FrancophonIA/ELRC3.0 huggingface dataset:
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 primjenjuje pod strožim uvjetima od normalnih jer se može pogrešno primijeniti ili uzrokovati ovisnost.
English: Why is Sixmo authorised in the EU?
Croatian: Zašto je lijek Sixmo odobren u EU-u?
English: For more information about using Sixmo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Sixmo pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Sixmo can only be obtained by ‘special' prescription.
Croatian: Lijek se izdaje samo na „poseban” recept.
English: The insertion and removal of the implant must be performed by a doctor who is experienced in minor surgery and has been trained to carry out the insertion and removal procedures.
Croatian: Ugradnju i uklanjanje implantata mora provesti liječnik kvalificiran za izvođenje malog kirurškog zahvata i koji je educiran za izvođenje postupka ugradnje i uklanjanja.
English: An overview of Sixmo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Sixmo i zašto je odobren u EU-u
English: Sixmo is available as an implant to be inserted under the skin, which continuously releases buprenorphine into the body.
Croatian: Sixmo se primjenjuje kao implantat koji se ugrađuje pod kožu i koji kontinuirano otpušta buprenorfin u tijelo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sixmo have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Sixmo nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: What are the risks associated with Sixmo?
Croatian: Koji su rizici povezani s lijekom Sixmo?
English: The patient receives four implants, which are inserted under local anaesthesia in the inner side of the upper arm and kept in place for 6 months.
Croatian: Bolesnik prima četiri implantata koja se ugrađuju pod lokalnom anestezijom u unutarnji dio nadlaktice i na mjestu ugradnje ostaju šest mjeseci.
English: The company that markets Sixmo will set up an educational programme for doctors who are expected to prescribe Sixmo to provide detailed information about the surgical procedure for the insertion and removal of the implant.
Croatian: Tvrtka koja stavlja lijek Sixmo u promet uspostavit će edukacijski program namijenjen liječnicima od kojih se očekuje da će propisivati lijek Sixmo radi pružanja detaljnih informacija o kirurškom zahvatu ugradnje i uklanjanja implantata.
English: While the effect of the implants tended to wear off with time in patients not previously treated with buprenorphine, it was maintained in patients who were already stable on low doses of buprenorphine and the use of Sixmo is therefore reserved for these patients.
Croatian: Premda je učinak implantata slabio s vremenom u bolesnika koji prethodno nisu bili liječeni buprenorfinom, njegov je učinak ostao postojan u bolesnika koji su već bili stabilni na niskim dozama buprenorfina te je stoga primjena lijeka Sixmo rezervirana za te bolesnike.
English: Treatment with Sixmo must be under the supervision of a healthcare professional experienced in the management of opioid dependence.
Croatian: Liječenje lijekom Sixmo mora se provoditi pod nadzorom zdravstvenog radnika s iskustvom u liječenju ovisnosti o opioidima.
English: During the 6 months of treatment, the percentage of negative urine tests for opioids was around 31% for Sixmo, 13% for placebo and 33% for sublingual buprenorphine.
Croatian: Tijekom šest mjeseci liječenja postotak negativnih analiza mokraće na opioide iznosio je otprilike 31 % za lijek Sixmo, 13 % za placebo i 33 % za sublingvalni buprenorfin.
English: As for all medicines, data on the use of Sixmo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Sixmo kontinuirano se prate.
English: The first study compared Sixmo with placebo (dummy) implants in 163 patients who had not received buprenorphine before.
Croatian: U prvom je ispitivanju Sixmo uspoređen s placebo implantatima (prividno liječenje) na 163 bolesnika koji ranije nisu primali buprenorfin.
English: The second study in 287 patients who had not received buprenorphine before compared Sixmo with placebo implants and with sublingual buprenorphine (given under the tongue).
Croatian: U drugom je ispitivanju na 287 bolesnika koji ranije nisu primali buprenorfin Sixmo uspoređen s placebo implantatima i sa sublingvalnim buprenorfinom (daje se pod jezik).
English: Three studies involving a total of 627 patients with opioid dependence showed that Sixmo is effective at reducing patients' intake of opioids.
Croatian: U trima je ispitivanjima na ukupno 627 bolesnika s ovisnošću o opioidima utvrđeno da lijek Sixmo učinkovito smanjuje količinu opioida koju bolesnici unose.
English: During the first 4 months of treatment, the percentage of negative urine tests for opioids was around 40% for patients treated with Sixmo, compared with around 28% for those treated with placebo.
Croatian: Tijekom prva četiri mjeseca liječenja postotak negativnih analiza mokraće na opioide iznosio je otprilike 40 % za bolesnike koji su liječeni lijekom Sixmo, u usporedbi s 28 % za one liječene placebom.
English: What benefits of Sixmo have been shown in studies?
Croatian: Koje su koristi od lijeka Sixmo utvrđene u ispitivanjima?
English: It must also not be used by patients who cannot have an MRI scan and by patients who have had an excessive formation of scar tissue, as this would make locating and removing the implants more difficult.
Croatian: Isto se tako ne smije primjenjivati u bolesnika koji ne smiju biti podvgrnuti snimanju magnetskom rezonancijom te u bolesnika kod kojih je zabilježeno prekomjerno stvaranje ožiljkastog tkiva jer bi to moglo otežati ugradnju i uklanjanje implantata.
English: The side effects of Sixmo are those expected for a buprenorphine medicine and side effects linked to the implant itself are considered manageable.
Croatian: Nuspojave lijeka Sixmo očekivane su za lijek s buprenorfinom, a smatra se da se nuspojave povezane sa samim implantatom mogu kontrolirati.
English: How does Sixmo work?
Croatian: Kako djeluje Sixmo?
English: In both of these studies, the number of urine tests that were negative for opioid use decreased towards the end of the treatment period, indicating a reduction of the effect of Sixmo over time.
Croatian: U obama ispitivanjima određeni se broj analiza mokraće, koji je bio negativan na opioide, smanjivao prema završetku razdoblja liječenja, što je ukazivalo na smanjenje učinka lijeka Sixmo tijekom vremena.
English: The third study compared Sixmo with sublingual buprenorphine in 177 patients whose opioid dependence was already being managed with sublingual buprenorphine at a daily dose of up to 8 mg. After 6 months of treatment, around 96% of patients who received Sixmo responded to treatment (i.e. there was no evidence of opioid use in at least 4 out of 6 months) compared with around 88% in patients on sublingual buprenorphine.
Croatian: Nakon šest mjeseci liječenja kod otprilike 96 % bolesnika koji su primali Sixmo postignut je odgovor na terapiju (tj. nije bilo znakova primjene opioida najmanje četiri od šest mjeseci), u usporedbi s otprilike 88 % bolesnika koji su uzimali sublingvalni buprenorfin.
English: How is Sixmo used?
Croatian: Kako se Sixmo primjenjuje?
English: For the full list of side effects of Sixmo, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Sixmo potražite u uputi o lijeku.
English: NeoRecormon is available in various strengths from 500 to 50,000 international units (IU).
Croatian: NeoRecormon je dostupan u različitim jačinama od 500 do 50 000 internacionalnih jedinica (IU).
English: The full EPAR for NeoRecormon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • to prevent anaemia in premature babies;
Croatian: • za sprječavanje anemije u prerano rođenih beba;
English: NeoRecormon is used in the following situations:
Croatian: NeoRecormon se primjenjuje u sljedećim situacijama:
English: The European Commission granted a marketing authorisation valid throughout the European Union for NeoRecormon on 17 July 1997.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek NeoRecormon na snazi u Europskoj uniji od 17. srpnja 1997.
English: The multidose formulation of NeoRecormon contains benzyl alcohol and must not be given to children below three years of age.
Croatian: NeoRecormon sadrži benzilni alkohol i ne smije se davati djeci mlađoj od tri godine.
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 NeoRecormon.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka NeoRecormon.
English: This is a summary of the European public assessment report (EPAR) for NeoRecormon.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku NeoRecormon.
English: For more information about treatment with NeoRecormon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom NeoRecormon pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The most common side effects (seen in between 1 and 10 patients in 100) are hypertension (high blood pressure), headache and thromboembolic events (formation of blood clots in the blood vessels).
Croatian: Najčešće nuspojave (mogu se javiti u 1 do 10 bolesnika na 100 osoba) su hipertenzija (visoki krvni tlak), glavobolja i tromboembolijski događaji (formiranje krvnih ugrušaka u krvnim žilama).
English: NeoRecormon must not be used in patients who have poorly controlled high blood pressure.
Croatian: Lijek NeoRecormon ne smije se primjenjivati u bolesnika koji imaju slabo kontrolirani visoki krvni tlak.
English: What measures are being taken to ensure the safe and effective use of NeoRecormon?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka NeoRecormon?
English: The effectiveness of NeoRecormon to treat or prevent anaemia has been studied in many studies including anaemia in chronic renal failure (1,663 patients, including some comparative studies against placebo (a dummy treatment)), autologous blood transfusion (419 patients, comparison with placebo), anaemia in premature babies (177 babies, comparison with no treatment), and in cancer patients (1,204 patients with different types of cancer, comparison with placebo).
Croatian: Djelotvornost lijeka NeoRecormon pri liječenju ili sprječavanju anemije ispitivala se u mnogim ispitivanjima uključujući anemiju u kroničnom zatajenju bubrega (1663 bolesnika, uključujući i neka komparativna ispitivanja u odnosu na placebo (prividno liječenje), autolognu transfuziju krvi (419 bolesnika, usporedba s placebom), anemiju u prerano rođenih beba (177 beba, usporedba sa slučajevima bez liječenja), te u bolesnika oboljelih od raka (1204 bolesnika s različitim tipovima raka, usporedba s placebom).
English: Other information about NeoRecormon
Croatian: Ostale informacije o lijeku NeoRecormon
English: It contains the active substance epoetin beta.
Croatian: Sadrži djelatnu tvar epoetin beta.
English: A risk management plan has been developed to ensure that NeoRecormon is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka NeoRecormon.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in adults and children with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly);
Croatian: • za liječenje anemije (malog broja crvenih krvnih stanica) koju uzrokuju simptomi u odraslih i djece s kroničnim zatajenjem bubrega (dugoročnim, progresivnim smanjenjem sposobnosti bubrega da ispravno funkcioniraju);
English: It also increased the amount of blood that could be taken from patients before surgery for autologous blood transfusion and reduced the need for transfusion in premature babies and in cancer patients receiving chemotherapy.
Croatian: Povećao je i količinu krvi koju bolesnici mogu dati prije kirurškog zahvata za autolognu transfuziju krvi te je smanjio potrebu za transfuzijom u prerano rođenih beba i bolesnika oboljelih od raka koji primaju kemoterapiju.
English: The dose, the frequency of injection, and how long it is used for depend on why NeoRecormon is used, and are adjusted according to the patient's response to treatment.
Croatian: Doza, učestalost injekcije i trajanje primjene ovise o razlogu primjene lijeka NeoRecormon, te se prilagođavaju u skladu s odgovorom bolesnika na liječenje.
English: NeoRecormon was more effective than placebo at increasing haemoglobin levels in patients with various types of anaemia, including those with chronic renal failure.
Croatian: NeoRecormon je bio djelotvorniji od placeba u povećanju razina hemoglobina u bolesnika s različitim tipovima anemije, uključujući i anemije povezane s kroničnim zatajenjem bubrega.
English: It is also available as a pre-filled syringe.
Croatian: Lijek je dostupan i kao napunjena štrcaljka.
English: It is available as a powder and solvent in a multidose vial, to be made up into a solution for injection.
Croatian: Dostupan je kao prašak i otapalo u višedoznoj bočici koji se zajedno miješaju kako bi se dobila otopina za injekciju.
English: The CHMP decided that NeoRecormon's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka NeoRecormon nadmašuju s njim povezane rizike te je za njega preporučio izdavanje odobrenja za stavljanje u promet.
English: The epoetin beta in NeoRecormon works in the body in the same way as the natural hormone to stimulate red blood cell production.
Croatian: Epoetin beta u lijeku NeoRecormon u tijelu djeluje na isti način kao prirodni hormon stimulirajući proizvodnju crvenih krvnih stanica.
English: The active substance in NeoRecormon, epoetin beta, is a copy of a human hormone called erythropoietin.
Croatian: Djelatna tvar u lijeku NeoRecormon, epoetin beta, kopija je ljudskog hormona naziva eritropoetin.
English: NeoRecormon is a medicine that stimulates red-blood-cell growth.
Croatian: NeoRecormon je lijek koji potiče rast crvenih krvnih stanica.
English: • to treat anaemia that is causing symptoms in adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer that does not affect the bone marrow);
Croatian: • za liječenje anemije sa simptomima u odraslih bolesnika koji primaju kemoterapiju za meijeloični rak (rak koji nema utjecaja na koštanu srž);
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NeoRecormon, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za NeoRecormon nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: In patients receiving chemotherapy or with chronic renal failure, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Croatian: Kod bolesnika koji primaju kemoterapiju ili imaju kronično zatajenje bubrega, anemiju može uzrokovati manjak eritropoetina ili organizam koji adekvatno ne reagira na eritropoetin koji se prirodno nalazi u tijelu.
English: The main measures of effectiveness in most of the studies were whether NeoRecormon increased haemoglobin levels or whether it reduced the need for blood transfusions.
Croatian: Glavna mjera djelotvornosti pri primjeni lijeka NeoRecormon u većini je ispitivanja bila uspješnost u povećanju razine hemoglobina ili uspješnost u smanjenju potrebe za transfuzijama krvi.
English: • to increase the amount of blood that can be taken from adult patients with moderate anaemia who are going to have an operation and need to have a supply of their own blood before surgery (autologous blood transfusion).This is only done when blood storage procedures are not available or are insufficient because the surgery requires a large volume of blood.
Croatian: • za povećanje količine krvi koju odrasli bolesnici s umjerenom anemijom i normalnim koncentracijama željeza u krvi mogu dati, a koji se podvrgavaju operaciji i doniraju svoju krv prije kirurškog zahvata (autologna transfuzija krvi); koristi se kad ne postoje postupci konzerviranja krvi ili oni nisu dovoljni jer kirurški zahvat zahtijeva veliku količinu krvi.
English: In patients who are to undergo autologous blood transfusion, NeoRecormon must not be used if they have had a heart attack or stroke within the last month, if they have angina pectoris (a severe type of chest pain), or if they are at risk of deep venous thrombosis (DVT, formation of blood clots in the deep veins of the body, usually in the leg).
Croatian: U bolesnika koji se spremaju za autolognu transfuziju krvi, lijek NeoRecormon ne smije se primjenjivati ako su bolesnici pretrpjeli srčani ili moždani udar u posljednjih mjesec dana, ako bolesnici boluju od angine pektoris (snažne boli u prsima) ili pak ako za bolesnike postoji rizik od duboke venske tromboze (DVT, stvaranje krvnih ugrušaka u dubokim venama, najčešće u nozi).
English: For patients with chronic renal failure, NeoRecormon can be injected into a vein or under the skin, but it must be injected under the skin in premature babies and patients receiving chemotherapy, and into a vein in patients who are going to have their blood extracted for their surgery.
Croatian: Za bolesnike s kroničnim zatajenjem bubrega lijek NeoRecormon može se injicirati u venu ili pod kožu, ali se pod kožu mora injicirati u slučaju prerano rođenih beba i bolesnika koji primaju kemoterapiju, a u venu u bolesnika koji daju krv za svoj kirurški zahvat.
English: Treatment with NeoRecormon should be initiated by a doctor who has experience in the care of patients with the types of anaemia that NeoRecormon is used to treat and prevent.
Croatian: Liječenje lijekom NeoRecormon treba započeti liječnik s iskustvom s bolesnicima s tipom anemije koja se liječi i sprječava lijekom NeoRecormon.
English: What is the risk associated with NeoRecormon?
Croatian: Koji su rizici povezani s lijekom NeoRecormon?
English: What is NeoRecormon?
Croatian: Što je NeoRecormon?
English: For the full list of all side effects reported with NeoRecormon, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka NeoRecormon potražite u uputi o lijeku.
English: Erythropoietin is produced by the kidneys and stimulates the production of red blood cells from the bone marrow.
Croatian: Eritropoetin se proizvodi u bubrezima i u koštanoj srži potiče proizvodnju crvenih krvnih stanica.
English: The types of side effects seen with NeoRecormon depend on the cause of the patient's anaemia.
Croatian: Tipovi nuspojava zabilježenih pri primjeni lijeka NeoRecormon ovise o uzroku anemije u bolesnika.
English: For more details, see the package leaflet.
Croatian: Za dodatne informacije vidjeti uputu o lijeku.
English: What is NeoRecormon used for?
Croatian: Za što se NeoRecormon koristi?
English: Why has NeoRecormon been approved?
Croatian: Zašto je lijek NeoRecormon odobren?
English: What benefit has NeoRecormon shown during the studies?
Croatian: Koje su koristi lijeka NeoRecormon utvrđene u ispitivanjima?
English: How is NeoRecormon used?
Croatian: Kako se NeoRecormon koristi?
English: How has NeoRecormon been studied?
Croatian: Kako je NeoRecormon ispitivan?
English: How does NeoRecormon work?
Croatian: Kako djeluje NeoRecormon?
English: Applicant company name, address
Croatian: Nositelj odobrenja naziv tvrtke, adresa
English: United Kingdom Hetero Europe S.L.
Croatian: Egyesült Királyság Hetero Europe S.L. Viladecans Business
English: Invented Name
Croatian: (Zaštićen) Naziv Jačina
English: End of December 2018
Croatian: Kraja prosinca 2018.
English: The final study report should be submitted by:
Croatian: Završno izvješće o ispitivanju treba se dostaviti do:
English: The protocol of this study should be submitted to the PRAC within 6 months after notification of the EC Decision.
Croatian: Protokol ovog ispitivanja treba se dostaviti PRAC-u u roku od 6 mjeseci nakon objavljivanja Odluke EK-a.
English: For chlormadinone-containing combined hormonal contraceptives The MAHs for chlormadinone containing CHCs should carry out a post-authorisation safety study to compare the risk of VTE with chlormadinone/ethinyestradiol versus levonorgestrel/ethinyestradiol.
Croatian: Nositelji odobrenja za KHK-ove koji sadrže klormadinon trebaju provesti ispitivanje sigurnosti primjene lijeka nakon stavljanja u promet kako bi se usporedio rizik od VTE s klormadinonom/ etiniestradiolom u odnosu na levonorgestrel/etiniestradiol.
English: National Competent Authorities of Member States or Reference Member States, if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Croatian: Uvjeti odobrenja za stavljanje lijeka u promet Nacionalna nadležna tijela država članica ili referentnih država članica, ako je primjenjivo, osigurat će da nositelji odobrenja ispune sljedeće uvjete:
English: Immediate Packaging
Croatian: Put primjene Unutarnje pakovanje Veličina pakiranja
English: (Possible mechanism)
Croatian: (Mogući mehanizam)
English: 32 weeks 26 % 144 weeks
Croatian: 32 tjedna 26 % 144 tjedna
English: Protect other people
Croatian: Zaštitite ostale ljude
English: You may have problems with your bones
Croatian: Možete imati problema s Vašim kostima
English: Then continue your treatment as before.
Croatian: Zatim nastavite s terapijom kao prije.
English: Patients at increased risk should be followed closely.
Croatian: Bolesnike s povećanim rizikom se mora pažljivo pratiti.
English: Write your doctor's details below:
Croatian: Ispod upišite podatke Vašeg liječnika:
English: ATC Code: J05AR04.
Croatian: ATK oznaka: J05AR04.
English: If you forget to take a dose, take it as soon as you remember.
Croatian: Ako zaboravite jednu dozu, uzmite je čim se sjetite.
English: So it is very important to talk to your doctor about any changes in your health.
Croatian: Iz tog razloga, jako je važno da razgovarate sa svojim liječnikom o svim promjenama Vašeg zdravstvenog stanja.
English: Don't drive or operate machines unless you're feeling well.
Croatian: Ne vozite i ne upravljajte sa strojevima ako se ne osjećate dobro.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne podatke.
English: Trizivir can be taken with or without food.
Croatian: Trizivir se može uzimati sa ili bez hrane.
English: Your doctor will monitor the effectiveness of your treatment.
Croatian: Liječnik će nadzirati učinkovitost Vašeg liječenja.
English: Swallow the tablets whole, with some water.
Croatian: Tablete progutajte cijele s malo vode.
English: If you do, within hours, your blood pressure could fall dangerously low, which could result in death.
Croatian: Ako to učinite, već unutar nekoliko sati Vaš krvni tlak može se spustiti do opasno niskih vrijednosti, što može uzrokovati smrt.
English: See your doctor as soon as possible.
Croatian: Posjetite svog liječnika čim je prije moguće.