natgillin/translations-raw huggingface dataset:
- Do not use Icandra if you are pregnant or breast-feeding (see also “Do not take Icandra”).
- Nemojte uzimati Icandru ako ste trudni ili dojite (također pogledajte „Nemojte uzimati Icandru“).
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.
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.
If pancreatitis is suspected, vildagliptin should be discontinued; if acute pancreatitis is confirmed, vildagliptin should not be restarted.
Ako postoji sumnja na pankreatitis, treba prestati uzimati vildagliptin; ako je akutni pankreatitis potvrđen, vildagliptin se ne smije ponovo uzimati.
You are also advised to pay particular attention to new onset of blisters or ulcers while taking Icandra.
Također Vam se savjetuje da posvetite posebnu pozornost novoj pojavi mjehurića ili čireva dok uzimate Icandru.
Your doctor will tell you exactly the dose of Icandra to take.
Liječnik će Vam reći točno koliko tableta Icandre trebate uzimati.
If no adequate strength of Icandra is available, individual monocomponents should be used instead of the fixed dose combination.
Ako nije dostupna odgovarajuća jačina lijeka Icandra, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
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.
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.
What Icandra is and what it is used for What you need to know before you take Icandra How to take Icandra
Što je Icandra i za što se koristi Što morate znati prije nego počnete uzimati Icandru Kako uzimati Icandru
Food does not affect the extent and rate of absorption of vildagliptin from Icandra.
Hrana ne utječe na opseg i brzinu apsorpcije vildagliptina iz Icandre.
Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which can lead to diabetic pre-coma.
Ketoacidoza je stanje u kojem se tvari koje se nazivaju ketonska tijela nakupljaju u krvi i mogu dovesti do dijabetičke predkome.
Icandra may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Icandra može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza, osobito ako Vam bubrezi ne rade ispravno.
Avoid excessive alcohol intake while taking Icandra since this may increase the risk of lactic acidosis (please see section “Warnings and precautions”).
Izbjegavajte prekomjerni unos alkohola dok uzimate Icandru jer to može povećati rizik od laktacidoze (vidjeti dio „Upozorenja i mjere opreza”).
You may need more frequent blood glucose and kidney function tests or your doctor may need to adjust the dosage of Icandra.
Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Icandra.
Icandra is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Icandra nije zamjena za inzulin u bolesnika koji trebaju inzulin i ne smije se primjenjivati u bolesnika sa šećernom bolešću tipa 1.
Information regarding overdose with vildagliptin is limited.
Vildagliptin Informacije o predoziranju vildagliptinom su ograničene.
If you need to have major surgery you must stop taking Icandra during and for some time after the procedure.
Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati lijek Icandra tijekom i još neko vrijeme nakon zahvata.
What Icandra contains - The active substances are vildagliptin and metformin hydrochloride.
Što Icandra sadrži - Djelatne tvari su vildagliptin i metforminklorid.
Your doctor will decide when you must stop and when to restart your treatment with Icandra.
Liječnik će odlučiti kada morate prekinuti i kada ćete nastaviti s liječenjem lijekom Icandra.
Icandra is not recommended for use in children and adolescents (< 18 years).
Icandra se ne preporučuje za primjenu u djece i adolescenata (<18 godina).
There have been no therapeutic clinical trials conducted with Icandra.
Nisu provedena terapijska klinička ispitivanja s Icandrom.
The following statements reflect the pharmacokinetic properties of the individual active substances of Icandra.
Izjave u nastavku odražavaju farmakokinetička svojstva pojedinih djelatnih tvari u Icandri.
The safety and efficacy of Icandra in children and adolescents (< 18 years) have not been established.
Sigurnost i djelotvornost Icandre u djece i adolescenata (<18 godina) nisu ustanovljene.
This type of diabetes is also known as noninsulin-dependent diabetes mellitus.
Ovaj tip šećerne bolesti je također poznat kao dijabetes melitus neovisan o inzulinu.
Lactic acidosis, a very rare but serious metabolic complication, most often occurs at acute worsening of renal function, or cardiorespiratory illness or sepsis.
Laktacidoza, vrlo rijetka, ali ozbiljna metabolička komplikacija, najčešće nastaje pri akutnom pogoršanju funkcije bubrega ili kardiorespiratornoj bolesti ili sepsi.
Stop taking Icandra for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Prestanite nakratko uzimati Icandru ako imate stanje koje može biti povezano s dehidracijom (značajan gubitak tjelesnih tekućina) kao što je jako povraćanje, proljev, vrućica, izloženost toplini ili ako pijete manje tekućine nego obično.
What you need to know before you take Icandra
Što morate znati prije nego počnete uzimati Icandru
How Icandra works
Kako Icandra djeluje
Some patients have had the following side effects while taking Icandra and insulin:
Neki su bolesnici imali sljedeće nuspojave kada su uzimali Icandru i inzulin:
The active substances of Icandra, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”.
Djelatne tvari Icandre, vildagliptin i metformin pripadaju skupini lijekova koji se nazivaju „oralni antidijabetici”.
Taking Icandra with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Uzimanje Icandre uz obrok ili neposredno nakon njega može ublažiti gastrointestinalne simptome povezane s metforminom (vidjeti dio 5.2).
• Lactic acidosis (very rare: may affect up to 1 user in 10,000): Icandra may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
• Laktacidoza (vrlo rijetko: može se javiti u manje od 1 na 10 000 osoba): Icandra može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza (vidjeti dio “Upozorenja i mjere opreza”).
No studies on the effect on human fertility have been conducted for Icandra (see section 5.3).
Nisu provedena nikakva ispitivanja o učinku Icandre na plodnost u ljudi (vidjeti dio 5.3).
Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Icandra should be individualised on the basis of the patient's current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin.
Odrasli s normalnom funkcijom bubrega (GFR≥90 ml/min) Doza antihiperglikemijske terapije Icandrom mora biti individualizirana prema bolesnikovom postojećem režimu, učinkovitosti i podnošljivosti, ne prelazeći pritom najvišu preporučenu dnevnu dozu od 100 mg vildagliptina.
However, bioequivalence of Icandra with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Međutim, bioekvivalencija Icandre s istodobno primijenjenim vildagliptinom i metforminom je dokazana (vidjeti dio 5.2).
As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Icandra should have their renal function monitored regularly (see sections 4.4 and 5.2).
Budući da se metformin izlučuje putem bubrega, a stariji bolesnici imaju sklonost smanjenju bubrežne funkcije, u starijih bolesnika koji primaju Icandru treba redovito pratiti funkciju bubrega (vidjeti dijelove 4.4 i 5.2).
The rate and extent of absorption of metformin from Icandra 50 mg/1000 mg were decreased when given with food as reflected by the decrease in Cmax by 26%, AUC by 7% and delayed Tmax (2.0 to 4.0 h).
Brzina i opseg apsorpcije metformina iz Icandre 50 mg/1000 mg se smanjuju kada se daje s hranom što se odražava sniženjem Cmax za 26%, AUC za 7% i odgođenim Tmax (2,0 do 4,0 h).
Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Icandra should not be used during breast-feeding (see section 4.3).
Zbog mogućeg rizika za hipoglikemiju u novorođenčeta vezanu uz metformin kao i zbog nedovoljno podataka u ljudi vezanih za vildagliptin, Icandra se ne smije primjenjivati tijekom dojenja (vidjeti dio 4.3).
If you have reduced kidney function, your doctor may prescribe a lower dose.
Ako imate smanjenu funkciju s bubrega, liječnik Vam može propisati nižu dozu.
Metformin is contraindicated in patients with GFR < 30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Metformin je kontraindiciran u bolesnika s GFR<30 ml/min i njegovu je primjenu potrebno privremeno prekinuti ako su prisutna stanja koja mijenjaju funkciju bubrega, (vidjeti dio 4.3).
Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Icandra.
U bolesnika koji razviju žuticu ili druge znakove koji upućuju na poremećaj jetrene funkcije treba prekinuti liječenje Icandrom.
You should stop taking Icandra and see your doctor immediately if you experience the following side effects:
Prestanite uzimati Icandru i odmah otiđite svom liječniku ako osjetite sljedeće nuspojave:
Talk to your doctor, pharmacist or nurse before taking Icandra if you are taking an anti-diabetic medicine known as a sulphonylurea.
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Icandru ako uzimate antidijabetički lijek iz skupine sulfonilureja.
Following withdrawal of treatment with Icandra and LFT normalisation, treatment with Icandra should not be re-initiated.
Nakon prekida liječenja sa Icandrom i normalizacije testova jetrene funkcije, liječenje sa Icandrom se ne smije ponovno započeti.
Stop taking Icandra and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Prestanite uzimati Icandru i odmah se obratite liječniku ili otiđite u najbližu bolnicu ako osjetite neke od simptoma laktacidoze, jer to stanje može dovesti do kome.
Should an increase in AST or in ALT of 3x ULN or greater persist, withdrawal of Icandra therapy is recommended.
Potraju li povišene vrijednosti AST-a ili ALT-a na razini od 3x GGN ili većoj, preporučuje se prekinuti terapiju Icandrom.
If this happens you must stop taking Icandra and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Ako Vam se to dogodi, morate prestati uzimati Lijek Icandra i odmah se obratiti liječniku ili otići u najbližu bolnicu, jer laktacidoza može dovesti do kome.
There are no adequate data from the use of Icandra in pregnant women.
Nema odgovarajućih podataka o primjeni Icandre u trudnica.
Some patients have experienced the following side effects while taking Icandra and a sulphonylurea: • Common: dizziness, tremor, weakness, low blood glucose, excessive sweating.
Neki su bolesnici imali sljedeće nuspojave kada su uzimali Icandru i sulfonilureju: • često: omaglica, tremor, slabost, niska razina glukoze u krvi, pojačano znojenje.
• Inflammation of the pancreas (pancreatitis) (frequency not known): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back as well as nausea and vomiting.
• Upala gušterače (pankreatitis) (učestalost nepoznata): simptomi uključuju jaku i upornu bol u trbuhu (područje trbuha), koja bi se mogla proširiti do leđa te mučninu i povraćanje.
When Icandra is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Kad se Icandra primjenjuje u kombinaciji sa sulfonilurejom, može se razmotriti niža doza sulfonilureje kako bi se smanjio rizik od hipoglikemije.
There have been no formal interaction studies for Icandra.
Nisu provedena formalna ispitivanja interakcija za Icandru.
Icandra should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
Icandra se ne smije primjenjivati u bolesnika s oštećenjem jetre, uključujući u kojih su vrijednosti alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST) prije početka liječenja bile >3 vrijednosti gornje granice normale (GGN) (vidjeti dijelove 4.3, 4.4 i 4.8).
If you stop taking Icandra
Ako prestanete uzimati Icandru
- For patients switching from co-administration of vildagliptin and metformin as separate tablets: Icandra should be initiated at the dose of vildagliptin and metformin already being taken.
U bolesnika koji prelaze s istodobne primjene vildagliptina i metformina kao zasebnih tableta: Icandru je potrebno započeti u dosadašnjim dozama vildagliptina i metformina.
If you forget to take Icandra
Ako ste zaboravili uzeti Icandru
Children and adolescents The use of Icandra in children and adolescents up to 18 years of age is not recommended.
Djeca i adolescenti Icandra se ne preporučuje za primjenu u djece i adolescenata ispod 18 godina.
The recommended dose is one film-coated tablet of either 50 mg/850 mg or 50 mg/1000 mg taken twice a day.
Preporučena doza je jedna filmom obložena tableta od 50 mg/850 mg ili 50 mg/1000 mg koja se uzima dvaput na dan.
Liver function should be monitored during treatment with Icandra at three-month intervals during the first year and periodically thereafter.
Jetrenu funkciju treba pratiti tijekom liječenja Icandrom u razmacima od tri mjeseca tijekom prve godine liječenja te povremeno nakon toga.
Icandra is indicated in the treatment of type 2 diabetes mellitus: - Icandra is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Icandra je indiciran u liječenju šećerne bolesti tipa 2: - Icandra je indiciran u liječenju odraslih bolesnika u kojih se ne može postići zadovoljavajuća kontrola glikemije primjenom oralnog metformina u maksimalno podnošljivoj dozi ili u bolesnika koji se već liječe kombinacijom odvojenih tableta vildagliptina i metformina.
Icandra combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
Icandra sadrži kombinaciju dviju antihiperglikemijskih tvari s komplementarnim mehanizmima djelovanja za poboljšanje kontrole glikemije u bolesnika sa šećernom bolešću tipa 2: vildagliptin, pripadnik skupine stimulatora Langerhansovih otočića gušterače i metforminklorid, pripadnik skupine bigvanida.
Driving and using machines If you feel dizzy while taking Icandra, do not drive or use any tools or machines.
Ako osjećate omaglicu dok uzimate Icandru, nemojte upravljati vozilima niti raditi s alatima ili strojevima.
- For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin:
- U bolesnika u kojih nije postignuta zadovoljavajuća kontrola dvojnom kombiniranom terapijom inzulinom i najvišom podnošljivom dozom metformina:
Icandra is used to treat adult patients with type 2 diabetes.
Icandra se primjenjuje za liječenje bolesnika sa šećernom bolešću tipa
Bioequivalence has been demonstrated between Icandra at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride tablets at the corresponding doses.
Potvrđena je bioekvivalencija triju jačina doza Icandre (50 mg/500 mg, 50 mg/850 mg i 50 mg/1000 mg) u usporedbi sa slobodnom kombinacijom tableta vildagliptina i metforminklorida u odgovarajućim dozama.
If necessary, the dosage of Icandra may need to be adjusted during concomitant therapy and on its discontinuation.
Ako je potrebno, dozu Icandre treba prilagoditi za vrijeme istodobne primjene te nakon njenog završetka.
Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation and increased risk of lactic acidosis.
Intravaskularna primjena jodiranih kontrastnih sredstava može dovesti do nefropatije izazvane kontrastom, što dovodi do nakupljanja metformina i povećanja rizika od laktacidoze.
Animal studies of up to 13-week duration have been conducted with the combined substances in Icandra.
Ispitivanja kombinacije tvari iz Icandre provedena su na životinjama u trajanju do 13 tjedana.
No data are available with regard to overdose of Icandra.
Nema dostupnih podataka o predoziranju Icandrom.
Therefore, you should not receive Icandra for the treatment of type 1 diabetes.
Stoga ne smijete uzimati Icandru za liječenje šećerne bolesti tipa
It is especially important to mention the following: - glucocorticoids generally used to treat inflammation - beta-2 agonists generally used to treat respiratory disorders - other medicines used to treat diabetes - medicines which increase urine production (diuretics) - medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) - certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II
- glukokortikoide koji se obično koriste za liječenje upala - beta-2 agoniste koji se obično koriste za liječenje poremećaja disanja - druge lijekove koji se koriste za liječenje šećerne bolesti - lijekove koji povećavaju stvaranje mokraće (diuretici) - lijekove koji se primjenjuju za liječenje boli i upale (NSAIL i COX-2-inhibitori, kao što su ibuprofen i celekoksib) - određene lijekove za liječenje povišenog krvnog tlaka (ACE inhibitori i antagonisti receptora angiotenzina II)neke lijekove koji utječu na štitnjaču, ili - neke lijekove koji utječu na živčani sustav.
- Icandra is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea.
- Icandra je indiciran u kombinaciji sa sulfonilurejom (tj. trojna kombinirana terapija) kao dodatak dijeti i tjelovježbi u odraslih bolesnika u kojih je kontrola nedostatna s metforminom i sulfonilurejom.
Symptoms of lactic acidosis include: vomiting stomach ache (abdominal pain) muscle cramps a general feeling of not being well with severe tiredness difficulty in breathing reduced body temperature and heartbeat
Simptomi laktacidoze uključuju: - povraćanje - bol u trbuhu (bol u abdomenu) - grčevi u mišićima - opće loše osjećanje uz jaki umor - otežano disanje - smanjena tjelesna temperatura i usporen rad srca
In particular, if you are following a diabetic weight control diet, continue with this while you are taking Icandra.
Ako se trebate pridržavati dijabetičke dijete za kontrolu tjelesne težine, onda svakako nastavite s njom i za vrijeme uzimanja Icandre.
A test to determine your liver function will be performed before the start of Icandra treatment, at three-month intervals for the first year and periodically thereafter.
Testovi jetrene funkcije će se napraviti prije početka liječenja Icandrom, potom tijekom prve godine u razmacima od tri mjeseca te poslije toga periodički.
EU/1/08/484/019-024 EU/1/08/484/031-033
EU/1/08/484/001-006 EU/1/08/484/013-015 EU/1/08/484/019-024 EU/1/08/484/031-033
Caution should be exercised in patients with a history of acute pancreatitis.
Potreban je oprez u bolesnika s anamnezom akutnog pankreatitisa.
- Icandra is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
- Icandra je indiciran u trojnoj kombiniranoj terapiji sa inzulinom kao dodatak dijeti i tjelovježbi za poboljšanje kontrole glikemije u odraslih bolesnika u kojih stabilna doza inzulina i metformina ne omogućuju odgovarajuću kontrolu glikemije.
LFTs should be performed prior to the initiation of treatment with Icandra in order to know the patient's baseline value.
Testove jetrene funkcije treba napraviti prije početka liječenja Icandrom kako bi se utvrdile početne vrijednosti.
Icandra may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Liječenje Icandrom može se započeti s jačinom tablete ili od 50 mg/850 mg ili od 50 mg/1000 mg dvaput na dan, kao jedna tableta ujutro i druga navečer.
Skin reactions such as erythema, pruritus and urticaria *A decrease in vitamin B12 absorption with decrease in serum levels has been very rarely observed in patients treated long-term with metformin.
*Smanjena apsorpcija vitamina B12 uz pad razine u serumu vrlo je rijetko zamijećena u bolesnika koji su dugotrajno liječeni metforminom.
The dose of Icandra should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Doza lijeka Icandra mora biti 50 mg vildagliptina dvaput na dan (ukupna dnevna doza 100 mg) i doza metformina slična dosadašnjoj dozi.
Icandra is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Icandra je dostupan u pakiranjima od 10, 30, 60, 120, 180 ili 360 filmom obloženih tableta i u višestrukim pakiranjima od 120 (2x60), 180 (3x60) ili 360 (6x60) filmom obloženih tableta.
Other side effects Some patients have experienced the following side effects while taking Icandra:
Neki su bolesnici imali sljedeće nuspojave kada su uzimali Icandru:
Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Icandra (see sections 4.2, 4.3 and 4.8).
Icandra se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre, uključujući one u kojih su ALT ili AST prije početka liječenja bili >3x GGN (vidjeti dijelove 4.2, 4.3 i 4.8).
Icandra 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Icandra 50 mg/1000 mg filmom obložene tablete su tamnožute, ovalne tablete s oznakom „NVR” na jednoj strain i „FLO” na drugoj strani.
How to take Icandra
Kako uzimati Icandru
Your doctor may want to reduce your dose of the sulphonylurea when you take it together with Icandra in order to avoid low blood glucose (hypoglycaemia).
Da bi izbjegao nisku koncentraciju glukoze u krvi (hipoglikemija), Vaš će liječnik možda htjeti smanjiti Vašu dozu sulfonilureje kad je uzimate zajedno s Icandrom.
What Icandra looks like and contents of the pack Icandra 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Icandra 50 mg/850 mg filmom obložene tablete su žute, ovalne tablete s oznakom „NVR” na jednoj strain i „SEH” na drugoj strani.