natgillin/translations-raw huggingface dataset:
The MAH shall draw up global corrective and preventive actions (CAPA) and use them to prevent endotoxin contamination at other sites producing dialysis solutions. 
Imetnik dovoljenja za promet z zdravilom pripravi celovite korektivne in preventivne ukrepe ter jih izvaja za preprečevanje kontaminacije z endotoksini tudi v drugih proizvodnih obratih, kjer proizvaja dializne raztopine.
This RMP shall follow the EU RMP template (as referenced in Volume 9a of The Rules Governing Medicinal Products in the European Union) and shall include the measures to assess the effectiveness of the risk minimisation in the agreed consolidated RMP. 
Ta načrt za obvladovanje tveganja bo oblikovan v skladu s predlogo načrta EU za obvladovanje tveganja (kot navaja zvezek 9a Pravil, ki urejajo zdravila v Evropski uniji) in bo vključeval ukrepe za ocenjevanje učinkovitosti zmanjševanja tveganja v dogovorjenem celovitem načrtu za obvladovanje tveganja.
During inspections of the local sites located under their territories, member states shall ensure that the MAH has appropriately transposed the experience acquired in Castlebar, in accordance with the global CAPA. 
Države članice zagotovijo, da je med inšpekcijskimi pregledi obratov na njihovem ozemlju imetnik dovoljenja za promet z zdravilom ustrezno prenesel izkušnje, pridobljene v Castlebaru, v skladu s celovitimi in korektivnimi ukrepi.
The MAH shall perform a 12 month monitoring after site qualification by the supervisory authority (IMB) in Castlebar. 
Imetnik dovoljenja za promet z zdravilom po kvalifikaciji obrata s strani nadzornega organa (IMB) v Castlebaru izvede 12-mesečno spremljanje.
The MAH shall perform epidemiological studies consisting of a clinical audit that will collect data on the number of peritonitis events in the EU in 2010 and 2011 and an observational study to assess the nature of peritonitis and non-peritonitis cases (including fatal outcomes) and their outcome, in accordance with the milestones for evaluation and reporting described in the consolidated RMP. 
Imetnik dovoljenja za promet z zdravilom izvede v skladu z mejniki za ocenjevanje in poročanje, opisanimi v celovitem načrtu za obvladovanje tveganja, epidemiološke študije, sestavljene iz klinične presoje, v kateri bodo zbrani podatki o številu dogodkov peritonitisa v EU v letih 2010 in 2011, ter opazovalne študije, v kateri se bo ocenila oblika peritonitisa in primerov brez peritonitisa (vključno s primeri s smrtnim izidom).
Conditions to be fulfilled by the MAH: 
Imetnik dovoljenja za promet z zdravilom mora izpolniti naslednje pogoje:
Further information on Ubac can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu UBAC so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
If pain persists for more than 12 hours after medical examination, the doctor should be contacted again. 
Če bolečina ne izgine po več kot 12 urah po zdravniškem pregledu, se je treba znova posvetovati z zdravnikom.
The European Medicines Agency decided that Ubac's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je odločila, da so koristi zdravila UBAC večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
This will help protect the cattle against the infection and reduce the risk of mastitis. 
S tem govedo zaščitimo pred okužbo in zmanjšamo tveganje za mastitis.
The full course should be repeated with each pregnancy. 
Celoten postopek je treba ponoviti ob vsaki brejosti.
The vaccine also contains ‘adjuvants' (Montanide ISA and MPLA) to stimulate a better reaction by the immune system. 
Cepivo vsebuje tudi „adjuvansa“ (montanid ISA in MPLA), ki spodbudita boljši odziv imunskega sistema.
Protection starts about 36 days after the second injection and lasts for the first 5 months of lactation (milk production). 
Zaščita začne učinkovati približno 36 dni po drugi injekciji in traja prvih pet mesecev laktacije (proizvodnje mleka).
Ubac (Streptococcus uberis vaccine, inactivated) EMA/296128/2018 
UBAC (cepivo proti Streptococcus uberis, inaktivirano) EMA/296128/2018
What benefits of Ubac have been shown in studies? 
Kakšne koristi zdravila UBAC so se pokazale v študijah?
During a 21 week observation period the incidence of new cases of S. uberis clinical mastitis was 50% lower in the group of 277 cattle vaccinated with Ubac compared to the group of 303 cattle given placebo (dummy treatment) (6.1% versus 12.2%). 
Med 21-tedenskim opazovalnim obdobjem je bila pojavnost novih primerov kliničnega mastitisa zaradi bakterije S. uberis za 50 % manjša v skupini 277 goved, cepljenih z zdravilom UBAC, v primerjavi s skupino 303 goved, ki so prejela placebo (zdravilo brez učinkovine) (6,1 % v primerjavi z 12,2 %).
Why is Ubac authorised in the EU? 
Zakaj je bilo zdravilo UBAC odobreno v EU?
Ubac (Streptococcus uberis vaccine, inactivated) 
UBAC (cepivo proti Streptococcus uberis, inaktivirano)
What is Ubac and what is it used for? 
Kaj je zdravilo UBAC in za kaj se uporablja?
An overview of Ubac and why it is authorised in the EU 
Pregled zdravila UBAC in zakaj je odobreno v EU
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or fingerthis could result in the loss of the finger if prompt medical attention is not given. 
Nenamerno injiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst na roki - brez takojšnje zdravniške oskrbe lahko pride do izgube prsta.
Other information about Ubac 
Druge informacije o zdravilu UBAC
The third injection is given about 15 days after calving. 
Tretja injekcija se da približno 15 dni po telitvi.
The whole herd should be vaccinated. 
Treba je cepiti celotno čredo.
What are the risks associated with Ubac? 
Kakšna tveganja so povezana z zdravilom UBAC?
Ubac received a marketing authorisation valid throughout the EU on 26 July 2018. 
Zdravilo UBAC je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 26/07/2018.
The withdrawal period for meat and milk from cattle treated with Ubac is ‘zero' days, which means that there is no mandatory waiting time. 
Karenca za meso in mleko goveda, zdravljenega z zdravilom UBAC, je „nič“ dni, kar pomeni, da ni obvezne čakalne dobe.
The first injection is given at about 60 days before the expected calving date followed by a second injection given at least 3 weeks before the expected calving date. 
Prva injekcija se da približno 60 dni pred predvidenim datumom telitve, druga injekcija pa najmanj tri tedne pred pričakovanim datumom telitve.
The package leaflet should be shown to the doctor. 
Zdravniku je treba pokazati navodilo za uporabo.
For more information about using Ubac, see the package leaflet or contact your veterinarian or pharmacist. 
Za več informacij glede uporabe zdravila UBAC glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
In the future, if the animals are exposed to disease-causing S. uberis bacteria, the immune system will be able to respond more quickly. 
Če so živali pozneje izpostavljene bakterijam S. uberis, ki povzročajo bolezen, se lahko imunski sistem nanje hitreje odzove.
Ubac is a vaccine used in cows and heifers (female cattle that have not yet calved) to reduce clinical mastitis (udder infections with visible signs in milk or the udder) caused by bacteria called Streptococcus uberis, which can reduce milk production. 
Zdravilo UBAC je cepivo, ki se uporablja pri kravah in telicah (govedu ženskega spola, ki še ni telilo), da se zmanjša klinični mastitis (vnetja vimena z vidnimi znaki v mleku ali vimenu), ki ga povzroča bakterija Streptococcus uberis in ki lahko zmanjša proizvodnjo mleka.
Ubac is given as a course of 3 injections into the neck muscles, alternating sides of the neck. 
Zdravilo se daje v sklopu treh injiciranj v vratno mišičevje, izmenoma na obeh straneh vratu.
The active substance in Ubac is obtained from the sticky substances that the S. uberis bacteria produce to protect themselves and attach to surfaces (known as biofilm adhesion components). 
Učinkovina v zdravilu UBAC je pridobljena iz lepljivih snovi, ki jih proizvaja bakterija S. uberis, da se zaščiti in se z njimi pritrdi na površine (poznanih kot komponente lepljivega biofilma).
A field study involved 6 farms with a history of S. uberis clinical mastitis and recently confirmed presence of S. uberis infection. 
Terenska študija je vključevala šest kmetij, na katerih se je v preteklosti že pojavil klinični mastitis zaradi bakterije S. uberis in na katerih je bila pred kratkim potrjena okužba z bakterijo S. uberis.
Ubac is a vaccine. 
Zdravilo UBAC je cepivo.
If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected. 
V primeru nenamernega injiciranja cepiva je treba nemudoma poiskati zdravniško pomoč, četudi je bila morda injicirana zelo majhna količina.
When Ubac is given to cattle, the animals' immune system recognises the active susbstance as ‘foreign' and makes antibodies against it. 
Ko goveda prejmejo zdravilo UBAC, imunski sistem živali prepozna učinkovino kot „tujek“ ter začne proti njej tvoriti protitelesa.
Ubac is also used to reduce the somatic cell count (SCC) in milk, which is a measure of mastitis without visible signs (subclinical mastitis). 
Zdravilo UBAC se uporablja tudi za zmanjšanje števila somatskih celic v mleku, ki so pokazatelj mastitisa brez vidnih znakov (subkliničnega mastitisa).
Ubac contains the active substance called biofilm adhesion component including lipoteichoic acid, which is derived from the sticky film produced by Streptococcus uberis strain 5616. 
Zdravilo UBAC vsebuje učinkovino, imenovano komponenta lepljivega biofilma, ki vsebuje lipoteihojsko kislino, pridobljeno iz lepljivega filma, ki ga proizvaja sev 5616 bakterije Streptococcus uberis.
Ubac is available as an injection and can only be obtained with a prescription. 
Zdravilo UBAC je na voljo v obliki injekcije, njegovo predpisovanje in izdaja pa je le na recept.
The withdrawal period is the time required after administration of a medicine before an animal can be slaughtered and the meat used for human consumption. 
Karenca je čas, ki mora preteči po dajanju zdravila, preden se lahko žival zakolje in meso uporabi za prehrano ljudi.
The most common side effects with UBAC (which may affect more than 1 in 10 animals) are a shortlived increase in rectal temperature of around 1 - 2 ºC within 24 hours of injection and a local injection site swelling of more than 5 cm in diameter. 
Najpogostejša neželena učinka zdravila UBAC (ki lahko prizadeneta več kot 1 žival od 10) sta kratkotrajno povišanje rektalne temperature za približno 1-2 °C v 24 urah po injiciranju in oteklina na mestu injiciranja s premerom več kot 5 cm. Oteklina na mestu injiciranja navadno izgine ali se njena velikost zmanjša v 17 dneh po cepljenju, v nekaterih primerih pa oteklina lahko traja do štiri tedne.
How is Ubac used? 
Kako se zdravilo UBAC uporablja?
How does Ubac work? 
Kako zdravilo UBAC deluje?
4 pre-filled syringes 
4 napolnjene injekcijske brizge
Subcutaneous use pre-filled syringe 1 ml (50 mg/ml) 12 (3 x 4) pre-filled syringes (multipack) 
1 ml (50 mg/ml) 12 (3 x 4) napolnjenih injekcijskih brizg (večodmerno pakiranje)
Subcutaneous use pre-filled syringe 1 ml (50 mg/ml) 4 pre-filled syringes 
1 ml (50 mg/ml) 4 napolnjene injekcijske brizge
Subcutaneous use pre-filled pen 1 ml (50 mg/ml) 4 pre-filled pens 
1 ml (50 mg/ml) 4 napolnjeni injekcijski peresniki
The effects were sustained for up to seven years. 
Učinki so se ohranili do sedem let.
This summary was last updated in 03-2014. 
Povzetek je bil nazadnje posodobljen 03-2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Siklos on 29 June 2007. 
Evropska komisija je dovoljenje za promet z zdravilom Siklos, veljavno po vsej Evropski uniji, izdala 29. junija 2007.
Siklos is taken once a day, preferably in the morning before breakfast. 
Zdravilo Siklos se jemlje enkrat dnevno, po možnosti zjutraj pred zajtrkom.
The number of cases of acute chest syndrome also fell by 25 to 33%. 
Tudi število primerov akutnega prsnega sindroma se je zmanjšalo za 25 do 33 %.
It is available as tablets (100 and 1,000 mg). 
Na voljo je v obliki tablet (100 in 1 000 mg).
What measures are being taken to ensure the safe and effective use of Siklos? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Siklos?
Hydroxycarbamide, which used to be known as hydroxyurea, has been available in the European Union (EU) for several decades for use in other illnesses, including some types of cancer. 
Hidroksikarbamid, nekdaj znan kot hidroksisečnina, je v Evropski uniji (EU) že nekaj desetletij na voljo za uporabo pri drugih boleznih, vključno z nekaterimi vrstami raka.
The 1,000 mg tablet has special score lines so that it can be easily divided into four equal parts. 
1 000-miligramska tableta ima posebne zareze, ki omogočajo enostavno razdelitev na štiri enake dele.
Blood cell counts normally return to normal within two weeks of stopping Siklos treatment. 
Število krvnih celic se na normalno raven običajno vrne v dveh tednih po prenehanju zdravljenja z zdravilom Siklos.
Patients who do not respond to this dose or who have side effects may need to stop or suspend treatment. 
Pri bolnikih, ki se ne odzivajo na ta odmerek ali imajo neželene učinke, bo morda treba zdravljenje prenehati ali prekiniti.
There were also fewer admissions into hospital, and fewer days spent in hospital. 
Zmanjšalo se je tudi število sprejemov v bolnišnico in bolnišničnih dni.
For more information about treatment with Siklos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Siklos preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
A risk management plan has been developed to ensure that Siklos is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Siklos je bil pripravljen načrt obvladovanja tveganj.
In particular, it presented evidence on the effectiveness of Siklos from 11 published studies involving 378 children and from three national registries of information on 155 children with sickle cell syndrome who were treated with Siklos for up to seven years. 
Predstavila je predvsem dokaze o učinkovitosti zdravila Siklos iz 11 objavljenih študij s 378 otroki in treh nacionalnih registrov s podatki o 155 otrocih s srpastoceličnim sindromom, ki so zdravilo Siklos prejemali do sedem let.
The summary of the opinion of the Committee for Orphan Medicinal Products for Siklos can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Siklos je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
In the study comparing Siklos with placebo in adults, there were fewer vaso-occlusive crises in the patients taking Siklos (2.5 crises per year) than in those taking placebo (4.5 crises per year). 
V študiji, v kateri so pri odraslih primerjali zdravilo Siklos s placebom, so zabeležili manj vazookluzivnih kriz pri bolnikih, ki so jemali zdravilo Siklos (2,5 krize na leto), kot pri tistih, ki so prejemali placebo (4,5 krize na leto).
This reduces the risk of blood vessels becoming blocked. 
To zmanjša tveganje za zamašitev krvnih žil.
This is a summary of the European public assessment report (EPAR) for Siklos. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Siklos.
The starting dose is usually 15 mg per kilogram body weight, using the most appropriate tablet strengths (100 or 1,000 mg) to make up the dose, breaking up the 1,000-mg tablet in quarters (250 mg) if needed. 
Začetni odmerek je običajno 15 mg na kilogram telesne mase, uporabi pa se najprimernejša jakost tablete (100 ali 1 000 mg) za pripravo odmerka, pri čemer se po potrebi 1 000-miligramska tableta zlomi na četrtine (250 mg).
Patients had fewer vaso-occlusive crises when treated with Siklos than before treatment, with the frequency falling by between 66% and 80% in children and adults. 
Bolniki, ki so prejemali zdravilo Siklos, so imeli po zdravljenju manj vazookluzivnih kriz kot pred njim, pri čemer se je njihova pogostnost pri otrocih in odraslih zmanjšala za 66 % do 80 %.
Siklos is a medicine that contains the active substance hydroxycarbamide. 
Siklos je zdravilo, ki vsebuje zdravilno učinkovino hidroksikarbamid.
The studies compared the number of vaso-occlusive crises before and after treatment with Siklos, as defined by any painful episode involving the arms, legs, abdomen, back or chest. 
V študijah so primerjali število vazookluzivnih kriz pred zdravljenjem z zdravilom Siklos in po njem, pri čemer so se te kazale z bolečimi epizodami v rokah, nogah, trebuhu, hrbtu ali prsnem košu.
Because hydroxycarbamide is a well-known substance that is already used in other medicines, the company used data from the scientific literature to support the use of Siklos in adults and children with sickle cell syndrome. 
Ker je hidroksikarbamid dobro znana učinkovina, ki se uporablja tudi v drugih zdravilih, je družba uporabila podatke iz znanstvene literature za podporo uporabe zdravila Siklos pri odraslih in otrocih s srpastoceličnim sindromom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Siklos. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The most common side effect with Siklos (seen in more than one patient in 10) is bone marrow suppression, causing neutropenia (low levels of neutrophils, a type of white blood cell), reticulocytopenia (low levels of reticulocytes, a type of immature red blood cell) and macrocytosis (enlargement of red blood cells). 
Najpogostejši neželen učinek zdravila Siklos (opažen pri več kot 1 bolniku od 10) je supresija kostnega mozga, ki povzroča nevtropenijo (nizke ravni nevtrofilcev, vrste belih krvnih celic), retikulocitopenijo (nizke ravni retikulocitov, vrste nezrelih rdečih krvnih celic) in makrocitozo (povečanje rdečih krvnih celic).
Because the number of patients with sickle cell syndrome is low, the disease is considered ‘rare', and Siklos was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2003. 
Ker je bolnikov s srpastoceličnim sindromom malo, velja ta bolezen za redko, zato je bilo zdravilo Siklos dne 9. julija 2003 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
What benefit has Siklos shown during the studies? 
Kakšne koristi je zdravilo Siklos izkazalo med raziskavami?
The CHMP decided that Siklos's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Siklos večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
What is the risk associated with Siklos? 
Kakšna tveganja so povezana z zdravilom Siklos?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Siklos, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Siklos in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
They can include acute chest syndrome, a life-threatening condition when the patient has sudden chest pain, fever, hard breathing or signs of fluid in the lungs on an X ray. 
Vključujejo lahko akutni prsni sindrom, tj. življenjsko nevarno stanje, ko se pri bolniku pojavijo nenadne bolečine v prsih, vročina, oteženo dihanje ali znaki tekočine v pljučih pri rentgenskem slikanju.
The company that makes Siklos will also provide information packs for doctors and for patients describing the safety information on the medicine. 
Družba, ki izdeluje zdravilo Siklos, bo za zdravnike in bolnike pripravilo informativne brošure z informacijami o varnosti zdravila.
The full EPAR for Siklos can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Siklos je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It also presented evidence from one study in 299 adults, in which the effects of Siklos were compared with those of placebo (a dummy treatment), as well as the results of other studies involving 430 adults and one national registry of information on 123 adults treated with Siklos. 
Predstavljeni so bili tudi podatki iz študije, ki je zajela 299 odraslih in primerjala učinke zdravila Siklos z učinki placeba (zdravila brez zdravilne učinkovine), kot tudi rezultati drugih študij, v katerih je sodelovalo 430 odraslih, ter podatki iz enega nacionalnega registra z informacijami o 123 odraslih, zdravljenih z zdravilom Siklos.
Other information about Siklos 
Druge informacije o zdravilu Siklos:
Although the precise way that it works in this disease is not understood, hydroxycarbamide can reduce the numbers of cells that are circulating in the blood, as well as prevent red blood cells changing shape in patients with sickle cell syndrome. 
Čeprav natančen način delovanja hidroksikarbamida pri tej bolezni ni znan, lahko zmanjša število celic, ki krožijo v krvi, ter prepreči spreminjanje oblike rdečih krvnih celic pri bolnikih s srpastoceličnim sindromom.
The active substance in Siklos, hydroxycarbamide, blocks the growth and reproduction of some cells, such as blood cells. 
Zdravilna učinkovina zdravila Siklos, hidroksikarbamid, zavira rast in reprodukcijo nekaterih celic, npr. krvnih celic.
Treatment with Siklos should be started by a doctor who has experience in the management of sickle cell syndrome. 
Zdravljenje z zdravilom Siklos mora uvesti zdravnik, ki ima izkušnje z zdravljenjem srpastoceličnega sindroma.
Patients taking Siklos should have blood tests before and regularly during treatment, to check their blood cell counts and also to monitor their kidneys and liver. 
Pri bolnikih, ki jemljejo zdravilo Siklos, je treba pred zdravljenjem in redno tudi med njim izvajati krvne preiskave za preverjanje števila krvnih celic ter spremljanje delovanja ledvic in jeter.
Siklos must not be used in people who have severe problems with their kidneys or liver, or who have dangerously low blood cell counts. 
Zdravilo Siklos se ne sme uporabljati pri bolnikih, ki imajo resne težave z ledvicami ali jetri ali ki imajo nevarno nizke ravni krvnih celic.
Siklos, reversible oligospermia or azoospermia (reduced or absent production of healthy sperm) is also very commonly seen. 
Pri moških, zdravljenih z zdravilom Siklos, sta zelo pogosto opaženi reverzibilni oligospermija ali azoospermija (zmanjšano ali odsotno nastajanje zdrave sperme).
Breast-feeding must be stopped while taking Siklos. 
Med jemanjem zdravila Siklos je treba prenehati dojiti.
It is used to prevent recurrent, painful vaso-occlusive crises that happen when blood vessels become blocked by the abnormal red blood cells, restricting the flow of blood to an organ. 
Uporablja se za preprečevanje vazookluzivnih kriz, ki nastanejo, ko nenormalne rdeče krvne celice zamašijo krvne žile in s tem omejijo pretok krvi do organa.
For the full list of all side effects reported with Siklos, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Siklos, glejte navodilo za uporabo.