natgillin/translations-raw huggingface dataset:
The full EPAR for Gliolan can be found here. 
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Gliolan je na voljo tukaj.
‘Invasive' means that the infection has spread into the blood; 
„Invazivna“ pomeni, da se je okužba razširila v kri;
It is given once a day by infusion lasting about one hour. 
Zdravilo se daje enkrat dnevno v obliki počasne infuzije, ki traja približno eno uro.
The European Commission granted a marketing authorisation valid throughout the European Union for Caspofungin MSD on 24 October 2001. 
Evropska komisija je dovoljenje za promet z zdravilom Caspofungin MSD, veljavno po vsej Evropski uniji, izdala 24. oktobra 2001.
What measures are being taken to ensure the safe and effective use of Cancidas? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cancidas?
This is known as ‘empirical treatment', which means that the doctor starts treatment based on an observation of the patient before confirming that the patient has the infection. 
Temu pravimo „empirično zdravljenje“, kar pomeni, da se zdravljenje začne na podlagi opazovanja bolnika, preden lahko zdravnik potrdi, da je bolnik okužen.
The name of the medicine was changed to Cancidas on 9 April 
Ime zdravila je bilo 9. aprila 2003 spremenjeno v Cancidas.
The full EPAR for Cancidas 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 Cancidas je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cancidas should be used with care in children below 12 months of age, because it has not been studied sufficiently in this age group. 
Zdravilo Cancidas je treba pri otrocih, mlajših od 12 mesecev, uporabljati previdno, saj zdravilo v tej starostni skupini ni bilo zadostno raziskano.
Other information about Cancidas 
Druge informacije o zdravilu Cancidas
This is a summary of the European public assessment report (EPAR) for Cancidas. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cancidas.
The most common side effects with Cancidas in adults (which may affect up to 1 in 100 people) are reduced levels of haemoglobin or red blood cells, reduced white blood cell count, low levels of potassium in the blood, headache, inflammation of the veins, shortness of breath, nausea, diarrhoea, vomiting, raised levels of liver enzymes and bilirubin (which may indicate liver problems), rash, itching, redness of skin, excessive sweating, joint pain, fever, chills, itching at injection site, and reduced levels of albumin, a protein in the blood. 
Najpogostejši neželeni učinki zdravila Cancidas pri odraslih (ki lahko prizadenejo največ 1 osebo od 10) so zmanjšana raven hemoglobina ali rdečih krvnih celic, zmanjšano število belih krvnih celic, nizka raven kalija v krvi, glavobol, vnetje ven, težave pri dihanju, navzeja, driska, bruhanje, povišane ravni jetrnih encimov in bilirubina (kar lahko kaže na težave z jetri), izpuščaj, srbenje, pordelost kože, čezmerno znojenje, bolečina v sklepih, povišana telesna temperatura, mrzlica, srbenje na mestu injiciranja in zmanjšane ravni albumina (beljakovine v krvi).
In patients between 12 months and 17 years of age, the dose is calculated using the child's height and weight. 
Pri bolnikih, starih od 12 mesecev do 17 let, se odmerek izračuna na podlagi otrokove višine in telesne mase.
It is not intended to provide practical advice on how to use Cancidas. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Fungal cells treated with Cancidas have incomplete or defective cell walls, making them fragile and unable to grow. 
Celice gliv, ki so izpostavljene zdravilu Cancidas, imajo nepopolne ali okvarjene celične stene, zaradi česar so občutljive in ne morejo rasti.
Treatment is continued for up to two weeks after the infection has been cured. 
Ko je okužba pozdravljena, se zdravljenje nadaljuje še do dva tedna.
It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide', which is necessary for the fungus to continue living and growing. 
Deluje tako, da posega v tvorbo ene od sestavin celične stene glive, ki se imenuje glukan polisaharid in je nujna, da bi lahko gliva živela in rasla.
What benefits of Cancidas have been shown in studies? 
Kakšne koristi je zdravilo Cancidas izkazalo v študijah?
• invasive aspergillosis (an infection caused by Aspergillus) when the patient does not respond to or does not tolerate amphotericin B or itraconazole (other antifungal medicines); 
• invazivno aspergilozo (drugo vrsto glivne okužbe, ki jo povzroča Aspergillus), če se bolnik ne odziva na amfotericin B ali itrakonazol (drugi protiglivni zdravili) ali ju ne prenaša;
Cancidas is an antifungal medicine used to treat the following fungal infections in adults and children: 
Cancidas je protiglivno zdravilo, ki se uporablja za zdravljenje naslednjih glivnih okužb pri odraslih in otrocih:
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cancidas have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cancidas upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
• suspected fungal infections (such as due to Candida or Aspergillus) when the patient is feverish and has low white blood cell counts. 
• domnevnimi glivnimi okužbami (npr. zaradi Candide or Aspergillusa), če je bolnik febrilen in mu primanjkuje belih krvničk.
• invasive candidiasis (an infection caused by Candida). 
• invazivne kandidioze (vrste glivne okužbe, ki jo povzroča Candida).
What is Cancidas and what is it used for? 
Kaj je zdravilo Cancidas in za kaj se uporablja?
What are the risks associated with Cancidas? 
Kakšna tveganja so povezana z zdravilom Cancidas?
Studies show that Cancidas treatment can lead to favourable responses in patients with fungal infections, including improvement of symptoms and the clearing of fungus from patient's body. 
Študije so pokazale, da se bolniki z glivno okužbo lahko pozitivno odzovejo na zdravljenje z zdravilom Cancidas, tudi z izboljšanjem simptomov in odstranitvijo glive iz bolnikovega telesa.
Similar responses were seen in a study in 49 children and adolescents with either invasive candidiasis or invasive aspergillosis: 50% of those with invasive candidiasis (5 out of 10) and 81% of those with invasive aspergillosis (30 out of 37) responded to Cancidas. 
Podobne odzive je pokazala študija pri 49 otrokih in mladostnikih z invazivno kandidiazo ali invazivno aspergilozo: 50 % (5 od 10) tistih z invazivno kandidiazo in 81 % (30 od 37) tistih z invazivno asperigilozo se je odzvalo na zdravilo Cancidas.
Why is Cancidas approved? 
Zakaj je bilo zdravilo Cancidas odobreno?
In adults, treatment starts with a 70 mg on the first day, followed by a daily dose of 50 mg, or 70 mg if the patient weighs more than 80 kg. A lower dose may be necessary in adults who have moderate problems with their liver. 
Pri odraslih se zdravljenje začne s 70-miligramskim uvajalnim odmerkom, ki mu sledi dnevni odmerek 50 mg oziroma 70 mg, če bolnik tehta več kot 80 kg.
The active substance in Cancidas, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins'. 
Zdravilna učinkovina v zdravilu Cancidas, kaspofungin, sodi v skupino protiglivnih zdravil, znanih kot ehinokandini.
For more information about treatment with Cancidas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Cancidas preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For the full list of all side effects reported with Cancidas in adults and children, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cancidas pri odraslih in otrocih, glejte navodilo za uporabo.
Finally, in 2 studies of patients with suspected fungal infection who were treated empirically, Cancidas was as effective as amphotericin B. In one of studies involving around 1,000 adults, 34% of patients had a favourable response with either Cancidas or amphotericin B Similar results were seen in the second study, which involved 82 children aged between two and 17 years. 
Poleg tega je bilo zdravilo Cancidas v dveh študijah pri bolnikih z domnevno glivno okužbo, ki so bili zdravljeni empirično, enako učinkovito kot amfotericin B. V eni od študij pri približno 1 000 odraslih se je 34 % bolnikov ugodno odzvalo na Cancidas ali amfotericin B. Podobne rezultate je pokazala druga študija, v katero je bilo vključenih 82 otrok, starih od 2 do 17 let.
For practical information about using Cancidas, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Cancidas naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The most common side effect in children is fever and this occurs in more than 1 patient in 10. 
Najpogostejši neželeni učinek pri otrocih (opažen pri več kot 1 od 10 bolnikov) je povišana telesna temperatura.
Cancidas treatment should be started by a doctor who has experience in the management of invasive fungal infections. 
Zdravljenje z zdravilom Cancidas mora uvesti zdravnik z izkušnjami z zdravljenjem invazivnih glivnih okužb.
Of the adults who did not respond to other treatments, 36% responded to Cancidas (19 out of 53). 
Od odraslih, ki se niso odzvali na drugo zdravljenje, se jih je 36 % (19 od 53) odzvalo na zdravilo Cancidas.
The list of fungi against which Cancidas is active can be found in the summary of product characteristics (also part of the EPAR). 
Za seznam gliv, proti katerim deluje zdravilo Cancidas, glejte povzetek glavnih značilnosti zdravila (ki je prav tako sestavni del EPAR).
Of those who did not tolerate other treatments, 70% responded to Cancidas (7 out of 10). 
Med tistimi, ki niso prenašali drugega zdravljenja, se jih je 70 % (7 od 10) odzvalo na zdravilo Cancidas.
Cancidas is a powder that is made up into a solution for infusion (drip) into a vein. 
Zdravilo Cancidas je prašek, namenjen za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
In a study of 239 adults with invasive candidiasis, 73% of the adults treated with Cancidas who could be assessed had a favourable response (80 out of 109), compared with 62% of the adults treated with amphotericin B (71 out of 115). 
Pri invazivni kandidiozi je bil pri 73 % (80 od 109) bolnikih, zdravljenih z zdravilom Cancidas, odziv ocenjen kot ugoden v primerjavi z 62 % (71 od 115) bolnikov, ki so prejemali amfotericin B.
How does Cancidas work? 
Kako zdravilo Cancidas deluje?
The CHMP decided that evidence form the studies with Cancidas show that the medicines benefits are greater than its risks for the treatment of invasive candidiasis or aspergillosis, and for empirical therapy for presumed fungal infections, in adults or children. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Cancidas pri zdravljenju invazivne kandidiaze ali aspergiloze ter empirični terapiji zaradi domnevnih glivnih okužb pri odraslih ali pediatričnih bolnikih večje od z njim povezanih tveganj, zato je priporočil, da se za zanj izda dovoljenje za promet.
In an invasive aspergillosis study involving 69 adults, 41% had a favourable response to Cancidas at the end of the study (26 out of 63). 
Pri invazivni aspergilozi je bil ob koncu študije pri 41 % (26 od 63) bolnikov odziv ugoden.
How is Cancidas used? 
Kako se zdravilo Cancidas uporablja?
Cancidas contains the active substance caspofungin 
Zdravilo Cancidas vsebuje zdravilno učinkovino kaspofungin.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC. 
Informacije o zdravilu lahko nadalje po potrebi posodobijo pristojni organi držav članic v povezavi z referenčno državo članico, v skladu s postopki, določenimi v 4. poglavju naslova III Direktive 2001/83/ES.
This product information is the outcome of the referral procedure to which this Commission decision relates. 
Te informacije o zdravilu so rezultat napotitvenega postopka, na katerega se nanaša sklep Komisije.
The active substance ibuprofen shows an environmental risk for the aquatic environment especially to fish. 
Za učinkovino ibuprofen so dokazali okoljsko tveganje za vodno okolje, še zlasti za ribe.
Do not take for more than 3 days. 
Ne jemljite več kot 3 dni.
The valid product information is the final version achieved during the Coordination group procedure with the following amendments (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below: 
Veljavne informacije o zdravilu so končna različica, sprejeta v postopku koordinacijske skupine, z naslednjimi spremembami (vstavitev, zamenjava ali izbris besedila, kot je primerno), tako da bodo odražale odobreno besedilo, ki je navedeno spodaj:
[The following wording should be amended as follows] If your symptoms do not get better after 3 days, if they get worse or if you get new symptoms, talk to your doctor. 
Če se vaši simptomi po 3 dneh ne izboljšajo, če se poslabšajo ali če se pojavijo novi simptomi, se posvetujte z zdravnikom.
[The following AEs are described as follows:] ‘Paraesthesia' to frequency Rare (moved from Very Rare) ‘Oedema' to frequency Common (moved from Very Rare) 
[Naslednji neželeni učinki so opisani, kot sledi:] »Parestezija« v pogostnosti Redki (premaknjeno iz Zelo redki) »Edem« v pogostnosti Pogosti (premaknjeno iz Zelo redki)
• are under 18 years Talk to a pharmacist or your doctor before taking if you: 
• mlajši od 18 let Pred začetkom jemanja se posvetujte s farmacevtom ali zdravnikom, če ste:
Amendments to the relevant sections of the product information 
Spremembe zadevnih poglavij informacij o zdravilu
The exact mechanism of action of ibuprofen is thought to be through peripheral inhibition of cyclooxygenases and subsequent prostaglandin synthesise inhibition. 
Natančen mehanizem delovanja ibuprofena naj bi bil preko perifernega zaviranja ciklooksigenaz in posledičnega zaviranja sinteze prostaglandinov.
[The following wording should be amended as follows] This medicinal product should not be taken with other medicinal products containing paracetamol, ibuprofen, acetylsalicylic acid, salicylates or with any other anti-inflammatory drugs (NSAIDs) unless under a doctor's instruction. 
Tega zdravila se ne sme jemati z drugimi zdravili, ki vsebujejo paracetamol, ibuprofen, acetilsalicilno kislino, salicilate ali s katerimi koli drugimi protivnetnimi zdravili (NSAIDnonsteroidal anti-inflammatory drugs), razen če so taka navodila zdravnika.
[The following phrase is deleted as it was duplication] 
[Naslednji stavek je izbrisan, saj je šlo za podvajanje.]
Section 4.4 Special warnings and precautions for use [The wording below should be inserted in this section] 
Poglavje 4.4 Posebna opozorila in previdnostni ukrepi [V to poglavje je treba vstaviti spodnje besedilo.]
B. Labelling Carton 
B. Označevanje Škatla
How to take {Paracetamol/Ibuprofen 500 mg/150mg film coated tablets}{Novogesic 500 mg/150 mg film coated tablets} 
Kako jemati zdravilo {Paracetamol/Ibuprofen 500 mg/150 mg filmsko obložene tablete}{Novogesic 500 mg/150 mg filmsko obložene tablete}
This medicine is for short term use and is not recommended for use beyond 3 days. 
To zdravilo je namenjeno za kratkotrajno uporabo in ga ni priporočljivo uporabljati dlje kot 3 dni.
Treatment should be stopped in those patients who develop severe liver failure (see section 4.3). 
Z zdravljenjem je treba prenehati pri bolnikih, pri katerih se pojavi huda odpoved jeter (glejte poglavje 4.3).
Section 6.1 List of excipients [The following phrase is amended] 
Poglavje 6.1 Seznam pomožnih snovi [Naslednji stavek je spremenjen.]
Dose reduction is recommended in patients showing signs of worsening hepatic function. 
Pri bolnikih, ki kažejo znake poslabšanja delovanja jeter, je priporočljivo zmanjšanje odmerka.
For short term use only (not more than 3 days). 
Samo za kratkotrajno uporabo (ne več kot 3 dni).
What {Paracetamol/Ibuprofen 500 mg/150mg film coated tablets}{Novogesic 500 mg/150 mg film coated tablets}contain macrogol/PEG 4000 
Kaj vsebuje zdravilo {Paracetamol/Ibuprofen 500 mg/150 mg filmsko obložene tablete}{Novogesic 500 mg/150 mg filmsko obložene tablete}
Do not take if you: [The wording below should be inserted in this section] 
Ne jemljite, če ste: [V to poglavje je treba vstaviti spodnje besedilo.]
For oral administration and short term use only (not more than 3 days). 
Za peroralno uporabo in samo za kratkotrajno uporabo (ne več kot 3 dni).
[The phrase below should be amended as follows] 
[Spodnji stavek je treba spremeniti, kot sledi.]
Children under18 years: [The following wording should be amended as follows] This product is not recommended forDo not give to children under 18 years. 
Otroci, mlajši od 18 let: [Naslednje besedilo je treba spremeniti, kot sledi.]
[The wording below should be inserted in this section] Treatment should be stopped in those patients who develop severe renal failure (see section 4.3). 
Z zdravljenjem je treba prenehati pri bolnikih, pri katerih se pojavi huda odpoved ledvic (glejte poglavje 4.3).
[The following wording should be amended as follows] For oral use. 
[Naslednje besedilo je treba spremeniti, kot sledi.]
Ibuprofen [The following phrase is deleted] 
Poglavje 5.3 Predklinični podatki o varnosti Ibuprofen [Naslednji stavek je izbrisan.]
Adults: [The wording below should be inserted in this section] Do not take for more than 3 days. 
Odrasli: [V to poglavje je treba vstaviti spodnje besedilo.]
This means that it has yet not been possible to obtain complete information about the product. 
To pomeni, da o izdelku še ni bilo mogoče pridobiti vseh podatkov.
This summary was last updated in May 2007. 
Ta povzetek je bil nazadnje posodobljen 05/2007.
The vaccine will only be used as part of an approved national disease control programme. 
Cepivo se bo uporabljalo le kot del odobrenega nacionalnega programa za nadzor bolezni.
The vaccine contains a mineral oil. 
Cepivo vsebuje mineralno olje.
This differentiation is important for disease surveillance and control. 
Razlikovanje je pomembno za spremljanje in nadzor bolezni.
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR). 
Če želite več informacij o podlagi za priporočila CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
If you need more information about how this product may be used, you should consult your national veterinary authority. 
Če potrebujete več informacij o uporabi tega izdelka, se posvetujte z vašim nacionalnim veterinarskim organom.
What are the precautions for the person who gives the medicine or comes into contact with the animal? 
Kakšni varnostni ukrepi so potrebni za osebo, ki daje zdravilo ali prihaja v stik z živaljo?
Due to the current epidemiological situation of avian influenza and the consequent threat to both human and animal health, the Committee recommended the granting of a Marketing Authorisation. 
Zaradi trenutne epidemiološke situacije v zvezi z aviarno influenco in posledične grožnje za zdravje ljudi in živali je odbor priporočil odobritev dovoljenja za promet z zdravilom.
The European Medicines Agency (EMEA) will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary. 
Evropska agencija za zdravila (EMEA) bo pregledala dodatne informacije, ki bodo dane na razpolago glede na sprejet časovni načrt, in bo po potrebi dopolnila ta povzetek.
• The results of the safety studies indicated that the product is safe for chickens and ducks. 
• Rezultati študij o varnosti so pokazali, da je izdelek varen za piščance in race.
This is because control of avian influenza is the responsibility of national veterinary authorities in consultation with the European Commission. 
Nadzor nad aviarno influenco je namreč v pristojnosti nacionalnih veterinarskih organov, ki se posvetujejo z Evropsko komisijo.
In common with many adjuvanted vaccines swelling may occur at the vaccination site which may last for about 14 days. 
Tako kot pri mnogih cepivih z dodatki (adjuvansi) lahko na mestu cepljenja nastane oteklina, ki lahko ostane približno 14 dni.
The vaccine is injected intramuscularly (into a muscle) or subcutaneously (under the skin). 
Cepivo se injicira intramuskularno (v mišico) ali subkutano (pod kožo).
When compared, the subcutaneous and intramuscular routes were shown to produce the same responses. 
Ob primerjavi subkutanega in intramuskularnega načina dajanja zdravila se je izkazalo, da so bili odzivi enaki.
In the future, if the birds are exposed to the avian flu virus, the immune system will be able to make those antibodies quicker and this will help them fight the disease. 
Če bodo ptice v prihodnosti izpostavljene virusu aviarne influence, bo njihov imunski sistem ta protitelesa tvoril hitreje, kar jim bo pomagalo v boju proti bolezni.
The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H7N1 to Intervet International BV on 14/05/2007. 
Evropska komisija je dovoljenje za promet z zdravilom Nobilis Influenza H7N1, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 14/05/2007
This means that vaccinated birds make antibodies against these two antigens. 
To pomeni, da tvorijo cepljene ptice protitelesa proti tema dvema antigenoma.
This strain has been chosen because it protects birds against virulent H7 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds. 
Ta sev je bil izbran, ker varuje ptice pred virulentnimi divjimi sevi H7 (navzkrižna zaščita), hkrati pa omogoča razlikovanje cepljenih ptic od okuženih ptic.
The Committee for Medicinal Products for Veterinary use concluded that the vaccine has been shown to be effective in reducing clinical disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection. 
Odbor za zdravila za uporabo v veterinarski medicini je sklenil, da je bila dokazana učinkovitost cepiva pri zmanjševanju kliničnih bolezni pri perutnini in da je cepivo lahko uporaben pripomoček pri nadzorovanju izbruha okužbe z aviarno influenco.
The vaccine was assessed in the context of an emergency situation which means that further studies with Nobilis H7N1 are still ongoing and will be assessed. 
Cepivo je bilo ocenjeno v izrednih razmerah, kar pomeni, da nadaljnje študije z zdravilom Nobilis Influenza H7N1 še vedno potekajo in bodo ovrednotene v prihodnosti.
Nobilis Influenza H7N1 is a vaccine containing an inactivated avian influenza virus H7N1 (inactivated means that the virus has been killed so that it can no longer cause the disease). 
Zdravilo Nobilis Influenza H7N1 je cepivo, ki vsebuje inaktivirani virus aviarne influence H7N1 (inaktiviran pomeni, da je bil virus ubit, zaradi česar ne more več povzročiti bolezni).
Vaccinated birds can be differentiated identified from infected birds by a diagnostic test for antibodies against the N1 component. 
Cepljene ptice je mogoče razlikovati od okuženih ptic z diagnostičnim testom za odkrivanje protiteles proti sestavini N1.
The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated birds. 
Cepivo ne vsebuje učinkovin, ki bi lahko predstavljale tveganje za ljudi, ki zaužijejo meso cepljenih ptic.
The person who injects the vaccine should be careful to avoid accidental self injection. 
Oseba, ki daje cepivo, mora paziti, da si zdravila po nesreči ne samoinjicira.