FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the HMPC conclusions on the use of matricaria oil medicines are based on their long-standing use.
Croatian: Zaključci HMPCa temelje se na dugotrajnoj primjeni lijekova koji sadrže kamiličino eterično ulje.
English: Use in the elderly (older than 65 years)
Croatian: Primjena u starijih (stariji od 65 godina)
English: • You have a head injury.
Croatian: • ako imate ozljedu glave.
English: Try to keep the person awake until emergency help arrives.
Croatian: Pokušajte tu osobu održati budnom dok ne stigne hitna pomoć.
English: The differences observed were not clinically significant.
Croatian: Zapažene razlike nisu bile klinički značajne.
English: Patients should be carefully monitored until an effective dose is reached.
Croatian: Bolesnike treba pozorno nadzirati sve dok se ne postigne učinkovita doza.
English: Do not give this medicine to children and adolescents below18 years of age.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima mlađima od 18 godina.
English: These differences continued to be significant at each subsequent time point in each individual study.
Croatian: Te su razlike nastavile biti značajne za svaku sljedeću vremensku točku u svakom pojedinačnom ispitivanju.
English: Tolerance, dependence
Croatian: Tolerancija, ovisnost
English: The reason of this difference is unknown.
Croatian: Nije poznat razlog za ovu razliku.
English: The rate of development of tolerance varies widely among individuals.
Croatian: Brzina razvoja tolerancije uvelike varira između pojedinaca.
English: Higher doses may be necessary.
Croatian: Mogu biti potrebne više doze.
English: Any change in dosage must be prescribed and monitored by your doctor.
Croatian: Bilo koju promjenu doze treba propisati i nadzirati Vaš liječnik.
English: Seek URGENT medical advice if:
Croatian: HITNO potražite liječnički savjet:
English: Effentora with food, drink and alcohol
Croatian: Effentora s hranom, pićem i alkoholom
English: Buccal tablet.
Croatian: Bukalna tableta.
English: Sometimes, your doctor may tell you to place the tablet under your tongue instead.
Croatian: Ponekad će Vam liječnik reći da stavite tabletu pod jezik.
English: • Risk of interactions with other medications
Croatian: • Rizik od interakcija s drugim lijekovima
English: Date of first authorisation: 04 April 2008 Date of latest renewal: 20 February 2013
Croatian: Datum posljednje obnove odobrenja: 20. veljače 2013.
English: Contact your doctor when experiencing such symptoms.
Croatian: Obratite se liječniku kad osjetite takve simptome.
English: The safety and efficacy of Effentora in children aged 0 to 18 years have not been established.
Croatian: Sigurnost i djelotvornost Effentore u djece u dobi od 0 do 18 godina nisu ustanovljene.
English: • Effentora may be used before or after, but not during, meals.
Croatian: • Effentora se smije uzimati prije ili nakon, ali ne za vrijeme obroka.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder or call the following number:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet ili nazovite sljedeći broj:
English: * Based on venous blood samples (plasma).
Croatian: * Na temelju uzoraka venske krvi (plazma).
English: • You are over 65 years old - you may need a lower dose and any dose increase will be reviewed very carefully by your doctor.
Croatian: • ako ste stariji od 65 godina - možda će Vam biti potrebna niža doza i liječnik će pažljivo provjeriti svako povišenje doze.
English: However, opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery).
Croatian: Međutim, opioidni analgetici oštećuju mentalnu i/ili tjelesnu sposobnost potrebnu za provođenje potencijalno opasnih zadataka (primjerice, upravljanje automobilom ili strojevima).
English: This can occur if your dose of Effentora is too high or if you take too much Effentora.
Croatian: To se može dogoditi ako je Vaša doza Effentore previsoka ili ako ste uzeli previše Effentore.
English: Its primary therapeutic actions are analgesia and sedation.
Croatian: Njegova su primarna terapijska djelovanja analgezija i sedacija.
English: Effentora should only be used for conditions specified in section 4.1.
Croatian: Effentoru treba koristiti samo za stanja navedena u dijelu 4.1.
English: Patients assessed pain intensity on a 11-point scale.
Croatian: Bolesnici su procijenili intenzitet boli na ljestvici od 11 bodova.
English: In clinical studies patients older than 65 years tended to titrate to a lower effective dose than younger patients.
Croatian: U kliničkim ispitivanjima bolesnici stariji od 65 godina tijekom titracije su bili skloni nižoj učinkovitoj dozi nego mlađi bolesnici.
English: Aluminium laminated blister of PVC/Al foil/Polyamide/PVC with paper/polyester lidding.
Croatian: Aluminijem obloženi blisteri PVC/Al folija/poliamid/PVC s papirnatim/poliesterskim pokrovom.
English: • Possible side effects (the most likely ones, how to recognise them and when to alert physicians)
Croatian: • Moguće nuspojave (one najvjerojatnije, kako ih prepoznati i kada obavijestiti liječnika)
English: The primary efficacy variable was the patient's assessment of pain intensity.
Croatian: Primarna varijabla djelotvornosti bila je bolesnikova procjena intenziteta boli.
English: • How to use EFFENTORA (how to take it, how to reach the effective dose during the titration process)?
Croatian: • Kako primjenjivati EFFENTORU (kako uzimati taj lijek, kako postići učinkovitu dozu tijekom postupka titracije)
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije pad
English: Sixty-seven percent of the patients were able to be titrated to an effective dose.
Croatian: Šezdeset i sedam posto bolesnika mogli su biti titrirani na djelotvornu dozu.
English: • Medicines called monoamine-oxidase (MAO) inhibitors (used for severe depression) or have done so in the past 2 weeks.
Croatian: • Lijekove zvane inhibitori monoamin oksidaze (MAO) (koji se koriste za jaku depresiju) ili ste ih uzimali tijekom protekla dva tjedna.
English: The number of tablet strengths available to the patients at any time should be minimised to prevent confusion and potential overdose.
Croatian: Broj tableta određene jačine dostupan bolesnicima u svakom trenutku treba biti što manji kako bi se spriječila zabuna i moguće predoziranje.
English: • Educational material for the healthcare professionals
Croatian: • Edukacijski materijal za zdravstvene radnike
English: • lack of sex hormones (androgen deficiency)
Croatian: • manjak spolnih hormona (nedostatak androgena)
English: Your doctor will decide if your dose needs to be changed.
Croatian: Liječnik će odlučiti je li Vam potrebno promijeniti dozu.
English: Time after Dose Administration (hours)
Croatian: Vrijeme nakon primjene doze (sati)
English: The educational material for healthcare professionals shall consist of four items: • Opioid prescribing guide
Croatian: Edukacijski materijal za zdravstvene radnike sastojat će se od četiri dijela: • Upute za propisivanje opioida
English: Doses above 800 micrograms were not evaluated in clinical studies.
Croatian: Doze iznad 800 mikrograma nisu ispitane u kliničkim ispitivanjima.
English: • The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics.
Croatian: • Rizik od nuspojava povećava se ako uzimate lijekove kao što su neki antidepresivi ili antipsihotici.
English: The plasma protein binding of fentanyl is 80% to 85%.
Croatian: Vezanje fentanila na proteine plazme iznosi 80 do 85%.
English: • Educational material for the patients
Croatian: • Edukacijski materijal za bolesnike
English: Contents of the pack and other information What Effentora contains
Croatian: Sadržaj pakiranja i druge informacije Što Effentora sadrži
English: It is important you know how you react to Effentora before driving or operating machinery.
Croatian: Važno je znati kako reagirate na Effentoru prije upravljanja vozilima ili strojevima.
English: Your doctor will tell you whether Effentora is suitable for you.
Croatian: Vaš liječnik će Vam reći je li Effentora odgovarajući lijek za Vas.
English: If this occurs, please seek immediate medical assistance.
Croatian: U tom slučaju odmah potražite liječničku pomoć.
English: • disturbed or blurred vision, red eye
Croatian: • poremećeni ili zamagljen vid, crvene oči
English: Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.
Croatian: Liječnik će procijeniti trebate li lijek za ublažavanje ili uklanjanje simptoma ustezanja.
English: Because of this, concomitant use should only be considered when other treatment options are not possible.
Croatian: Zbog toga se istodobnu primjenu može razmatrati samo kad nema drugih terapijskih mogućnosti.
English: Pharmacokinetic Parameters* in Adult Subjects Receiving Effentora
Croatian: Farmakokinetički parametri* u odraslih ispitanika koji primaju Effentoru
English: A document explaining the titration process and the dosing recommendations after treatment initiation
Croatian: Dokumenta s objašnjenim postupkom titracije i preporukama za doziranje nakon početka liječenja
English: In general, the effective concentration and the concentration at which toxicity occurs increase with increasing tolerance to opioids.
Croatian: Najčešće se djelotvorne koncentracije i koncentracije pri kojima se javlja toksičnost povećavaju s porastom tolerancije na opioide.
English: You may drink some water before using Effentora to help moisten your mouth, but you should not drink or eat anything while taking the medicine.
Croatian: Možete popiti malo vode prije nego što uzmete Effentoru kako biste ovlažili usta, ali ne smijete ništa piti ni jesti kad uzmete ovaj lijek.
English: It is recommended that two tablets should be placed in each side of the mouth.
Croatian: Preporučuje se da se po dvije tablete stave u svaku stranu usta.
English: • Open the blister only when you are ready to use the tablet.
Croatian: • Otvorite blister tek onda kad ste spremni uzeti tabletu.
English: • Do not drink alcohol while using Effentora.
Croatian: • Nemojte uzimati alkohol dok koristite Effentoru.
English: Effentora should not be used during pregnancy unless you have discussed this with your doctor.
Croatian: Effentoru ne smijete koristiti u trudnoći osim ako ste o tome razgovarali sa svojim liječnikom.
English: As with all opioids, there is a risk of clinically significant respiratory depression associated with the use of fentanyl.
Croatian: Kao i sa svim opioidima postoji rizik od klinički značajne respiratorne depresije povezane s uporabom fentanila.
English: You must let your doctor know immediately if you are using Effentora more than four times per day, as a change may be required to your treatment regimen.
Croatian: Morate odmah obavijestiti svog liječnika ako Effentoru uzimate više od četiri puta na dan jer će Vam možda trebati promijeniti režim liječenja.
English: • You drink alcohol; please refer to section Effentora with food, drink and alcohol.
Croatian: • ako pijete alkohol; molimo pogledajte odlomak "Effentora s hranom, pićem i alkoholom".
English: Pharmacotherapeutic group: analgesics; opioids; ATC code N02AB03.
Croatian: Farmakoterapijska skupina: analgetici, opioidi; ATK oznaka N02AB03.
English: You should discuss with your doctor whether it is safe for you to drive, or operate machinery after taking Effentora.
Croatian: Raspravite sa svojim liječnikom je li sigurno da vozite ili upravljate strojevima nakon uzimanja Effentore.
English: Patients should not consume any food and drink when a tablet is in the buccal cavity.
Croatian: Bolesnici ne smiju uzimati hranu i piće kad je tableta u bukalnoj šupljini.
English: Dosage increase should be done with caution.
Croatian: Dozu treba povisiti oprezno.
English: Further findings at maternally toxic doses in F1 pups were delayed physical development, sensory functions, reflexes and behaviour.
Croatian: Daljnji nalazi pri dozama toksičnim za majku u F1 štenadi bili su odgođen fizički razvoj, senzorne funkcije, refleksi i ponašanje.
English: It is recommended that one tablet should be placed in each side of the mouth.
Croatian: Preporučuje se da se po jedna tableta stavi u svaku stranu usta.
English: However, in these patients, a starting dose higher than 100 micrograms may be considered.
Croatian: Međutim, u tih se bolesnika može razmotriti primjena početne doze veće od 100 mikrograma.
English: What Effentora is and what it is used for
Croatian: Što je Effentora i za što se koristi
English: If you become very sleepy or have slow and/or shallow breathing, you or your carer should contact your doctor immediately and call for emergency help.
Croatian: Ako postanete vrlo pospani ili sporo i/ili plitko dišete, Vi ili Vaš njegovatelj morate se odmah obratiti liječniku i pozvati hitnu pomoć.
English: Taking the medicine in this way allows it to be absorbed quickly to relieve your breakthrough pain.
Croatian: Uzimanje lijeka na ovaj način omogućava brzu apsorpciju kako bi se ublažila probijajuća bol.
English: Patients and their carers must be instructed that Effentora contains an active substance in an amount that can be fatal, especially to a child.
Croatian: Bolesnicima i njihovim njegovateljima treba objasniti da Effentora sadrži djelatnu tvar u količini koja može biti smrtonosna, posebno za dijete.
English: Linearity/non-linearity Dose proportionality from 100 micrograms to 1000 micrograms has been demonstrated.
Croatian: Linearnost/nelinearnost Dokazana je proporcionalnost doze od 100 mikrograma do 1000 mikrograma.
English: If you begin to feel very dizzy, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away.
Croatian: Ako počnete osjećati jaku omaglicu ili postanete vrlo pospani prije nego što se tableta u potpunosti otopi, isperite usta vodom i odmah ispljunite preostale djeliće tablete u umivaonik ili toaletnu školjku.
English: ** Data for Tmax presented as median (range).
Croatian: ** Podaci za Tmax prikazani su kao medijan (raspon).
English: In these cases, a second tablet of the same strength may be used.
Croatian: U tim se slučajevima može uzeti druga tableta iste jačine.
English: Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone.
Croatian: Neke promjene koje se mogu opaziti uključuju povišenje prolaktina u serumu i sniženja kortizola i testosterona u plazmi.
English: In each Member State where EFFENTORA is marketed the Marketing Authorisation Holder (MAH) shall agree an updated educational programme with the National Competent Authority.
Croatian: U svakoj zemlji članici u kojoj je EFFENTORA stavljena u promet, nositelj odobrenja dogovorit će nadopunjeni edukacijski program s nacionalnim nadležnim tijelom.
English: More than 90% of the administered dose of fentanyl is eliminated by biotransformation to N-dealkylated and hydroxylated inactive metabolites.
Croatian: Više od 90% primijenjene doze fentanila eliminira se biotransformacijom u N-dealkilirane i hidroksilirane neaktivne metabolite.
English: Norfentanyl is not pharmacologically active in animal studies.
Croatian: Norfentanil se nije pokazao farmakološki aktivnim u ispitivanjima na životinjama.
English: The remaining half of the total dose is swallowed and slowly absorbed from the gastrointestinal tract.
Croatian: Preostala se polovica ukupne doze proguta te se polako apsorbira iz gastrointestinalnog trakta.
English: • You have a history of alcoholism or any drug abuse or dependence.
Croatian: • ako imate anamnezu alkoholizma ili zlouporabe droga ili ovisnosti o drogama.
English: In order to minimise the risks of opioid-related undesirable effects and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process.
Croatian: Kako bi se minimizirao rizik od neželjenih učinaka povezanih s opioidima te ustanovila učinkovita doza, nužno je da zdravstveni radnici pomno nadziru bolesnike tijekom titracije.
English: Hyperalgesia
Croatian: Hiperalgezija
English: You must however continue to take your usual opioid pain relieving medicine to treat your persistent cancer pain as advised by your doctor.
Croatian: Međutim, morate nastaviti uzimati svoj uobičajeni opioidni lijek protiv bolova zbog liječenja stalnog karcinomskog bola, kako Vam je savjetovao Vaš liječnik.
English: Accidental use in children
Croatian: Nehotična primjena u djece
English: Do not change doses of Effentora or your other pain medicines on your own.
Croatian: Nemojte sami mijenjati doze Effentore ili svojih drugih lijekova protiv bolova.
English: Therefore it is not possible to definitively separate the effects of Effentora alone.
Croatian: Stoga nije moguće definitivno razdvojiti učinke same
English: What Effentora looks like and contents of the pack
Croatian: Kako Effentora izgleda i sadržaj pakiranja
English: • Brochure on breakthrough pain
Croatian: • Brošure o probijajućem bolu
English: Patients and carers must be advised to dispose of any unopened tablets remaining from a prescription as soon as they are no longer needed.
Croatian: Bolesnike i njegovatelje treba savjetovati da sve neotvorene tablete koje ostanu neupotrijebljene zbrinu čim ih više ne budu trebali.
English: • Do not attempt to crush or split the tablet.
Croatian: • Nemojte pokušavati smrviti ili prelomiti tabletu.
English: • The most serious side effects are shallow breathing, low blood pressure and shock.
Croatian: • Najozbiljnije nuspojave su plitko disanje, nizak krvni tlak i šok.
English: If you have not been using these medicines you must not use Effentora, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop.
Croatian: Ako niste uzimali ove lijekove ne smijete uzeti Effentoru jer može povećati rizik od opasnog usporavanja disanja i/ili plitkog disanja ili čak potpunog prestanka disanja.
English: Please tell your doctor about all sedative medicines you are taking (such as sleeping pills, medicines to treat anxiety, some medicines to treat allergic reactions (antihistamines), or tranquillisers) and follow your doctor's dose recommendation closely.
Croatian: Obavijestite liječnika o svim sedativima koje uzimate (poput tableta za spavanje, lijekova za liječenje tjeskobe, nekih lijekova za liječenje alergijskih reakcija (antihistaminika) ili lijekova za smirenje) i strogo se pridržavajte doze koju je preporučio liječnik.
English: Careful consideration should be given to patients with hypovolaemia and hypotension.
Croatian: Treba biti oprezan kod bolesnika s hipovolemijom i hipotenzijom.
English: Fentanyl concentrations obtained in serum were higher than in plasma: Serum AUC and Cmax were approximately 20% and 30% higher than plasma AUC and Cmax, respectively.
Croatian: Koncentracije fentanila dobivene u serumu bile su više nego u plazmi: Serumske vrijednosti AUC i Cmax bile su približno 20% i 30% više od plazmatskih vrijednosti AUC i Cmax.
English: Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.
Croatian: Opioidi mogu prikriti kliničko stanje bolesnika s ozljedom glave te ih treba koristiti samo ako su klinički potrebni.
English: Other medicines and Effentora
Croatian: Drugi lijekovi i Effentora
English: Patients receiving Effentora concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time.
Croatian: Bolesnike koji primaju Effentoru istodobno s umjerenim ili jakim inhibitorima CYP3A4 potrebno je pažljivo nadzirati na dulje vrijeme.
English: The treatment for the persistent background pain should be kept as prescribed.
Croatian: Liječenje stalno prisutnog osnovnog bola treba održavati kako je propisano.
English: Physicians should keep in mind the potential of abuse of fentanyl.
Croatian: Liječnici trebaju imati na umu moguću zloporabu fentanila.
English: The analgesic effects of fentanyl are related to its plasma level.
Croatian: Analgetski učinci fentanila povezani su s njegovom plazmatskom razinom.
English: When you place a tablet in your mouth, it dissolves and the medicine is absorbed through the lining of your mouth, into the blood system.
Croatian: Kad stavite tabletu u usta, ona se otapa i lijek se apsorbira kroz sluznicu usta u krvotok.
English: * See section Description of selected adverse reactions
Croatian: * Vidjeti dio Opis odabranih nuspojava
English: For the most effective relief, let your doctor know about your pain and how Effentora is working for you, so that the dose can be changed if needed.
Croatian: Za najučinkovitije olakšanje boli obavijestite svog liječnika o boli te kako Effentora djeluje na Vas tako da se doza može promijeniti po potrebi.
English: • If you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na fentanil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: • loss of consciousness, stop in breathing, convulsion (fits)
Croatian: • gubitak svijesti, prestanak disanja, konvulzije (napadaji)
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel.Nr.
Croatian: Österreich ratiopharm Arzneimittel Vertriebs-GmbH
English: Transient pH changes accompanying the effervescent reaction may optimise dissolution (at a lower pH) and membrane permeation (at a higher pH).
Croatian: Prolazne promjene pH koje prate efervescentnu reakciju mogu poboljšati otapanje (pri nižem pH) i prolaz kroz membranu (pri višem pH).
English: Each tablet contains either:
Croatian: Jedna tableta sadrži jedno od sljedećeg:
English: Breakthrough pain is additional, sudden pain that occurs in spite of you having taken your usual opioid pain-relieving medicines.
Croatian: Probijajuća bol je dodatna, iznenadna bol koja se javlja usprkos tome što ste uzeli svoju uobičajenu dozu opioidnog analgetika.
English: • You have liver or kidney problems, as these organs have an effect on the way in which your system breaks down the medicine.
Croatian: • ako imate probleme s jetrom ili bubrezima jer ti organi utječu na način na koji Vaše tijelo razgrađuje lijek.
English: This product should only be used by patients already taking other opioids.
Croatian: Ovaj lijek smiju upotrebljavati samo bolesnici koji već uzimaju druge opioide.
English: Plasma Fentanyl Concentration (ng/mL)
Croatian: Plazmatske koncentracije fentanila (ng/mL)
English: Patients with xerostomia
Croatian: Bolesnici s kserostomijom
English: • 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.
Croatian: • ako osjećate bol ili povećanu osjetljivost na bol (hiperalgezija) koja se ne smanjuje uz višu dozu lijeka koju Vam je propisao liječnik.
English: The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist's action (e.g., the half-life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary.
Croatian: Trajanje respiratorne depresije nakon predoziranja može biti dulje od učinaka djelovanja antagonista opioida (primjerice, poluvijek naloksona u rasponu je od 30 do 81 minute) te ga može biti potrebno ponovno primijeniti.
English: These effects could either be indirect effects due to altered maternal care and/or decreased lactation rate or a direct effect of fentanyl on the pups.
Croatian: Ti učinci mogu biti ili neizravni učinci zbog promijenjene maternalne skrbi i/ili smanjene laktacije ili izravni učinci fentanila na štence.
English: Effentora should be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet which usually takes approximately 14-25 minutes.
Croatian: Effentoru treba staviti i držati unutar bukalne šupljine dovoljno dugo da se omogući raspad tablete, a to obično traje otprilike 14-25 minuta.