natgillin/translations-raw huggingface dataset:
If necessary, the second dose can be given later but within 6 months after the first dose. 
Po potrebi se drugi odmerek lahko injicira pozneje, najpozneje pa šest mesecev po prejemu prvega odmerka.
Further information on Shingrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Več informacij o zdravilu Shingrix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Shingrix was assessed in two main studies in around 30,000 adults. 
Zdravilo Shingrix so ocenjevali v dveh glavnih študijah pri približno 30 000 odraslih.
It also contains an ‘adjuvant' which is made of substances to help strengthen the immune responses to the vaccine. 
Vsebuje tudi adjuvans, narejen iz snovi, ki okrepijo imunski odziv na cepivo.
What measures are being taken to ensure the safe and effective use of Shingrix? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Shingrix?
After a patient has had chickenpox, the virus can lie dormant in the nerves and become active again if the immune system (the body's natural defences) weakens due, for example, to ageing or to an illness. 
Potem ko je bolnik prebolel norice, virus lahko v živcih ostane v mirujočem stanju in se spet aktivira, če imunski sistem (naravna odpornost telesa) oslabi, na primer zaradi staranja ali bolezni.
The most common side effects with Shingrix (which may affect more than 1 in 10 people) are reactions at the site of injection (such as pain, redness and swelling), chills, fever, muscle pain, tiredness, headache and side effects of the digestive system such as nausea, vomiting, diarrhoea and stomach pain. 
Najpogostejši neželeni učinki zdravila Shingrix (ki se lahko pojavijo pri več kot 1 bolniku od 10) so reakcije na mestu injiciranja (kot so bolečina, rdečina in oteklina), mrzlica, zvišana telesna temperatura, bolečine v mišicah, utrujenost, glavobol in neželeni učinki v prebavilih, kot so slabost, bruhanje, driska in bolečine v želodcu.
It is available as a powder and a suspension to be mixed together by a doctor or a nurse before being injected into the upper arm muscle. 
Zdravilo je na voljo v obliki praška in suspenzije, ki ju zdravnik ali medicinska sestra zmeša pred injiciranjem v mišico nadlahti.
The European Medicines Agency therefore decided that Shingrix's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Shingrix večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
In both studies, the main measure of effectiveness was the number of people having shingles in the group receiving the vaccine compared with the group receiving placebo (a dummy vaccine). 
V obeh študijah je bilo glavno merilo učinkovitosti število ljudi, ki so zboleli za pasovcem, in sicer v skupini, ki je prejela cepivo, v primerjavi s skupino, ki je prejela placebo (cepivo brez zdravilne učinkovine).
The vaccination course consists of 2 injections given 2 months apart. 
Sklop cepljenja je sestavljen iz dveh injekcij z dvomesečnim razmakom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Shingrix have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Shingrix upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
As for all medicines, data on the use of Shingrix is continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Shingrix stalno spremljajo.
For more information about using Shingrix, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Shingrix glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The studies also looked at the number of people who had post-herpetic neuralgia after vaccination. 
V študijah so ugotavljali tudi število ljudi, ki so po cepljenju zboleli za postherpetično nevralgijo.
Other information about Shingrix 
Druge informacije o zdravilu Shingrix
Shingrix (herpes zoster vaccine, recombinant, adjuvanted) 
Shingrix (cepivo proti herpesu zostru, rekombinantno, z adjuvansom)
Shingrix can only be obtained with a prescription and should be used according to official recommendations. 
Predpisovanje in izdaja zdravila Shingrix je le na recept, uporabljati pa se mora v skladu z uradnimi priporočili.
Why is Shingrix authorised in the EU? 
Zakaj je bilo zdravilo Shingrix odobreno v EU?
Side effects reported with Shingrix are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Shingrix, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Side effects related to the use of Shingrix seemed to be mostly temporary and were manageable with standard care. 
Zdi se, da so neželeni učinki, povezani z uporabo zdravila Shingrix, večinoma začasni in obvladljivi s standardnim zdravljenje.
Looking at the results for adults in this age group from both studies together, 25 adults out of 8,250 who received Shingrix had shingles within 4 years after vaccination compared with 284 out of 8,346 who received placebo. 
Skupna analiza rezultatov odraslih te starostne skupine iz obeh študij je pokazala, da je 25 odraslih od 8 250, ki so prejeli zdravilo Shingrix, po štirih letih po cepljenju zbolelo za pasovcem, v primerjavi z 284 od 8 346, ki so prejeli placebo.
An overview of Shingrix and why it is authorised in the EU 
Pregled zdravila Shingrix in zakaj je odobreno v EU
What benefits of Shingrix have been shown in studies? 
Kakšne koristi zdravila Shingrix so se pokazale v študijah?
Shingrix has been shown to be highly effective at preventing shingles and post-herpetic neuralgia across all age groups older than 50 years for at least 4 years after vaccination. 
Dokazali so, da je zdravilo Shingrix zelo učinkovito pri preprečevanju pasovca in postherpetične nevralgije pri vseh starostnih skupinah od 50. leta starosti naprej, in sicer vsaj štiri leta po cepljenju.
The second study involved adults aged 70 and over who received either Shingrix or placebo. 
Druga študija je vključevala odrasle, starejše od 70 let, ki so prejeli zdravilo Shingrix ali placebo.
Patients given Shingrix will be able to produce antibodies against the virus more quickly when the virus is reactivated and they will therefore have protection against the disease. 
Bolniki, ki prejmejo zdravilo Shingrix, bodo ob reaktivaciji virusa lahko hitreje tvorili protitelesa in bodo tako zaščiteni pred boleznijo.
In the first study with adults aged 50 years and over, 7,695 received Shingrix and 7,710 received placebo. 
V prvi študiji pri odraslih od 50. leta starosti naprej jih je 7 695 prejelo zdravilo Shingrix, 7 710 pa placebo.
What is Shingrix and what is it used for? 
Kaj je zdravilo Shingrix in za kaj se uporablja?
What are the risks associated with Shingrix? 
Kakšna tveganja so povezana z zdravilom Shingrix?
This indicates that Shingrix prevented 97% of shingles cases and 100% of cases of post-herpetic neuralgia in this study. 
To kaže, da je zdravilo Shingrix v tej študiji preprečilo 97 % primerov pasovca in 100 % primerov postherpetične nevralgije.
Shingrix is a vaccine used to protect adults aged 50 years and over against shingles (herpes zoster) and post-herpetic neuralgia (long-lasting nerve pain following shingles). 
Zdravilo Shingrix je cepivo, ki se uporablja za zaščito odraslih od 50. leta starosti naprej pred pasovcem (herpesom zostrom) in pred postherpetično nevralgijo (dolgotrajno bolečino živcev, ki sledi pasovcu).
For the full list of side effects and restrictions with Shingrix, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Shingrix glejte navodilo za uporabo.
Shingrix contains small amounts of the surface antigens (proteins from the surface) of the virus to stimulate the body to make antibodies against the virus. 
Zdravilo Shingrix vsebuje majhno količino površinskih antigenov (beljakovin s površine) virusa, ki telo spodbudijo k tvorbi protiteles proti virusu.
Shingrix has been designed to prevent shingles in people who have been in contact with the varicella zoster virus (the virus that causes chickenpox) and have already developed antibodies against the virus. 
Zdravilo Shingrix je namenjeno preprečevanju pasovca pri ljudeh, ki so bili v stiku z virusom varicella zoster (virusom, ki povzroča norice) in so že razvili protitelesa proti virusu.
Shingrix has been shown to be effective at preventing shingles and post-herpetic neuralgia. 
Dokazali so, da je zdravilo Shingrix učinkovito pri preprečevanju pasovca in postherpetične nevralgije.
Shingles is a painful, blistering rash caused by the reactivation of the virus that causes chickenpox. 
Pasovec je boleč izpuščaj z mehurji, ki ga povzroči reaktivacija virusa, ki povzroča norice.
This indicates that Shingrix prevented 91% of shingles cases and 89% of cases of post-herpetic neuralgia in adults aged 70 years and older. 
To kaže, da je zdravilo Shingrix pri odraslih, starejših od 70 let, preprečilo 91 % primerov pasovca in 89 % primerov postherpetične nevralgije.
How does Shingrix work? 
Kako zdravilo Shingrix deluje?
How is Shingrix used? 
Kako se zdravilo Shingrix uporablja?
After almost 4 years, nobody had had post-herpetic neuralgia in the Shingrix group compared with 18 in the placebo group. 
Po skoraj štirih letih v skupini, ki je prejela zdravilo Shingrix, nihče ni zbolel za postherpetično nevralgijo, v skupini s placebom pa jih je zbolelo 18.
After just over 3 years on average, 6 adults had had shingles in the Shingrix group compared with 210 in the placebo group. 
Po povprečno dobrih treh letih je v skupini, ki je prejela zdravilo Shingrix, za pasovcem zbolelo šest odraslih, v skupini s placebom pa 210.
After 4 years, 4 adults had had post-herpetic neuralgia in the Shingrix group compared with 36 in the placebo group. 
Po skoraj štirih letih so v skupini, ki je prejela zdravilo Shingrix, za postherpetično nevralgijo zboleli štirje, v skupini s placebom pa jih je zbolelo 36.
Further information on Incruse Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Incruse Ellipta so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
1 Previously known as Incruse. 
1 Predhodno znano kot zdravilo Incruse.
Incruse Ellipta was investigated in four main studies involving over 4,000 patients. 
Zdravilo Incruse Ellipta so proučevali v štirih glavnih študijah, ki so vključevale več kot 4 000 bolnikov.
The European Medicines Agency decided that Incruse Ellipta's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Incruse Ellipta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The most common side effects with Incruse Ellipta (which may affect up to 1 in 10 people) are headache, nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (nose and throat infection), sinusitis (inflammation of the sinuses), cough, urinary tract infection (infection of the structures that carry urine), and tachycardia (increased heart rate). 
Najpogostejši neželeni učinki zdravila Incruse Ellipta (ki se lahko pojavijo pri največ 1 bolniku od 10) so glavobol, nazofaringitis (vnetje nosu in žrela), okužba zgornjih dihal (okužba nosu in žrela), sinuzitis (vnetje sinusov), kašelj, okužba sečil (okužba struktur za odvajanje urina) in tahikardija (povečan srčni utrip).
The main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second). 
Glavno merilo učinkovitosti je bila sprememba forsiranega ekspiracijskega volumna (FEV1 - največja količina zraka, ki jo oseba lahko izdihne v eni sekundi) pri bolnikih.
As medicines of the same class as Incruse Ellipta may have an effect on the heart and blood vessels in the brain, the company that markets Incruse Ellipta will carry out a long-term study in patients to collect further information on its safety in comparison with tiotropium. 
Ker lahko zdravila, ki spadajo v isti razred kot zdravilo Incruse Ellipta, vplivajo na srce in krvne žile v možganih, bo podjetje, ki trži zdravilo Incruse Ellipta, pri bolnikih izvedlo dolgoročno študijo, da bo zbralo dodatne informacije o njegovi varnosti v primerjavi s tiotropijem.
What measures are being taken to ensure the safe and effective use of Incruse Ellipta? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Incruse Ellipta?
It is available as an inhalation powder in a portable inhaler device. 
Na voljo je v obliki praška za inhaliranje v prenosnem inhalatorju.
Incruse Ellipta received a marketing authorisation valid throughout the EU on 28 April 2014. 
Za zdravilo Incruse Ellipta je bilo 28. aprila 2014 izdano dovoljenje za promet, veljavno po vsej EU.
Incruse Ellipta is used for maintenance (regular) treatment. 
Zdravilo Incruse Ellipta se uporablja za vzdrževalno (redno) zdravljenje.
As for all medicines, data on the use of Incruse Ellipta are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Incruse Ellipta stalno spremljajo.
Side effects reported with Incruse Ellipta are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Incruse Ellipta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Incruse Ellipta have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Incruse Ellipta upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
A double dose of Incruse Ellipta only showed small improvements compared with a single dose, which were not considered relevant. 
Z dvojnim odmerkom zdravila Incruse Ellipta je bilo v primerjavi z enkratnim odmerkom doseženo le majhno izboljšanje tega rezultata, ki se ne šteje za pomembno.
Results showed that Incruse Ellipta improved lung function by an average FEV1 of 127 ml more than placebo after 12 weeks of treatment and by 115 ml more than placebo after 24 weeks of treatment. 
Rezultati so pokazali, da je zdravilo Incruse Ellipta po 12 tednih zdravljenja izboljšalo delovanje pljuč v smislu povečanja povprečne vrednosti FEV1 za 127 ml več kot placebo, po 24 tednih pa za 115 ml več.
The Agency also noted that there were no major safety concerns with Incruse Ellipta, with side effects being manageable and similar to other medicines of the same class (antimuscarinic bronchodilators). 
Ugotovila je tudi, da ni večjih pomislekov glede varnosti zdravila Incruse Ellipta, saj so njegovi neželeni učinki obvladljivi in podobni kot pri drugih zdravilih iz istega razreda (antimuskarinski bronhodilatatorji).
Other information about Incruse Ellipta 
Druge informacije o zdravilu Incruse Ellipta
In the study comparing Incruse Ellipta with tiotropium, FEV1 improvements over 24 weeks were similar for both medicines. 
V študiji, v kateri so zdravilo Incruse Ellipta primerjali s tiotropijem, so bila izboljšanja vrednosti FEV1 v obdobju 24 tednov pri obeh zdravilih podobna.
An overview of Incruse Ellipta and why it is authorised in the EU 
Pregled zdravila Incruse Ellipta in zakaj je odobreno v EU
Incruse Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. 
Zdravilo Incruse Ellipta se uporablja za lajšanje simptomov kronične obstruktivne pljučne bolezni (KOPB) pri odraslih.
The Agency concluded that Incruse Ellipta was shown to be effective at improving lung function and symptoms of COPD. 
Zaključila je, da se je zdravilo Incruse Ellipta izkazalo za učinkovito pri izboljševanju delovanja pljuč in simptomov KOPB.
What benefits of Incruse Ellipta have been shown in studies? 
Kakšne koristi zdravila Incruse Ellipta so se pokazale v študijah?
The active substance in Incruse Ellipta, umeclidinium bromide, is a muscarinic receptor antagonist. 
Učinkovina v zdravilu Incruse Ellipta, umeklidinijev bromid, je antagonist muskarinskih receptorjev.
Why is Incruse Ellipta authorised in the EU? 
Zakaj je bilo zdravilo Incruse Ellipta odobreno v EU?
What is Incruse Ellipta and what is it used for? 
Kaj je zdravilo Incruse Ellipta in za kaj se uporablja?
What are the risks associated with Incruse Ellipta? 
Kakšna tveganja so povezana z zdravilom Incruse Ellipta?
Three studies compared Incruse Ellipta with placebo (a dummy treatment), while one study compared Incruse Ellipta with tiotropium (another medicine for COPD). 
V treh študijah so zdravilo Incruse Ellipta primerjali s placebom (zdravilom brez učinkovine), v eni študiji pa s tiotropijem (drugim zdravilom za zdravljenje KOPB).
For the full list of side effects and restrictions with Incruse Ellipta, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Incruse Ellipta glejte navodilo za uporabo.
Incruse Ellipta can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila Incruse Ellipta je le na recept.
How is Incruse Ellipta used? 
Kako se zdravilo Incruse Ellipta uporablja?
How does Incruse Ellipta work? 
Kako zdravilo Incruse Ellipta deluje?
Incruse Ellipta contains the active substance umeclidinium bromide. 
Zdravilo vsebuje učinkovino umeklidinijev bromid.
Key elements to be included in the educational material 
Ključni elementi, ki morajo biti vključeni v izobraževalno gradivo
• Educational material 
• Izobraževalno gradivo
If use of eltrombopag is deemed necessary, the starting dose must be 25mg once daily. 
Če je uporaba eltrombopaga nujna, mora biti začetni odmerek 25 mg enkrat na dan.
The Member States must ensure that all conditions with regard to the safe and effective use of the medicinal products described below are implemented: 
Države članice morajo zagotoviti uveljavitev vseh spodaj opisanih pogojev za varno in učinkovito uporabo zdravil:
• Measure serum ALT, AST and bilirubin prior to initiation of Revolade, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose. 
• Meritve ALT, AST in bilirubina v serumu pred uvedbo zdravila Revolade, vsaka 2 tedna med obdobjem prilagajanja odmerka in nato vsak mesec po opredelitvi stabilnega odmerka.
The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following: 
Takšen program mora izvesti nacionalno, da bodo pred predpisovanjem zdravila vsi zdravniki dobili informacijski komplet za zdravstveno osebje, ki vsebuje naslednje:
• Revolade should be interrupted if platelet counts increase to > 250,000/μl. 
• Uporabo zdravila Revolade je treba prekiniti, če se število trombocitov poveča na > 250.000/µl.
• Awareness to prescribers of the labelled indication and warnings associated with non-indicated populations (e.g. not recommended for use in children, pregnant or lactating females, other off label uses). 
• Pri zdravnikih zagotoviti poznavanje odobrenih indikacij in opozoril, povezanih z uporabo pri neindiciranih populacijah (npr. uporaba zdravila ni priporočljiva pri otrocih, nosečnicah in doječih ženskah, druge uporabe zunaj okvira odobrenih indikacij).
• Discontinue Revolade if ALT levels increase (≥ 3X the upper limit of normal [ULN]) and are: - progressive, or - persistent for > 4 weeks, or - accompanied by increased direct bilirubin, or - accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation. 
• Prekinitev uporabe zdravila Revolade, če se pojavi zvišanje ALT (≥ 3-kratna zgornja normalna meja [ZNM]), ki: - napreduje ali - traja > 4 tedne ali - ga spremlja zvišanje direktnega bilirubina ali - ga spremljajo klinični simptomi okvare jeter ali znaki jetrne dekompenzacije.
Once the platelet count is < 100,000/μl, reinitiate therapy at a reduced daily dose. 
Ko je število trombocitov < 100.000/µl, znova začnite zdravljenje z manjšim dnevnim odmerkom.
• Educate patients on the appropriate administration of Revolade (e.g. titration of Revolade, fooddrug interaction, dose recommendations for special populations [e.g. east Asians]). 
• Seznanitev bolnikov z ustrezno uporabo zdravila Revolade (npr. titriranjem tega zdravila, interakcijah s hrano/zdravili, priporočili za odmerjanje v posebnih populacijah [npr. pri vzhodnih Azijcih].
• Eltrombopag should not be used in patients with hepatic impairment (Child Pugh score ≥ 5) unless the expected benefit outweighs the identified risk of portal venous thrombosis. 
• Pri bolnikih z zmerno do hudo okvaro jeter se eltrombopag ne sme uporabljati, razen če pričakovana korist zdravljenja prevlada nad znanim tveganjem za pojav tromboze portalne vene.
• Educate patients about the potential for hepatic enzyme elevations, importance of monthly laboratory monitoring of ALT and AST, as well as the signs and symptoms associated with liver injury (e.g. jaundice). 
• Seznanitev bolnikov z možnostjo zvišanja jetrnih encimov, pomenom vsakomesečnih laboratorijskih kontrol ALT in AST ter znaki in simptomi, ki spremljajo okvaro jeter (npr. zlatenica).
• Educate patients about chronic liver disease and the risk of thromboembolic events. 
• Seznanitev bolnikov o bolnikih s kronično boleznijo jeter in tveganjem trombemboličnih dogodkov.
• Educate patients about the potential for thromboembolic events (TEE) in patients with chronic ITP and those known risk factors for thromboembolic events (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome). 
• Seznanitev bolnikov z možnostjo trombemboličnih dogodkov pri kronični ITP in v primeru znanih dejavnikov tveganja za trombembolične dogodke (npr. faktor V Leiden, pomanjkanje ATIII, antifosfolipidni sindrom).
• A dose reduction is recommended for ITP patients with platelet counts between 150,000250,000/μl. 
• Bolnikom, ki imajo število trombocitov od 150.000 do 250.000/µl, je odmerek priporočljivo zmanjšati.
• Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling 
• Povzetek glavnih značilnosti zdravila in navodilo za uporabo
20 November 2015 
Datum prve odobritve: 20. november 2015
It has been reported that pemetrexed may cause fatigue. 
Poročali so, da lahko pemetreksed povzroči utrujenost.
Based on the planned date of your infusion of pemetrexed and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them. 
Na podlagi načrtovanega datuma vaše infuzije pemetrekseda in/ali glede na delovanje vaših ledvic vam mora zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
Reconstituted and infusion solution: The product should be used immediately. 
Rekonstituirane raztopine in raztopine za infundiranje: Izdelek moramo uporabiti nemudoma.
Creatinine elevation 10.7 Creatinine clearance decreased** 
Povišan kreatinin 10,7 Znižan očistek kreatinina**
Calculate the dose and the number of Pemetrexed Hospira vials needed. 
Izračunajte odmerek in število potrebnih vial zdravila Pemetreksed Hospira.
Do not use Pemetrexed Hospira - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6). 
Ne uporabljajte zdravila Pemetreksed Hospira - če ste alergični na pemetreksed ali katero koli sestavino tega zdravila (navedeno v poglavju 6).