FrancophonIA/ELRC3.0 huggingface dataset:
English: One vial contains 20 mg of basiliximab.
Croatian: Jedna bočica sadrži 20 mg basiliksimaba.
English: One vial contains 10 mg of basiliximab.
Croatian: Jedna bočica sadrži 10 mg basiliksimaba.
English: Each vial contains 20 mg basiliximab*.
Croatian: Jedna bočica sadrži 20 mg basiliksimaba*.
English: Caution should be exercised when patients previously given Simulect are re-exposed to a subsequent course of therapy with this medicinal product.
Croatian: Kada se terapija Simulectom nastavlja u bolesnika koji su ranije primili Simulect, potreban je oprez.
English: For infusion, the reconstituted solution should be diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ml (5%).
Croatian: Za infuziju, rekonstituirana otopina se razrjeđuje fiziološkom otopinom ili 50 mg/ml (5%) otopinom glukoze do volumena od 50 ml ili većeg.
English: Simulect 20 mg powder for solution for injection/infusion basiliximab
Croatian: Simulect 20 mg prašak i otapalo za otopinu za injekciju/infuziju basiliksimab
English: Simulect 20 mg powder and solvent for solution for injection or infusion basiliximab
Croatian: Simulect 20 mg prašak i otapalo za otopinu za injekciju ili infuziju basiliksimab
English: To prepare the solution for infusion or injection, add 5 ml of water for injections from the accompanying ampoule aseptically to the vial containing the Simulect powder.
Croatian: Za pripremu otopine za infuziju ili injekciju, aseptički dodajte 5 ml vode za injekcije iz priložene ampule u bočicu koja sadrži Simulect prašak.
English: For infusion, the reconstituted solution should be diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ml (5%).
Croatian: Za infuziju, rekonstituirana otopina se razrjeđuje fiziološkom otopinom ili 50 mg/ml (5%) otopinom glukoze do volumena od 25 ml ili većeg.
English: Each vial contains 10 mg basiliximab*.
Croatian: Jedna bočica sadrži 10 mg basiliksimaba*.
English: Simulect 10 mg powder and solvent for solution for injection or infusion basiliximab
Croatian: Simulect 10 mg prašak i otapalo za otopinu za injekciju ili infuziju basiliksimab
English: Simulect 10 mg powder for solution for injection/infusion basiliximab
Croatian: Simulect 10 mg prašak i otapalo za otopinu za injekciju/infuziju basiliksimab
English: - If you get any side effects, talk to your doctor, nurse or pharmacist.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, medicinsku sestru ili ljekarnika.
English: If you get any side effects, talk to your doctor, nurse or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, medicinsku sestru ili ljekarnika.
English: Chemical and physical stability of the reconstituted solution is demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature (see section 6.6).
Croatian: oC ili 4 sata na sobnoj temperaturi (vidjeti dio 6.6).
English: Each vial contains 10 mg of basiliximab.
Croatian: Jedna bočica sadržava 10 mg basiliksimaba.
English: This will help you to remember to take it.
Croatian: To će Vam pomoći da je se sjetite uzeti.
English: However, try to take it at the same time each day.
Croatian: Ipak, pokušajte ju uzimati svaki dan u isto vrijeme.
English: It is important to tell your doctor:
Croatian: Važno je obavijestiti svog liječnika:
English: Then take your next dose at the usual time.
Croatian: Potom uzmite sljedeću dozu u uobičajeno vrijeme.
English: A double dose should not be taken on the same day.
Croatian: Ne smije se uzeti dvostruka doza u istom danu.
English: • You can take the tablet at any time of the day.
Croatian: • Tabletu možete uzeti u bilo koje vrijeme dana.
English: These conditions can cause dehydration.
Croatian: Ova stanja mogu uzrokovati dehidraciju.
English: • Jardiance can also be used with other medicines.
Croatian: • Jardiance se također može koristiti zajedno s drugim lijekovima.
English: eGFR ≥45 to
Croatian: eGFR ≥45 do
English: Jardiance is not recommended for children and adolescents under 18 years, because it has not been studied in these patients.
Croatian: Jardiance se ne preporučuje djeci i adolescentima mlađim od 18 godina, jer lijek nije ispitan u ovih bolesnika.
English: The signs of low blood sugar may include:
Croatian: Znakovi niske razine šećera u krvi mogu uključivati:
English: Do not change your dose unless your doctor has told you to.
Croatian: Ne mijenjate svoju dozu osim ako Vam liječnik to nije propisao.
English: The relevance of this finding to humans is unclear.
Croatian: Značaj ovog rezultata za ljude nije jasan.
English: These may be medicines taken by mouth or insulin given by injection.
Croatian: To mogu biti lijekovi koji se uzimaju kroz usta ili inzulin koji se daje injekcijom.
English: Do not use Jardiance if you are pregnant.
Croatian: Ne koristite Jardiance ako ste trudni.
English: Systemic exposure of each metabolite was less than 10% of total drug-related material.
Croatian: Sistemska izloženost svakom metabolitu je iznosila manje od 10% ukupnog materijala povezanog s lijekom.
English: • excessive hunger, headache
Croatian: • izraženu glad, glavobolju
English: • if you are taking a medicine used to remove water from the body (diuretic).
Croatian: • ako uzimate lijek koji se koristi za uklanjanje vode iz tijela (diuretik).
English: • unusual thirst
Croatian: • neuobičajenu žeđ
English: • Your doctor will prescribe the strength that is right for you.
Croatian: • Vaš liječnik će propisati jačinu lijeka koja je za Vas ispravna.
English: The tablets can be taken with or without food, swallowed whole with water.
Croatian: Tablete se mogu uzeti sa ili bez hrane, progutane cijele s vodom.
English: • if you have “type 1 diabetes”.
Croatian: • ako imate „šećernu bolest tipa 1“.
English: Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Croatian: Vaš liječnik će Vas uputiti kako da ispravite nisku razinu šećera u krvi i što učiniti ako primijetite bilo koji od gore navedenih znakova.
English: What Jardiance is and what it is used for
Croatian: Što je Jardiance i za što se koristi
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 May 2014
Croatian: Datum prvog odobrenja: 22. svibnja 2014.
English: Therapeutic experience in patients aged 85 years and older is limited.
Croatian: Terapijsko iskustvo u bolesnika u dobi od 85 i više godina je ograničeno.
English: • Do not take a double dose of Jardiance to make up for a forgotten dose.
Croatian: • Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu lijeka Jardiance.
English: Your doctor will decide whether to increase your dose to 25 mg once a day.
Croatian: Vaš liječnik će odlučiti trebate li povisiti dozu na 25 mg jedanput dnevno.
English: These findings were absent after a 13 weeks drug-free recovery period.
Croatian: Ovi nalazi nisu bili prisutni nakon razdoblja oporavka od 13 tjedana bez primjene lijeka.
English: Diet and exercise can help your body use its blood sugar better.
Croatian: Dijeta i tjelovježba mogu pomoći Vašem tijelu da ono što bolje iskoristi šećer u krvi.
English: The safety and efficacy of empagliflozin in children and adolescents has not yet been established.
Croatian: Sigurnost i djelotvornost empagliflozina u djece i adolescenata nisu još ustanovljene.
English: • if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink.
Croatian: • ako povraćate, imate proljev ili vrućicu ili ako ne možete jesti ili piti.
English: Remember to take all medicines as directed by your doctor to achieve the best results for your health.
Croatian: Upamtite da se svi lijekovi uzimaju prema uputama liječnika kako bi se postigao najbolji rezultat za
English: These changes were not considered to be clinically meaningful.
Croatian: Ove promjene se ne smatraju klinički značajnima.
English: • If it is 12 hours or more until your next dose, take Jardiance as soon as you remember.
Croatian: • Ako do sljedeće doze ima 12 ili više sati, uzmite Jardiance čim se sjetite.
English: The maximum daily dose is 25 mg (see below and section 4.4).
Croatian: Maksimalna dnevna doza iznosi 25 mg (vidjeti niže i dio 4.4).
English: 24 weeks and maintained for 76 weeks.
Croatian: Ovaj učinak je opažen nakon 24 tjedana, a održan je 76 tjedana.
English: Glimepirideb
Croatian: Glimepiridb
English: • pain in the pelvis, or mid-back pain (when kidneys are infected)
Croatian: • bol u zdjelici, ili sredini leđa (kada su inficirani bubrezi)
English: What you need to know before you take Jardiance
Croatian: Što morate znati prije nego počnete uzimati Jardiance
English: Your doctor may decide to temporarily or permanently stop your treatment with Jardiance.
Croatian: Vaš liječnik može odlučiti privremeno ili trajno prekinuti Vaše liječenje lijekom Jardiance.
English: If you forget to take Jardiance What to do if you forget to take a tablet depends on how long it is until your next dose.
Croatian: Što učiniti ako ste zaboravili uzeti tabletu, ovisi o tome koliko vremena je preostalo do sljedeće doze.
English: Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: • if you are 85 years old or older as you should not start taking Jardiance.
Croatian: • ako imate 85 ili više godina, ne smijete početi s uzimanjem lijeka Jardiance.
English: Both tumours are common in rats and are unlikely to be relevant to humans.
Croatian: Oba tumora su česti u štakora i vjerojatno nisu relevantni za ljude.
English: Possible signs are listed in section 4, ‘Possible side effects' under ‘dehydration'.
Croatian: Mogući znakovi su navedeni u dijelu 4, ‘Moguće nuspojave' pod ‘dehidracija'.
English: As a precautionary measure, it is preferable to avoid the use of Jardiance during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Jardiance tijekom trudnoće.
English: If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice.
Croatian: Ako imate simptome niske razine šećera u krvi, uzmite tablete glukoze, obrok s puno šećera ili popijte voćni sok.
English: Do not drive or use any tools or machines, if you feel dizzy while taking Jardiance.
Croatian: Nemojte voziti ili koristiti druge alate ili strojeve, ako osjećate omaglicu tijekom uzimanja lijeka Jardiance.
English: Do not stop taking Jardiance without first consulting your doctor.
Croatian: Ne prekidajte uzimanje lijeka Jardiance bez prethodnog savjetovanja s liječnikom.
English: Possible signs of losing too much fluid from your body are listed in section 4 ‘Possible side effects'.
Croatian: Mogući znakovi prevelikog gubitka tekućine iz tijela navedeni su u dijelu 4 ‘Moguće nuspojave'.
English: If you take more Jardiance than you should If you take more Jardiance than you should, talk to a doctor immediately or go to a hospital immediately.
Croatian: Ako uzmete više Jardiancea nego što ste trebali, odmah se javite liječniku ili smjesta otiđite u bolnicu.
English: • if you are 75 years old or older, as increased passing of urine due to the medicine may affect fluid balance in your body and increase your risk of dehydration.
Croatian: • ako imate 75 ili više godina, jer pojačano izlučivanje mokraće uslijed djelovanja lijeka može utjecati na poremećaj ravnoteže tekućina u Vašem tijelu i povećati rizik od dehidracije.
English: Pruritus (generalised)
Croatian: Svrbež (generalizirani)
English: If you stop taking Jardiance
Croatian: Ako prestanete uzimati Jardiance
English: In both cases, treatment with empagliflozin may be restarted once the patient's condition has stabilised.
Croatian: U oba slučaja, liječenje empagliflozinom može se ponovno započeti nakon što se bolesnikovo stanje stabiliziralo.
English: If a dose is missed, it should be taken as soon as the patient remembers.
Croatian: U slučaju propuštene doze, doza se treba uzeti čim se bolesnik sjeti.
English: Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili se vidi da je bilo otvarano.
English: • You can take the tablet with or without food
Croatian: • Tabletu možete uzeti sa ili bez hrane.
English: The tablet is 11.1 mm long and has a width of 5.6 mm.
Croatian: Tablete su dugačke 11,1 mm i široke 5,6 mm.
English: However, animal studies have shown adverse effects on postnatal development (see section 5.3).
Croatian: Međutim, ispitivanja na životinjama su pokazala štetne učinke na postnatalni razvoj (vidjeti dio 5.3).
English: SGLT2 is highly expressed in the kidney, whereas expression in other tissues is absent or very low.
Croatian: SGLT2 je jako izražen u bubregu, dok u drugim tkivima nije prisutan ili je vrlo nizak.
English: • If it is less than 12 hours until your next dose, skip the missed dose.
Croatian: • Ako do sljedeće doze ima manje od 12 sati, preskočite propuštenu dozu.
English: Thereafter, plasma concentrations declined in a biphasic manner with a rapid distribution phase and a relatively slow terminal phase.
Croatian: Potom su se koncentracije u plazmi smanjile na bifazni način s brzom distribucijskom fazom i relativno sporom terminalnom fazom.
English: The genital tract infections were mild or moderate in intensity.
Croatian: Infekcije genitalnog trakta bile su blage ili umjerene u intenzitetu.
English: An urge to pass urine or more frequent urination may be due to the way Jardiance works, but as they can also be signs of urinary tract infection, if you note an increase in such symptoms, you should also contact your doctor.
Croatian: Osjećaj nagona za mokrenjem ili češće mokrenje mogu se javiti zbog načina djelovanja lijeka Jardiance, ali budući da oni ujedno mogu biti znakovi infekcije mokraćnog sustava, ako primijetite povećanje ovih simptoma, morate se obratiti svom liječniku.
English: The frequency of reported nocturia was similar for placebo and empagliflozin (<1%).
Croatian: Učestalost prijavljene nokturije je bila slična za placebo i empagliflozin (<1%).
English: Measure your blood sugar if possible and rest.
Croatian: Ako je moguće izmjerite razinu šećera u krvi i mirujte.
English: Patients aged 75 years and older may be at an increased risk of volume depletion.
Croatian: Bolesnici u dobi od 75 i više godina mogu biti pod povećanim rizikom od deplecije volumena.
English: Your blood sugar levels may increase when you stop taking Jardiance.
Croatian: Razina šećera u krvi se može povećati ako prestanete s uzimanjem lijeka Jardiance.
English: • The starting dose of Jardiance is one 10 mg tablet once a day.
Croatian: • Početna doza lijeka Jardiance je jedna tableta od 10 mg jedanput dnevno.
English: • Jardiance is used to treat type 2 diabetes in adult patients (aged 18 years and older) that cannot be controlled by diet and exercise alone.
Croatian: • Jardiance se koristi za liječenje šećerne bolesti tipa 2 u odraslih bolesnika (u dobi od 18 ili više godina), koja se ne može kontrolirati samo dijetom i tjelovježbom.
English: • Your doctor may limit your dose to 10 mg once a day if you have a kidney problem.
Croatian: • Vaš liječnik može ograničiti dozu na 10 mg jedanput dnevno ako imate bolest bubrega.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, fertility and early embryonic development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti, plodnosti i ranog embrionalnog razvoja.
English: In patients 75 years and older, an increased risk for volume depletion should be taken into account (see sections 4.4 and 4.8).
Croatian: U bolesnika u dobi od 75 i više godina treba uzeti u obzir povećani rizik od deplecije volumena (vidjeti dijelove 4.4 i 4.8).
English: Co-medication with known inducers of UGT enzymes should be avoided due to a potential risk of decreased efficacy.
Croatian: Potrebno je izbjegavati istodobno liječenje poznatim induktorima enzima UGT zbog potencijalnog rizika smanjene djelotvornosti.
English: The inter-subject and residual variabilities for empagliflozin oral clearance were 39.1% and 35.8%,
Croatian: Interindividualne i rezidualne varijabilnosti za oralni klirens empagliflozina iznosile su 39,1% odnosno 35,8%.
English: Risk for volume depletion
Croatian: Rizik od deplecije volumena
English: Other medicines and Jardiance Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli, ili biste mogli uzeti bilo koje druge lijekove.
English: The observed increase in urine volume was not dose-dependent and is not clinically meaningful.
Croatian: Opaženo povećanje volumena mokraće nije bilo ovisno o dozi i nije klinički značajno.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete ovaj lijek kao i tijekom liječenja:
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim problemima nepodnošenja galaktoze, nedostatkom Lapp laktaze, ili malapsorpcijom glukoze-galaktoze ne smiju uzimati ovaj lijek.
English: - Prior to initiation of any concomitant medicinal product that may have a negative impact on renal function.
Croatian: - Prije započinjanja istodobne terapije bilo kojim lijekom koji može imati negativan učinak na funkciju bubrega.
English: • if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Croatian: • ako uzimate druge lijekove koji snižavaju razinu šećera u Vašoj krvi poput inzulina ili lijeka „sulfonilureje“.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Jardiance in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka Jardiance u jednoj ili više podskupina pedijatrijske populacije sa šećernom bolešću tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10), često (≥ 1/100 i <1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥1/10 000 i < 1/1000), ili vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Therefore assessment of renal function is recommended as follows: - Prior to empagliflozin initiation and periodically during treatment, i.e. at least yearly (see sections 4.2, 5.1 and 5.2).
Croatian: Stoga se preporučuje procjena funkcije bubrega kako slijedi: - Prije započinjanja terapije empagliflozinom i periodično tijekom liječenja, tj. barem jedanput godišnje (vidjeti dijelove 4.2, 5.1 i 5.2)
English: If you have type 2 diabetes, your pancreas does not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively.
Croatian: Ako imate šećernu bolest tipa 2, Vaša gušterača ne stvara dovoljno inzulina za regulaciju razine glukoze u krvi, a Vaše tijelo ne može učinkovito koristiti vlastiti inzulin.
English: Initiation of empagliflozin therapy in this population is not recommended (see section 4.2).
Croatian: Započinjanje terapije empagliflozinom u ovoj populaciji se ne preporučuje (vidjeti dio 4.2).
English: In the population pharmacokinetic analysis, AUC was estimated to be 13.5% higher in Asians with a body mass index of 25 kg/m2 compared to non-Asians with a body mass index of 25 kg/m2.
Croatian: U farmakokinetičkoj analizi populacije procijenjeno je da je AUC bio 13,5% viši u Azijata s indeksom tjelesne mase 25 kg/m2 u usporedbi s ne-Azijatima s indeksom tjelesne mase od 25 kg/m2.
English: Your doctor may ask you to stop taking Jardiance until you recover to prevent loss of too much body fluid.
Croatian: Vaš liječnik može zatražiti da prestanete uzimati Jardiance sve dok se ne oporavite kako bi se spriječio preveliki gubitak tjelesne tekućine.
English: • shaking, sweating, feeling very anxious or confused, fast heart beat
Croatian: • drhtavicu, znojenje, osjećaj snažne tjeskobe ili smetenosti, brze otkucaje srca
English: Your doctor may ask you to stop taking Jardiance.
Croatian: Vaš liječnik može zatražiti da prestanete uzimati Jardiance.
English: Jardiance contains lactose (milk sugar).
Croatian: Jardiance sadrži laktozu (mliječni šećer).
English: It is not known if DKA is more likely to occur with higher doses of empagliflozin.
Croatian: Nije poznato je li vjerojatnost pojave DKA veća pri višim dozama empagliflozina.
English: Four studies had treatment durations of 24 weeks; extensions of those and other studies had patients exposed to empagliflozin for up to 102 weeks.
Croatian: Trajanje liječenja u četiri ispitivanja iznosilo je 24 tjedna; s produžetkom tih i drugih ispitivanja bolesnici su bili izloženi empagliflozinu do 102 tjedna.
English: Therefore, caution should be exercised in patients for whom an empagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or patients aged 75 years and older.
Croatian: Stoga treba biti oprezan u bolesnika u kojih bi empagliflozinom inducirani pad krvnog tlaka mogao predstavljati rizik, poput bolesnika s poznatom kardiovaskularnom bolešću, bolesnika na antihipertenzivnoj terapiji s hipotenzijom u anamnezi ili bolesnika u dobi od 75 i više godina.
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Jardiance is used in combination with a sulphonylurea and/or insulin.
Croatian: Bolesnike je potrebno savjetovati da poduzmu mjere opreza kako bi izbjegli hipoglikemiju tijekom upravljanja vozilima i rada sa strojevima, naročito ako se Jardiance primjenjuje u kombinaciji sa sulfonilurejom i/ili inzulinom.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke na plodnost (vidjeti dio 5.3).
English: How to take Jardiance
Croatian: Kako uzimati Jardiance
English: • Jardiance can be used without other medicines in patients who cannot take metformin (another diabetes medicine).
Croatian: • Jardiance se može koristiti bez drugih lijekova u bolesnika koji ne mogu uzimati metformin
English: No major metabolites of empagliflozin were detected in human plasma and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O glucuronide).
Croatian: U humanoj plazmi nisu pronađeni glavni metaboliti empagliflozina, a najzastupljeniji metaboliti bila su tri konjugata glukuronida (2-, 3-, i 6- O-glukuronid).
English: Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT-2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
Croatian: Ponovno započinjanje liječenja SGLT2 inhibitorima u bolesnika s prethodnom pojavom DKA tijekom liječenja SGLT2 inhibitorima se ne preporučuje, osim ako nije identificiran i razriješen drugi jasni precipitirajući čimbenik.