natgillin/translations-raw huggingface dataset:
For more information about using Exjade, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Exjade glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The film-coated tablets are to be swallowed with water while the dispersible tablets are to be mixed with a liquid to make up a suspension that the patient can drink.
Filmsko obložene tablete je treba pogoltniti z vodo, disperzibilne tablete pa se s tekočino zmešajo v suspenzijo, ki jo bolnik lahko spije.
Another study involved 184 patients who could not be treated with deferoxamine, including patients with beta thalassaemia major and with other types of anaemia.
Dodatna študija je vključevala 184 bolnikov, ki niso mogli jemati deferoksamina, med katerimi so bili bolniki z beta talasemijo major in drugimi vrstami slabokrvnosti.
This pack aims to inform them about the treatment recommendations with Exjade, including choosing the right dose, that the doses are different for dispersible tablets compared to film-coated tablets or granules, and the need to monitor the patient's health, especially kidney function.
Namen tega gradiva je seznaniti jih s tveganji in priporočili v zvezi z zdravilom Exjade, vključno z izbiro ustreznega odmerka, s tem, da se odmerki za disperzibilne tablete razlikujejo od odmerkov za filmsko obložene tablete in zrnca, ter dejstvom, da je treba spremljati bolnikovo zdravje, zlasti delovanje ledvic.
In a further main study involving 166 patients from 10 years of age (including 21 patients aged 10 to 18 years) with non-transfusion-dependent thalassaemia syndromes and iron overload, Exjade was more effective than placebo (a dummy treatment).
V nadaljnji glavni študiji, v katero je bilo vključenih 166 bolnikov, ki so bili starih 10 let ali več (vključno z 21 bolniki, starimi od 10 do 18 let) in so imeli sindrome od transfuzije neodvisne talasemije ter preobremenitev z železom, je bilo zdravilo Exjade učinkovitejše od placeba (zdravila brez zdravilne učinkovine).
Exjade can only be obtained with a prescription and treatment should be started and supervised by a doctor who is experienced in the treatment of chronic iron overload.
Predpisovanje in izdaja zdravila Exjade je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem kronične preobremenitve z železom.
Effectiveness was determined by the level of iron in the liver before and after one year of treatment.
Učinkovitost so merili z opazovanjem ravni železa v jetrih pred enoletnim zdravljenjem z zdravili in po njem.
Exjade is a medicine used to treat chronic iron overload (an excess of iron in the body) in:
Zdravilo Exjade se uporablja za zdravljenje kronične preobremenitve z železom (prevelike količine železa v krvi) pri:
The starting dose of Exjade depends on the patient's body weight, on which form of the medicine is being taken, what the medicine is used for, and on the level of iron overload.
Začetni odmerek zdravila Exjade je odvisen od telesne mase bolnika, oblike zdravila, ki se jemlje, namena uporabe zdravila in preobremenitve z železom.
The most common side effect with Exjade (which may affect more than 1 in 10 people) is increased blood creatinine (a marker of kidney problems).
Najpogostejši neželeni učinek zdravila Exjade (ki se pojavijo pri več kot 1 bolniku od 10) je zvišana raven kreatinina (označevalca težav z ledvicami) v krvi.
How is Exjade used?
Kako se zdravilo Exjade uporablja?
The dose is then adjusted as needed, every 3 to 6 months, according to the iron levels in the blood.
Odmerek se glede na raven železa v krvi prilagodi na tri do šest mesecev.
Cases of metabolic acidosis (when the body produces more acid than it gets rid of) have been reported with Exjade, mostly in patients with kidney impairment.
Pri zdravljenju z zdravilom Exjade so poročali tudi o primerih metabolične acidoze (kadar organ proizvaja več kisline, kot jo izloča), in sicer zlasti pri bolnikih z okvaro ledvic.
In more than half of these patients the iron level was reduced satisfactorily after a year of treatment with Exjade, including patients aged between 2 and 5 years.
Pri več kot polovici teh bolnikov, vključno z bolniki, starimi od dve do pet let, je bila raven železa po enem letu zdravljenja z zdravilom Exjade zadovoljivo nižja.
Treatment may need to be interrupted or stopped depending on the results of the tests.
Od teh testov je odvisno, ali se bo zdravljenje morda ustavilo ali opustilo.
• patients from 6 years of age who have beta thalassaemia major (an inherited blood disorder in which patients do not have enough normal haemoglobin in the blood) and who receive frequent blood transfusions;
• bolnikih od šestega leta starosti dalje, ki imajo beta talasemijo major (dedno krvno bolezen, pri kateri bolniki nimajo dovolj normalnega hemoglobina v krvi) in ki prejemajo pogoste transfuzije krvi;
Exjade must not be used in people whose creatinine clearance is less than 60 ml per minute.
Bolniki z očistkom kreatinina, manjšim od 60 ml na minuto, ne smejo jemati zdravila Exjade.
Exjade contains the active substance deferasirox.
Zdravilo Exjade vsebuje zdravilno učinkovino deferasiroks.
Kidney and liver tests should be done before starting treatment and at regular intervals during treatment with Exjade.
Pred začetkom zdravljenja z zdravilom Exjade in v rednih intervalih med njim je treba opraviti preskuse delovanja ledvic in jeter.
For the full list of side effects of Exjade, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Exjade, glejte navodilo za uporabo.
• children aged 2 to 5 years with beta thalassaemia major who receive frequent blood transfusions, when deferoxamine (another medicine used to treat iron overload) cannot be used or is inadequate;
• otrocih v starosti od dveh do petih let z beta talasemijo major, ki pogosto prejemajo transfuzije krvi, kadar deferoksamina (drugega zdravila, ki se uporablja za zdravljenje prenasičenosti z železom) ni mogoče uporabljati ali ta ni ustrezen;
How does Exjade work?
Kako zdravilo Exjade deluje?
Interruption of treatment with Exjade should be considered in patients who develop this condition.
Pri bolnikih, ki razvijejo to klinično stanje, je treba zdravljenje z zdravilom Exjade prekiniti.
Cases of kidney and liver failure have been reported with Exjade.
Pri zdravljenju z zdravilom Exjade so poročali o primerih odpovedi ledvic in jeter.
Novantrone is marketed in the following EU member states: Cyprus, Finland, France, Germany, Greece, Italy, Romania, Slovenia, Spain and Sweden, as well as Iceland and Norway.
Zdravilo Novantrone se trži v naslednjih državah članicah EU: Ciper, Finska, Francija, Nemčija, Grčija, Italija, Romunija, Slovenija, Španija in Švedska ter Islandija in Norveška.
It is also available in the EU under the trade names Elsep and Ralenova.
V EU je na voljo tudi pod trgovskima imenoma Elsep in Ralenova.
Daily doses vary from 6 to 14 mg per square metre of body surface area (calculated using the patient's height and weight).
Dnevni odmerki so od 6 do 14 mg na kvadratni meter telesne površine (izračunano glede na bolnikovo telesno višino in maso).
• Non-Hodgkin's lymphoma;
• ne-Hodgkinovega limfoma;
On 28 April 2016, the European Medicines Agency completed a review of Novantrone.
Evropska agencija za zdravila je 28. aprila 2016 zaključila pregled zdravila Novantrone.
Why was Novantrone reviewed?
Zakaj je bilo zdravilo Novantrone pregledano?
Novantrone has been authorised in the EU via national procedures.
Zdravilo Novantrone je bilo v EU odobreno po nacionalnih postopkih.
The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), 4.8 (side effects) and 5.1 (pharmacodynamic properties).
Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji 4.4 (Posebna opozorila in previdnostni ukrepi), 4.5 (Medsebojno delovanje z drugimi zdravili), 4.6 (Plodnost, nosečnost in dojenje), 4.7 (Vpliv na sposobnost vožnje in upravljanja strojev), 4.8 (Neželeni učinki) in 5.1 (Farmakodinamične lastnosti).
• Relief of pain in patients with advanced prostate cancer;
• lajšanje bolečine pri bolnikih z napredovalim rakom prostate;
The company that markets these medicines is MEDA.
Ta zdravila trži farmacevtska družba MEDA.
The European Commission issued a decision on this opinion on 24/06/2016.
Evropska komisija je o tem mnenju izdala odločbo dne 2z4.
Patients will receive a guide to the risks and an alert card describing the signs and symptoms to watch out for.
Bolniki bodo prejeli priročnik o tveganju in opozorilno kartico, na kateri bodo navedeni znaki in simptomi, na katere morajo biti pozorni.
It is also used to treat patients with worsening multiple sclerosis when no alternative treatments are available.
Uporablja se tudi za zdravljenje bolnikov s poslabšanjem multiple skleroze, če ni na voljo drugega zdravljenja.
What is Novantrone?
Kaj je zdravilo Novantrone?
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.
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.
Additionally, Novantrone must not be used for the treatment of multiple sclerosis in pregnant women.
Poleg tega se zdravilo Novantrone ne sme uporabljati za zdravljenje multiple skleroze pri nosečnicah.
Therefore, to avoid potential serious side effects in breastfed infants, breastfeeding must be discontinued before starting treatment with Novantrone.
Za preprečevanje možnih neželenih učinkov pri dojenih otrocih je treba pred začetkom zdravljenja z zdravilom Novantrone prekiniti dojenje.
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.
Mitoksantron, zdravilna učinkovina v zdravilu Novantrone, prehaja v materino mleko in v njem so jo zaznali do enega meseca po prenehanju uporabe zdravila.
A risk management plan will be developed to ensure that Novantrone is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Novantrone bo pripravljen načrt obvladovanja tveganj.
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).
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).
The CHMP agreed that Novantrone can be used for the treatment of the following conditions:
Odbor CHMP je soglašal, da se zdravilo Novantrone lahko uporablja za zdravljenje naslednjih stanj:
• Metastatic breast cancer (breast cancer that has spread to other parts of the body);
• metastatskega raka dojk (raka dojke, ki se je razširil na druge dele telesa);
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.
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.
The CHMP also harmonised the recommendations on how to use Novantrone for the different indications.
Odbor CHMP je uskladil tudi priporočila o načinu uporabe zdravila Novantrone za različne indikacije.
As part of this plan, the company will provide educational materials about the use of Novantrone in patients with multiple sclerosis.
V okviru tega načrta bo imetnik dovoljenja za promet zagotovil izobraževalno gradivo o uporabi zdravila Novantrone pri bolnikih z multiplo sklerozo.
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.
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.
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.
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.
• ‘Blast crisis' in chronic myeloid leukaemia (the final, rapidly progressive stage of another type of cancer of white blood cells);
• „blastne krize“ pri kronični mieloični levkemiji (končnem, hitro napredujočem stadiju druge vrste raka belih krvničk);
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.
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.
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.
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.
• Highly active relapsing multiple sclerosis associated with rapidly evolving disability, in patients for whom no alternative treatments are available.
• multiple skleroze z zelo aktivnimi recidivi, povezane s hitro napredujočo nezmožnostjo, pri bolnikih,
The company will prepare a survey for healthcare professionals to check how well these materials work.
Imetnik dovoljenja za promet bo izvedel raziskavo pri zdravnikih, s katero bo preveril učinkovitost omenjenega gradiva.
Novantrone should only be given by infusion into a vein.
Zdravilo Novantrone se daje samo z infundiranjem v veno.
• Acute myeloid leukaemia (cancer of a type of white blood cell called myeloid cells);
• akutne mieloične levkemije (raka vrste belih krvničk, imenovanih mieloične celice);
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.
Da bi uskladili dovoljenja za promet z zdravilom Novantrone v EU, je Evropska komisija 1. oktobra 2014 napotila zadevo na odbor CHMP.
Novantrone was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
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.
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.
Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Priporočljivo je, da imate pri sebi nekaj kock sladkorja, bonbone,piškote ali sladek sadni sok.
One tablet should be taken once daily.
Enkrat dnevno vzemite eno tableto.
In particular, patients have experienced the following serious side effects:
Konkretno so bili pri bolnikih opaženi naslednji resnejši neželeni učinki:
Pioglitazone tablets are taken orally once daily with or without food.
Tablete, ki vsebujejo pioglitazon, se jemljejo peroralno enkrat dnevno s hrano ali brez nje.
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.
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.
In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
V kliničnih študijah so bolniki jemali pioglitazon v višjem od najvišjega priporočenega odmerka 45 g dnevno.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2 - 5%.
Stopnje pojavnosti edemov primerjalnih skupin (sulfonilsečnina, metformin) so bile 2-5 %.
Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Skoraj vse osebe (95 %) so prejemale kardiovaskularna zdravila (beta blokatorje, ACE inhibitorje, antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, aspirin, statine, fibrate).
If ALT levels remain > 3 times the upper limit of normal, therapy should be discontinued.
Če ravni ALT ostanejo > 3-kratne zgornje meje normalnih vrednosti, je treba zdravljenje prekiniti.
Pioglitazone has no or negligible influence on the ability to drive and use machines.
Pioglitazon nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
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.
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.
14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 98 tablets
14 tablet 28 tablet 30 tablet 56 tablet 60 tablet 90 tablet 98 tablet
Your blood sugar will be checked, and your dose of Pioglitazone Krka may need to be changed.
Preverili bodo raven vašega krvnega sladkorja in vaš odmerek zdravila Pioglitazone Krka bo morda potrebno spremeniti.
Your doctor will check whether Pioglitazone Krka is working 3 to 6 months after you start taking it.
Zdravnik bo preveril, ali zdravilo Pioglitazone Krka deluje, 3 do 6 mesecev po tem, ko začnete jemati zdravilo.
Blister packs (OPA/Al/PVC-Al foil): 14, 28, 30, 56, 60, 90 and 98 tablets in a box.
Pretisni omoti (OPA/Al/PVC-Al folija): 14, 28, 30, 56, 60, 90 in 98 tablet v škatli.
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.
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.
The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use Pioglitazone.
Imetnik dovoljenja za promet z zdravilom bo zagotovil izobraževalni paket, namenjen vsem zdravnikom, ki bodo predvidoma predpisovali/uporabljali pioglitazon.
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.
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.
The tablets are available in boxes of 14, 28, 30, 56, 60, 90 and 98 tablets in blisters.
Tablete so na voljo v škatlah po 14, 28, 30, 56, 60, 90 in 98 tablet v pretisnih omotih.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete , ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
You can usually continue to take other medicines whilst you are being treated with Pioglitazone Krka.
Običajno lahko še naprej jemljete druga zdravila, medtem ko se zdravite z zdravilom Pioglitazone Krka.
Oedema was reported in 6 - 9% of patients treated with pioglitazone over one year in controlled clinical trials.
O edemih so poročali pri 6-9 % bolnikov, zdravljenih s pioglitazonom leto dni v kontroliranih kliničnih preskušanjih.
A 24month mechanistic study in male rats demonstrated that administration of pioglitazone resulted in an increased incidence of hyperplastic changes in the bladder.
24 mesecev trajajoča mehanska raziskava na samcih podgan je pokazala, da je dajanje pioglitazona povzročilo povečano incidenco hiperplastičnih sprememb v mehurju.
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).
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).
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.
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.
Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins; ATC code: A10BG03.
Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, zdravila za zniževanje krvnega sladkorja, brez insulinov, oznaka ATC: A10BG03.
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.
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.
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.
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.
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).
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).
These effects were independent of pioglitazone's effects on glycaemia and were statistically significant different to glibenclamide.
Ti učinki niso bili odvisni od pioglitazonovih učinkov na glikemijo in so se statistično značilno razlikovali od glibenklamida.