FrancophonIA/ELRC3.0 huggingface dataset:
English: Stop taking Saxenda and contact a doctor immediately if you experience severe pain in your upper abdomen, usually worst on the right side under the ribs.
Croatian: Prestanite s primjenom lijeka Saxenda te se odmah obratite liječniku ako iskusite jaku bol u gornjem dijelu trbuha, obično najgoru na desnoj strani ispod rebara.
English: The long-term clinical impact of this mean increase in heart rate has not been established.
Croatian: Dugoročni klinički učinak tog srednjeg povećanja srčane frekvencije nije ustanovljen.
English: Signs may include reduction in urine volume, metallic taste in mouth and easily bruising.
Croatian: Znakovi mogu uključivati smanjeni volumen urina, metalni okus u ustima i lako nastajanje modrica.
English: Pancreatitis is a serious, potentially life-threatening medical condition.
Croatian: Pankreatitis je ozbiljno medicinsko stanje, potencijalno opasno po život.
English: If you use more Saxenda than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako primijenite više lijeka Saxenda nego što ste trebali, odmah razgovarajte s liječnikom ili odite u bolnicu.
English: Change in Body Weight (%) Saxenda Placebo
Croatian: Promjena u tjelesnoj težini (%) Saxenda Placebo
English: Once you reach the recommended dose of 3.0 mg in week 5 of treatment, keep using this dose until your treatment period ends.
Croatian: Jednom kada dostignete preporučenu dozu od 3,0 mg u 5. tjednu liječenja, nastavite primjenjivati tu dozu do kraja razdoblja liječenja.
English: The heart rate peaked after approximately 6 weeks.
Croatian: Srčana frekvencija dostigla je vršnu vrijednost nakon otprilike 6 tjedana.
English: • You doctor will instruct you to gradually increase your dose by 0.6 mg usually each week until you reach the recommended dose of 3.0 mg once a day.
Croatian: • Liječnik će Vas uputiti kako postupno povećati dozu za 0,6 mg, obično svaki tjedan dok ne dođete do preporučene doze od 3,0 mg jednom dnevno.
English: In addition, liraglutide had a beneficial effect on plasma lipids.
Croatian: Dodatno, liraglutid je imao pozitivan učinak na lipide u plazmi.
English: HR: 0.87 95% CI 0.78; 0.97 p<0.001 for non-inferiority p=0.005 for superiority
Croatian: 95% CI 0.78; 0.97 p<0.001 za neinferiornost p=0.005 za superiornost
English: The reactions usually occurred during the first weeks of treatment and diminished within a few days or weeks on continued treatment.
Croatian: Te reakcije obično se pojavljuju tijekom prvih tjedana liječenja i smanjuju se unutar nekoliko dana ili tjedana neprekidnog liječenja.
English: These findings in rodents are caused by a non-genotoxic, specific GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive.
Croatian: Ovi nalazi u glodavaca uzrokovani su negenotoksičnim, specifičnim mehanizmom posredovanim GLP-1 receptorom, na koji su glodavci osobito osjetljivi.
English: Liraglutide is endogenously metabolised in a similar manner to large proteins without a specific organ as major route of elimination.
Croatian: Liraglutid se endogeno metabolizira na sličan način kao i veliki proteini te nije utvrđen nijedan specifični organ kao glavni put eliminacije.
English: For further instructions on administration, see section 6.6.
Croatian: Za daljnje upute o primjeni vidjeti dio 6.6.
English: If you are not sure how to split your dose using two pens, then select and inject the dose you need with a new pen.
Croatian: Ako niste sigurni kako podijeliti dozu između dvije brizgalice, odaberite i injicirajte dozu koja Vam je potrebna iz nove brizgalice.
English: The Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcomes Results (LEADER) trial included 9,340 patients with insufficiently controlled type 2 diabetes.
Croatian: Liraglutide Effect and Action in Diabetes Evaluation of Cardiovascular Outcomes Results) uključivalo je 9340 bolesnika s nedovoljno kontroliranom šećernom bolešću tipa 2.
English: Saxenda is available in pack sizes containing 1, 3 or 5 pens.
Croatian: Saxenda je dostupna u pakiranjima koja sadrže 1, 3 ili 5 brizgalica.
English: In the 160-weeks part of trial 1, the weight loss occurred mainly in the first year and was sustained throughout 160 weeks.
Croatian: U 160-tjednom dijelu 1. ispitivanja, gubitak tjelesne težine nastupio je većinom tijekom prve godine, te se održao tijekom 160 tjedana.
English: Pack sizes of 1, 3 or 5 pre-filled pens.
Croatian: Veličine pakiranja: 1, 3 ili 5 napunjenih brizgalica.
English: Interaction studies did not show any clinically relevant delay of absorption and therefore no dose adjustment is required.
Croatian: Ispitivanja interakcija nisu pokazala klinički značajnu odgodu apsorpcije pa stoga nije potrebno prilagođavanje doze.
English: Apnoea-Hypopnoea Index (AHI)
Croatian: Indeks apneja-hipopneja (AHI)
English: Placebo Liraglutide
Croatian: Placebo Liraglutid
English: • Do not inject Saxenda which has been frozen.
Croatian: • Nemojte injicirati lijek Saxenda koji je bio zamrznut.
English: You can select up to 3.0 mg per dose.
Croatian: Možete odabrati do 3,0 mg po dozi.
English: Saxenda should not be used in children and adolescents under 18 years of age.
Croatian: Saxenda se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: GLP-1 receptors are also expressed in specific locations in the heart, vasculature, immune system and kidneys.
Croatian: GLP-1 receptori eksprimiraju se i na specifičnim mjestima u srcu, krvnim žilama, imunološkom sustavu i bubrezima.
English: In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Croatian: U slučaju predoziranja potrebno je započeti odgovarajuće potporno liječenje prema bolesnikovim kliničkim znakovima i simptomima.
English: None of the reports included severe hypoglycaemia.
Croatian: Niti jedna od prijava nije uključivala tešku hipoglikemiju.
English: • Turn the dose selector until the dose counter shows the flow check symbol (
Croatian: • Okrećite izbornik doze dok brojčanik doze ne prikaže simbol za provjeru protoka (
English: What Saxenda looks like and contents of the pack
Croatian: Kako Saxenda izgleda i sadržaj pakiranja
English: • Caregivers must be very careful when handling used needles - to prevent needle injury and cross-infection.
Croatian: • Osobe koje skrbe za bolesnika trebaju biti osobito oprezne pri rukovanju rabljenim iglama - kako bi spriječile ozljede iglom i prijenos infekcije.
English: There is little experience with this medicine in patients of 75 years and older.
Croatian: Malo je iskustva s primjenom ovog lijeka u bolesnika u dobi od 75 godina i starijih.
English: • you are taking warfarin or other medicines by mouth that reduce your blood clotting (anticoagulants).
Croatian: • uzimate kroz usta varfarin ili druge lijekove koji smanjuju sposobnost zgrušavanja krvi (antikoagulansi).
English: Table 1 Dose escalation schedule Dose
Croatian: Tablica 1 Raspored povećavanja doze Doza
English: • Check the name and coloured label of your pen, to make sure that it contains Saxenda.
Croatian: • Provjerite naziv i obojenu naljepnicu na brizgalici kako biste bili sigurni da sadrži lijek Saxenda.
English: If you feel dizziness be extra careful while driving or using machines.
Croatian: Ako osjetite omaglicu, budite posebno oprezni pri vožnji i radu sa strojevima.
English: If you need any further information, talk to your doctor.
Croatian: Ako su Vam potrebne dodatne informacije, obratite se svom liječniku.
English: Events were isolated and the majority resolved during continued treatment with Saxenda.
Croatian: Događaji su bili izolirani i većina je razriješena tijekom daljnjeg liječenja lijekom Saxenda.
English: Use in these patients is not recommended (see section 4.2).
Croatian: Ne preporučuje se primjena u tih bolesnika (vidjeti dio 4.2).
English: Change in Body Weight (%)
Croatian: Promjena u tjelesnoj težini (%)
English: Last observation carried forward.
Croatian: Zadnje opažanje preneseno dalje
English: It is unknown whether the reduced pup growth is caused by reduced pup milk intake due to a direct GLP-1 effect or reduced maternal milk production due to decreased caloric intake.
Croatian: Nije poznato je li smanjeni rast mladunaca uzrokovan smanjenim unosom mlijeka u mladunaca zbog izravnog učinka GLP-1 ili smanjenom proizvodnjom majčinog mlijeka zbog smanjenog unosa kalorija.
English: Stop taking Saxenda and contact a doctor immediately if you notice any of the following serious side effects:
Croatian: Prestanite primjenjivati lijek Saxenda i odmah se obratite liječniku ako primijetite bilo koju od navedenih ozbiljnih nuspojava:
English: This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease.
Croatian: Ovaj se lijek ne preporučuje ako imate teških problema sa želucem ili crijevima, što rezultira odgođenim pražnjenjem želuca (što se naziva gastropareza), kao ni ako imate upalnu bolest crijeva.
English: • If you forget a dose and remember it within 12 hours from when you usually use the dose, inject it as soon as you remember.
Croatian: • Ako ste zaboravili primijeniti jednu dozu i sjetite se unutar 12 sati od kada obično primjenjujete dozu, injicirajte je čim se sjetite.
English: This is because it is not known if Saxenda may affect the baby.
Croatian: To je zato što nije poznato utječe li Saxenda na dijete.
English: This usually occurs the first 3 months of treatment
Croatian: To se najčešće događa u prva 3 mjeseca liječenja.
English: Heart rate should be monitored at regular intervals consistent with usual clinical practice.
Croatian: Srčanu frekvenciju potrebno je pratiti u redovitim razmacima u skladu s uobičajenom kliničkom praksom.
English: Before week 0 patients were only treated with low-calorie diet and exercise.
Croatian: Prije 0. tjedna bolesnici su liječeni samo niskokalorijskom dijetom i tjelovježbom.
English: The dose selector changes the dose.
Croatian: Izbornik doze mijenja dozu.
English: If you use more Saxenda than you should
Croatian: Ako primijenite više lijeka Saxenda nego što ste trebali
English: Change the needle as described in step 5 ‘After your injection' and repeat all steps starting with step 1 ‘Prepare your pen with a new needle'.
Croatian: Promijenite iglu kako je opisano u koraku 5 „Nakon injiciranja“ i ponovite sve korake počevši od koraka 1 „Pripremite brizgalicu s novom iglom“: Provjerite jeste li odabrali cijelu dozu koju trebate.
English: • increase of pancreatic enzymes, such as lipase and amylase.
Croatian: • Porast enzima gušterače, kao što su lipaza i amilaza.
English: Talk to your doctor, pharmacist or nurse before using Saxenda.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite lijek Saxenda.
English: If no drop appears, repeat step 2 ‘Check the flow' up to 6 times.
Croatian: Ako se kapljica ne pojavi, ponovite korak 2 „Provjerite protok“ do šest puta.
English: If a patient wishes to become pregnant or pregnancy occurs, treatment with liraglutide should be discontinued.
Croatian: Ako bolesnica želi zatrudnjeti ili se trudnoća dogodi, liječenje liraglutidom potrebno je prekinuti.
English: Get help from a person with good eyesight who is trained to use the Saxenda pre-filled pen.
Croatian: Zatražite pomoć osobe koja dobro vidi i koja je naučila kako koristiti Saxenda napunjenu brizgalicu.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Saxenda in one or more subsets of the paediatric population in the treatment of obesity and in the treatment of Prader-Willi Syndrome (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Saxenda u jednoj ili više podskupina pedijatrijske populacije za liječenje pretilosti i za liječenje sindroma Prader-Willi (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Detailed instructions for use are provided on the other side of this leaflet.
Croatian: Detaljne upute za uporabu nalaze se na poleđini ove Upute o lijeku.
English: Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility (see section 5.3).
Croatian: Osim neznatnog sniženja broja živih implantata, ispitivanja na životinjama nisu ukazala na štetne učinke na plodnost (vidjeti dio 5.3).
English: Anaphylactic reactions may potentially be life threatening.
Croatian: Anafilaktičke reakcije mogu potencijalno biti opasne po život.
English: The majority of events were mild or moderate.
Croatian: Većina događaja bila je blagog ili umjerenog intenziteta.
English: Both treatment periods were followed by a 12-week off drug/placebo observational follow-up period.
Croatian: Nakon oba perioda liječenja slijedio je 12-tjedni opservacijski period praćenja bez primjene lijeka ili placeba.
English: Stay on this programme while you are using Saxenda.
Croatian: Pridržavajte se tog programa dok primjenjujete lijek Saxenda.
English: The use of Saxenda is not recommended if you have severe heart failure.
Croatian: Primjena lijeka Saxenda se ne preporučuje ako imate teško zatajenje srca.
English: Baseline, kg (SD)
Croatian: Početna vrijednost, kg (SD)
English: ****From controlled phase 2, 3a and 3b clinical trials.
Croatian: ***Vidjeti dio 4.4. ****Iz kontroliranih kliničkih ispitivanja faze 2, 3a i 3b.
English: Cholelithiasis*** Cholecystitis***
Croatian: Kolelitijaza*** Kolecistitis***
English: Never touch the dose counter when you inject.
Croatian: Nikada ne dirajte brojčanik doze dok injicirate lijek.
English: The mean apparent volume of distribution after subcutaneous administration is 20-25 L (for a person weighing approximately 100 kg).
Croatian: Srednji prividni volumen distribucije nakon supkutane primjene iznosi 20-25 l (za osobu težine otprilike 100 kg).
English: Saxenda is unlikely to affect your ability to drive and use machines.
Croatian: Malo je vjerojatno da će Saxenda utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Example 0.6 mg selected
Croatian: Primjer: odabrano je 0,6 mg
English: When starting treatment with Saxenda, you may lose body fluid or become dehydrated.
Croatian: Kada započnete liječenje lijekom Saxenda, može doći do gubitka tjelesne tekućine ili možete dehidrirati.
English: Do not use the pen scale.
Croatian: Nemojte koristiti skalu na brizgalici.
English: Talk to your doctor if you have or have had a disease of the pancreas.
Croatian: Obratite se svojem liječniku ako imate ili ste imali bolest gušterače.
English: Because of lack of experience, Saxenda should not be used during breast-feeding.
Croatian: Zbog nedostatka iskustva, Saxenda se ne smije primjenjivati tijekom dojenja.
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas
Croatian: • Jaku i ustrajnu bol u abdomenu (području trbuha) koja se može protezati na leđa, kao i mučninu i povraćanje, jer to mogu biti znakovi upale gušterače (pankreatitisa).
English: In particular, tell your doctor, pharmacist or nurse if:
Croatian: Naročito je potrebno da liječnika, ljekarnika ili medicinsku sestru obavijestite ako:
English: The urine and faeces radioactivity was mainly excreted during the first 6-8 days and corresponded to three minor metabolites, respectively.
Croatian: Radioaktivnost se u mokraći i stolici uglavnom izlučivala tijekom prvih 6-8 dana, a odgovarala je trima sporednim metabolitima.
English: These reactions were usually mild and transitory and the majority disappeared during continued treatment.
Croatian: Te reakcije obično su bile blage i prolazne te je većina nestala tijekom daljnjeg liječenja.
English: 3 Select your dose
Croatian: 3 Odaberite dozu
English: If a dose is missed within 12 hours from when it is usually taken, the patient should take the dose as soon as possible.
Croatian: Ako se doza propusti unutar 12 sati od kada se obično primjenjuje, bolesnik treba uzeti dozu što je prije moguće.
English: Absolute bioavailability of liraglutide following subcutaneous administration is approximately 55%.
Croatian: Apsolutna bioraspoloživost liraglutida nakon supkutane primjene otprilike je 55%.
English: *human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in Saccharomyces cerevisiae.
Croatian: *Analog humanog glukagonu sličnog peptida-1 (GLP-1) proizveden tehnologijom rekombinantne DNK u Saccharomyces cerevisiae.
English: • Use Saxenda at about the same time each day - choose a time of the day that works best for you.
Croatian: • Primjenjujte lijek Saxenda svakoga dana otprilike u isto vrijeme - odaberite vrijeme u danu koje
English: If you adjust your insulin dose your doctor may recommend you to monitor your blood sugar more frequently.
Croatian: Ako prilagodite Vašu dozu inzulina, liječnik Vam može preporučiti da češće pratite razinu šećera u krvi.
English: • Trial 1 (SCALE Obesity & Pre-Diabetes - 1839): A total of 3,731 patients with obesity (BMI
Croatian: • 1. ispitivanje (SCALE Obesity & Pre-Diabetes-1839): Ukupno 3731 bolesnika, pretilih
English: Increased lipase
Croatian: Povišena lipaza
English: Cholelithiasis and cholecystitis may lead to hospitalisation and cholecystectomy.
Croatian: Kolelitijaza i kolecistitis mogu rezultirati hospitalizacijom i kolecistektomijom.
English: Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight.
Croatian: Liječenje lijekom Saxenda potrebno je prekinuti nakon 12 tjedana na dozi od 3,0 mg/dan ako bolesnici ne izgube barem 5% svoje početne tjelesne težine.
English: Use a calculator to plan the doses as instructed by your doctor or nurse.
Croatian: Koristite kalkulator za planiranje doza sukladno uputama koje ste dobili od svog liječnika ili medicinske sestre.
English: If there is still no drop, change the needle and repeat step 2 ‘Check the flow' once more.
Croatian: Ako se kapljica i dalje ne pojavi, promijenite iglu i ponovite korak 2 „Provjerite protok“ još jednom.
English: • The best places to inject are the front of your waist (abdomen), the front of your thighs or your upper arm.
Croatian: • Najbolja mjesta za injiciranje su prednja strana trbuha (abdomen), prednja strana bedara ili nadlaktice.
English: Patients should be informed of the symptoms of increased heart rate (palpitations or feelings of a racing heartbeat while at rest).
Croatian: Bolesnike je potrebno informirati o simptomima povećane srčane frekvencije (palpitacije ili osjećaj ubrzanih otkucaja srca tijekom mirovanja).
English: The selected dose must line up precisely with the dose pointer to ensure that you get a correct dose.
Croatian: Odabrana doza mora se precizno poravnati s pokazivačem doze kako biste dobili točnu dozu.
English: Tell your doctor if you have diabetes.
Croatian: Obavijestite svog liječnika ako imate šećernu bolest.
English: Non-lethal thyroid C-cell tumours were seen in two-year carcinogenicity studies in rats and mice.
Croatian: Nesmrtonosni tumori C-stanica štitnjače zabilježeni su u dvogodišnjim ispitivanjima kancerogenosti u štakora i miševa.
English: How much to inject
Croatian: Koliko injicirati
English: The dose should be increased to 3.0 mg once daily in increments of 0.6 mg with at least one week intervals to improve gastro-intestinal tolerability (see table 1).
Croatian: Dozu je potrebno povećati do 3,0 mg jednom dnevno s povećanjima od 0,6 mg uz najmanje jednotjedne intervale kako bi se poboljšala gastrointestinalna podnošljivost lijeka (vidjeti tablicu 1).
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Croatian: Kategorije učestalosti su definirane kako slijedi: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000).
English: The 3.0 mg daily dose of liraglutide provided adequate systemic exposures over the body weight range of 60-234 kg evaluated for exposure response in the clinical trials.
Croatian: Dnevna doza liraglutida od 3,0 mg omogućuje odgovarajuće sistemske izloženosti za raspon tjelesne težine 60-234 kg za koji je u kliničkim ispitivanjima procijenjen odgovor na izloženost.
English: If so, the full dose will not be delivered.
Croatian: U tom slučaju neće se primijeniti puna doza.
English: Most episodes of gastrointestinal events were mild to moderate, transient and the majority did not lead to discontinuation of therapy.
Croatian: Većina epizoda gastrointestinalnih događaja bila je blagog do umjerenog intenziteta, prolazna i u većini slučajeva nije rezultirala prekidom terapije.
English: Specific data on weight loss, responders, time course and cumulative distribution of weight change (%) for trials 1-4 are presented in tables 3-7 and figures 1, 2 and 3.
Croatian: Specifični podaci o gubitku tjelesne težine, ispitanicima koji su odgovorili na liječenje, vremenskom tijeku i kumulativnoj distribuciji promjene tjelesne težine (%) za 1.-4. ispitivanja navedeni su u tablicama 3-7 te na slikama 1, 2 i 3.
English: Novo Nordisk A/S Hallas Allé 4400 Kalundborg Denmark
Croatian: 4400 Kalundborg Danska
English: **Insomnia was mainly seen during the first 3 months of treatment.
Croatian: **Nesanica je uglavnom zabilježena tijekom prva 3 mjeseca liječenja.
English: Saxenda is for subcutaneous use only.
Croatian: Saxenda je namijenjena samo za supkutanu primjenu.
English: The predicted mean weight loss in early responders who complete 1 year of treatment is 11.2% of their baseline body weight (9.7% for males and 11.6% for females).
Croatian: Predviđeni srednji gubitak tjelesne težine u ispitanika s ranim odgovorom na liječenje koji dovrše jednu godinu liječenja iznosi 11,2% njihove tjelesne težine na početku ispitivanja (9,7% za muškarce i 11,6% za žene).
English: Weight loss response after 12 weeks with liraglutide (3.0 mg) treatment
Croatian: Odgovor u obliku gubitka tjelesne težine nakon 12 tjedana liječenja liraglutidom (3,0 mg)
English: Table 2 Adverse reactions reported MedDRA system organ classes
Croatian: Tablica 2 Prijavljene nuspojave MedDRA klasifikacija organskih sustava
English: Saxenda works by acting on receptors in the brain that control your appetite, causing you to feel fuller and less hungry.
Croatian: Saxenda djeluje na receptore u mozgu koji kontroliraju apetit i tako stvara osjećaj punoće te Vas čini manje gladnima.
English: Events reported included severe nausea and severe vomiting which are also the expected symptoms of an overdose with liraglutide.
Croatian: Prijavljeni događaji uključivali su tešku mučninu i teško povraćanje koji su ujedno očekivani simptomi predoziranja liraglutidom.
English: • Do not expose your pen to dust, dirt or liquid.
Croatian: • Ne izlažite brizgalicu prašini, prljavštini ili tekućini.
English: The primary endpoint was the time from randomisation to first occurrence of any major adverse cardiovascular events (MACE): cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
Croatian: Primarna mjera ishoda bilo je vrijeme od randomizacije do prvog nastupa bilo kojeg velikog kardiovaskularnog štetnog događaja (MACE): kardiovaskularna smrt, infarkt miokarda bez smrtnog ishoda ili moždani udar bez smrtnog ishoda.
English: Do not use Saxenda after the expiry date which is stated on the pen label and carton after ‘EXP'.
Croatian: Saxenda se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici brizgalice i kutiji iza oznake „EXP“.
English: Always watch the dose counter to know how many mg you inject.
Croatian: Uvijek motrite brojčanik doze kako biste znali koliko mg ste injicirali.
English: Cardiometabolic risk factors
Croatian: Kardiometabolički faktori rizika