natgillin/translations-raw huggingface dataset:
In the second pivotal study (study 2), the primary endpoint was SPID30, which was also statistically significant compared to placebo (p<0.0001). 
U drugom ključnom kliničkom ispitivanju (ispitivanje 2) primarni ishod bila je vrijednost SPID30 koja je također bila statistički značajna u usporedbi s placebom (p<0,0001).
If treatment of a BTP episode requires more than one tablet, an increase in dose to the next higher available strength should be considered to treat the next BTP episode. 
Ako liječenje epizode probijajuće boli zahtijeva više od jedne tablete, za liječenje sljedeće epizode treba razmotriti povećanje doze do sljedeće više jačine koja je na raspolaganju.
The Effentora tablet should not be sucked, chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed. 
Tablete Effentore se ne smije cuclati, žvakati ili gutati jer to može uzrokovati niže plazmatske koncentracije nego kad se lijek uzima prema uputama.
In the pivotal clinical study (study 1), the primary endpoint was the average sum of differences in pain intensity scores from dosing to 60 minutes, inclusive (SPID60), which was statistically significant compared to placebo (p<0.0001). 
U ključnom kliničkom ispitivanju (ispitivanje 1) primarni ishod bio je prosječni zbroj razlika u rezultatima intenziteta boli od doziranja do 60 minuta uključivo (SPID60) koja je bili statistički značajna u usporedbi s placebom (p<0,0001).
• Information on the titration process as indicated in the labelling - Instructions on the safe use (to avoid the risk of overdosing), on storage (to avoid the risk of accidental exposure), and disposal of fentanyl buccal tablet - Boxed statements as follows: 
• Informacija o postupku titracije kako je to navedeno na označivanju - Upute o sigurnoj primjeni (kako bi se izbjegao rizik od predoziranja), o čuvanju (kako bi se izbjegao rizik od slučajnog izlaganja) i zbrinjavanju bukalnih tableta fentanila
CYP3A4 inducers Co-administration with agents that induce 3A4 activity may reduce the efficacy of Effentora. 
Induktori CYP3A4 Istodobna primjena s lijekovima koji induciraju aktivnost 3A4 može reducirati djelotvornost Effentore.
For dose-readjustment the same principles apply as outlined for dose titration (see above). 
Za ponovnu prilagodbu doze primjenjuju se isti principi kako je to opisano u titraciji doze (vidjeti prethodni tekst).
The following adverse reactions have been reported with Effentora and/or other fentanyl-containing compounds during clinical studies and post marketing experience. 
Sljedeće su nuspojave prijavljene s Effentorom i/ili drugim tvarima koje sadrže fentanil tijekom kliničkih ispitivanja te nakon stavljanja lijeka u promet.
As with other opioids, in case of insufficient pain control in response to an increased dose of fentanyl, the possibility of opioid-induced hyperalgesia should be considered. 
Kao i kod drugih opioida, u slučaju da kontrola boli kao odgovor na povišenu dozu fentanila nije zadovoljavajuća, potrebno je razmotriti vjerojatnost razvoja hiperalgezije izazvane opioidima.
Loss of consciousness and respiratory arrest have been observed in the context of overdose (see section 4.9). 
Gubitak svijesti i respiratorni arest primijećeni su kod predoziranja (vidjeti dio 4.9).
After buccal administration of Effentora, fentanyl undergoes initial rapid distribution that represents an equilibration of fentanyl between plasma and the highly perfused tissues (brain, heart and lungs). 
Nakon bukalne primjene Effentore, fentanil prolazi početnu brzu distribuciju koja predstavlja ravnotežu fentanila između plazme i izuzetno dobro prokrvljenih tkiva (mozak, srce i pluća).
Caution is advised when Effentora is co-administered with drugs that affect the serotoninergic neurotransmitter systems. 
Preporučuje se oprez kod istodobne primjene Effentore i lijekova koji utječu na serotoninergički neurotransmitorski sustav.
Opening the blister package 
Otvaranje blistera
It is important that the maintenance opioid treatment used to treat the patient's persistent pain has been stabilised before Effentora therapy begins and that the patient continues to be treated with the maintenance opioid treatment whilst taking Effentora. 
Važno je da se terapija održavanja opioidima, kojom se liječi bolesnikova trajna bol, stabilizira prije početka liječenja Effentorom te da bolesnik nastavi terapiju održavanja opioidima dok istodobno uzima Effentoru.
Immediate management of opioid overdose includes removal of the Effentora buccal tablet, if still in the mouth, ensuring a patent airway, physical and verbal stimulation of the patient, assessment of the level of consciousness, ventilatory and circulatory status, and assisted ventilation (ventilatory support) if necessary. 
Hitno liječenje predoziranja opioidima uključuje vađenje bukalne tablete Effentore, ako je još uvijek u ustima, vodeći računa da su bolesnikovi dišni putovi prohodni, fizičku i verbalnu stimulaciju bolesnika, procjenu razine svijesti, ventilatorni i cirkulatorni status i, ako je potrebno, potpomognutu ventilaciju (potpora ventilaciji).
The pain-relieving medicine in Effentora is very strong and could be life-threatening if taken accidentally by a child. 
Lijek za ublažavanje bolova u Effentori vrlo je jak te može biti opasan po život ako ga slučajno uzme dijete.
It is recommended that increased caution should be exercised in titrating the dose of Effentora in elderly patients. 
Preporučuje se povećani oprez u titraciji doze Effentore za starije bolesnike.
The judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome. 
U nekim slučajevima može biti potrebna razborita primjena naloksona ili drugih antagonista opioida, ali je povezana s rizikom od nastanka akutnog sindroma ustezanja.
Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2. 
Statistički značajno poboljšanje u razlikama intenziteta boli uočena je kod Effentore naspram placeba već nakon 10 minuta u ispitivanju 1 i nakon 15 minuta (najranija mjerena vremenska točka) u ispitivanju
Blister packs are supplied in cartons of 4 or 28 tablets. 
Blisteri se isporučuju u kutijama od 4 ili 28 tableta.
Alternatively, the tablet could be placed sublingually (see section 5.2). 
Tableta se može staviti i sublingvalno (vidjeti dio 5.2).
However if your doctor does prescribe Effentora together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. 
Međutim, ako Vam liječnik propiše Effentoru zajedno sa sedativima, mora ograničiti dozu i trajanje istodobnog liječenja.
• Safe use, storage and disposal of EFFENTORA. 
• Sigurna primjena, čuvanje i zbrinjavanje EFFENTORA.
Evaluation of brain slides from the carcinogenicity study in rats revealed brain lesions in animals administered high doses of fentanyl citrate. 
Pregled rezova mozgova štakora na kojima je ispitivana kancerogenost pokazao je lezije mozga u životinja kojima su davane visoke doze fentanilcitrata.
Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl. 
Tolerancija i fizička i/ili psihološka ovisnost mogu se razviti nakon opetovane primjene opioida poput fentanila.
Pre-emptive use of Effentora for predictable pain episodes was not investigated in the clinical trials. 
Preemptivna primjena Effentore za predvidive epizode boli nije proučavana u kliničkim ispitivanjima.
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 foetus. 
Preporučuje se ne koristiti fentanil tijekom trudova i porođaja (uključujući i carski rez) jer fentanil prolazi kroz posteljicu i može uzrokovati respiratornu depresiju u fetusa.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
(EURD popis) predviđenom člankom 107.c stavkom 7 Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
Talk to your doctor or pharmacist BEFORE using Effentora if: 
Obratite se svom liječniku ili ljekarniku PRIJE nego što uzmete Effentoru:
Whilst you are being treated with Effentora, do not use other fentanyl treatments previously prescribed for your breakthrough pain. 
Dok se liječite Effentorom nemojte uzimati druge lijekove koji sadrže fentanil, a koji su Vam bili prethodno propisani za liječenje probijajuće boli.
If your doctor suspects Effentora-related increased sensitivity to pain (hyperalgesia), a reduction of your Effentora dose may be considered (see section 2 under “Warnings and precautions”). 
Ako liječnik posumnja na pojačanu osjetljivost na bol (hiperalgezija) zbog Effentore, može se razmotriti sniženje doze Effentore (pogledajte dio 2, pod „Upozorenja i mjere opreza“).
• For titration to 600 micrograms and 800 micrograms, tablets of 200 micrograms should be used. 
• Za titraciju do 600 i 800 mikrograma treba koristiti tablete od 200 mikrograma.
Dose readjustment of the background opioid therapy may be required if patients consistently present with more than four BTP episodes per 24 hours. 
Ponovna prilagodba doze osnovne opioidne terapije može biti potrebna ako se kod bolesnika dosljedno javljaju više od četiri epizode probijajuće boli u 24 sata.
Effentora should not be used in pregnancy unless clearly necessary. 
Effentora se ne smije primjenjivati tijekom trudnoće osim ako to nije nužno.
• You are suffering from any condition that has an effect on your breathing (such as asthma, 
• ako patite od bilo kojeg stanja koje utječe na Vaše disanje (poput astme, piskanja pri disanju ili nedostatka zraka).
If Effentora is used for a long time during pregnancy, there is also a risk of the new-born child having withdrawal symptoms which might be life-threatening if not recognized and treated by a doctor. 
Ako se Effentora dugotrajno primjenjuje tijekom trudnoće, također postoji rizik od simptoma ustezanja u novorođenčeta, koji mogu biti opasni po život ako ih liječnik ne prepozna i ne liječi.
• prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn which can be life-threatening (see section 2) 
• produljeno liječenje fentanilom u trudnoći može u novorođenčadi prouzročiti simptome ustezanja koji mogu biti opasni za život (pogledajte dio 2).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 4 TABLETS 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER SA 4 TABLETE
A comparison study between one 400 mcg Effentora tablet administered either buccally (i.e., between the cheek and the gum) or sublingually met the criteria of bioequivalence. 
Usporedno ispitivanje primjene jedne tablete Effentore od 400 mikrograma bukalno (tj. između obraza i desni) ili sublingvalno ispunilo je kriterije bioekvivalencije.
Because of these risks, concomitant prescribing of opioids and benzodiazepines or related drugs should be made only in patients for whom alternative treatment options are inadequate. 
Zbog tih se rizika istodobna primjena opioida i benzodiazepina ili sličnih lijekova smije propisati samo u bolesnika u kojih nema drugog prikladnog terapijskog izbora.
Hypogonadism Adrenal insufficiency, androgen deficiency 
Endokrini poremećaji hipogonadizam insuficijencija nadbubrežnih žlijezda, nedostatak androgena
• You have an exceptionally slow heart rate or other heart problems. 
• ako Vam srce radi iznimno sporo ili imate druge srčane probleme.
• Allergic reactions such as rash, redness, swollen lip and face, hives 
• alergijske reakcije kao što su osip, crvenilo, oticanje usana i lica, koprivnjača
The tablet must be used immediately once removed from the blister. 
Tabletu treba primijeniti odmah nakon vađenja iz blistera.
The safety and efficacy of Effentora have been evaluated in patients taking the drug at the onset of the breakthrough pain episode. 
Sigurnost i djelotvornost Effentore procijenjena je u bolesnika koji su uzimali lijek prilikom nastupa epizode probijajuće boli.
Patients who identified an effective dose entered the double-blind phase of the study. 
Bolesnici kojima je određena djelotvorna doza Effentore ušli su u dvostruko slijepu fazu ispitivanja.
With long-term use of fentanyl during pregnancy, there is a risk of neonatal opioid withdrawal syndrome which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 
Pri dugotrajnoj primjeni fentanila tijekom trudnoće, postoji rizik od sindroma ustezanja od opioida u novorođenčeta, koji može biti po život opasan ako se ne prepozna i ne liječi, te zahtijeva zbrinjavanje sukladno protokolima koje su razvili neonatolozi.
There are no adequate data from the use of fentanyl in pregnant women. 
Nema podataka ili su podaci o primjeni fentanila u trudnica ograničeni.
Patients should be instructed not to attempt to crush or split the tablet. 
Bolesnike je potrebno upozoriti da ne pokušavaju smrviti ili razlomiti tabletu.
Therefore they must keep all tablets out of the sight and reach of children. 
Stoga se tablete moraju čuvati izvan pogleda i dohvata djece.
The clinical studies of Effentora were designed to evaluate safety and efficacy in treating BTP and all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent pain. 
Klinička ispitivanja Effentore osmišljena su kako bi se procijenila sigurnost i djelotvornost u liječenju probijajuće boli, a svi su bolesnici istodobno uzimali i opioide poput morfija s odgođenim otpuštanjem ili transdermalni fentanil za perzistentnu bol.
resulting in a median terminal elimination half-life t1/2 of approximately 22 hours following buccal administration of the effervescent formulation and approximately 18 hours following intravenous administration. 
Ta je faza eliminacije spora što rezultira medijanom terminalnog poluvremena eliminacije t1/2 od približno 22 sata nakon bukalne primjene efervescentne formulacije, i približno 18
After administration of Effentora, impaired hepatic and renal function may both increase the bioavailability of swallowed fentanyl and decrease its systemic clearance, which could lead to increased and prolonged opioid effects. 
Nakon primjene Effentore, oštećene funkcije jetre i bubrega mogu povećati bioraspoloživost progutanog fentanila i smanjiti njegov sistemski klirens što može uzrokovati povećane i produljene učinke opioida.
Patients should be instructed NOT to attempt to push the tablet through the blister because this could damage the buccal tablet. 
Bolesnike treba upozoriti da NE pokušavaju progurati tabletu kroz blister jer to može oštetiti bukalnu tabletu.
The influence of hepatic and renal impairment on the pharmacokinetics of the medicinal product has not been evaluated, however, when administered intravenously the clearance of fentanyl has been shown to be altered in hepatic and renal impairment due to alterations in metabolic clearance and plasma proteins. 
Utjecaj jetrenog i bubrežnog oštećenja na farmakokinetiku lijeka nije ispitan, međutim, prilikom intravenske primjene pokazalo se da je klirens fentanila izmijenjen u bolesnika s oštećenjem jetre ili bubrega zbog izmjena u metaboličkom klirensu i proteinima plazme.
Chronic obstructive pulmonary disease 
Kronična opstruktivna plućna bolest
• lack of testosterone, abnormal sensation in eye, observing flashes of light, brittle nails 
• manjak testosterona, abnormalni osjet u oku, prisutnost bljeskova svjetlosti, lomljivi nokti
Therefore, special care should be taken during the titration process in patients with moderate or severe hepatic or renal impairment. 
Stoga je potreban posebni oprez u postupku titracije bolesnicima s umjerenim ili teškim oštećenjem jetre ili bubrega.
OTFC data was dose adjusted (800 mcg to 400 mcg) 
OTFC podaci su načinjeni prema prilagodbi (800 mikrograma na 400 mikrograma)
Maintenance opioid treatment 
Terapija održavanja opioidima
Tachycardia Bradycardia 
Srčani poremećaji tahikardija bradikardija
The absorption profile of Effentora is largely the result of an initial rapid absorption from the buccal mucosa, with peak plasma concentrations following venous sampling generally attained within an hour after oromucosal administration. 
Profil apsorpcije Effentore uvelike je rezultat početne brze apsorpcije iz bukalne sluznice, a vršne plazmatske koncentracije venskog uzorka uglavnom se postižu unutar jednog sata nakon primjene na sluznicu usta.
No more than two tablets should be used to treat any individual BTP episode, except when titrating using up to four tablets as described above. 
Za liječenje pojedinačne epizode probijajuće boli ne bi trebalo primijeniti više od dvije tablete osim kad se za potrebe titracije, kako je to prethodno opisano, primjenjuje do četiri tablete.
• After 30 minutes, if pieces of the tablet remain, they may be swallowed with a glass of water. 
• Ako su nakon pola sata preostali dijelovi tablete, možete ih progutati s čašom vode.
• Titration guide tool Key elements to be included in the educational material for healthcare professionals: - Prescription of EFFENTORA only by physicians experienced in the management of opioid therapy in cancer patients - Prescription of EFFENTORA only to critically selected patients with close following on 
• Vodič za titraciju Ključni elementi koji moraju biti uključeni u edukacijski materijal za zdravstvene radnike: - da EFFENTORU smiju propisivati samo liječnici s iskustvom u provođenju terapije opioidima u onkoloških bolesnika
Each blister contains 4 buccal tablets, supplied in cartons of 4 or 28 buccal tablets. 
Jedan blister sadrži 4 bukalne tablete, dostupne u kutijama sa 4 ili 28 bukalnih tableta.
If you think someone has accidentally taken Effentora please seek immediate medical assistance. 
Što učiniti ako netko slučajno uzme Effentoru Ako mislite da je netko slučajno uzeo Effentoru, odmah potražite liječničku pomoć.
Dwell time (defined as the length of time that the tablet takes to fully disintegrate following buccal administration), does not affect early systemic exposure to fentanyl. 
Vrijeme zadržavanja (definirano kao vrijeme potrebno za potpuni raspad tablete pri bukalnoj primjeni) ne utječe na rano sistemsko izlaganje fentanilu.
Following the administration of Effentora, the terminal elimination phase of fentanyl is the result of the redistribution between plasma and a deep tissue compartment. 
Nakon primjene Effentore završna faza eliminacije fentanila rezultat je preraspodjele između plazme i odjeljka dubokog tkiva.
Particular caution should be used when titrating Effentora in patients with non-severe chronic obstructive pulmonary disease or other medical conditions predisposing them to respiratory depression, as even normally therapeutic doses of Effentora may further decrease respiratory drive to the point of respiratory failure. 
Posebno treba biti oprezan kad se Effentora titrira u bolesnika s lakšom kroničnom opstruktivnom plućnom bolesti ili drugim medicinskim stanjima koja ih čine podložnim respiratornoj depresiji, jer čak i normalne terapijske doze Effentore mogu dodatno smanjiti respiratorni poticaj do stupnja respiratornog zatajenja.
Anaphylaxis and hypersensitivity have been reported in association with the use of oral transmucosal fentanyl products (see Section 4.8). 
Zabilježene su anafilaksija i preosjetljivost povezane s primjenom peroralnih transmukoznih pripravaka fentanila (vidjeti dio 4.8).
• Do not use this medicine after the expiry/use before date which is stated on the blister package label and the carton. 
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji.
Improper patient selection (e.g., use in patients without maintenance opioid therapy) and/or improper dosing have resulted in fatal outcome with Effentora as well as with other fentanyl products. 
Pogrešan odabir bolesnika (primjerice, primjena u bolesnika bez terapije održavanja opioidima) i/ili nepravilno doziranje rezultirali su smrtnim ishodom s Effentorom kao i s drugim lijekovima na bazi fentanila.
Absolute bioavailability Fraction absorbed transmucosally Tmax (minute) ** Cmax (ng/ml) 
Frakcija apsorbirana kroz sluznicu Tmax (minuta) ** Cmax (ng/ml)
Fentanyl can get into breast milk and may cause side effects in the breast-fed infant. 
Fentanil može prijeći u majčino mlijeko i može uzrokovati nuspojave u dojenčeta.
The free fraction of fentanyl increases with acidosis. 
Slobodna se frakcija fentanila povećava u acidozi.
• You have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency) with opioid use (see section 4 under “Serious side effects”). 
• ako ste bilo kad kod primjene opioida razvili insuficijenciju nadbubrežnih žlijezda ili manjak spolnih hormona (nedostatak androgena) (pogledajte dio 4, pod „Ozbiljne nuspojave“).
The backing foil should be peeled back to expose the tablet. 
Foliju na poleđini treba odvojiti i povući prema nazad kako bi se oslobodila tableta.
Not to be sucked, chewed or swallowed whole. 
Tablete se ne smiju sisati, žvakati ili progutati cijele.
During titration, if adequate analgesia is not obtained within 30 minutes after the start of administration of a single tablet, a second Effentora tablet of the same strength may be used. 
Ako se tijekom titracije ne postigne odgovarajuća analgezija unutar 30 minuta nakon početka primjene pojedinačne tablete, može se primijeniti druga tableta Effentore iste jačine.
Tolerance, physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl (see section 4.4). 
Tolerancija, fizička i/ili psihološka ovisnost mogu nastati nakon opetovanih primjena opioida poput fentanila (vidjeti dio 4.4).
Although muscle rigidity interfering with respiration has not been seen following the use of Effentora, this is possible with fentanyl and other opioids. 
Iako nakon primjene Effentore nije zapažena mišićna rigidnost koja interferira s disanjem, to je moguće s fentanilom ili drugim opioidima.
In case of buccal mucosa irritation, a change in tablet placement within the buccal cavity should be recommended. 
U slučaju iritacije bukalne sluznice preporučuje se promijeniti mjesto stavljanja tablete u bukalnoj šupljini.
Increased intracranial pressure, impaired consciousness Effentora should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness. 
Effentoru treba primjenjivati s krajnjim oprezom u bolesnika koji mogu biti posebno osjetljivi na intrakranijalne učinke retencije CO2 poput onih s potvrđenim porastom intrakranijalnog tlaka ili poremećajem svijesti.
If switching from another oral fentanyl citrate product, independent dose titration with Effentora is required as bioavailability between products differs significantly. 
Kod prebacivanja s drugog peroralnog lijeka koji sadrži fentanilcitrat, potrebna je neovisna titracija doze s Effentorom jer se bioraspoloživost između lijekova značajno razlikuje.
Once the right dose has been determined with your doctor, use 1 tablet for an episode of breakthrough pain as a general rule. 
Kada Vam liječnik odredi pravilnu dozu, uzimajte u pravilu 1 tabletu za epizodu probijajuće boli.
Effentora should be administered with caution to patients with moderate or severe hepatic or renal impairment (see section 4.4). 
Effentoru treba primijeniti s oprezom bolesnicima s umjerenim ili teškim oštećenjem funkcije jetre ili bubrega (vidjeti dio 4.4).