FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk management plan has been developed to ensure that Qutenza is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Qutenza je bil pripravljen načrt obvladovanja tveganj.
English: Once the patch is removed, the area is cleaned using the cleansing gel provided.
Slovenian: Po odstranitvi obliža je treba predel očistiti s priloženim čistilnim gelom.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Qutenza's benefits are greater than its risks and recommended that Qutenza be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Qutenza večje od z njim povezanih tveganj, in je priporočil, da se zanj izda dovoljenje za promet.
English: Qutenza should be applied by a doctor or by a healthcare professional under the supervision of a doctor.
Slovenian: Zdravilo Qutenza mora nanesti zdravnik ali zdravstveni delavec pod nadzorom zdravnika.
English: It stimulates the ‘transient receptor potential vanilloid 1' (TRPV1) receptor which is found in the nerves in the skin that detect pain.
Slovenian: Spodbuja vaniloidni receptor 1 (TRPV1), ki je v živcih na koži, ki zaznavajo bolečino.
English: All of the patients had neuropathic pain due to either post-herpetic neuralgia (pain that occurs in people who have had shingles, an infection caused by the varicella zoster virus) or HIV-associated neuropathy (damage to the nerves caused by HIV infection).
Slovenian: Vsi bolniki so imeli nevropatsko bolečino zaradi postherpetične nevralgije (bolečine, ki se pojavlja pri ljudeh, ki so preboleli pasovec, tj. okužbo, ki jo povzroča virus varicella zoster) ali nevropatije, povezane z virusom HIV (poškodbe živcev, ki jo povzroča okužba z virusom HIV).
English: What benefit has Qutenza shown during the studies?
Slovenian: Kakšne koristi je zdravilo Qutenza izkazalo med študijami?
English: The main measure of effectiveness in all main studies was the reduction in the 24-hour pain score during an eight- or 12-week period after application of the patch.
Slovenian: Glavno merilo učinkovitosti v vseh glavnih študijah je bilo zmanjšanje 24-urnega točkovanja bolečine v osem- ali dvanajsttedenskem obdobju po nanosu obliža.
English: Qutenza can cause a burning sensation on the skin.
Slovenian: Zdravilo Qutenza lahko povzroči pekoč občutek na koži.
English: A fifth study compared Qutenza with a placebo (dummy) patch in 369 patients with painful peripheral diabetic neuropathy, a form of neuropathic pain associated with diabetes; a supportive study looked at repeated treatment over one year.
Slovenian: V peti študiji so zdravilo Qutenza primerjali s placebom (obližem brez zdravilne učinkovine) pri 369 bolnikih z bolečo diabetično periferno nevropatijo, tj. obliko nevropatske bolečine, povezane s sladkorno boleznijo; v podporni študiji so proučevali ponavljajoče se zdravljenje v enem letu.
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 Qutenza.
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.
English: Patches can be cut to match the area to cover.
Slovenian: Obliž je mogoče razrezati, da ustreza velikosti predela, ki ga bo prekrival.
English: Alternatively, medicines for pain may be taken.
Slovenian: Lahko pa se vzamejo tudi protibolečinska zdravila.
English: Qutenza is used to treat peripheral neuropathic pain (pain that is caused by damage to the nerves) in adults.
Slovenian: Zdravilo Qutenza se uporablja za zdravljenje periferne nevropatske bolečine (bolečine, ki jo povzroča poškodba živcev) pri odraslih osebah.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Qutenza, 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 the full list of all side effects and restrictions with Qutenza, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Qutenza glejte navodilo za uporabo.
English: What is the risk associated with Qutenza?
Slovenian: Kakšna tveganja so povezana z zdravilom Qutenza?
English: The active substance in Qutenza, capsaicin, is a substance normally found in chilli peppers.
Slovenian: Zdravilna učinkovina v zdravilu Qutenza, kapsaicin, je snov, ki jo najdemo v papriki čili.
English: The most common side effects with Qutenza (seen in more than 1 patient in 10) are pain and redness at the site of application.
Slovenian: Najpogostejša neželena učinka zdravila Qutenza (opažena pri več kot 1 bolniku od 10) sta bolečina in pordelost na mestu nanosa.
English: Why has Qutenza been approved?
Slovenian: Zakaj je bilo zdravilo Qutenza odobreno?
English: Before applying Qutenza, the area may be treated with a local anaesthetic to numb it; this helps to reduce discomfort.
Slovenian: Pred nanosom zdravila Qutenza se lahko na predel nanese lokalni anestetik, da omrtvi, kar zmanjša neugodje.
English: Qutenza was more effective at reducing neuropathic pain than the control patches.
Slovenian: Zdravilo Qutenza je bilo pri zmanjševanju nevropatske bolečine učinkovitejše od kontrolnih obližev.
English: In the two studies of patients with post-herpetic neuralgia, the reduction in pain scores after eight weeks was 30 and 32% in patients who were given Qutenza, compared with 20 and 24% in patients who received the control patches.
Slovenian: V dveh študijah bolnikov s postherpetično nevralgijo je bilo zmanjšanje točkovanja bolečine po osmih tednih 30 in 32 % pri bolnikih, ki so prejemali zdravilo Qutenza, v primerjavi z 20 in 24 % pri bolnikih, ki so prejeli kontrolne obliže.
English: In one of the studies of patients with HIV-associated neuropathy, patients who were given Qutenza experienced a 23% reduction in pain scores after 12 weeks compared with an 11% reduction in patients who were given the control.
Slovenian: V eni od študij z bolniki z nevropatijo, povezano z virusom HIV, so bolniki, ki so prejemali zdravilo Qutenza, po 12 tednih zabeležili 23-odstotno zmanjšanje pri točkovanju bolečine v primerjavi z 11-odstotnim zmanjšanjem pri bolnikih, ki so prejemali kontrolno zdravilo.
English: In patients with painful peripheral diabetic neuropathy, the reduction in pain score from week 2 to after 8 weeks with Qutenza was about 27% compared with 21% for the placebo.
Slovenian: Pri bolnikih z bolečo diabetično periferno nevropatijo je zdravilo Qutenza v dveh do osmih tednih zmanjšalo vrednost pri točkovanju bolečine za 27 % v primerjavi z 21 % pri placebu.
English: In the second study of patients with HIV-associated neuropathy, although Qutenza reduced pain by 30% it was not shown to be more effective than the control.
Slovenian: V drugi študiji z bolniki z nevropatijo, povezano z virusom HIV, ni bilo dokazano, da je zdravilo Qutenza učinkovitejše od kontrolnega zdravila, čeprav je zmanjšalo bolečino za 30 %.
English: How has Qutenza been studied?
Slovenian: Kako je bilo zdravilo Qutenza raziskano?
English: What is Qutenza used for?
Slovenian: Za kaj se zdravilo Qutenza uporablja?
English: How does Qutenza work?
Slovenian: Kako zdravilo Qutenza deluje?
English: Qutenza has been compared with control patches containing lower amounts of capsaicin (0.04%) in four main studies involving a total of 1,619 adults with moderate to severe neuropathic pain.
Slovenian: V štirih glavnih študijah, v katere je bilo vključenih 1 619 odraslih z zmerno do hudo nevropatsko bolečino, so zdravilo Qutenza primerjali s kontrolnimi obliži, ki so vsebovali nižje količine kapsaicina (0,04 %).
English: How is Qutenza used?
Slovenian: Kako se zdravilo Qutenza uporablja?
English: Qutenza is a cutaneous patch (a patch that delivers a medicine into the skin).
Slovenian: Zdravilo Qutenza je dermalni obliž (obliž, ki dovaja zdravilo na kožo).
English: What measures are being taken to ensure the safe and effective use of Refixia?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Refixia?
English: The full EPAR for Refixia 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) za zdravilo Refixia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Refixia nonacog beta pegol
Slovenian: Refixia nonakog beta pegol
English: Other information about Refixia
Slovenian: Druge informacije o zdravilu Refixia
English: Since this could potentially cause problems especially in children below 12 years of age, Refixia is only approved for use in in adults and children from 12 years of age.
Slovenian: Ker lahko to povzroči težave, zlasti pri otrocih, mlajših od 12 let, je zdravilo Refixia odobreno le za uporabo pri odraslih in otrocih od 12. leta starosti naprej.
English: This is a summary of the European public assessment report (EPAR) for Refixia.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Refixia.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Refixia'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 Refixia večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: It is not intended to provide practical advice on how to use Refixia.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: In the second study in 25 children aged below 13 years, all patients were given Refixia as a weekly preventive treatment.
Slovenian: V drugi študiji, ki je vključevala 25 otrok, mlajših od 13 let, so zdravilo Refixia kot tedensko preventivno zdravljenje prejemali vsi bolniki.
English: What benefits of Refixia have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Refixia izkazalo v študijah?
English: Hypersensitivity (allergic) reactions are uncommon with Refixia (may affect up to 1 in 100 patients) and may include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing.
Slovenian: Preobčutljivostne (alergijske) reakcije so pri zdravilu Refixia občasne (lahko se pojavijo pri največ 1 bolniku od 100) in lahko vključujejo oteklost, pekoč občutek in zbadanje na mestu injiciranja, mrzlico, vročinske oblive, srbeč izpuščaj, glavobol, koprivnico, nizek krvni tlak, letargijo, navzeo in bruhanje, nemir, hiter srčni utrip, tiščanje v prsnem košu in piskajoče dihanje.
English: What is Refixia and what is it used for?
Slovenian: Kaj je zdravilo Refixia in za kaj se uporablja?
English: What are the risks associated with Refixia?
Slovenian: Kakšna tveganja so povezana z zdravilom Refixia?
English: Patients or their carers may be able to inject Refixia themselves at home once they have been trained appropriately.
Slovenian: Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo Refixia injicirajo sami doma.
English: The company that markets Refixia will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Slovenian: Družba, ki trži zdravilo Refixia, bo izvedla študijo za proučitev potencialnega učinka kopičenja PEG v horoidnem pletežu možganov in v drugih organih.
English: For further information on how to use this medicine, see the summary of product characteristics (also part of the EPAR).
Slovenian: Za več informacij o uporabi zdravila glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Why is Refixia approved?
Slovenian: Zakaj je bilo zdravilo Refixia odobreno?
English: In a study involving 74 adults and adolescents aged 13 or above, 29 patients given Refixia as a weekly preventive treatment had around 1 bleeding episode a year, and 15 patients given Refixia for treating bleedings ‘on demand' had around 16 bleeding episodes a year.
Slovenian: V študiji, ki je vključevala 74 odraslih in mladostnikov, starih 13 let ali več, je 29 bolnikov, ki so prejemali zdravilo Refixia kot tedensko preventivno zdravljenje, imelo približno 1 epizodo krvavitve na leto; 15 bolnikov, ki so prejemali zdravilo Refixia za zdravljenje krvavitev po potrebi, pa je imelo približno 16 epizod krvavitev na leto.
English: Around 86% of bleeding episodes resolved with one injection.
Slovenian: Približno 86 % epizod krvavitev so obvladali z eno injekcijo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Refixia have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Refixia upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Refixia must not be used in patients allergic to hamster proteins.
Slovenian: Zdravilo Refixia se ne sme uporabljati pri bolnikih z alergijo na hrčkove beljakovine.
English: It replaces the missing factor IX, thereby helping the blood to clot and giving temporary control of bleeding.
Slovenian: Nadomešča manjkajoči faktor IX ter tako pripomore k strjevanju krvi in omogoči začasen nadzor nad krvavitvijo.
English: The dose and frequency of treatment depend on whether Refixia is used to treat or prevent bleeding, or to reduce bleeding during surgery, the extent and location of the bleeding, and the patient's bodyweight.
Slovenian: Odmerek in pogostnost injiciranja sta odvisna od tega, ali se zdravilo Refixia uporablja za zdravljenje ali preprečevanje krvavitev ali za zmanjšanje krvavitev med kirurškim posegom, od obsega in mesta krvavitve in od bolnikove telesne mase.
English: 87% of bleeding episodes resolved with one injection of Refixia.
Slovenian: 87 % epizod krvavitev so obvladali z eno injekcijo zdravila Refixia.
English: Refixia is available as a powder and a liquid that are mixed together to make a solution for injection into a vein.
Slovenian: Zdravilo Refixia je na voljo v obliki praška in vehikla, ki se zmešata za pripravo raztopine za injiciranje v veno.
English: It can be used in adults and children from 12 years of age.
Slovenian: Zdravilo Refixia se lahko uporablja pri odraslih in mladostnikih, starih 12 let in več.
English: Patients had around 1 bleeding episode per year and Refixia was rated excellent or good at treating around 93% of bleeding episodes.
Slovenian: Bolniki so imeli na leto približno 1 epizodo krvavitve na leto, zdravilo Refixia pa je bilo ocenjeno kot odlično ali dobro pri zdravljenju približno 93 % epizod krvavitev.
English: The active substance in Refixia, nonacog beta pegol, works in the body in the same way as human factor IX.
Slovenian: Zdravilna učinkovina zdravila Refixia, nonakog beta pegol, deluje v telesu enako kot humani faktor IX.
English: Refixia can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Slovenian: Predpisovanje in izdaja zdravila Refixia je le na recept, zdravljenje z njim pa mora biti pod nadzorom zdravnika z izkušnjami pri zdravljenju hemofilije.
English: Studies show that Refixia is effective at preventing and treating bleeding episodes in patients with haemophilia B and its safety is comparable to that of other factor IX products.
Slovenian: Študije so pokazale, da zdravilo Refixia učinkovito preprečuje in zdravi epizode krvavitev pri bolnikih s hemofilijo B in da je varnost zdravila primerljiva z varnostjo drugih zdravil s faktorjem IX.
English: For practical information about using Refixia, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Refixia naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: In addition, when bleeding did occur, Refixia was rated excellent or good at treating around 92% of bleeding episodes.
Slovenian: Poleg tega je bilo ob pojavu krvavitve zdravljenje z zdravilom Refixia ocenjeno kot odlično ali dobro pri približno 92 % epizod krvavitev.
English: Factor IX medicines can also potentially cause problems due to the formation of blood clots in the blood vessels.
Slovenian: Zdravila s faktorjem IX lahko povzročijo težave tudi zaradi nastajanja krvnih strdkov v krvnih žilah.
English: For more information about treatment with Refixia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Refixia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: How is Refixia used?
Slovenian: Kako se zdravilo Refixia uporablja?
English: However, part of the active substance in Refixia (called PEG) may accumulate in the body, including in a structure in the brain called choroid plexus, following long-term treatment.
Slovenian: Vendar pa se lahko del zdravilne učinkovine zdravila Refixia (imenovan PEG) po dolgotrajnem zdravljenju kopiči v telesu, tudi v strukturi v možganih, imenovani horoidni pletež.
English: Patients with haemophilia B lack factor IX, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Slovenian: Bolnikom s hemofilijo B primanjkuje faktorja IX, tj. beljakovine, potrebne za normalno strjevanje krvi, zato hitro zakrvavijo.
English: Refixia is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX.
Slovenian: Zdravilo Refixia se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo B, prirojeno motnjo strjevanja krvi zaradi pomanjkanja koagulacijske beljakovine, imenovane faktor IX.
English: Some patients taking factor IX medicines may develop inhibitors (antibodies) against factor IX, causing the medicine to stop working and resulting in a loss of bleeding control.
Slovenian: Pri bolnikih, ki jemljejo zdravila s faktorjem IX, obstaja tudi tveganje, da se bodo pri njih pojavili zaviralci (protitelesa) faktorja IX, ki bodo izničili njegovo delovanje ter tako povzročili izgubo nadzora nad krvavitvijo.
English: Refixia contains the active substance nonacog beta pegol.
Slovenian: Zdravilo Refixia vsebuje zdravilno učinkovino nonakog beta pegol.
English: Refixia has been shown to be effective at both treating bleeding episodes and keeping the number of episodes low.
Slovenian: Zdravilo Refixia se je pokazalo kot učinkovito pri zdravljenju in zmanjševanju števila epizod krvavitev.
English: How does Refixia work?
Slovenian: Kako zdravilo Refixia deluje?
English: Date of first authorisation: 16 March 2016
Slovenian: Datum prve odobritve: 16. marec 2016
English: Produced from the plasma of human donors.
Slovenian: Izdelano iz plazme človeških darovalcev.
English: • The product is now ready for use.
Slovenian: • Zdravilo je zdaj pripravljeno za uporabo.
English: • If you are using this medicine for the first time, your doctor will supervise you
Slovenian: • Če zdravilo uporabljate prvič, vas bo nadziral zdravnik.
English: These include:
Slovenian: Ti ukrepi vključujejo:
English: The dose and frequency should be based on the individual clinical response.
Slovenian: Odmerek in pogostnost dajanja morata temeljiti na kliničnem odzivu posameznika.
English: In case of shock, the current medical standards for shock treatment should be observed.
Slovenian: V primeru šoka je treba upoštevati veljavne zdravstvene standarde za zdravljenje šoka.
English: In this situation, the appropriate dose would be:
Slovenian: V tem primeru bo ustrezni odmerek:
English: Dissolving your medicines before use
Slovenian: Raztapljanje zdravil pred uporabo
English: Paediatric population (less than 12 years of age)
Slovenian: Pediatrična populacija (mlajši od 12 let)
English: EXP: Use within 1 hour of reconstitution.
Slovenian: EXP: Uporabite v 1 uri po rekonstituciji.
English: Make up the medicine as follows:
Slovenian: Pripravite zdravilo, kot sledi:
English: Your doctor will recommend an appropriate dose for you.
Slovenian: Zdravnik vam bo priporočil ustrezen odmerek za vas.
English: How much is given regularly for long-term prevention of bleeds?
Slovenian: Koliko zdravila je treba redno dajati za dolgoročno preprečevanje krvavitev?
English: Inject your normal dose as you remember and then continue dosing as instructed by your doctor.
Slovenian: Injicirajte si običajni odmerek, ko se spomnite, nato pa nadaljujte z uporabo po navodilih zdravnika.
English: Do not shake the vial.
Slovenian: Ne pretresajte viale.
English: The listed warnings and precautions for adults also apply to children (aged 2 to 11 years) and adolescents (aged 12 to 18 years).
Slovenian: Navedena opozorila in previdnostni ukrepi za odrasle veljajo tudi za otroke (stare od 2 do 11 let) in mladostnike (stare od 12 do 18 let).
English: Your doctor will usually tell you your dose in terms of the number of full vials that supply the dose most suited to you.
Slovenian: Zdravnik vam bo običajno pojasnil vaš odmerek v smislu števila polnih vial, ki so potrebne za odmerek, ki je najprimernejši za vas.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Your doctor will check regularly for the development of these antibodies, and especially before an operation.
Slovenian: Zdravnik vas bo redno spremljal, da bo preveril, ali je prišlo do nastanka teh protiteles, še zlasti pred operacijo.
English: Your doctor will explain to you how much you should use, when you should use it and for how long.
Slovenian: Zdravnik vam bo razložil, koliko zdravila uporabite, kdaj ga morate uporabiti in koliko časa ga boste uporabljali.
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults (see section 5.1).
Slovenian: Predvidevamo, da so pogostnost, vrste in resnost neželenih reakcij pri otrocih enaki kot pri odraslih (glejte poglavje 5.1).
English: Virus safety
Slovenian: Virusna varnost
English: Generally the doses for children less than 12 years old are larger than doses for adolescents which should follow those in adults.
Slovenian: Običajno so odmerki pri otrocih, mlajših od 12 let, večji od odmerkov pri mladostnikih, ki naj bi ustrezali tistim za odrasle.
English: If the solution is cloudy or has any particles, do not use it.
Slovenian: Če je raztopina motna ali vsebuje delce, je ne uporabite.
English: Coagadex was considered to be good (7%) or excellent (91%) in treating 98% of bleeding episodes.
Slovenian: Zdravilo Coagadex je bilo ocenjeno kot »dobro« (7 %) ali odlično (91 %) pri zdravljenju 98 % epizod krvavitev.
English: The dose you need will be calculated by your doctor.
Slovenian: Odmerek, ki ga potrebujete, bo izračunal zdravnik.
English: However, chemical and physical in-use stability has been demonstrated for 1 hour at room temperature (up to 25°C +/-2°C).
Slovenian: Dokazano pa je bilo, da je raztopina za infundiranje kemično in fizikalno stabilna še 1 uro pri sobni temperaturi (do 25 °C +/- 2 °C).
English: The median dosing interval for all of the nine children was 3 days (range 2 to 8 days).
Slovenian: Mediani interval odmerjanja pri vseh devet otrocih je bil 3 dni (razpon od 2 dni do 8 dni).