FrancophonIA/ELRC3.0 huggingface dataset:
English: Nyxoid is a medicine used for emergency treatment in case of known or suspected overdose of opioid drugs (such as heroin or morphine).
Slovenian: Zdravilo Nyxoid se uporablja za nujno zdravljenje v primeru prevelikega odmerka opioidov (kot sta heroin ali morfin) ali sumu nanj.
English: For practical information about using Nyxoid, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Nyxoid naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For the full list of all side effects and restrictions with Nyxoid, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Nyxoid glejte navodilo za uporabo.
English: How does Nyxoid work?
Slovenian: Kako zdravilo Nyxoid deluje?
English: Nyxoid naloxone
Slovenian: Nyxoid nalokson
English: How is Nyxoid used?
Slovenian: Kako se zdravilo Nyxoid uporablja?
English: The active substance in Nyxoid, naloxone, counteracts the effects of opioid drugs.
Slovenian: Zdravilna učinkovina v zdravilu Nyxoid, nalokson, izniči delovanje opioidov.
English: It contains the active substance naloxone.
Slovenian: Vsebuje zdravilno učinkovino nalokson.
English: The recommended dose is one spray into one nostril given immediately on suspecting an opioid overdose and while awaiting emergency services; if the first dose does not have an effect, a second dose should be given after 2-3 minutes in the other nostril.
Slovenian: Priporočeni odmerek je en vpih v eno nosnico, ki se da takoj po sumu na prevelik odmerek opioida in med čakanjem na prihod reševalcev.
English: Typical opioid withdrawal syndrome is expected after Nyxoid is given to people addicted to opioids; symptoms include restlessness, agitation, feeling or being sick, a fast heart rate and sweating.
Slovenian: Simptomi vključujejo nemir, vznemirjenost, siljenje na bruhanje ali bruhanje, hiter srčni utrip in znojenje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Moventig on 8 December 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Moventig, veljavno po vsej Evropski uniji, izdala 8. decembra 2014.
English: In terms of safety, the side effects were considered acceptable or manageable.
Slovenian: Kar zadeva varnost so se neželeni učinki šteli za sprejemljive ali obvladljive.
English: Moventig naloxegol
Slovenian: Moventig naloksegol
English: What measures are being taken to ensure the safe and effective use of Moventig?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Moventig?
English: The recommended dose is one 25 mg tablet a day.
Slovenian: Priporočen odmerek je ena 25-miligramska tableta na dan.
English: The full EPAR and risk management plan summary for Moventig 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 Moventig sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Moventig and what is it used for?
Slovenian: Kaj je zdravilo Moventig in za kaj se uporablja?
English: The response to treatment was based on an improvement of the number of spontaneous bowel movements per week which had to be maintained for most of the duration of the study.
Slovenian: Odziv na zdravljenje je temeljil na povečanju števila spontanih iztrebljanj na teden, ki ga je bilo treba ohranjati večji del obdobja študije.
English: Other information about Moventig
Slovenian: Druge informacije o zdravilu Moventig
English: Although studies in patients with cancerrelated pain had not been conducted, based on the mechanism of action of the medicine, the benefit for these patients was not expected to be different but the safety should be closely monitored.
Slovenian: Čeprav na bolnikih z bolečinami zaradi raka niso bile izvedene študije, ki bi temeljile na mehanizmu učinkovanja zdravila, korist za te bolnike naj ne bi bila drugačna, vendar bi bilo treba skrbno spremljati varnost.
English: It is not intended to provide practical advice on how to use Moventig.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: A risk management plan has been developed to ensure that Moventig is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Moventig je bil pripravljen načrt obvladovanja tveganj.
English: This is a summary of the European public assessment report (EPAR) for Moventig.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Moventig.
English: What benefits of Moventig have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Moventig izkazalo v študijah?
English: What are the risks associated with Moventig?
Slovenian: Kakšna tveganja so povezana z zdravilom Moventig?
English: Why is Moventig approved?
Slovenian: Zakaj je bilo zdravilo Moventig odobreno?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Moventig'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 Moventig večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: It must also not be used with certain medicines that affect the way Moventig is broken down in the body.
Slovenian: Prav tako se ne sme uporabljati skupaj z nekaterimi zdravili, ki vplivajo na njegovo razgradnjo v telesu.
English: Moventig is available as tablets (12.5 and 25 mg).
Slovenian: Zdravilo Moventig je na voljo v tabletah (12,5 mg in 25 mg).
English: A lower starting dose of 12.5 mg may be prescribed in patients with moderately or severely reduced kidney function or who are taking certain other medicines that increase the effects of Moventig.
Slovenian: Manjši začetni odmerek 12,5 mg se lahko predpiše bolnikom z zmerno ali hudo odpovedjo ledvic ali bolnikom, ki jemljejo nekatera druga zdravila, ki povečujejo učinke zdravila Moventig.
English: The most common side effects with Moventig (which may affect more than 5 in 100 people) are abdominal pain (stomach ache), diarrhoea, nausea (feeling sick), headache and flatulence (passing wind).
Slovenian: Najpogostejši neželeni učinki zdravila Moventig (ki lahko prizadenejo več kot 5 od 100 oseb) so abdominalne bolečine (bolečine v trebuhu), driska, navzea (slabost), glavobol in flatulenca (vetrovi).
English: This means that it attaches to a specific type of opioid receptor called the ‘mu-opioid receptor' and blocks opioids from binding to these receptors.
Slovenian: To pomeni, da se veže na določeno vrsto opioidnega receptorja, ki se imenuje „muopioidni receptor“, in blokira vezavo opioidov na te receptorje.
English: It is used in patients in whom treatment with laxatives has failed.
Slovenian: Uporablja se pri bolnikih, pri katerih je bilo zdravljenje z odvajali neuspešno.
English: For more information about treatment with Moventig, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Moventig preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For the full list of all side effects and restrictions reported with Moventig, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Moventig, glejte navodilo za uporabo.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Moventig, 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 Moventig in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: When looking at the results of both main studies together, 48% (115 out of 241) of adults who previously had an inadequate response to laxatives and who took 25 mg Moventig responded to treatment compared with 30% (72 out of 239) of adults on placebo.
Slovenian: Iz skupnih rezultatov obeh glavnih študij je razvidno, da se je na zdravljenje odzvalo 48 % (115 od 241) odraslih, ki so se prej nezadostno odzvali na odvajala in so prejemali 25 mg zdravila Moventig, v primerjavi s 30 % (72 od 239) odraslih, ki so prejemali placebo.
English: The studies involved 1,352 adults with constipation caused by opioids that were being used to treat non-cancer pain, half of whom had an inadequate response to laxatives (720).
Slovenian: V študijo je bilo vključenih 1 352 odraslih z zaprtjem, povzročenim z opioidi, ki so se uporabljali za zdravljenje bolečin, ki niso bile povezane z rakom, od katerih se je polovica neustrezno odzvala na odvajala (720).
English: However, these receptors are also found in the gut and when opioids attach to the gut receptors, they reduce the movement of the gut and can cause constipation.
Slovenian: Vendar so ti receptorji tudi v črevesju, in če se opioidi vežejo na receptorje v črevesju, zmanjšajo gibanje črevesja in lahko povzročijo zaprtje.
English: Naloxegol is less able to enter the brain than naloxone, meaning that it can block the mu-opioid receptors in the gut but less in the brain.
Slovenian: Naloksegol ima manjšo sposobnost prehajanja v možgane kot nalokson, kar pomeni, da lahko blokira mu-opioidne receptorje v črevesju, manj pa v možganih.
English: Moventig must not be used in patients who have or who are at high risk of bowel obstruction (blockage in the gut) or in patients with cancer who are at a high risk of gastro-intestinal perforation (a hole that develops in the wall of the gut).
Slovenian: Zdravilo Moventig se ne sme uporabljati pri bolnikih, ki imajo ali bi zelo verjetno lahko imeli obstrukcijo (zaporo) črevesja, ali pri bolnikih z rakom, ki so izpostavljeni velikemu tveganju za perforacijo prebavil (predrtje stene črevesja).
English: Moventig is a medicine used in adults to treat constipation caused by pain relief medicines called opioids.
Slovenian: Moventig je zdravilo, ki se uporablja pri odraslih za zdravljenje zaprtja, povzročenega z zdravili za lajšanje bolečin, imenovanimi opioidi.
English: For practical information about using Moventig, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Moventig naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The majority of side effects affecting the gut were mild to moderate, occurred early in treatment and got better during continued treatment.
Slovenian: Večina neželenih učinkov na prebavilih je bila razvrščenih med blage do zmerne, pojavili so se zgodaj med zdravljenjem in so med nadaljevanjem zdravljenja izzveneli.
English: The CHMP considered that Moventig had shown a clinically relevant benefit when used in adults who have not responded adequately to previous treatment with laxatives.
Slovenian: Po mnenju odbora CHMP je zdravilo Moventig pokazalo pomembno klinično korist pri uporabi pri odraslih, ki se niso zadostno odzvali na predhodno zdravljenje z odvajali.
English: For adults who took 12.5 mg Moventig and who previously had an inadequate response to laxatives, 43% (102 out of 240) responded to treatment.
Slovenian: Pri odraslih, ki so prejemali 12,5 mg zdravila Moventig in so se prej nezadostno odzvali na odvajala, se jih je na zdravljenje odzvalo 43 % (102 od 240).
English: Before starting treatment with Moventig, treatment with laxatives should be stopped.
Slovenian: Pred začetkom zdravljenja z zdravilom Moventig je priporočljivo prekiniti zdravljenje z odvajali.
English: How is Moventig used?
Slovenian: Kako se zdravilo Moventig uporablja?
English: People either received Moventig (at 12.5 and 25 mg) or placebo (a dummy treatment) for 12 weeks.
Slovenian: Bolniki so 12 tednov prejemali Moventig (po 12,5 mg ali 25 mg) ali placebo (zdravilo brez zdravilne učinkovine).
English: By blocking receptors in the gut, Moventig reduces the constipation due to opioids, but does not interfere with their pain relief effects.
Slovenian: Zdravilo Moventig z blokiranjem receptorjev v črevesju zmanjšuje zaprtje zaradi opioidov, vendar ne učinkuje negativno na lajšanje bolečin.
English: The active substance in Moventig, naloxegol, is a peripheral mu-opioid-receptor antagonist.
Slovenian: Zdravilo Moventig vsebuje zdravilno učinkovino naloksegol, ki je periferni antagonist mu-opioidnih receptorjev.
English: Opioids relieve pain by attaching to ‘opioid receptors' in the brain and spinal cord.
Slovenian: Opioidi lajšajo bolečino z vezavo na opioidne receptorje v možganih in hrbtenjači.
English: Moventig contains the active substance naloxegol.
Slovenian: Moventig vsebuje zdravilno učinkovino naloksegol.
English: Naloxegol is derived from naloxone, a well-known substance that is used to block the action of opioids.
Slovenian: Naloksegol je derivat naloksona, znane učinkovine, ki se uporablja za zaviranje učinkovanja opioidov.
English: How does Moventig work?
Slovenian: Kako zdravilo Moventig deluje?
English: Moventig has been shown to be effective at treating constipation in adults who had an inadequate response to laxatives in two main studies.
Slovenian: Zdravilo Moventing se je v dveh glavnih študijah izkazalo za učinkovito pri zdravljenju zaprtja pri odraslih z nezadostnim odzivom na odvajala.
English: Take 3 times per day; morning, afternoon and evening.
Slovenian: Vzemite 3-krat na dan: zjutraj, popoldne in zvečer.
English: † and ‡
Slovenian: † in ‡
English: Ribavirin can be very damaging to an unborn baby.
Slovenian: Ribavirin je lahko zelo škodljiv za nerojenega otroka.
English: Date of first authorisation: 18 July 2011 Date of latest renewal: 18 February 2016
Slovenian: Datum zadnjega podaljšanja: 18. februar 2016
English: This should be discussed
Slovenian: O tem se pogovorite
English: Then continue taking your capsules as normal.
Slovenian: Potem nadaljujte z jemanjem kapsul kot po navadi.
English: Interaction (postulated mechanism of action, if known)
Slovenian: Medsebojno delovanje (predvideni mehanizem delovanja, če je znan)
English: Component of a multipack, can't be sold separately
Slovenian: Del multi-pakiranja, se ne prodaja posamezno.
English: Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur:
Slovenian: Vi in vaš partner morata biti zato posebej pazljiva pri spolnih odnosih, če obstaja kakršna koli možnost za zanositev:
English: 84 hard capsules.
Slovenian: 84 trdih kapsul.
English: tongue or throat - these are signs of an allergic reaction.
Slovenian: ustnic, jezika ali žrela - to so znaki alergijske reakcije.
English: Take the capsules in the morning, afternoon and evening with a meal or light snack.
Slovenian: Kapsule vzemite zjutraj, popoldan in zvečer ob obroku ali z lahkim prigrizkom.
English: • The Summary of Product Characteristics (in full)
Slovenian: • Povzetek glavnih značilnosti zdravila (v celoti),
English: • The active substance is boceprevir.
Slovenian: • Učinkovina je boceprevir.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o
English: Red printing ink containing:
Slovenian: Rdeče črnilo za tisk, ki vsebuje:
English: Daily doses of 3,600 mg have been taken by healthy volunteers for 5 days without untoward symptomatic effects.
Slovenian: Zdravi prostovoljci so 5 dni jemali dnevne odmerke 3.600 mg brez neugodnih simptomatskih učinkov.
English: C/C C/T
Slovenian: C/C C/T T/T
English: Clinical Study
Slovenian: Klinična študija
English: These recommendations are based on either drug interaction studies (indicated with *) or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy.
Slovenian: Ta priporočila temeljijo ali na študijah medsebojnega delovanja (označeno z *) ali predvidenega medsebojnega delovanja zaradi pričakovanega obsega interakcij in možnosti za resne neželene učinke ali zmanjšanja učinkovitosti.
English: Prompt evaluation and treatment of infections is recommended.
Slovenian: Priporočamo takojšnjo oceno in zdravljenje okužb.
English: Your doctor may need to increase the frequency of your blood tests to check how well your blood can
Slovenian: Zdravnik bo morda moral povečati pogostnost krvnih preiskav, da bo lahko spremljal, kako dobro se lahko vaša kri strjuje.
English: • so your doctor knows if the treatment is working for you
Slovenian: • da bo zdravnik vedel, ali zdravljenje pri vas deluje,
English: The use without food could seriously compromise your chance of success of treatment.
Slovenian: Uporaba brez hrane lahko bistveno zmanjša možnosti za uspeh zdravljenja.
English: SPRINT-2 (previously untreated subjects)
Slovenian: SPRINT-2 (predhodno nezdravljeni preiskovanci)
English: < 1-log10 decline
Slovenian: < 1-log10 zmanjšanje
English: • some neuroleptics
Slovenian: • nekatere nevroleptike
English: • Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Stop taking Victrelis and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Slovenian: Prenehajte jemati zdravilo Victrelis in takoj obiščite zdravnika, če opazite katerega od naslednjih resnih neželenih učinkov - morda boste potrebovali nujno zdravljenje:
English: *Please see section 5.1 clinical trial descriptions for each treatment arm.
Slovenian: *Prosimo, glejte opise kliničnih preskušanj v poglavju 5.1 za vsako skupino zdravljenja.
English: • have another liver problem in addition to hepatitis C infection • have HIV (human immunodeficiency virus) or have ever had any other problems with your
Slovenian: • če imate druge težave z jetri poleg okužbe s hepatitisom C, • če imate HIV (virus humane imunske pomanjkljivosti) ali ste kdaj imeli kakšne druge težave z
English: Other clinical experience has not identified differences in responses between the older and younger patients (see section 5.2).
Slovenian: Druge klinične izkušnje niso pokazale razlik v odzivu med starejšimi in mlajšimi bolniki (glejte poglavje 5.2).
English: Detailed information on this medicine is available on the European Medicines Agency web site:
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila:
English: Exposure to boceprevir in nursing human infants is estimated to be less than 1% of the dose.
Slovenian: Ocenjujejo, da je izpostavljenost boceprevirju pri človeških dojenčkih manj kot 1 % odmerka.
English: • Do not take a double dose to make up for a forgotten dose.
Slovenian: • Ne vzemite dvojnega odmerka, da bi nadoknadili izpuščeni odmerek.
English: (Refer to the stopping rule in Table 1 for all patients.)
Slovenian: (Za vse bolnike glejte pravilo prenehanja zdravljenja v preglednici 1.)
English: Loss of replicon RNA appears to be first-order with respect to time of treatment.
Slovenian: Upad replikacijske enote RNA je, kot kaže, prvega reda glede na čas zdravljenja.
English: This includes medicines obtained without a prescription and herbal medicines.
Slovenian: To velja tudi za zdravila, ki ste jih dobili brez recepta in za zdravila
English: Accumulation is minimal and pharmacokinetic steady state is achieved after approximately 1 day of three times daily dosing.
Slovenian: Kopičenje je minimalno, farmakokinetično stanje dinamičnega ravnovesja je doseženo po približno 1 dnevu uporabe trikrat na dan.
English: • have or anyone in your family has an irregular heartbeat, especially a condition called “QT
Slovenian: • če imate ali ima kdo iz vaše družine nepravilen srčni utrip, še posebej stanje, imenovano
English: The safety and efficacy of Victrelis in children aged below 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Victrelis pri otrocih do 18. leta starosti še nista dokazani.
English: Neutropenia affects the body's ability to fight off infections
Slovenian: Nevtropenija prizadane zmožnost telesa za borbo proti okužbam.
English: • The duration of the administration of these medicines will depend on your response and
Slovenian: • Čas jemanja teh zdravil bo odvisen od vašega odziva in načrta zdravljenja.
English: • warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Slovenian: • varfarin in druga podobna zdravila, imenovana antagonisti vitamina K, ki se uporabljajo za redčenje krvi.
English: Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Slovenian: želatina titanov dioksid (E171) rumeni železov oksid (E172) rdeči železov oksid (E172)
English: Inner carton without Blue Box
Slovenian: Notranja škatla brez modrega okvirčka
English: • have ever had a blood problem such as neutropenia (lack of a certain type of white blood cells).
Slovenian: • če ste kdaj imeli težave s krvjo, kot je nevtropenija (pomanjkanje določene vrste belih krvnih celic).
English: Data obtained in juvenile rats suggest that the pharmacokinetic profile of boceprevir may be different than in adult rats, possibly due to immaturity of some metabolic pathways.
Slovenian: Podatki, pridobljeni pri podganjih mladičih, kažejo, da je farmakokinetični profil boceprevirja lahko drugačen kot pri odraslih podganah, možno zaradi nezrelosti nekaterih metabolnih poti.
English: The last available value in the period at and after FW 24.
Slovenian: Zadnja razpoložljiva vrednost v in po 24.
English: It should be noted that retrospective analyses bridging the data between the two pivotal studies have led to a recommended posology that differs from the regimen studied in some patient subgroups.
Slovenian: Upoštevati je treba, da so retrospektivne analize, ki so povezale podatke iz dveh ključnih študij, pripeljale do priporočenega odmerjanja, ki se pri nekaterih podskupinah bolnikov razlikuje od preučevanega režima.
English: • to help your doctor decide how long you will be treated with Victrelis.
Slovenian: • za pomoč zdravniku pri presoji, kako dolgo se morate zdraviti z zdravilom Victrelis,
English: Clinical studies of boceprevir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Slovenian: Klinične študije boceprevirja niso vključevale zadostnega števila preiskovancev, starih 65 let in več, da bi bilo mogoče ugotoviti, ali se starejši preiskovanci odzivajo drugače kot mlajši.
English: The data indicate that boceprevir is eliminated primarily by the liver.
Slovenian: Podatki kažejo, da se boceprevir izloča primarno preko jeter.
English: Effects of food on oral absorption
Slovenian: Vpliv hrane na absorpcijo po peroralni uporabi
English: o The duration of the tritherapy after the first 4 weeks of bitherapy should not be less than 32 weeks.
Slovenian: o Trajanje trojnega zdravljenja po prvih štirih tednih dvojnega zdravljenja ne sme biti krajše od 32 tednov.
English: See section 4.
Slovenian: Odziv v 4.
English: Caution is warranted and clinical monitoring of patients is recommended.
Slovenian: Potrebna je previdnost in priporočljiv je kliničen nadzor bolnikov.