FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency considered that the combined use of the active ingredients in Qtrilmet produces worthwhile reduction in HbA1c and that all the active ingredients contribute to this effect.
Croatian: Europska agencija za lijekove zaključila je da se kombiniranom primjenom djelatnih sastojaka u lijeku Qtrilmet postiže znatno smanjenje razine glikoziliranog hemoglobina i da svi djelatni sastojci doprinose tom učinku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qtrilmet have 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 Qtrilmet nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Diabetes leads to high levels of glucose in the blood.
Croatian: Šećerna bolest uzrokuje visoke razine glukoze u krvi.
English: As for all medicines, data on the use of Qtrilmet are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Qtrilmet kontinuirano se prate.
English: The most common side effects with Qtrilmet (which may affect more than 1 in 10 people) are infections of the nose and throat, hypoglycaemia (low blood sugar) when used with a sulphonylurea and effects on the gut such as nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Croatian: Najčešće nuspojave lijeka Qtrilmet (koje se mogu pojaviti u više od 1 na 10 bolesnika) jesu infekcije nosa i grla, hipoglikemija (niska razina šećera u krvi) kada se koristi sa sulfonilurejom i učinci na crijeva poput mučnine, povraćanja, proljeva, bolova u trbuhu i gubitak apetita.
English: Insulin is important for controlling how the body converts glucose (a type of sugar) to energy and how the glucose is stored in the body.
Croatian: Inzulin je važan za kontrolu načina na koji tijelo glukozu pretvara u energiju i načina na koji se glukoza pohranjuje u tijelu.
English: • adults whose blood sugar is not controlled well enough with metformin combined with either saxagliptin or dapagliflozin (including those also taking a sulphonylurea, another type of diabetes medicine);
Croatian: • odraslih čija se razina šećera u krvi ne može dovoljno dobro kontrolirati metforminom u kombinaciji sa saksagliptinom ili dapagliflozinom (uključujući i one koji uzimaju sulfonilureju, drugu vrstu lijeka protiv šećerne bolesti),
English: It is available in two strengths of tablets containing: metformin 850 mg, saxagliptin 2.5 mg and dapagliflozin 5 mg; and metformin 1,000 mg, saxagliptin 2.5 mg and dapagliflozin 5 mg.
Croatian: Dostupan je u dvije jačine tableta koje sadrže: 850 g metformina, 2,5 mg saksagliptina i 5 mg dapagliflozina odnosno 1 000 metformina, 2,5 mg saksagliptina i 5 mg dapagliflozina.
English: Qtrilmet can only be obtained with a prescription.
Croatian: Lijek Qtrilmet izdaje se samo na recept.
English: Qtrilmet must also not be used in patients with certain kidney, liver or heart problems or metabolic acidosis (build-up of acid in the blood), or in patients with certain conditions that can lead to metabolic acidosis.
Croatian: Lijek Qtrilmet ne smije se primjenjivati u bolesnika koji imaju problema s bubrezima, jetrom ili srcem ili metaboličku acidozu (stvaranja kiseline u krvi) ili u bolesnika s određenim stanjima koje mogu dovesti do metaboličke acidoze.
English: • Metformin works mainly by reducing glucose production and reducing its absorption from the gut.
Croatian: • Metformin uglavnom djeluje tako da smanjuje proizvodnju glukoze i njezinu apsorpciju iz crijeva.
English: Qtrilmet must not be used in people who are hypersensitive (allergic) to metformin, saxagliptin or dapagliflozin or to any of the other ingredients or in people who have had serious allergic reactions to a DPP-4 inhibitor (medicines similar to saxagliptin) or to a SGLT2 inhibitor (medicines similar to dapagliflozin).
Croatian: Lijek Qtrilmet ne smije se primjenjivati u osoba koje su preosjetljive (alergične) na metformin, saksagliptin ili dapagliflozin ili na bilo koji drugi sastojak lijeka ili u osoba koje su imale ozbiljne alergijske reakcije na inhibitor DPP-4 (lijekove slične saksagliptinu) ili na inhibitor SGLT2 (lijekove slične dapagliflozinu.
English: The dose of Qtrilmet is calculated to match the dose of metformin the patient has been taking.
Croatian: Doza lijeka Qtrilmet određuje se na način da odgovara dozi metformina koju bolesnik uzima.
English: • Saxagliptin blocks the breakdown of incretin hormones, which are released after a meal and cause the pancreas to produce insulin.
Croatian: • Saksagliptin inhibira razgradnju inkretinskih hormona koji se oslobađaju nakon obroka i potiču gušteraču na proizvodnju inzulina.
English: • adults who are already taking metformin, saxagliptin and dapagliflozin.
Croatian: • odraslih koji već uzimaju metformin, saksagliptin i dapagliflozin.
English: How does Qtrilmet work?
Croatian: Kako djeluje Qtrilmet?
English: • Dapagliflozin blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Croatian: • Dapagliflozin inhibira djelovanje proteina u bubrezima naziva suprijenosnik natrija i glukoze 2 (SGLT2).
English: What benefits of Qtrilmet have been shown in studies?
Croatian: Koje su koristi od lijeka Qtrilmet utvrđene u ispitivanjima?
English: Qtrilmet is a diabetes medicine that contains the active substances metformin, saxagliptin and dapagliflozin.
Croatian: Qtrilmet je lijek protiv šećerne bolesti koji sadrži djelatne tvari metformin, saksagliptin i dapagliflozin.
English: Three main studies have shown that the combination of metformin, saxagliptin and dapagliflozin was effective at lowering blood glucose in adults with type 2 diabetes.
Croatian: U trima glavnim ispitivanjima utvrđeno je da kombinacija metformina, saksagliptina i dapagliflozina djeluje na snižavanje razine glukoze u krvi u odraslih sa šećernom bolesti tipa 2.
English: For the full list of side effects and restrictions of Qtrilmet, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Qtrilmet potražite u uputi o lijeku.
English: By blocking their breakdown, saxagliptin causes the pancreas to produce more insulin when blood glucose levels are high.
Croatian: Inhibiranjem te razgradnje, saksagliptin potiče gušteraču da proizvodi više inzulina kada su razine glukoze u krvi visoke.
English: How is Qtrilmet used?
Croatian: Kako se Qtrilmet primjenjuje?
English: In the first main study in 534 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 1.47 percentage points compared with metformin combined with either saxagliptin (0.88 percentage point reduction) or dapagliflozin (1.20 percentage point reduction).
Croatian: U prvom ispitivanju na 534 bolesnika, kombinacija metformina, saksagliptina i dapagliflozina smanjila je prosječnu razinu glikoziliranog hemoglobina za 1,47 postotnih bodova u usporedbi s metforminom kombiniranim ili sa saksagliptinom (smanjenje za 0,88 postotnih bodova) ili s dapagliflozinom (smanjenje za 1,20 postotnih bodova).
English: In the third study in 320 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 0.82 percentage points compared with a reduction of 0.10 percentage points in patients receiving metformin, saxagliptin and placebo.
Croatian: U trećem ispitivanju na 320 bolesnika kombinacija metformina, saksagliptina i dapagliflozina smanjila je prosječnu razinu glikoziliranog hemoglobina za 0,82 postotna boda u usporedbi sa smanjenjem od 0,10 postotnih bodova u bolesnika koji su primali metformin, saksagliptin i placebo.
English: In the second study in 315 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 0.51 percentage points compared with a reduction of 0.16 percentage points in patients receiving metformin, dapagliflozin and placebo (dummy treatment).
Croatian: U drugom ispitivanju na 315 bolesnika kombinacija metformina, saksagliptina i dapagliflozina smanjila je prosječnu razinu glikoziliranog hemoglobina za 0,51 postotni bod u usporedbi sa smanjenjem od 0,16 postotnih bodova u bolesnika koji su primali metformin, dapagliflozin i placebo (prividno liječenje).
English: The pattern of Qtrilmet's side effects is manageable and similar to that in patients treated with saxagliptin and dapagliflozin added to metformin.
Croatian: Nuspojave za lijek Qtrilmet moguće je kontrolirati, a njihov je uzorak sličan onome u bolesnika liječenih saksagliptinom i dapagliflozinom koji su dodani metforminu.
English: You may need to use both hands.
Croatian: Možda ćete trebati koristiti obje ruke.
English: The results have been negative.
Croatian: Rezultati su bili negativni.
English: Always follow your local guidelines.
Croatian: Uvijek slijedite lokalne smjernice.
English: Call a doctor immediately.
Croatian: Odmah nazovite liječnika.
English: These notes are a reminder.
Croatian: Ove bilješke su podsjetnik.
English: Not for children
Croatian: Nije za djecu
English: Not known (cannot be estimated from the available data).
Croatian: nepoznato (ne može se procijeniti iz dostupnih podataka)
English: MS also tends to flare up from time to time: this is called a relapse.
Croatian: MS može također buknuti s vremena na vrijeme; to se naziva relapsom.
English: - Thoughts about committing suicide.
Croatian: Razmišljanja o samoubojstvu.
English: This is rare.
Croatian: To je rijetko.
English: Allow the skin to dry.
Croatian: Pustite da se koža osuši.
English: Sensitivity to light.
Croatian: Osjetljivo na svjetlost.
English: Experience with exposure during the second and third trimester is very limited.
Croatian: Iskustva s izloženosti tijekom drugog i trećeg tromjesečja vrlo su ograničena.
English: Part of a multi-pack.
Croatian: Dio višestrukog pakiranja.
English: You will hear a “click” indicating the injection process has begun.
Croatian: Čut ćete „klik“ koji označava da je proces injiciranja započeo.
English: This is the safety lock.
Croatian: To je sigurnosna brava.
English: Alternate the left and right thighs.
Croatian: Izmjenjujte lijevo i desno bedro.
English: Alternative assay techniques are not sufficiently sensitive.
Croatian: Druge tehnike određivanja nisu dovoljno osjetljive.
English: The figures are based on how many people said they'd had them.
Croatian: Brojevi su temeljeni na tome koliko je osoba izjavilo da ih imaju.
English: Everyone has their own set of MS symptoms.
Croatian: Svatko ima svoju skupinu simptoma MS-e.
English: The syringe will not empty.
Croatian: Štrcaljka se neće isprazniti.
English: - Depression or problems affecting your moods
Croatian: Depresiju ili probleme koji utječu na Vaše raspoloženje
English: No formal interaction studies have been performed in humans.
Croatian: Nisu provedena formalna ispitivanja interakcija na ljudima.
English: Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8 i 5.1, međutim nije moguće dati preporuku o doziranju.
English: If you have a fever, drink plenty of water to keep you hydrated.
Croatian: Ako imate vrućicu, pijte puno vode kako biste ostali hidrirani.
English: You can't pass it on to anyone else.
Croatian: Ne možete ih prenijeti na nekog drugog.
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Croatian: Na temelju životinjskih ispitivanja (vidjeti dio 5.3) postoji mogućnost povećanog rizika za spontani pobačaj.
English: Point the needle cover away from you and anyone else.
Croatian: Usmjerite zaštitni pokrov igle podalje od Vas i drugih.
English: On each left hand page you'll find useful tips and explanations on how to get the best from your medicine.
Croatian: Na svakoj lijevoj stranici naći ćete korisne savjete i objašnjenja kako dobiti najviše koristi od svog lijeka.
English: These symptoms are not really flu.
Croatian: Ti simptomi nisu stvarna gripa.
English: This latter clinical effect was observed after more than one year of treatment.
Croatian: Taj kasniji klinički učinak primijećen je nakon više od jedne godine liječenja.
English: Once the pen is sealed there is no risk of injury.
Croatian: Jednom kad je brizgalica zatvorena, nema opasnosti od povrede.
English: This is unlikely to happen again.
Croatian: Mala je vjerojatnost da se to ponovno dogodi.
English: In MS, your body's defence system reacts against its own myelin - the ‘insulation' that surrounds nerve fibres.
Croatian: Kod MS-e obrambeni sustav Vašeg organizma reagira protiv vlastitog mijelina - „izolacije“ koja okružuje živčana vlakna.
English: • Apply pressure to the injection site for a few seconds.
Croatian: • Primijenite pritisak na mjesto injiciranja nekoliko sekundi.
English: Wash your hands thoroughly with soap and water and dry them.
Croatian: Temeljito operite ruke sapunom i vodom, te ih osušite.
English: Tip: Place the pen down on the table before beginning step 2.
Croatian: Savjet: Stavite brizgalicu na stol prije početka 2. koraka
English: No direct comparison with the dose currently recommended in adults is available.
Croatian: Nije dostupna izravna usporedba s dozom koja je trenutno preporučena za odrasle.
English: If you inject more than you should
Croatian: Ako injicirate više lijeka nego što ste trebali
English: Mutagenesis: Limited but relevant mutagenesis tests have been carried out.
Croatian: Mutageneza: provedeni su ograničeni, ali relevantni testovi za određivanje mutageneze.
English: Speak to your doctor or pharmacist about a suitable dose.
Croatian: Razgovarajte sa svojim liječnikom ili ljekarnikom o prikladnoj dozi.
English: Elderly: Clinical studies did not include a sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients.
Croatian: Stariji: Klinička ispitivanja nisu uključila dovoljan broj bolesnika sa 65 godina starosti i više kako bi se utvrdilo imaju li oni drugačiji odgovor na lijek u odnosu na mlađe bolesnike.
English: - The sealed plastic tray is damaged or opened.
Croatian: Zatvoreni plastični spremnik je oštećen ili otvoren.
English: When myelin is damaged, the messages between the brain and other parts of the body are disrupted.
Croatian: Kad se mijelin ošteti, prijenos poruka između mozga i ostalih dijelova tijela se poremeti.
English: A. Getting ready 1.
Croatian: Priprema 1.
English: An effect on MRI parameters was also seen.
Croatian: Primijećen je i učinak na MRI parametre.
English: These symptoms are usually present during the first few months of treatment.
Croatian: Ti simptomi obično su prisutni tijekom prvih nekoliko mjeseci liječenja.
English: Date of first authorisation: 13 March 1997 Date of latest renewal: 13 March 2007
Croatian: Datum prvog odobrenja: 13. ožujka 1997.
English: It only happens when you inject and the effects soon pass.
Croatian: To se događa samo kad dobivate injekciju i učinak brzo prođe.
English: It gives you an idea how likely you are to get similar side effects.
Croatian: Time se dobiva predodžba o tome koja je vjerojatnost da i Vi dobijete slične nuspojave.
English: You may also wish to make a note of these details in case you are asked for this information in the future.
Croatian: Bilo bi dobro da i sami zabilježite te detalje za slučaj da Vas netko ubuduće upita o njima.
English: In this leaflet…
Croatian: U ovoj uputi...
English: Interferons are natural substances made in your body to help protect you from infections and diseases.
Croatian: Interferoni su prirodne tvari koje nastaju u Vašem tijelu kako bi pomogle zaštititi Vas od infekcija i bolesti.
English: You can get a larger print version of this leaflet by calling the local representatives.
Croatian: Možete dobiti veću tiskanu verziju ove upute o lijeku tako da nazovete lokalnog predstavnika.
English: Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
Croatian: Liječenje treba započeti pod nadzorom liječnika koji ima iskustva u liječenju ove bolesti.
English: Although the list of possible side effects can seem worrying, it's possible that you may not have any of them.
Croatian: Iako bi Vas popis mogućih nuspojava mogao zabrinuti, moguće je da ne dobijete niti jednu nuspojavu.
English: However, based on the mode of clearance of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Croatian: Međutim, na temelju načina uklanjanja djelatne tvari, nema teoretskih razloga za bilo kakvo prilagođavanje doze kod starijih bolesnika.
English: • Continue to hold the pen on your skin and count slowly for a full
Croatian: • Nastavite držati brizgalicu na koži i polako odbrojite punih 10
English: It was also shown that there was a one-third reduction in annual relapse rate.
Croatian: Pokazano je i smanjenje godišnje stope relapsa za jednu trećinu.
English: Johnson & Johnson Romania S.R.L.
Croatian: România Johnson & Johnson Romania S.R.L.
English: If you have severe depression or thoughts about suicide, you must not use Avonex.
Croatian: Ako patite od teške depresije ili razmišljate o samoubojstvu, ne smijete koristiti Avonex.
English: • Press the blue activation button with your thumb to start the injection.
Croatian: • Pritisnite plavi aktivacijski gumb palcem kako biste započeli injiciranje.
English: Try to use Avonex at the same time on the same day each week.
Croatian: Pokušajte koristiti Avonex svaki tjedan isti dan u isto vrijeme.
English: This leaflet is changed from time to time.
Croatian: Ova uputa o lijeku se povremeno mijenja.
English: More about depression.
Croatian: Više o depresiji.
English: Glycosylation of other proteins is known to affect their stability, activity, biodistribution, and half-life in blood.
Croatian: Poznato je da glikozilacija drugih proteina utječe na njihovu stabilnost, aktivnost, biodistribuciju i poluvrijeme života u krvi.
English: Do not stop your Avonex treatment without speaking to your neurologist.
Croatian: Nemojte prekinuti liječenje Avonexom bez da se obratite svom neurologu.
English: No additional benefit has been shown by administering a higher dose (60 micrograms) once a week.
Croatian: Nije primijećena dodatna korist od davanja veće doze (60 mikrograma) jednom tjedno.
English: Tell your doctor if you are using, have recently used or might use any other medicines, especially those used to treat epilepsy or depression.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, naročito one za liječenje epilepsije ili depresije.
English: Do not make changes unless your doctor tells you.
Croatian: Nemojte mijenjati način liječenja, osim ako Vaš liječnik ne odredi drugačije.
English: This means less risk of irritation to your skin and muscle.
Croatian: To smanjuje rizik od iritacije kože i mišića.
English: Call a doctor immediately as they may be signs of a possible liver problem.
Croatian: Odmah nazovite liječnika jer to mogu biti znakovi mogućih jetrenih problema.
English: Do not use two injections to make up for a missed injection.
Croatian: Nemojte uzeti dvije injekcije kako biste nadoknadili propuštenu injekciju.
English: The interaction of AVONEX with corticosteroids or adrenocorticotropic hormone (ACTH) has not been studied systematically.
Croatian: Interakcija AVONEXA s kortikosteroidima ili s adrenokortikotropnim hormonom (ACTH) nije sustavno ispitivana.
English: The intramuscular injection site should be varied each week (see section 5.3).
Croatian: Mjesto davanja intramuskularne injekcije treba mijenjati svaki tjedan (vidjeti dio 5.3).
English: The small rectangular window area will disappear.
Croatian: Mali pravokutni prozorčić će nestati.
English: • Patients diagnosed with relapsing multiple sclerosis (MS).
Croatian: • bolesnika s dijagnozom relapsne multiple skleroze (MS).
English: Doctors may prescribe a 25 mm, 25 gauge needle to patients for whom such a needle is appropriate to administer an intramuscular injection.
Croatian: Liječnici mogu propisati 25 mm, 25 G (gauge) iglu bolesnicima kojima je takva igla prikladnija za primjenu intramuskularne injekcije.
English: It is estimated that the plateau for the incidence of neutralising antibody formation is reached after 12 months of treatment.
Croatian: Procjenjuje se da se plato incidencije neutralizirajućih protutijela dosegne nakon 12 mjeseci liječenja.
English: Avonex and allergic reactions.
Croatian: Avonex i alergijske reakcije.
English: Genesis Pharma Cyprus Ltd
Croatian: Κύπρος Genesis Pharma Cyprus Ltd
English: AVONEX exerts its biological effects by binding to specific receptors on the surface of human cells.
Croatian: AVONEX iskazuje svoje biološko djelovanje vezanjem na specifične receptore na površini ljudskih stanica.
English: Pharmacotherapeutic Group: Interferons, ATC code: L03 AB07.
Croatian: Farmakoterapijska skupina: Interferoni, ATK oznaka: L03 AB07.
English: Other medicines and AVONEX
Croatian: Drugi lijekovi i AVONEX
English: Relax your muscle.
Croatian: Opustite mišić.
English: • Use your other hand, and with one quick motion pull up the injector shield (grooved area) over the needle until the needle is fully covered.
Croatian: • Upotrijebite drugu ruku i jednim brzim pokretom povucite štitnik injektora (izbrazdani dio) preko igle dok igla ne bude sasvim prekrivena.
English: Talk to your doctor to see if this is appropriate for you.
Croatian: Razgovarajte sa svojim liječnikom je li to primjereno za vas.
English: • After 10 seconds pull the pen straight out to remove the needle from the injection site.
Croatian: • Nakon 10 sekundi ravno izvucite brizgalicu kako biste uklonili iglu s mjesta injiciranja.
English: The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
Croatian: Rizik za spontani pobačaj u trudnica izloženih interferonu beta ne može se adekvatno procijeniti na temelju postojećih podataka, ali oni zasad ne upućuju na povećani rizik.
English: Paediatric population: The safety and efficacy of AVONEX in adolescents aged 12 to 16 years have not yet been established.
Croatian: Pedijatrijska populacija: Sigurnost i djelotvornost AVONEXA u adolescenata u dobi od 12 do 16 godina nisu još ustanovljene.
English: However, in case of overdose, patients should be hospitalised for observation and appropriate supportive treatment given.
Croatian: Ipak, u slučajevima predoziranja, bolesnike treba hospitalizirati radi promatranja i uvesti prikladno suportivno liječenje.
English: • Check the safety lock is released.
Croatian: • Provjerite je li sigurnosna brava otpuštena.
English: Avonex is not to be used in children below the age of 12 years.
Croatian: Avonex se ne smije primjenjivati u djece mlađe od 12 godina.
English: You may get a needle injury.
Croatian: Možete se povrijediti iglom.
English: Biogen Sweden AB
Croatian: Sverige Biogen Sweden AB
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni, mislite da ste trudni ili planirate zatrudnjeti, prije uzimanja ovog lijeka posavjetujte se s liječnikom ili ljekarnikom.
English: Because Avonex is based on a protein, there is a small chance of an allergic reaction.
Croatian: Budući da se Avonex bazira na proteinu, postoji mala mogućnost pojave alergijske reakcije.
English: The potential of additive effects from multiple medicinal products or other hepatotoxic agents (e.g. alcohol) has not been determined.
Croatian: Mogući zbirni učinci više lijekova ili drugih hepatotoksičnih tvari (na primjer alkohola) nisu utvrđeni.
English: - If you notice any irritation or skin problems after an injection, talk to your doctor.
Croatian: - Ako primijetite iritaciju ili probleme s kožom nakon injekcije, razgovarajte sa svojim liječnikom.
English: Biogen Denmark A/S
Croatian: Danmark Biogen Denmark A/S