FrancophonIA/ELRC3.0 huggingface dataset:
English: − Suliqua 30-60 (containing insulin glargine 100 units/ml with lixisenatide 33 micrograms/ml)this pen can deliver between 30 and 60 dose steps per day.
Croatian: − Suliqua 30-60 (sadrži 100 jedinica/ml inzulina glargina i 33 mikrograma/ml liksisenatida).
English: Suliqua 10-40 (containing insulin glargine 100 units/ml with lixisenatide 50 micrograms/ml) - this pen can deliver between 10 and 40 dose steps per day.
Croatian: Suliqua 10-40 (sadrži 100 jedinica/ml inzulina glargina i 50 mikrograma/ml liksisenatida).
English: − Suliqua 10-40 (containing insulin glargine 100 units/ml with lixisenatide 50 micrograms/ml)this pen can deliver between 10 and 40 dose steps per day.
Croatian: − Suliqua 10-40 (sadrži 100 jedinica/ml inzulina glargina i 50 mikrograma/ml liksisenatida).
English: It has been available in the EU since the 1950s.
Croatian: Dostupan je u Europskoj uniji (EU) od 1950-ih.
English: Further information on Xigduo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/xigduo.
Croatian: Više informacija o lijeku Xigduo dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/xigduo.
English: Xigduo must not be used in:
Croatian: Xigduo se ne smije primjenjivati u:
English: The majority of these data had already been used in the authorisation of Forxiga.
Croatian: Većina tih podataka već je bila upotrijebljena za davanje odobrenja za lijek Forxiga.
English: Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;
Croatian: Dapagliflozin je od 2012. odobren u Europskoj uniji (EU) pod nazivom Forxiga.
English: What is Xigduo and what is it used for?
Croatian: Što je Xigduo i za što se koristi?
English: Xigduo contains two different active substances, which work in different ways:
Croatian: Xigduo sadržava dvije djelatne tvari, koje različito djeluju:
English: What measures are being taken to ensure the safe and effective use of Xigduo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Xigduo?
English: • patients who are intoxicated with alcohol (drunkenness) or who regularly drink excessive amounts of alcohol.
Croatian: • bolesnika pod utjecajem alkohola (alkoholiziranosti) ili onih koji redovito konzumiraju prekomjerne količine alkohola.
English: Xigduo received a marketing authorisation valid throughout the EU on 16 January 2014.
Croatian: Lijek Xigduo dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 16. siječnja 2014.
English: Side effects reported with Xigduo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Xigduo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Other information about Xigduo
Croatian: Ostale informacije o lijeku Xigduo
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xigduo 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 Xigduo nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: • patients with reduced liver function;
Croatian: • bolesnika sa smanjenom jetrenom funkcijom,
English: What are the risks associated with Xigduo?
Croatian: Koji su rizici povezani s lijekom Xigduo?
English: • in combination with other diabetes medicines when these medicines together with metformin are not controlling the diabetes well enough.
Croatian: • u kombinaciji s drugim lijekovima protiv dijabetesa ako ti lijekovi u kombinaciji s metforminom ne osiguravaju dostatnu kontrolu dijabetesa.
English: Xigduo can also be used to replace dapagliflozin and metformin taken as separate tablets.
Croatian: Xigduo se može koristiti i kao zamjena za dapagliflozin i metformin koji se uzimaju u odvojenim tabletama.
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 smanjuje njezinu apsorpciju u crijevima.
English: Why is Xigduo authorised in the EU?
Croatian: Zašto je lijek Xigduo odobren u EU-u?
English: Dapagliflozin in combination with metformin was evaluated in 6 main studies involving 3,200 adults with type 2 diabetes.
Croatian: Dapagliflozin u kombinaciji s metforminom ispitan je u šest glavnih ispitivanja kojima je bilo obuhvaćeno 3 200 odraslih osoba s dijabetesom tipa 2.
English: HbA1c (glycosylated haemoglobin) is a substance in the blood which gives an indication of how well the blood glucose is controlled.
Croatian: HbA1c (glikozilirani hemoglobin) je tvar u krvi koja pokazuje koliko se dobro kontrolira razina glukoze u krvi.
English: • on its own in patients whose disease is not controlled well enough with metformin alone;
Croatian: • kao monoterapija u bolesnika čiju se bolest ne može dovoljno dobro kontrolirati samo metforminom,
English: As for all medicines, data on the use of Xigduo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Xigduo kontinuirano se prate.
English: An overview of Xigduo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Xigduo i zašto je odobren u EU-u
English: • patients with diabetic precoma (a dangerous condition that can occur in diabetes);
Croatian: • bolesnika s dijabetičkom pretkomom (opasnim stanjem do kojeg može doći u osoba s dijabetesom),
English: A long-term study, involving over 17,000 patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease.
Croatian: U dugoročnom ispitivanju koje je obuhvaćalo više od 17 000 bolesnika s dijabetesom tipa 2 pratili su se učinci dapagliflozinoma na kardiovaskularne bolesti (srce i cirkulacija).
English: Regarding its safety profile, this was considered similar to the safety profile of dapagliflozin.
Croatian: Sigurnosni profil lijeka smatra se sličnim sigurnosnom profilu dapagliflozina.
English: • patients with any form of acute metabolic acidosis (build up of acid in the blood), such as diabetic ketoacidosis (high blood levels of acids called ‘ketones') or lactic acidosis (build-up of lactic acid in the body);
Croatian: • bolesnika koji imaju bilo koji oblik akutne metaboličke acidoze (nakupljanje kiseline u krvi) poput dijabetičke ketoacidoze (visoke razine kiselina naziva „ketoni” u krvi) ili laktacidoze (nakupljanje mliječne kiseline u tijelu),
English: For further information about using Xigduo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Xigduo pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: The European Medicines Agency decided that Xigduo's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Xigduo nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: When Xigduo is added to treatment with insulin or a medicine that helps the body to produce insulin, such as a sulphonylurea, the doctor may need to lower the dose of insulin or sulphonylurea to prevent hypoglycaemia (low blood sugar levels).
Croatian: Ako se Xigduo primjenjuje s inzulinom ili lijekom koji pomaže tijelu proizvesti inzulin poput sulfonilureje, liječnik će možda trebati sniziti dozu inzulina ili sulfonilureje kako bi se smanjio rizik od hipoglikemije (niske razine šećera u krvi).
English: Xigduo is used:
Croatian: Xigduo se koristi:
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the amount of glucose (sugar) in the blood or when the body cannot use insulin effectively.
Croatian: Dijabetes tipa 2 bolest je pri kojoj gušterača ne proizvodi dovoljno inzulina za kontrolu količine glukoze u krvi ili tijelo ne može učinkovito iskoristiti inzulin.
English: • dapagliflozin blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Croatian: • dapagliflozin blokira djelovanje proteina u bubrezima naziva suprijenosnik natrija i glukoze 2 (SGLT2).
English: The Agency also noted that giving the combination of dapagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
Croatian: Agencija je napomenula i da davanje kombinacije dapagliflozina i metformina u jednoj tableti može osigurati dodatnu opciju liječenja za bolesnike s dijabetesom tipa 2 i doprinijeti boljem pridržavanju terapije.
English: The Agency considered Xigduo to be effective for treating type 2 diabetes; it also leads to weight loss, which is considered beneficial in patients with diabetes.
Croatian: Agencija smatra da se lijekom Xigduo učinkovito liječi dijabetes tipa 2; uz to, njime se postiže gubitak težine, što se smatra korisnim za osobe oboljele od dijabetesa.
English: Xigduo is available as tablets containing 5 mg of dapagliflozin with 850 mg of metformin and as 5 mg of dapagliflozin with 1,000 mg of metformin.
Croatian: Lijek Xigduo dostupan je u obliku tableta koje sadržavaju 5 mg dapagliflozina i 850 mg metformina i tableta s 5 mg dapagliflozina i 1 000 mg metformina.
English: The most common side effects with Xigduo (which may affect more than 1 in 10 people) are hypoglycaemia (when used together with insulin or a sulphonylurea) and gastrointestinal symptoms (symptoms affecting the stomach and gut).
Croatian: Najčešće su nuspojave lijeka Xigduo (koje se mogu javiti u više od 1 na 10 osoba) hipoglikemija (ako se lijek primjenjuje zajedno s inzulinom ili sulfonilurejom) i gastrointestinalni simptomi (simptomi koji zahvaćaju želudac i crijeva).
English: As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
Croatian: Kao rezultat djelovanja obiju djelatnih tvari snižava se razina glukoze u krvi, što pomaže u kontroli dijabetesa tipa 2.
English: The recommended dose is 1 tablet taken twice a day with a meal; the strength should be chosen so that in total, patients receive 10 mg of dapagliflozin each day and the same (or almost the same) dose of metformin they were taking before starting Xigduo.
Croatian: Preporučena je doza jedna tableta dvaput dnevno uz obrok, pri čemu se jačina određuje tako da bolesnici ukupno prime 10 mg dapagliflozina svaki dan i istu (ili skoro istu) dozu metformina u odnosu na onu koju su uzimali prije početka terapije lijekom Xigduo.
English: How does Xigduo work?
Croatian: Kako djeluje Xigduo?
English: What benefits of Xigduo have been shown in studies?
Croatian: Koje su koristi od lijeka Xigduo utvrđene u ispitivanjima?
English: Further studies confirmed that different doses of dapagliflozin with metformin decreased HbA1c more than placebo plus comparable doses of metformin, and that dapagliflozin plus metformin was at least as effective in reducing HbA1c levels as the diabetes medicine glipizide (a type of medicine known as a sulphonylurea).
Croatian: Dodatnim ispitivanjima potvrđeno je da se različitim dozama dapagliflozina s metforminom razina HbA1c snižava više nego primjenom placeba i usporedivih doza metformina te da je dapagliflozin s metforminom u najmanju ruku jednako učinkovit u snižavanju razine HbA1c kao i lijek protiv dijabetesa glipizid (vrsta lijeka poznatog pod nazivom sulfonilureja).
English: In one main study, when dapagliflozin was used at a dose of 5 mg twice a day in addition to metformin (the same combination as in Xigduo), it decreased HbA1c levels by 0.65 percentage points after 16 weeks, compared with a reduction of 0.30 percentage points with placebo (a dummy treatment) and metformin.
Croatian: U jednom glavnom ispitivanju, u kojem se dapagliflozin davao u dozi od 5 mg dvaput dnevno u kombinaciji s metforminom (ista kombinacija kao i u lijeku Xigduo), razina HbA1c snizila se za 0,65 postotnih bodova nakon 16 tjedana, u usporedbi sa smanjenjem od 0,30 postotnih bodova kada se davao placebo (prividno liječenje) i metformin.
English: A sixth study showed that after 24 weeks of treatment, patients taking dapagliflozin plus metformin had an average reduction in body weight of around 2 kg more than those taking placebo plus metformin.
Croatian: U šestom ispitivanju utvrđeno je da su nakon liječenja od 24 tjedna bolesnici koji su primali dapagliflozin i metformin izgubili u prosjeku oko 2 kg tjelesne težine više nego oni koji su primali placebo i metformin.
English: By blocking the action of SGLT2, dapagliflozin causes the kidneys to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Croatian: Blokiranjem djelovanja proteina SGLT2, dapagliflozin omogućuje izlučivanje veće količine glukoze mokraćom iz bubrega, čime se smanjuje razina glukoze u krvi.
English: The study indicated that dapagliflozin's effects were in line with those of other diabetes medicines that also work by blocking SGLT2.
Croatian: Ispitivanjem je utvrđeno da su učinci dapagliflozinoma jednaki onima drugih lijekova protiv dijabetesa koji također djeluju tako što blokiraju djelovanje proteina SGLT2.
English: such as heart or lung failure (the heart and lungs not working as well as they should), recent heart attack or shock;
Croatian: • bolesnika s bolestima koje mogu izazvati hipoksiju tkiva (snižene razine kisika u tjelesnim tkivima) poput zatajenja srca ili pluća (pri čemu srce i pluća ne funkcioniraju onako dobro kao što bi trebali), nedavnog srčanog udara ili šoka,
English: Two other studies showed that dapagliflozin taken with metformin and another diabetes medicine, sitagliptin or insulin, for 24 weeks, further decreased HbA1c: the dapagliflozin combination decreased HbA1c levels by 0.40 percentage points more than placebo and metformin when added to sitagliptin, and by 0.61 percentage points more than placebo and metformin when added to insulin.
Croatian: U dvama drugim ispitivanjima utvrđeno je da je dapagliflozin, kada se uzimao s metforminom i još jednim lijekom protiv dijabetesa poput sitagliptina ili inzulina tijekom 24 tjedna, dodatno snizio razinu HbA1c: primjenom kombinacije koja sadrži dapagliflozin snižena je razina HbA1c za 0,40 postotnih bodova više nego primjenom placeba i metformina kada su dodani sitagliptinu te za 0,61 postotnih bodova više nego primjenom placeba i metformina kada su dodani inzulinu.
English: • patients with severe reduction in kidney function or with conditions that could alter kidney function,
Croatian: • bolesnika s ozbiljnim smanjenjem funkcije bubrega ili sa stanjima koja mogu promijeniti funkciju bubrega poput dehidracije, teške infekcije ili šoka,
English: For the full list of side effects of Xigduo, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Xigduo potražite u uputi o lijeku.
English: Xigduo is a diabetes medicine used, together with diet and exercise in adults with type 2 diabetes.
Croatian: Xigduo je lijek protiv dijabetesa koji se, u kombinaciji s dijetom i tjelovježbom, koristi u odraslih osoba s dijabetesom tipa 2. Sadržava djelatne tvari dapagliflozin i metformin.
English: Date of first authorisation: 18 September 2015
Croatian: Datum prvog odobrenja: 18. rujna 2015
English: The device is constructed so that you will not be able to open it.
Croatian: Naprava je konstruirana na način da je nećete moći otvoriti.
English: Follow the instructions carefully.
Croatian: Pažljivo slijedite upute.
English: What Zalviso is and what it is used for
Croatian: Što je Zalviso i za što se koristi
English: Appropriate measures should be taken to maintain stable arterial pressure.
Croatian: Potrebno je poduzeti odgovarajuće mjere za održanje stabilnog arterijskog tlaka.
English: Ask the medical staff how to throw away medicines you no longer use.
Croatian: Pitajte medicinsko osoblje kako baciti lijekove koje više ne koristite.
English: Zalviso with alcohol
Croatian: Zalviso s alkoholom
English: • Educational materials for the healthcare professionals
Croatian: • edukacijski materijali za zdravstvene radnike
English: If you take more Zalviso than you should
Croatian: Ako uzmete više Zalvisa nego što ste trebali
English: The frequencies are defined as:
Croatian: Učestalosti su definirane kao:
English: Component of multipack, can't be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati odvojeno.
English: Only 2 % of the dose is excreted in unchanged form.
Croatian: Svega 2% doze izlučuje se u nepromijenjenom obliku.
English: Do not drink alcohol while using Zalviso.
Croatian: Nemojte piti alkohol tijekom uzimanja Zalvisa.
English: Contact your doctor when experiencing such symptoms.
Croatian: Obratite se svom liječniku ako iskusite te simptome.
English: You will then be able to take a tablet as needed to relieve your pain.
Croatian: Potom ćete moći uzeti tabletu prema potrebi kako bi olakšali svoju bol.
English: This does not rule out more direct countermeasures.
Croatian: Ovo ne isključuje direktnije protumjere.
English: Zalviso was also considered to be easier to use by healthcare professionals (P = 0.017).
Croatian: Zdravstveni radnici su također smatrali Zalviso jednostavnijim za upotrebu (P = 0,017).
English: The device will work for 3 days (72 hours), which is also the maximum recommended duration of your treatment.
Croatian: Naprava će raditi 3 dana (72 sata), što je ujedno i maksimalno preporučeno trajanje
English: Children and adolescents Zalviso should not be used in children and adolescents below 18 years.
Croatian: Djeca i adolescenti Zalviso se ne smije primijeniti u djece i adolescenata mlađih od 18 godina.
English: After receiving a dose you will not be able to release another dose for 20 minutes and you will not be able to take more than 3 doses in one hour.
Croatian: Nakon što ste primili dozu, nećete moći osloboditi drugu dozu tijekom 20 minuta i nećete moći uzeti više od 3 doze u jednom satu.
English: Additional Zalviso cartridges may be utilized if needed.
Croatian: Mogu se upotrijebiti dodatni Zalviso ulošci ako je potrebno.
English: Hypnotic activity can be demonstrated by EEG alterations.
Croatian: Hipnotičku aktivnost je moguće demonstrirati promjenama u EEG-u.
English: Talk to your doctor or nurse if you did not fully understand the instructions or are unsure about the correct handling of the administration device.
Croatian: Obratite se svom liječniku ili medicinskoj sestri ako niste u potpunosti razumjeli upute ili niste sigurni kako se pravilno rukuje napravom za primjenu lijeka.
English: It was concluded from these studies that Zalviso sublingual tablets have no or minimal potential for local irritation.
Croatian: Iz tih se ispitivanja zaključilo da Zalviso sublingvalne tablete nemaju ili imaju minimalan potencijal za lokalnu iritaciju.
English: You can control your treatment and should only activate the device when in need of pain relief.
Croatian: Možete kontrolirati Vaše liječenje, a napravu trebate aktivirati samo kad želite olakšati bol.
English: Other medicines and Zalviso Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Zalviso Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: What you need to know before you take Zalviso
Croatian: Što morate znati prije nego počnete uzimati Zalviso
English: Blood pressure increased Blood pressure decreased
Croatian: Krvožilni poremećaji povišeni krvni tlak sniženi krvni tlak
English: OUTER CARTON for 1, 10 and 20 cartridges
Croatian: VANJSKA KUTIJA za 1, 10 i 20 uložaka
English: Do not use the device if any component is visibly damaged.
Croatian: Ne upotrebljavajte napravu ako je bilo koji sastavni dio vidljivo oštećen.
English: - Significant respiratory depression.
Croatian: Značajna respiracijska depresija.
English: What Zalviso is and what it is used for What you need to know before you take Zalviso How to take Zalviso
Croatian: Što je Zalviso i za što se koristi Što morate znati prije nego počnete uzimati Zalviso Kako uzimati Zalviso
English: In clinical trials during repeated administrations the bioavailability decreased to 37.6 %.
Croatian: U kliničkim ispitivanjima tijekom ponovljenih primjena bioraspoloživost se smanjila na 37,6%.
English: The safety and efficacy of Zalviso in children aged below 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Zalviso u djece mlađe od 18 godina nisu ustanovljene.
English: You should not eat or drink and should talk as little as possible for 10 minutes after each dose.
Croatian: Ne smijete jesti ili piti i potrebno je što je moguće manje govoriti 10 minuta nakon svake doze.
English: Reproductive toxicity has been shown in animal studies (see section 5.3).
Croatian: Reproduktivna toksičnost je pokazana u ispitivanjima na životinjama (vidjeti dio 5.3).
English: The safety and efficacy in elderly patients was similar to that observed in younger adults (see section 5.2).
Croatian: Sigurnost i djelotvornost terapije u starijih bolesnika bile su slične onima opaženim u mlađih odraslih osoba (vidjeti dio 5.2).
English: It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above.
Croatian: Bilo bi dobro da upozorite prijatelje ili rođake na prethodno spomenute znakove i simptome.
English: Sufentanil has potential for abuse.
Croatian: Sufentanil ima potencijal za zloupotrebu.
English: Sufentanil was not teratogenic in rats and rabbits.
Croatian: Sufentanil nije bio teratogen u štakora i kunića.
English: Sufentanil does not induce histamine release.
Croatian: Sufentanil ne inducira oslobađanje histamina.
English: This may range from hypoventilation to respiratory arrest.
Croatian: To se može kretati u rasponu od hipoventilacije do respiracijskog aresta.
English: Primary attention should be given to obstruction of airways and the necessity of assisted or controlled ventilation.
Croatian: Primarnu pozornost treba posvetiti opstrukciji dišnih putova i potrebi za asistiranu ili kontroliranu ventilaciju.
English: Patients with BMI > 30 kg/m
Croatian: Bolesnici s indeksom tjelesne mase> 30 kg/m
English: Warnings and precautions Talk to your doctor or nurse before taking Zalviso.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili medicinskoj sestri prije nego uzmete Zalviso.
English: There are no indications to date that the use of sufentanil during pregnancy increases the risk of congenital abnormalities.
Croatian: Do danas nema pokazatelja da primjena sufentanila tijekom trudnoće povećava rizik od kongenitalnih abnormalnosti.
English: Because of these risks, concomitant prescribing with these sedating medicinal products should be reserved for patients for whom alternative treatment options are not possible.
Croatian: Zbog tih rizika istodobno propisivanje s tim lijekovima za smirenje potrebno je čuvati za bolesnike za koje nisu dostupne alternativne metode liječenja.
English: Local tolerance
Croatian: Lokalna podnošljivost
English: Biotransformation takes place primarily in the liver and the small intestine.
Croatian: Biotransformacija se primarno odvija u jetri i tankom crijevu.
English: In clinical trials approximately 30 % of enrolled patients were 65 to 75 years of age.
Croatian: U kliničkim ispitivanjima približno 30% uključenih bolesnika je bilo u dobi od 65 do 75 godina.
English: Sufentanil may produce bradycardia.
Croatian: Sufentanil može stvoriti bradikardiju.
English: The administration device will make you wait 20 minutes between doses to prevent you from taking more Zalviso than you should.
Croatian: Naprava za primjenu lijeka primorat će Vas da čekate 20 minuta između doza kako bi Vas se spriječilo da uzmete više Zalvisa nego što biste trebali.