FrancophonIA/ELRC3.0 huggingface dataset:
English: No effect on lumbar spine BMD Z-score was evident after 6 months of treatment.
Croatian: Nakon 6 mjeseci liječenja nije bio vidljiv učinak na BMD Z-vrijednost.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Aclasta (zoledronic acid) for osteoporosis.
Croatian: U bolesnika koji primaju Aclastu (zoledronatna kiselina) za osteoporozu prijavljena je nuspojava koja se zove osteonekroza čeljusti (ONJ) (oštećenje koštanog tkiva čeljusti) nakon stavljanja lijeka u promet.
English: Since zoledronic acid is not metabolised in humans and the substance was found to have little or no capacity as a direct-acting and/or irreversible metabolism-dependent inhibitor of P450 enzymes, zoledronic acid is unlikely to reduce the metabolic clearance of substances which are metabolised via the cytochrome P450 enzyme systems.
Croatian: P450 enzima, nije vjerojatno da će zoledronatna kiselina smanjiti metabolički klirens lijekova koje se metaboliziraju putem enzimskih sustava citokroma P450.
English: Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
Croatian: Uz primjenu Aclaste, preporučuje se odgovarajući unos kalcija i vitamina D.
English: Class effects
Croatian: Učinci skupine
English: Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to post-dose symptoms such as pyrexia, vomiting and diarrhoea
Croatian: Nepoznato** Dehidracija sekundarno uz simptome nakon doziranja kao što su pireksija, povraćanje i proljev
English: Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastro-oesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Croatian: Manje često Dispepsija, bol u gornjem abdomenu, bol u abdomenu, bolest gastroezofagealnog refluksa, konstipacija, suha usta, ezofagitis, zubobolja, gastritis
English: 1 bottle contains 5 mg zoledronic acid (as monohydrate).
Croatian: 1 bočica sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
English: Absolute reduction in fracture incidence % (CI)
Croatian: Relativno smanjenje incidencije prijeloma % (CI)
English: Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Croatian: Vrlo rijetko (mogu se javiti u do 1 na 10000 osoba) Obratite se liječniku ako imate bol u uhu, iscjedak iz uha i/ili infekciju uha.
English: Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Croatian: Jedna bočica sa 100 ml otopine sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
English: Each bottle of 100 ml contains 5 mg zoledronic acid (as monohydrate).
Croatian: Jedna bočica od 100 ml sadrži 5 mg zoledronatne kiseline (u obliku hidrata).
English: Uncommon Influenza, nasopharyngitis Blood and lymphatic system disorders Uncommon Anaemia Immune system disorders
Croatian: Poremećaji krvi i limfnog sustava
English: Not known** Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects)
Croatian: Atipični subtrohanterni i dijafizalni prijelomi bedrene kosti† (nuspojava klase bisfosfonata) Vrlo rijetko Osteonekroza vanjskog slušnog kanala (nuspojava razreda bisfosfonata) Nepoznato** Osteonekroza čeljusti (vidjeti dijelove 4.4 i 4.8 učinci po skupinama)
English: Influenza-like illness, chills, fatigue, asthenia, pain, malaise, infusion site reaction
Croatian: Bolest nalik gripi, zimica, umor, astenija, bol, malaksalost, reakcija na mjestu infuzije Manje često Periferni edem, žeđ, reakcija akutne faze, bol u prsištu koja nije vezana uz srce
English: Uncommon Insomnia
Croatian: Manje često Anemija
English: Only clear solution free from particles and discoloration should be used.
Croatian: Upotrebljavati se smije samo bistra otopina u kojoj nema vidljivih čestica i koja nije promijenila boju.
English: Relative reduction in fracture incidence %
Croatian: Relativno smanjenje rizika za incidenciju prijeloma (%)
English: EU/1/14/960/001
Croatian: EU/1/14/960/001 DUAVIVE
English: Oral use blister (UPVC/ Monochlorotrifluor ethylene)
Croatian: Blister (UPVC/ monoklorotrifluoroetilen)
English: 0.45 mg / 20 mg
Croatian: 0,45 mg/20 mg Tableta s prilagođenim oslobađanjem
English: Route of Administration
Croatian: Put primjene Pakiranje
English: DUAVIVE
Croatian: Kroz usta
English: (Invented) name
Croatian: EU broj postupka (Zaštićeno) ime Doza
English: Close monitoring even in apparently uncomplicated cases.
Croatian: Pažljivo praćenje čak i u naizgled nekompliciranih slučajeva.
English: For further information please see section 2.
Croatian: Za dodatne informacije pogledajte dio 2.
English: This risk persists until significant remission occurs.
Croatian: Taj će rizik trajati sve dok ne nastupi značajna remisija.
English: Do this even if there are no signs of discomfort or poisoning.
Croatian: Učinite to čak i ako nema znakova nelagode ili otrovanja.
English: • If you are a young adult.
Croatian: • ako ste mlada odrasla osoba.
English: The mechanism leading to this risk is unknown.
Croatian: Mehanizam koji dovodi do ovog rizika nije poznat.
English: It may be necessary to adjust the dosage of these drugs.
Croatian: Može biti potrebno prilagoditi dozu ovih lijekova.
English: In such cases, it is important to contact your doctor who probably will change your medication.
Croatian: U takvim slučajevima, važno je obratiti se liječniku koji će Vam vjerojatno promijeniti lijek.
English: The underlying illness may persist for a long time.
Croatian: Osnovna bolest može dugo trajati.
English: This medicine is taken every evening as a single daily dose.
Croatian: Ovaj se lijek uzima svake večeri kao jedna dnevna doza.
English: Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths.
Croatian: Ne mogu se postići svi režimi doziranja sa svim farmaceutskim oblicima/jačinama.
English: This appears to be associated with the antidepressant activity.
Croatian: Čini se da je to povezano s antidepresivnim djelovanjem.
English: Admission to hospital (intensive care unit) if required.
Croatian: Prijem u bolnicu (jedinica intenzivne skrbi), ako je potrebno.
English: Contact your doctor immediately.
Croatian: Odmah se obratite liječniku.
English: Patients with special risks
Croatian: Bolesnici pod posebnim rizikom
English: Long-term carcinogenicity studies have not been performed.
Croatian: Dugotrajna ispitivanja kancerogenosti nisu provedena.
English: You may be more likely to think like this:
Croatian: Takvim mislima možete biti skloniji:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu naknadno ažurirati informacije o lijeku, gdje je prikladno u suradnji s referentnom državom članicom, u skladu s postupcima navedenima u Poglavlju 4 Glave III Direktive 2001/83/EZ.
English: Further treatment with oral formulation:
Croatian: Daljnje liječenje oralnom formulacijom:
English: Although these investigations revealed partially contradictory results, particularly a potential to induce chromosome aberrations cannot be excluded.
Croatian: Iako su ta istraživanja dala djelomično kontradiktorne rezultate, osobito se ne može isključiti mogućnost izazivanja kromosomskih aberacija.
English: Secure an IV access.
Croatian: Osigurati i.v. pristup.
English: Patients who display signs of toxicity should be monitored for a minimum of 12 hours.
Croatian: Bolesnike koji pokazuju znakove toksičnosti potrebno je pratiti najmanje 12 sati.
English: Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase.
Croatian: S obzirom na to da je predoziranje često namjerno, bolesnici mogu pokušati samoubojstvo na druge načine tijekom faze oporavka.
English: • uncontrolled movements
Croatian: • nekontrolirane pokrete
English: Consider a 50% reduction of the recommended starting dose.
Croatian: Razmotrite sniženje preporučene početne doze za 50 %.
English: X with alcohol
Croatian: X s alkoholom
English: Contents of the pack and other information What X contains
Croatian: Sadržaj pakiranja i druge informacije Što X sadrži
English: The dose should be increased gradually.
Croatian: Dozu je potrebno postupno povećavati.
English: You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Croatian: Možete ih zamoliti da Vam kažu ako smatraju da Vam se depresija ili anksioznost pogoršavaju ili ako su zabrinuti zbog promjena u Vašem ponašanju.
English: The plasma protein binding is about 95%.
Croatian: Vezanje za proteine plazme iznosi oko 95 %.
English: In the listing below the following convention is used:
Croatian: U popisu niže koristi se sljedeća konvencija:
English: Your doctor will re-evaluate your treatment after 3 months and if needed perform a new ECG.
Croatian: Liječnik će ponovno procijeniti Vaše liječenje nakon 3 mjeseca i po potrebi napraviti novi EKG.
English: Respiratory depression.
Croatian: Respiratorna depresija.
English: As with other medicines for the treatment of depression it may take a few weeks before you feel any improvement.
Croatian: Kao i kod drugih lijekova za liječenje depresije, može biti potrebno nekoliko tjedana prije nego što osjetite ikakvo poboljšanje.
English: Treatment in respirator is advised to prevent a possible respiratory arrest.
Croatian: Savjetuje se liječenje pomoću respiratora kako bi se spriječio mogući respiratorni arest.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Croatian: Budući da poboljšanje možda neće nastupiti tijekom prvih nekoliko tjedana liječenja ili dulje, bolesnike je potrebno pažljivo nadzirati sve dok ne nastupi takvo poboljšanje.
English: • are taking any other medication that may cause heart problems, or
Croatian: • uzimate neki drugi lijek koji može prouzročiti srčane tegobe ili
English: The reason for the effect on fertility is unknown.
Croatian: Razlog za taj učinak na plodnost nije poznat.
English: Lowered consciousness progressing into coma.
Croatian: Sniženje svijesti koje napreduje u komu.
English: Perform electrocardiograph-look for QRS>0.16 seconds 4.
Croatian: Provesti elektrokardiografsko snimanje - paziti na QRS > 0,16 sekundi.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Croatian: Uobičajeno je kliničko iskustvo da rizik od samoubojstva može biti povećan u ranim fazama oporavka.
English: • Suicidal thoughts or behaviour.
Croatian: • Suicidalne misli ili ponašanje.
English: The duration of treatment is decided by your doctor.
Croatian: O trajanju liječenja odlučuje Vaš liječnik.
English: In case of sufficient effect, the dose should be as low as possible.
Croatian: U slučaju da je učinak dovoljan, doza treba biti što je moguće niža.
English: Do not chew them.
Croatian: Nemojte ih žvakati.
English: In children under 6 years of age.
Croatian: U djece u dobi ispod 6 godina.
English: • excitement, anxiety, difficulties sleeping, nightmares
Croatian: • uzbuđenje, tjeskoba, poteškoće sa spavanjem, noćne more
English: This condition may be signs of acute glaucoma.
Croatian: Ovo stanje može biti znak akutnog glaukoma.
English: Symptoms of overdose include:
Croatian: Simptomi predoziranja uključuju:
English: You should immediately have an eye examination before the treatment with this medicine can be continued.
Croatian: Odmah morate otići na pregled očiju prije nego što se može nastaviti s liječenjem ovim lijekom.
English: Suicide/suicidal thoughts
Croatian: Samoubojstvo/suicidalne misli
English: • increased sensitivity to sunlight
Croatian: • pojačana osjetljivost na sunčevu svjetlost
English: It is generally recommended to initiate treatment in the lower dose range as recommended for adult.
Croatian: Općenito se preporučuje započeti liječenje dozama u nižem rasponu kakve se preporučuju za odrasle.
English: Initial treatment:
Croatian: Početno liječenje:
English: Your doctor will most likely choose to initiate your treatment with Saroten film-coated tablets before starting treatment with X.
Croatian: Liječnik će najvjerojatnije odlučiti započeti Vaše liječenje Saroten filmom obloženim tabletama prije početka liječenja lijekom X.
English: Continuous ECG-monitoring of cardiac function for 3-5 days.
Croatian: Kontinuirano praćenje srčane funkcije pomoću EKG-a tijekom 3-5 dana.
English: • dry mouth and tongue
Croatian: • suha usta i jezik
English: Some medicines may affect the action of other medicines and this can sometimes cause serious side effects.
Croatian: Neki lijekovi mogu utjecati na djelovanje drugih lijekova i to ponekad može prouzročiti ozbiljne nuspojave.
English: Likewise, you should tell your dentist that you take this medicine if you are to receive a local anaesthetic.
Croatian: Isto tako, trebate obavijestiti svog zubara da uzimate ovaj lijek ako ćete primiti lokalni anestetik.
English: Take the container of this medicine with you if you go to a doctor or hospital.
Croatian: Ponesite spremnik ovog lijeka sa sobom ako idete liječniku ili u bolnicu.
English: • changes in taste
Croatian: • promjene okusa
English: Your liver may be affected.
Croatian: Jetra može biti zahvaćena.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Croatian: Takve misli mogu biti izraženije kad tek počinjete uzimati antidepresive, jer tim lijekovima treba vremena da počnu djelovati, obično oko dva tjedna, a ponekad i dulje.
English: Take this medicine 1-1½ hours before bedtime.
Croatian: Uzmite ovaj lijek 1 - 1½ sat prije odlaska na spavanje.
English: There is considerably individual variability in response to overdose.
Croatian: Postoji znatna individualna varijabilnost u odgovoru na predoziranje.
English: • disorder of the peripheral nerves
Croatian: • poremećaj perifernih živaca
English: Tell your doctor if you have, or have had in the past, any medical problems, especially if you have
Croatian: Obavijestite svog liječnika ako imate ili ste u prošlosti imali ikakvih zdravstvenih tegoba, osobito ako imate
English: The pellets must not be chewed.>
Croatian: Pelete se ne smiju žvakati.>
English: This medicine may cause drowsiness and dizziness, especially in the beginning of the treatment.
Croatian: Ovaj lijek može uzrokovati omamljenost i omaglicu, osobito na početku liječenja.
English: In treating depression the duration of treatment is individual, and is usually at least 6 months.
Croatian: Kod liječenja depresije, trajanje liječenja je individualno i obično traje najmanje 6 mjeseci.
English: Generally, the lowest effective dose should be used for the shortest duration required to treat the symptoms.
Croatian: Uglavnom, potrebno je primijeniti najnižu djelotvornu dozu tijekom najkraćeg razdoblja potrebnog za liječenje simptoma.
English: If you get any of the following symptoms you should see your doctor immediately:
Croatian: Ako dobijete neki od sljedećih simptoma, odmah se obratite liječniku:
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec YYYY}>.
English: X can be taken with or without food.
Croatian: X se može uzimati s hranom ili bez nje.
English: • have or had a problem where your heart cannot pump the blood round your body as well as it should (a condition called heart failure),
Croatian: • imate ili ste imali problem kod kojeg srce ne može pumpati krv kroz tijelo onako dobro kako bi trebalo (to se stanje naziva zatajenje srca)
English: • aged below 6 years: see section 2 Do not take X
Croatian: • u dobi do 6 godina: pogledajte dio 2 Nemojte uzimati X
English: Children are especially susceptible to cardiotoxicity and seizures.
Croatian: Djeca su osobito osjetljiva na kardiotoksičnost i napadaje.
English: Warnings and precautions Talk to your doctor or pharmacist before taking X.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete X.
English: Some patients with manic-depressive illness may enter into a manic phase.
Croatian: Neki bolesnici s manično-depresivnim poremećajem mogu ući u maničnu fazu.
English: • if you have taken MAOIs within the last 14 days
Croatian: • ako ste uzimali MAO inhibitor unutar prethodnih 14 dana
English: Reuptake prevention of these monoamine neurotransmitters potentiate their action in the brain.
Croatian: Sprječavanje ponovne pohrane ovih monoaminskih neurotransmitera pojačava njihovo djelovanje u mozgu.
English: The metabolism is subject to genetic polymorphism.
Croatian: Metabolizam je podložan genskom polimorfizmu.
English: If you have difficulty in swallowing the capsules, you can open them and put the pellets in e.g. yoghurt or a cold drink.
Croatian: Ako imate poteškoća s gutanjem kapsula, možete ih otvoriti i staviti zrnca u, primjerice, jogurt ili hladni napitak.
English: • increased production of breast milk or breast milk outflow without breast feeding
Croatian: • pojačano stvaranje mlijeka ili izlučivanje mlijeka nevezano s dojenjem
English: The renal elimination of unchanged amitriptyline is insignificant (about 2%).
Croatian: Eliminacija nepromijenjenog amitriptilina putem bubrega je beznačajna (oko 2 %).
English: If you are treated with X, you have to stop taking this medicine and wait for 14 days before you start treatment with a MAOI.
Croatian: Ako se liječite lijekom X, morate prestati uzimati taj lijek i pričekati 14 dana prije nego što počnete liječenje MAO inhibitorom.
English: The maximum plasma concentration is reached only after 1 to 5 (-8) hours.
Croatian: Maksimalna koncentracija u plazmi postiže se tek nakon 1 do 5 (-8) sati.
English: *Case reports of suicidal thoughts or behaviour were reported during the treatment with or just after conclusion of the treatment with amitriptyline (see section 4.4).
Croatian: *Slučajevi suicidalnih misli ili ponašanja prijavljeni su tijekom liječenja ili neposredno nakon završetka liječenja amitriptilinom (vidjeti dio 4.4)
English: Widening of the QRS-complex usually correlates well with the severity of the toxicity following acute overdoses.
Croatian: Proširenje QRS kompleksa obično dobro korelira s težinom toksičnosti nakon akutnih predoziranja.
English: The systemic bioavailability is about 50% of the intravenous injection.>
Croatian: Sistemska bioraspoloživost iznosi oko 50 % intravenske injekcije.>
English: If you stop your treatment too soon, your symptoms may return.
Croatian: Ako prerano prestanete s liječenjem, simptomi
English: The maintenance dose is the lowest effective dose.
Croatian: Doza održavanja je najniža djelotvorna doza.
English: Regular reassessment is recommended to confirm that continuation of the treatment remains appropriate for the patient.
Croatian: Preporučuje se redovito praćenje kako bi se potvrdilo da je nastavak terapije i dalje primjeren za bolesnika.
English: The pellets in the capsule contain sucrose.
Croatian: Pelete u kapsuli sadrže saharozu.
English: This medicine can be taken with or without food.
Croatian: Ovaj se lijek može uzimati s hranom ili bez nje.
English: Thoughts of suicide and worsening of your depression If you are depressed, you can sometimes have thoughts of harming or killing themselves.
Croatian: Misli o samoubojstvu i pogoršanje depresije Ako ste depresivni, ponekad možete razmišljati o samoozljeđivanju ili samoubojstvu.
English: The dose can be taken once daily, or be divided into two doses.
Croatian: Doza se može uzeti jedanput dnevno ili se podijeliti u dvije doze.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, such as:
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, kao što su:
English: • loss of consciousness
Croatian: • gubitak svijesti
English: Dosage and duration of treatment will be determined by you physician based on the severity of your disease and your clinical response.
Croatian: Dozu i trajanje liječenja odredit će Vaš liječnik na temelju težine Vaše bolesti i Vašeg kliničkog odgovora.
English: If required, the available dose range can be exploited.
Croatian: Po potrebi se može iskoristiti dostupni raspon doza.
English: This is characterized by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical activity.
Croatian: Ona je obilježena obilnom količinom ideja koje se brzo izmjenjuju, pretjeranom radošću i prekomjernom fizičkom aktivnošću.
English: There was a possible association with an effect on fertility in rats, namely a lower pregnancy rate.
Croatian: Postojala je moguća povezanost s učinkom na plodnost u štakora, točnije, nižom stopom graviditeta.
English: ATC code: N 06 AA 09
Croatian: ATK oznaka: N 06 AA 09 Mehanizam djelovanja
English: If you stop taking X
Croatian: Ako prestanete uzimati X
English: Contact your doctor or nearest hospital casualty department immediately.
Croatian: Odmah se obratite svom liječniku ili hitnoj službi u najbližoj bolnici.
English: This medicine should not be used for children below 6 years of age.
Croatian: Ovaj se lijek ne smije primjenjivati u djece mlađe od 6 godina.
English: Effects on the blood could be a decrease in the number of red cells (which carry oxygen around the body), white cells (which help to fight infection) and platelets (which help with clotting).
Croatian: Učinci na krv mogu biti smanjenje broja crvenih krvnih stanica (koje prenose kisik po tijelu), bijelih krvnih stanica (koje pomažu u borbi protiv infekcije) i krvnih pločica (koje pomažu u zgrušavanju krvi).
English: Contraindicated combinations
Croatian: Kontraindicirane kombinacije
English: Talk to your doctor about the duration of your treatment and continue to take this medicine for as long as your doctor recommends.
Croatian: Razgovarajte s liječnikom o trajanju Vašeg liječenja i nastavite uzimati ovaj lijek onoliko dugo koliko to preporučuje liječnik.
English: Levels above 300-400 ng/ml are associated with increased risk of disturbance in cardiac conduction in terms of prolonged QRS-complex or AV block.
Croatian: Razine iznad 300 - 400 ng/ml povezane su s povećanim rizikom od poremećaja provođenja podražaja u srcu u smislu produljenog QRS kompleksa ili AV bloka.
English: How and when to take X
Croatian: Kako i kada uzimati X
English: • oral contraceptives
Croatian: • oralni kontraceptivi
English: You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.
Croatian: Možda će Vam pomoći da kažete članu obitelji ili bliskom prijatelju da ste depresivni i zamolite ih da pročitaju ovu uputu o lijeku.
English: In plasma the amount of total 10-hydroxynortriptyline dominates but most of the metabolites are conjugated.
Croatian: U plazmi preteže količina ukupnog 10-hidroksinortriptilina, ali većina metabolita je konjugirana.
English: Before starting treatment, your doctor will conduct an ECG of your heart to check for sign of unusual heartbeat.
Croatian: Prije početka liječenja, liječnik će napraviti EKG srca kako bi provjerio postoje li znakovi neuobičajenih otkucaja srca.
English: • delirium (especially in elderly patients), hallucinations (especially in patients with schizophrenia),
Croatian: • delirij (osobito u starijih bolesnika), halucinacije (osobito u bolesnika sa shizofrenijom)
English: • feeling of inner restlessness and a compelling need to be in constant motion
Croatian: • osjećaj unutarnjeg nemira i nesavladive potrebe da se bude u stalnom pokretu
English: However, the capsules can be opened and the pellets swallowed with a cold drink or e.g. yoghurt.
Croatian: Međutim, kapsule se mogu otvoriti i pelete progutati s hladnim napitkom ili npr. jogurtom.
English: • disturbance in attention
Croatian: • poremećaj pozornosti