FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/.
English: The most commonly reported adverse reactions were nausea, vomiting, and application site reactions such as erythema and pruritus.
Slovenian: Najpogosteje opisani neželeni učinki so navzea, bruhanje in reakcije na mestu aplikacije, kot sta eritem in pruritus.
English: In this study 28 paediatric patients, 6 to 16 years old, were treated with IONSYS fentanyl 40 micrograms after experiencing inadequate analgesia with IONSYS fentanyl 25 micrograms.
Slovenian: V tej študiji so 28 pediatričnih bolnikov, starih od 6 do 16 let, zdravili s sistemom IONSYS s 40 mikrogrami fentanila, potem ko je bila analgezija s sistemom IONSYS s 25 mikrogrami fentanila neustrezna.
English: Around 75% of fentanyl is excreted into the urine, mostly as metabolites, with less than 10% as unchanged active substance.
Slovenian: Okoli 75 % fentanila se izloči z urinom, večinoma v obliki presnovkov, z manj kot 10-odstotno vsebnostjo nespremenjene zdravilne učinkovine.
English: Your doctor or nurse will remove the IONSYS system before you leave hospital.
Slovenian: Zdravnik ali medicinska sestra bosta sistem odstranila, preden boste zapustili bolnišnico.
English: Prior to launch of IONSYS in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora pred začetkom trženja zdravila Ionsys dogovoriti s pristojnim nacionalnim organom v vsaki državi članici o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini distribucije in vseh drugih vidikih programa.
English: • Blinking red light for 15 seconds
Slovenian: • 15 sekund utripa rdeča lučka
English: They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients.
Slovenian: Te učinkovine imajo visoko afiniteto za opioidne receptorje s sorazmerno majhno intrinzično aktivnostjo, zato delno zavrejo analgetični učinek fentanila in lahko povzročijo odtegnitvene simptome pri bolnikih, odvisnih od opioidov.
English: This effect could either be due to altered maternal care or a direct effect of fentanyl on the pups.
Slovenian: Ta učinek bi lahko bil posledica spremenjene oskrbe samice ali neposrednega učinka fentanila na mladiče.
English: IONSYS is a transdermal system (to be applied on intact skin) that contains a strong analgesic (pain reliever) medicine called fentanyl.
Slovenian: IONSYS je transdermalni sistem (namenjen namestitvi na nepoškodovano kožo), ki vsebuje močan analgetik (učinkovino za lajšanje bolečin) fentanil.
English: In summary, the limited size of the overall paediatric exposure is insufficient to guide safe and effective dosing of IONSYS in patients younger than 18 years of age.
Slovenian: Omejena izpostavljenost pediatrične populacije ne zadošča za varno in učinkovito vodenje odmerjanja zdravila IONSYS pri bolnikih, mlajših od 18 let.
English: It works by delivering fentanyl through your skin to relieve your pain.
Slovenian: Deluje tako, da dovaja fentanil skozi kožo in lajša bolečine.
English: If you have a genetic condition (polymorphism) which affects certain enzymes in your body (CYP3A4 and CYP3A5), inform your doctor.
Slovenian: Če imate genetsko bolezen (polimorfizem), ki vpliva na nekatere encime v telesu (CYP3A4 in CYP3A5), o tem obvestite svojega zdravnika.
English: Studies with female rats revealed reduced fertility and enhanced embryo mortality.
Slovenian: Študije na podganjih samicah so pokazale zmanjšano plodnost in povečano umrljivost zarodkov.
English: The pharmacokinetic absorption profile will repeat with each application to a new skin site, therefore with each new application,
Slovenian: Farmakokinetični absorpcijski profil se ponovi pri vsaki aplikaciji na nov kožni predel, zato je pri vsaki novi aplikaciji absorpcija na začetku manjša.
English: Transdermal system
Slovenian: transdermalni sistem
English: The average volume of distribution for fentanyl at steady state is 6 L/kg, the average clearance is 53 L/h.
Slovenian: Povprečni volumen porazdelitve fentanila v stanju dinamičnega ravnovesja je 6 l/kg in povprečni očistek 53 l/h.
English: Severe respiratory depression or cystic fibrosis.
Slovenian: Huda depresija dihanja ali cistična fibroza.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where IONSYS is launched all healthcare professionals who are expected to prescribe, dispense or administer IONSYS are informed through an information letter on having access to / are provided with the following items:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora po razpravi in dogovoru s pristojnimi nacionalnimi organi v državah članicah, v katerih se bo zdravilo Ionsys tržilo, zagotoviti, da bodo vsi zdravstveni delavci, pri katerih se pričakujejo predpisovanje, izdajanje ali uporaba zdravila Ionsys, prejeli oziroma bodo z informativnim dopisom obveščeni o dostopu do tega gradiva:
English: caution is recommended in these patients (see section 4.4).
Slovenian: Kljub temu je pri teh bolnikih potrebna previdnost (glejte poglavje 4.4).
English: Hair at the application site should be clipped (not shaved) before system application.
Slovenian: Pred namestitvijo sistema je treba pristriči (ne obriti) dlake na mestu aplikacije.
English: Mutagenicity testing in bacteria and in rodents yielded negative results.
Slovenian: Rezultati testiranja mutagenosti na bakterijah in glodavcih so bili negativni.
English: Fentanyl may produce bradycardia or hypotension and should, therefore, be administered with caution to patients with bradyarrhythmias or any significant cardiovascular disease.
Slovenian: Fentanil lahko povzroči bradikardijo ali hipotenzijo, zato se mora uporabljati previdno pri bolnikih z bradiaritmijami ali katero koli pomembno boleznijo srca in ožilja.
English: As with all fentanyl products, the clearance of fentanyl may be reduced in elderly patients, with a consequent increase in half life.
Slovenian: Kot pri vseh zdravilih s fentanilom je lahko očistek fentanila pri starejših bolnikih zmanjšan, s posledičnim podaljšanjem razpolovnega časa.
English: • pain when urinating
Slovenian: • bolečine pri uriniranju
English: Literature has shown that the genetic polymorphisms only account for a small amount of variability in concentrations of fentanyl with transdermal administration.
Slovenian: Iz literature je razvidno, da genetski polimorfizmi predstavljajo le majhno količino variabilnosti v koncentracijah fentanila pri transdermalnem dajanju.
English: The safety and efficacy of IONSYS in children and adolescents younger than 18 years of age has not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila IONSYS pri otrocih in mladostnikih, starih manj kot 18 let, nista dokazani.
English: • feeling confused or agitated
Slovenian: • občutek zmedenosti ali vznemirjenosti
English: Tell your doctor or nurse if you have taken them within the last 14 days before using IONSYS;
Slovenian: Obvestite zdravnika ali medicinsko sestro, če ste ta zdravila jemali v zadnjih 14 dneh pred uporabo zdravila
English: IONSYS should be used with caution in patients with hearing impairment who might not be able to hear the audible signals from the system.
Slovenian: Okvara sluha Zdravilo IONSYS je treba uporabljati previdno pri bolnikih z okvaro sluha, ki morda ne bodo slišali zvočnih signalov sistema.
English: What IONSYS looks like and contents of the pack IONSYS is a transdermal system and is made up of an electronic controller (the top housing) and a drug unit (the red bottom housing).
Slovenian: Izgled zdravila IONSYS in vsebina pakiranja IONSYS je transdermalni sistem, sestavljen iz elektronskega upravljalnika (zgornji del ohišja) in zdravilne enote (rdeči spodnji del ohišja).
English: • if you are allergic (hypersensitive) to fentanyl, or any of the other ingredients of IONSYS (listed in section 6).
Slovenian: • če ste alergični na fentanil ali katero koli sestavino zdravila IONSYS (navedeno v poglavju 6);
English: In these studies, 1313 patients undergoing major surgery were randomized to PCA with intravenous morphine (1 mg morphine bolus, 5 minute lock-out, total of 10 mg/h) delivered by a pump, and 1288 patients were randomized to IONSYS.
Slovenian: V teh študijah so 1313 bolnikov, ki so prestali večji kirurški poseg, randomizirali v skupino PCA z intravenskim morfinom (1 mg morfina v obliki bolusa, 5-minutna blokada, skupaj 10 mg/h), dovajanim s črpalko, medtem ko so 1288 bolnikov randomizirali na zdravilo IONSYS.
English: Each IONSYS works for one day (24 hours) and contains 80 doses.
Slovenian: Vsak sistem IONSYS deluje en dan (24 ur) in vsebuje 80 odmerkov.
English: Table 2 Active Comparator Trials (n=2569) Evaluable Patients
Slovenian: Preglednica 2 Ocenljivi bolniki v preskušanjih z aktivnim primerjalnim zdravilom (n = 2569)
English: Fentanyl is highly lipophilic and is well distributed beyond the vascular system, with a large apparent volume of distribution.
Slovenian: Fentanil je zelo lipofilen in se dobro porazdeli prek žilnega sistema, z velikim navideznim volumnom porazdelitve.
English: Study C-2000-007 evaluated patients after undergoing abdominal, thoracic, or orthopedic surgeries; Study CAPSS-319 evaluated patients after undergoing total hip replacement; Study CAPSS-320 assessed IONSYS in patients following abdominal and pelvic surgeries; and Study FEN-PPA-401 assessed patients following major abdominal or orthopedic surgery.
Slovenian: V študiji C-2000-007 so ocenili bolnike po opravljenih posegih na trebuhu, prsnem košu ali po ortopedskih kirurških posegih; v študiji CAPSS-319 so ocenili bolnike po popolni nadomestitvi kolka; v študiji CAPSS-320 so ocenili zdravilo IONSYS pri bolnikih po kirurških posegih na trebuhu in medenici, v študiji FEN-PPA-401 pa bolnike po večjih posegih na trebuhu ali večjih ortopedskih kirurških posegih.
English: • you are taking medicines that might make you sleepy such as sleeping tablets, tranquilisers, medicines for anxiety or medicines for allergies (anti-histamines);
Slovenian: • jemljete zdravila, od katerih lahko postanete zaspani, npr. uspavala, pomirjevala, zdravila za anksioznost ali zdravila za alergije (antihistaminiki);
English: Depression Thinking abnormal thoughts
Slovenian: • depresija, nenormalne misli
English: • The importance of the healthcare professional ensuring that the patient understands how to operate the IONSYS system and that only he/she can press the dosing button during use.
Slovenian: • Kako pomembno je, da zdravstveni delavec bolnika pouči o delovanju sistema Ionsys in da sme med uporabo samo on pritiskati gumb za odmerjanje.
English: If it beeps at any other time, or more than once, tell your doctor or nurse immediately.
Slovenian: Če zapiska ob katerem koli drugem času ali več kot enkrat, o tem nemudoma obvestite zdravnika ali medicinsko sestro.
English: There are 6 systems per carton.
Slovenian: V škatli je 6 sistemov.
English: Upon system removal after the last dose, the decline in serum fentanyl concentration is similar to that of intravenous fentanyl.
Slovenian: Po odstranitvi sistema po zadnjem odmerku je upadanje serumske koncentracije fentanila podobno kot pri intravenskem dajanju fentanila.
English: Some medicines can affect the way IONSYS works, or make it more likely that you will have side effects.
Slovenian: Nekatera zdravila lahko vplivajo na delovanje zdravila IONSYS ali povečajo verjetnost neželenih učinkov.
English: The total plasma clearance of fentanyl following intravenous administration is approximately 42 L/h
Slovenian: Celotni plazemski očistek fentanila po intravenski aplikaciji je približno 42 l/h.
English: IONSYS should be removed prior to certain procedures such as cardioversion (electrical current used to restore normal heart rhythm), defibrillation (electric shock given to the heart) or diathermy (electrical current used in physical therapy or surgery).
Slovenian: Pomembne informacije, ki jih je treba upoštevati Sistem IONSYS je treba odstraniti pred nekaterimi postopki, npr. kardioverzijo (električni tok, ki se uporablja za ponovno vzpostavitev normalnega srčnega ritma), defibrilacijo (električni šok za srce) ali diatermijo (električni tok, ki se uporablja pri fizioterapiji ali operacijah).
English: The primary efficacy endpoint was the patient global assessment of method of pain control at 24 hours used to test equivalence between IONSYS and intravenous PCA morphine using a pre-specified ± 10% equivalence boundary with a 2-sided 95% confidence interval.
Slovenian: Primarni opazovani dogodek učinkovitosti je bila bolnikova celovita presoja metode obvladovanja bolečine po 24 urah, ki so jo uporabili za ugotavljanje enakovrednosti med zdravilom IONSYS in intravenskim zdravljenjem PCA z morfinom z vnaprej določeno ±10odstotno mejo enakovrednosti in dvostranskim 95-odstotnim intervalom zaupanja.
English: • The importance of reading the “IONSYS Instructions for Use and Disposal” including the troubleshooting guide and ensuring that the patient understands what to do in the event
Slovenian: • Kako pomembno je prebrati »navodila za uporabo in odstranjevanje zdravila Ionsys«, vključno z vodnikom za odpravljanje težav, in zagotoviti, da bolnik razume, kaj storiti ob okvari ali nepravilnem delovanju pripomočka.
English: Steady state absorption of the nominal 40 microgram dose is achieved about 12 hours after application, indicating that the skin becomes more permeable to fentanyl during the first 12 hours.
Slovenian: 40 mikrogramov v stanju dinamičnega ravnovesja je dosežena približno 12 ur po aplikaciji, kar pomeni, da koža v prvih 12 urah postane prepustnejša za fentanil.
English: Patients who completed 24 hours of IONSYS treatment in the seven controlled studies used a wide range of the available 80 doses, with a mean of 29.0 doses/patient (range of 0-93 doses) with the majority of patients (56.5%) using between 11 to 50 doses.
Slovenian: IONSYS v sedmih nadzorovanih študijah, so uporabili širok spekter razpoložljivih 80 odmerkov, s srednjo vrednostjo 29,0 odmerka/bolnika (razpon 0-93 odmerkov), večina bolnikov (56,5 %) od 11 do 50 odmerkov.
English: • When replacing an IONSYS system, the new system must be applied to a different site on the chest or upper outer arm.
Slovenian: • Pri zamenjavi sistema IONSYS je treba novi sistem namestiti na drugo mesto na prsih ali zunanjem delu nadlahti.
English: To avoid oral ingestion of the fentanylcontaining hydrogel, which may cause life-threatening hypoventilation or death, the hydrogel must not touch the mouth or other mucosal areas.
Slovenian: Za preprečitev zaužitja hidrogela z vsebnostjo fentanila, ki bi lahko povzročil smrtno nevarno hipoventilacijo ali smrt, hidrogel ne sme priti v stik z usti ali drugimi predeli sluznice.
English: Iatrogenic addiction following opioid administration is rare.
Slovenian: Iatrogena odvisnost po jemanju opioidov je redka.
English: Among these patients, the incidence of nausea was similar to adult patients; however, vomiting (32.1%) and fever (60.7%) were each reported at a higher incidence in paediatric patients relative to adults.
Slovenian: Pri teh bolnikih je bila incidenca navzee podobna kot pri odraslih, medtem ko so pediatrični bolniki pogosteje poročali o bruhanju (32,1 %) in zvišani telesni temperaturi (60,7 %) v primerjavi z odraslimi.
English: They will check that IONSYS is working properly.
Slovenian: Preverila bosta, ali sistem pravilno deluje.
English: If using tape, apply it along the edges of IONSYS system, do not cover the dosing button or display.
Slovenian: Če uporabite trak, ga nalepite ob robovih sistema IONSYS in ne prekrijte gumba za odmerjanje ali prikazovalnika.
English: • Patients should not wear more than one IONSYS at the same time.
Slovenian: • Bolniki ne smejo nositi več kot enega sistema IONSYS
English: Local arrangements should be in place to ensure that used systems are returned appropriately (e.g., to hospital pharmacies) for disposal of the residual fentanyl in the hydrogel.
Slovenian: Zagotavljanje ustreznega vračanja uporabljenih sistemov (npr. v bolnišnične lekarne) za odstranjevanje ostankov fentanila v hidrogelu mora biti lokalno urejeno.
English: What IONSYS is and what it is used for 2.
Slovenian: Kaj je zdravilo IONSYS in za kaj ga uporabljamo 2.
English: Do not press the dosing button.
Slovenian: Ne pritisnite gumba za odmerjanje.
English: Excessive sweating may reduce delivery of fentanyl.
Slovenian: Ob čezmernem potenju se lahko dovajanje fentanila zmanjša.
English: The concomitant use of other central nervous system depressants including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, and alcoholic beverages, may produce additive depressant effects.
Slovenian: Sočasna uporaba drugih zaviralcev osrednjega živčnega sistema, vključno z drugimi opioidi, sedativi ali hipnotiki, splošnimi anestetiki, fenotiazini, pomirjevali, relaksanti skeletnih mišic, sedativnimi antihistaminiki in alkoholnimi pijačami, lahko poveča pomirjevalni učinek.
English: A single IONSYS system provided a sufficient number of doses for 99% of the studied patients over 24 hours.
Slovenian: En sistem IONSYS je v 24 urah zagotovil zadostno število odmerkov za 99 %
English: IONSYS should not be used in pregnancy unless clearly necessary.
Slovenian: Zdravilo IONSYS ne smete uporabljati med nosečnostjo, če ni nujno potrebno.
English: However, caution is advised when prescribing IONSYS in morbidly obese patients because they may be at increased risk of other comorbid respiratory conditions (i.e., sleep apnoea) potentially pre-disposing them to hypoventilation or more severe adverse reactions (see section 4.8).
Slovenian: Vendar je potrebna previdnost pri predpisovanju zdravila IONSYS bolezensko debelim bolnikom, saj so lahko izpostavljeni večjemu tveganju za druge pridružene bolezni dihal (npr. spalno apnejo), zaradi česar so dovzetnejši za hipoventilacijo ali hujše neželene učinke (glejte poglavje 4.8).
English: • chest pain, feeling of general discomfort or uneasiness
Slovenian: • bolečine v prsih, splošno slabo počutje ali nelagodje
English: If you feel faint or if you have difficulty in breathing while being treated with IONSYS, tell a doctor or nurse immediately.
Slovenian: Če med zdravljenjem z zdravilom IONSYS občutite omotico ali imate težave z dihanjem, o tem takoj obvestite zdravnika ali medicinsko sestro.
English: IONSYS should be applied to intact, non-irritated and non-irradiated skin.
Slovenian: Zdravilo IONSYS je treba uporabiti na nepoškodovani, nerazdraženi in neobsevani koži.
English: The flashing digital display may be turned off by pressing the dose button for six seconds.
Slovenian: Utripajoči digitalni prikazovalnik lahko izklopite tako, da za šest sekund pritisnete gumb za odmerjanje.
English: Preparation of application site
Slovenian: Priprava mesta aplikacije
English: Fentanyl is an opioid analgesic, interacting predominantly with the opioid μ-receptor.
Slovenian: Fentanil je opioidni analgetik, ki deluje zlasti na opioidne μ-receptorje.
English: Unlike morphine, no active fentanyl metabolites are eliminated by the kidney.
Slovenian: Za razliko od morfina se skozi ledvice ne izločajo nobeni aktivni presnovki fentanila.
English: • Hold the controller in one hand and pull the red tab with the other hand to separate the hydrogel housing from the system.
Slovenian: • Držite upravljalnik v eni roki in povlecite rdeči zavihek z drugo roko, da ločite hidrogelno ohišje od sistema.
English: Pressing the button during delivery of a dose will not result in additional fentanyl being administered.
Slovenian: Pritisk na gumb med sproščanjem odmerka ne povzroči dodatnega dovajanja fentanila.
English: Published literature indicates potential for increased fentanyl exposure in patients with genetic polymorphisms affecting CYP3A4 and CYP3A5, with a small variability in concentrations with transdermal administration; therefore, IONSYS should be used with caution in these patients (see section 5.2)
Slovenian: Objavljena literatura kaže potencial za povečano izpostavljenost fentanilu pri bolnikih z genetskimi polimorfizmi, ki vplivajo na CYP3A4 in CYP3A5, z majhno variabilnostjo v koncentracijah pri transdermalnem dajanju; zato je treba zdravilo IONSYS uporabljati previdno pri teh bolnikih (glejte poglavje 5.2).
English: Fentanyl is excreted into human milk.
Slovenian: Fentanil se izloča v materino mleko.
English: • The doctor or nurse will get IONSYS ready to use and attach it to your upper outer arm or chest.
Slovenian: • Zdravnik ali medicinska sestra bosta dobila sistem IONSYS, ki je že pripravljen za uporabo, in vam ga pritrdila na zunanji del nadlahti ali na prsi.
English: Do not use this medicine after the expiry date which is stated on the carton, or tray or sachet label, after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali nalepki na podstavku ali vrečki poleg oznake »Uporabno do:«.
English: At the initiation of each dose, an electrical current moves a pre-determined amount of fentanyl from the active substance-containing reservoir through the skin and into systemic circulation.
Slovenian: Na začetku vsakega odmerjanja električni tok premakne vnaprej določeno količino fentanila iz rezervoarja z učinkovino skozi kožo v sistemski krvni obtok.
English: Following long-term treatment fentanyl may cause withdrawal symptoms in the newborn.
Slovenian: Po dolgoročnem zdravljenju lahko fentanil povzroči odtegnitvene simptome pri novorojencu.
English: IONSYS should be administered with caution to patients with moderate or severe hepatic or renal impairment (see section 4.4).
Slovenian: Zdravilo IONSYS je treba uporabljati previdno pri bolnikih z zmerno ali hudo okvaro jeter ali ledvic (glejte poglavje 4.4).
English: If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube.
Slovenian: Odvisno od kliničnega stanja je treba vzpostaviti in vzdrževati odprto in neovirano dihalno pot, po možnosti z orofaringealnim ali endotrahealnim tubusom.
English: • if you suffer from severe breathing problems or cystic fibrosis.
Slovenian: • če imate hude težave z dihanjem ali cistično fibrozo.
English: The free fraction of fentanyl increases with acidosis.
Slovenian: Prosta frakcija fentanila narašča ob acidozi.
English: • itching skin
Slovenian: • srbeča koža
English: • At the end of 24 hours of use, or after 80 doses have been delivered, remove IONSYS by gently lifting the red tab and loosening it from the skin application site.
Slovenian: • Ob koncu 24-urne uporabe ali po dovedenih 80 odmerkih odstranite sistem IONSYS tako, da previdno povlečete rdeči zavihek in zrahljate stik sistema z mestom aplikacije.
English: The used IONSYS will be disposed of by medical staff.
Slovenian: Uporabljen sistem IONSYS bo odstranilo medicinsko osebje.
English: When IONSYS is applied without activating the electrical current, the average absorption rate of fentanyl over 24 hours was 2.3 micrograms fentanyl/hour, indicating minimal passive delivery.
Slovenian: Pri uporabi sistema IONSYS brez sproženja električnega toka je bila povprečna hitrost absorpcije fentanila v 24 urah 2,3 mikrograma fentanila/uro, kar pomeni minimalno pasivno dovajanje.
English: Following an on-demand dose of fentanyl by IONSYS, fentanyl has an absorption half-life of approximately 15 minutes.
Slovenian: Po dovajanju odmerka fentanila na zahtevo s sistemom IONSYS ima fentanil absorpcijski razpolovni čas približno 15 minut.
English: • fluid retention/swelling in the body
Slovenian: • zastajanje tekočine/otekanje v telesu