FrancophonIA/ELRC3.0 huggingface dataset:
English: Tresiba 200 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch).
Croatian: Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici Otopina za injekciju (FlexTouch).
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČI BIOLOŠKЕ DJELATNЕ TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: MARKETING AUTHORISATION NUMBER EU/1/12/807/005 10 pens of 3 mL
Croatian: 12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/807/005 10 brizgalica od 3 ml
English: The patient should discard the needle after each injection.
Croatian: Nakon svakog injiciranja, bolesnik treba zbrinuti iglu.
English: See your delivery system manual for further instructions.
Croatian: Za dodatne informacije pročitajte Upute za uporabu Vašeg pomagala za primjenu inzulina.
English: Each pre-filled pen contains 600 units of insulin degludec in 3 mL solution.
Croatian: Jedna napunjena brizgalica sadrži 600 jedinica degludek inzulina u 3 ml otopine.
English: Tresiba 100 units/mL solution for injection in pre-filled pen Tresiba 100 units/mL packaging and label are light green.
Croatian: Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Pakiranje i naljepnica lijeka Tresiba 100 jedinica/ml su svjetlozelene boje.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) Multipack: 10 (2 packs of 5) 3 mL pre-filled pens
Croatian: Višestruko pakiranje: 10 (2 pakiranja po 5) napunjenih brizgalica od 3 ml
English: Tresiba 200 units/mL solution for injection in pre-filled pen Tresiba 200 units/mL packaging and label are dark green with striping with a red box highlighting the formulation strength.
Croatian: Pakiranje i naljepnica lijeka Tresiba 200 jedinica/ml su tamnozelene boje s prugama, a jačina formulacije istaknuta je crvenim okvirom.
English: Tresiba 100 units/mL solution for injection in pre-filled pen Before first use:
Croatian: Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Prije prve uporabe:
English: Tresiba 100 units/mL solution for injection in cartridge 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) in a carton.
Croatian: Tresiba 100 jedinica/ml otopina za injekciju u ulošku 3 ml otopine u ulošku (staklo tipa 1) s klipom (halobutil) i pokrovom od laminirane gume (halobutil/poliizopren) u kutiji.
English: Keep cartridges in the outer carton in order to protect from light.
Croatian: Uloške čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
English: *Statistically significant a Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance.
Croatian: *Statistički značajno a Potvrđena hipoglikemija definirana je kao epizoda potvrđena razinom glukoze u plazmi < 3,1 mmol/l ili time što je bolesniku potrebna pomoć druge osobe.
English: • Check the name and strength on the label of your pen to make sure that it contains Tresiba 200 units/mL.
Croatian: • Provjerite naziv i jačinu na naljepnici Vaše brizgalice kako biste bili sigurni da sadrži lijek Tresiba 200 jedinica/ml.
English: Stop using Tresiba and see a doctor straight away if the reactions become serious.
Croatian: Ako reakcije postanu ozbiljnije, prestanite primjenjivati lijek Tresiba i odmah posjetite liječnika.
English: Favours insulin glargine
Croatian: U korist glargin inzulina
English: No safety issues were identified with Tresiba with respect to adverse events and standard safety parameters.
Croatian: Što se tiče nuspojava i standardnih sigurnosnih pokazatelja nisu identificirana sigurnosna pitanja s lijekom Tresiba.
English: INFORMATION IN BRAILLE Tresiba pre-filled pen 100 units/mL
Croatian: Tresiba napunjena brizgalica 100 jedinica/ml
English: Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles) and multipack of 6 (2 x 3) (without needles) pre-filled pens of 3 mL.
Croatian: Veličine pakiranja: 1 (sa ili bez igala), 2 (bez igala), 3 (bez igala), 5 (bez igala) i višestruko pakiranje koje sadrži 6 (2 x 3) (bez igala) napunjenih brizgalica od 3 ml.
English: Tresiba 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch).
Croatian: Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici Otopina za injekciju (FlexTouch).
English: Pack sizes of 1 (with or without needles), 5 (without needles) and multipack of 10 (2 x 5) (without needles) pre-filled pens of 3 mL.
Croatian: Veličine pakiranja: 1 (sa ili bez igala), 5 (bez igala) i višestruko pakiranje koje sadrži 10 (2 x 5) (bez igala) napunjenih brizgalica od 3 ml.
English: Difference: -0.29 [-0.65; 0.06]
Croatian: Razlika: -0,29 [-0,65; 0,06]
English: • Check the name and strength on the label of your pen to make sure that it contains Tresiba 100 units/mL.
Croatian: • Provjerite naziv i jačinu na naljepnici Vaše brizgalice kako biste bili sigurni da sadrži lijek Tresiba 100 jedinica/ml.
English: Tresiba 100 units/mL solution for injection in cartridge Before first use:
Croatian: Tresiba 100 jedinica/ml otopina za injekciju u ulošku Prije prve uporabe:
English: Pack sizes of 1 (with or without needles), 5 (without needles) and multipack containing 10 (2 packs of 5) (without needles) pre-filled pens.
Croatian: Veličine pakiranja: 1 (sa ili bez igala), 5 (bez igala) i višestruko pakiranje koje sadrži 10 (2 pakiranja po 5) (bez igala) napunjenih brizgalica.
English: Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles) and multipack containing 6 (2 packs of 3) (without needles) pre-filled pens.
Croatian: Veličine pakiranja: 1 (sa ili bez igala), 2 (bez igala), 3 (bez igala), 5 (bez igala) i višestruko pakiranje koje sadrži 6 (2 pakiranja po 3) (bez igala) napunjenih brizgalica.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (100 units/mL cartridge (Penfill))
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (100 jedinica/ml uložak (Penfill))
English: • oral contraceptives (birth control pills)
Croatian: • oralne kontraceptive (tablete za sprječavanje začeća) • hormone štitnjače, za probleme sa štitnjačom
English: Tresiba 200 units/mL solution for injection in pre-filled pen
Croatian: Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici
English: Each pre-filled pen contains 300 units of insulin degludec in 3 mL solution.
Croatian: Jedna napunjena brizgalica sadrži 300 jedinica degludek inzulina u 3 ml otopine.
English: • your blood sugar got so low that you passed out
Croatian: • Vam se razina šećera u krvi toliko snizila da ste izgubili svijest • ste primijenili injekciju glukagona
English: If the insulin looks cloudy, do not use the pen.
Croatian: Ne koristite brizgalicu ako inzulin izgleda zamućeno.
English: Tresiba 100 units/mL solution for injection in cartridge Solution for injection (Penfill).
Croatian: Tresiba 100 jedinica/ml otopina za injekciju u ulošku Otopina za injekciju (Penfill).
English: Tresiba can be used in elderly.
Croatian: Stariji bolesnici (≥ 65 godina) Tresiba se može primjenjivati u starijih bolesnika.
English: Tresiba 200 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Croatian: Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici 3 ml otopine u ulošku (staklo tipa 1) s klipom (halobutil) i pokrovom od laminirane gume
English: Each cartridge contains 300 units of insulin degludec of insulin in 3 ml solution.
Croatian: Jedan uložak sadrži 300 jedinica degludek inzulina u 3 ml otopine.
English: Insulin glargine (100 units/mL)2
Croatian: Glargin inzulin (100 jedinica/ml)2
English: Hypersensitivity Urticaria
Croatian: Degludek inzulin
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL (200 units/mL pre-filled pen (FlexTouch))
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BRIZGALICI (200 jedinica/ml napunjena brizgalica (FlexTouch))
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL (100 units/mL pre-filled pen (FlexTouch))
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BRIZGALICI (100 jedinica/ml napunjena brizgalica (FlexTouch))
English: Keep the cartridge in the outer carton in order to protect it from light
Croatian: Uloške čuvati u vanjskoj kutiji radi zaštite od svjetlosti
English: Tresiba 200 units/mL solution for injection in pre-filled pen insulin degludec
Croatian: Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici degludek inzulin
English: Difference: -0.13 [-0.29; 0.03]
Croatian: Razlika: -0,13 [-0,29; 0,03]5
English: OTHER SPECIAL WARNINGS, IF NECESSARY Use only clear, colourless solution Single patient use only
Croatian: Upotrijebiti samo bistru, bezbojnu otopinu.
English: Insulin glargine (100 units/mL)1
Croatian: Glargin inzulin (100 jedinica/ml)1
English: Tresiba 100 units/mL solution for injection in cartridge After first opening or carried as a spare, the medicinal product may be stored for a maximum of 8 weeks.
Croatian: Nakon prvog otvaranja ili ako se nosi kao rezervni, lijek se može čuvati najviše 8 tjedana.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (Penfill) 5 x 3 mL
Croatian: Otopina za injekciju (Penfill)
English: 4 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance.
Croatian: 4 Potvrđena hipoglikemija definirana je kao epizoda potvrđena razinom glukoze u plazmi < 3,1 mmol/l ili time što je bolesniku potrebna pomoć druge osobe.
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING CARTON FOR MULTIPACK (100 units/mL pre-filled pen (FlexTouch))
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU KUTIJA ZA VIŠESTRUKO PAKIRANJE (100 jedinica/ml napunjena brizgalica (FlexTouch))
English: Keep the cap on the pen in order to protect from light.
Croatian: Zatvarač držati na brizgalici radi zaštite od svjetlosti.
English: STATEMENT OF ACTIVE SUBSTANCE One pre-filled pen contains 600 units of insulin degludec in 3 mL solution 1 mL solution contains 200 units of insulin degludec (equivalent to 7.32 mg)
Croatian: 1 ml otopine sadrži 200 jedinica degludek inzulina (što odgovara 7,32 mg),
English: Insulin glargine (100 units/mL)
Croatian: glargin inzulin (100 jedinica/ml)
English: 2 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance.
Croatian: 2 Potvrđena hipoglikemija definirana je kao epizoda potvrđena razinom glukoze u plazmi < 3,1 mmol/l ili time što je bolesniku potrebna pomoć druge osobe.
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING CARTON FOR MULTIPACK (200 units/mL pre-filled pen (FlexTouch))
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU KUTIJA ZA VIŠESTRUKO PAKIRANJE (200 jedinica/ml napunjena brizgalica (FlexTouch))
English: 6.1 List of excipients
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Glicerol
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK LABEL (200 units/mL pre-filled pen (FlexTouch))
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA ZA VIŠESTRUKO PAKIRANJE (200 jedinica/ml napunjena brizgalica (FlexTouch))
English: Tresiba 100 units/mL solution for injection in pre-filled pen insulin degludec
Croatian: Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici degludek inzulin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK LABEL (100 units/mL pre-filled pen (FlexTouch))
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA ZA VIŠESTRUKO PAKIRANJE (100 jedinica/ml napunjena brizgalica (FlexTouch))
English: Tresiba 100 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Croatian: Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici 3 ml otopine u ulošku (staklo tipa 1) s klipom (halobutil) i pokrovom od laminirane gume
English: Tresiba 100 units/mL solution for injection in cartridge insulin degludec
Croatian: Tresiba 100 jedinica/ml otopina za injekciju degludek inzulin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (100 units/mL pre-filled pen (FlexTouch))
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (100 jedinica/ml napunjena brizgalica (FlexTouch))
English: Tresiba 100 units/mL and Tresiba 200 units/mL solution for injection in a pre-filled pen Tresiba is available in two strengths.
Croatian: Tresiba 100 jedinica/ml i Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (200 units/mL pre-filled pen (FlexTouch))
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (200 jedinica/ml napunjena brizgalica (FlexTouch))
English: Elimination
Croatian: Lipodistrofija
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Tresiba 200 units/mL solution for injection insulin degludec
Croatian: Uputa o lijeku: Informacije za bolesnika Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici degludek inzulin
English: STATEMENT OF ACTIVE SUBSTANCE One cartridge contains 300 units of insulin degludec in 3 mL solution 1 mL solution contains 100 units of insulin degludec (equivalent to 3.66 mg)
Croatian: 1 ml otopine sadrži 100 jedinica degludek inzulina (što odgovara 3,66 mg),
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Tresiba 100 units/mL solution for injection insulin degludec
Croatian: Uputa o lijeku: Informacije za bolesnika Tresiba 100 jedinica/ml otopina za injekciju u ulošku degludek inzulin
English: How to use Tresiba
Croatian: U korist lijeka Tresiba
English: MARKETING AUTHORISATION NUMBERS EU/1/12/807/007 5 cartridges of 3 mL EU/1/12/807/008 10 cartridges of 3 mL
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/807/007 5 uložaka od 3 ml
English: Discard the needle safely after each injection
Croatian: Nakon svakog injiciranja na siguran način iglu baciti u otpad.
English: In addition to standard of care for diabetes and cardiovascular disease Nocturnal severe hypoglycaemia was defined as episodes between midnight and 6 a.m.
Croatian: Teška noćna hipoglikemija definirana je kao epizode u razdoblju od ponoći do 6 sati ujutro
English: Tresiba Flex2
Croatian: Razlika je za Tresiba Flex - Tresiba
English: LIST OF EXCIPIENTS
Croatian: Naljepnica brizgalice
English: NAME OF THE MEDICINAL PRODUCT Tresiba 100 units/mL solution for injection in pre-filled pen insulin degludec
Croatian: Uputa o lijeku: Informacije za bolesnika Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici degludek inzulin
English: Your blood sugar level may either rise or fall.
Croatian: Može doći do porasta ili pada razine šećera u krvi.
English: (sinusitis), o inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: Tell your doctor before you start taking Qtrilmet if you have any of these signs;
Croatian: Ako se bilo što od gore navedenoga odnosi na Vas (ili niste sigurni), obratite se svom liječniku prije nego uzmete Qtrilmet.
English: Each tablet is to be swallowed whole.
Croatian: Svaku tabletu treba progutati cijelu.
English: The increased/decreased risk was not statistically significant in any of the organ systems.
Croatian: Povećan/smanjen rizik nije bio statistički značajan ni u jednom organskom sustavu.
English: Consumption of alcohol and medicinal products containing alcohol should be avoided.
Croatian: Zbog toga se mora izbjegavati uzimanje alkohola i lijekova koji sadrže alkohol.
English: The safety and efficacy of this medicinal product in children and adolescents aged 0 to < 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost ovog lijeka kod djece i adolescenata u dobi od 0 od < 18 godina još nisu ustanovljene.
English: Qtrilmet should not be used during pregnancy.
Croatian: Qtrilmet se ne smije koristiti tijekom trudnoće.
English: The recommended dose is two tablets once a day.
Croatian: Preporučena doza su dvije tablete jedanput na dan.
English: What to do if you forget to take Qtrilmet on time.
Croatian: Što trebate učiniti ako ste zaboravili uzeti Qtrilmet na vrijeme.
English: Take the tablets at around the same time each day.
Croatian: - Uzmite tablete svaki dan u približno isto vrijeme.
English: What Qtrilmet is and what it is used for
Croatian: Što je Qtrilmet i za što se koristi
English: Do not take a double dose of Qtrilmet to make up for a forgotten dose.
Croatian: - Nemojte uzeti dvostruku dozu lijeka Qtrilmet da biste nadoknadili zaboravljenu dozu.
English: Qtrilmet is not recommended during pregnancy and your doctor will ask you to stop taking this medicine if you become pregnant or plan to have a baby.
Croatian: Qtrilmet se ne preporučuje tijekom trudnoće, pa će Vaš liječnik zatražiti da ga prestanete uzimati ako zatrudnite ili planirate imati dijete.
English: Randomised and treated patients.
Croatian: Randomizirani i liječeni bolesnici.
English: Swallow the tablets whole with half a glass of water.
Croatian: Uzimanje lijeka - Tablete progutajte cijele, s pola čaše vode.
English: This leads to a high level of sugar (glucose) in your blood.
Croatian: To dovodi do visoke razine šećera (glukoze) u krvi.
English: Common A Uncommon B Rare Very rare Not known
Croatian: Često A Manje često B Rijetko Vrlo rijetko Nepoznato
English: Lactic acidosis is a medical emergency and must be treated in a hospital.
Croatian: Laktacidoza je hitno medicinsko stanje koje se mora liječiti u bolnici.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Croatian: Nakon peroralne doze prividni terminalni poluvijek eliminacije iznosi približno 6,5 sati.
English: Fournier's gangrene has to be treated immediately.
Croatian: Fournierova gangrena mora se odmah liječiti.
English: Your blood sugar may rise without this medicine.
Croatian: Razina šećera u krvi može porasti ako ne uzimate ovaj lijek.
English: UNIQUE IDENTIFIER 2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR 2D BARKOD
English: In both cases, treatment with Qtrilmet may be restarted once the patient's condition has stabilised.
Croatian: U oba se slučaja liječenje lijekom Qtrilmet može ponovno započeti nakon što se bolesnikovo stanje stabilizira.
English: This medicine is taken by mouth to treat diabetes and each of the active substances works in a different way to treat the condition.
Croatian: Ovaj se lijek uzima kroz usta za liječenje šećerne bolesti, a svaka od djelatnih tvari pritom djeluje na drugačiji način.
English: It is important to check your feet regularly - and follow the advice on foot care from your health care professional.
Croatian: Važno je da redovito provjeravate svoja stopala i da se pridržavate savjeta o njezi stopala koje Vam da Vaš zdravstveni radnik.
English: These pharmacokinetic effects are not clinically meaningful and do not require dose adjustment.
Croatian: Ti farmakokinetički učinci nisu klinički važni i ne zahtijevaju prilagodbu doze.
English: If you take more Qtrilmet tablets than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako uzmete više Qtrilmet tableta nego što ste trebali, odmah se obratite svom liječniku ili otiđite u bolnicu.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union references 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 PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (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: Qtrilmet is only given to adults aged 18 years and older.
Croatian: Qtrilmet se daje samo odraslim osobama u dobi od 18 ili više godina.
English: Do not take Qtrilmet if any of the above apply to you.
Croatian: Nemojte uzimati Qtrilmet ako se bilo što od prethodno navedenoga odnosi na Vas.
English: Each belongs to a group of medicines called “oral anti-diabetics”.
Croatian: Sve one pripadaju skupini lijekova koji se zovu ‘oralni antidijabetici'.
English: In particular, talk to your doctor before taking Qtrilmet if you are taking any of the following medicines:
Croatian: Osobito je važno da razgovarate sa svojim liječnikom prije nego što uzmete Qtrilmet ako uzimate bilo koji od sljedećih lijekova:
English: Your doctor may prescribe other medicines to lower the amount of sugar in your blood.
Croatian: Liječnik će Vam možda propisati i druge lijekove za snižavanje razine šećera u krvi.
English: If pregnancy is detected, treatment with this medicinal product should be discontinued.
Croatian: Ako se utvrdi trudnoća, liječenje ovim lijekom mora se prekinuti.
English: Generally, the most common adverse events reported in ≥ 65 years old were similar to < 65 years old.
Croatian: Općenito su najčešći štetni događaji prijavljeni kod ispitanika u dobi od ≥ 65 godina bili slični onima prijavljenima kod ispitanika u dobi od < 65 godina.
English: SGLT2 inhibitors should be used with caution in these patients.
Croatian: Inhibitore SGLT2 treba primjenjivati uz oprez kod tih bolesnika.
English: If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly.
Croatian: Ako imate šećernu bolest tipa 2, gušterača Vam ne proizvodi dovoljno inzulina ili tijelo ne može pravilno iskoristiti inzulin koji proizvodi.
English: Your doctor may ask you to stop taking Qtrilmet.
Croatian: Liječnik će možda zatražiti da prestanete uzimati Qtrilmet.
English: Frequency categories were defined according to very common (≥ 1/10), common (≥ 1/100 to ˂ 1/10), uncommon (≥ 1/1,000 to ˂ 1/100), rare ( 1/10,000 to < 1/1,000), very rare ( 1/100,000 to < 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definirane su 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), vrlo rijetko ( 1/100 000 i < 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If you take more Qtrilmet than you should
Croatian: Ako uzmete više lijeka Qtrilmet nego što ste trebali
English: A GFR should be assessed before initiation of treatment with metformin containing medicinal products and at least annually thereafter.
Croatian: Potrebno je ocijeniti GFR prije uvođenja lijekova koji sadrže metformin i najmanje jednom godišnje nakon toga.
English: Take your tablets with food.
Croatian: - Uzmite tablete s hranom.
English: Concomitant use not recommended
Croatian: Istodobna primjena se ne preporučuje
English: The efficacy and safety profiles of Qtrilmet in these patients have not been established.
Croatian: Nije utvrđen profil djelotvornosti i sigurnosti lijeka Qtrilmet kod tih bolesnika.
English: UNIQUE IDENTIFIER HUMAN READABLE DATA
Croatian: JEDINSTVENI IDENTIFIKATOR PODACI ČITLJIVI LJUDSKIM OKOM
English: It is unknown whether this constitutes a class effect.
Croatian: Nije poznato radi li se o učinku razreda lijekova.
English: Your doctor may decide to temporarily or permanently stop your treatment with Qtrilmet.
Croatian: Liječnik će možda odlučiti privremeno ili trajno prekinuti liječenje lijekom Qtrilmet.
English: Occasionally, the inactive ingredients of this medicine will be eliminated in the faeces as a soft, hydrated mass that may resemble the original tablet.
Croatian: Ponekad se neaktivni sastojci ovog lijeka eliminiraju kroz feces u obliku mekane, hidrirane mase koja može nalikovati izvornoj tableti.