FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Ivabradine Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Ivabradine Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This is a summary of the European public assessment report (EPAR) for Ivabradine Accord.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ivabradine Accord.
English: Ivabradine Accord ivabradine
Slovenian: Ivabradine Accord ivabradin
English: Ivabradine Accord is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Ivabradine Accord je na voljo v obliki tablet (5 in 7,5 mg), njegovo predpisovanje in izdaja je le na recept.
English: Also, the doctor will consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.
Slovenian: Zdravnik bi moral prav tako razmisliti o prekinitvi zdravljenja, če zdravilo le omejeno blaži simptome ali znižuje srčni utrip.
English: The Committee recommended that Ivabradine Accord be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Ivabradine Accord odobri za uporabo v EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ivabradine Accord has been shown to have comparable quality and to be bioequivalent to Procoralan.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ivabradine Accord primerljivo raven kakovosti kot zdravilo Procoralan ter da mu je biološko enakovredno.
English: What measures are being taken to ensure the safe and effective use of Ivabradine Accord?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ivabradine Accord?
English: Ivabradine Accord therefore reduces or prevents the symptoms of angina.
Slovenian: Zdravilo Ivabradine Accord tako zmanjša ali prepreči simptome angine pektoris.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Procoralan, and do not need to be repeated for Ivabradine Accord.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Procoralan, zato jih ni treba ponoviti za zdravilo Ivabradine Accord.
English: As for every medicine, the company provided studies on the quality of Ivabradine Accord.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Ivabradine Accord.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivabradine Accord have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Ivabradine Accord, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Slovenian: Priporočeni začetni odmerek je 5 mg dvakrat na dan ob obrokih, ta odmerek pa lahko zdravnik odvisno od bolnikovega srčnega utripa ter simptomov pozneje poveča na 7,5 mg dvakrat na dan ali zmanjša na 2,5 mg (polovička petmiligramske tablete) dvakrat na dan.
English: When this current is blocked, the heart rate is lowered, so that the heart has less work to do and needs less oxygenated blood.
Slovenian: Z zaviranjem tega toka upočasni srčni utrip, tako da ima srce manj dela in potrebuje manj krvi s kisikom.
English: Ivabradine Accord is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (heart disease caused by blockage of the blood vessels that supply the heart muscle).
Slovenian: Zdravilo Ivabradine Accord je zdravilo za bolezni srca, ki se uporablja za zdravljenje simptomov dolgotrajne stabilne angine pektoris (bolečine v prsnem košu, čeljusti in hrbtu zaradi telesnega napora) pri odraslih z boleznijo koronarnih arterij (boleznijo srca, ki jo povzroča zamašitev krvnih žil, ki dovajajo kri v srčno mišico).
English: This means that Ivabradine Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Procoralan.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Procoralan, ki je že odobreno v Evropski uniji (EU).
English: What are the benefits and risks of Ivabradine Accord?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Ivabradine Accord?
English: For more information about treatment with Ivabradine Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ivabradine Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It is used either in patients who cannot take beta-blockers (another type of medicine to treat angina) or in combination with a beta-blocker in patients whose disease is not controlled by beta-blockers alone.
Slovenian: Uporablja se pri bolnikih, ki ne smejo jemati zaviralcev receptorjev beta (druge vrste zdravil za zdravljenje angine pektoris), ali v kombinaciji z zaviralci receptorjev beta pri tistih bolnikih, pri katerih bolezni ni mogoče nadzorovati zgolj s temi zaviralci.
English: Ivabradine Accord is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body) and a normal heart rhythm whose heart rate is at least 75 beats per minute.
Slovenian: Zdravilo Ivabradine Accord se uporablja tudi pri bolnikih z dolgotrajnim srčnim popuščanjem (kadar srce po telesu ne more črpati dovolj krvi) in normalnim srčnim ritmom, ki pa ne sme biti nižji od 75 utripov na minuto.
English: For practical information about using Ivabradine Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ivabradine Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The medicine is used in patients with a normal heart rhythm whose heart rate is at least 70 beats per minute.
Slovenian: Zdravilo se uporablja pri bolnikih z normalnim srčnim ritmom, ki pa ne sme biti nižji od 70 utripov na minuto.
English: Other information about Ivabradine Accord
Slovenian: Druge informacije o zdravilu Ivabradine Accord
English: It is used in combination with standard therapy including beta-blockers, or in patients who cannot be treated with beta-blockers.
Slovenian: Uporablja se v kombinaciji s standardnim zdravljenjem, ki vključuje antagoniste adrenergičnih receptorjev beta, ali pri bolnikih, ki teh antagonistov ne smejo jemati.
English: By lowering the heart rate, Ivabradine Accord reduces the stress on the heart, thereby slowing the progression of heart failure and improving symptoms.
Slovenian: Zdravilo Ivabradine Accord z upočasnitvijo srčnega utripa zmanjša obremenitev srca ter upočasni napredovanje srčnega popuščanja in ublaži simptome.
English: What is Ivabradine Accord and what is it used for?
Slovenian: Kaj je zdravilo Ivabradine Accord in za kaj se uporablja?
English: Therefore, the CHMP's view was that, as for Procoralan, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Procoralan odtehtajo znana tveganja.
English: The active substance in Ivabradine Accord, ivabradine, blocks the ‘If current' in the sinus node, the natural ‘pacemaker' that regulates the heart rate.
Slovenian: Zdravilna učinkovina v zdravilu Ivabradine Accord, ivabradin, zavira „tok If“ v sinusnem vozlu, ki je naravni „srčni spodbujevalec“, ki uravnava srčni utrip.
English: The symptoms of angina are caused by the heart muscle not receiving enough oxygenated blood.
Slovenian: Simptome angine pektoris povzroča premajhen dotok krvi s kisikom v srčno mišico.
English: It is not intended to provide practical advice on how to use Ivabradine Accord.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Ivabradine Accord contains the active substance ivabradine.
Slovenian: Zdravilo Ivabradine Accord vsebuje zdravilno učinkovino ivabradin.
English: Why is Ivabradine Accord approved?
Slovenian: Zakaj je bilo zdravilo Ivabradine Accord odobreno?
English: Treatment must be stopped if the heart rate is persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue.
Slovenian: Pri bolnikih, starejših od 75 let, se lahko uporabi manjši začetni odmerek 2,5 mg dvakrat na dan. Zdravljenje je treba prekiniti, če je srčni utrip vztrajno pod 50 utripov na minuto ali če se nadaljujejo simptomi bradikardije (počasnega srčnega utripa).
English: How has Ivabradine Accord been studied?
Slovenian: Kako je bilo zdravilo Ivabradine Accord raziskano?
English: How does Ivabradine Accord work?
Slovenian: Kako zdravilo Ivabradine Accord deluje?
English: How is Ivabradine Accord used?
Slovenian: Kako se zdravilo Ivabradine Accord uporablja?
English: Repeat every 12 to 24 hours.
Slovenian: Ponavljajte vsakih 12 do 24 ur.
English: • There were also deviations from the final protocol and statistical analysis plan.
Slovenian: • obstajajo tudi odstopanja od končnega protokola in načrta statistične analize.
English: • Risk Management plan (RMP)
Slovenian: • Načrt za obvladovanje tveganja (RMP)
English: This association was consistently observed in multivariable analysis.
Slovenian: Ta povezava je bila dosledno ugotovljena v multivariabilni analizi.
English: This indicates that the system is activated (D).
Slovenian: Tako je sistem aktiviran (D).
English: If bleeding is not controlled
Slovenian: Če krvavitev ni nadzorovana
English: • you have been told you have heart disease or are at risk for heart disease.
Slovenian: • so vam povedali, da imate bolezen srca ali pri vas obstaja tveganje za bolezen srca.
English: This must be checked by an experienced doctor.
Slovenian: To mora preveriti izkušen zdravnik.
English: The expert group was of the view that the relevant available data sources have been considered.
Slovenian: Strokovna skupina je menila, da so bili upoštevani ustrezni razpoložljivi viri podatkov.
English: The relevance for clinical practice in the EU (and therefore for the products subject to this procedure) is therefore questioned.
Slovenian: Zato je vprašljiva ustreznost klinične prakse v EU (in torej za zdravila, ki so predmet tega postopka).
English: The experts emphasized that collaboration between academia, industry and regulators should be encouraged to collect harmonised data through registries.
Slovenian: Strokovnjaki so poudarili, da je treba spodbujati sodelovanje med akademskim svetom, industrijo in regulativnimi organi za zbiranje usklajenih podatkov prek registrov.
English: • Treatment regimens in EU are different from those in the SIPPET study.
Slovenian: • režimi zdravljenja v EU se razlikujejo od režimov v študiji SIPPET.
English: 20024 Garbagnate Milanese (MI) Italy
Slovenian: 20024 Garbagnate Milanese (MI) Italija
English: • where the bleed is and how serious it is
Slovenian: • mesta krvavitve in kako resna je krvavitev
English: EXP (End of the 12 month period, if stored at room temperature): ........... Do not use after this date.
Slovenian: EXP (konec 12 mesečnega obdobja, če ga shranjujete pri sobni temperaturi): ............ Ne uporabljajte po tem datumu.
English: The required dose is determined using the following formulae:
Slovenian: Potrebni odmerek se izračuna z uporabo naslednje formule:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04 August 2000
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 4. avgust 2000
English: During continuous infusion, infusion bags should be changed every 24 hours.
Slovenian: Med kontinuirano infuzijo je treba infuzijske vreče zamenjati vsakih 24 ur.
English: If you notice any of the following symptoms during injection/infusion:
Slovenian: Če opazite katerega od naslednjih simptomov med injiciranjem/infundiranjem:
English: • Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.
Slovenian: • Takoj uporabite vaš naslednji odmerek in zdravljenje nadaljujte v rednih presledkih, kot vam je svetoval zdravnik.
English: (pre- and postoperative)
Slovenian: (pred in po posegu)
English: Published observational studies
Slovenian: Objavljene opazovalne študije
English: Date of latest renewal: 06 August 2010
Slovenian: Datum zadnjega podaljšanja: 6. avgust 2010
English: However, please 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: Ad hoc expert group meeting
Slovenian: Sestanek ad hoc strokovne skupine
English: Please consult your doctor immediately.
Slovenian: Takoj se posvetujte z zdravnikom.
English: Bio-Set System:
Slovenian: Sistem Bio-Set
English: These factors make control of such studies and interpretation of the results challenging.
Slovenian: Ti dejavniki predstavljajo izziv pri nadzorovanju in interpretaciji takšnih študij.
English: Interactions with other medicines are not known.
Slovenian: Medsebojno delovanje z drugimi zdravili ni znano.
English: Frequencies have been evaluated according to the following convention: very common: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: However, in many cases little information was provided on the methods, patient populations and nature of the inhibitors to assess the information in the context of more recent published data.
Slovenian: Vendar pa je bilo v številnih primerih premalo podatkov o metodah, populaciji bolnikov in naravi zaviralcev, da bi ocenili informacije v okviru novejših objavljenih podatkov.
English: The PRAC adopted a recommendation on 01 September 2017 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Slovenian: Odbor PRAC je 1. septembra 2017 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnaval odbor CHMP.
English: For products for which section 4.2 contains the following statement for PUPs: “<Previously untreated patients.
Slovenian: Za zdravila, pri katerih poglavje 4.2 vsebuje naslednjo izjavo za predhodno nezdravljene bolnike: „<Predhodno nezdravljeni bolniki.
English: Data have been obtained from clinical studies in 61 children under 6 years of age and non-interventional studies in children of all ages.
Slovenian: Podatki so bili pridobljeni v kliničnih preskušanjih pri 61 otrocih, mlajših od 6 let in neintervencijskih kliničnih preskušanjih pri otrocih vseh starosti.
English: The lead authors of the SIPPET study were also invited to respond to a list of questions regarding the study methods and findings and to present their conclusions at the February 2017 PRAC plenary meeting.
Slovenian: Vodilni avtorji študije SIPPET so bili pozvani, naj odgovorijo na seznam vprašanj v zvezi z metodami v študiji in ugotovitvami ter predstavijo svoje sklepe na plenarnem zasedanju odbora PRAC februarja 2017.
English: 4.7 Effects on ability to drive or use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev
English: Frequency of doses (hours)/ Duration of therapy (days)
Slovenian: Pogostost odmerjanja (ure)/ trajanje zdravljenja (dnevi)
English: VWF is not present in rFVIII, but there is significant heterogeneity within the rFVIII class for instance due to the different manufacturing processes used, with a wide range of products from different manufacturers produced over the past 20 years.
Slovenian: VWF ni prisoten pri rFVIII, vendar je v razredu rFVIII znatna heterogenost, na primer zaradi različnih proizvodnih postopkov, saj je bil v zadnjih 20 letih proizveden širok nabor zdravil različnih izdelovalcev.
English: A retrospective review has been done on 40 patients, and 39 patients were included in a prospective investigator-initiated clinical study.
Slovenian: Retrospektivni pregled je bil narejen pri 40 bolnikih, v prospektivno klinično študijo na pobudo raziskovalca, pa je bilo vključenih 39 bolnikov.
English: How much KOGENATE Bayer you should use and how often you should use it depends on many factors such as:
Slovenian: Koliko zdravila KOGENATE Bayer morate uporabiti in kako pogosto je odvisno od več dejavnikov, kot so:
English: Furthermore, over time there have been changes in manufacturing process of individual products and changes in treatment regimens between centres, hence “like for like” comparisons between products is not always possible.
Slovenian: Poleg tega je sčasoma prišlo do sprememb v proizvodnem postopku pri posameznih zdravilih in sprememb v shemah zdravljenja med centri, zato primerjave „med podobnimi“ niso vedno možne.
English: The material should not be warmer than body temperature (not exceed 37 °C).
Slovenian: Ne smeta biti toplejši kot je telesna temperatura (ne več kot 37 °C).
English: Therefore, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
English: The PRAC considered the views expressed by experts during an ad-hoc meeting.
Slovenian: Odbor PRAC je obravnaval stališča, ki so jih izrazili strokovnjaki na ad hoc sestanku.
English: The PRAC consulted an ad-hoc expert meeting on some of the aspects that formed part of the detailed grounds submitted by LFB Biomedicaments.
Slovenian: Odbor PRAC se je posvetoval s strokovnjaki na ad hoc sestanku glede nekaterih vidikov, ki so del podrobno opisanih razlogov, predložnih s strani družbe LFB Biomedicaments.
English: In particular, only 13 patients (10% of the FVIII arm) received a third generation rFVIII product.
Slovenian: Pravzaprav je le 13 bolnikov (10 % veje FVIII) prejelo zdravilo z rFVIII tretje generacije.
English: • if you are allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6 and end of section 2).
Slovenian: • če ste alergični na oktokog alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6 in v zadnjem odstavku poglavja 2),
English: Do not touch the syringe tip with your hand or any surface.
Slovenian: Ne dotikajte se konice injekcijske brizge z roko ali katero koli površino.
English: For infusion, the product must be prepared under aseptic conditions.
Slovenian: Za infundiranje je treba zdravilo pripraviti v aseptičnih pogojih.
English: These different manufacturing processes (including the different cell lines used to engineer the rFVIII products) can in theory lead to differential immunogenicity.
Slovenian: Različni proizvodni postopki (vključno z različnimi celičnimi linijami, ki se uporabljajo za pripravo zdravil rFVIII) lahko teoretično vodijo do različne imunogenosti.
English: The available data showed that in many studies including the EUHASS registry (Iorio A, 20174; Fischer K, 20155) the frequency could be classified as “uncommon”.
Slovenian: Iz razpoložljivih podatkov je razvidno, da se v številnih študijah, vključno z registrom EUHASS (Iorio A, 20174; Fischer K, 20155) pogostnost lahko razvrsti kot „občasno“.
English: • The SIPPET study has methodological limitations, with particular uncertainty around whether the randomisation process (block size of 2) may have introduced a selection bias in the study.
Slovenian: • študija SIPPET ima metodološke omejitve, zlasti negotovost, ali je postopek randomizacije (velikost bloka 2) v študiji lahko povzročil pristranskost izbire;
English: Although this became non-significant when UK patients (also included in the RODIN/Pednet study were excluded.
Slovenian: Vendar je to postalo statistično nepomembno, ko so iz študije izključili bolnike iz Združenega kraljestva (vključeni tudi v študijo RODIN/Pednet).
English: PRAC also considered grounds submitted by LFB Biomedicaments as basis for their request for reexamination of the PRAC recommendation and the views of two experts meetings held on 22 February and 3 August 2017.
Slovenian: Odbor PRAC je upošteval tudi razloge, ki jih je predložila družba LFB Biomedicaments kot podlago za zahtevo za ponovno preučitev priporočila odbora PRAC, ter mnenji z dveh strokovnih sestankov, ki sta potekala 22. februarja in 3. avgusta 2017;
English: In case of shock, standard medical treatment for shock should be implemented.
Slovenian: V primeru šoka je treba začeti s standardnimi ukrepi za zdravljenje šoka.
English: The safety and efficacy of {(Invented) name} in previously untreated patients have not yet been established.
Slovenian: Varnost in učinkovitost zdravila {(izmišljeno) ime} pri predhodno nezdravljenih bolnikih še nista bili dokazani.
English: Wash your hands thoroughly using soap and warm water.
Slovenian: Roke si temeljito umijte z milom in toplo vodo.
English: Prevention of bleeding
Slovenian: Preprečevanje krvavitve
English: The PRAC recommended changes to the product information accordingly.
Slovenian: Odbor PRAC je v skladu s tem priporočil spremembe informacij o zdravilu.
English: Bayer Corporation (license holder) Bayer HealthCare LLC 800 Dwight Way
Slovenian: Bayer Corporation (imetnik licence) Bayer HealthCare LLC 800 Dwight Way
English: KOGENATE Bayer should be injected intravenously over 2 to 5 minutes.
Slovenian: Zdravilo KOGENATE Bayer je treba injicirati intravensko 2 do 5 minut.
English: Every 24 hours, at least 1 day, until healing is achieved.
Slovenian: Vsakih 24 ur, vsaj 1 dan, dokler se rana ne zaceli.
English: The additional points of clarification provided by the SIPPET authors do not fully resolve this uncertainty.
Slovenian: Dodatna pojasnila, ki so jih predložili avtorji študije SIPPET, teh negotovosti ne odpravijo v celoti.
English: • if you are allergic to mouse or hamster protein.
Slovenian: • če ste alergični na beljakovine miši ali hrčkov.
English: Now remove and discard the adapter housing (E).
Slovenian: Zdaj odstranite in zavrzite ohišje adapterja (E).
English: However, the general estimates of inhibitor rates from these studies for individual products are broadly in line with the findings from large observational studies.
Slovenian: Vendar so splošne ocene stopenj pojava zaviralcev iz teh študij za posamezna zdravila na splošno v skladu z ugotovitvami velikih opazovalnih študij.
English: Not known (frequency cannot be estimated from the available data): • dysgeusia (strange taste)
Slovenian: Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) • disgevzija (neobičajen okus)
English: The solution must be prepared on a clean and dry surface.
Slovenian: Raztopino morate pripraviti na čisti in suhi površini.
English: Do not use this medicine after the expiry date which is stated on labels and cartons.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepkah in škatlah.