FrancophonIA/ELRC3.0 huggingface dataset:
English: Rituzena must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients.
Slovenian: Zdravila Rituzena ne smejo jemati osebe, ki so preobčutljive za (alergične na) rituksimab, mišje beljakovine ali na katero koli drugo sestavino zdravila.
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.
Slovenian: Vsi ti podatki so bili zato ocenjeni kot zadostni za zaključek, da se bo zdravilo Rituzena pri odobrenih indikacijah z vidika učinkovitosti vedlo enako kot zdravilo MabThera.
English: Rituzena should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.
Slovenian: Zdravilo Rituzena se lahko daje samo pod skrbnim nadzorom izkušenega zdravnika in v ustanovah, kjer je nemudoma na voljo oprema za oživljanje.
English: The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in most cancer patients and in more than 1 in 10 GPA or MPA patients at the time of the first infusion.
Slovenian: Najpogostejši neželeni učinki rituksimaba so reakcije, povezane z infuzijo (kot so zvišana telesna temperatura, mrazenje in drgetanje), ki se pri prvi infuziji pojavljajo pri večini bolnikov z rakom in pri več kot 1 od 10 bolnikov z Wegenerjevo granulomatozo ali mikroskopskim poliangiitisom.
English: The reference medicine for Rituzena is MabThera.
Slovenian: Referenčno zdravilo za zdravilo Rituzena je zdravilo MabThera.
English: It is not intended to provide practical advice on how to use Rituzena.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Therefore, the Agency's view was that, as for MabThera, the benefit outweighs the identified risk and it recommended that Rituzena be given marketing authorisation.
Slovenian: Agencija je tako menila, da enako kot pri zdravilu MabThera, koristi odtehtajo znana tveganja, in priporočila, da se za zdravilo Rituzena izda dovoljenje za promet.
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.
Slovenian: Poleg tega so s študijo, v kateri so zdravilo Rituzena primerjali z zdravilom MabThera pri bolnikih z revmatoidnim artritisom (kar podpira njegovo uporabo pri drugih vnetnih boleznih, kot sta Wegenerjeva granulomatoza in mikroskopski poliangiitis), dokazali, da sta obe zdravili podobno učinkoviti, podporna študija pri folikularnem limfomu pa je dokazala učinkovitost pri raku.
English: Doctors prescribing Rituzena for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.
Slovenian: Zdravniki, ki predpisujejo zdravilo Rituzena za zdravljenje raka, bodo prejeli izobraževalno gradivo, v katerem bodo opozorjeni na to, da je zdravilo treba dajati le z infundiranjem v veno.
English: • granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis
Slovenian: • granulomatoze s poliangiitisom (GPA ali Wegenerjeve granulomatoze) in mikroskopskega poliangiitisa (MPA), ki sta vnetni bolezni krvnih žil.
English: Depending on the condition it is used to treat, Rituzena may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids).
Slovenian: Zdravilo Rituzena se odvisno od bolezni, za katero se uporablja, lahko daje sočasno s kemoterapijo (drugimi zdravili za zdravljenje raka) ali z zdravili za zdravljenje vnetnih bolezni (kortikosteroidi).
English: Because Rituzena is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Rituzena.
Slovenian: Zdravilo Rituzena je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti rituksimaba, izvedenih z zdravilom MabThera, z zdravilom Rituzena ni treba ponavljati.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Rituzena has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Rituzena po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu MabThera in da se po telesu enako porazdeli.
English: How is Rituzena used?
Slovenian: Kako se zdravilo Rituzena uporablja?
English: In GPA and MPA, destroying the B cells lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing
Slovenian: Pri Wegenerjevi granulomatozi in mikroskopskem poliangiitisu se z uničenjem celic B zniža tvorba protiteles, ki naj bi imela pomembno vlogo pri napadanju krvnih žil in povzročanju vnetja.
English: The company that markets Rituzena will provide doctors and patients using the medicine for noncancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Slovenian: Družba, ki trži zdravilo Rituzena, bo za zdravnike in bolnike, ki uporabljajo zdravilo za nerakave bolezni, pripravila izobraževalno gradivo, v katerem bo opisano, da je zdravilo treba dajati v ustanovah, kjer je na voljo oprema za oživljanje, in da obstaja tveganje okužbe, vključno s progresivno multifokalno levkoencefalopatijo (PML).
English: Rituzena is a ‘biosimilar medicine'.
Slovenian: Zdravilo Rituzena je „podobno biološko zdravilo“.
English: When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL, where B cells have become cancerous.
Slovenian: Rituksimab z vezavo na CD20 povzroči odmrtje celic B, kar pripomore k zdravljenju limfoma in kronične limfocitne levkemije, pri kateri so celice B postale rakaste.
English: For the full list of side effects reported with Rituzena, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rituzena, glejte navodilo za uporabo.
English: For practical information about using Rituzena, patients should read the package leaflet or contact their
Slovenian: Za praktične informacije o uporabi zdravila Rituzena naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
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.
Slovenian: Laboratorijske študije, v katerih so zdravilo Rituzena primerjali z zdravilom MabThera, so pokazale, da je zdravilna učinkovina zdravila Rituzena po zgradbi, čistosti in biološkem delovanju zelo podobna zdravilni učinkovini v zdravilu MabThera.
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).
Slovenian: Poleg tega so zdravilo Rituzena v glavni študiji, v katero je bilo vključenih 372 bolnikov z aktivnim revmatoidnim artritisom (vnetno boleznijo), primerjali z zdravilom MabThera, injiciranim v veno.
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
Slovenian: • folikularnega limfoma in difuznega velikoceličnega B ne-Hodgkinovega limfoma (dveh vrst neHodgkinovega limfoma, tj. krvnega raka);
English: Studies have also shown that giving Rituzena produces similar levels of the active substance in the
Slovenian: Študije so pokazale tudi, da zdravilo Rituzena vzpostavi podobne ravni zdravilne učinkovine v telesu kot zdravilo MabThera.
English: Rituzena can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na recept.
English: Further treatment should be symptomatic.
Slovenian: Nadaljnje zdravljenje naj bo simptomatsko.
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
Slovenian: Če to velja za vas, uporabljajte ustrezno kontracepcijo, da preprečite možnost nenačrtovane nosečnosti.
English: - if you retain water (fluid retention) or have heart failure problems in particular if you are over 75 years old.
Slovenian: - če zadržujete vodo (zastajanje tekočine) ali imate težave s srčnim popuščanjem, zlasti če ste starejši od 75 let.
English: Overall no additional risk of accumulation is to be assumed in such patients.
Slovenian: Na splošno pri takih bolnikih ni treba predvideti dodatnega tveganja akumulacije.
English: Distribution The estimated volume of distribution in humans is 0.25 L/kg.
Slovenian: Porazdelitev Ocenjeni volumen porazdelitve pri človeku je 0,25 l/kg.
English: Talk to your doctor before stopping this treatment.
Slovenian: Posvetujte se s svojim zdravnikom, preden prekinete to zdravljenje.
English: Artificial sweeteners have no effect.
Slovenian: Umetna sladila nimajo takšnega učinka.
English: Your doctor will check whether Tandemact is working 3 to 6 months after you start taking it.
Slovenian: Zdravnik bo preveril ali zdravilo Tandemact deluje, 3 do 6 mesecev po tem, ko začnete jemati zdravilo.
English: In healthy persons, the minimum effective oral dose is approximately 0.6 mg.
Slovenian: Pri zdravih osebah je najmanjši učinkoviti peroralni odmerek približno 0,6 mg.
English: - if you are already taking other medicines for the treatment of diabetes.
Slovenian: - če že jemljete druga zdravila za zdravljenje sladkorne bolezni.
English: However, this did not lead to an increase in mortality in this study.
Slovenian: Vendar pa v tej študiji to ni povzročilo povečane smrtnosti.
English: This check should be repeated at intervals.
Slovenian: Ta pregled je treba ponavljati v rednih časovnih presledkih.
English: There was no relevant accumulation.
Slovenian: Ni bilo nobenega pomembnega kopičenja.
English: These problems generally get better after you stop taking Tandemact.
Slovenian: Te težave se običajno izboljšajo, ko prenehate jemati zdravilo Tandemact.
English: Your doctor will tell you the dose to take or if necessary to change to a different dose.
Slovenian: Zdravnik vam bo povedal kakšen odmerek vzemite ali, če je potrebno, da odmerek spremenite.
English: The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Slovenian: Najvišji poročani odmerek 120 mg/dan štiri dni, zatem pa 180 mg/dan sedem dni, ni bil povezan s kakimi simptomi.
English: Children and adolescents Use in children and adolescents under 18 years is not recommended.
Slovenian: Otroci in mladostniki Uporabe pri otrocih in mladostnikih, mlajših od 18 let ne priporočamo.
English: - if you have a problem with your liver.
Slovenian: - če imate težave s srcem.
English: Via Crosa 86, 28065 Cerano (NO) Italy
Slovenian: Via Crosa 86, 28065 Cerano (NO) Italija
English: Do not throw away any medicines via waste water or household waste.
Slovenian: Zdravila ne smete odvreči v odpadno vode ali med gospodinjske odpadke.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 January 2007
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 08. januar 2007 Datum zadnjega podaljšanja: 09. september 2016
English: Tandemact is contraindicated in patients with:
Slovenian: Zdravilo Tandemact je kontraindicirano pri:
English: In particular, patients have experienced the following serious side effects:
Slovenian: V glavnem so se pri bolnikih pojavili naslednji resni neželeni učinki:
English: Tandemact should be used every day to work properly.
Slovenian: Zdravilo Tandemact je treba jemati vsak dan, da bi delovalo pravilno.
English: These can also hide the signs of hypoglycaemia, so special care is needed when taking these medicines
Slovenian: Ta zdravila lahko tudi prikrijejo znake hipoglikemije, zato je potrebna posebna pozornost pri jemanju teh zdravil.
English: Do not use Tandemact if you are pregnant.
Slovenian: Ne jemljite zdravila Tandemact, če ste noseči.
English: The tablets should be swallowed with a glass of water.
Slovenian: Tablete je treba pogoltniti s kozarcem vode.
English: In case of (severe) overdose hospitalisation in an intensive care department is indicated.
Slovenian: V primeru (resnega) prevelikega odmerka je indicirana hospitalizacija v oddelku za intenzivno nego.
English: Symptoms can almost always be promptly controlled by immediate intake of carbohydrates (sugar).
Slovenian: Simptomi so lahko skoraj vedno takoj pod nadzorom s takojšnjim zaužitjem ogljikovih hidratov (sladkorja).
English: It is important to know what symptoms to expect when hypoglycaemia (low blood sugar) occurs.
Slovenian: Pomembno je vedeti, katere simptome lahko pričakujete, ko se pojavi hipoglikemija (nizka raven sladkorja v krvi).
English: The recommended dose of Tandemact is one tablet taken once daily.
Slovenian: Priporočeni odmerek zdravila Tandemact je ena tableta vzeta enkrat dnevno.
English: In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Slovenian: V kliničnih študijah so bolniki jemali pioglitazon v višjem od najvišjega priporočenega odmerka 45 mg na dan.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference 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.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: 2 In very rare cases mild hypersensitivity reactions may develop into serious reactions with dyspnoea, fall in blood pressure and sometimes shock.
Slovenian: 2 V zelo redkih primerih se lahko blage preobčutljivostne reakcije razvijejo v resne reakcije z dispnejo, padcem krvnega tlaka in včasih šokom.
English: What Tandemact is and what it is used for
Slovenian: Kaj je zdravilo Tandemact in za kaj ga uporabljamo
English: You must tell your doctor if you are, you think you may be pregnant or are planning to have a baby.
Slovenian: Svojemu zdravniku povejte, če menite, da ste noseči ali načrtujete zanositev.
English: Your blood sugar could fall below the normal level.
Slovenian: Krvni sladkor lahko pade pod normalno raven.
English: Pharmacokinetics in five non-diabetic patients after bile duct surgery were similar to those in healthy persons.
Slovenian: Farmakokinetika pri petih nediabetičnih bolnikih po operaciji žolčevoda je bila podobna tisti pri zdravih ljudeh.
English: The tablets are taken orally shortly before or with the first main meal.
Slovenian: Tablete se jemljejo peroralno neposredno pred ali s prvim glavnim obrokom.
English: Based on the experience with glimepiride and with other sulphonylureas the following interactions have to be mentioned.
Slovenian: Na podlagi izkušenj z glimepiridom in drugimi sulfonilsečninami, je treba omeniti naslednja medsebojna delovanja.
English: It is known from other sulphonylureas that, despite initially successful countermeasures, hypoglycaemia may recur.
Slovenian: Iz uporabe drugih sulfonilsečnin je znano, da se lahko kljub prvotno uspešnim protiukrepom, hipoglikemija ponovno pojavi.
English: Patients who experience visual disturbance should be cautious when driving or using machines.
Slovenian: Bolniki, ki imajo izkušnjo z motnjo vida bi morali biti previdni pri vožnji ali upravljanju s stroji.
English: very rare very rare hypersensitivity and allergic reactions3
Slovenian: zelo redki zelo redki preobčutljivost in alergijske reakcije3
English: For this reason, other medicinal products should only be taken with Tandemact with the knowledge (or at the prescription) of the doctor.
Slovenian: Zato se lahko druga zdravila jemljejo skupaj z zdravilom Tandemact zgolj ob vednosti (ali po navodilu) zdravnika.
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).
Slovenian: Glimepirid ima zelo nizek volumen porazdelitve (približno 8,8 litrov), kar je približno enako površini porazdelitve albumina, visoko vezavo na beljakovine (99%) in nizek očistek (približno 48 ml/min).
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.
Slovenian: Vprašajte svojega zdravnika ali farmacevta za dodatne informacije, če niste prepričani, kako prepoznati to stanje in kaj morate storiti, če se pojavijo simptomi.
English: In diabetic patients, good metabolic control over 24 hours can be achieved with a single daily dose.
Slovenian: Pri diabetikih je mogoče dobro 24-urno presnovno urejenost doseči z enim samim odmerkom na dan.
English: Pharmacokinetics were similar in males and females, as well as in young and elderly (above 65 years) patients.
Slovenian: Farmakokinetike so bile podobne pri moških in ženskah ter pri mlajših in starejših (nad 65 let) bolnikih.
English: Although in very rare cases fatal outcome has been reported, causal relationship has not been established.
Slovenian: Čeprav so poročali o zelo redkih primerih s smrtnim izidom, vzročna povezanost ni bila ugotovljena.
English: What you need to know before you take Tandemact
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Tandemact
English: Comparison of single and multiple once-daily dosing revealed no significant differences in pharmacokinetics, and the intra-individual variability was very low.
Slovenian: Primerjava med jemanjem odmerkov enkrat in večkrat na dan ni pokazala nobenih pomembnih razlik v farmakokinetiki, intraindividualna variabilnost pa je bila zelo nizka.
English: - if you have problems with your enzyme called Glucose-6-phosphodehydrogenase since it can decrease your red cells.
Slovenian: - če imate težave z encimom, imenovanim glukoza-6-fosfodehidrogenaza, ker lahko le-ta zmanjša število rdečih krvnih telesc.
English: This study showed an increase in reports of heart failure; however this did not lead to an increase in mortality in this study.
Slovenian: Študija je pokazala povečano število poročil o srčnem popuščanju; vendar pa v tej študiji to ni povzročilo povečane smrtnosti.
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.
Slovenian: Čeprav je hidroksi-presnovek glimepirida povzročil majhno, a pomembno znižanje glukoze v serumu zdravih ljudi, to predstavlja le manjši del celotnega učinka zdravila.
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.
Slovenian: Formalne raziskave o interakcijah za zdravilo Tandemact niso bile narejene, vendar sočasno jemanje učinkovin pri bolnikih pri klinični uporabi ni povzročilo nobenih nepričakovanih interakcij.
English: Take Tandemact daily as prescribed.
Slovenian: Jemljite zdravilo Tandemact vsak dan, kakor vam je predpisano.
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Tandemact.
Slovenian: Obstaja lahko povečana možnost zanositve, saj lahko pride do ponovne ovulacije, ko vzamete zdravilo Tandemact.
English: 6 Elevation of liver enzymes may occur.
Slovenian: 6 Jetrni encimi se lahko zvišajo.
English: The safety and efficacy of Tandemact in children and adolescents under 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Tandemact pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
English: These findings were observed across species at plasma concentrations  4 times the clinical exposure.
Slovenian: Te ugotovitve so potrdila opažanja pri vseh vrstah pri plazemskih koncentracijah  4-kratne plazemske koncentracije pri klinični izpostavitvi.
English: After ingestion of an overdose of glimepiride, hypoglycaemia may occur, lasting from 12 to 72 hours, and may recur after initial recovery.
Slovenian: Po zaužitju prevelikega odmerka glimepirida se lahko pojavi hipoglikemija, ki traja od 12 do 72 ur in se lahko po navideznem okrevanju ponovi.
English: very rare very rare
Slovenian: zelo redki zelo redki
English: After high doses, slightly longer half-lives were noted.
Slovenian: Po višjih odmerkih so bili opaženi malce daljši razpolovni časi.
English: Other medicines and Tandemact
Slovenian: Druga zdravila in zdravilo Tandemact
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.
Slovenian: - če imate posebno obliko diabetične očesne bolezni imenovano makularni edem (otekanje zadnjega dela očesa), če opazite kakršnokoli spremembo vida, se posvetujte z zdravnikom.
English: Your blood sugar level can be increased by taking sugar.
Slovenian: Raven sladkorja v krvi se lahko poveča tako, da vzamete sladkor.
English: very rare very rare allergic vasculitis2
Slovenian: zelo redki zelo redki alergijski vaskulitis2
English: In the latter (covering embryotoxicity, teratogenicity and developmental toxicity), undesirable effects observed were considered to be secondary to the hypoglycaemic effects induced by the compound in dams and in offspring.
Slovenian: Pri slednjem (ki zajema embriotoksičnost, teratogenost in razvojno toksičnost) so bili opaženi neželeni učinki sekundarni hipoglikemičnim učinkom, ki jih je sestavina povzročila pri samicah in potomcih.
English: Your doctor may take blood tests to monitor your blood cell levels and liver function.
Slovenian: Zdravnik se lahko odloči za krvne preiskave, da preveri raven krvnih celic in delovanje jeter.
English: Immune system disorders allergic shock2
Slovenian: Bolezni imunskega sistema alergijski šok2
English: Severe hypoglycaemia or prolonged hypoglycaemia, only temporarily controlled by the usual amounts of sugar, require immediate medical treatment and occasionally hospitalisation.
Slovenian: V primeru hude ali podaljšane hipoglikemije, ki jo je moč le začasno nadzirati z običajnimi količinami sladkorja, je potrebno takojšnje zdravljenje in včasih hospitalizacija.
English: Rare (may affect up to 1 in 1,000 people) - noticeable changes in blood
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - opazne spremembe v krvi
English: Two metabolites - most probably resulting from hepatic metabolism (major enzyme is CYP2C9) - were identified both in urine and faeces: the hydroxy derivative and the carboxy derivative.
Slovenian: Dva metabolita - verjetno zaradi jetrne presnove (glavni encim je CYP2C9) - sta bila najdena tako v urinu kot tudi v blatu: hidroksi-derivat in karboksi-derivat.
English: Cross allergenicity with sulphonylureas, sulphonamides or related substances is possible.
Slovenian: Možna je navzkrižna alergenost s sulfonilsečninami, sulfonamidi ali sorodnimi snovmi.
English: Tell your doctor or pharmacist if you are taking any of these.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete katero od teh zdravil.