FrancophonIA/ELRC3.0 huggingface dataset:
English: The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if - you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of nervous disease (diabetic autonomic neuropathy), - you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly, - you have almost normal or, at least, greatly improved blood sugar levels, - you have recently changed from an animal insulin to a human insulin such as LUSDUNA, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Slovenian: - če imate skoraj normalno ali vsaj močno izboljšano koncentracijo krvnega sladkorja, - če ste pred kratkim prešli z živalskega insulina na humani insulin, kot je zdravilo LUSDUNA, - če jemljete ali ste jemali določena druga zdravila (glejte poglavje 2, "Druga zdravila in zdravilo
English: • General disorders
Slovenian: • Splošne težave
English: Retinopathy
Slovenian: Dojenje
English: Insulin cartridge dose window injection button
Slovenian: telo peresnika gumb za nastavitev vložek z insulinom okence odmerka gumb za injiciranje zunanji pokrovček igle notranji pokrovček igle
English: The pen won't let you dial past the number of insulin units left in the pen.
Slovenian: Injekcijski peresnik onemogo a nastavitev odmerka, ki je ve ji od števila preostalih enot insulina v njem.
English: Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins.
Slovenian: Da bi se izognili napakam pri uporabi zdravila zaradi zamenjave med insulinom glargin in drugimi insulini, je treba pred vsakim injiciranjem preveriti označevanje insulina.
English: Your abdomen, thigh, or back of your upper arm, are the best sites for injection.
Slovenian: Najprimernejša mesta za injiciranje so trebuh, stegno in zadnji del nadlakti.
English: See section 4.
Slovenian: do 60 enot.
English: The cartridge is sealed in a disposable pen injector.
Slovenian: Vložek je zapečaten v injekcijski peresnik, ki se po končani uporabi zavrže.
English: Carefully read the instructions for use included in the package before using Nexvue.
Slovenian: Pred uporabo napolnjenega injekcijskega peresnika Nexvue natančno preberite navodila za njegovo uporabo, priložena v pakiranju.
English: There was one death in each group (less than 1%).
Slovenian: V vsaki skupini je umrla ena oseba (manj kot 1 %).
English: Further information on Pradaxa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Nadaljnje informacije o zdravilu Pradaxa so na voljo na spletni strani agencije:ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In the study, around 18,000 adults were treated for one to three years.
Slovenian: V študiji so približno 18 000 odraslih zdravili od enega do treh let.
English: What measures are being taken to ensure the safe and effective use of Pradaxa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pradaxa?
English: Pradaxa received a marketing authorisation valid throughout the EU on 18 March 2008.
Slovenian: Za zdravilo Pradaxa je bilo 18. marca 2008 izdano dovoljenje za promet, veljavno po vsej EU.
English: Patients will also receive an alert card summarising key safety information on the medicine.
Slovenian: Bolniki bodo prejeli tudi opozorilno kartico, ki povzema ključne varnostne informacije o tem zdravilu.
English: Pradaxa is an anticoagulant medicine used for:
Slovenian: Pradaxa je antikoagulantno zdravilo, ki se uporablja za:
English: This means that it is converted into dabigatran in the body.
Slovenian: To pomeni, da se šele v telesu pretvori v dabigatran.
English: Therefore the European Medicines Agency decided that Pradaxa's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Pradaxa večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: It blocks a substance called thrombin, which is central to the process of blood clotting.
Slovenian: Zavira snov, imenovano trombin, ki je ključna za proces strjevanja krvi.
English: Other information about Pradaxa
Slovenian: Druge informacije o zdravilu Pradaxa
English: Why is Pradaxa authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Pradaxa odobreno v EU?
English: As for all medicines, data on the use of Pradaxa are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Pradaxa stalno spremljajo.
English: In both studies, there was some evidence that a 220 mg dose of Pradaxa may be more effective than a 150 mg dose.
Slovenian: V obeh študijah je bilo nekaj dokazov, da je lahko 220-miligramski odmerek zdravila Pradaxa učinkovitejši od 150-miligramskega.
English: It must not be used in patients taking any other anticoagulant medicine, except when the anticoagulant medicine is being switched or when heparin (another anticoagulant medicine) is being used in specific medical procedures.
Slovenian: Ne sme se uporabljati pri bolnikih, ki jemljejo kateri koli drugi antikoagulant, razen kadar se antikoagulant zamenja ali kadar se pri posameznih medicinskih posegih uporablja heparin (drugi antikoagulant).
English: What benefits of Pradaxa have been shown in studies?
Slovenian: Kakšne koristi zdravila Pradaxa so se pokazale v študijah?
English: Pradaxa (dabigatran etexilate)
Slovenian: Pradaxa (dabigatran eteksilat)
English: Three patients in the Pradaxa group died (less than 1%), but two of these deaths were unrelated to blood clots.
Slovenian: V skupini, ki je prejemala zdravilo Pradaxa, so umrli trije bolniki (manj kot 1 %), vendar dve od teh smrti nista bili povezani s krvnimi strdki.
English: Dabigatran is an anticoagulant, meaning that it prevents the blood from coagulating (clotting).
Slovenian: Dabigatran je antikoagulant, kar pomeni, da preprečuje koagulacijo (strjevanje) krvi.
English: All patients at increased risk of bleeding should be monitored closely and the doctor may reduce the dose of Pradaxa.
Slovenian: Vse bolnike s povečanim tveganjem za krvavitev je treba natančno spremljati, zdravnik pa lahko odmerek zdravila Pradaxa tudi zmanjša.
English: The company that makes Pradaxa will provide an educational pack for all doctors who are expected to prescribe the medicine, to increase awareness of the risk of bleeding and provide guidance on how to manage it.
Slovenian: Podjetje, ki izdeluje zdravilo Pradaxa, bo pripravilo izobraževalno gradivo za vse zdravnike, ki bodo predpisovali zdravilo, in tako povečalo ozaveščenost o tveganjih za krvavitve ter zagotovilo smernice za njihovo obvladovanje.
English: An overview of Pradaxa and why it is authorised in the EU
Slovenian: Pregled zdravila Pradaxa in zakaj je odobreno v EU
English: These clots, present in conditions such as deep vein thrombosis (DVT), can be dangerous if they move to another part of the body such as the lungs.
Slovenian: Ti strdki, ki so prisotni pri boleznih, kot je globoka venska tromboza, so lahko nevarni, če se premaknejo v drug del telesa, npr. v pljuča.
English: What are the risks associated with Pradaxa?
Slovenian: Kakšna tveganja so povezana z zdravilom Pradaxa?
English: The dose and duration of treatment depend on the condition Pradaxa is being used to treat, the patient's age and kidney function, and other medicines the patient is taking.
Slovenian: Odmerek in trajanje zdravljenja sta odvisna od bolezni, za zdravljenje katere se zdravilo Pradaxa uporablja, bolnikove starosti in delovanja ledvic ter drugih zdravil, ki jih bolnik jemlje.
English: Pradaxa is available as capsules (75, 110 and 150 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Pradaxa je na voljo v obliki kapsul (75 mg, 110 mg in 150 mg), njegovo predpisovanje in izdaja pa je le na recept.
English: The most common side effect with Pradaxa (which may affect more than 1 in 10 people) is bleeding.
Slovenian: Najpogostejši neželeni učinek zdravila Pradaxa (ki se lahko pojavi pri več kot 1 bolniku od 10 ), je krvavitev.
English: Since certain patients who take Pradaxa are at increased risk of bleeding, a number of precautions were included in the prescribing information.
Slovenian: Ker so nekateri bolniki, ki jemljejo zdravilo Pradaxa, izpostavljeni povečanemu tveganju za krvavitve, so bili v informacije o predpisovanju vključeni številni previdnostni ukrepi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pradaxa have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pradaxa upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For more information about using Pradaxa, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Pradaxa glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Side effects reported with Pradaxa are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Pradaxa, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Patients who have atrial fibrillation are also at risk of blood clots which can travel to the brain and cause a stroke.
Slovenian: Pri bolnikih z atrijsko fibrilacijo prav tako obstaja tveganje za nastanek krvnih strdkov, ki lahko pridejo do možganov in povzročijo možgansko kap.
English: • treating deep vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (PE, a clot in a blood vessel supplying the lungs) in adults, and preventing these conditions from occurring again.
Slovenian: • zdravljenje globoke venske tromboze (DVT, krvnega strdka v globoki veni, običajno v nogi) in pljučne embolije (strdka v krvni žili, ki oskrbuje pljuča) ter preprečevanje njune ponovitve pri odraslih.
English: Although the studies showed a small higher risk of heart problems with Pradaxa than with warfarin, the benefits of Pradaxa were still considered to outweigh its risks.
Slovenian: Čeprav so študije pokazale, da je ob jemanju zdravila Pradaxa tveganje za težave s srcem nekoliko večje kot pri varfarinu, še vedno velja, da koristi zdravila Pradaxa odtehtajo z njim povezana tveganja.
English: What is Pradaxa and what is it used for?
Slovenian: Kaj je zdravilo Pradaxa in za kaj se uporablja?
English: The first study involved a total of 2,101 patients who had had a knee replacement operation.
Slovenian: V prvo študijo je bilo vključenih skupno 2 101 bolnikov, katerim je bilo kirurško vstavljeno umetno koleno.
English: Pradaxa must also not be used in patients with serious liver problems or in patients being treated with certain medicines.
Slovenian: Zdravilo Pradaxa se tudi ne sme uporabljati pri bolnikih z resnimi težavami z jetri ali tistih, ki se zdravijo z določenimi zdravili.
English: Pradaxa compared well with warfarin in reducing the risk of strokes in patients with atrial fibrillation without increasing the risk of major bleeding.
Slovenian: Zdravilo Pradaxa je dobro primerljivo z varfarinom pri zmanjševanju tveganja za možgansko kap pri bolnikih z atrijsko fibrilacijo, ne da bi se pri tem povečalo tveganje za večje krvavitve.
English: When Pradaxa is used long term in patients with non-valvular atrial fibrillation, or when it is used in patients with DVT or PE, kidney function should be assessed at least once a year if their kidney function is mildly to moderately reduced or if they are over 75 years old.
Slovenian: Če se zdravilo Pradaxa dolgotrajno uporablja pri bolnikih z atrijsko fibrilacijo brez okvare srčnih zaklopk ali če se uporablja pri bolnikih z globoko vensko trombozo ali pljučno embolijo, je treba delovanje njihovih ledvic v primeru, da imajo blago do zmerno ledvično okvaro ali če so starejši od 75 let, oceniti vsaj enkrat na leto.
English: Pradaxa, which is taken by mouth, is more convenient for patients.
Slovenian: Zdravilo Pradaxa, ki se jemlje peroralno, je za bolnike bolj priročno.
English: One of these studies compared Pradaxa with warfarin and the other compared Pradaxa with placebo (a dummy treatment).
Slovenian: V eni od teh študij so zdravilo Pradaxa primerjali z varfarinom, v drugi pa s placebom (zdravilom brez učinkovine).
English: • preventing stroke and the formation of clots in adults who have an abnormal heartbeat called ‘nonvalvular atrial fibrillation' and are considered to be at risk of stroke;
Slovenian: • preprečevanje kapi in nastajanja krvnih strdkov pri odraslih z motnjami srčnega utripa, imenovanimi „atrijska fibrilacija brez okvare srčnih zaklopk“, in pri katerih obstaja tveganje za kap;
English: Another two studies looked at the prevention of VTE or PE in around 4,200 adults with symptoms of recurring blood clots and who were on long-term treatment with anticoagulants.
Slovenian: V dveh drugih študijah so proučevali preprečevanje globoke venske tromboze ali pljučne embolije pri okoli 4 200 odraslih bolnikih s simptomi ponavljajočih se krvnih strdkov, ki so se dolgotrajno zdravili z antikoagulanti.
English: However, the number of bleeding events was lower for Pradaxa than for warfarin.
Slovenian: Kljub temu je bilo število epizod krvavitve pri uporabi zdravila Pradaxa manjše kot pri uporabi varfarina.
English: Two main studies in over 5,100 adults with symptoms of DVT or PE, and who were initially treated with an injectable anticoagulant, compared Pradaxa with warfarin.
Slovenian: V dveh glavnih študijah, v katerih je sodelovalo več kot 5 100 odraslih bolnikov s simptomi globoke venske tromboze ali pljučne embolije, ki so bili najprej zdravljeni z injekcijami antikoagulantov, so zdravilo Pradaxa primerjali z varfarinom.
English: The second study involved a total of 3,494 patients who had had a hip replacement.
Slovenian: V drugo študijo je bilo vključenih skupno 3 494 bolnikov, pri katerih je bila opravljena kirurška vstavitev umetnega kolka.
English: Prevention of blood clots after hip or knee replacement
Slovenian: Preprečevanje krvnih strdkov po vstavitvi kolka ali kolena
English: Pradaxa must not be used in patients who have severely reduced kidney function, who are currently bleeding significantly or who have a condition putting them at significant risk of major bleeding.
Slovenian: Zdravilo Pradaxa se ne sme uporabljati pri bolnikih, ki imajo hudo ledvično okvaro, obilno krvavitev ali stanje, zaradi katerega so izpostavljeni precejšnjemu tveganju za večje krvavitve.
English: Prevention of blood clots or stroke in patients at risk of stroke
Slovenian: Preprečevanje krvnih strdkov ali kapi pri bolnikih s tveganjem za možgansko kap
English: How is Pradaxa used?
Slovenian: Kako se zdravilo Pradaxa uporablja?
English: Pradaxa contains the active substance dabigatran etexilate.
Slovenian: Zdravilo Pradaxa vsebuje učinkovino dabigatran eteksilat.
English: How does Pradaxa work?
Slovenian: Kako zdravilo Pradaxa deluje?
English: In all patients, kidney function should also be assessed before starting treatment to exclude patients with severely reduced kidney function, and should be re-assessed during treatment if any worsening is suspected.
Slovenian: Pri vseh bolnikih je treba pred začetkom zdravljenja oceniti tudi delovanje ledvic, da se izključijo bolniki s hudo ledvično okvaro.
English: • preventing the formation of blood clots in the veins in adults who have had an operation to replace a hip or knee;
Slovenian: • preprečevanje nastajanja krvnih strdkov v venah pri odraslih po operativni vstavitvi umetnega kolka ali kolena;
English: For the full list of all side effects reported with Pradaxa, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Pradaxa, glejte navodilo za uporabo.
English: Pradaxa (220 or 150 mg a day) was as effective as enoxaparin (an anticoagulant given by injection) in preventing formation of blood clots or death in patients who had undergone hip or knee replacement in two main studies.
Slovenian: Zdravilo Pradaxa (220 mg ali 150 mg na dan) je bilo v dveh študijah enako učinkovito kot enoksaparin (antikoagulant, ki se daje z injekcijo) pri preprečevanju nastajanja krvnih strdkov ali smrti pri bolnikih, pri katerih je bila opravljena vstavitev kolka ali kolena.
English: Pradaxa (110 mg or 150 mg twice a day) was as effective as warfarin (another anticoagulant given by mouth) in preventing stroke or a blood clot blocking blood vessels in other parts of the body in a study of patients with non-valvular atrial fibrillation who were considered to be at risk of stroke.
Slovenian: Zdravilo Pradaxa (110 mg ali 150 mg dvakrat na dan) je bilo pri preprečevanju možganske kapi ali zamašitve krvnih žil s krvnim strdkom v drugih delih telesa pri bolnikih z atrijsko fibrilacijo, ki ni povezana s srčnimi zaklopkami, pri katerih naj bi obstajalo tveganje za kap, enako učinkovito kot varfarin (drug antikoagulant, ki se jemlje peroralno).
English: In addition, the overall benefit of Pradaxa in the treatment and prevention of DVT and PE is comparable to that of warfarin.
Slovenian: Poleg tega so skupne koristi zdravila Pradaxa pri zdravljenju in preprečevanju globoke venske tromboze in pljučne embolije primerljive koristim varfarina.
English: The proportion of patients who had a stroke or other problems caused by blood clots each year was around 1.5% for patients taking 110 mg Pradaxa (183 patients out of 6,015) and 1.1% for patients taking 150 mg Pradaxa (135 out of 6,076), compared with 1.7% for patients taking warfarin (203 out of 6,022).
Slovenian: Delež bolnikov, ki so vsako leto imeli možgansko kap ali drugo težavo, povezano s krvnimi strdki, je bil okoli 1,5 % (183 od 6 015) pri tistih bolnikih, ki so jemali zdravilo Pradaxa v odmerku 110 mg, in 1,1 % (135 od 6 076) pri tistih, ki so jemali zdravilo Pradaxa v odmerku 150 mg, v primerjavi z 1,7 % (203 od 6 022) pri bolnikih, ki so jemali varfarin.
English: The active substance in Pradaxa, dabigatran etexilate, is a ‘prodrug' of dabigatran.
Slovenian: Učinkovina v zdravilu Pradaxa, dabigatran eteksilat, je predzdravilo dabigatrana.
English: Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in their leg veins.
Slovenian: Pri bolnikih, pri katerih se izvede operativna vstavitev umetnega kolka ali kolena, obstaja veliko tveganje za nastanek krvnih strdkov v venah nog.
English: The effect of Pradaxa in preventing blood clots in patients who have undergone a hip or knee replacement is comparable to that of enoxaparin.
Slovenian: Učinkovitost zdravila Pradaxa pri preprečevanju nastajanja krvnih strdkov pri bolnikih po operativni vstavitvi umetnega kolka ali kolena je primerljiva z učinkovitostjo enoksaparina.
English: In the second study, blood clots or blood-clot-related death occurred in 0.4% (3 out of 681) of patients treated with Pradaxa, compared with 5.6% (37 out of 662) of patients treated with placebo.
Slovenian: V drugi študiji so se krvni strdki oziroma smrt bolnika zaradi krvnih strdkov pojavili pri 0,4 % (3 od 681) bolnikov, zdravljenih z zdravilom Pradaxa, v primerjavi s 5,6 % (37 od 662) bolnikov, zdravljenih s placebom.
English: Treatment and prevention of DVT and PE
Slovenian: Zdravljenje ter preprečevanje globoke venske tromboze in pljučne embolije
English: Blood clots or blood-clot-related death occurred in 2.7% (68 out of 2,553) of patients treated with Pradaxa, compared with 2.4% (62 out of 2,554) of patients treated with warfarin.
Slovenian: Krvni strdki oziroma smrt bolnika zaradi krvnih strdkov so se pojavili pri 2,7% (68 od 2 553) bolnikov, zdravljenih z zdravilom Pradaxa, v primerjavi z 2,4% (62 od 2 554) bolnikov, zdravljenih z varfarinom.
English: In the first study, blood clots or blood-clot-related death occurred in 1.8% (26 out of 1,430) of patients treated with Pradaxa, compared with 1.3% (18 out of 1,426) of patients treated with warfarin.
Slovenian: V prvi študiji so se krvni strdki oziroma smrt bolnika zaradi krvnih strdkov pojavili pri 1,8% (26 od 1 430) bolnikov, zdravljenih z zdravilom Pradaxa, v primerjavi z 1,3% (18 od 1 426) bolnikov, zdravljenih z varfarinom.
English: During the treatment period, blood clots were detected in 6% of the patients taking 220 mg Pradaxa (53 out of 880), compared with 7% of the patients receiving enoxaparin (60 out of 897).
Slovenian: Med zdravljenjem so krvne strdke odkrili pri 6 % (53 od 880) bolnikov, ki so prejemali 220-miligramski odmerek zdravila Pradaxa, v primerjavi s 7 % (60 od 897) bolnikov, ki so prejemali enoksaparin.
English: During the treatment period, blood clots were detected in 36% of the patients taking 220 mg Pradaxa (183 out of 503), compared with 38% of the patients receiving enoxaparin (193 out of 512).
Slovenian: Med zdravljenjem so krvne strdke odkrili pri 36 % (183 od 503) bolnikov, ki so prejemali 220-miligramski odmerek zdravila Pradaxa, v primerjavi z 38 % (193 od 512) bolnikov, ki so prejemali enoksaparin.
English: Pradaxa was as effective as warfarin in reducing formation of blood clots in the veins (DVT) or lungs (PE), or blood-clot-related death during treatment.
Slovenian: Zdravilo Pradaxa je bilo pri preprečevanju nastajanja krvnih strdkov v venah ali pljučih ali smrti, povezane s krvnimi strdki, enako učinkovito kot varfarin.
English: • life-time maximum dose
Slovenian: • vseživljenjski največji odmerek
English: • evaluation of the left-ventricular ejection fraction (LVEF)
Slovenian: • ocena iztisnega deleža levega prekata (LVEF)
English: Conditions to the marketing authorisations
Slovenian: Pogoji dovoljenj za promet z zdravilom
English: The Marketing Authorisation Holders of Novantrone and associated names shall submit for assessment to the Reference Member State a Risk Management Plan containing key elements as described in the CHMP assessment report.
Slovenian: Imetniki dovoljenja za promet z zdravilom Novantrone in povezanimi imeni referenčni državi članici v oceno predložijo načrt za obvladovanje tveganj, ki vsebuje ključne elemente, opisane v poročilu o oceni zdravila odbora CHMP.
English: The Marketing Authorisation Holder(s) shall ensure that in each Member State where Novantrone and associated names are marketed, all healthcare professional (HCP) and patients/carers who are expected to prescribe and dispense or use Novantrone in treatment of multiple sclerosis have access to/are provided with the following educational package:
Slovenian: Imetnik(-i) dovoljenja za promet z zdravilom zagotovijo, da bodo v vsaki državi članici, kjer se tržijo zdravilo Novantrone in povezana imena, vsi zdravstveni delavci in bolniki/negovalci, za katere se pričakuje, da bodo predpisovali in izdajali ali uporabljali zdravilo Novantrone za zdravljenje multiple skleroze, imeli dostop do naslednjega izobraževalnega paketa/ga prejeli: Brošura za zdravstvene delavce z naslednjimi ključnimi elementi:
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Slovenian: Pristojni nacionalni organi ene ali več držav članic ali referenčnih držav članic bodo zagotovili, kjer je to ustrezno, da imetnik(-i) dovoljenja za promet z zdravilom izpolnjuje(-jo) naslednje pogoje:
English: • signs and symptoms of cardiotoxicity and haematotoxicity
Slovenian: • znaki in simptomi kardiotoksičnosti in hematotoksičnosti