FrancophonIA/ELRC3.0 huggingface dataset:
English: It is available as ‘buccal tablets' (tablets that dissolve in the mouth).
Croatian: Dostupan je kao „bukalne tablete” (tablete koje se tope u ustima).
English: The main measure of effectiveness was the change in pain intensity over the first 30 or 60 minutes after taking the tablet.
Croatian: Glavna mjera djelotvornosti bila je promjena u intenzitetu boli tijekom prvih 30 ili 60 minuta nakon uzimanja tablete.
English: Effentora was more effective than placebo in reducing pain in both studies.
Croatian: Lijek Effentora bio je djelotvorniji od placeba u snižavanju boli u oba ispitivanja.
English: Patients should not eat or drink anything while the tablet is in the mouth.
Croatian: Bolesnici ne smiju ništa jesti ili piti dok im se tablete nalaze u ustima.
English: The full EPAR for Effentora can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Effentora nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Doses of Effentora above 800 micrograms have not been tested.
Croatian: Doze lijeka Effentora snažnije od 800 mikrograma nisu testirane.
English: Effentora fentanyl
Croatian: Effentora fentanil
English: The most serious of these are respiratory depression (inhibition of breathing), circulatory depression (slow heartbeat), hypotension (low blood pressure) and shock (a steep fall in blood pressure).
Croatian: Najozbiljnija takva nuspojava je respiratorna depresija (inhibicija disanja), depresija cirkulacije (usporeni otkucaji srca), hipotenzija (niski krvni tlak) i šok (nagli pad u krvnom tlaku).
English: The tablets usually dissolve in 14 to 25 minutes, releasing the active substance, which is absorbed directly into the bloodstream.
Croatian: Tablete se najčešće otope za 14 do 25 minuta otpuštajući djelatnu tvar, koja se apsorbira izravno u krvotok.
English: The European Commission granted a marketing authorisation valid throughout the EU for Effentora on 4 April 2008.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Effentora vrijedi na prostoru Europske unije od 4. travnja 2008.
English: The tablets should be removed from the packaging immediately before being placed between the gum and the cheek.
Croatian: Tablete treba izvaditi iz ambalaže neposredno prije nego što će se staviti između zubnog mesa i obraza.
English: Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
Croatian: Probijajuća bol nastupa kada bolesnik osjeti dodatnu, iznenadnu bol usprkos kontinuiranom liječenju analgeticima.
English: Effentora is taken at the start of a breakthrough pain episode.
Croatian: Lijek Effentora treba uzeti na početku epizode probijajuće boli.
English: If this dose stops controlling the pain well enough, the doctor will need to work out a new individual dose.
Croatian: Ako ova doza više ne kontrolira bol u dostatnoj mjeri, liječnik mora odrediti novu individualnu dozu.
English: They should only have the necessary strengths of Effentora tablets available at any one time, to prevent confusion and possible overdose.
Croatian: U određenom trenutku moraju imati samo potrebne jačine tableta lijeka Effentora kako bi spriječili zabunu i moguće predoziranje.
English: In both studies, each patient was treated during 10 separate episodes of breakthrough pain: in seven of these episodes, each patient received Effentora, and in the other three episodes, each patient received placebo (a dummy tablet).
Croatian: U oba ispitivanja, svaki je bolesnik liječen tijekom 10 zasebnih epizoda probijajuće boli: u sedam ovih epizoda svaki je bolesnik zaprimio lijek Effentora, a u druge tri epizode svaki je bolesnik zaprimio placebo (prividno liječenje).
English: This is a summary of the European public assessment report (EPAR) for Effentora.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Effentora.
English: The most common side effects with Effentora (that may affect more than 1 patient in 10) are dizziness, headache, nausea (feeling sick), vomiting, and reactions at the site of application including bleeding, pain, ulcers, irritation, unusual sensations, numbness, redness, swelling and spots.
Croatian: Najčešće nuspojave lijeka Effentora (kod više od 1 na 10 osoba) su vrtoglavica, glavobolja, mučnina (osjećaj slabosti), povraćanje i reakcije u mjestu primjene uključujući krvarenje, bol, čireve, nadraženost, neobične osjete, tupost, crvenilo, oticanje i pjege.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Effentora.
Croatian: Objašnjava kako je Odbor za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Effentora.
English: Effentora is used to treat ‘breakthrough' pain in adults with cancer who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Croatian: Effentora se koristi za liječenje „probijajuće” boli u odraslih osoba oboljelih od raka koji već koriste opioide (grupu analgetika koja uključuje morfij i fentanil) s ciljem dugoročne kontrole boli uzrokovane rakom.
English: What measures are being taken to ensure the safe and effective use of Effentora?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Effentora?
English: Effentora can also cause the side effects typically seen with other opioids, but these tend to decrease or stop with continued use.
Croatian: Effentora može također uzrokovati nuspojave koje su najčešće uočene s opioidima, no ove se nuspojave smanjuju ili prestaju tijekom kontinuirane primjene.
English: The ability of Effentora to treat breakthrough pain was tested in two main studies involving a total of 150 adults with cancer who were being treated with opioids.
Croatian: Sposobnost lijeka Effentora za liječenje probijajuće boli testirana je u dva glavna ispitivanja, koja su obuhvatila ukupno 150 odraslih osoba oboljelih od raka koji su liječeni opioidima.
English: A risk management plan has been developed to ensure that Effentora is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Effentora.
English: Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to prevent pain
Croatian: Nakon što uđe u krvni tok, fentanil djeluje na receptore u mozgu i kralježničnu moždinu kako bi spriječio bol.
English: Once the appropriate dose for the patient has been found, the patient should take this dose as a single tablet.
Croatian: Nakon što je utvrđena odgovarajuća doza za bolesnika, bolesnik mora uzeti tu dozu u obliku jedne tablete.
English: For more information about treatment with Effentora, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Effentora pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku
English: Other information about Effentora
Croatian: Ostale informacije o lijeku Effentora
English: Effentora must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression, or who have severe obstructive lung conditions (diseases that severely impede breathing).
Croatian: Effentora se ne smije koristiti u bolesnika koji već ne uzimaju opioide za održavanje kontrole boli, koji imaju ozbiljnu respiratornu depresiju ili koji imaju ozbiljno opstruktivno stanje pluća (bolesti koje ozbiljno otežavaju disanje).
English: The active substance in Effentora, fentanyl, is an opioid.
Croatian: Djelatna tvar lijeka Effentora, fentanil, je opioid.
English: The CHMP decided that Effentora's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Effentora nadmašuju njegove rizike i preporučio je izdavanje odobrenja za stavljanje lijeka u promet.
English: When a patient starts to take Effentora, the doctor will need to work out the appropriate individual dose that will provide adequate pain relief for the patient with few side effects.
Croatian: Kada bolesnik počne uzimati lijek Effentora, liječnik mora odrediti odgovarajuću individualnu dozu koja će omogućiti primjereno ublažavanje boli za bolesnika s malo nuspojava.
English: The company that makes Effentora will also provide educational materials in each European Union (EU) Member State to make sure that patients and doctors are aware of how the medicine should be used safely, the risks of accidental exposure to fentanyl and how to dispose of Effentora.
Croatian: Proizvođač lijeka Effentora dostavit će edukacijske materijale svakoj državi članici Europske unije (EU) kako bi osigurao da su bolesnici i liječnici upoznati sa sigurnom primjenom lijeka, rizicima povezanima s izlaganjem fentanilu i načinu izlaganja lijeku Effentora.
English: It must not be used to treat short-term pain other than breakthrough pain.
Croatian: Smije se primjenjivati samo za liječenje probijajuće boli i niti jedne druge kratkoročne boli.
English: In the second study, pain intensity had fallen by 9.7 points at 60 minutes after Effentora and by 4.9 points after placebo.
Croatian: U drugom je ispitivanju, intenzitet bola pala za 9,7 bodova u 60. minuti nakon što je bolesnik uzeo lijek Effentora i za 4,9 bodova nakon što je uzeo placebo.
English: Effentora is a medicine that contains the active substance fentanyl.
Croatian: Effentora je lijek koji sadrži djelatnu tvar fentanil.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Effentora, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Effentora uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: Patients should not possess or use any other medicines containing fentanyl for the treatment of breakthrough cancer pain at the same time as using Effentora.
Croatian: Bolesnici ne smiju imati ili koristiti druge lijekove koji sadrže fentanil za liječenje probijajuće boli uzrokovane rakom istovremeno s primjenom lijeka Effentora.
English: Treatment with Effentora should be started by and remain under the guidance of a doctor who has experience in the management of opioid treatment in cancer patients.
Croatian: Liječenje lijekom Effentora treba započeti i ostati pod vodstvom liječnika iskusnog u liječenju opioidnom terapijom bolesnika oboljelih od raka.
English: In the first study, pain intensity had fallen by an average of 3.2 points at 30 minutes after the patients took Effentora and by 2.0 points after they took placebo.
Croatian: U prvom je ispitivanju intenzitet bola smanjena za prosječno 3,2 boda 30 minuta nakon što je bolesnik uzeo lijek Effentora te za 2,0 bodova nakon što je uzeo placebo.
English: Patients should be closely monitored for these side effects.
Croatian: Bolesnici trebaju obratiti pažnju na ove nuspojave.
English: This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.
Croatian: To znači da se lijek mora koristiti u strožim uvjetima od normalnih budući da se može zlouporabiti ili uzrokovati ovisnost.
English: What is the risk associated with Effentora?
Croatian: Koji su rizici povezani s lijekom Effentora?
English: What is Effentora?
Croatian: Što je Effentora?
English: In Effentora, it is given as a buccal tablet, so that the fentanyl is absorbed through the lining of the mouth.
Croatian: Lijek Effentora primjenjuje se u obliku bukalnih tableta tako da se fentanil apsorbira kroz sluznicu usta.
English: What benefit has Effentora shown during the studies?
Croatian: Koje su koristi lijeka Effentora dokazane u ispitivanjima?
English: What is Effentora used for?
Croatian: Za što se Effentora koristi?
English: For the full list of all side effects reported with Effentora, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Effentora, potražite u uputi o lijeku.
English: Why has Effentora been approved?
Croatian: Zašto je lijek Effentora odobren
English: How is Effentora used?
Croatian: Kako se Effentora koristi?
English: How has Effentora been studied?
Croatian: Kako se Effentora ispitivao?
English: How does Effentora work?
Croatian: Kako djeluje Effentora?
English: EU/1/15/995/001 DUTREBIS 150 mg / 300 mg Film-coated tablet
Croatian: EU/1/15/995/001 DUTREBIS 150 mg/300 mg Filmom obložena tableta
English: Oral use bottle (HDPE)
Croatian: Za primjenu kroz usta boca (HDPE)
English: Pharmaceutical form Route of administration Immediate Packaging
Croatian: Farmaceutski oblik Put primjene
English: 0.9 ml intravenous use syringe (glass) with needle safety guard with needle safety guard
Croatian: Veličina pakovanja napunjena štrcaljka (staklo) sa sigurnosnim štitnikom za iglu napunjena štrcaljka (staklo) sa sigurnosnim štitnikom za iglu
English: Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje
English: Immediate Packaging
Croatian: 4 napunjene štrcaljke
English: Your doctor will review your treatment.
Croatian: Vaš će liječnik preispitati mogućnosti liječenja.
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nepoznato (učestalost se ne može procijeniti na temelju dostupnih podataka)
English: Depression can be serious and may sometimes lead to suicidal thoughts.
Croatian: Depresija može biti ozbiljna i ponekad uzrokovati suicidalne misli.
English: Adopted at the 1-4 October 2018 PRAC
Croatian: Usvojeno na sjednici PRAC-a 1.- 4. listopada 2018.
English: -> Talk to your doctor about the risks and benefits of taking {product name}.
Croatian: -> razgovarajte s liječnikom o rizicima i koristima uzimanja lijeka {naziv lijeka}.
English: Do not discontinue {product name} without consulting your doctor, as this may harm you and your unborn child.
Croatian: Nemojte prekidati primjenu lijeka {naziv lijeka} bez savjetovanja s liječnikom jer možete naštetiti sebi i svojem nerođenom djetetu.
English: If you are pregnant, if you become pregnant, or if you are planning to have a baby:
Croatian: Ako ste trudni, zatrudnite ili planirate imati dijete:
English: Tell your doctor immediately if you become pregnant or are planning to become pregnant.
Croatian: Odmah obavijestite svog liječnika ako zatrudnite ili planirate trudnoću.
English: Warnings and precautions Talk to your doctor or pharmacist before taking this medicine if you: - Have diabetes.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek ako: - imate šećernu bolest.
English: Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide.
Croatian: Depresija može biti ozbiljna te je poznato da predstavlja rizični faktor za suicidalno ponašanje i suicid.
English: Fertility, pregnancy and lactation
Croatian: 4.6. Plodnost, trudnoća i dojenje
English: The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births (0.05-0.1%).
Croatian: Incidencija defekata neuralne cijevi u općoj populaciji varira od 0,5 do 1 slučaja na 1000 živorođene djece (0,05 - 0,1 %).
English: • abnormal levels of fats (lipids) in the blood
Croatian: abnormalne razine masnoća (lipida) u krvi
English: If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
Croatian: Ako primijetite promjene raspoloženja i simptome depresije, obratite se liječniku što prije radi daljnjeg savjetovanja.
English: If you could get pregnant while receiving {product name}, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection), to prevent pregnancy.
Croatian: Ako biste mogli zatrudnjeti dok primate lijek {naziv lijeka}, morate primjenjivati pouzdanu metodu barijerne kontracepcije (na primjer kondom) uz druge metode kontracepcije, uključujući oralne (tablete) ili druge hormonske kontraceptive (na primjer, implantate, injekcija) da biste spriječili trudnoću.
English: Some women using hormonal contraceptives including {product name} have reported depression or depressed mood.
Croatian: Neke žene koje uzimaju hormonsku kontracepciju, uključujući {naziv lijeka} prijavile su pojavu depresije ili depresivnog raspoloženja.
English: In animal reproductive toxicology studies, no adverse development outcomes, including neural tube defects, were identified (see section 5.3).
Croatian: U ispitivanjima reproduktivne toksičnosti u životinja nisu primijećeni štetni razvojni ishodi, uključujući defekte neuralne cijevi (vidjeti dio 5.3).
English: More than 1000 outcomes from second and third trimester exposure in pregnant women indicate no evidence of increased risk of malformative and foeto/neonatal negative effects.
Croatian: Više od 1000 ishoda izloženosti trudnica u drugom i trećem tromjesečju ne pokazuje povećan rizik od malformacijskih i fetalnih/neonatalnih negativnih učinaka.
English: Due to the potential risk of neural tube defects, dolutegravir should not be used during the first trimester unless there is no alternative.
Croatian: Zbog mogućeg rizika od defekata neuralne cijevi, dolutegravir se ne smije primjenjivati tijekom prvog tromjesečja, osim ako nema drugog izbora.
English: Preliminary data from a surveillance study has suggested an increased incidence of neural tube defects (0.9%) in mothers exposed to dolutegravir at the time of conception compared with mothers exposed to non-dolutegravir containing regimens (0.1%).
Croatian: Preliminarni podaci iz ispitivanja s ciljem praćenja upućuju na porast incidencije defekata neuralne cijevi (0,9 %) u majki izloženih dolutegraviru u vrijeme začeća u odnosu na majke koje su bile izložene režimima koji ne sadržavaju dolutegravir (0,1 %).
English: Direct acting antivirals (DAAV) indicated for the treatment of hepatitis C2 - Dysglycaemia (EPITT no 19234)
Croatian: Direktno djelujući antivirotici (DAAV) indicirani za liječenje hepatitisa C2 - disglikemija (EPITT br. 19234)
English: However, as the mechanism by which dolutegravir may interfere in human pregnancy is unknown, the safety in use during the second and third trimester cannot be confirmed.
Croatian: Međutim, kako nije poznat mehanizam kojim dolutegravir može utjecati na trudnoću u žena, ne može se potvrditi da je uporaba u drugom i trećem tromjesečju sigurna.
English: As neural tube defects occur within the first 4 weeks of foetal development (at which time the neural tubes are sealed) this potential risk would concern women exposed to dolutegravir at the time of conception and in early pregnancy.
Croatian: Budući da se defekti neuralne cijevi pojavljuju unutar prva četiri tjedna razvoja fetusa (u to vrijeme neuralne cijevi se zatvaraju), taj mogući rizik odnosi se na žene izložene dolutegraviru u vrijeme začeća i u ranoj trudnoći.
English: Package leaflet 2.
Croatian: Uputa o lijeku 2.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like {product name}.
Croatian: U nekih bolesnika sa šećernom bolesti zabilježene su niske razine šećera u krvi (hipoglikemija) nakon početka liječenja lijekovima kao što je {naziv lijeka}.
English: Hormonal contraceptives3 - Suicidality with hormonal contraceptives following a recent publication (EPITT no
Croatian: Hormonski kontraceptivi3 - suicidalnost uz hormonske kontraceptive nakon nedavne objave (EPITT br. 19144)
English: Dolutegravir should only be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus.
Croatian: Dolutegravir se smije primjenjivati tijekom drugog i trećeg tromjesečja trudnoće samo kada očekivana korist nadmašuje potencijalni rizik za fetus.
English: What you need to know before you take {product name} Warnings and precautions
Croatian: Što morate znati prije nego počnete uzimati lijek {naziv lijeka} Upozorenja i mjere opreza
English: Taking {product name} at the time of becoming pregnant or during the first twelve weeks of pregnancy, may increase the risk of a type of birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
Croatian: Ako uzimate lijek {naziv lijeka} u vrijeme začeća ili tijekom prvih dvanaest tjedana trudnoće, povećava se rizik od urođene mane pod nazivom defekt neuralne cijevi, kao što je spina bifida (rascjep kralježnice).
English: WOCBP who are taking dolutegravir should use effective contraception throughout treatment.
Croatian: Žene u reproduktivnoj dobi koje uzimaju dolutegravir trebaju koristiti učinkovitu kontracepciju tijekom cijelog liječenja.
English: Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use (see section 4.8).
Croatian: Posebna upozorenja i mjere opreza pri uporabi Depresivno raspoloženje i depresija dobro su poznate nuspojave primjene hormonskih kontraceptiva (vidjeti dio 4.8).
English: Dolutegravir was shown to cross the placenta in animals.
Croatian: Dokazano je da dolutegravir prolazi kroz posteljicu u životinja.
English: Undesirable effects Tabulated list of adverse reactions Metabolism and nutrition disorders Frequency ‘Not known'': Dyslipidaemia
Croatian: Tablični popis nuspojava Poremećaji metabolizma i prehrane Učestalost „nepoznato”: dislipidemija
English: Dolutegravir - Evaluation of preliminary data from an observational study on birth outcomes in human immunodeficiency virus (HIV)-infected women (EPITT no
Croatian: Dolutegravir - evaluacija preliminarnih podataka iz opservacijskog ispitivanja o ishodima porođaja u žena zaraženih virusom humane imunodeficijencije (HIV) (EPITT br. 19244)
English: Teriflunomide - Dyslipidaemia (EPITT no 19227)
Croatian: Teriflunomid - dislipidemija (EPITT br. 19227)
English: Glucose levels of diabetic patients initiating {direct acting antiviral / DAA} therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Croatian: Razine glukoze u bolesnika s dijabetesom koji započinju liječenje lijekom {direktno djelujući antivirotik / DAA} treba pažljivo nadzirati, posebno unutar prva tri mjeseca, te prema potrebi prilagoditi lijek protiv dijabetesa.
English: Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of dolutegravir.
Croatian: Žene reproduktivne dobi trebaju se testirati na trudnoću prije početka liječenja dolutegravirom.
English: What you need to know before you take {product name}
Croatian: Što morate znati prije nego počnete uzimati {naziv lijeka}
English: The physician in charge of the diabetic care of the patient should be informed when {direct acting antiviral / DAA} therapy is initiated.
Croatian: Liječnik zadužen za praćenje dijabetesa u bolesnika mora biti obaviješten o uvođenju terapije lijekom {direktno djelujući antivirotik / DAA}.
English: What you need to know before you take {product name} Pregnancy
Croatian: Što morate znati prije nego počnete uzimati lijek {naziv lijeka} Trudnoća
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting {product name}.
Croatian: Nakon što počnete uzimati lijek {naziv lijeka}, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijek protiv šećerne bolesti.