FrancophonIA/ELRC3.0 huggingface dataset:
English: Ebilfumin can also be used as preventative treatment in exceptional cases, for instance when the seasonal flu vaccine may not provide sufficient protection and when there is a pandemic (a global epidemic of flu).
Slovenian: Zdravilo Ebilfumin se lahko v izjemnih primerih uporablja tudi za preventivno zdravljenje, npr. kadar cepivo za sezonsko gripo morda ne zagotavlja zadostne zaščite in je izbruhnila pandemija (epidemija gripe po vsem svetu).
English: Other information about Ebilfumin
Slovenian: Druge informacije o zdravilu Ebilfumin
English: As for every medicine, the company provided studies on the quality of Ebilfumin.
Slovenian: Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Ebilfumin.
English: An overview of Ebilfumin and why it is authorised in the EU
Slovenian: Pregled zdravila Ebilfumin in zakaj je odobreno v EU
English: Because Ebilfumin is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Ebilfumin generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Ebilfumin is an antiviral medicine used to treat or prevent influenza (flu).
Slovenian: Zdravilo Ebilfumin je protivirusno zdravilo, ki se uporablja za zdravljenje ali preprečevanje influence (gripe).
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Tamiflu, and do not need to be repeated for Ebilfumin.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Tamiflu, zato jih ni treba ponoviti za zdravilo Ebilfumin.
English: For children who weigh less than 40 kg, the dose is calculated according to the child's weight.
Slovenian: Pri otrocih, ki tehtajo manj kot 40 kg, se odmerek izračuna glede na njihovo telesno maso.
English: Side effects reported with Ebilfumin are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Ebilfumin, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ebilfumin has been shown to have comparable quality and to be bioequivalent to Tamiflu.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ebilfumin primerljivo raven kakovosti in je bioekvivalentno z zdravilom Tamiflu.
English: For more information about using Ebilfumin, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Ebilfumin glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: As for all medicines, data on the use of Ebilfumin are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ebilfumin stalno spremljajo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ebilfumin have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ebilfumin upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: This means that Ebilfumin contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Tamiflu.
Slovenian: To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Tamiflu.
English: Oseltamivir works on the neuraminidases of both influenza-A (the most common type) and influenza-B viruses.
Slovenian: Oseltamivir deluje na nevraminidaze virusov influence A (najpogostejša vrsta) in influence B.
English: The usual dose for adults and children weighing more than 40 kg is 75 mg given twice a day for 5 days.
Slovenian: Običajni odmerek za odrasle in otroke, ki tehtajo več kot 40 kg, je 75 mg dvakrat na dan pet dni zapored.
English: During a flu pandemic, Ebilfumin can also be used to prevent flu in babies below 1 year of age.
Slovenian: Med pandemijo gripe se lahko zdravilo Ebilfumin uporablja tudi za preprečevanje gripe pri dojenčkih, mlajših od enega leta.
English: When Ebilfumin is used during a flu epidemic, it is given for up to 6 weeks.
Slovenian: Kadar se zdravilo Ebilfumin uporablja med epidemijo gripe, se lahko daje do šest tednov.
English: • To treat flu, it can be used in adults and children (including full-term newborns) who have the symptoms of flu, when the flu virus is circulating in the community;
Slovenian: • Pri zdravljenju gripe se lahko uporablja pri odraslih in otrocih (vključno z donošenimi novorojenčki), ki imajo simptome gripe, kadar je virus gripe prisoten v okolici.
English: The active substance in Ebilfumin, oseltamivir, acts on the flu virus, blocking some of the enzymes on its surface known as neuraminidases.
Slovenian: Učinkovina v zdravilu Ebilfumin, oseltamivir, deluje na virus gripe, in sicer zavira določene encime na površini virusa, imenovane nevraminidaze.
English: Why is Ebilfumin authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Ebilfumin odobreno v EU?
English: The usual dose for adults and children weighing more than 40 kg is 75 mg given once a day for 10 days after contact with an infected person.
Slovenian: Običajni odmerek za odrasle in otroke, ki tehtajo več kot 40 kg, je 75 mg enkrat na dan deset dni zapored po stiku z osebo, okuženo z gripo.
English: What is Ebilfumin and what is it used for?
Slovenian: Kaj je zdravilo Ebilfumin in za kaj se uporablja?
English: • To prevent flu, it can be used in adults and children over 1 year of age who have been in contact with someone who has flu and flu is circulating in the community.
Slovenian: • Pri preprečevanju gripe se lahko uporablja pri odraslih in otrocih, starejših od enega leta, ki so bili v stiku z osebo, okuženo z gripo, in kadar je virus gripe prisoten v skupnosti.
English: In the treatment of flu, Ebilfumin must be started within two days of the onset of symptoms.
Slovenian: Pri zdravljenju gripe je treba zdravilo Ebilfumin začeti jemati v dveh dneh po pojavu simptomov.
English: In the prevention of flu, Ebilfumin must be started within two days of contact with someone who has flu.
Slovenian: Pri preprečevanju gripe je treba jemanje zdravila Ebilfumin začeti v dveh dneh po stiku z osebo, okuženo z gripo.
English: This is generally done on a caseby-case basis.
Slovenian: O tovrstnem zdravljenju se odloča za vsak primer posebej.
English: Ebilfumin contains the active substance oseltamivir.
Slovenian: Zdravilo Ebilfumin vsebuje učinkovino oseltamivir.
English: Therefore, the Agency's view was that, as for Tamiflu, the benefit of Ebilfumin outweighs the identified risk and it can be authorised for use in the EU.
Slovenian: Zato je menila, da koristi zdravila Ebilfumin, enako kot pri zdravilu Tamiflu, odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
English: How has Ebilfumin been studied?
Slovenian: Kako je bilo zdravilo Ebilfumin raziskano?
English: How does Ebilfumin work?
Slovenian: Kako zdravilo Ebilfumin deluje?
English: How is Ebilfumin used?
Slovenian: Kako se zdravilo Ebilfumin uporablja?
English: The recommended dose is 800 mg on days 1 and 8 of each 3-week cycle.
Slovenian: Priporočeni odmerek je 800 mg prvi in osmi dan vsakega 3-tedenskega cikla.
English: Most of the patients (95%) had cancer cells with EGFR.
Slovenian: Večina bolnikov (95 %) je imela rakave celice z EGFR.
English: What measures are being taken to ensure the safe and effective use of Portrazza?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Portrazza?
English: The risk of reactions can be reduced by adjusting the dose or infusion rate or by using preventive medicines.
Slovenian: Tveganje za reakcije je mogoče zmanjšati s prilagoditvijo odmerka ali hitrosti infuzije ali z uporabo preventivnih zdravil.
English: The full EPAR and risk management plan summary for Portrazza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Portrazza sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Portrazza
Slovenian: Druge informacije o zdravilu Portrazza
English: The most common serious side effects are severe skin reactions (6% of patients) and blood clots (4% of patients).
Slovenian: Najpogostejši resni neželeni učinki so hude kožne reakcije (6 % bolnikov) in krvni strdki (4 % bolnikov).
English: In this study, patients treated with Portrazza in addition to chemotherapy lived on average 1.6 months longer than those treated with chemotherapy alone (11.5 months versus 9.9 months).
Slovenian: V tej študiji so bolniki, ki so ob kemoterapiji dodatno prejemali zdravilo Portrazza, živeli v povprečju 1,6 meseca dlje od bolnikov, zdravljenih samo s kemoterapijo (11,5 meseca v primerjavi z 9,9 meseca).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore concluded that Portrazza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Portrazza večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Portrazza must not be used in patients who have had a severe or life-threatening reaction to any of the ingredients of the medicine.
Slovenian: Zdravila Portrazza ne smejo uporabljati bolniki, ki so imeli hudo ali smrtno nevarno reakcijo na katero koli sestavino zdravila.
English: In addition, the company that markets the medicine will provide doctors with educational material with information on risk of blood clots and on the small number of cardiac arrest cases seen in studies.
Slovenian: Poleg tega bo podjetje, ki trži zdravilo, zdravnikom priskrbelo izobraževalno gradivo z informacijami o tveganju za krvne strdke in o maloštevilnih primerih srčnega zastoja iz študij.
English: The most common side effects with Portrazza (which may affect more than 1 in 10 people) are skin reactions, vomiting, stomatitis (inflammation of the lining of the mouth), fever, weight loss and low blood measurements of various minerals (magnesium, calcium, phosphate and potassium).
Slovenian: Najpogostejši neželeni učinki zdravila Portrazza (ki lahko prizadenejo več kot 1 osebo od 10) so kožne reakcije, bruhanje, stomatitis (vnetje ustne sluznice), vročina, izguba telesne mase in nizke vrednosti različnih mineralov v krvi (magnezija, kalcija, fosfata in kalija).
English: This is a summary of the European public assessment report (EPAR) for Portrazza.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Portrazza.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Slovenian: Pojasnjuje, kako je agencija to ocenila zdravilo, na podlagi česar je priporočila njegovo odobritev v EU in pogoje njegove uporabe.
English: What is Portrazza and what is it used for?
Slovenian: Kaj je zdravilo Portrazza in za kaj se uporablja?
English: In case of a severe infusion or skin reaction, treatment may have to be stopped permanently.
Slovenian: V primeru hude alergične reakcije na infuzijo ali kožne reakcije je morda treba trajno prenehati z zdravljenjem.
English: Why is Portrazza approved?
Slovenian: Zakaj je bilo zdravilo Portrazza odobreno?
English: It is not intended to provide practical advice on how to use Portrazza.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What benefits of Portrazza have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Portrazza izkazalo v študijah?
English: EGFR normally controls the growth and division of cells, but in cancer cells EGFR is often overactive, causing them to divide uncontrollably.
Slovenian: EGFR običajno nadzoruje rast in delitev celic, vendar je v rakavih celicah pogosto čezmerno aktivna in povzroča njihovo nenadzorovano delitev.
English: A risk management plan has been developed to ensure that Portrazza is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Portrazza je bil pripravljen načrt obvladovanja tveganj.
English: What are the risks associated with Portrazza?
Slovenian: Kakšna tveganja so povezana z zdravilom Portrazza?
English: During infusions, resources should be available to deal with reactions that may occur.
Slovenian: Med infuzijami mora biti na voljo oprema za obvladovanje morebitnih reakcij.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Portrazza, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: By attaching to and blocking EGFR, necitumumab helps to reduce the growth and spread of the cancer.
Slovenian: Z vezavo na EGFR in njenim zaviranjem pomaga necitumumab zmanjšati rast in širjenje raka.
English: A main study of 1,093 patients with advanced squamous non-small cell lung cancer showed that adding Portrazza to gemcitabine and cisplatin chemotherapy can lead to a modest improvement in survival.
Slovenian: Glavna študija s 1 093 bolniki z napredovalim skvamoznim nedrobnoceličnim pljučnim rakom je pokazala, da lahko dodajanje zdravila Portrazza pri kemoterapiji z gemcitabinom in cisplatinom prispeva k zmernemu izboljšanju preživetja.
English: In the main study, adding Portrazza to gemcitabine and cisplatin chemotherapy improved survival by a modest one and a half months without causing significant worsening in overall patient health.
Slovenian: V glavni študiji je dodajanje zdravila Portrazza pri kemoterapiji z gemcitabinom in cisplatinom izboljšalo preživetje za skromen mesec in pol brez povzročitve bistvenega poslabšanja splošnega zdravja bolnika.
English: For the first 6 cycles, Portrazza is given together with gemcitabine and cisplatin chemotherapy, after which it is given on its own for as long the disease remains stable and the patient can tolerate it.
Slovenian: Prvih šest ciklov se zdravilo Portrazza daje skupaj s kemoterapijo z gemcitabinom in cisplatinom, zatem se daje samostojno, dokler bolezen ostane stabilna in bolnik prenaša zdravilo.
English: Portrazza is a medicine for treating advanced stages of a type of lung cancer known as squamous nonsmall cell lung cancer.
Slovenian: Portrazza je zdravilo za zdravljenje napredovalih stopenj vrste pljučnega raka, imenovanega skvamozni nedrobnocelični pljučni rak.
English: Portrazza is available as a concentrate for making a solution and can only be obtained with a prescription.
Slovenian: Zdravilo Portrazza je na voljo kot koncentrat za pripravo raztopine in se izdaja le na recept.
English: For the full list of all side effects reported with Portrazza, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Portrazza, glejte navodilo za uporabo.
English: For practical information about using Portrazza, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Portrazza naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For more information about treatment with Portrazza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Portrazza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Portrazza is only used in adults whose cancer cells have a specific protein (EGFR) on their surface and it is used together with gemcitabine and cisplatin chemotherapy.
Slovenian: Zdravilo Portrazza se uporablja samo pri odraslih, pri katerih imajo rakave celice na površini specifično beljakovino (EGFR), in sicer skupaj s kemoterapijo z gemcitabinom in cisplatinom.
English: There was no improved survival in patients with non-EGFR cancer cells.
Slovenian: Pri bolnikih z rakavimi celicami brez EGFR ni bilo izboljšanja preživetja.
English: How is Portrazza used?
Slovenian: Kako se zdravilo Portrazza uporablja?
English: Portrazza is given as a one hour infusion (drip) into a vein.
Slovenian: Zdravilo Portrazza se daje kot enourna infuzija (kapalna infuzija) v veno.
English: The active substance in Portrazza, necitumumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to EGFR on the surface of the cancer cells.
Slovenian: Zdravilna učinkovina zdravila Portrazza, necitumumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino EGFR na površini rakavih celic in se veže nanjo.
English: How does Portrazza work?
Slovenian: Kako zdravilo Portrazza deluje?
English: Portrazza contains the active substance necitumumab.
Slovenian: Zdravilo Portrazza vsebuje zdravilno učinkovino necitumumab.
English: Dissolution was evaluated over an 8-hour period.
Slovenian: Raztapljanje so preučevali v 8-urnem obdobju.
English: Overall summary of the scientific evaluation of Ethirfin and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Ethirfin in povezanih imen (glejte Dodatek I)
English: About 20% of the responders reported chronic pain (>6 months).
Slovenian: Okoli 20 odstotkov odzivnih bolnikov je poročalo o kronični bolečini (> 6 mesecev).
English: The application was submitted to the reference Member State Denmark and to the concerned Member States (CMS) Germany, Ireland, Italy and the United Kingdom.
Slovenian: Vloga je bila predložena referenčni državi članici Danski in zadevnim državam članicam Nemčiji, Irski, Italiji in Združenemu kraljestvu.
English: Source; Brennan et al., Addiction 2005; 100 : 777-86
Slovenian: Vir; Brennan et al. Addiction 2005; 100:777-86
English: • The Committee is also of the opinion that further risk minimisation measures would not adequately address the concern,
Slovenian: • Odbor tudi meni, da nadaljnji ukrepi za zmanjševanje tveganja ne bi ustrezno obravnavali zadeve,
English: This may be further aggravated by the fact that many patients with chronic pain will also suffer from depression.
Slovenian: To lahko nadalje poslabša dejstvo, da se pri velikem številu bolnikov s kronično bolečino pojavlja tudi depresija.
English: This strength is considered representative for the other (20, 60 and 120 mg) strengths as all strengths are dose proportional and manufactured with the same microgranules.
Slovenian: Ta jakost je reprezentativna za druge jakosti (20, 60 in 120 mg), saj so vse jakosti sorazmerne z odmerkom in se proizvedejo z istimi mikro zrnci.
English: Concurrent depression and pain have a much greater impact than either disorder alone and, in patients with pain, depression is associated to more pain sites, greater pain intensity, longer duration of pain, and greater likelihood of poor treatment response (Bair, J et al., Psychosom Med. 2008 October; 70(8): 890-897).
Slovenian: Sočasna depresija in bolečina imata bistveno večji vpliv kot vsaka motnja posebej, pri bolnikih z bolečino je depresija povezana z več mesti bolečine, večjo intenzivnostjo bolečine, daljšim trajanjem bolečine in večjo verjetnostjo, da bo odziv na zdravljenje slab (Bair, J. et al., Psychosom Med. 2008 oktober; 70(8): 890-897).
English: However, a significant percentage of the patients with chronic pain who uses opioids still reports high alcohol intake (10.8%) and binge drinking at least once a month (22.3%), despite existing warnings.
Slovenian: Vendar pa velik delež bolnikov s kronično bolečino, ki jemljejo opioide, še vedno poroča o visokem vnosu alkohola (10,8 odstotka) in popivanju najmanj enkrat mesečno (22,3 odstotka) kljub obstoječim opozorilom.
English: It was shown that the dissolution rate increases with increased concentration of ethanol in the dissolution medium.
Slovenian: Ugotovitve kažejo, da se stopnja raztapljanja povečuje s povečanjem koncentracije etanola v mediju za raztapljanje.
English: Whereas
Slovenian: ORa
English: The CHMP considered the matter and adopted an Opinion in July 2010 recommending the renewal of the marketing authorisation subject to conditions considered essential to the safe and effective use of the product.
Slovenian: CHMP je preučil zadevo in julija 2010 sprejel mnenje, v katerem je priporočil podaljšanje dovoljenje za promet z zdravilom v skladu s pogoji, ki so bistveni za varno in učinkovito uporabo zdravila.
English: While it may be argued that patients may use less alcohol as a self-medication strategy if they are sufficiently treated with analgesics like opioids, the results of a recently published Danish Health survey (Ekholm et al. Eur J Pain 2009; 13: 606-12) reveal a different pattern of behavior.
Slovenian: Čeprav nekateri morda zagovarjajo stališče, da bi bolniki zaužili manj alkohola kot sredstva za samozdravljenje, če bi bili ustrezno zdravljeni z analgetiki, kot so opioidi, so rezultati nedavno objavljene danske zdravstvene raziskave (Ekholm et al. Eur J Pain 2009; 13:606-12) pokazali drugačen vzorec vedenja.
English: In the scientific literature, drinking alcohol is referred as a coping mechanism to deal with the stress associated with pain.
Slovenian: V znanstveni literaturi je uživanje alkohola znano kot mehanizem za obvladovanje stresa, povezanega z bolečino.
English: Out of specification results were obtained after 0.25 hours in 20% alcohol, after 0.5 hour in 10% alcohol and after 2 hours in 5% alcohol.
Slovenian: Rezultati zunaj specifikacijskih meja so bili pridobljeni po 0,25 ure pri 20-odstotnem alkoholu, po 0,5 ure pri 10-odstotnem alkoholu in po 2 urah pri 5-odstotnem alkoholu.
English: Dissolution profiles have been performed using the 200 mg capsule strength only.
Slovenian: Profili raztapljanja so bili preučevani samo z uporabo kapsul jakosti 200 mg.
English: It is noted that the product already contains a specific contraindication for concomitant intake of alcohol.
Slovenian: Znano je, da zdravilo že vključuje specifično kontraindikacijo za sočasno uživanje alkohola.
English: Ethypharm submitted an application for the renewal, under the mutual recognition procedure, of Ethirfin and associated names, 20mg, 60 mg, 120 mg and 200 mg.
Slovenian: Družba Ethypharm je v okviru postopka z medsebojnim priznavanjem predložila vlogo za podaljšanje dovoljenja za promet z zdravilom Ethirfin in povezanimi imeni, 20 mg, 60 mg, 120 mg in 200 mg.
English: At the end of the CMD(h) procedure, and since there could be no agreement the procedure was referred to the CHMP.
Slovenian: Ker do zaključka postopka CMD(h) ni prišlo do soglasja, je bila zadeva napotena na CHMP.
English: Modified-release products are complex dosage forms designed to release drugs in a controlled manner to achieve desired efficacy and safety profiles.
Slovenian: Zdravila s spremenjenim sproščanjem so kompleksne oblike odmerjanja, ki so namenjene nadzorovanemu sproščanju zdravil, da sta doseženi želena učinkovitost in varnost.
English: In this study, subjects were interviewed about their number of alcohol consumptions of the last week and frequency of binge drinking in the last month (5292 responders).
Slovenian: V tej študiji so preiskovance spraševali o številu zaužitih enot alkohola v preteklem tednu in pogostosti popivanja v preteklem mesecu (5292 odzivnih bolnikov).