FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no human data on fertility available.
Slovenian: Ni razpoložljivih podatkov o vplivu na plodnost pri človeku.
English: Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.
Slovenian: Zdravnik bo ocenil, ali potrebujete zdravljenje za zmanjšanje oziroma odstranitev odtegnitvenih simptomov.
English: Concomitant use of medicinal products containing sodium oxybate and fentanyl is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba zdravil, ki vsebujejo natrijev oksibat in fentanil, je kontraindicirana (glejte poglavje 4.3).
English: Fentanyl is metabolised primarily in the liver via CYP3A4.
Slovenian: Fentanil se presnavlja predvsem v jetrih prek CYP3A4.
English: No studies of the effects on the ability to drive and use machines have been performed.
Slovenian: Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: Every time you use Instanyl nasal spray, make sure you or your carer fills in the information on the card.
Slovenian: Vsakič, ko uporabite pršilo za nos Instanyl, se prepričajte, da ste vi ali vaš negovalec izpolnili podatke na kartici.
English: Consult your doctor while using Instanyl, if: - you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine as prescribed by your doctor.
Slovenian: Med uporabo zdravila Instanyl se posvetujte z zdravnikom, če: - imate bolečino ali zvečano občutljivost za bolečino (hiperalgezijo), ki se ne odziva na večje odmerke zdravila, ki vam jih predpiše zdravnik.
English: Fentanyl is highly lipophilic.
Slovenian: Fentanil je močno lipofilen.
English: Once the dose has been established according to the steps described above, the patient should be maintained on this strength of Instanyl.
Slovenian: Po določitvi odmerka v skladu z zgoraj opisanimi koraki naj se bolnika vzdržuje na tej jakosti zdravila Instanyl.
English: If someone has accidentally taken Instanyl, they may have the same symptoms as described above for overdose.
Slovenian: Če kdo nenamerno uporabi Instanyl, se lahko pojavijo enaki znaki, kot so opisani zgoraj za preveliko odmerjanje.
English: Symbols in the electronic display
Slovenian: Simboli na elektronskem zaslonu
English: About 75 of fentanyl is excreted into the urine, mostly as inactive metabolites, with less than 10 as unchanged active substance.
Slovenian: Približno 75% fentanila se izloči z urinom, večinoma v obliki neaktivnih presnovkov in manj kot 10% v obliki nespremenjene učinkovine.
English: Caution should therefore be taken in treatment of elderly, cachectic or debilitated patients.
Slovenian: Pri zdravljenju starejših, kahektičnih ali oslabelih bolnikov je torej potrebna previdnost.
English: The single-dose container should not be tested before use.
Slovenian: Enoodmernega vsebnika se pred uporabo ne sme preskušati.
English: If serotonin syndrome is suspected, treatment with Instanyl should be discontinued.
Slovenian: Pri sumu na serotoninski sindrom je treba zdravljenje z zdravilom Instanyl prekiniti.
English: Animal data shows that following absorption, fentanyl is rapidly distributed to the brain, heart, lungs, kidneys and spleen followed by a slower redistribution to muscles and fat.
Slovenian: Podatki raziskav na živalih kažejo, da se po absorpciji fentanil hitro porazdeli v možgane, srce, pljuča, ledvice in vranico, temu pa sledi počasnejše prerazporejanje v mišice in maščobo.
English: - if the person has stopped breathing, you should attempt to resuscitate her/him until emergency help arrives.
Slovenian: - če oseba preneha dihati, jo morate poskusiti oživljati do prihoda nujne medicinske pomoči.
English: The display counts downward after each pump (P5, P4, P3, P2 and P1).
Slovenian: Na zaslonu se vrednost odšteje po vsakem pritisku vsebnika (P5, P4, P3, P2 in P1).
English: The use of concomitant central nervous system depressants may increase the risk of respiratory depression (see section 4.5).
Slovenian: Sočasna uporaba depresorjev osrednjega živčevja lahko poveča tveganje za depresijo dihanja (glejte poglavje 4.5).
English: The elimination half-life is approximately 3-4 hours for Instanyl in cancer patients.
Slovenian: Razpolovni čas izločanja zdravila Instanyl pri bolnikih z rakom znaša približno 3-4 ure.
English: Instruction for opening and closing the box: - Pick up the box
Slovenian: Navodilo za odpiranje in zapiranje škatle:
English: If the breakthrough pain is still ongoing, you may take Instanyl as prescribed by your doctor.
Slovenian: Če še vedno čutite prebijajočo bolečino, lahko uporabite Instanyl, kot vam je predpisal zdravnik.
English: • If your nasal spray is still not working properly, talk to your pharmacist.
Slovenian: • Če vaše pršilo za nos še vedno ne deluje pravilno, se posvetujte s svojim farmacevtom.
English: - if you have problems with your heart especially slow heart rate, low blood pressure or low blood volume.
Slovenian: - če imate težave s srcem, predvsem počasno bitje srca, nizek krvni tlak ali zmanjšan volumen krvi.
English: Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.
Slovenian: Depresija dihanja po prevelikem odmerjanju lahko traja dlje kot delovanje opioidnega antagonista.
English: • The prescriber must make use of the checklist for prescribers
Slovenian: • Predpisovalec mora uporabiti kontrolni seznam za predpisovalce.
English: - while waiting for the emergency help, you must try to keep the person awake by talking to or gently shaking the person every now and then.
Slovenian: - med čakanjem na nujno medicinsko pomoč morate poskušati obdržati osebo v budnem stanju z besedami ali z občasnim nežnim stresanjem.
English: Do not change the dose of Instanyl or your other pain medicines on your own.
Slovenian: Odmerkov zdravila Instanyl ali drugih zdravil proti bolečinam ne spreminjajte sami.
English: The MAH shall ensure that, all physicians, pharmacists and patients expected to prescribe/dispense/use Instanyl are provided with educational material regarding the correct and safe use of the product.
Slovenian: Imetnik dovoljenja za promet z zdravilom zagotovi, da bodo imeli vsi zdravniki, farmacevti in bolniki, ki naj bi predpisovali/izdajali/uporabljali zdravilo Instanyl na razpolago izobraževalno gradivo glede pravilne in varne uporabe zdravila.
English: The nasal spray container contains batteries.
Slovenian: Vsebnik za pršilo za nos vsebuje baterije.
English: Try to keep the person awake until emergency help arrives.
Slovenian: Poskusite obdržati osebo v budnem stanju do prihoda nujne medicinske pomoči.
English: Instanyl should not be used in pregnancy unless clearly necessary and if the benefits outweigh the risks.
Slovenian: Zdravila Instanyl ne smete uporabljati v nosečnosti, razen če je nujno potrebno in če koristi odtehtajo tveganja.
English: Do not throw away Instanyl via wastewater or household waste.
Slovenian: Ne zavrzite pršila Instanyl v odpadne vode ali med gospodinjske odpadke.
English: Carcinogenicity studies (26-week dermal alternative bioassay in Tg.AC transgenic mice; two-year subcutaneous carcinogenicity study in rats) with fentanyl did not reveal any findings indicative of oncogenic potential.
Slovenian: Študije karcinogenosti (26-tedenska vsebnost v kožnem nadomestku na Tg.AC transgenih miših; dvoletna študija subkutane karcinogenosti na podganah) s fentanilom niso razkrile izsledkov, ki bi kazali na onkogeni potencial.
English: In a study on pre- and postnatal development the survival rate of offspring was significantly reduced at doses which slightly reduced maternal weight.
Slovenian: V študiji o razvoju pred rojstvom in po njem je bila stopnja preživetja mladičev pomembno nižja pri odmerkih, ki so blago znižali materino težo.
English: This is the approximate number of doses that can be delivered from the nasal spray, before the battery is too low and the display turns off.
Slovenian: To je približno število odmerkov, ki jih je mogoče še dati s pršilom za nos, preden se bo baterija izpraznila in prikazovalnik ugasnil.
English: Generally, the maintenance strength of Instanyl should be increased when a patient requires more than one dose per breakthrough pain episode for several consecutive episodes.
Slovenian: V splošnem je treba vzdrževalno jakost zdravila Instanyl povečati, kadar bolnik v več zaporednih epizodah potrebuje več kot en odmerek na posamezno epizodo prebijajoče bolečine.
English: The safety and efficacy of Instanyl in children aged below 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Instanyl pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: • aprepitant (used to treat severe nausea);
Slovenian: • aprepitant (za zdravljenje hude slabosti),
English: Instanyl should be used with caution in patients with cerebral tumour or head injury.
Slovenian: Zdravilo Instanyl je treba previdno uporabljati pri bolnikih z možganskim tumorjem ali poškodbo glave.
English: The safety and efficacy of Instanyl have been evaluated in patients taking the medicinal product at the onset of a breakthrough pain episode.
Slovenian: Varnost in učinkovitost zdravila Instanyl sta bili ovrednoteni pri bolnikih, ki so uporabili zdravilo ob začetku epizode prebijajoče bolečine.
English: Furthermore, Instanyl was significantly superior to placebo in BTP relief at 10, 20, 40, and 60 minutes following administration.
Slovenian: Poleg tega je bilo zdravilo Instanyl pomembno boljše od placeba pri lajšanju prebijajoče bolečine 10, 20, 40 in 60 minut po vnosu.
English: Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn which can be life-threatening (see section 2)
Slovenian: Dolgotrajno zdravljenje s fentanilom v nosečnosti lahko pri novorojenčku povzroči odtegnitvene simptome, ki so lahko smrtno nevarni (glejte poglavje 2).
English: Maximum daily dose: Treatment of up to four breakthrough pain episodes, each with no more than two doses separated by at least 10 minutes.
Slovenian: Največji dnevni odmerek: Zdravljenje do štirih epizod prebijajoče bolečine, vsake z največ dvema odmerkoma v razmiku vsaj 10 minut.
English: However, higher values for Tmax were observed in a dose-proportionality study in healthy volunteers.
Slovenian: Pri zdravih prostovoljcih pa so v raziskavi o sorazmernosti odmerkov opazili višje vrednosti Tmax.
English: Remove the protective cap from the spray.
Slovenian: Odstranite zaščitno zaporko s pršila.
English: Ask your pharmacist.
Slovenian: Posvetujte se s farmacevtom.
English: Therefore, the patient must be instructed that the priming should be conducted in a well ventilated area, pointing away from the patient and other people, and away from surfaces and objects that could come into contact with other people, particularly children.
Slovenian: Zato je treba bolnika opozoriti, da mora pršilo pripravljati v dobro prezračenem prostoru, da mora pršilo obrniti proč od sebe in drugih ljudi, in stran od površin in predmetov, ki bi lahko prišli v stik z drugimi ljudmi, zlasti otroki.
English: - any medicines that might have an effect on the way in which your body breaks down Instanyl, such as:
Slovenian: - katera koli zdravila, ki bi lahko vplivala na razgradnjo zdravila Instanyl v telesu, kot so:
English: If you experience that the nasal spray does not work as described in the “Instructions for use” please contact your doctor or pharmacist.
Slovenian: Če opazite, da pršilo za nos ne deluje, kot je opisano v »Navodilu za uporabo«, se posvetujte z zdravnikom ali farmacevtom.
English: In serious cases taking too much Instanyl may cause coma, sedation, convulsions or severe breathing difficulties (very slow or shallow breathing).
Slovenian: V resnih primerih uporaba prevelikega odmerka zdravila Instanyl lahko povzroči komo, sedacijo, krče ali resne težave z dihanjem (zelo počasno ali plitvo dihanje).
English: Do not press the plunger yet.
Slovenian: Bata še ne pritisnite.
English: The nasal spray can only be used when the lock symbol is not visible in the display.
Slovenian: Pršilo za nos se lahko uporablja le, ko simbol ključavnice na zaslonu ni viden.
English: All three strengths of Instanyl demonstrated statistically significant (p < 0.001) higher pain intensity difference at 10 minutes (PID10) compared with placebo.
Slovenian: Vse tri jakosti zdravila Instanyl so bile statistično pomembno (p < 0,001) povezane z večjo razliko v intenzivnosti bolečine po 10 minutah (PID10) kot placebo.
English: The dose of Instanyl is independent of your usual cancer pain treatment.
Slovenian: Odmerek zdravila Instanyl je neodvisen od vašega običajnega zdravljenja bolečine zaradi raka.
English: Depending on the nasal spray, the starting number can be 10, 20, 30 or 40.
Slovenian: Odvisno od pršila za nos je lahko začetna vrednost 10, 20, 30
English: The COUNTDOWN-CLOCK symbol is displayed together with the LOCK-symbol.
Slovenian: Simbol ODŠTEVAJOČE URE se prikaže skupaj s simbolom KLJUČAVNICE.
English: However, opioid analgesics are known to impair the mental and/or physical ability required for driving or operating machinery.
Slovenian: Znano pa je, da opioidna protibolečinska zdravila poslabšajo psihično in/ali fizično sposobnost, ki je potrebna za vožnjo ali upravljanje s stroji.
English: Elderly patients may have a reduced clearance, a prolonged half-life and higher sensitivity to fentanyl than younger patients.
Slovenian: Starejši bolniki imajo lahko zmanjšan očistek, podaljšan razpolovni čas in večjo občutljivost na fentanil v primerjavi z mlajšimi bolniki.
English: Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Instanyl is given concurrently with medicinal products that affect CYP3A4 activity.
Slovenian: Fentanil se presnavlja predvsem prek izoencimskega sistema citokroma P450 3A4 (CYP3A4), zato lahko pride do medsebojnega delovanja, če se zdravilo Instanyl uporablja sočasno z zdravili, ki vplivajo na aktivnost CYP3A4.
English: Clinical data show that fentanyl is absorbed very rapidly through the nasal mucosa.
Slovenian: Klinični podatki kažejo, da se fentanil zelo hitro absorbira skozi nosno sluznico.
English: Repeat this procedure for ‘P2' and ‘P1' (press the white button and pump) until the display changes to show the number of doses in the nasal spray (i.e. 10, 20, 30 or 40 doses) and flashing lock symbol.
Slovenian: Ponovite postopek za »P2« in »P1« (pritiskajte belo tipko in bat črpalke), dokler se vrednosti na zaslonu ne spremenijo in se prikaže število odmerkov v pršilu za nos (npr. 10, 20, 30 ali 40 odmerkov) in simbol ključavnice utripa.
English: • Instanyl nasal spray should not be used to treat any other short-term pain or pain status.
Slovenian: • Instanyl pršilo za nos se ne sme uporabljati za zdravljenje drugih kratkotrajnih bolečin ali bolečinskih stanj.
English: This observation was most distinct for patients receiving Instanyl 50 micrograms.
Slovenian: Ta ugotovitev je bila najizrazitejša pri bolnikih, ki so prejemali 50-mikrogramski odmerek zdravila Instanyl.
English: Cachectic patients may have reduced clearance of fentanyl.
Slovenian: Kahektični bolniki imajo lahko zmanjšan očistek fentanila.
English: Dose increase should be done with caution.
Slovenian: Pri povečanju odmerkov je potrebna previdnost.
English: - if you suffer from recurrent episodes of nose bleeding.
Slovenian: - če se vam ponavljajo krvavitve iz nosu.
English: If you stop using Instanyl
Slovenian: Če ste prenehali uporabljati zdravilo Instanyl
English: Opioids act by blocking the pain signals to the brain.
Slovenian: Opioidi zavirajo prenos bolečinskih signalov do možganov.
English: The dose of Instanyl for treatment of breakthrough pain was independent of the daily maintenance dose of opioid in the clinical studies (see section 5.1).
Slovenian: Odmerek zdravila Instanyl za zdravljenje prebijajoče bolečine je bil v kliničnih študijah neodvisen od dnevnega vzdrževalnega odmerka opioida (glejte poglavje 5.1).
English: Other signs may be hypothermia, decreased muscle tonus, bradycardia and hypotension.
Slovenian: Drugi znaki so lahko hipotermija, zmanjšan mišični tonus, bradikardija in hipotenzija.
English: The initial strength should be one dose of 50 micrograms in one nostril, titrating upwards as necessary through the range of available strengths (50, 100, and 200 micrograms).
Slovenian: Začetna jakost naj znaša en odmerek po 50 mikrogramov v eno nosnico, titracija navzgor pa poteka po potrebi v razponu razpoložljivih jakosti (50, 100 in 200 mikrogramov).
English: The countdown-clock is counting downwards.
Slovenian: Odštevajoča ura odšteva čas.
English: - if you have problems with your brain function, e.g. due to a brain tumour, a head injury or increased intracranial pressure.
Slovenian: - če imate motnje v delovanju možganov, npr. zaradi možganskega tumorja, poškodbe glave ali povečanega znotrajlobanjskega tlaka.
English: Change in dose must be done together with your doctor.
Slovenian: Odmerjanje lahko spreminjate le skupaj z zdravnikom.
English: Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients.
Slovenian: Zdravljenje naj se začne in ostane pod nadzorom zdravnika, ki ima izkušnje z vodenjem opioidnega zdravljenja pri bolnikih z rakom.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking any medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete to zdravilo.
English: If you forget to use Instanyl
Slovenian: Če ste pozabili uporabiti zdravilo Instanyl
English: If severe or persistent hypotension occurs, hypovolemia should be considered and the condition should be managed with appropiate parenteral fluid therapy.
Slovenian: Če se pojavi resna ali trajna hipotenzija, je treba pomisliti na hipovolemijo in jo zdraviti z ustreznim vnosom parenteralnih tekočin.
English: The number of doses in the display changes to 5.
Slovenian: Število odmerkov na zaslonu se spremeni v 5.
English: The display counts down one number and the lock symbol is displayed shortly.
Slovenian: Na zaslonu se odšteje vrednost za eno številko in kmalu se prikaže simbol ključavnice.
English: Do not point in the direction of surfaces and objects that could come into contact with other people, particularly children.
Slovenian: Ne usmerjajte pršila v površine in predmete, ki bi lahko prišli v stik z drugimi ljudmi, zlasti otroki.
English: • Keep your head upright
Slovenian: • Držite glavo pokonci.
English: Instanyl should not be used pre-emptively.
Slovenian: Zdravila Instanyl se ne sme uporabljati preventivno.
English: In a pharmacokinetic interaction study it was found that the maximum plasma concentration of nasally applied fentanyl was reduced about 50% by the concomitant use of oxymetazoline, while the time to reach Cmax (Tmax) was doubled.
Slovenian: V študiji o farmakokinetičnem medsebojnem delovanju je bilo ugotovljeno, da se maksimalna plazemska koncentracija nazalno uporabljenega fentanila ob sočasni uporabi oksametazolina zmanjša za 50%, medtem ko se čas do doseganja Cmax (Tmax) podvoji.
English: Hallucination, drug dependence (addiction), drug abuse
Slovenian: Psihiatrične motnje nespečnost halucinacije, odvisnost od zdravil (zasvojenost), zloraba zdravil
English: Special care should be taken if you are treated with any of the following medicines: - any medicines which might normally make you sleepy (have a sedative effect) such as sleeping pills, medicines to treat anxiety, antihistamines, or tranquillisers.
Slovenian: Posebna previdnost je potrebna, če se zdravite s katerim koli od naslednjih zdravil: - katera koli zdravila, ki običajno povzročijo zaspanost (imajo sedativni učinek), npr. uspavalne tablete, zdravila za zdravljenje tesnobe, antihistaminiki ali pomirjevala.
English: Pack sizes: 2, 6, 8 and 10 single-dose containers.
Slovenian: Velikosti pakiranj: 2, 6, 8 in 10 enoodmernih vsebnikov.
English: During the determination of your right dose, your doctor may instruct you to change to a higher dose.
Slovenian: V obdobju določanja pravilnega odmerka vam utegne zdravnik naročiti, da uporabite višji odmerek.
English: When you first start using Instanyl, your doctor will work with you to find the dose that will relieve your breakthrough pain.
Slovenian: Ko boste začeli uporabljati zdravilo Instanyl, bo zdravnik v sodelovanju z vami določil odmerek za lajšanje prebijajoče bolečine.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega,
English: In a fertility and early embryonic development study in rats, a male-mediated effect was observed at high doses (300 µg/kg/day, s.c.) and is consistent with the sedative effects of fentanyl in animal studies.
Slovenian: V študiji vplivov na plodnost in zgodnji embrionalni razvoj pri podganah so opazili vpliv na samce pri visokih odmerkih (300 µg/kg/dan, v podkožje), kar se sklada s sedativnimi učinki fentanila v študijah pri živalih.
English: The plasma protein binding of fentanyl is approximately 80.
Slovenian: Delež vezave fentanila na plazemske proteine znaša približno 80%.
English: If your breakthrough pain is not relieved after 10 minutes, you may use only one puff more for this episode.
Slovenian: Če prebijajoča bolečina po 10 minutah ne mine, lahko za to epizodo uporabite le še en dodaten vpih.
English: There have also been reports of patients developing a hole in the septum of the nose - the structure, which separates the nostrils.
Slovenian: Poročali so tudi o predrtju nosnega pretina - pregrade, ki ločuje nosnici.
English: If you feel any of the above symptoms you should seek immediate medical assistance.
Slovenian: Če se pojavi kateri koli od zgornjih znakov, morate takoj poiskati medicinsko pomoč.
English: Fentanyl is an opioid analgesic interacting primarily with the opioid μ-receptor as a pure agonist with low affinity for the - and κ-opioid receptors.
Slovenian: Fentanil je opioidno protibolečinsko zdravilo, ki deluje predvsem na opioidni μ-receptor kot čisti agonist ter ima nizko afiniteto za δ- in κ-opioidne receptorje.
English: • Not to use Instanyl nasal spray to treat any other kind of pain, such as headaches, back pain or toothache.
Slovenian: • Ne uporabljati Instanyl pršila za nos za zdravljenje drugih vrst bolečine, kot so glavobol, bolečina v križu ali zobobol.
English: • Only the patient or carer should handle the nasal spray as it contains medication that is attractive for people to abuse.
Slovenian: • S pršilom za nos lahko rokuje le bolnik ali njegov negovalec, saj vsebuje zdravilno učinkovino, ki je privlačna za osebe, ki so nagnjeni k zlorabi narkotikov.
English: The treatment for the persistent background pain should be kept as prescribed.
Slovenian: Z zdravljenjem stalne kronične bolečine je treba nadaljevati, kot je bilo predpisano.
English: If you experience withdrawal symptoms, you should contact your doctor.
Slovenian: Če občutite odtegnitvene simptome, morate poklicati zdravnika.
English: • If it is blocked, aim the nasal spray away from you (and any other people) and push firmly down on the pump.
Slovenian: • Če je pršilni nastavek zamašen, usmerite pršilo za nos stran od sebe (in drugih ljudi) ter bat črpalke močno pritisnite navzdol.
English: Do not drink alcohol whilst being treated with Instanyl, as it can increase the risk of experiencing dangerous side effects.
Slovenian: Med zdravljenjem z zdravilom Instanyl ne uživajte alkohola, ker lahko poveča tveganje za pojav nevarnih neželenih učinkov.