FrancophonIA/ELRC3.0 huggingface dataset:
English: The nasal spray is now ready for use, when the next breakthrough pain episode occurs.
Slovenian: Pršilo za nos je zdaj pripravljeno za uporabo, ko se naslednjič pojavi prebijajoča bolečina.
English: Takeda GmbH Robert-Bosch-Strasse 8 D - 78224 Singen Germany
Slovenian: Takeda GmbH Robert-Bosch-Strasse 8 D - 78224 Singen
English: Instanyl is not recommended for use in patients who have received Monoamine Oxidase Inhibitors (MAOIs) within 14 days because severe and unpredictable potentiation by MAOIs inhibitors has been reported with opioid analgesics.
Slovenian: Zdravilo Instanyl ni priporočljivo za uporabo pri bolnikih, ki so v zadnjih 14 dnevih prejemali zaviralce monoaminooksidaze (MAOI), ker obstajajo poročila o resnem in nepredvidljivem povečanju učinka opioidnih protibolečinskih zdravil zaradi zaviralcev MAO.
English: A priming sequence of 5 actuations of the nasal spray container is required, indicated by ‘P5', ‘P4', ‘P3', ‘P2' and ‘P1' in the display.
Slovenian: Vsebnik pršila za nos je treba 5-krat zaporedoma aktivirati, kar je na zaslonu označeno s »P5«, »P4«, »P3«, »P2« in »P1«.
English: This effect could either be due to altered maternal care or a direct effect of fentanyl on the pups.
Slovenian: Vzrok za ta učinek bi bila lahko sprememba v materini skrbi za mladiče ali neposreden učinek fentanila na mladiče.
English: Talk to your doctor before using Instanyl, especially: - if you suffer from a long-term obstructive lung disease, your breathing may be impaired by
Slovenian: Pred začetkom uporabe zdravila Instanyl se posvetujte z zdravnikom, še posebej: - če imate dolgotrajno obstruktivno pljučno bolezen, lahko zdravilo Instanyl oslabi dihanje.
English: Together these symptoms may be a sign of a potentially life-threatening condition called adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones.
Slovenian: Kombinacija vseh teh simptomov je lahko znak bolezni, ki je lahko smrtno nevarna in se imenuje insuficienca nadledvičnic; pri tej bolezni nadledvičnice ne izdelujejo dovolj hormonov.
English: Particular caution should be exercised when titrating Instanyl in elderly patients.
Slovenian: Pri titriranju zdravila Instanyl pri starejših bolnikih je potrebna posebna previdnost.
English: Educational material for the patients should contain the following:
Slovenian: Izobraževalno gradivo za bolnike mora vsebovati naslednje:
English: The number of doses in the display changes to ‘5'.
Slovenian: Število odmerkov na zaslonu se spremeni v »5«.
English: • For the multi-dose nasal spray: information about the dose counting scheme.
Slovenian: • Za večodmerno pršilo za nos: informacije o shemi štetja odmerkov.
English: The influence of hepatic and renal impairment on the pharmacokinetics of Instanyl have not been evaluated; however, when administered intravenously the clearance of fentanyl has shown to be altered due to hepatic and renal impairment caused by alterations in metabolic clearance and plasma proteins.
Slovenian: Vpliv jetrne ali ledvične okvare na farmakokinetiko zdravila Instanyl ni bil ovrednoten, izkazalo pa se je, da se po intravenskem vnosu očistek fentanila zaradi jetrne in ledvične okvare ter posledičnih sprememb v presnovnem očistku in plazemskih proteinih spremeni.
English: In patients with chronic obstructive pulmonary diseases, fentanyl may have more severe adverse reactions.
Slovenian: Kronična pljučna bolezen Pri bolnikih s kroničnimi obstruktivnimi pljučnimi boleznimi ima lahko fentanil hujše neželene učinke.
English: The content is:
Slovenian: Vsebina:
English: - If you are taking a medicine which contains sodium oxybate.
Slovenian: - če jemljete zdravilo, ki vsebuje natrijev oksibat.
English: LOCK symbol
Slovenian: Simbol KLJUČAVNICE
English: • Each single-dose container is sealed in a child-resistant blister.
Slovenian: • Vsak enoodmerni vsebnik je zapečaten v za otroke varnem pretisnem omotu.
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 dependent patients.
Slovenian: Imajo visoko afiniteto za opioidne receptorje z relativno nizko intrinzično aktivnostjo, zato delujejo delno antagonistično na protibolečinski učinek fentanila in lahko povzročijo odtegnitvene simptome pri bolnikih, ki so odvisni od opioidov.
English: If you think someone has accidentally taken Instanyl, please seek immediate medical assistance.
Slovenian: Če menite, da je kdo nenamerno uporabil zdravilo Instanyl, takoj poiščite medicinsko pomoč.
English: The initial dose is one puff of 50 micrograms in one nostril each time you have an episode of breakthrough pain.
Slovenian: Začetni odmerek je en vpih po 50 mikrogramov v eno nosnico ob vsakem pojavu prebijajoče bolečine.
English: The nasal spray is ready, when the display shows the number of doses (i.e. 10, 20, 30 or 40 doses).
Slovenian: Pršilo za nos je pripravljeno, ko se na zaslonu prikaže število odmerkov (tj. 10, 20, 30 ali 40 odmerkov).
English: • Priming should be performed in a well ventilated area.
Slovenian: • je treba pršilo pripravljati v dobro prezračenem prostoru.
English: - if you have serious difficulties breathing or suffer from a serious obstructive lung disease.
Slovenian: - če imate resne težave z dihanjem ali resno obstruktivno pljučno bolezen.
English: - if you suffer from short-term pain other than breakthrough pain.
Slovenian: - če imate drugo kratkotrajno bolečino, ki ni prebijajoča bolečina.
English: The following adverse reactions have been reported with Instanyl and/or other fentanyl-containing compounds during clinical studies and post marketing experience:
Slovenian: Z uporabo zdravila Instanyl in/ali drugih zdravil, ki vsebujejo fentanil, so poročali o naslednjih neželenih učinkih iz kliničnih študij in obdobja po začetku trženja:
English: You should not start breast-feeding until at least 5 days after the last dose of Instanyl.
Slovenian: Preden začnete dojiti, mora miniti vsaj 5 dni od zadnjega odmerka zdravila Instanyl.
English: Administration of Instanyl in single doses ranging from 50 to 200 micrograms fentanyl per dose in opioid tolerant cancer patients produces a rapid Cmax level of 0.35 to 1.2 ng/ml.
Slovenian: Uporaba enkratnega odmerka zdravila Instanyl v razponu od 50 do 200 mikrogramov fentanila na odmerek pri bolnikih z rakom, ki imajo razvito toleranco na opioide, hitro privede do koncentracij Cmax od 0,35 do 1,2 ng/ml.
English: Signs of toxicity are deep sedation, ataxia, miosis, convulsions and respiratory depression, which is the main symptom.
Slovenian: Znaki zastrupitve so globoka sedacija, ataksija, mioza, krči in depresija dihanja, ki je glavni simptom.
English: • Blow your nose if it feels blocked or you have a cold.
Slovenian: • Useknite se, če imate zamašen nos ali če ste prehlajeni.
English: The pain-relieving medicine in Instanyl is very strong and can be life-threatening to children.
Slovenian: Zdravilo Instanyl je zelo močno protibolečinsko zdravilo in lahko ogrozi življenje otrok.
English: Patients should be individually titrated to a dose that provides adequate analgesia with tolerable adverse drug reactions.
Slovenian: Bolnike je treba posamično titrirati do odmerka, ki zagotavlja zadostno protibolečinsko delovanje ob znosnih neželenih učinkih zdravila.
English: Breakthrough pain is an additional sudden pain that occurs despite you having taken your usual opioid pain relieving medicines.
Slovenian: Prebijajoča bolečina je nenadna dodatna bolečina, ki se pojavi kljub jemanju običajnih opioidnih zdravil za lajšanje bolečine.
English: Explanation
Slovenian: Razlaga
English: It is recommended that concomitant use of nasal decongestants is avoided (see section 5.2).
Slovenian: Priporočljivo se je izogibati sočasni uporabi nosnih dekongestivov (glejte poglavje 5.2).
English: No distinct correlation between the maintenance opioid dose and Instanyl doses have been established, however in the second pivotal study patients receiving low maintenance opioid dose tended to achieve effective pain relief with a lower strength of Instanyl compared to patients taking higher levels of maintenance opioid dose.
Slovenian: Med vzdrževalnim odmerkom opioidov in odmerki zdravila Instanyl niso ugotovili izrazite soodvisnosti, so pa v drugi ključni študiji bolniki, ki so prejemali nižje vzdrževalne odmerke opioidov, dosegali zadovoljivo lajšanje bolečine z nižjimi jakostmi zdravila Instanyl v primerjavi z bolniki na višjih vzdrževalnih odmerkih opioidov.
English: Tick off one box after each dose [Tick boxes of 10, 20 or 40 tick boxes]
Slovenian: Po vsakem odmerku odkljukajte en okvirček [Okvirčki po 10, 20 ali 40 okvirčkov].
English: • CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment of fungal infections);
Slovenian: • zaviralci CYP3A4, npr. ketokonazol, itrakonazol ali flukonazol (za zdravljenje glivičnih okužb),
English: The lock symbol starts flashing, when the locking period is over.
Slovenian: Simbol ključavnice začne utripati po izteku obdobja zaklepanja.
English: If the battery symbol appears in the display, it is recommended that you contact your doctor to get a new nasal spray.
Slovenian: Če se na zaslonu prikaže ikona baterije, je priporočljivo, da se obrnete na svojega zdravnika, da vam predpiše novo pršilo za nos.
English: The secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Slovenian: Sekundarni farmakološki učinki so depresija dihanja, bradikardija, hipotermija, zaprtost, mioza, fizična odvisnost in evforija.
English: Previous facial radiotherapy.
Slovenian: Predhodna radioterapija v predelu obraza.
English: Titration to a higher dose necessitates contact with the health care professional.
Slovenian: Titracija do višjega odmerka mora potekati v sodelovanju z zdravstvenim delavcem.
English: In these patients, opioids may decrease respiratory drive.
Slovenian: Pri teh bolnikih opioidi lahko zmanjšajo težnjo po dihanju.
English: The most serious adverse reactions are respiratory depression (potentially leading to apnoea or respiratory arrest), circulatory depression, hypotension and shock and all patients should be closely monitored for these.
Slovenian: Najresnejši neželeni učinki so depresija dihanja (ki lahko vodi v apnejo ali zastoj dihanja), depresija krvnega obtoka, hipotenzija in šok, zato je treba vse bolnike skrbno nadzorovati zaradi morebitnega pojava teh učinkov.
English: After intravenous administration of fentanyl the initial distribution half-life is approximately 6 minutes and a similar half-life is seen after the nasal administration of Instanyl.
Slovenian: Po intravenskem vnosu fentanila znaša začetni razpolovni čas porazdelitve približno 6 minut, razpolovni čas pa je podoben tudi pri nazalnem vnosu zdravila Instanyl.
English: If adverse reactions are intolerable or persistent, the strength should be reduced or treatment with Instanyl be replaced by other analgesics.
Slovenian: Če so neželeni učinki neznosni ali stalno prisotni, je treba zmanjšati jakost ali zdravilo Instanyl nadomestiti z drugimi protibolečinskimi zdravili.
English: Redose with same strength.
Slovenian: Ponovite odmerek enake jakosti.
English: The clinical experience with Instanyl in patients with background opioid treatment equivalent to ≥ 500 mg/day morphine or ≥ 200 micrograms/hour transdermal fentanyl is limited.
Slovenian: Klinične izkušnje z zdravilom Instanyl pri bolnikih, ki prejemajo vzdrževalno zdravljenje z opioidi v ekvivalentnem odmerku ≥ 500 mg/dan morfina ali ≥ 200 mikrogramov/uro transdermalnega fentanila, so omejene.
English: You should discontinue Instanyl when you no longer have any breakthrough pain.
Slovenian: Z uporabo zdravila Instanyl morate prenehati, če nimate več prebijajočih bolečin.
English: When the lock symbol starts flashing, press the white side button; the lock symbol disappears in the display.
Slovenian: Ko začne simbol ključavnice utripati, pritisnite beli gumb ob strani; simbol ključavnice izgine z zaslona.
English: The results of summary of PID at 60 minutes (SPID0-60) showed that all strengths of Instanyl had significantly higher mean SPID0-60 scores compared with placebo (p < 0.001) demonstrating better pain relief of Instanyl compared to placebo during 60 minutes.
Slovenian: Skupni rezultati PID po 60 minutah (SPID0-60) so pokazali, da so imele vse jakosti zdravila Instanyl pomembno višje vrednosti SPID0-60 v primerjavi s placebom (p < 0,001), kar pomeni, da zdravilo
English: The signs and symptoms of fentanyl overdose are expected to be an extension of its pharmacological actions e.g. lethargy, coma and severe respiratory depression.
Slovenian: Pričakovani znaki in simptomi prevelikega odmerjanja fentanila so podaljšanje njegovega farmakološkega delovanja, npr. letargija, koma in resna depresija dihanja.
English: The use of such other drugs at the same time as Instanyl, may cause deep sedation and affect your ability to breath, which may lead to come and be life-threatening.
Slovenian: Uporaba tovrstnih drugih zdravil sočasno z zdravilom Instanyl lahko povzroči globoko sedacijo in vpliva na sposobnost dihanja, kar lahko privede do kome in je lahko smrtno nevarno.
English: Limited data on pharmacokinetics are available for the use of fentanyl in cachectic (debilitated) patients.
Slovenian: Podatki o farmakokinetiki fentanila pri kahektičnih (oslabelih) bolnikih so omejeni.
English: • Only to use Instanyl nasal spray if they are using other opioid pain medicine on a daily basis.
Slovenian: • Instanyl pršilo za nos uporabljati samo, če že vsakodnevno uporabljajo drugo opioidno protibolečinsko zdravilo.
English: This should clear any blockage.
Slovenian: To bi moralo odmašiti nastavek.
English: For concomitant use of nasal vasoconstrictor see section 4.5.
Slovenian: Za sočasno uporabo nosnega vazokonstriktorja glejte poglavje 4.5.
English: Patients should wait 4 hours before treating another breakthrough pain episode with Instanyl during both titration and maintenance therapy.
Slovenian: Bolniki morajo počakati 4 ure pred začetkom zdravljenja naslednje epizode prebijajoče bolečine z zdravilom Instanyl, tako v obdobju titracije kot tudi med vzdrževalnim zdravljenjem.
English: If you use more Instanyl than you should or if you think someone has accidentally used Instanyl You should contact your doctor, hospital or emergency room for assessment of the risk and for advice if you have taken more Instanyl than you should.
Slovenian: Če ste uporabili večji odmerek zdravila Instanyl, kot bi smeli, pokličite svojega zdravnika, bolnišnico ali urgentno službo za oceno tveganja in za nasvet.
English: The nasal spray must be pumped 5 times (primed), before it can be used (see section ‘Preparing the Instanyl nasal spray').
Slovenian: Pred uporabo je treba pršilo za nos 5-krat pritisniti (aktivirati) (glejte poglavje »Priprava pršila za nos Instanyl«).
English: In clinical trials elderly patients tend to titrate to a lower effective strength than patients less than 65 years of age.
Slovenian: V kliničnih preskušanjih so starejše bolnike običajno titrirali do nižje jakosti kot bolnike, mlajše od
English: When the time has passed the lock symbol starts flashing.
Slovenian: Ko se čas izteče, začne simbol ključavnice utripati.
English: These actions can be followed by administration of a specific opioid antagonist such as naloxone.
Slovenian: Tem ukrepom lahko sledi vnos specifičnega antagonista opioidov, npr. naloksona.
English: On exceptional occasions where a new episode occurs earlier, you can use Instanyl to treat it but you must wait at least 2 hours before doing so.
Slovenian: V izjemnih primerih, ko se nova epizoda bolečine pojavi prej, jo lahko zdravite z zdravilom Instanyl, vendar morate pred tem počakati vsaj 2 uri.
English: If you think you are becoming dependent on Instanyl, it is important that you inform you doctor.
Slovenian: Če menite, da postajate odvisni od zdravila Instanyl, o tem obvestite svojega zdravnika.
English: Severe respiratory depression or severe obstructive lung conditions.
Slovenian: Resna depresija dihanja ali resne obstruktivne bolezni pljuč.
English: It is recommended that the patient's head is in upright position when administrating Instanyl.
Slovenian: Priporočljivo je, da je bolnikova glava med uporabo zdravila Instanyl v pokončnem položaju.
English: Limited data on pharmacokinetics, efficacy and safety are available for the use of Instanyl in patients above 65 years of age.
Slovenian: Podatki o farmakokinetiki, učinkovitosti in varnosti zdravila Instanyl pri bolnikih, starejših od 65 let,
English: Before patients are titrated with Instanyl, it is expected that their background persistent pain is controlled by use of chronic opioid therapy and that they are experiencing no more than four episodes of breakthrough pain per day.
Slovenian: Pred titracijo zdravila Instanyl se pričakuje, da je stalna bolečina pod nadzorom s kroničnim opioidnim zdravljenjem in da bolnik ne čuti več kot štirih epizod prebijajoče bolečine na dan.
English: Concomitant use of Instanyl with other medicinal products (other than oxymetazoline) administered via the nose has not been evaluated in the clinical trials.
Slovenian: Sočasna uporaba zdravila Instanyl z drugimi zdravili (poleg oksimetazolina), ki se vnašajo nazalno, ni bila ovrednotena s kliničnimi preskušanji.
English: Once primed, the display shows the number of doses left and the nasal spray is ready for use again.
Slovenian: Ko ste pršilo pripravili, se na zaslonu prikaže število preostalih odmerkov in pršilo za nos je znova pripravljeno za uporabo.
English: Patients being treated with medicinal products containing sodium oxybate.
Slovenian: Bolniki, zdravljeni z zdravili, ki vsebujejo natrijev oksibat.
English: If discontinuation of all opioid therapy is required, the patient must be closely followed by the physician as gradual downward opioid titration is necessary in order to avoid the possibility of abrupt withdrawal effects.
Slovenian: Če je potrebna prekinitev zdravljenja z vsemi opioidi, mora zdravnik bolnika skrbno spremljati in s titracijo postopoma zmanjševati odmerke opioidov, da se izogne možnemu odtegnitvenemu sindromu.
English: • Not to use Instanyl nasal spray for treatment of more than four breakthrough cancer pain episodes a day.
Slovenian: • Ne uporabljati Instanyl pršila za nos za zdravljenje več kot štirih epizod prebijajoče bolečine zaradi raka na dan.
English: Clinically significant respiratory depression may occur with fentanyl, and patients must be observed for these effects.
Slovenian: Pri uporabi fentanila lahko pride do klinično pomembne depresije dihanja, zato je treba spremljati bolnike zaradi morebitnega pojava teh učinkov.
English: • It must be pumped 3 or 4 times (primed) until a fine mist appears.
Slovenian: - Pred prvo uporabo pršila za nos: • Pršilo pritisnite 3- do 4-krat (temeljito), dokler se ne pojavi fina meglica.
English: Sleepiness, drowiness, dizziness, reduced body temperature, slow heart beat, difficulties coordinating arms and legs.
Slovenian: zaspanost, dremavost, omotica, znižana telesna temperatura, upočasnjen srčni utrip, težave s koordinacijo rok in nog.
English: Before using the nasal spray for the first time, it must be pumped 5 times (primed) to give a full dose of Instanyl.
Slovenian: Pred prvo uporabo pršila za nos je treba pršilo 5-krat pritisniti (aktivirati), da dobite celoten odmerek zdravila Instanyl.
English: Educational material for the physicians should contain the following:
Slovenian: Izobraževalno gradivo za zdravnike mora vsebovati naslednje:
English: Instanyl shows linear kinetics.
Slovenian: Za zdravilo Instanyl je značilna linearna kinetika.
English: 1.8 ml - 10 doses 2.9 ml - 20 doses 5.0 ml - 40 doses
Slovenian: 1,8 ml - 10 odmerkov 2,9 ml - 20 odmerkov 5,0 ml - 40 odmerkov
English: Caution is advised when Instanyl is coadministered with medicinal products that affect the serotoninergic neurotransmitter systems.
Slovenian: Pri sočasni uporabi zdravila Instanyl z zdravili, ki vplivajo na sistem serotoninergičnih nevrotransmiterjev, je potrebna previdnost.
English: What Instanyl contains
Slovenian: Kaj vsebuje navodilo
English: Instanyl should not be used during childbirth because fentanyl may cause serious breathing problems in the new-born child.
Slovenian: Zdravila Instanyl se ne sme uporabljati med porodom, ker lahko fentanil pri novorojenčku povzroči resne težave z dihanjem.
English: - if you use other nasal spray products, e.g. for common cold or allergy.
Slovenian: - če uporabljate druga pršila za nos, npr. za prehlad ali alergijo.
English: Impaired renal or hepatic function
Slovenian: Okvarjena ledvična ali jetrna funkcija
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to special and restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na poseben recept in le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: • Information about dose counting scheme included in the labelling and the educational material for the multi-dose nasal spray.
Slovenian: • Informacije o shemi štetja odmerkov, ki so vključene v označevanje in izobraževalna gradiva za večodmerno pršilo za nos.
English: In animal studies, male and female fertility was impaired at sedative doses (see section 5.3).
Slovenian: V študijih na živalih so ugotovili zmanjšano plodnost samcev in samic ob sedativnih odmerkih (glejte poglavje 5.3).
English: • troleandomycin, clarithromycin, or erythromycin (medicines for treatment of bacterial infections);
Slovenian: • troleandomicin, klaritromicin ali eritromicin (zdravila za zdravljenje bakterijskih okužb),
English: Instanyl can cause dizziness, drowsiness and visual disturbances, which may affect your ability to drive or use machines.
Slovenian: Zdravilo Instanyl lahko povzroči omotico, zaspanost in motnje vida, ki lahko vplivajo na vašo sposobnost za vožnjo ali upravljanje strojev.
English: It is advised not to use fentanyl during labour and delivery (including caesarean section) because fentanyl passes through the placenta and may cause respiratory depression in the newborn (neonate).
Slovenian: Fentanila se ne sme uporabljati med popadki in porodom (vključno s carskim rezom), ker fentanil prehaja skozi posteljico in lahko povzroči depresijo dihanja pri novorojenčku (novorojencu).
English: Comparable bioavailability (AUC) of fentanyl was achieved with and without oxymetazoline, while fentanyl Cmax decreased and Tmax increased by a factor two when oxymetazoline was administered.
Slovenian: Z oksimetazolinom ali brez njega je bila dosežena primerljiva biološka uporabnost (AUC) fentanila, vendar pa se je pri uporabi oksimetazolina znižala vrednost Cmax in povišala vrednost Tmax fentanila za količnik dve.
English: Contact your doctor to confirm the correct dose of your usual medicine if you are not sure.
Slovenian: V primeru dvoma pokličite svojega zdravnika in preverite pravilnost odmerka svojega običajnega zdravila.
English: - if you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain.
Slovenian: - če za nadzor svoje stalne bolečine ne uporabljate redno predpisanega opioidnega zdravila že vsaj en teden (npr. kodeina, fentanila, hidromorfona, morfina, oksikodona, petidina), vsak dan in po rednem režimu.
English: - if you take medicines called partial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine (medicines for treatment of pain) as you may experience symptoms of withdrawal syndrome.
Slovenian: - če jemljete zdravila, imenovana delni agonisti/antagonisti, npr. buprenorfin, nalbufin in pentazocin (zdravila za zdravljenje bolečine), saj se lahko pojavijo simptomi odtegnitvenega sindroma.
English: You should wait for 4 hours before treating the next episode of breakthrough pain.
Slovenian: Počakati bi morali 4 ure, preden zdravite naslednjo epizodo prebijajoče bolečine.