FrancophonIA/ELRC3.0 huggingface dataset:
English: On the basis of the scientific conclusions for sufentanil the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing sufentanil is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za sufentanil odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) sufentanil nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: For instructions on the setup and handling of the Zalviso administration device before administration, see section 6.6.
Slovenian: Za navodila glede nastavitve in ravnanja s pripomočkom za aplikacijo zdravila Zalviso pred dajanjem glejte poglavje 6.6.
English: Therefore, it should be used with caution in patients with previous or pre-existing bradyarrhythmias.
Slovenian: Zato ga je treba pri bolnikih s preteklimi ali obstoječimi bradiaritmijami uporabljati previdno.
English: Maximum concentrations of sufentanil are achieved approximately 50 minutes after a single dose; this is shortened to approximately 20 minutes following repeat dosing.
Slovenian: Največje koncentracije sufentanila so dosežene približno 50 minut po enkratnem odmerjanju; to se skrajša na približno 20 minut po ponavljajočem odmerjanju.
English: After treatment discontinuation the health-care professional has to remove the cartridge from the device and any unused and/or not completely empty cartridges have to be disposed by the health-care professional in accordance with local laws and requirements for controlled substances.
Slovenian: Po prekinitvi zdravljenja bo zdravstveni delavec odstranil vložek iz pripomočka in vse neuporabljene in/ali ne povsem prazne vložke zavrgel v skladu z lokalnimi zakoni in zahtevami za nadzorovane učinkovine.
English: The shorter duration of activity of the opiate antagonist compared to sufentanil should be taken into account.
Slovenian: Upoštevati je treba, da je trajanje aktivnosti opioidnega antagonista v primerjavi s sufentanilom lahko krajše.
English: The Ames test revealed no mutagenic activity of sufentanil.
Slovenian: Amesov test ni pokazal mutagene aktivnosti sufentanila.
English: 52078 Aachen Germany
Slovenian: 52078 Aachen Nemčija
English: It is not recommended to use these medicines at the same time as Zalviso.
Slovenian: Teh zdravil ni priporočljivo jemati sočasno z zdravilom Zalviso.
English: Repeat antagonist administration may be required as the duration of respiratory depression may last longer than the duration of the effect of the antagonist (see section 4.9).
Slovenian: Morda bo treba dajanje antagonista ponoviti, saj respiratorna depresija lahko traja dlje kot učinek antagonista (glejte poglavje 4.9).
English: Prior to launch of Zalviso 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: Pred prihodom zdravila Zalviso na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi ostalimi vidiki programa.
English: Due to the limited number of patients with moderate to severe hepatic impairment, a potential effect of hepatic dysfunction as covariate on clearance may not have been detected.
Slovenian: Zaradi omejenega števila bolnikov z zmerno do hudo jetrno okvaro potencialnega učinka jetrne disfunkcije kot sospremenljivke očistka morda niso odkrili.
English: One cartridge is packed in a sachet including an oxygen absorber.
Slovenian: En vložek je pakiran v vrečico, ki vsebuje tudi absorbent kisika.
English: There are no data on the effects of sufentanil on fertility in women or men.
Slovenian: O učinkih sufentanila na plodnost pri ženskah ali moških ni podatkov.
English: If a decision is made to prescribe Zalviso concomitantly with sedating medicinal products the duration of the concomitant treatment should be as short as possible.
Slovenian: Če se odločite, da boste zdravilo Zalviso predpisali sočasno s sedativnimi zdravili, mora biti trajanje sočasnega zdravljenja čim krajše.
English: Other symptoms that may occur are loss of consciousness, coma, cardiovascular shock and muscle rigidity.
Slovenian: Drugi simptomi, ki se lahko pojavijo, so izguba zavesti, koma, kardiovaskularni šok in togost mišic.
English: The most serious side effects are severe breathing problems like slow and shallow breathing, which may even lead to stopping breathing or inability to breathe.
Slovenian: Najresnejši neželeni učinki so hude težave z dihanjem, kot je počasno ali plitko dihanje, kar lahko povzroči celo ustavitev dihanja ali nezmožnost dihanja.
English: Based on the combined safety data from these clinical studies, nausea and vomiting were the most frequently reported adverse reactions (≥1/10 frequency).
Slovenian: Na podlagi kombiniranih podatkov o varnosti iz teh kliničnih študij so največkrat (pogostnost ≥ 1/10) poročali o neželenih učinkih navzei in bruhanju.
English: Cardiovascular stability is also the result of minimal effects on cardiac preload, cardiac flow rate and myocardial oxygen consumption.
Slovenian: Kardiovaskularna stabilnost je tudi posledica minimalnih učinkov na pritok v srce, hitrost srčnega pretoka in miokardno porabo kisika.
English: Patients reported in all the 3 Phase III trials a clinically meaningful pain relief within the first hour of treatment with Zalviso (pain intensity difference to baseline and total pain response >1 NRS).
Slovenian: Bolniki so v vseh treh preizkušanjih 3. faze poročali o klinično pomembni ublažitvi bolečine v prvi uri zdravljenja z zdravilom Zalviso (razlika v intenzivnosti bolečine glede na izhodišče in skupen odziv na bolečino > 1 NRS).
English: Sufentanil should be used with caution in patients who may be particularly susceptible to the cerebral effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness.
Slovenian: Sufentanil je treba previdno uporabljati pri bolnikih, ki so posebno občutljivi na cerebralne učinke retencije CO2, na primer pri bolnikih z znaki povišanega intrakranialnega tlaka ali zmanjšane zavesti.
English: Tell your doctor or nurse before treatment if you: - are suffering from any condition that affects your breathing (such as asthma, wheezing, or shortness of breath).
Slovenian: Pred začetkom zdravljenja povejte zdravniku ali medicinski sestri, če: - imate kakršno koli stanje, ki vpliva na dihanje (kot so astma, piskajoče dihanje ali zasoplost).
English: Patients who were treated with Zalviso between 48 and 72 hours in the three controlled trials used a wide range of the available 216 doses, with a mean of 49 doses/patient (range of 8-153 doses) with the majority of patients (69.7 %) using between 24 to 72 doses.
Slovenian: Bolniki, ki so se zdravili z zdravilom Zalviso od 48 do 72 ur v treh nadzorovanih preskušanjih so uporabili širok razpon od 216 razpoložljivih odmerkov s povprečjem 49 odmerkov na bolnika (razpon 8-153 odmerkov), pri čemer je večina bolnikov (69,7%) uporabila od 24 do 72 odmerkov.
English: Sufentanil may increase plasma serotonin level and its concomitant use with other serotoninergic agents may increase the risk of serotonin syndrome.
Slovenian: Sufentanil lahko poviša raven serotonina v plazmi, njegova sočasna uporaba z drugimi serotoninergičnimi zdravili pa lahko poveča tveganje za nastanek serotoninskega sindroma.
English: Patients on chronic opioid therapy or opioid addicts may require higher analgesic doses than the Zalviso administration device can deliver.
Slovenian: Bolnikih na kronični opioidni terapiji ali opioidni odvisniki bodo morda potrebovali višje analgetične odmerke, kot jih lahko pripomoček za aplikacijo zdravila Zalviso dostavi.
English: - The other ingredients are mannitol (E421), calcium hydrogen phosphate (anhydrous), hypromellose, croscarmellose sodium, stearic acid, magnesium stearate, sunset yellow FCF Aluminium Lake (E110) (see section 2 “What you need to know before you take Zalviso”)
Slovenian: - Druge sestavine zdravila so manitol (E421), kalcijev hidrogenfosfat (brezvodni), hipromeloza, premreženi natrijev karmelozat, stearinska kislina, magnezijev stearat, barvilo sončno rumeno FCF (E110) (glejte poglavje 2 »Kaj morate vedeti, preden boste vzeli zdravilo Zalviso«)
English: The maximum amount of sublingual sufentanil that can be delivered via the Zalviso administration device over an hour is 45 micrograms (3 doses).
Slovenian: Največja količina sublingvalnega sufentanila, ki jo je možno dostaviti s pripomočkom za aplikacijo zdravila Zalviso v eni uri, je 45 mikrogramov (3 odmerki).
English: Before you start using Zalviso, your doctor or nurse will show you how to use the Zalviso administration device.
Slovenian: Pred začetkom uporabe zdravila Zalviso vam bo zdravnik ali medicinska sestra pokazal, kako uporabljati pripomoček za aplikacijo zdravila Zalviso.
English: The pharmacokinetics of sufentanil after sublingual administration can be described as a threecompartment model with first-order absorption.
Slovenian: Farmakokinetiko sufentanila po podjezični aplikaciji je možno opisati kot tripredalčni model z absorpcijo prve stopnje.
English: Sufentanil is primarily metabolised in the liver and excreted in the urine and faeces.
Slovenian: Sufentanil se primarno presnavlja v jetrih in izloča z urinom in blatom.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Zalviso is launched all healthcare professionals who are expected to prescribe Zalviso are informed through an information letter on having access to / are provided with the following items:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo po razpravi in dogovoru s pristojnim nacionalnim organom v vsaki državi članici, kjer bo zdravilo Zalviso na trgu, vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali zdravilo Zalviso, z dopisom obveščeni o dostopu ali prejeli naslednja gradiva:
English: Therefore, Zalviso should be used with caution in patients at risk of ileus.
Slovenian: Zato je treba zdravilo Zalviso previdno uporabljati pri bolnikih s tveganjem za ileus.
English: There is insufficient data on the use of sufentanil during human pregnancy to evaluate its potential harmful effects.
Slovenian: Podatki o uporabi sufentanila pri nosečnicah niso zadostni za oceno njegovih škodljivih učinkov.
English: Buccal administration study showed an increased bioavailability of 78 % when the tablets were placed in front of the front lower teeth.
Slovenian: Študija bukalnega dajanja je pokazala, da se je biološka razpoložljivost pri namestitvi tablet pred sprednje spodnje zobe povečala na 78%.
English: In the micronucleus test in female rats, single intravenous doses of sufentanil as high as 80 µg/kg (approximately 2.5 times the upper human intravenous dose) produced no structural chromosome mutations.
Slovenian: V mikrojedrnem testu pri podganjih samicah enkratni intravenski odmerki sufentanila do 80 µg/kg (približno 2,5-kratnik največjega intravenskega odmerka pri ljudeh) niso povzročili strukturnih kromosomskih mutacij.
English: Sufentanil overdose is manifested by an exaggeration of its pharmacological effects.
Slovenian: Preveliko odmerjanje sufentanila se kaže s povečanjem njegovih farmakoloških učinkov.
English: Analgesic doses of Zalviso resulted in respiratory depressive effects in some patients in the clinical trials.
Slovenian: Analgetični odmerki zdravila Zalviso so v kliničnih preskušanjih pri nekaterih bolnikih povzročili respiratorne depresivne učinke.
English: The fully charged Zalviso administration device will operate without recharging for up to 72 hours.
Slovenian: Povsem poln pripomoček za aplikacijo zdravila Zalviso bo brez dodatnega polnjenja delal do 72 ur.
English: Sufentanil may obscure the clinical course of patients with head injury.
Slovenian: Sufentanil lahko zakrije klinični potek pri bolnikih s poškodbo glave.
English: Sufentanil caused embryolethality in rats and rabbits who were treated for 10-30 days during pregnancy with 2.5 times the maximum human dose by intravenous administration.
Slovenian: Sufentanil je pri samicah podgan in kuncev, ki so v obdobju brejosti od 10 do 30 dni prejemale 2,5-kratnik največjega intravenskega odmerka pri človeku, povzročil embrioletalnost.
English: Sufentanil may produce bradycardia.
Slovenian: Sufentanil lahko povzroči bradikardijo.
English: Interaction with other sublingually administered products or products intended to dilute/establish an effect in the oral cavity were not evaluated and simultaneous administration should be avoided.
Slovenian: Medsebojnega delovanja z drugimi podjezično apliciranimi zdravili ali zdravili, ki se raztopijo/ustvarijo učinek v ustni votlini, niso preučili, zato se je treba sočasni uporabi izogniti.
English: Sufentanil should be used with caution in patients with brain tumours.
Slovenian: Sufentanil je treba uporabljati previdno pri bolnikih s tumorji možganov.
English: Before use, the health-care professional should ensure that the patients have been appropriately instructed on how to operate the Zalviso administration device to self-administer tablets as needed to manage their pain post-operatively.
Slovenian: Pred uporabo mora zdravstveni delavec zagotoviti, da je bolnik prejel ustrezna navodila o uporabi pripomočka za samoaplikacijo tablet zdravila Zalviso, kot je potrebno za nadzor pooperativnih bolečin.
English: Sufentanil has been shown to induce opioid-like effects in a variety of laboratory animals (dogs, rats, guinea pigs, hamsters) at doses above those inducing analgesia and in two repeat-dose studies with sufentanil sublingual tablets administered buccally in Golden Syrian hamster.
Slovenian: Odkrili so, da sufentanil inducira opioidne učinke pri različnih laboratorijskih živalih (psih, podganah, morskih prašičkih, hrčkih) v odmerkih, ki so višji od tistih, ki povzročajo analgezijo, in v dveh študijah s ponovljenimi odmerki podjezičnih tablet sufentanila, ki so jih sirijskemu hrčku dajali bukalno.
English: Management of overdose should be focused on treating symptoms of µ-opioid receptor agonism including administration of oxygen.
Slovenian: Pri ukrepanju v primeru prevelikega odmerjanja se je treba osredotočiti na zdravljenje simptomov agonizma µ-opioidnih receptorjev, vključno z dajanjem kisika.
English: Do not drink alcohol while using Zalviso.
Slovenian: Med uporabo zdravila Zalviso ne pijte alkohola.
English: Sufentanil may cause respiratory depression (see section 4.4) and also suppresses the cough reflex.
Slovenian: Sufentanil lahko povzroči respiratorno depresijo (glejte poglavje 4.4) in zavre refleks kašljanja.
English: Heart rate increased Heart rate decreased*
Slovenian: Zvečan srčni utrip Zmanjšan srčni utrip*
English: Respiratory depression caused by sufentanil can be reversed by opioid antagonists.
Slovenian: Respiratorna depresija, ki jo povzroči sufentanil, je reverzibilna z opioidnimi antagonisti.
English: Carcinogenicity studies have not been conducted on sufentanil.
Slovenian: Študij kancerogenosti za sufentanil niso izvedli.
English: Some adverse reactions were not observed in the clinical trials with Zalviso.
Slovenian: Nekaterih neželenih učinkov niso opazili v kliničnih preskušanjih z zdravilom Zalviso.
English: The tablets dissolve under your tongue and should not be crushed, chewed, or swallowed.
Slovenian: Tablete se pod jezikom raztopijo in jih ne smete lomiti, žvečiti ali pogoltniti.
English: Sufentanil has potential for abuse.
Slovenian: Sufentanil je možno zlorabljati.
English: Repeat-dose toxicity
Slovenian: Toksičnost pri ponavljajočem odmerjanju
English: Pharmacokinetic data from intravenous sufentanil administration did not reveal age related differences.
Slovenian: Farmakokinetični podatki za intravensko apliciranje sufentanila niso razkrili razlik zaradi starosti.
English: After a single dose, the median CST½ was 2.2 hours, increasing to a median value of 2.5 h after multiple dosing: the sublingual delivery route thus substantially extends the duration of action associated with intravenous sufentanil administration (CST½ of 0.14 hours).
Slovenian: Po enkratnem odmerku je bila mediana vrednost CST½ 2,2 uri in se je povečala na mediano vrednost 2,5 ure po večkratnem odmerjanju: podjezični način uporabe je tako znatno podaljšal trajanje delovanja v primerjavi z intravenskim dajanjem sufentanila (vrednost CST½ 0,14 ure).
English: High doses of intravenously administered sufentanil are known to cause muscle rigidity, probably as a result of an effect on the substantia nigra and the striate nucleus.
Slovenian: Znano je, da visoki odmerki intravensko apliciranega sufentanila povzročajo mišično togost, verjetno kot posledico učinka na substanco nigro in striatni nukleus.
English: The embryolethal effect was considered secondary to the toxicity for the mother animal.
Slovenian: Učinek embrioletalnosti se smatra kot posledica toksičnosti za samico.
English: As demonstrated in the active-controlled trial, the average time between Zalviso doses was approximately double as long as compared to intravenous morphine patient-controlled analgesia (approximately 80 minutes compared to approximately 45 minutes) over the first 48 hours.
Slovenian: Kot je bilo dokazano v preskušanjih, nadzorovanih z zdravilno učinkovino, je bil v prvih 48 urah povprečni čas med odmerki zdravila Zalviso približno dvakrat daljši v primerjavi z intravensko analgezijo z morfinom, ki jo nadzirajo bolniki (približno 80 minut v primerjavi s približno 45 minutami).
English: Similar CST½ values were observed following both single and repeated administration demonstrating that there is a predictable and consistent duration of action after multiple dosing of the sublingual tablet.
Slovenian: so opazili po enkratnem in ponavljajočem dajanju, kar dokazuje, da obstaja predvidljivo in dosledno trajanje delovanja po večkratnem odmerjanju podjezičnih tablet.
English: Low doses of intravenous sufentanil associated with likely vagal (cholinergic) activity cause mild bradycardia and mildly reduced systemic vascular resistance without significantly lowering blood pressure (see section 4.4).
Slovenian: Nizki odmerki intravenskega sufentanila, povezani z verjetno vagalno (holinergično) aktivnostjo, povzročajo blago bradikardijo in blago zmanjšan sistemski žilni upor brez pomembnega znižanja krvnega tlaka (glejte poglavje 4.4).
English: Biotransformation takes place primarily in the liver and the small intestine.
Slovenian: Biotransformacija poteka pretežno v jetrih in tankem črevesu.
English: The respiratory effects of sufentanil should be assessed by clinical monitoring, e. g. respiratory rate, sedation level and oxygen saturation.
Slovenian: Respiratorni učinek sufentanila je treba oceniti s kliničnim spremljanjem, npr. hitrostjo dihanja, ravnijo sediranosti in zasičenostjo s kisikom.
English: Somnolence Paraesthesia Ataxia* Dystonia* Hyperreflexia*
Slovenian: Somnolenca Parestezija Ataksija* Distonija* Hiperrefleksija*
English: Clinically relevant plasma levels are largely determined by the time for the sufentanil plasma concentration to drop from Cmax to 50 % of Cmax after discontinuation of dosing (context sensitive halftime or CST½) rather than by the terminal half-life.
Slovenian: Klinično pomembne plazemske koncentracije so v veliki meri odvisne od časa, potrebnega za znižanje koncentracije sufentanila v plazmi z vrednosti Cmax na 50% vrednosti Cmax po prekinitvi odmerjanja (na kontekst občutljiv razpolovni čas CST½), ne pa od končnega razpolovnega časa.
English: Patients should be advised not to drive or operate machinery if they experience somnolence, dizziness, or visual disturbance while taking or after the treatment with Zalviso.
Slovenian: Bolnikom je treba naročiti, naj ne vozijo in ne upravljajo s stroji, če med ali po zdravljenju z zdravilom Zalviso občutijo zaspanost, omotico ali motnje vida.
English: The cartridge should be used only with the Zalviso administration device, consisting of a controller and a dispenser to ensure the proper use of this system.
Slovenian: Vložek se lahko uporablja samo s pripomočkom za aplikacijo zdravila Zalviso, ki ga sestavljata kontroler in dispenzor za zagotavljanje pravilne uporabe tega sistema.
English: Breastfeeding is not recommended when sufentanil is administered, due to the risk of opioid effects or toxicity in the breastfed newborns/infants (see section 4.9).
Slovenian: Med dajanjem sufentanila se dojenje ne priporoča zaradi tveganja opioidnih učinkov ali toksičnosti za dojenega novorojenca/dojenčka (glejte poglavje 4.9).
English: Efficacy of Zalviso for patient-controlled analgesia was demonstrated in 3 Phase III clinical trials in acute post-surgical nociceptive and visceral pain (post-surgical pain following major abdominal or orthopaedic surgery): 2 trials were double-blind placebo-controlled (Zalviso N = 430 patients; placebo N = 161 patients) and 1 was an open-label active-controlled (Zalviso N = 177 patients; morphine N = 180 patients) trial.
Slovenian: Učinkovitost zdravila Zalviso za analgezijo, ki jo nadzira bolnik, so dokazali v treh kliničnih preskušanjih 3. faze pri akutni pooperativni nociceptivni in visceralni bolečini (pooperativni bolečini po obsežni abdominalni ali ortopedski operaciji): dve preskušanji sta bili dvojno slepi in nadzorovani s placebom (zdravilo Zalviso, N = 430 bolnikov; placebo, N = 161 bolnikov), eno pa je bilo odprto in nadzorovano z zdravilno učinkovino (zdravilo Zalviso, N = 177 bolnikov; morfin, N = 180 bolnikov).
English: After multiple administrations, a longer mean terminal half-life of up to 18 hours was determined, owing to the higher plasma concentrations of sufentanil achieved after repeated dosing and due to the possibility to quantify these concentrations over a longer time period.
Slovenian: Po večkratnem dajanju je bil opažen daljši povprečni končni razpolovni čas, do 18 ur, kar je mogoče pripisati višjim koncentracijam sufentanila v plazmi po ponavljajočem odmerjanju in možnosti, da se koncentracije količinsko oceni v daljšem obdobju.
English: As Zalviso may affect your breathing, your doctor or nurse will check your breathing during treatment; - have a head injury or brain tumour; - have problems with your heart and circulation, especially slow heart rate, irregular heart beats, low blood volume or low blood pressure; - have moderate to severe liver or severe kidney problems, as these organs have an effect on the way in which your body breaks down and eliminates the medicine; - have a history of medicine or alcoholabuse; - are regularly using a prescribed opioid medicine (e.g. codeine, fentanyl, hydromorphone,
Slovenian: Ker lahko zdravilo Zalviso vpliva na vaše dihanje, bo zdravnik ali medicinska sestra med zdravljenjem preverjal vaše dihanje; - imate poškodbo glave ali možganski tumor; - imate težave s srcem in ožiljem, zlasti počasni srčni utrip, nepravilen srčni utrip, zmanjšan volumen krvi ali nizek krvni tlak; - imate zmerne do hude jetrne ali hude ledvične težave, saj ti organi vplivajo na način razgradnje zdravila v telesu in njegovega izločanja ; - ste v preteklosti imeli težave z zlorabo zdravil ali alkohola; - redno jemljete predpisano opioidno zdravilo (npr. kodein, fentanil, hidromorfon, oksikodon); - imate nenormalno počasno odvajanje blata; - imate bolezen žolčnika ali trebušne slinavke.
English: Very common side effects (may affect more than 1 in 10 people): nausea, vomiting, fever.
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): slabost, bruhanje, zvišana telesna temperatura.
English: Clinical trials have shown that sufentanil administered intravenously causes less respiratory depression when compared with equianalgesic doses of fentanyl.
Slovenian: Klinična preskušanja kažejo, da intravensko apliciran sufentanil povzroča manj respiratorne depresije kot ekvivalentni analgetični odmerki fentanila.