FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Slovenian: Zdravljenje se lahko izvaja samo pod nadzorom zdravnika specialista in med zdravljenjem je potrebno pogosto skrbno spremljanje delovanja ledvic, vrednosti elektrolitov in krvnega tlaka.
English: • The PRAC reviewed the totality of the available data, including clinical trials, meta-analysis and publications, the MAHs' responses as well as the report from the Scientific Advisory Group in Cardiovascular Issues;
Slovenian: • Odbor PRAC je pregledal vse razpoložljive podatke, vključno s kliničnimi preskušanji, metaanalizami in publikacijami, odgovori imetnikov dovoljenj za promet z zdravili ter poročilom znanstveno svetovalne skupine za srčno-žilna vprašanja;
English: The PRAC therefore concluded that dual RAS blockade therapy should not be routinely used in the treatment of heart failure and is not recommended in the general population although it may benefit certain patients who remain symptomatic while receiving monotherapy or who cannot otherwise use alternative therapies, including potentially patients with diabetic nephropathy.
Slovenian: Zato je zaključil, naj se zdravljenje z dvojnim zaviranjem renin-angiotenzinskega sistema ne uporablja rutinsko pri zdravljenju srčnega popuščanja in da to zdravljenje ni priporočeno pri splošni populaciji, čeprav lahko koristi določenim bolnikom, pri katerih simptomi med prejemanjem monoterapije ne izginejo ali pri katerih nadomestno zdravljenje ni mogoče, morebiti vključno z bolniki z diabetično nefropatijo.
English: The PRAC however clearly specified, based on data from the ONTARGET3 and VA NEPHRON-D4 studies that ACE-inhibitors and ARBs should not be used concomitantly in patients with diabetic nephropathy.
Slovenian: Vendar pa je jasno navedel, da na podlagi podatkov iz študij ONTARGET3 in VA NEPHRON-D4 sočasna uporaba zaviralcev ACE in zaviralcev angiotenzinskih receptorjev ni dovoljena pri bolnikih z diabetično nefropatijo.
English: The CHMP, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and is of the opinion that the marketing authorisations for RAS-acting agents should be varied.
Slovenian: Po preučitvi priporočila odbora PRAC se je odbor CHMP strinjal z njegovimi splošnimi znanstvenimi zaključki in menil, da je treba dovoljenja za promet z zdravili za snovi, ki delujejo na reninangiotenzinski sistem, spremeniti.
English: Scientific conclusions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Slovenian: Znanstveni zaključki in podrobna obrazložitev znanstvenih razlogov za odstopanja od priporočila odbora PRAC
English: • The PRAC was of the view that there is considerable evidence, in particular from the ONTARGET, ALTITUDE and VA NEPHRON-D trials which conclusively demonstrates that dual RAS blockade therapy through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and renal failure compared to monotherapy;
Slovenian: • Odbor PRAC je menil, da obstaja veliko dokazov, zlasti iz preskušanj ONTARGET, ALTITUDE in VA NEPHRON-D, ki jasno kažejo, da je zdravljenje z dvojnim zaviranjem renin-angiotenzinskega sistema s kombinirano uporabo zaviralcev ACE, zaviralcev angiotenzinskih receptorjev II ali aliskirena povezano s povečanim tveganjem za neželene dogodke, vključno s hipotenzijo, hiperkaliemijo in ledvično odpovedjo, v primerjavi z monoterapijo;
English: The concept of dual RAS blockade through the combined use of several RAS-acting agents, emerged in the late 1990's based on an experimental model hypothesising that the combined use of an ARB, an ACE-inhibitor or aliskiren could provide a more complete blockade of the RAS which could translate into better control of blood pressure and nephroprotective and cardioprotective effects.
Slovenian: Zasnova dvojnega zaviranja renin-angiotenzinskega sistema s kombinirano uporabo več snovi, ki delujejo na renin-angiotenzinski sistem, se je pojavil v poznih 90. letih 20. stoletja na eksperimentalnem modelu, katerega hipoteza je bila, da lahko kombinirana uporaba zaviralca angiotenzinskih receptorjev, zaviralca ACE ali aliskirena zagotovi močnejše zaviranje reninangiotenzinskega sistema, kar bi lahko pomenilo boljše obvladovanje krvnega tlaka ter nefroprotektivnih in kardioprotektivnih učinkov.
English: 2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
Slovenian: 2 - Podrobna obrazložitev znanstvenih razlogov za odstopanja od priporočila odbora PRAC
English: • The PRAC considered that the available efficacy data indicates that dual RAS blockade therapy does not provide significant benefit in the general patient population although certain patient subpopulations may benefit from treatment, provided that it occurs only under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure;
Slovenian: • Odbor PRAC je menil, da razpoložljivi podatki o učinkovitosti nakazujejo, da zdravljenje z dvojnim zaviranjem renin-angiotenzinskega sistema ne zagotavlja pomembne koristi pri splošni populaciji bolnikov, čeprav lahko določeni podpopulaciji bolnikov to zdravljenje koristi, če poteka pod nadzorom zdravnika specialista in se pogosto skrbno spremlja delovanje ledvic, vrednosti elektrolitov in krvnega tlaka;
English: The PRAC was of the opinion that the concerns identified during this procedure with regard to the safety and the lack of efficacy of dual RAS blockade therapy could be adequately managed through changes to the product information, without the need for additional risk minimisation measures.
Slovenian: Odbor PRAC je menil, da je mogoče zadržke, ugotovljene med tem postopkom v zvezi z varnostjo in pomanjkanjem učinkovitosti zdravljenja z dvojnim zaviranjem renin-angiotenzinskega sistema, ustrezno obvladovati s spremembami informacij o zdravilu brez potrebe po dodatnih ukrepih za zmanjševanje tveganja.
English: The PRAC considered that the available efficacy data indicates that dual RAS blockade therapy does not provide significant benefit in the general patient population, although there is evidence to suggest that some selected patient subpopulations may benefit from this dual RAS blockade therapy.
Slovenian: Odbor PRAC je menil, da razpoložljivi podatki o učinkovitosti kažejo, da zdravljenje z dvojnim zaviranjem renin-angiotenzinskega sistema ne zagotavlja pomembne koristi pri splošni populaciji bolnikov, čeprav obstajajo dokazi, ki kažejo na to, da lahko nekaterim izbranim podpopulacijam bolnikov to zdravljenje z dvojnim zaviranjem renin-angiotenzinskega sistema koristi.
English: A warning was introduced to state that dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren is not recommended and, if considered absolutely necessary, should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Slovenian: Uvedeno je bilo opozorilo, da zdravljenje z dvojnim zaviranjem renin-angiotenzinskega sistema s kombinirano uporabo zaviralcev ACE, zaviralcev angiotenzinskih receptorjev ali aliskirena ni priporočeno in da se lahko uporabi, če je nujno potrebno, samo pod nadzorom zdravnika specialista in ob stalnem skrbnem spremljanju delovanja ledvic, vrednosti elektrolitov in krvnega tlaka.
English: Annex IV Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Slovenian: Znanstveni zaključki, podlaga za spremembo pogojev dovoljenj za promet z zdravilom ter podrobna obrazložitev znanstvenih razlogov za odstopanja od priporočila odbora PRAC
English: • The PRAC was of the opinion that the concerns identified with regard to safety and the lack of additional efficacy of dual RAS blockade therapy are a class effect and that the conclusions of the review therefore apply to all the active substances involved in this procedure;
Slovenian: • Odbor PRAC je menil, da so zadržki, ugotovljeni v zvezi z varnostjo in pomanjkanjem dodatne učinkovitosti zdravljenja z dvojnim zaviranjem renin-angiotenzinskega sistema, razredni učinek in da zaključki pregleda zato veljajo za vse zdravilne učinkovine v tem postopku;
English: The PRAC concluded that the benefit-risk balance of RAS-acting agents remains favourable, including in the context of dual RAS blockade therapy, subject to the agreed revisions to the product information.
Slovenian: Odbor PRAC je zaključil, da razmerje med tveganji in koristmi za snovi, ki delujejo na reninangiotenzinski sistem, ostaja ugodno, tudi pri zdravljenju z dvojnim zaviranjem renin-angiotenzinskega sistema, ob upoštevanju dogovorjenega pregleda informacij o zdravilu.
English: Having considered the matter, the PRAC therefore recommended the variation of the marketing authorisations for RAS-acting agents.
Slovenian: Po preučitvi zadeve je priporočil spremembo dovoljenj za promet z zdravili za snovi, ki delujejo na reninangiotenzinski sistem.
English: The PRAC was of the opinion that there is considerable evidence from large clinical trials and meta-analyses which conclusively demonstrates that dual RAS blockade therapy through the combined use of ACE-inhibitors, ARBs or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and renal failure compared to monotherapy, in particular in patients with diabetic nephropathy.
Slovenian: Menil je, da obstaja veliko dokazov iz obsežnih kliničnih preskušanj in metaanaliz, ki jasno kažejo, da je zdravljenje z dvojnim zaviranjem reninangiotenzinskega sistema s kombinirano uporabo zaviralcev ACE, zaviralcev angiotenzinskih receptorjev ali aliskirena povezano s povečanim tveganjem za neželene učinke, vključno s hipotenzijo, hiperkaliemijo in ledvično odpovedjo, v primerjavi z monoterapijo, zlasti pri bolnikih z diabetično nefropatijo.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of RAS-acting agents remains favourable, provided that their product information is revised to reflect the concerns associated with dual RAS blockade therapy.
Slovenian: je odbor PRAC zaključil, da razmerje med tveganji in koristmi za snovi, ki delujejo na reninangiotenzinski sistem, ostaja ugodno, če se uvedejo spremembe informacij o zdravilu, tako da bodo odražale zadržke, povezane z zdravljenjem z dvojnim zaviranjem renin-angiotenzinskega sistema.
English: • The PRAC was of the opinion that the concerns identified with regard to the safety and the lack of additional efficacy of dual RAS blockade therapy can be adequately managed through changes to the product information, without the need for additional risk minimisation measures.
Slovenian: • Odbor PRAC je menil, da je mogoče zadržke, ugotovljene v zvezi z varnostjo in pomanjkanjem dodatne učinkovitosti zdravljenja z dvojnim zaviranjem renin-angiotenzinskega sistema, ustrezno obvladovati s spremembami informacij o zdravilu brez potrebe po dodatnih ukrepih za zmanjševanje tveganja;
English: For candesartan- and valsartan-containing products, which are also authorised in the treatment of heart failure, additional information was agreed upon to reflect the fact that dual RAS blockade therapy in combination with an ACE-inhibitor may be of benefit in certain patients who cannot use other heart failure treatments, provided that they are used under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
Slovenian: Za zdravila, ki vsebujejo kandesartan in valsartan, ki so prav tako odobrena za zdravljenje srčnega popuščanja, so sprejeli dodatne informacije, ki odražajo, da je lahko zdravljenje z dvojno blokado renin-angiotenzinskega sistema v kombinaciji z zaviralci ACE koristno pri določenih bolnikih, pri katerih ni mogoče uporabiti drugih vrst zdravljenja za srčno popuščanje, če so
English: In particular, the publication of a meta-analysis by Makani et al1 involving over 68,000 patients raised concerns that combining several RAS-acting agents may be associated with an increased risk of hyperkalaemia, hypotension and kidney failure, compared with the single use of one RAS-acting agent.
Slovenian: Zadržki, da je lahko kombinacija več snovi, ki delujejo na renin-angiotenzinski sistem, povezana s povečanim tveganjem za hiperkaliemijo, hipotenzijo in ledvično odpovedjo v primerjavi z uporabo samo ene snovi, ki deluje na reninangiotenzinski sistem, so se pojavili predvsem zaradi objave metaanalize, ki so jo izvedli Makani in sod.1 in je vključevala več kot 68 000 bolnikov.
English: Follow-up continued up to Day 77.
Slovenian: Spremljanje se je nadaljevalo do 77. dneva.
English: Date of first authorisation: 21 March 2002 Date of latest renewal: 21 March 2007
Slovenian: Datum pridobitve dovoljenja za promet: 21. marec 2002 Datum zadnjega podaljšanja dovoljenja za promet: 21. marec 2007
English: Conditions you need to look out for
Slovenian: Stanja, na katera morate biti pozorni
English: This is shown in Picture 3 at the beginning of these instructions
Slovenian: Opisano prikazuje slika 3 na začetku tega navodila.
English: Wash your hands thoroughly with soap and water and dry them with a towel.
Slovenian: Temeljito si umijte roke z milom in vodo in jih osušite z brisačo.
English: Do not inject a double dose to make up for a forgotten dose.
Slovenian: Ne injicirajte si dvojnega odmerka, da bi nadomestili pozabljeni odmerek.
English: No conclusion can be drawn with regard to clinical efficacy in this uncontrolled study.
Slovenian: Zaključki glede klinične učinkovitosti v tej nekontrolirani študiji niso mogoči.
English: Sit or lie down in a comfortable position.
Slovenian: Udobno sedite ali lezite.
English: The median duration of treatment in this study was 3.5 days.
Slovenian: Mediana trajanja zdravljenja v tej študiji je bila 3,5 dneva.
English: • Take the dose as soon as you remember.
Slovenian: • Odmerek injicirajte takoj, ko se spomnite.
English: • if you are 75 years old or older.
Slovenian: • če ste stari 75 let ali več.
English: Two patients had reports of bleeding during the study.
Slovenian: Pri dveh bolnikih so poročali o krvavitvi med študijo.
English: For additional instructions for use and handling and disposal see section 6.6.
Slovenian: Za dodatna navodila za uporabo in ravnanje z zdravilom ter odstranjevanje glejte poglavje 6.6.
English: You should inject at about the same time each day.
Slovenian: Zdravilo si morate injicirati vsak dan ob približno istem času.
English: The distribution volume of fondaparinux is limited (7-11 litres).
Slovenian: Volumen porazdelitve fondaparinuksa je majhen (7-11 litrov).
English: Do not use this medicine:
Slovenian: Tega zdravila ne smete uporabljati:
English: Where the instruction for a syringe is different this is clearly stated.
Slovenian: Kjer se navodila za uporabo injekcijske brizge razlikujejo, je to jasno navedeno.
English: • after the expiry date shown on the label and carton
Slovenian: • po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli;
English: The syringes are pre-filled with the exact dose you need.
Slovenian: Injekcijske brizge so napolnjene z natančnim odmerkom, ki ga potrebujete.
English: The majority of patients were Hispanic (67%) and 58% were male.
Slovenian: Večina bolnikov je bila hispanskega porekla (67 %) in 58 % je bilo moških.
English: 10 mg once a day.
Slovenian: 10 mg enkrat na dan.
English: • Do not inject Arixtra into muscle.
Slovenian: • Ne injicirajte zdravila Arixtra v mišico.
English: TVR - target vessel revascularization
Slovenian: TVR - revaskularizacija ciljne žile ("target vessel revascularization")
English: Signs include:
Slovenian: Med znaki so:
English: No studies on the effect on the ability to drive and to use machines have been performed.
Slovenian: Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
English: The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
Slovenian: Razpolovni čas izločanja (t½) je približno 17 ur pri zdravih mladih osebah in približno 21 ur pri zdravih starejših osebah.
English: Rare: non-protein-nitrogen (Npn) 2 increased
Slovenian: Redki: zvišanje vrednosti neproteinskega dušika (Npn) 2
English: Over 4,874 patients were studied in controlled Phase II and III clinical studies.
Slovenian: V kontroliranih kliničnih študijah faze II in III so proučevali več kot 4.874 bolnikov.
English: The safety and efficacy of 1.5 mg has not been studied.
Slovenian: Varnost in učinkovitost odmerka 1,5 mg nista raziskani.
English: Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalised Ratio 2 to 3).
Slovenian: Zdravljenje se mora nadaljevati vsaj 5 dni in dokler se ne vzpostavi primerna peroralna antikoagulacija (internacionalno normalizirano razmerje 2 do 3).
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Pred uporabo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: The mortality benefit shown in the fondaparinux group was maintained until the end of follow-up at Day 180.
Slovenian: Korist fondaparinuksa pri zmanjšanju umrljivosti se je ohranila do konca spremljanja na 180. dan.
English: • fainting or dizziness, low blood pressure
Slovenian: • omedlevica ali omotica, nizek krvni tlak;
English: After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%).
Slovenian: Po subkutani uporabi se fondaparinuks popolno in hitro absorbira (absolutna biološka uporabnost 100 %).
English: • if you are bleeding excessively
Slovenian: • če prekomerno krvavite,
English: The majority of patients (88%) achieved target fondaparinux concentrations at 4 hours after the first dose of fondaparinux.
Slovenian: Večina bolnikov (88 %) je dosegla ciljno koncentracijo fondaparinuksa po 4 urah že po prvem odmerku fondaparinuksa.
English: The average duration of administration in clinical trials was 7 days and the clinical experience from treatment beyond 10 days is limited.
Slovenian: Povprečno trajanje uporabe v kliničnih preskušanjih je bilo 7 dni, klinične izkušnje z zdravljenjem, ki bi trajalo dlje kot 10 dni, so omejene.
English: Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no evidence for the formation of active metabolites.
Slovenian: Čeprav ni v celoti ovrednotena, ni dokazov za presnovo fondaparinuksa in zlasti ne za tvorbo aktivnih metabolitov.
English: Odds Ratio1 (95%CI)
Slovenian: Razmerje obetov1 (95 % IZ)
English: • if you have a risk of uncontrolled bleeding (haemorrhage) including:
Slovenian: • če imate tveganje za pojav nenadzorovane krvavitve, vključno z:
English: Prevention of VTE following Surgery
Slovenian: Preprečevanje VTE po operaciji
English: • if you have opened a syringe and you do not use it straightaway.
Slovenian: • če ste odprli injekcijsko brizgo in je niste takoj uporabili.
English: No clinical data on exposed pregnancies are available.
Slovenian: Klinični podatki o izpostavljenosti med nosečnostjo niso na voljo.
English: This medicinal product is for single use only.
Slovenian: To zdravilo je namenjeno samo za enkratno uporabo.
English: If co-administration is essential, close monitoring is necessary.
Slovenian: Če je sočasna uporaba nujna, je potreben skrben nadzor.
English: The risk of bleeding increases with increasing renal impairment.
Slovenian: Nevarnost krvavitve narašča z naraščajočo ledvično okvaro.
English: Types of safety syringe
Slovenian: Vrste varnostnih brizg
English: Oral absorption by the child is however unlikely.
Slovenian: Vendar je peroralna absorpcija pri dojenčku le malo verjetna.
English: • Patients who are to undergo surgery or other invasive procedures
Slovenian: • Bolniki, ki morajo na operacijo ali drug invaziven poseg
English: Clinical studies
Slovenian: Klinične študije
English: Remove the syringe from the carton and check that:
Slovenian: Iz škatle vzemite injekcijsko brizgo in preverite:
English: Picture 3.
Slovenian: Slika 3.
English: The majority of events were asymptomatic distal DVT.
Slovenian: Večina dogodkov so bile asimptomatske distalne DVT.
English: Release the plunger and the needle will automatically withdraw from the skin and go back into the security sleeve where it will be locked permanently (picture F).
Slovenian: Popustite bat in igla se bo samodejno odstranila iz kože ter se umaknila v zaščitni tulec, kjer bo trajno zaprta (slika F).
English: However, studies performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile compared to Caucasian healthy subjects.
Slovenian: Vendar raziskave z zdravimi osebami v Aziji (Japonci) niso razkrile drugačnega farmakokinetičnega profila, kot ga imajo zdravi Kavkazijci.
English: Rare: post-operative wound infection
Slovenian: Redki: pooperacijska okužba rane
English: • Arixtra does not have to be kept in the fridge.
Slovenian: • Zdravila Arixtra ni treba shranjevati v hladilniku.
English: Sites of administration should alternate between the left and the right anterolateral and left and right posterolateral abdominal wall.
Slovenian: Mesto injiciranja je treba izmenjavati med levo in desno anterolateralno in levo in desno posterolateralno stranjo trebušne stene.
English: As a result, the concentration of fondaparinux is expressed as milligrams (mg).
Slovenian: Zato koncentracijo fondaparinuksa izražamo v miligramih (mg).
English: Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
Slovenian: Telesna masa - Plazemski očistek fondaparinuksa se povečuje s telesno maso (9 % povečanje na 10 kg).
English: Fondaparinux is intended for subcutaneous use only.
Slovenian: Fondaparinuks je namenjen samo za subkutano uporabo.
English: Severe allergic reactions (anaphylaxis): These are very rare in people (up to 1 in 10,000) taking Arixtra.
Slovenian: Hude alergijske reakcije (anafilaksija): Te so pri osebah, ki jemljejo zdravilo Arixtra, zelo redke (do 1 od 10.000).
English: Fondaparinux is excreted to 64 - 77 % by the kidney as unchanged compound.
Slovenian: Fondaparinuks se izloča preko ledvic, 64 - 77 % v nespremenjeni obliki.
English: Medical patients who are at high risk for thromboembolic complications based on an individual risk assessment
Slovenian: Internistični bolniki, pri katerih obstaja velika nevarnost trombemboličnih zapletov na podlagi individualne ocene tveganja
English: There are no data available on the effect of fondaparinux on human fertility.
Slovenian: Na voljo ni podatkov o vplivu fondaparinuksa na plodnost pri človeku.
English: • increase in the amount of non-protein nitrogen in the blood
Slovenian: • povečanje vrednosti neproteinskega dušika v krvi.
English: • Do not touch the needle or allow it to touch any surface before the injection.
Slovenian: • Ne dotikajte se igle in pazite, da se igla pred injiciranjem ne dotakne nobene površine.
English: • anxiety or confusion
Slovenian: • anksioznost ali zmedenost;
English: Arixtra is used to:
Slovenian: Zdravilo Arixtra se uporablja za:
English: You should continue Arixtra treatment for as long as your doctor has told you, since Arixtra prevents development of a serious condition.
Slovenian: Zdravilo Arixtra morate uporabljati tako dolgo, kot vam je predpisal zdravnik, ker zdravilo Arixtra preprečuje razvoj resnega zdravstvenega stanja.
English: Other medicines and Arixtra
Slovenian: Druga zdravila in zdravilo Arixtra
English: The baseline characteristics and duration of fondaparinux treatment were comparable in both UFH
Slovenian: Izhodiščne značilnosti in trajanje zdravljenja s fondaparinuksom so bili v obeh skupinah UFH primerljivi.