FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rituzena have also been included in the summary of product characteristics and
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Rituzena nalaze se i u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Why is Rituzena approved?
Croatian: Zašto je lijek Rituzena odobren?
English: For more information about treatment with Rituzena, read the package leaflet (also part of the EPAR) or contact your doctor or
Croatian: Više informacija o liječenju lijekom Rituzena pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Thus, all these data were considered sufficient to conclude that Rituzena will behave in the same way in terms of effectiveness as MabThera in its approved indications.
Croatian: Svi ti podatci stoga se smatraju dovoljnim za donošenje zaključka da će lijek Rituzena za odobrene indikacije djelovati na isti način kao i lijek MabThera u pogledu učinkovitosti.
English: In addition, Rituzena has been compared with MabThera given into a vein in a main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease).
Croatian: Nadalje, lijek Rituzena uspoređen je s lijekom MabThera primjenom u venu u glavnom ispitivanju u kojem su sudjelovale 372 osobe koje boluju od reumatoidnog artritisa (upalna bolest).
English: How is Rituzena used?
Croatian: Kako se Rituzena koristi?
English: Laboratory studies comparing Rituzena with MabThera have shown that the active substance in Rituzena is highly similar to that in MabThera in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojem su uspoređivani lijekovi Rituzena i MabThera pokazala su da je djelatna tvar u lijeku Rituzena vrlo slična djelatnoj tvari u lijeku MabThera u pogledu strukture, čistoće i biološke aktivnosti.
English: Rituzena can only be obtained with a prescription.
Croatian: Rituzena se izdaje samo na liječnički recept.
English: What benefits of Rituzena have been shown in studies?
Croatian: Koje su koristi lijeka Rituzena utvrđene u ispitivanjima?
English: In addition, a study comparing Rituzena to MabThera in patients with rheumatoid arthritis (which can support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are similarly effective, and a supportive study in follicular lymphoma showed effectiveness in cancer.
Croatian: Nadalje, ispitivanje u kojem su se usporedili lijekovi Rituzena i MabThera u bolesnika s reumatoidnim artritisom (što podržava njihovu uporabu za druge upalne poremećaje, kao što su GPA i MPA) pokazalo je da je djelotvornost oba lijeka slična.
English: For the full list of side effects reported with Rituzena, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Rituzena potražite u uputi o lijeku.
English: Further evidence came from supportive studies, including one involving 121 patients with advanced follicular lymphoma, where adding Rituzena to chemotherapy medicines was at least as effective as adding Rituxan, the US version of MabThera.
Croatian: Pokazalo se da je dodavanje lijeka Rituzena lijekovima za kemoterapiju barem jednako djelotvorno kao dodavanje lijeka Rituxan, američke verzije lijeka MabThera.
English: Rituzena is a medicine used in adults to treat the following blood cancers and inflammatory conditions: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's
Croatian: • folikularnog limfoma i difuznog ne-Hodgkinova limfoma velikih B-stanica (dva oblika ne
English: For practical information about using Rituzena, patients should read the package leaflet or contact their
Croatian: Praktične informacije o primjeni lijeka Rituzena bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Studies have also shown that giving Rituzena produces similar levels of the active substance in the
Croatian: Ispitivanja su dokazala i da primjena lijeka Rituzena dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka MabThera.
English: Rituzena contains the active
Croatian: Rituzena rituksimab
English: At the request of the European Medicines Agency;
Croatian: • Na zahtjev Europske agencije za lijekove;
English: Further treatment should be symptomatic.
Croatian: Daljnje liječenje treba biti simptomatsko.
English: Artificial sweeteners have no effect.
Croatian: Umjetna sladila nemaju učinka.
English: Do not use Tandemact if you are pregnant.
Croatian: Nemojte uzimati Tandemact ako ste trudni.
English: Two-year clinical studies have shown maintenance of this effect.
Croatian: Klinička ispitivanja u trajanju od dvije godine pokazala su održanost tog učinka.
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
Croatian: Ako se ovo odnosi na Vas, koristite odgovarajuću kontracepciju kako biste izbjegli moguću neplaniranu trudnoću.
English: Passage of the blood brain barrier is low.
Croatian: Prolazak kroz krvno-moždanu barijeru je nizak.
English: - if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old.
Croatian: - ako zadržavate vodu (nakupljanje tekućine) ili imate tegobe s zatajenjem srca, osobito ako ste stariji od 75 godina.
English: These patients may be at risk of pregnancy.
Croatian: U tih bolesnica postoji rizik od trudnoće.
English: What Tandemact is and what it is used for
Croatian: Što je Tandemact i za što se koristi
English: Date of latest renewal: 09 September 2016
Croatian: Datum posljednje obnove odobrenja: 09. rujna 2016.
English: Your doctor will take this into account when treating your diabetes.
Croatian: Liječnik će to uzeti u obzir kod liječenja Vaše šećerne bolesti.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Croatian: To može predstavljati rizik u situacijama kad su te sposobnosti posebno važne (npr. upravljanje vozilima i rada sa strojevima).
English: - if you are already taking other medicines for the treatment of diabetes.
Croatian: - ako već uzimate druge lijekove za liječenje šećerne bolesti.
English: Distribution The estimated volume of distribution in humans is 0.25 L/kg.
Croatian: Procijenjeni volumen distribucije u ljudi je 0,25 l/kg.
English: For this reason, other medicinal products should only be taken with Tandemact with the knowledge (or at the prescription) of the doctor.
Croatian: Zbog toga se drugi lijekovi smiju uzimati s lijekom Tandemact samo uz znanje (ili na recept) liječnika.
English: Symptoms may not be present for up to 24 hours after ingestion.
Croatian: Simptomi ne moraju biti prisutni prva 24 sata nakon ingestije.
English: Take Tandemact daily as prescribed.
Croatian: Uzimajte Tandemact svaki dan kako je propisano.
English: It should be considered whether it is advisable to drive or use machines in these circumstances.
Croatian: Potrebno je razmotriti je li preporučljivo upravljati vozilima ili raditi sa strojevima u takvim okolnostima.
English: very rare very rare
Croatian: vrlo rijetko vrlo rijetko
English: Your doctor will check whether Tandemact is working 3 to 6 months after you start taking it.
Croatian: Liječnik će provjeriti djelovanje lijeka Tandemact 3 do 6 mjeseci nakon što ga počnete uzimati.
English: In healthy persons, the minimum effective oral dose is approximately 0.6 mg.
Croatian: U zdravih osoba, najmanja djelotvorna peroralna doza iznosi približno 0,6 mg.
English: It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Croatian: Preporučuje se da nosite sa sobom kocku šećera, slatkiše, kekse ili zašećereni voćni sok.
English: The presence of microcrystals exacerbated the hyperplastic response but was not considered to be the primary cause of hyperplastic changes.
Croatian: Prisutnost mikrokristala pogoršala je hiperplastički odgovor, ali nije se smatrala primarnim uzrokom hiperplastičkih promjena.
English: These can also hide the signs of hypoglycaemia, so special care is needed when taking these medicines
Croatian: Ovi lijekovi također mogu prikriti znakove hipoglikemije, tako da je potrebna posebna skrb kad se uzimaju ovi lijekovi.
English: In particular, patients have experienced the following serious side effects:
Croatian: Bolesnici su imali sljedeće ozbiljne nuspojave:
English: Tandemact should be used every day to work properly.
Croatian: Tandemact se mora uzimati svaki dan da bi ispravno djelovao.
English: Talk to your doctor or pharmacist before taking Tandemact (see also section 4) - if you have a problem with your heart.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Tandemact (također pogledajte dio 4) - ako imate srčane tegobe.
English: In case of (severe) overdose hospitalisation in an intensive care department is indicated.
Croatian: U slučaju (jakog) predoziranja indicirana je hospitalizacija na odjel intenzivne skrbi.
English: If you take more Tandemact than you should
Croatian: Ako uzmete više lijeka Tandemact nego što ste trebali
English: Renal elimination of the two metabolites was impaired.
Croatian: Bubrežna eliminacija ova dva metabolita bila je narušena.
English: Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Croatian: Provjeravajte tjelesnu težinu u redovitim vremenskim razmacima; ako Vam se tjelesna težina poveća, obavijestite svog liječnika.
English: If you have the impression that the effect of Tandemact is too weak, talk to your doctor.
Croatian: Ako imate dojam da je učinak lijeka Tandemact preslab, obratite se Vašem liječniku.
English: What Tandemact is and what it is used for What you need to know before you take Tandemact How to take Tandemact
Croatian: Što je Tandemact i za što se koristi Što morate znati prije nego počnete uzimati Tandemact Kako uzimati Tandemact
English: Pharmacokinetics were similar in males and females, as well as in young and elderly (above 65 years) patients.
Croatian: Farmakokinetika je bila slična u muškaraca i žena, kao i u mlađih i starijih (u dobi iznad 65 godina) bolesnika.
English: Based on the experience with glimepiride and with other sulphonylureas the following interactions have to be mentioned.
Croatian: Na temelju iskustva s glimepiridom i drugim sulfonilurejama, potrebno je spomenuti sljedeće interakcije.
English: Tandemact with alcohol
Croatian: Tandemact s alkoholom
English: Patients should be aware of the risk of pregnancy and if a patient wishes to become pregnant or if pregnancy occurs, the treatment should be discontinued (see section 4.6).
Croatian: Bolesnice moraju znati da takav rizik postoji, a ako bolesnica želi zatrudnjeti ili ako nastupi trudnoća, liječenje treba prekinuti (vidjeti dio 4.6).
English: Overall no additional risk of accumulation is to be assumed in such patients.
Croatian: Uglavnom, smatra se da nema dodatnog rizika od nakupljanja u takvih bolesnika.
English: Severe hypoglycaemia or prolonged hypoglycaemia, only temporarily controlled by the usual amounts of sugar, require immediate medical treatment and occasionally hospitalisation.
Croatian: Teška hipoglikemija ili produljena hipoglikemija, samo privremeno kontrolirana uobičajenim količinama šećera, zahtijeva hitno medicinsko zbrinjavanje, a ponekad i hospitalizaciju.
English: However if you miss a dose, skip the missed dose and just carry on with the next dose as normal.
Croatian: Međutim, ako propustite uzeti dozu, preskočite propuštenu dozu i samo nastavite s uzimanjem lijeka kao i obično.
English: Other medicines and Tandemact
Croatian: Drugi lijekovi i Tandemact
English: 14 tablets 28 tablets 30 tablets 50 tablets 90 tablets 98 tablets
Croatian: 14 tableta 28 tableta 30 tableta 50 tableta 90 tableta 98 tableta
English: Tandemact helps control the level of sugar in your blood when you have type 2 diabetes by increasing the amount of insulin available and helping your body make better use of it.
Croatian: Tandemact pomaže u kontroli razine šećera u krvi kad imate šećernu bolest tipa 2 tako što povećava količinu dostupnog inzulina i pomaže Vašem tijelu da ga bolje iskoristi.
English: Before you start taking Tandemact you will have a blood sample taken to check your liver function.
Croatian: Prije nego počnete uzimati Tandemact uzet će Vam uzorak krvi da se provjeri funkcija Vaše jetre.
English: very rare very rare hypersensitivity and allergic reactions3
Croatian: vrlo rijetko vrlo rijetko preosjetljivost i alergijske reakcije3
English: After high doses, slightly longer half-lives were noted.
Croatian: Nakon primjene visokih doza opažen je malo dulji poluvijek.
English: After ingestion of an overdose of glimepiride, hypoglycaemia may occur, lasting from 12 to 72 hours, and may recur after initial recovery.
Croatian: Nakon ingestije prevelike doze glimepirida može nastati hipoglikemija, koja može trajati od 12 do 72 sata i može se ponovno vratiti nakon početnog oporavka.
English: The tablets are taken orally shortly before or with the first main meal.
Croatian: Tablete se uzimaju peroralno neposredno prije ili tijekom prvog glavnog obroka.
English: The tablets should be swallowed with a glass of water.
Croatian: Tablete se moraju progutati uz čašu vode.
English: Talk to your doctor before stopping this treatment.
Croatian: Obratite se svom liječniku prije nego prestanete uzimati ovaj lijek.
English: Your blood sugar could fall below the normal level.
Croatian: Šećer u krvi Vam se može spustiti ispod normalne razine.
English: Immune system disorders allergic shock2
Croatian: Poremećaji imunološkog sustava alergijski šok2
English: If you stop using Tandemact, your blood sugar may go up.
Croatian: Ako prestanete uzimati Tandemact, šećer u krvi Vam se može povisiti.
English: The recommended dose of Tandemact is one tablet taken once daily.
Croatian: Preporučena doza lijeka Tandemact je jedna tableta jedanput na dan.
English: In diabetic patients, good metabolic control over 24 hours can be achieved with a single daily dose.
Croatian: U bolesnika sa šećernom bolešću dobra metabolička kontrola tijekom 24 sata može se postići jednokratnom dnevnom dozom.
English: Do not use Tandemact if you are breastfeeding or are planning to breast-feed (see section “Do not take Tandemact”).
Croatian: Nemojte uzimati Tandemact ako dojite ili planirate dojiti (pogledajte dio „Nemojte uzimati Tandemact“).
English: You should swallow the tablets with a glass of water.
Croatian: Tablete morate progutati uz čašu vode.
English: 5 Gastro-intestinal complaints are very rare and seldom lead to discontinuation of therapy.
Croatian: 5 Gastrointestinalne tegobe vrlo su rijetke i rijetko dovode do prekida terapije.
English: Frequencies are defined as: 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 (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: Učestalost se definira na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i <1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Croatian: Pioglitazon i svi djelatni metaboliti u velikom su opsegu vezani za proteine plazme (> 99%).
English: If ALT levels remain > 3 x the upper limit of normal, therapy should be discontinued.
Croatian: Ako razine ALT ostanu povišene > 3 puta iznad gornje granice normale, terapiju se mora prekinuti.
English: - if you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye), talk to your doctor if you notice any change to your vision.
Croatian: - ako imate posebnu vrstu bolesti oka koja se javlja kod šećerne bolesti i zove se makularni edem (oticanje stražnje strane oka), razgovarajte sa svojim liječnikom ako primijetite bilo kakvu promjenu u svom vidu. - ako imate tegobe s jetrom.
English: Your doctor will tell you the dose to take or if necessary to change to a different dose.
Croatian: Liječnik će Vam reći koju dozu da uzimate i trebate li je promijeniti.
English: Your blood sugar level can be increased by taking sugar.
Croatian: Razina šećera u krvi može se povisiti uzimanjem šećera.
English: very rare very rare allergic vasculitis2
Croatian: vrlo rijetko vrlo rijetko alergijski vaskulitis2
English: Comparison of single and multiple once-daily dosing revealed no significant differences in pharmacokinetics, and the intra-individual variability was very low.
Croatian: Usporedba primjene jednostruke i višestruke doze jedanput na dan nije pokazala značajne razlike u farmakokinetici i varijabilnost između pojedinaca bila je vrlo niska.
English: Thus free (unbound) pioglitazone concentration is unchanged.
Croatian: Stoga koncentracija slobodnog (nevezanog) pioglitazona ostaje neizmijenjena.
English: Almost half of the patients had a previous myocardial infarction and approximately 20% had had a stroke.
Croatian: Gotovo je polovica bolesnika prethodno imala infarkt miokarda, a približno ih je 20% imalo moždani udar.
English: There was no significant difference in effect regardless of whether glimepiride was given 30 minutes or immediately before a meal.
Croatian: Nema značajne razlike u učinku glimepirida primijenjenog 30 minuta prije ili neposredno prije obroka.
English: - if you have problems with your enzyme called Glucose-6-phosphodehydrogenase since it can decrease your red cells.
Croatian: - ako imate tegobe zbog enzima koji se zove glukoza-6-fosfodehidrogenaza, jer to može sniziti broj crvenih krvnih stanica.
English: This type 2 diabetes usually develops in adulthood where the body either does not produce enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces.
Croatian: Ovaj tip 2 šećerne bolesti obično nastaje u odrasloj dobi kad tijelo ili ne proizvodi dovoljno inzulina (hormona koji kontrolira razinu šećera u krvi) ili ne može učinkovito iskoristiti inzulin koji proizvodi.
English: These problems generally get better after you stop taking Tandemact.
Croatian: Ove se tegobe općenito poboljšaju nakon prestanka uzimanja lijeka Tandemact.
English: Alertness and reaction time may be impaired due to low or high blood sugar due to glimepiride, especially when beginning or after altering treatment, or when Tandemact is not taken regularly.
Croatian: Budnost i vrijeme reakcije mogu biti narušeni zbog niskog ili visokog šećera u krvi zbog glimepirida, osobito na početku ili nakon promjene liječenja ili kad se Tandemact ne uzima redovito.
English: However, this did not lead to an increase in mortality in this study.
Croatian: Međutim, to nije dovelo do povećane smrtnosti u tom ispitivanju.
English: Although the hydroxy metabolite of glimepiride caused a small but significant decrease in serum glucose in healthy persons, it accounts for only a minor part of the total effect.
Croatian: Iako je hidroksi-metabolit glimepirida prouzročio malo, ali značajno sniženje glukoze u serumu u zdravih osoba, odgovoran je samo za manji dio ukupnog učinka.
English: What you need to know before you take Tandemact
Croatian: Što morate znati prije nego počnete uzimati lijek Tandemact
English: The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Croatian: Zabilježeni edemi općenito su bili blagi do umjereni i obično nisu zahtijevali prekid liječenja.
English: If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing stop taking this medicine and talk to your doctor immediately.
Croatian: Ako imate ozbiljnu alergijsku reakciju, uključujući koprivnjaču ili oticanje lica, usana, jezika ili grla, ovo može izazvati teškoće u disanju i gutanju, pa prestanite s uzimanjem lijeka i odmah obavijestite svog liječnika.
English: Rare (may affect up to 1 in 1,000 people) - noticeable changes in blood
Croatian: Rijetko (može se javiti u do 1 na 1000 osoba) - primjetne promjene u krvnoj slici
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Ask your doctor or pharmacist for more information if you are not sure how to recognise this and what you should do if you experience the symptoms.
Croatian: Obratite se liječniku ili ljekarniku za dodatne informacije ako niste sigurni kako to prepoznati i što učiniti kad osjetite te simptome.
English: There have been no formal interaction studies for Tandemact, however, the concomitant use of the active substances in patients in clinical use has not resulted in any unexpected interactions.
Croatian: Nisu provedena službena ispitivanja interakcija lijeka Tandemact, međutim, istovremena primjena djelatnih tvari u sklopu kliničke primjene u bolesnika nije rezultirala neočekivanim interakcijama.
English: Tandemact is contraindicated in patients with:
Croatian: Tandemact je kontraindiciran u bolesnika sa sljedećim stanjima:
English: This leads to insulin release through exocytosis.
Croatian: To dovodi do oslobađanja inzulina putem egzocitoze.
English: quinolones, clarithromycin (to treat bacterial or fungal infections)
Croatian: klaritromicin (za liječenje bakterijskih ili gljivičnih infekcija)
English: The European Medicines Agency has waived the obligation to submit the results of studies with Tandemact in all subsets of the paediatric population in type 2 diabetes mellitus.
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Tandemact u svim podskupinama pedijatrijske populacije u tipu 2 šećerne bolesti.
English: 2 In very rare cases mild hypersensitivity reactions may develop into serious reactions with dyspnoea, fall in blood pressure and sometimes shock.
Croatian: 2 U vrlo rijetkim slučajevima blage reakcije preosjetljivosti mogu napredovati do ozbiljnih reakcija s dispnejom, padom krvnog tlaka i ponekad šokom.
English: In very rare cases, impairment of liver function (e.g. with cholestasis and jaundice) may develop, as well as hepatitis which may progress to liver failure.
Croatian: U vrlo rijetkim slučajevima može se razviti oštećenje funkcije jetre (npr. s kolestazom i žuticom), kao i hepatitis koji može napredovati do zatajenja jetre.
English: Symptoms can almost always be promptly controlled by immediate intake of carbohydrates (sugar).
Croatian: Simptomi se gotovo uvijek mogu brzo ukloniti ako se odmah uzmu ugljikohidrati (šećer).
English: Dietary acidification significantly decreased but did not abolish the incidence of tumours.
Croatian: Dijetna acidifikacija značajno je snizila, ali nije spriječila pojavu tumora.
English: Total plasma concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Croatian: Koncentracija ukupnog pioglitazona u plazmi je neizmijenjena, ali volumen distribucije je povećan.
English: Your blood sugar will be checked, and your dose of Tandemact may need to be changed.
Croatian: Provjerit će Vam šećer u krvi i možda će Vam morati promijeniti dozu lijeka Tandemact.
English: Glimepiride has a very low distribution volume (approximately 8.8 litres) which is roughly equal to the albumin distribution space, high protein binding (> 99%), and a low clearance (approximately 48 mL/min).
Croatian: Glimepirid ima vrlo mali volumen distribucije (približno 8,8 litara), koji otprilike odgovara prostoru distribucije albumina, u visokom se postotku veže za proteine (> 99%) i ima niski klirens (približno 48 ml/min).