FrancophonIA/ELRC3.0 huggingface dataset:
English: Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling.
Croatian: Toplinski zalijepljen kartonski ovitak koji sadrži 1 blister s 11 filmom obloženih tableta od 0,5 mg vareniklina i 14 filmom obloženih tableta od 1 mg vareniklina i 1 blister s 28 filmom obloženih tableta od 1 mg vareniklina ili 2 blistera s 14 filmom obloženih tableta od 1 mg vareniklina - unutarnje i vanjsko označivanje.
English: A gradual approach to quitting smoking with CHAMPIX should be considered for patients who are not able or willing to quit abruptly.
Croatian: U bolesnika koji ne mogu ili ne žele naglo prestati pušiti, treba razmotriti pristup postepenog prestanka pušenja uz lijek CHAMPIX.
English: PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PCTFE/PVC blisteri s aluminijskom folijom koji sadrže 1 prozirni blister s 11 x 0,5 mg filmom obloženih tableta i 14 x 1 mg filmom obloženih tableta te 1 prozirni blister s 28 x 1 mg filmom obloženih tableta ili 2 prozirna blistera s 14 x 1 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
English: Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling
Croatian: Toplinski zalijepljen kartonski ovitak koji sadrži 1 blister s 11 filmom obloženih tableta od 0,5 mg vareniklina i 14 filmom obloženih tableta od 1 mg vareniklina te 1 blister s 28 filmom obloženih tableta od 1 mg vareniklina ili 2 blistera s 14 filmom obloženih tableta od 1 mg vareniklina - unutarnje i vanjsko označivanje
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg varenicline film-coated tablets, heat sealed card
Croatian: Blister s 14 filmom obloženih tableta od 1 mg vareniklina, toplinski zalijepljen kartonski ovitak
English: Bronchitis, sinusitis
Croatian: Vareniklin naspram bupropion
English: 28 film-coated tablets
Croatian: Pakiranje za terapiju održavanja sadrži: 28 filmom obloženih tableta
English: 2.00 (1.54, 2.59), P<0.0001
Croatian: 2,00 (1,54; 2,59), P<0,0001 1.77 (1,33; 2,36), P<0,0001
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS One blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets, heat sealed card
Croatian: Jedan blister s 28 filmom obloženih tableta od 1 mg vareniklina ili 2 blistera s 14 filmom obloženih tableta od 1 mg vareniklina, toplinski zalijepljen kartonski ovitak
English: PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PVC blisteri s aluminijskom folijom koji sadrže 1 prozirni blister s 11 x 0,5 mg filmom obloženih tableta i 14 x 1 mg filmom obloženih tableta te 1 prozirni blister s 28 x 1 mg filmom obloženih tableta ili 2 prozirna blistera s 14 x 1 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
English: Heat sealed card pack containing 2 blister packs of 28 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets- inner and outer labelling
Croatian: Toplinski zalijepljen kartonski ovitak koji sadrži 2 blistera s 28 filmom obloženih tableta od 1 mg vareniklina ili 4 blistera s 14 filmom obloženih tableta od 1 mg vareniklina - unutarnje i vanjsko označivanje
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets
Croatian: Blister s 11 filmom obloženih tableta od 0,5 mg vareniklina
English: 1.74 (1.43, 2.10), P<0.0001
Croatian: Vareniklin naspram NRT-a 1,74 (1,43 2,10), P<0,0001 1,62 (1,32 1,99), P<0,0001
English: EU/1/06/360/014
Croatian: EU/1/06/360/003 EU/1/06/360/014
English: Upper respiratory tract inflammation, respiratory tract congestion, dysphonia, rhinitis allergic, throat irritation, sinus congestion, upperairway cough syndrome, rhinorrhoea Laryngeal pain, snoring Gastrointestinal disorders Very common Nausea Common
Croatian: Srčani poremećaji manje često infarkt miokarda, angina pektoris, tahikardija, palpitacije, ubrzan srčani ritam rijetko fibrilacija atrija, sniženje ST-segmenta u elektrokardiogramu, smanjenje amplitude T-vala u elektrokardiogramu Krvožilni poremećaji manje često povišen krvni tlak, navale vrućine Poremećaji dišnog sustava, prsišta i sredoprsja često dispneja, kašalj manje često upala gornjih dišnih puteva, kongestija dišnih puteva, disfonija, alergijski rinitis, nadraženost grla, kongestija sinusa, prekomjerna sekrecija sluzi iz nosa niz ždrijelo, rinoreja
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets, heat sealed card
Croatian: Blister s 11 filmom obloženih tableta od 0,5 mg vareniklina i 14 filmom obloženih tableta od 1 mg vareniklina, toplinski zalijepljen kartonski ovitak
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.5 mg of varenicline (as tartrate).
Croatian: Jedna filmom obložena tableta sadrži 0,5 mg vareniklina (u obliku vareniklintartarata).
English: Package leaflet: Information for the user CHAMPIX 0.5 mg film-coated tablets CHAMPIX 1 mg film-coated tablets Varenicline
Croatian: CHAMPIX 0,5 mg filmom obložene tablete CHAMPIX 1 mg filmom obložene tablete vareniklin
English: What is Odomzo and what is it used for?
Croatian: Što je Odomzo i za što se koristi?
English: Odomzo is available as capsules (200 mg) and the recommended dose is one capsule taken once a day at least two hours after the last meal and an hour before the next.
Croatian: Odomzo je dostupan kao kapsule (200 mg), a preporučena doza iznosi jednu kapsulu na dan koja se uzima najmanje dva sata nakon posljednjeg obroka te sat vremena prije sljedećeg obroka.
English: The main measure of effectiveness was the response to treatment, based on a reduction in tumour size and improvement in other signs of cancer; treatment was considered sufficiently effective if the response rate was at least 30%.
Croatian: Glavna mjera djelotvornosti bio je odgovor na terapiju, na temelju smanjenja veličine tumora i poboljšanja drugih znakova raka; terapija se smatrala dostatno djelotvornom ako je stopa odgovora iznosila najmanje 30 %.
English: The most common side effects with Odomzo (which may affect more than 1 in 10 people) are muscle spasms, hair loss, taste disturbance, tiredness, nausea, vomiting, muscle and bone pain, belly ache, headache, diarrhoea, weight loss, loss of appetite, and itching.
Croatian: Najčešće su nuspojave lijeka Odomzo (koje mogu nastupiti u više od 1 na10 osoba) mišićni spazmi, gubitak kose, poremećaj okusa, umor, mučnina, povraćanje, mišićna i koštana bol, bol u trbuhu, glavobolja, proljev, gubitak tjelesne težine, gubitak apetita i svrbež.
English: It will also supply educational material to doctors and to patients, including a reminder card about the risks of the medicine and, in particular, the possibility of serious harm to the unborn baby if Odomzo is taken during pregnancy.
Croatian: Također će dostaviti liječnicima i bolesnicima edukacijski materijal, uključujući i karticu s podsjetnikom o rizicima uzimanja lijeka te, posebice, o mogućnosti ozbiljnog oštećenja nerođene djece ako se Odomzo uzima tijekom trudnoće.
English: What measures are being taken to ensure the safe and effective use of Odomzo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Odomzo?
English: The company is also required to analyse available tumour material from patients whose cancer worsened despite treatment, in order to determine why the treatment did not work.
Croatian: Od tvrtke se također očekuje da će analizirati dostupne materijale o tumoru prikupljene od bolesnika čiji se rak pogoršao usprkos terapiji, kako bi se utvrdilo zašto terapija nije djelovala.
English: Of those with locally advanced basal cell carcinoma, around 56% (37 of 66 patients) on the 200-mg dose and 45% (58 of 128 patients) started on the 800-mg dose responded to treatment.
Croatian: Od osoba s lokalno uznapredovalim karcinomom bazalnih stanica, otprilike 56 % onih (37 od 66 bolesnika) koji su primali dozu od 200 mg i 45 % onih (58 od 128 bolesnika) koji su započeli s dozom od 800 mg odgovorilo je na terapiju.
English: This is a summary of the European public assessment report (EPAR) for Odomzo.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Odomzo.
English: This pathway normally controls a number of cell activities including cell growth and how cells develop correctly to make up different body organs in unborn babies.
Croatian: Ovaj put normalno kontrolira niz staničnih aktivnosti uključujući rast stanica i kako se stanice ispravno razvijaju kako bi se izgradili različiti tjelesni organi u nerođene djece.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Odomzo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Odomzo nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Substances that affect the Hedgehog pathway can result in serious harm to an unborn baby.
Croatian: Tvari koje utječu na signalni put Hedgehog mogu rezultirati ozbiljnim oštećenjem nerođenog djeteta.
English: A risk management plan has been developed to ensure that Odomzo is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Odomzo.
English: Patients were started on two different doses of Odomzo: 200 or 800 mg once a day.
Croatian: Terapija bolesnika započeta je s dvije različite doze lijeka Odomzo: 200 ili 800 mg jednom na dan.
English: Odomzo is a cancer medicine used to treat adults with basal cell carcinoma (a type of skin cancer) which is locally advanced (has started to spread nearby) and which cannot be treated either by surgery or by radiotherapy (treatment with radiation).
Croatian: Odomzo je antitumorski lijek koji se koristi za liječenje odraslih osoba s karcinomom bazalnih stanica (tipom raka kože) koji je lokalno uznapredovao (počeo se širiti u okolno tkivo) i koji se ne može liječiti kirurškim zahvatom ili radioterapijom (terapijom zračenjem).
English: Odomzo is continued as long as it has a beneficial effect or until it can no longer be taken because of side effects.
Croatian: Terapija lijekom Odomzo nastavlja se tako dugo dok terapija ima korisno djelovanje ili se više ne može uzimati zbog nuspojava.
English: Why is Odomzo approved?
Croatian: Zašto je lijek Odomzo odobren?
English: It also considered that the side effects were manageable.
Croatian: Zaključio je da je nuspojave moguće kontrolirati.
English: Other information about Odomzo
Croatian: Ostale informacije o lijeku Odomzo
English: By attaching to this protein, sonidegib blocks the Hedgehog signalling pathway and thereby reduces the growth and spread of cancer cells.
Croatian: Vezivanjem na ovaj protein, sonidegib inhibira signalni put Hedgehog i time smanjuje rast i širenje stanica raka.
English: Odomzo was studied in one main study involving 230 patients with basal cell carcinoma which was either locally advanced or metastatic (spread to other parts of the body).
Croatian: Odomzo je ispitan u jednom glavnom ispitivanju koje je obuhvatilo 230 bolesnika s karcinomom bazalnih stanica koji je lokalno uznapredovao ili metastazirao (raširio se u druge dijelove tijela).
English: The Committee considered that the benefits of Odomzo had been shown for patients with locally advanced disease.
Croatian: Odbor je smatrao da su koristi lijeka Odomzo dokazane za bolesnike s lokalno uznapredovalom bolesti.
English: Women who are pregnant or who are breastfeeding must not take Odomzo.
Croatian: Trudnice ili dojilje ne smiju uzimati lijek Odomzo.
English: Some cancers, including basal cell carcinoma, result from overactivity of a specific set of cell processes called the Hedgehog signalling pathway.
Croatian: Pojedine vrste raka, uključujući karcinom bazalnih stanica, rezultat su prekomjerne aktivnosti određenog niza staničnih postupaka naziva signalni put Hedgehog.
English: Odomzo can only be obtained with a prescription.
Croatian: Odomzo se izdaje samo na liječnički recept.
English: Furthermore, the company is to supply further analysis from its main study on the effectiveness and safety of Odomzo, including its effectiveness in rapidly growing and slow-growing basal cell carcinoma.
Croatian: Nadalje, tvrtka treba dostaviti daljnju analizu glavnog ispitivanja o djelotvornosti i sigurnoj primjeni lijeka Odomzo, uključujući njegovu djelotvornost u slučaju brzorastućeg i spororastućeg karcinomu bazalnih stanica.
English: What are the risks associated with Odomzo?
Croatian: Koji su rizici povezani s lijekom Odomzo?
English: In addition, the company will send a letter to doctors when Odomzo is launched.
Croatian: Nadalje, tvrtka će dostaviti pismo liječenja kada se lijek Odomzo stavi u promet.
English: Odomzo contains the active substance sonidegib.
Croatian: Odomzo sadrži djelatnu tvar sonidegib.
English: Sonidegib, the active substance in Odomzo, attaches to a protein that controls the Hedgehog signalling pathway.
Croatian: Sonidegib, djelatna tvar lijeka Odomzo, vezuje se na protein koji kontrolira signalni put Hedgehog.
English: The full EPAR and risk management plan summary for Odomzo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Odomzo kao i sažetak plana upravljanja rizikom za lijek Odomzo nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Odomzo pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Odomzo, including the precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Odomzo nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Response rates were less than 20% in patients with metastatic cancer started on either 200 or 800 mg Odomzo and the company withdrew its application for use in metastatic basal cell carcinoma.
Croatian: Stopa odgovora bila je manja od 20 % u bolesnika kod kojih je rak metastazirao, čija je terapija započela s dozom od 200 ili 800 mg lijeka Odomzo te je društvo povuklo svoj zahtjev za primjenu u slučaju metastaziralog karcinoma bazalnih stanica.
English: It is not intended to provide practical advice on how to use Odomzo.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Odomzo.
English: For practical information about using Odomzo, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Odomzo pročitajte u uputi o lijeku, odnosno obratite se svojem liječniku ili ljekarniku.
English: What benefits of Odomzo have been shown in studies?
Croatian: Koje su koristi lijeka Odomzo utvrđene u ispitivanjima?
English: Therefore, women taking Odomzo must take effective measures to prevent pregnancy during treatment and for 20 months after stopping it. Men taking Odomzo must always use condoms for sex with female partners and for 6 months after stopping treatment.
Croatian: Stoga, žene koje uzimaju lijek Odomzo moraju poduzeti djelotvorne mjere kako bi spriječile trudnoću tijekom terapije i tijekom 20 mjeseci nakon prestanka uzimanja terapije.
English: How is Odomzo used?
Croatian: Kako se Odomzo koristi?
English: How does Odomzo work?
Croatian: Kako djeluje Odomzo?
English: Women who could potentially become pregnant must not take Odomzo unless they comply with the Odomzo pregnancy prevention programme.
Croatian: Žene reproduktivne dobi smiju uzimati lijek Odomzo jedino ako usklade terapiju lijeka Odomzo sa svojim rasporedom prevencije trudnoće.
English: It should only be prescribed by a specialist doctor experienced in the treatment of advanced basal cell carcinoma or under the supervision of such a doctor.
Croatian: Lijek smije propisati, odnosno njegovo propisivanje smije nadzirati, samo liječnik specijalist s iskustvom u terapiji uznapredovalog karcinoma bazalnih stanica.
English: For the full list of all side effects reported with Odomzo, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Odomzo potražite u uputi o lijeku.
English: Cats and dogs
Croatian: Za mačke i pse
English: Solution for injection
Croatian: Otopina za injekcije
English: Subcutaneos use
Croatian: Primjena supkutano
English: 1 vial
Croatian: 1 Staklena bočica
English: 1 bottle + 1 oral syringe + 1 press-in bottle adapter
Croatian: 1 boca +1 oralna štrcaljka za usta + 1 nastavak za bocu
English: 1 vial + 1 vial + 2 vial adapters + 1 syringe + 1 infusion set + 2 alcohol swabs +1 sterile swab + 1 plaster
Croatian: 1 bočica + 1 bočica + 2 nastavka za bočice + 1 štrcaljka + 1 set za infuziju s iglom+ 2 alkoholna jastučića +1 sterilni netkani jastučić + 1 ljepljivi flaster
English: Powder: 2100 U Solvent: 20 ml
Croatian: Prašak : 2100 U Otapalo: 20 ml
English: 2100 U Powder for solution for injection
Croatian: 2100 U prašak i otapalo za otopinu za injekciju
English: Intravenous use Powder: vial (glass)
Croatian: Prašak: bočica (staklo) Otapalo: bočica (staklo)
English: The amount of Icandra that people have to take varies depending on their condition.
Croatian: Količina Icandre koju ljudi moraju uzimati ovisi o njihovu stanju.
English: Icandra with alcohol
Croatian: Icandra s alkoholom
English: If you take more Icandra than you should
Croatian: Ako uzmete više Icandre nego što ste trebali
English: Other medicines and Icandra
Croatian: Drugi lijekovi i Icandra
English: Your doctor will discuss with you the potential risk of taking Icandra during pregnancy.
Croatian: Vaš liječnik će s Vama razgovarati o mogućim rizicima uzimanja Icandre tijekom trudnoće.
English: What Icandra is and what it is used for
Croatian: Što je Icandra i za što se koristi
English: Icandra is not a substitute for insulin.
Croatian: Icandra nije zamjena za inzulin.
English: When and how to take Icandra - Swallow the tablets whole with a glass of water, - Take one tablet in the morning and the other in the evening with or just after food.
Croatian: Kada i kako uzimati Icandru - Tablete progutajte cijele sa čašom vode, - Uzmite jednu tabletu ujutro i drugu navečer s obrokom ili odmah nakon obroka.
English: Do not stop taking Icandra unless your doctor tells you to.
Croatian: Nemojte prestati uzimati Icandru ako Vam to nije rekao Vaš liječnik.
English: If you take too many Icandra tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately.
Croatian: Ako uzmete previše tableta Icandre, ili ako je netko drugi uzeo Vaše tablete, odmah se obratite liječniku ili ljekarniku.
English: Do not take Icandra - if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Icandru - ako ste alergični na vildagliptin, metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: PA/Alu/PVC/Alu 2 years PCTFE/PVC/Alu 18 months
Croatian: PA/Alu/PVC/Al 2 godine PCTFE/PVC/Al 18 mjeseci
English: Icandra should not be used during pregnancy.
Croatian: Icandra se ne smije primjenjivati tijekom trudnoće.
English: - Do not use Icandra if you are pregnant or breast-feeding (see also “Do not take Icandra”).
Croatian: - Nemojte uzimati Icandru ako ste trudni ili dojite (također pogledajte „Nemojte uzimati Icandru“).
English: During treatment with Icandra, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or have worsening renal function.
Croatian: Tijekom liječenja lijekom Icandra, liječnik će Vam provjeravati funkciju bubrega najmanje jedanput godišnje ili češće ako ste starija osoba i/ili ako Vam se funkcija bubrega pogoršava.
English: If pancreatitis is suspected, vildagliptin should be discontinued; if acute pancreatitis is confirmed, vildagliptin should not be restarted.
Croatian: Ako postoji sumnja na pankreatitis, treba prestati uzimati vildagliptin; ako je akutni pankreatitis potvrđen, vildagliptin se ne smije ponovo uzimati.
English: You are also advised to pay particular attention to new onset of blisters or ulcers while taking Icandra.
Croatian: Također Vam se savjetuje da posvetite posebnu pozornost novoj pojavi mjehurića ili čireva dok uzimate Icandru.
English: Your doctor will tell you exactly the dose of Icandra to take.
Croatian: Liječnik će Vam reći točno koliko tableta Icandre trebate uzimati.
English: If no adequate strength of Icandra is available, individual monocomponents should be used instead of the fixed dose combination.
Croatian: Ako nije dostupna odgovarajuća jačina lijeka Icandra, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Eucreas before or at the time of the injection.
Croatian: Ako trebate dobiti injekciju kontrastnog sredstva koje sadrži jod u krvnu žilu, na primjer, u sklopu rendgenskog snimanja ili skeniranja, morate prestati uzimati lijek Icandra prije ili u vrijeme injekcije.
English: What Icandra is and what it is used for What you need to know before you take Icandra How to take Icandra
Croatian: Što je Icandra i za što se koristi Što morate znati prije nego počnete uzimati Icandru Kako uzimati Icandru
English: Food does not affect the extent and rate of absorption of vildagliptin from Icandra.
Croatian: Hrana ne utječe na opseg i brzinu apsorpcije vildagliptina iz Icandre.
English: Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which can lead to diabetic pre-coma.
Croatian: Ketoacidoza je stanje u kojem se tvari koje se nazivaju ketonska tijela nakupljaju u krvi i mogu dovesti do dijabetičke predkome.
English: Icandra may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Croatian: Icandra može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza, osobito ako Vam bubrezi ne rade ispravno.
English: Avoid excessive alcohol intake while taking Icandra since this may increase the risk of lactic acidosis (please see section “Warnings and precautions”).
Croatian: Izbjegavajte prekomjerni unos alkohola dok uzimate Icandru jer to može povećati rizik od laktacidoze (vidjeti dio „Upozorenja i mjere opreza”).
English: You may need more frequent blood glucose and kidney function tests or your doctor may need to adjust the dosage of Icandra.
Croatian: Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Icandra.
English: Icandra is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Croatian: Icandra nije zamjena za inzulin u bolesnika koji trebaju inzulin i ne smije se primjenjivati u bolesnika sa šećernom bolešću tipa 1.
English: Information regarding overdose with vildagliptin is limited.
Croatian: Vildagliptin Informacije o predoziranju vildagliptinom su ograničene.