FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Duloxetine Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Duloxetine Zentiva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Patients who also have major depression should start with 60 mg once a day.
Slovenian: Pri bolnikih, ki imajo tudi velike depresivne motnje, mora biti začetni odmerek 60 mg enkrat na dan.
English: What are the benefits and risks of Duloxetine Zentiva?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Duloxetine Zentiva?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Zentiva, 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: For practical information about using Duloxetine Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Duloxetine Zentiva naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Slovenian: Zdravilna učinkovina v tem zdravilu, duloksetin, je zaviralec ponovnega privzema serotonina in noradrenalina.
English: Duloxetine Zentiva contains the active substance duloxetine and is is a ‘generic medicine'.
Slovenian: Zdravilo Duloxetine Zentiva vsebuje zdravilno učinkovino duloksetin in je „generično zdravilo“.
English: In patients who respond to Duloxetine Zentiva, treatment should continue for several months, to prevent the disorder coming back.
Slovenian: Pri bolnikih, ki se odzovejo na zdravilo Duloxetine Zentiva, mora zdravljenje trajati več mesecev, da se prepreči ponoven pojav bolezni.
English: Other information about Duloxetine Zentiva
Slovenian: Druge informacije o zdravilu Duloxetine Zentiva
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of up to 120 mg per day.
Slovenian: Pri zdravljenju bolečine diabetične nevropatije je priporočeni odmerek 60 mg na dan, nekateri bolniki pa bodo morda potrebovali večji odmerek do 120 mg na dan.
English: Because Duloxetine Zentiva 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 Duloxetine Zentiva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What is Duloxetine Zentiva and what is it used for?
Slovenian: Kaj je zdravilo Duloxetine Zentiva in za kaj se uporablja?
English: Because Duloxetine Zentiva is a generic medicine of Cymbalta, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Duloxetine Zentiva generično zdravilo za zdravilo Cymbalta, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The dose of Duloxetine Zentiva should be reduced gradually when stopping treatment.
Slovenian: Ob prenehanju zdravljenja je treba odmerek zdravila Duloxetine Zentiva zmanjševati postopoma.
English: It is not intended to provide practical advice on how to use Duloxetine Zentiva.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Duloxetine Zentiva approved?
Slovenian: Zakaj je bilo zdravilo Duloxetine Zentiva odobreno?
English: For major depression, the recommended dose of Duloxetine Zentiva is 60 mg once a day.
Slovenian: Pri zdravljenju velikih depresivnih motenj je priporočeni odmerek zdravila Duloxetine Zentiva 60 mg enkrat na dan. Do odziva na zdravilo običajno pride v dveh do štirih tednih.
English: How has Duloxetine Zentiva been studied?
Slovenian: Kako je bilo zdravilo Duloxetine Zentiva raziskano?
English: How is Duloxetine Zentiva used?
Slovenian: Kako se zdravilo Duloxetine Zentiva uporablja?
English: How does Duloxetine Zentiva work?
Slovenian: Kako zdravilo Duloxetine Zentiva deluje?
English: Further information on Oncaspar can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR Oncaspar.
Slovenian: Nadaljnje informacije o zdravilu Oncaspar so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR Oncaspar.
English: The healthcare professional should give the medicine in a hospital where resuscitation equipment is available.
Slovenian: Zdravnik mora zdravilo dati v bolnišnici, kjer je na voljo oprema za oživljanje.
English: Oncaspar (pegaspargase)
Slovenian: Oncaspar (pegaspargaza)
English: Oncaspar received a marketing authorisation valid throughout the EU on 14 January 2016.
Slovenian: Zdravilo Oncaspar je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 14. januarja 2016.
English: However, the data in adult patients were limited and the company that markets the medicine is to provide further data of its benefit in this group of patients.
Slovenian: Vendar so bili podatki pri odraslih bolnikih omejeni, zato mora družba, ki trži zdravilo, priskrbeti dodatne podatke o njegovih koristih pri tej skupini bolnikov.
English: It contains the active substance pegaspargase.
Slovenian: Vsebuje učinkovino pegaspargazo.
English: This compares with 66% of those treated with another asparaginase.
Slovenian: Do takega rezultata je prišlo pri 66 % otrok, zdravljenih z drugo asparaginazo.
English: The European Medicines Agency therefore decided that Oncaspar's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Oncaspar večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Oncaspar?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Oncaspar?
English: The company that markets Oncaspar will complete two more studies on the safety and effectiveness of Oncaspar, which will help further clarify the benefits and risks of this medicine in adults and in newly diagnosed patients.
Slovenian: Družba, ki trži zdravilo Oncaspar, bo dokončala še dve študiji o varnosti in učinkovitosti tega zdravila, ki bosta pripomogli k pojasnitvi njegovih koristi in tveganj pri odraslih in bolnikih z novo diagnosticirano boleznijo.
English: Oncaspar is used in combination with other cancer medicines.
Slovenian: Zdravilo Oncaspar se uporablja v kombinaciji z drugimi zdravili za zdravljenje raka.
English: The asparaginase enzyme in this medicine is linked to a chemical which slows down its removal from the body and can reduce the risk of allergic reactions.
Slovenian: Encim asparaginaza v tem zdravilu je pripojen na kemično snov, ki upočasnjuje njegovo odstranjevanje iz telesa in lahko zmanjša tveganje za alergijske reakcije.
English: Other information about Oncaspar
Slovenian: Druge informacije o zdravilu Oncaspar
English: Oncaspar is normally given every 14 days by injection into a muscle or by infusion (drip) into a vein, with the dose depending on age and body surface area.
Slovenian: Zdravilo Oncaspar se običajno daje vsakih 14 dni z injiciranjem v mišico ali infundiranjem (kapalno infuzijo) v veno, odmerek pa je odvisen od starosti bolnika in njegove telesne površine.
English: As for all medicines, data on the use of Oncaspar are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Oncaspar stalno spremljajo.
English: Side effects reported with Oncaspar are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Oncaspar, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oncaspar 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 Oncaspar upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: As for its risks, the side effects of Oncaspar are similar to those of other asparaginase medicines and are considered manageable
Slovenian: Kar zadeva tveganja, so neželeni učinki zdravila Oncaspar podobni kot pri drugih zdravilih, ki vsebujejo asparaginazo, in veljajo za obvladljive.
English: An overview of Oncaspar and why it is authorised in the EU
Slovenian: Pregled zdravila Oncaspar in zakaj je odobreno v EU
English: Why is Oncaspar authorised in the EU?
Slovenian: Zakaj je zdravilo Oncaspar odobreno v EU?
English: The most common side effects with Oncaspar (which may affect more than 1 in 10 people) include signs of liver problems (raised levels of liver enzymes and bilirubin in the blood), reduced blood clotting, high levels of fats in the blood, high levels of blood glucose and low levels of white blood cells accompanied by fever.
Slovenian: Najpogostejši neželeni učinki zdravila Oncaspar (ki lahko prizadenejo več kot 1 osebo od 10) vključujejo znake težav z jetri (povišane ravni jetrnih encimov in bilirubina v krvi), zmanjšano strjevanje krvi, visoke ravni maščob v krvi, visoke ravni glukoze v krvi in nizke ravni belih krvnih celic, ki jih spremlja povišana telesna temperatura.
English: What benefits of Oncaspar have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Oncaspar izkazalo v študijah?
English: What are the risks associated with Oncaspar?
Slovenian: Kakšna tveganja so povezana z zdravilom Oncaspar?
English: Oncaspar must not be used in patients with severe liver disease, patients who have ever had pancreatitis (including pancreatitis caused by previous asparaginase treatments) or patients who have had severe bleeding or serious blood clots following asparaginase treatment.
Slovenian: Zdravilo Oncaspar se ne sme uporabljati pri bolnikih z resnim obolenjem jeter, bolnikih, ki so v preteklosti imeli pankreatitis (vključno s pankreatitisom, ki je posledica prejšnjih zdravljenj z asparaginazo), in bolnikih, ki so imeli po zdravljenju z asparaginazo hude krvavitve ali resne krvne strdke.
English: For more information about using Oncaspar, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Oncaspar glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The cancer cells need this amino acid to grow and multiply, and so its reduction in the blood causes the cells to die.
Slovenian: Rakave celice to aminokislino potrebujejo za rast in razmnoževanje, zato upad njene ravni v krvi povzroči odmrtje teh celic.
English: Oncaspar also comes with the advantage of requiring fewer injections as the medicine stays longer in the body than some other asparaginases.
Slovenian: Prednost zdravila Oncaspar je, da je potrebnih manj injekcij, saj zdravilo ostane v krvi dlje časa kot nekatere druge asparaginaze.
English: In a study in 118 children newly diagnosed with ALL, 75% of those treated with Oncaspar (in combination with other medicines) were free of the cancer after 7 years, without having relapse or a new cancer during that period.
Slovenian: V študiji s 118 otroki, pri katerih je bila na novo diagnosticirana akutna limfoblastna levkemija, je bil pri 75 % otrok, zdravljenih z zdravilom Oncaspar (v kombinaciji z drugimi zdravili), po sedmih letih rak ozdravljen brez ponovitve bolezni ali pojava novega raka v tem obdobju.
English: The active substance (pegaspargase) contains the enzyme asparaginase which works by breaking up and reducing the blood levels of the amino acid asparagine.
Slovenian: Učinkovina (pegaspargaza) vsebuje encim asparaginazo, ki razgrajuje aminokislino asparagin in zmanjšuje njeno koncentracijo v krvi.
English: What is Oncaspar and what is it used for?
Slovenian: Kaj je zdravilo Oncaspar in za kaj se uporablja?
English: Oncaspar is a cancer medicine used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts.
Slovenian: Zdravilo Oncaspar je zdravilo za zdravljenje raka, ki se uporablja pri odraslih in otrocih za zdravljenje akutne limfoblastne levkemije (ALL), vrste raka belih krvnih celic, imenovanih limfoblasti.
English: In another study of 76 children whose cancer returned after earlier treatment, around 40% of Oncaspar-treated patients (some of whom were allergic to other asparaginase treatments) were cleared of the cancer, compared with 47% of patients treated with an asparaginase comparator.
Slovenian: V drugi študiji s 76 otroki, pri katerih se je rak po predhodnem zdravljenju ponovno pojavil, je bilo ozdravljenih približno 40 % bolnikov, zdravljenih z zdravilom Oncaspar (med njimi so bili nekateri alergični na druga zdravila z asparaginazo), in 47 % bolnikov, zdravljenih s primerjalnim zdravilom z asparaginazo.
English: Oncaspar can only be obtained with a prescription and only healthcare professionals with experience of cancer treatments should prescribe and give the medicine.
Slovenian: Predpisovanje in izdaja zdravila Oncaspar je le na recept, predpisujejo in dajejo pa ga lahko le zdravniki, ki imajo izkušnje z zdravljenjem raka.
English: Studies showed Oncaspar to be effective in patients with ALL, including patients who were allergic to asparaginase.
Slovenian: Študije so pokazale, da je zdravilo Oncaspar učinkovito pri bolnikih z akutno limfoblastno levkemijo, vključno z bolniki, ki so alergični na asparaginazo.
English: How is Oncaspar used?
Slovenian: Kako se zdravilo Oncaspar uporablja?
English: How does Oncaspar work?
Slovenian: Kako zdravilo Oncaspar deluje?
English: For the full list of side effects of Oncaspar, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Oncaspar, glejte navodilo za uporabo.
English: The sooner treatment is started, the better the chances of survival.
Slovenian: Prej ko se zdravljenje začne, boljše so možnosti za preživetje.
English: This is a programme through which doctors can request a medicine for one of their patients before the medicine is fully authorised.
Slovenian: To je program, v okviru katerega lahko zdravniki zahtevajo zdravilo za enega od svojih bolnikov, preden je zdravilo v celoti odobreno.
English: With additional Orfadin treatment, the survival rate increases to 82%.
Slovenian: Z dodatnim zdravljenjem z zdravilom Orfadin se stopnja preživetja poveča na 82 %.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orfadin on 21 February 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Orfadin, veljavno po vsej Evropski uniji, izdala 21. februarja 2005.
English: The largest study of Orfadin was carried out in 257 patients in 87 different hospitals in 25 countries, as part of a ‘compassionate-use' programme.
Slovenian: V največji študiji zdravila Orfadin je sodelovalo 257 bolnikov v 87 različnih bolnišnicah v 25 državah kot del programa „sočutne uporabe“.
English: As the company had submitted the additional information requested, the ‘exceptional circumstances' ended on 21 September 2009.
Slovenian: Ker je družba predložila dodatne zahtevane podatke, so 21. septembra 2009 izjemne okoliščine prenehale veljati.
English: It is available as capsules (2 mg, 5 mg, 10 mg and 20 mg) and as a suspension (4 mg/ml) to be taken by mouth.
Slovenian: Na voljo je v obliki kapsul (2 mg, 5 mg, 10 mg in 20 mg) in v obliki suspenzije (4 mg/ml), ki se jemlje peroralno.
English: Orfadin nitisinone
Slovenian: Orfadin nitizinon
English: What measures are being taken to ensure the safe and effective use of Orfadin?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Orfadin?
English: Other information about Orfadin
Slovenian: Druge informacije o zdravilu Orfadin
English: The capsules are usually swallowed whole, but they may be opened and their contents mixed into a small amount of water or formula just before swallowing.
Slovenian: Kapsule se navadno pogoltnejo cele, vendar se lahko odprejo, da se vsebina tik pred zaužitjem zmeša z manjšo količino vode ali formule.
English: The recommended starting dose is 1 mg per kilogram body weight per day, divided into two doses.
Slovenian: Priporočeni začetni dnevni odmerek znaša 1 mg na kilogram telesne mase in se vzame v dveh delih.
English: The main benefit of Orfadin is to greatly extend life expectancy.
Slovenian: Glavna korist zdravila Orfadin je, da močno podaljša pričakovano življenjsko dobo.
English: This is a summary of the European public assessment report (EPAR) for Orfadin.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Orfadin.
English: Orfadin is intended for long-term use.
Slovenian: Zdravilo Orfadin je namenjeno za dolgotrajno uporabo.
English: For more information about treatment with Orfadin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Orfadin preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: A risk management plan has been developed to ensure that Orfadin is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Orfadin je bil pripravljen načrt obvladovanja tveganj.
English: Many of these side effects can be the result of high tyrosine levels caused by patients not eating the right foods.
Slovenian: Mnogi neželeni učinki so lahko posledica visoke ravni tirozina, ki jih povzroči neustrezno prehranjevanje bolnikov.
English: What benefit has Orfadin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Orfadin izkazalo med študijami?
English: Thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), granulocytopenia (low levels of granulocytes, a type of white blood cell), conjunctivitis (inflammation of the membrane that lines the eyelid), corneal opacity (clouding of the cornea, the transparent layer in front of the pupil), keratitis (inflammation of the cornea), photophobia (increased sensitivity of the eyes to light) and eye pain are also common (seen in between 1 and 10 patients in 100).
Slovenian: Pogosti neželeni učinki (opaženi pri 1 do 10 bolnikih od 100) so tudi trombocitopenija (nizko število trombocitov), levkopenija (nizko število belih krvnih celic), granulocitopenija (nizko število granulocitov, vrste belih krvnih celic), konjunktivitis (vnetje očesne veznice), motnjava roženice (prosojnega prednjega dela očesa, ki pokriva zenico), keratitis (vnetje roženice), fotofobija (povečana občutljivost oči za svetlobo) in bolečine v očeh.
English: This is a rare disease in which the body is unable to completely break down the amino acid tyrosine, and harmful substances are formed, causing serious liver problems and liver cancer.
Slovenian: To je redka bolezen, pri kateri telo ni sposobno popolnoma razgraditi aminokisline tirozin, zaradi česar nastajajo škodljive snovi, ki povzročajo hude težave z jetri, vključno z rakom.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Orfadin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Orfadin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Treatment with Orfadin leads to high levels of tyrosine in the blood (due to the medicine's mode of action); this side effect is seen in more than 1 patient in 10.
Slovenian: Zdravljenje z zdravilom Orfadin lahko povzroči visoke koncentracije tirozina v krvi (zaradi načina delovanja zdravila); ta neželeni učinek je opažen pri 1 bolniku od 10.
English: For example, a baby less than two months old with HT-1 would normally have only a 28% chance of surviving for five years using a modified diet alone.
Slovenian: Pri dojenčku z dedno tirozinemijo tipa 1, mlajšem od dveh mesecev, je na primer verjetnost, da preživi pet let, če se zdravi zgolj s prilagojeno dieto, običajno samo 28-odstotna.
English: Treatment should be started as early as possible and the dose of Orfadin adjusted according to the patient's response and body weight.
Slovenian: Zdravljenje je treba začeti čim prej, odmerek zdravila pa je treba prilagoditi bolnikovemu odzivu in telesni masi.
English: The oral suspension is for children who have difficulty swallowing capsules.
Slovenian: Peroralna raztopina je namenjena otrokom, ki imajo težave pri požiranju kapsul.
English: The CHMP noted that Orfadin seems to be an effective treatment for HT-1, particularly if it is started early, before the patient's liver is too damaged.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da se zdravilo Orfadin zdi učinkovito pri zdravljenju dedne tirozinemije tipa 1, zlasti če se začne jemati dovolj zgodaj, preden so bolnikova jetra preveč poškodovana.
English: Therefore, the CHMP decided that Orfadin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je odbor za zdravila za uporabo v humani medicini (CHMP), zaključil, da so koristi zdravila Orfadin večje od z njim povezanih tveganj in priporočil, da se zanj izda dovoljenje za promet.
English: Because the number of patients with HT-1 is low, the disease is considered ‘rare', and Orfadin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 December 2000.
Slovenian: Ker je bolnikov z dedno tirozinemijo tipa 1 malo, velja bolezen za redko, zato je bilo zdravilo Orfadin 29. decembra 2000 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Orfadin, 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: What is the risk associated with Orfadin?
Slovenian: Kakšna tveganja so povezana z zdravilom Orfadin?
English: However, as tyrosine remains in the body during Orfadin treatment, patients need to eat a special diet low in tyrosine.
Slovenian: Ker pa tirozin med zdravljenjem z zdravilom Orfadin ostane v telesu, bolniki potrebujejo posebno dieto z nizko vsebnostjo tirozinov.
English: Orfadin is used to treat hereditary tyrosinaemia type 1 (HT-1).
Slovenian: Zdravilo Orfadin se uporablja za zdravljenje dedne tirozinemije tipa 1 (HT-1).
English: For the full list of all side effects and restrictions with Orfadin, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Orfadin glejte navodilo za uporabo.
English: 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 Orfadin.
Slovenian: 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.