vrednotenje in posledično izdajanje mnenj CHMP potekalo postopoma.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for dialysis solutions from Baxter group of companies and associated companies produced at Castlebar (see annex I).
• Odbor je upošteval postopek v skladu s členom 31 Direktive 2001/83/ES za dializne raztopine, ki jih proizvaja skupina družb in povezanih družb Baxter v obratu Castlebar (glejte Prilogo I).
Further to the out-of-specification endotoxin results observed in batches manufactured in one area of the Castlebar manufacturing site, an investigation into the root cause was undertaken.
Poleg rezultatov zunaj specifikacijskih meja za endotoksine, ki so bili opaženi v serijah, proizvedenih na določenem območju proizvodnega obrata v Castlebaru, je bila izvedena tudi preiskava glavnega vzroka.
A more sensitive method for endotoxin testing should be implemented and its limit of detection will be tightened for both finished product and excipients.
Uvesti je treba natančnejšo metodo za testiranje endotoksinov, pri kateri se bo meja zaznavanja znižala tako za končna zdravila kot pomožne snovi.
• The Committee considers that the establishment of a 12 month monitoring period, upon qualification of the Castlebar plant by the IMB, is appropriate.
• Odbor meni, da je ustrezno, da nadzorni organ (IMB) izvaja 12-mesečno obdobje spremljanja po kvalifikaciji obrata v Castlebaru.
• The Committee considers that critical enhancements have been introduced, including the re-design of the affected lines, introduction of modern rapid microbial methods on site to raw materials, excipients and finished product, and a more sensitive method for endotoxin testing, with tightened limit of detection for both finished product and excipients.
• Odbor meni, da so bile uvedene najpomembnejše izboljšave, vključno s preureditvijo okuženih linij, uvedbo hitrih sodobnih mikrobioloških metod na mestu za surovine, pomožne snovi in končno zdravilo ter natančnejšim načinom testiranja za endotoksine z nižjo mejo zaznavanja tako za končna zdravila kot za pomožne snovi.
The outcome of global CAPA will be provided to the national competent authorities and any changes considered necessary should be addressed through the appropriate change management protocols and subsequent regulatory procedures at a national level, as applicable.
Izid celovitih korektivnih in preventivnih ukrepov bo predložen pristojnim nacionalnim organom, kakršne koli spremembe, ki naj bi bile potrebne, pa je treba reševati z ustreznimi protokoli za upravljanje sprememb in naknadnimi regulativnimi postopki na nacionalni ravni.
Cleaning/sanitisation procedures were also reviewed and installation and qualification of all of these enhancements should be reviewed by the supervisory authority through inspections before any solutions produced in these lines can be released to the market.
Pregledani so bil tudi postopki čiščenja/sanacije, nadzorni organ pa naj bi z inšpekcijskimi pregledi pregledal tudi postavitev in kvalifikacijo vseh navedenih izboljšav, šele nato pa bi bilo mogoče na trg sprostiti katero koli raztopino, proizvedeno na teh linijah.
The MAH should use this to prevent endotoxin contamination at other sites producing dialysis solutions for Europe, and apply all lessons learned accordingly.
Imetnik dovoljenja za promet z zdravilom mora to uporabiti tudi v drugih obratih, kjer proizvaja dializne raztopine za Evropo, da bi preprečil kontaminacijo z endotoksini, in v skladu s tem upoštevati vse pridobljene izkušnje.
As an additional measure, a consolidated risk management plan (RMP) specific for the re-launch of dialysis solutions manufactured at the Castlebar lines affected by the endotoxin issue has been submitted.
Kot dodatni ukrep je bil predložen tudi celovit načrt za obvladovanje tveganja, pripravljen posebej za ponovno sproščanje dializnih raztopin, proizvedenih na linijah v Castlebaru, okuženih z endotoksinom.
Cleaning/sanitisation procedures were also reviewed and installation and qualification of all of these enhancements should be reviewed by the supervisory authority through inspection of the Castlebar site.
Pregledani so bil tudi postopki čiščenja/sanacije, nadzorni organ pa naj z inšpekcijskimi pregledi obrata v Castlebaru pregledal tudi postavitev in kvalifikacijo vseh navedenih izboljšav.
Weekly reports of adverse drug reactions and batch signal data was undertaken, and a batch recall performed in case a signal arose with a particular batch.
Pripravljala so se tedenska poročila o neželenih učinkih zdravil in opozorilni podatki o seriji, v primeru pojavljanja opozorilnih znakov pri določeni seriji pa je bila ta umaknjena.
• Finally, the Committee considers that a pharmacovigilance inspection should be carried out for completeness and to ensure that communication of safety signals to healthcare professionals and competent authorities is adequate, and the systems in place to collect safety information and provide it to the regulatory networks are accurately and consistently applied.
• CHMP meni, da je za celovitost in zagotovitev ustreznega poročanja o varnostnih opozorilih zdravstvenim delavcem in pristojnim organom treba izvesti farmakovigilančni pregled ter zagotoviti, da se uvedeni sistemi za zbiranje varnostnih podatkov in njihovo posredovanje regulativnim omrežjem izvajajo natančno in dosledno.
Additional risk minimisation activities focus on reporting of batch numbers, communication via a direct healthcare professional communication and an adverse event questionnaire in addition to quality risk minimisation activities.
Poleg ukrepov za zmanjševanje tveganja v zvezi s kakovostjo dajejo dodatni ukrepi za zmanjševanje tveganja poseben poudarek na poročanje o številkah serij, poročanje prek neposrednih obvestil za zdravstvene delavce in vprašalnik o neželenih učinkih.
This heightened pharmacovigilance was applied to products from alternative sites supplying Europe.
Farmakovigilanca je bila poostrena tudi za vsa zdravila, ki so se dobavljala v Evropo in so bila proizvedena v nadomestnih proizvodnih obratih.
In view of the above, the Committee considers that the benefit risk balance of dialysis solutions from Baxter produced at Castlebar under review through this procedure, is positive under normal conditions of use and therefore recommends the variation to the terms of the marketing authorisations, subject to conditions set out in the Annex III.
Ob upoštevanju navedenega je Odbor menil, da je razmerje med tveganji in koristmi dializnih raztopin družbe Baxter, proizvedenih v Castlebaru, ki so bile pregledane v tem postopku, pod normalnimi pogoji uporabe pozitivno, zato je priporočil spremembo pogojev dovoljenj za promet z zdravili v skladu s pogoji, navedenimi v Prilogi III.
Member states should ensure that measures are implemented in accordance with global CAPA during inspections of the sites located under their territories.
Države članice morajo zagotoviti, da se med inšpekcijskimi pregledi obratov na njihovem ozemlju izvajajo ukrepi v skladu s celovitimi korektivnimi in preventivnimi ukrepi.
In view of the above, the Committee considers that the benefit risk balance of dialysis solutions from Baxter group of companies and associated companies produced at Castlebar (see Annex I) is positive and therefore recommends the variation to the terms of the marketing authorisations, subject to the conditions set out in annex III.
Ob upoštevanju navedenega Odbor meni, da je razmerje med tveganji in koristmi za dializne raztopine, ki jih proizvaja skupina družb in povezanih družb Baxter v obratu Castlebar, pod normalnimi pogoji uporabe pozitivno, zato priporoča spremembo pogojev dovoljenj za promet z zdravilom v skladu s pogoji, navedenimi v Prilogi III.
If changes to processes, frequencies or limits emerge from this period of monitoring, the MAH should submit the appropriate variations to the national competent authorities to update the marketing authorisations of the affected dialysis solutions, as applicable.
Če bodo v obdobju intenzivnega spremljanja sprejete kakršne koli spremembe postopkov, pogostnosti ali meja, mora imetnik dovoljenja za promet z zdravilom pristojnemu nacionalnemu organu po potrebi predložiti ustrezne spremembe za posodobitev dovoljenj za promet z zadevnimi dializnimi raztopinami.
Once this process is completed, the marketing authorisation holder (MAH) should submit variations to the national competent authorities to update the marketing authorisations of the affected dialysis solutions.
Po zaključku tega postopka mora imetnik dovoljenja za promet z zdravilom pristojnim nacionalnim organom predložiti spremembe za posodobitev dovoljenj za promet z zdravilom za oporečne dializne raztopine.
The MAH proposed a change management plan on the development of the CAPA which was agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom je predlagal načrt upravljanja sprememb pri oblikovanju celovitih korektivnih in preventivnih ukrepov, kar je potrdil tudi CHMP.
The MAH should update the existing marketing authorisations and submit variations to national competent authorities in accordance with the agreed change management plan.
Imetnik dovoljenja za promet z zdravilom mora posodobiti obstoječa dovoljenja za promet z zdravilom in v skladu z dogovorjenim načrtom upravljanja sprememb pristojnim nacionalnim organom predložiti spremembe.
An article 31 referral procedure of Directive 2001/83/EC was initiated by the European Commission (EC) following receipt of information from Baxter indicating that their manufacturing problem related to outof-specifications results for endotoxins in dialysis solutions produced at Castlebar was not resolved and the root cause had not been identified.
Evropska komisija je po prejemu informacij od družbe Baxter, ki so kazale, da težave v zvezi z rezultati zunaj specifikacijskih meja za endotoksine v dializnih raztopinah, proizvedenih v Castlebaru, niso bile odpravljene ter da glavni vzrok za njihovo pojavljanje ni bil ugotovljen, sprožila napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES.
The MAH should submit the relevant data to national competent authorities for review, in line with the agreed milestones for evaluation and reporting as described in the RMP.
Imetnik dovoljenja za promet z zdravilom mora v skladu s potrjenimi mejniki za ocenjevanje in poročanje, opisanimi v načrtu za obvladovanje tveganja, pristojnim nacionalnim organom v pregled predložiti zadevne podatke.
The MAH should submit variations to increase the diversity of supply, to national competent authorities in line with agreed timelines.
Imetnik dovoljenja za promet z zdravilom mora pristojnim nacionalnim organom v skladu z dogovorjenim časovnim načrtom predložiti spremembe za povečanje raznovrstnosti oskrbe.
The MAH should also submit the appropriate variations to the national competent authorities to update the marketing authorisations affected dialysis solutions, in accordance with agreed change management plans.
Imetnik dovoljenja za promet z zdravilom mora v skladu z dogovorjenimi načrti upravljanja sprememb pristojnim nacionalnim organom predložiti tudi ustrezne spremembe za posodobitev dovoljenj za promet z zadevnimi dializnimi raztopinami.
5 vials
5 viale
(Invented) name
(Izmišljeno) ime Jakost Farmacevtska oblika
Strength Pharmaceutical Form Route of Administration
Pot uporabe Stična ovojnina
None of these cases were fatal or life-threatening.
Nobeden od teh primerov ni bil smrten ali smrtno nevaren.
This medicine will be given to you by your doctor.
To zdravilo vam bo dajal vaš zdravnik.
No specific measure has been proven to be recommendable.
Za noben specifičen ukrep ni bilo dokazano, da bi bil posebej priporočljiv.
There are also links to other websites about rare diseases and treatments.
Tam so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Not known (frequency cannot be estimated from the available data)
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
If extravasation is suspected, general safety measures should be implemented.
Če posumimo na ekstravazacijo, je treba izvesti splošne varnostne ukrepe.
DNA (which carries your genetic information),  if you are pregnant, or think you may be pregnant.
DNK (ki prenaša vaše genetične informacije),  če ste noseči ali mislite, da bi utegnili biti noseči.
1 vial 5 vials
1 viala 5 vial
This medicine contains no other ingredients.
To zdravilo ne vsebuje nobenih drugih sestavin.
The recommended dose and schedule of administration is:
Priporočeni odmerek in razpored dajanja sta:
Further results are shown in Table 1.
Nadaljnje rezultate kaže preglednica 1.
Unopened vial 5 years
Neodprta viala 5 let
Non-inferiority of FT10 versus the reference FB2 was statistically proven (Figure 1).
Neinferiornost FT10 proti referenci FB2 je bilo statistično dokazano (slika 1).
• Active non-controlled infectious disease
• aktivne neobvladane infekcijske bolezni
The two-year projected overall survival was 90%.
Dveletno napovedano skupno preživetje je bilo 90 %.
Solutions showing any sign of precipitation should not be used.
Raztopin, ki kažejo znake precipitacije, ne smete uporabiti.
Juvenile animal studies
Študije na mladih živalih
This procedure is very important, because moistening of powder that sticks to the surface results in caking.
Ta postopek je zelo pomemben, ker ovlažitev praška, ki je prilepljen na površino, povzroči nastanek pogače.
Concomitant use of live attenuated vaccines is not recommended.
Sočasna uporaba živih atenuiranih cepiv ni priporočljiva.
A total of 37 patients (52.9%) were younger than 12 years.
Vsega skupaj 37 bolnikov (52,9 %) je bilo mlajših od 12 let.
If you are affected, do not drive or use machines.
Če imate te znake, ne upravljajte vozil in strojev.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili, ki so na voljo brez recepta.
The treosulfan concentrations in brain tissue were 95%-98% lower than in plasma.
Koncentracije treosulfana so bile v možganskem tkivu za 95 %-98 % nižje kot v plazmi.
64% of patients had AML and 36% MDS.
64 % bolnikov je imelo AML, 36 % pa MDS.
• problems sleeping (insomnia)
• težave s spanjem (nespečnost, insomnia),
Secondary malignancies are well-established complications in long-term survivors after alloHSCT.
Sekundarne maligne bolezni so dokazane komplikacije pri dolgoročno preživelih bolnikih po alloHSCT.
Your child will be monitored for signs of side effects affecting nerves and breathing problems.
Vašega otroka bodo spremljali glede znakov neželenih učinkov, ki prizadenejo živce, in težav z dihanjem.
Trecondi may increase the risk of having another cancer in the future.
Zdravilo Trecondi lahko zveča tveganje, da boste v prihodnosti dobili raka druge vrste.
Therefore, infants ≤ 4 months of age should be monitored for signs of neurological adverse reactions.
Zato je treba dojenčke, stare ≤ 4 mesece, spremljati glede znakov nevroloških neželenih učinkov.
You will have regular blood tests during treatment to check your blood cell counts do not fall too low.
Med zdravljenjem vam bodo redno delali preiskave krvi, s katerimi bodo preverjali, da se števila vaših krvničk ne bodo preveč zmanjšala.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če se zdravilo ne uporabi takoj, je za trajanje shranjevanja med uporabo in razmere shranjevanja odgovoren uporabnik.
Events were defined as relapse of disease, graft failure or death (whatever occurred first).
Dogodki so bili definirani kot recidiv bolezni, neuspeh presadka ali smrt (tisto od naštetega, kar se je zgodilo najprej).
All five paediatric patients received alloHSCT for primary immunodeficiencies, i.e. diseases with an increased risk for neoplasias per se.
Vseh pet pediatričnih bolnikov je prejelo alloHSCT za primarne imunske pomanjkljivosti, tj. bolezni z zvečanim tveganjem neoplazij samih po sebi.
Conventional dose calculation simply based on BSA results in a significantly higher exposure (AUC) of smaller children and infants with low BSA compared to adolescents or adults.
Običajni izračun odmerka preprosto na podlagi BSA ima za posledico značilno večjo izpostavljenost (AUC) majhnih otrok in dojenčkov z majhno BSA v primerjavi z mladostniki ali odraslimi.
At the recommended dose, this is the desired effect.
To je želeni učinek pri priporočenem odmerku.
If you were given more Trecondi than you should Because this medicine is given by a doctor, you will be given the correct dose.
Če so vam dali večji odmerek zdravila Trecondi, kot bi smeli Ker vam to zdravilo daje zdravnik, boste prejeli pravilen odmerek.
Mean apparent terminal half-life of treosulfan was comparable between the different age groups and ranged between 1.3 and 1.6 hours.
Povprečni navidezni terminalni razpolovni čas treosulfana je bil primerljiv med različnimi starostnimi skupinami in je bil v mejah med 1,3 in 1,6 ure.
Eleven patients had a relapse/progression.
Enajst bolnikov je imelo recidiv/napredovanje bolezni.
No dose adjustment is necessary in any subset of the elderly population.
Pri nobeni podskupini starejše populacije ni potrebno prilagajanje odmerka.
However, if you think you have received more of this medicine than you should, tell your doctor or nurse as soon as possible.
Če pa vseeno mislite, da ste prejeli več tega zdravila, kot bi ga smeli, to čimprej povejte zdravniku ali medicinski sestri.
If this happens, vigorously shake the vial to redissolve the cake.
Če se to zgodi, močno stresajte vialo, da se pogača spet raztopi.
A total of 7 of the 70 patients (10.0%) died, two patients because of relapse/progression, three patients transplant-related and two further patients for other reasons.
Sedem od 70 bolnikov (10,0 %) je umrlo, dva bolnika zaradi recidiva/napredovanja bolezni, trije bolniki v zvezi s presadkom, še dva nadaljnja bolnika pa iz drugih vzrokov.
Remnants of the medicinal product as well as all materials that have been used for reconstitution and administration must be destroyed according to standard procedures applicable to antineoplastic agents, with due regard to current laws related to the disposal of hazardous waste.
Ostanke zdravila in vseh materialov, ki ste jih porabili pri rekonstituciji in dajanju zdravila, morate uničiti v skladu s standardnimi postopki, ki veljajo za antineoplastična sredstva, pri čemer upoštevajte trenutno zakonodajo, ki ureja odstranjevanje nevarnih odpadkov.
Table 1: Treatment results at 24 months (Full analysis set) Parameter
Preglednica 1: Rezultati zdravljenja pri 24 mesecih (celotni nabor za analizo)