FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose of Novantrone and the duration of treatment depend on the disease it is used for, whether it is used in combination with other medicines, on the height and weight of the patient, and on the response to treatment.
Slovenian: Priporočeni odmerek zdravila Novantrone in trajanje zdravljenja sta odvisna od bolezni, za katero se zdravilo uporablja, uporabe v kombinaciji z drugimi zdravili, telesne višine in mase bolnika ter odziva na zdravljenje.
English: Additionally, Novantrone must not be used for the treatment of multiple sclerosis in pregnant women.
Slovenian: Poleg tega se zdravilo Novantrone ne sme uporabljati za zdravljenje multiple skleroze pri nosečnicah.
English: Therefore, to avoid potential serious side effects in breastfed infants, breastfeeding must be discontinued before starting treatment with Novantrone.
Slovenian: Za preprečevanje možnih neželenih učinkov pri dojenih otrocih je treba pred začetkom zdravljenja z zdravilom Novantrone prekiniti dojenje.
English: Mitoxantrone, the active substance in Novantrone, passes into breast milk and has been detected in breast milk for up to one month after the medicine was discontinued.
Slovenian: Mitoksantron, zdravilna učinkovina v zdravilu Novantrone, prehaja v materino mleko in v njem so jo zaznali do enega meseca po prenehanju uporabe zdravila.
English: A risk management plan will be developed to ensure that Novantrone is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Novantrone bo pripravljen načrt obvladovanja tveganj.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Novantrone in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Novantrone v Evropski uniji (EU).
English: The CHMP agreed that Novantrone can be used for the treatment of the following conditions:
Slovenian: Odbor CHMP je soglašal, da se zdravilo Novantrone lahko uporablja za zdravljenje naslednjih stanj:
English: • Metastatic breast cancer (breast cancer that has spread to other parts of the body);
Slovenian: • metastatskega raka dojk (raka dojke, ki se je razširil na druge dele telesa);
English: The educational materials will include a guide and checklist for healthcare professionals informing of the risks of cardiotoxicity (harm to the heart) and leukaemia with the medicine, and how patients should be monitored.
Slovenian: Izobraževalno gradivo bo vsebovalo priročnik in kontrolni seznam za zdravstvene delavce o tveganju kardiotoksičnosti (škodljivosti za srce) in levkemije zaradi uporabe zdravila in o načinih spremljanja bolnikov.
English: The CHMP also harmonised the recommendations on how to use Novantrone for the different indications.
Slovenian: Odbor CHMP je uskladil tudi priporočila o načinu uporabe zdravila Novantrone za različne indikacije.
English: As part of this plan, the company will provide educational materials about the use of Novantrone in patients with multiple sclerosis.
Slovenian: V okviru tega načrta bo imetnik dovoljenja za promet zagotovil izobraževalno gradivo o uporabi zdravila Novantrone pri bolnikih z multiplo sklerozo.
English: This has led to divergences across Member States in the medicine's authorised uses, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets.
Slovenian: To je med državami članicami povzročilo razlike glede odobrenih načinov uporabe zdravila, kar se odraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo.
English: Novantrone is a medicine that is used in the treatment of cancers including breast cancer, non-Hodgkin's lymphoma (a cancer of the lymphatic system, which is part of the immune system) and certain types of blood cancer, as well as pain caused by prostate cancer.
Slovenian: Novantrone je zdravilo, ki se uporablja za zdravljenje raka, vključno z rakom dojke in ne-Hodgkinovim limfomom (rakom limfnega sistema, ki je del imunskega sistema) in določenih vrst krvnega raka.
English: • ‘Blast crisis' in chronic myeloid leukaemia (the final, rapidly progressive stage of another type of cancer of white blood cells);
Slovenian: • „blastne krize“ pri kronični mieloični levkemiji (končnem, hitro napredujočem stadiju druge vrste raka belih krvničk);
English: The CHMP also agreed that Novantrone should no longer be approved for the treatment of acute lymphocytic leukaemia (a cancer of a different type of white blood cells) and liver cancer.
Slovenian: Odbor CHMP je tudi menil, da zdravilo Novantrone ne sme biti več odobreno za zdravljenje akutne limfatične levkemije (raka druge vrste belih krvničk) in raka jeter.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, considered that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: Odbor CHMP je na podlagi predloženih podatkov in interne znanstvene razprave menil, da je treba uskladiti povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo po vsej EU.
English: • Highly active relapsing multiple sclerosis associated with rapidly evolving disability, in patients for whom no alternative treatments are available.
Slovenian: • multiple skleroze z zelo aktivnimi recidivi, povezane s hitro napredujočo nezmožnostjo, pri bolnikih,
English: The company will prepare a survey for healthcare professionals to check how well these materials work.
Slovenian: Imetnik dovoljenja za promet bo izvedel raziskavo pri zdravnikih, s katero bo preveril učinkovitost omenjenega gradiva.
English: Novantrone should only be given by infusion into a vein.
Slovenian: Zdravilo Novantrone se daje samo z infundiranjem v veno.
English: • Acute myeloid leukaemia (cancer of a type of white blood cell called myeloid cells);
Slovenian: • akutne mieloične levkemije (raka vrste belih krvničk, imenovanih mieloične celice);
English: On 1 October 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Novantrone in the EU.
Slovenian: Da bi uskladili dovoljenja za promet z zdravilom Novantrone v EU, je Evropska komisija 1. oktobra 2014 napotila zadevo na odbor CHMP.
English: Novantrone was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Novantrone potrebno usklajevanje.
English: Novantrone contains the active substance mitoxantrone and it is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Slovenian: Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Slovenian: Priporočljivo je, da imate pri sebi nekaj kock sladkorja, bonbone,piškote ali sladek sadni sok.
English: Nederland Focus Care Pharmaceuticals B.V.
Slovenian: Focus Care Pharmaceuticals B.V.
English: One tablet should be taken once daily.
Slovenian: Enkrat dnevno vzemite eno tableto.
English: In particular, patients have experienced the following serious side effects:
Slovenian: Konkretno so bili pri bolnikih opaženi naslednji resnejši neželeni učinki:
English: Pioglitazone tablets are taken orally once daily with or without food.
Slovenian: Tablete, ki vsebujejo pioglitazon, se jemljejo peroralno enkrat dnevno s hrano ali brez nje.
English: Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Slovenian: Preden bo priročnik za predpisovanje zdravila dostavljen vsaki državi članici, mora imetnik dovoljenja za promet z zdravilom uskladiti vsebino in obliko izobraževalnega gradiva, vključno s komunikacijskim načrtom, s pristojnim nacionalnim organom.
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 g dnevno.
English: The oedema rates for comparator groups (sulphonylurea, metformin) were 2 - 5%.
Slovenian: Stopnje pojavnosti edemov primerjalnih skupin (sulfonilsečnina, metformin) so bile 2-5 %.
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Slovenian: Skoraj vse osebe (95 %) so prejemale kardiovaskularna zdravila (beta blokatorje, ACE inhibitorje, antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, aspirin, statine, fibrate).
English: If ALT levels remain > 3 times the upper limit of normal, therapy should be discontinued.
Slovenian: Če ravni ALT ostanejo > 3-kratne zgornje meje normalnih vrednosti, je treba zdravljenje prekiniti.
English: Pioglitazone has no or negligible influence on the ability to drive and use machines.
Slovenian: Pioglitazon nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Slovenian: Ni jasno ali obstaja neposredna povezava med pioglitazonom in makularnim edemom, vendar pa morajo biti zdravniki pozorni na možnost makularnega edema, če bolnik poroča o motnjah vidne ostrine; upoštevati je treba ustrezno oftalmološko mnenje.
English: 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 98 tablets
Slovenian: 14 tablet 28 tablet 30 tablet 56 tablet 60 tablet 90 tablet 98 tablet
English: Your blood sugar will be checked, and your dose of Pioglitazone Krka may need to be changed.
Slovenian: Preverili bodo raven vašega krvnega sladkorja in vaš odmerek zdravila Pioglitazone Krka bo morda potrebno spremeniti.
English: Your doctor will check whether Pioglitazone Krka is working 3 to 6 months after you start taking it.
Slovenian: Zdravnik bo preveril, ali zdravilo Pioglitazone Krka deluje, 3 do 6 mesecev po tem, ko začnete jemati zdravilo.
English: Blister packs (OPA/Al/PVC-Al foil): 14, 28, 30, 56, 60, 90 and 98 tablets in a box.
Slovenian: Pretisni omoti (OPA/Al/PVC-Al folija): 14, 28, 30, 56, 60, 90 in 98 tablet v škatli.
English: Pioglitazone Krka helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Slovenian: Zdravilo Pioglitazone Krka pomaga nadzorovati raven sladkorja v krvi, če imate sladkorno bolezen tipa 2, in sicer tako, da telesu pomaga bolje izkoristiti insulin, ki ga izdela.
English: The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil izobraževalni paket, namenjen vsem zdravnikom, ki bodo predvidoma predpisovali/uporabljali pioglitazon.
English: When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start with the lowest available dose and increase the dose gradually.
Slovenian: Pri zdravljenju bolnikov, ki imajo vsaj en dejavnik tveganja za razvoj kongestivnega srčnega popuščanja (npr. predhodni miokardni infarkt ali simptomatska koronarna arterijska bolezen in starejši bolniki), bi moral zdravnik začeti zdravljenje z najnižjim možnim odmerkom in ga postopoma višati.
English: The tablets are available in boxes of 14, 28, 30, 56, 60, 90 and 98 tablets in blisters.
Slovenian: Tablete so na voljo v škatlah po 14, 28, 30, 56, 60, 90 in 98 tablet v pretisnih omotih.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete , ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Krka.
Slovenian: Običajno lahko še naprej jemljete druga zdravila, medtem ko se zdravite z zdravilom Pioglitazone Krka.
English: Oedema was reported in 6 - 9% of patients treated with pioglitazone over one year in controlled clinical trials.
Slovenian: O edemih so poročali pri 6-9 % bolnikov, zdravljenih s pioglitazonom leto dni v kontroliranih kliničnih preskušanjih.
English: A 24month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in an increased incidence of hyperplastic changes in the bladder.
Slovenian: 24 mesecev trajajoča mehanska raziskava na samcih podgan je pokazala, da je dajanje pioglitazona povzročilo povečano incidenco hiperplastičnih sprememb v mehurju.
English: If you take Pioglitazone Krka with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Slovenian: Če ste vzeli zdravilo Pioglitazone Krka z drugimi zdravili za zdravljenje sladkorne bolezni, je bolj verjetno, da vrednost vašega krvnega sladkorja pade pod normalno raven (hipoglikemija).
English: Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Slovenian: Čeprav študija ni dosegla svojega prvotnega cilja, ki je bil sestavljen iz smrtnosti iz vseh razlogov, neusodnih miokardnih infarktov, kapi, akutnih koronarnih sindromov, težjih amputacij nog, koronarnih revaskularizacij in revaskularizacij nog, rezultati kažejo, da ni dolgoročnih kardiovaskularnih skrbi glede uporabe pioglitazona.
English: Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins; ATC code: A10BG03.
Slovenian: Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, zdravila za zniževanje krvnega sladkorja, brez insulinov, oznaka ATC: A10BG03.
English: When Pioglitazone Krka is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Slovenian: Če boste jemali zdravilo Pioglitazone Krka skupaj z drugimi zdravili za zdravljenje sladkorne bolezni (kot so insulin, klorpropamid, glibenklamid, gliklazid, tolbutamid), vam bo zdravnik povedal, ali morate jemati nižje odmerke teh zdravil.
English: If you take more Pioglitazone Krka than you should If you accidentally take too many Pioglitazone Krka tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Pioglitazone Krka, kot bi smeli Če po nesreči zaužijete preveč tablet Pioglitazone Krka ali če kdo drug ali otrok zaužije vaša zdravila, nemudoma obvestite svojega zdravnika ali farmacevta.
English: Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Slovenian: Obvestite svojega zdravnika, kakor hitro je mogoče, če imate znake srčnega popuščanja, kot so nenavadno težko dihanje ali hitro povečanje telesne mase ali lokalizirana oteklina (edem).
English: These effects were independent of pioglitazone's effects on glycaemia and were statistically significant different to glibenclamide.
Slovenian: Ti učinki niso bili odvisni od pioglitazonovih učinkov na glikemijo in so se statistično značilno razlikovali od glibenklamida.
English: Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments.
Slovenian: O motnjah vida so poročali predvsem zgodaj v poteku zdravljenja, povezane pa so s spremembami vrednosti glukoze v krvi zaradi začasnih sprememb turgidnosti in refrakcijskega indeksa leče, kot jih opažamo tudi pri zdravljenju z drugimi hipoglikemiki.
English: If ALT levels are increased to 3 times the upper limit of normal during pioglitazone therapy, liver enzyme levels should be reassessed as soon as possible.
Slovenian: Če se med zdravljenjem s pioglitazonom ravni ALT zvišajo do 3-kratne zgornje meje normalnih vrednosti, je treba ravni jetrnih encimov čimprej ponovno kontrolirati.
English: The safety and efficacy of pioglitazone in children and adolescents under 18 years of age have not been established.
Slovenian: Varnost in učinkovitost pioglitazona pri otrocih in mladostnikih, mlajših od 18 let, nista potrjeni.
English: Immune System Disorders Hypersensitivity and allergic reactions not known not known not known not known not known
Slovenian: Bolezni imunskega sistema preobčutljivost in alergijske reakcije neznana neznana neznana
English: It is an anti-diabetic medicine used to treat type 2 (noninsulin dependent) diabetes mellitus, when metformin is not suitable or has failed to work adequately.
Slovenian: Je antidiabetično zdravilo za zdravljenje sladkorne bolezni tipa 2 (od insulina neodvisne sladkorne bolezni), ko metformin ni primeren ali ne deluje na ustrezen način.
English: However, certain medicines are especially likely to affect the amount of sugar in your blood: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections) Tell your doctor or pharmacist if you are taking any of these.
Slovenian: Vendar pa nekatera zdravila še posebej verjetno vplivajo na količino sladkorja v krvi: - gemfibrozil (uporablja se za zniževanje holesterola), - rifampicin (uporablja se za zdravljenje tuberkuloze in drugih okužb).
English: Pioglitazone Krka with food and drink You may take your tablets with or without food.
Slovenian: Zdravilo Pioglitazone Krka skupaj s hrano in pijačo Tablete lahko zaužijete s hrano ali brez nje.
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Krka and insulin experienced the development of heart failure.
Slovenian: Nekateri bolniki z dolgotrajno sladkorno boleznijo tipa 2 in srčno boleznijo ali predhodno kapjo, ki so bili zdravljeni z zdravilom Pioglitazone Krka in insulinom so doživeli razvoj srčnega popuščanja.
English: There may be an increased possibility of your becoming pregnant because you may ovulate again when you take Pioglitazone Krka.
Slovenian: Obstaja povečana možnost zanositve, ker lahko spet pride do ovulacije, ko ste vzeli zdravilo Pioglitazone Krka.
English: - Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Slovenian: - Pioglitazon je indiciran tudi za kombinacijo z insulinom pri odraslih bolnikih s sladkorno boleznijo tipa 2 z nezadostnim nadzorom glikemije, ki se zdravijo z insulinom, za katere je metformin, zaradi kontraindikacij ali neprenašanja, neprimeren (glejte poglavje 4.4).
English: There have been rare reports of hepatocellular dysfunction during post-marketing experience (see section 4.8).
Slovenian: V okviru izkušenj v obdobju trženja so poročali o redkih primerih hepatocelularne disfunkcije (glejte poglavje 4.8).
English: common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness - increased appetite
Slovenian: pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - glavobol - omotica - bolečine v sklepih - impotenca - bolečine v hrbtu - težko dihanje - majhno znižanje števila rdečih krvnih celic - vetrovi občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) - sladkor v urinu, beljakovine v urinu - povišanje vrednosti encimov - občutek vrtenja (vrtoglavica) - potenje - utrujenost - povečan apetit
English: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;
Slovenian: kot monoterapija - pri odraslih bolnikih (predvsem bolnikih s prekomerno telesno maso), nezadostno nadzorovanih z dieto in gibanjem, pri katerih je metformin, zaradi kontraindikacij ali neprenašanja, neprimeren.
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Bladder Cancer
Slovenian: Rak mehurja
English: Before you start taking Pioglitazone Krka you will have a blood sample taken to check your liver function.
Slovenian: Pred začetkom jemanja zdravila Pioglitazone Krka vam bodo odvzeli vzorec krvi, da se preveri delovanje vaših jeter.
English: Management Symptomatic and general supportive measures should be taken in case of overdose.
Slovenian: Obravnava V primerih prevelikega odmerjanja so potrebni splošni podporni ukrepi ter lajšanje simptomov.
English: Following initiation of therapy with pioglitazone it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Slovenian: Po uvedbi zdravljenja s pioglitazonom je priporočeno, da jetrne encime spremljate redno po klinični presoji.
English: - The other ingredients are lactose monohydrate, hydroxypropylcellulose (E463), croscarmellose sodium, magnesium stearate (E572).
Slovenian: - Druge sestavine zdravila so laktoza monohidrat, hidroksipropilceluloza (E463), premreženi natrijev karmelozat, magnezijev stearat (E572).
English: Use in children and adolescents Use in children under 18 years is not recommended.
Slovenian: Uporaba pri otrocih in mladostnikih Uporabe zdravila pri bolnikih, mlajših od 18 let, ne priporočamo.
English: What Pioglitazone Krka is and what it is used for
Slovenian: Kaj je zdravilo Pioglitazone Krka in za kaj ga uporabljamo
English: Children and adolescents Use in children under 18 years is not recommended.
Slovenian: Otroci in mladostniki Uporabe zdravila pri bolnikih, mlajših od 18 let, ne priporočamo.
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
Slovenian: Če se to nanaša na vas, vzemite primerno kontracepcijo, da preprečite možnost nenačrtovane nosečnosti; - če imate težave z jetri ali s srcem.
English: as dual oral therapy in combination with - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;
Slovenian: kot dvojno peroralno zdravljenje v kombinaciji: - s sulfonilsečnino, le pri odraslih bolnikih, ki ne prenašajo metformina ali je metformin pri njih kontraindiciran, z nezadostnim nadzorom glikemije kljub najvišjemu toleriranemu odmerku monoterapije s sulfonilsečnino.