FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding safety, this was considered in line with that of other medicines of the same class.
Croatian: Sigurnost primjene ovog lijeka smatra se podudarnom sa sigurnošću primjene drugih lijekova iz iste skupine.
English: In addition, the results indicated that treatment with Steglujan was associated with a beneficial reduction in body weight.
Croatian: Nadalje, rezultati su pokazali da je liječenje lijekom Steglujan bilo povezano s korisnim smanjenjem tjelesne težine.
English: Why is Steglujan authorised in the EU?
Croatian: Zašto je lijek Steglujan odobren u EU-u?
English: At the start of the studies, patients' HbA1c was above 7.0%.
Croatian: Na početku ispitivanja razine HbA1c u bolesnika bile su iznad 7,0 %.
English: Side effects reported with Steglujan are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Steglujan pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: How is Steglujan used?
Croatian: Kako se Steglujan koristi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Steglujan 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 Steglujan nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: An overview of Steglujan and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Steglujan i zašto je odobren u EU-u
English: The result is a high level of glucose in the blood.
Croatian: Posljedica toga je visoka razina glukoze u krvi.
English: • patients who are already taking ertugliflozin and sitagliptin as separate tablets.
Croatian: • u bolesnika koji već uzimaju ertugliflozin i sitagliptin kao zasebne tablete.
English: As for all medicines, data on the use of Steglujan is continuously monitored.
Croatian: Kao za sve lijekove, podaci o primjeni lijeka Steglujan kontinuirano se prate.
English: Steglujan is available as tablets in 2 strengths of ertugliflozin and sitagliptin (5 mg/100 mg and 15 mg/100 mg) and can only be obtained with a prescription.
Croatian: Lijek Steglujan dostupan je u obliku tableta koje sadržavaju ertugliflozin i sitagliptin u dvije jačine (5 mg/100 mg i 15 mg/100 mg) i izdaje se samo na liječnički recept.
English: The second study found that adding ertugliflozin to a combination of sitagliptin and metformin was more effective than placebo (a dummy treatment).
Croatian: U drugom ispitivanju utvrđeno je da je dodavanje ertugliflozina kombinaciji sitagliptina i metformina djelotvornije od placeba (prividno liječenje).
English: In patients whose blood sugar needs further control, the dose can be increased to one 15 mg/100 mg tablet once a day.
Croatian: U bolesnika u kojih je potrebna dodatna regulacija šećera u krvi doza se može povećati na tabletu u dozi od 15 mg/100 mg jedanput na dan.
English: Treatment with Steglujan also led to weight loss, which is considered beneficial in patients with diabetes.
Croatian: Liječenje lijekom Steglujan dovelo je i do gubitka tjelesne težine, što se smatra korisnim u bolesnika sa šećernom bolešću.
English: Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Croatian: Sitagliptin također snižava količinu glukoze koju proizvodi jetra tako što povećava razine inzulina i snižava razine hormona glukagona.
English: Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Croatian: Dijabetes tipa 2 bolest je pri kojoj tijelo ne proizvodi dovoljno inzulina za regulaciju razine glukoze u krvi ili pri kojoj se tijelo ne može učinkovito koristiti inzulinom.
English: The third study compared Steglujan with placebo in patients who were not taking other diabetes medicines and in whom diet and exercise were not enough to control their blood sugar levels.
Croatian: U trećem ispitivanju lijek Steglujan uspoređen je s placebom u bolesnika koji nisu uzimali druge lijekove za liječenje dijabetesa i u kojih dijeta i tjelovježba nisu bili dovoljni za regulaciju razine šećera u krvi.
English: Other information about Steglujan
Croatian: Ostale informacije o lijeku Steglujan
English: HbA1c levels fell by between 0.8 and 0.9 points, compared with a fall of 0.1 with placebo.
Croatian: Razine HbA1c smanjile su se za od 0,8 do 0,9 postotnih bodova, u usporedbi sa smanjenjem od 0,1 postotnog boda pri primjeni placeba.
English: Sitagliptin blocks the breakdown of incretin hormones in the body.
Croatian: Sitagliptin onemogućuje razgradnju inkretinskih hormona u tijelu.
English: The recommended starting dose is one 5 mg/100 mg tablet taken once a day.
Croatian: Preporučena početna doza jest jedna tableta u dozi od 5 mg/100 mg jedanput na dan.
English: Steglujan is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes.
Croatian: Steglujan je lijek koji se primjenjuje za regulaciju razine glukoze (šećera) u krvi u odraslih osoba s dijabetesom tipa 2.
English: Together, these actions reduce blood glucose levels and help to control type 2 diabetes.
Croatian: Ti procesi zajedno snižavaju razinu glukoze u krvi i pomažu pri kontroli dijabetesa tipa 2.
English: The European Medicines Agency decided that Steglujan's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Steglujan nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: • patients whose blood glucose levels are not satisfactorily controlled with the diabetes medicines metformin and/or a sulphonylurea, in combination with either ertugliflozin or sitagliptin;
Croatian: • u bolesnika u kojih se odgovarajuća regulacija razine glukoze u krvi ne može postići lijekovima za liječenje dijabetesa metforminom i/ili sulfonilurejom, u kombinaciji s ertugliflozinom ili sitagliptinom;
English: It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.
Croatian: To čini tako da onemogućuje djelovanje proteina u bubrezima (naziva SGLT2) koji vraća glukozu iz bubrega natrag u krvotok.
English: These hormones stimulate the pancreas to produce insulin.
Croatian: Ti hormoni potiču gušteraču na proizvodnju inzulina.
English: This study found that adding Steglujan to diet and exercise was much more effective than placebo, with HbA1c levels falling by between 1.6 and 1.7 points with the combination of ertugliflozin and sitagliptin compared with a fall of 0.4 points with placebo.
Croatian: U tom ispitivanju utvrđeno je da je dodavanje lijeka Steglujan dijeti i tjelovježbi znatno djelotvornije od placeba te je smanjenje razine HbA1c bilo od 1,6 do 1,7 postotnih bodova pri primjeni kombinacije ertugliflozina i sitagliptina, u usporedbi sa smanjenjem od 0,4 postotna boda pri primjeni placeba.
English: Ertugliflozin helps to lower blood glucose by making the patient pass out glucose in the urine.
Croatian: Ertugliflozin pridonosi smanjivanju glukoze u krvi tako što u bolesnika potiče izlučivanje glukoze mokraćom.
English: Prolonging the action of incretin hormones makes the pancreas produce more insulin when blood glucose levels are high.
Croatian: Produženo djelovanje inkretinskih hormona potiče gušteraču na proizvodnju više inzulina pri visokim razinama glukoze u krvi.
English: The benefits of Steglujan were lower in patients with kidney problems.
Croatian: Koristi lijeka Steglujan bile su manje u bolesnika koji imaju problema s bubrezima.
English: Three main studies, involving 1,987 patients showed that Steglujan was effective at lowering blood glucose levels in patients with type 2 diabetes, as measured by the decrease in blood levels of HbA1c (a measure of blood glucose) after 6 months of treatment.
Croatian: Učinkovitost lijeka Steglujan u smanjivanju razine glukoze u krvi bolesnika s dijabetesom tipa 2 dokazana je u trima glavnim ispitivanjima na 1 987 bolesnika, što je izmjereno smanjenjem razine HbA1c u krvi (mjerilo razine glukoze u krvi) nakon šest mjeseci liječenja.
English: It is used together with diet and exercise in the following patients:
Croatian: Primjenjuje se u sljedećih bolesnika, u kombinaciji s dijetalnom prehranom i tjelovježbom:
English: Steglujan was shown to be effective at controlling blood glucose levels.
Croatian: Pokazalo se da Steglujan učinkovito regulira razine glukoze u krvi.
English: The two active substances in Steglujan work in different ways to lower glucose levels:
Croatian: Dvije djelatne tvari u lijeku Steglujan djeluju na smanjenje razine glukoze u krvi na različite načine:
English: Treatment with the combination of ertugliflozin and sitagliptin lowered HbA1c levels by up to 1.5 percentage points, compared with reductions of up to 1.1 for ertugliflozin and for sitagliptin on their own.
Croatian: U liječenju kombinacijom ertugliflozina i sitagliptina razina HbA1c smanjila se do 1,5 postotnih bodova, u usporedbi sa smanjenjem od do 1,1 postotnog boda u liječenju monoterapijom ertugliflozinom i sitagliptinom.
English: Steglujan contains the active substances ertugliflozin and sitagliptin.
Croatian: Lijek Steglujan sadržava djelatne tvari ertugliflozin i sitagliptin.
English: What benefits of Steglujan have been shown in studies?
Croatian: Koje su koristi lijeka Steglujan utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions with Steglujan, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Steglujan potražite u uputi o lijeku.
English: The first study, in patients who were all taking metformin, compared the combination of ertugliflozin and sitagliptin with ertugliflozin or sitagliptin on their own.
Croatian: U prvom ispitivanju uspoređena je kombinacija ertugliflozina i sitagliptina s monoterapijom ertugliflozinom ili sitagliptinom u bolesnika koji su uzimali metformin.
English: 1 g / 0.5 g Powder for concentrate for solution for infusion
Croatian: 1 g/0,5 g prašak za koncentrat za otopinu za infuziju u venu bočica (staklo) 10 bočica
English: Appropriate measures should be taken to maintain stable arterial pressure.
Croatian: Potrebno je poduzeti odgovarajuće mjere za održavanje stabilnog arterijskog tlaka.
English: Phone: +49 - 89-893 119 22
Croatian: Fax: +49 - 89-893 119 20
English: This leaflet was last revised in.
Croatian: Ova je uputa zadnji put revidirana u
English: Increased mortality was noted in all treatment groups.
Croatian: Povećana smrtnost zabilježena je u svim liječenim skupinama.
English: You will not give yourself this medicine.
Croatian: Nećete si sami davati ovaj proizvod.
English: See section 4.
Croatian: Vidjeti dio 4.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži vama važne podatke.
English: After receiving a dose you will not be given another dose for at least one hour.
Croatian: Nakon primanja doze nećete dobiti drugu dozu barem jedan sat.
English: 35, 80339 Munich, Germany.
Croatian: 35 80339 München, Njemačka.
English: In the case of an excessive dry mouth, patients may be given ice cubes.
Croatian: U slučaju pretjerane suhoće usta, bolesnicima se mogu dati kockice leda.
English: The majority (>90%) of healthcare professionals found Dzuveo easy to use.
Croatian: Većina (> 90 %) zdravstvenih radnika ocijenila je lijek Dzuveo jednostavnim za upotrebu.
English: Dzuveo will be available in cartons of 5 and 10.
Croatian: Dzuveo će biti dostupan u kutijama od pet i deset komada.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svojem liječniku za savjet prije uzimanja ovog lijeka.
English: Abuse potential and tolerance
Croatian: Mogućnost zloupotrebe i tolerancija
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na mrežnom mjestu Europske agencije za lijekove http://www.ema.europa.eu.
English: Propak Health Ltd,
Croatian: Proizvođač Propak Health Ltd,
English: Of the 221 patients, 147 received active treatment and 74 received placebo.
Croatian: Od 221 bolesnika, 147 je primilo aktivno liječenje, a 74 je primalo placebo.
English: • The method of use of the device;
Croatian: • metoda upotrebe uređaja;
English: Minimum 1 hour dosing interval.
Croatian: Minimalni interval doziranja od 1 sat.
English: Dzuveo should not be used beyond 48 hours.
Croatian: Dzuveo se ne smije upotrebljavati dulje od 48 sati.
English: Medicines should not be thrown away via wastewater or household waste.
Croatian: Lijekovi se ne smiju bacati u otpadne vode ili u kućni otpad.
English: Email: edgar.fenzl@fgk-rs.de
Croatian: edgar.fenzl@fgk-rs.de
English: Each pack contains either 5 or 10 pouches.
Croatian: Svako pakiranje sadrži pet ili deset vrećica.
English: This does not rule out more direct countermeasures.
Croatian: To ne isključuje primjenu izravnijih protumjera.
English: Depending on individual sensitivity, the clinical picture is determined by the degree of respiratory depression.
Croatian: Ovisno o individualnoj osjetljivosti, klinička slika određuje se stupnjem respiratorne depresije.
English: Hypnotic activity can be demonstrated by EEG alterations.
Croatian: Hipnotička aktivnost može se prikazati promjenama na EEG-u.
English: Any change in efficacy/tolerability associated with the increased exposure would be compensated in practice by an increase in the amount of time between doses (see section 4.2).
Croatian: Svaka promjena djelotvornosti/podnošljivosti povezana s povećanom izloženosti u praksi bi se nadoknadila povećanjem količine vremena među dozama (vidjeti dio 4.2.).
English: hallucinating or seeing things that are not there, nervousness.
Croatian: osjećaj ushićenja, haluciniranje ili viđenje stvari koje nisu tamo, živčanost.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR - PODATCI ČITLJIVI LJUDSKIM OKOM
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first utilisation: 25 June 2018
Croatian: Datum prvog odobrenja: 25 lipanj 2018
English: What Dzuveo is and what it is used for
Croatian: Što je Dzuveo i za što se koristi
English: Fertility and early embryonic development studies were conducted in male and female rats.
Croatian: Ispitivanja plodnosti i ranog embrionalnog razvoja provedena su u mužjaka i ženki štakora.
English: Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible, or when sufentanil is used in an emergency setting.
Croatian: Zbog tih rizika, istodobno propisivanje s tim sedativnim lijekovima treba se ograničiti na bolesnike za koje alternativne mogućnosti liječenja nisu moguće ili kada se sufentanil upotrebljava u hitnim slučajevima.
English: Sublingual tablet.
Croatian: Sublingvalna tableta.
English: Sufentanil does not induce histamine release.
Croatian: Sufentanil ne inducira otpuštanje histamina.
English: - Allergic reactions, itching of the skin.
Croatian: - Alergijske reakcije, svrbež kože.
English: Biotransformation takes place primarily in the liver and the small intestine.
Croatian: Biotransformacija se odvija prvenstveno u jetri i tankom crijevu.
English: Repeat antagonist administration may be required as the duration of respiratory depression may last longer than the duration of the effect of the antagonist (see section 4.9).
Croatian: Možda će biti potrebna ponovljena primjena antagonista jer trajanje respiratorne depresije može biti dulje od trajanja djelovanja antagonista (vidjeti dio 4.9.).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web- portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u popisu referentnih datuma Unije (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
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 nužnosti potpomognute ili kontrolirane ventilacije.
English: This should be considered when prescribing or administering sufentanil where there is concern about an increased risk of misuse, abuse or diversion.
Croatian: To se treba uzeti u obzir pri propisivanju ili primjeni sufentanila ako postoji zabrinutost zbog povećanog rizika pogrešne upotrebe, zloupotrebe ili diverzije.
English: In that case, the opioid antagonist can be administered repeatedly or by infusion.
Croatian: U tom slučaju, opioidni antagonist može se davati u više navrata ili infuzijom.
English: Sufentanil is rapidly metabolised to a number of inactive metabolites, with oxidative N- and O-dealkylation being the major routes of elimination.
Croatian: Sufentanil se brzo metabolizira u niz neaktivnih metabolita, pri čemu su oksidacijska N- i O-dealkilacija glavni putevi eliminacije.
English: Your healthcare provider will dispose of any waste according to hospital policies.
Croatian: Vaš zdravstveni radnik zbrinut će otpad u skladu s propisima bolnice.
English: - Inability to pass urine.
Croatian: - Nemogućnost uriniranja.
English: • The minimum dosing interval of one sublingual tablet per hour, in order to prevent / minimise the important identified risk of respiratory depression and the important potential risk of overdose;
Croatian: • minimalni interval doziranja jedne sublingvalne tablete po satu, radi sprječavanja/umanjivanja važnog utvrđenog rizika respiratorne depresije i važnog mogućeg rizika predoziranja;
English: Tell the patient to touch their tongue to the roof of their mouth if possible.
Croatian: Recite bolesniku da, ako može, jezikom dodirne svod usta.
English: Maximum concentrations of sufentanil are achieved approximately 60 minutes after a single dose; this is shortened to approximately 40 minutes following repeated hourly dosing.
Croatian: Maksimalne koncentracije sufentanila postižu se otprilike 60 minuta nakon jedne doze; to se skraćuje na otprilike 40 minuta nakon ponavljanja doziranja svaki sat.
English: Do not drink alcohol while using Dzuveo.
Croatian: Dzuveo s alkoholom Nemojte piti alkohol dok uzimate Dzuveo.
English: The safety and efficacy of sufentanil in children and adolescents below 18 years have not been established.
Croatian: Sigurnost i djelotvornost sufentanila u djece i adolescenata mlađih od 18 godina nisu utvrđene.
English: It can increase the risk of experiencing severe breathing problems.
Croatian: Može povećati rizik od teških problema s disanjem.
English: Patients at higher risk are those with respiratory impairment or reduced respiratory reserve.
Croatian: Bolesnici s većim rizikom su oni s oštećenjem respiratorne funkcije ili smanjenom respiratornom rezervom.
English: 3-4 Ballyboggan Industrial Estate, Ballyboggan Road, Finglas, Dublin 11, Ireland.
Croatian: 3-4 Ballyboggan Industrial Estate, Ballyboggan Road, Finglas, Dublin 11, Irska.
English: If you are having a blood test ensure your doctor knows you are taking this medicine.
Croatian: Ako radite pretrage krvi, obvezno obavijestite liječnika da uzimate ovaj lijek.
English: Dzuveo is provided in a disposable single-dose applicator, to be administered by a healthcare provider as needed by the individual patient, but no more than once every hour, resulting in a maximum dose of 720 micrograms /day.
Croatian: Dzuveo se isporučuje u jednokratnom aplikatoru za jednu dozu koju treba dati pružatelj zdravstvenih usluga ovisno o potrebama pojedinog bolesnika, ali ne više od jednom svaki sat, što rezultira maksimalnom dozom od 720 mikrograma na dan.
English: The shorter duration of activity of the opiate antagonist compared to that of sufentanil should be taken into account.
Croatian: Treba uzeti u obzir kraće trajanje djelovanja antagonista opijata u usporedbi sa sufentanilom.
English: • Detailed instruction on how to handle overdose / respiratory depression
Croatian: • detaljne upute o tome kako postupati s predoziranjem / respiratornom depresijom.
English: - Inability to manage blood sugar (diabetes), increased cholesterol.
Croatian: - Nemogućnost kontrole šećera u krvi (dijabetes), povišeni kolesterol.
English: The central volume of distribution after intravenous application of sufentanil is approximately 14 litres and the volume of distribution at steady state is approximately 350 litres.
Croatian: Središnji volumen distribucije nakon intravenske primjene sufentanila iznosi otprilike 14 litara, a volumen distribucije u stanju dinamičke ravnoteže iznosi otprilike 350 litara.
English: Pharmacotherapeutic group: Anesthetics, opioid anesthetics, ATC Code: N01AH03.
Croatian: Farmakoterapijska skupina: anestetici, opioidni anestetici, ATK oznaka: N01AH03.
English: All effects of sufentanil can immediately and completely be blocked by administration of a specific antagonist such as naloxone.
Croatian: Svi učinci sufentanila mogu se odmah i potpuno blokirati primjenom specifičnog antagonista kao što je nalokson.
English: It was concluded from these studies that sufentanil sublingual tablets have no or minimal potential for local irritation.
Croatian: Na temelju tih ispitivanja zaključeno je da sublingvalne tablete sufentanila nemaju potencijal za lokalnu iritaciju ili je on minimalan.
English: Gastrointestinal effects
Croatian: Gastrointestinalni učinci
English: - Fatty lumps underneath skin.
Croatian: - Masne kvržice pod kožom.
English: Similar CST½ values were observed following both single and repeated administration, demonstrating that there is a predictable and consistent duration of action after multiple dosing of the sublingual tablet.
Croatian: Slične vrijednosti CST½ zabilježene su nakon jednokratne i ponovljene primjene, pokazujući da postoji predvidljivo i dosljedno trajanje djelovanja nakon višestrukog doziranja sublingvalne tablete.
English: The oxygen absorber packet should be discarded.
Croatian: Paket apsorbera kisika treba baciti.
English: It is only prescribed by a doctor who is experienced in the use of strong painkillers like sufentanil and knows the effects it may have on you, in particular on your breathing (see ‘Warnings and precautions' above).
Croatian: Propisuje ga samo liječnik koji ima iskustva u primjeni snažnih lijekova protiv bolova kao što je sufentanil i zna kakve učinke može na vas imati, osobito na disanje (vidjeti prethodno navedena Upozorenja i mjere opreza).
English: Your doctor or nurse will ensure that: - this medicine is not used after the expiry date which is stated on the label and carton after EXP.
Croatian: Vaš liječnik ili medicinska sestra osigurat će: - da se ovaj lijek ne primjenjuje nakon isteka roka valjanosti navedenog na naljepnici i kutiji.
English: Tell your doctor or nurse before treatment if you: - Are suffering from any condition that affects your breathing (such as asthma, wheezing, or shortness of breath).
Croatian: Obratite se svojem liječniku ili medicinskoj sestri prije liječenja ako: - bolujete od bilo kojeg stanja koje utječe na vaše disanje (kao što je astma, piskanje pri disanju ili nedostatak zraka).
English: You should not eat or drink and should talk as little as possible for 10 minutes after each dose.
Croatian: Ne smijete jesti niti piti te trebate što manje govoriti tijekom 10 minuta nakon svake doze.