FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor or pharmacist before taking Procoralan - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
Slovenian: če opažate simptome, kot so utrujenost, vrtoglavost ali zasoplost (to bi lahko pomenilo, da se vaše srce preveč upočasnjuje); če imate simptome atrijske fibrilacije (nenavadno visok srčni utrip v mirovanju (nad 110 utripov na minuto) ali brez posebnega vzroka nereden srčni utrip, ki ga je težko izmeriti); če ste nedavno imeli možgansko kap (možganski napad); če imate blago do zmerno znižan krvni tlak;
English: Talk to your doctor if you are breast-feeding or intending to breast-feed as breastfeeding should be discontinued if you take Procoralan.
Slovenian: Če dojite ali nameravate dojiti se posvetujte z zdravnikom, ker morate z dojenjem prekiniti, če jemljete zdravilo
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Resting heart rate below 70 beats per minute prior to treatment - Cardiogenic shock - Acute myocardial infarction - Severe hypotension (< 90/50 mmHg) - Severe hepatic insufficiency - Sick sinus syndrome - Sino-atrial block - Unstable or acute heart failure - Pacemaker dependent (heart rate imposed exclusively by the pacemaker) - Unstable angina - AV-block of 3rd degree - Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals
Slovenian: hudo jetrno popuščanje sindrom bolnega sinusnega vozla sinoatrijski blok nestabilno ali akutno srčno popuščanje odvisnost od srčnega spodbujevalnika (srčna frekvenca, ki jo narekuje izključno srčni spodbujevalnik) nestabilna angina pektoris atrioventrikularni blok 3. stopnje kombinacija z močnimi zaviralci citokroma P450 3A4, kot so azolski antimikotiki (ketokonazol, itrakonazol), makrolidni antibiotiki (klaritromicin, eritromicin peroralno, josamicin, telitromicin), zaviralci proteaze virusa HIV (nelfinavir, ritonavir) in nefazodon (glejte poglavji 4.5 in 5.2) kombinacija z verapamilom ali diltiazemom, zmernima zaviralcema citokroma P450 3A4, ki imata lastnosti zniževanja srčne frekvence (glejte poglavje 4.5)
English: Ivabradine is indicated : - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta blocker dose.
Slovenian: Ivabradin je indiciran: pri odraslih, pri katerih so antagonisti adrenergičnih receptorjev beta kontraindicirani ali jih ne prenašajo,
English: Procoralan 5 mg film-coated tablets Procoralan 7.5 mg film-coated tablets ivabradine
Slovenian: Procoralan 7,5 mg filmsko obložene tablete ivabradin
English: NAME OF THE MEDICINAL PRODUCT Procoralan 5 mg film-coated tablets ivabradine
Slovenian: Procoralan 5 mg filmsko obložene tablete ivabradin
English: How to store Procoralan
Slovenian: Shranjevanje zdravila Procoralan
English: Procoralan (ivabradine) is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Slovenian: Kaj je zdravilo Procoralan in za kaj ga uporabljamo Procoralan (ivabradin) je zdravilo za srce, namenjeno za zdravljenje: simptomatske stabilne angine pektoris (bolezen, ki povzroča bolečine v prsih) pri odraslih bolnikih,
English: The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: 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: <1/1.000); zelo redki (<1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The study demonstrated a clinically and statistically significant relative risk reduction of 18% in the rate of the primary composite endpoint of cardiovascular mortality and hospitalisation for worsening heart failure (hazard ratio: 0.82, 95%CI [0.75;0.90] - p<0.0001) apparent within 3 months of initiation of treatment.
Slovenian: (razmerje tveganja: 0,82, 95 % interval zaupanja [0,75;0,90] - p<0,0001), vidnega po 3 mesecih po začetku zdravljenja.
English: itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris); - if you are a woman able to have children and not using reliable contraception; - if you are pregnant or trying to become pregnant; - if you are breast-feeding.
Slovenian: če imate srčno popuščanje, ki se je pred kratkim poslabšalo; če vam srčni utrip narekuje izključno vaš srčni spodbujevalnik; če imate hude težave z jetri; če že jemljete zdravila proti glivičnim okužbam (na primer ketokonazol, itrakonazol), makrolidne antibiotike (na primer josamicin, klaritromicin, telitromicin ali eritromicin peroralno), zdravila proti okužbam z virusom HIV (na primer nelfinavir, ritonavir) ali nefazodon (zdravilo proti depresiji) ali diltiazem, verapamil (uporabljata se za zniževanje krvnega tlaka oz. zdravljenje angine pektoris);
English: - in clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals;
Slovenian: - v kliničnih elektrofizioloških študijah ivabradin ni vplival na čase atrioventrikularnega ali intraventrikularnega prevajanja ali na interval QT s popravkom; - pri bolnikih z disfunkcijo levega prekata (iztisnim deležem levega prekata med 30 in 45 %) ivabradin ni imel nobenih škodljivih učinkov na iztisni delež levega prekata.
English: United Kingdom Servier Laboratories Ltd Tel: +44 (0)1 753 666409
Slovenian: Tel: +44 (0)1 753 666409
English: conducted in 6505 adult patients with stable chronic CHF (for ≥ 4 weeks), NYHA class II to IV, with a reduced left ventricular ejection fraction (LVEF ≤ 35%) and a resting heart rate ≥ 70 bpm.
Slovenian: z zmanjšanim iztisnim deležem levega prekata (LVEF ≤ 35 %) in srčno frekvenco v mirovanju ≥ 70
English: The SHIFT study was a large multicentre, international, randomised double-blind placebo controlled outcome trial.
Slovenian: V združeni analizi vseh dvojno slepih nadzorovanih kliničnih preskušanj II.
English: - in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30
Slovenian: - Bolniki z jetrnim popuščanjem: pri bolnikih z blagim jetrnim popuščanjem (Child-Pughov seštevek do
English: Immediate Packaging Pack size
Slovenian: Farmacevtska oblika Stična ovojnina Ovojnina
English: The infusion should last around 15 minutes.
Slovenian: Infundiranje traja približno 15 minut.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Respreeza on 20 August 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Respreeza, veljavno po vsej Evropski uniji, izdala 20. avgusta 2015.
English: What measures are being taken to ensure the safe and effective use of Respreeza?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Respreeza?
English: Other information about Respreeza
Slovenian: Druge informacije o zdravilu Respreeza
English: The full EPAR for Respreeza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Respreeza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Allergic reactions have been observed during treatment, some of which were severe.
Slovenian: Med zdravljenjem so opazili alergijske reakcije, od katerih so bile nekatere hude.
English: The company that markets Respreeza will carry out a further study to assess whether an increased dose of 120 mg/kg may lead to improved effects compared with the currently recommended dose.
Slovenian: Družba, ki trži zdravilo Respreeza, bo izvedla dodatno študijo, s katero bo ocenila, ali lahko višji odmerek 120 mg/kg izboljša njegove učinke v primerjavi s trenutno priporočenim odmerkom.
English: The recommended dose of Respreeza is 60 mg per kilogram body weight, given once a week.
Slovenian: Priporočeni odmerek zdravila Respreeza je 60 mg na kilogram telesne mase, ki se daje enkrat na teden.
English: No other major concerns have been identified about the safety of the medicine.
Slovenian: Z vidika varnosti pri tem zdravilu niso ugotovili nobenih drugih večjih zadržkov.
English: This is a summary of the European public assessment report (EPAR) for Respreeza.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Respreeza.
English: What benefits of Respreeza have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Respreeza izkazalo v študijah?
English: Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Respreeza's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Respreeza večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: What is Respreeza and what is it used for?
Slovenian: Kaj je zdravilo Respreeza in za kaj se uporablja?
English: It is not intended to provide practical advice on how to use Respreeza.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What are the risks associated with Respreeza?
Slovenian: Kakšna tveganja so povezana z zdravilom Respreeza?
English: The decrease in lung density after 24 months was around 2.6 g/l in patients who received Respreeza, compared with a decrease of around 4.2 g/l in patients receiving placebo.
Slovenian: Zmanjšanje pljučne gostote v 24 mesecih je bilo pri bolnikih, ki so prejemali zdravilo Respreeza, približno 2,6 g/l, pri bolnikih, ki so prejemali placebo, pa približno 4,2 g/l.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Respreeza have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Respreeza upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The most common side effects with Respreeza (which may affect up to 1 in 10 people) are dizziness, headache, dyspnoea (shortness of breath) and nausea.
Slovenian: Najpogostejši neželeni učinki zdravila Respreeza (ki lahko prizadenejo največ 1 osebo od 10) so omotica, glavobol, dispneja (kratka sapa) in navzeja (slabost).
English: Subsequent infusions can be given by a caregiver or by the patient.
Slovenian: Pozneje lahko zdravilo infundira negovalec ali bolnik.
English: For more information about treatment with Respreeza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Respreeza preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Allergic reactions were the main safety concern with Respreeza, but advice on how to manage this risk has been included in the product information.
Slovenian: Pri zdravilu Respreeza je bil glavni varnostni zadržek alergijska reakcija, vendar so v informacije o zdravilu vključili nasvet o tem, kako obvladovati to tveganje.
English: Why is Respreeza approved?
Slovenian: Zakaj je bilo zdravilo Respreeza odobreno?
English: Respreeza is used to slow down damage to the lungs in patients with severe disease.
Slovenian: Zdravilo Respreeza se uporablja za upočasnitev poškodbe pljuč pri bolnikih s hudo boleznijo.
English: Because of the risk of severe allergic reactions, Respreeza must not be used in patients who are lacking IgA, a protein in the blood, and who have developed antibodies against it because these patients are more prone to allergic reactions.
Slovenian: Zaradi tveganja hudih alergijskih reakcij se zdravilo Respreeza ne sme uporabljati pri bolnikih s pomanjkanjem beljakovine v krvi, imenovane IgA, in tistih, pri katerih so se razvila protitelesa proti njej, saj so ti bolniki bolj nagnjeni k alergijskim reakcijam.
English: For practical information about using Respreeza, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Respreeza naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For the full list of all side effects and restrictions with Respreeza, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Respreeza glejte navodilo za uporabo.
English: Lung density is an indicator of the extent of lung damage: the bigger the decrease in lung density, the greater is the damage to the lung.
Slovenian: Pljučna gostota je pokazatelj obsežnosti pljučne poškodbe: večje kot je zmanjšanje pljučne gostote, večja je poškodba pljuč.
English: In the study, Respreeza was compared with placebo (a dummy treatment) and the main measure of effectiveness was the decrease in lung density.
Slovenian: V tej študiji so zdravilo Respreeza primerjali s placebom (zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bilo zmanjšanje pljučne gostote.
English: Respreeza human alpha1-proteinase inhibitor
Slovenian: Respreeza humani zaviralec alfa1-proteinaze
English: Respreeza is available as a powder and solvent to be made into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Respreeza je na voljo v obliki praška in vehikla za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: Respreeza is a medicine used in adults with alpha1-proteinase inhibitor deficiency, an inherited disorder that can cause lung problems such as increasing shortness of breath and which may also affect the liver.
Slovenian: Respreeza je zdravilo, ki se uporablja pri odraslih s pomanjkanjem zaviralca alfa1-proteinaze, tj. dedne motnje, ki lahko povzroči težave s pljuči, kot je slabšajoča kratka sapa, in lahko prizadene tudi jetra.
English: The active substance in Respreeza, human alpha1-proteinase inhibitor, is a natural protein in the blood which protects lung tissue from damage.
Slovenian: Zdravilna učinkovina v zdravilu Respreeza, humani zaviralec alfa1-proteinaze, je naravna beljakovina krvi, ki pljučno tkivo ščiti pred poškodbo.
English: How is Respreeza used?
Slovenian: Kako se zdravilo Respreeza uporablja?
English: The first infusion should be given under the supervision of a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Slovenian: Prvo infundiranje je treba opraviti pod nadzorom zdravstvenega delavca z izkušnjami z zdravljenjem pomanjkanja zaviralca alfa1-proteinaze.
English: It is obtained from human blood and works by replacing the protein that is lacking in patients with alpha1-proteinase inhibitor deficiency.
Slovenian: Pridobiva se iz človeške krvi in deluje tako, da nadomesti beljakovino, ki je bolniki s pomanjkanjem zaviralca alfa1-proteinaze nimajo.
English: Respreeza contains the active substance human alpha1-proteinase inhibitor.
Slovenian: Zdravilo Respreeza vsebuje zdravilno učinkovino humani zaviralec alfa1-proteinaze.
English: The main study with Respreeza showed that the medicine is effective at slowing down the damage to the lungs in patients with alpha1-proteinase inhibitor deficiency, and this effect is considered relevant for patients with severe disease.
Slovenian: Glavna študija zdravila Respreeza je pokazala, da je zdravilo učinkovito pri upočasnitvi poškodbe pljuč pri bolnikih s pomanjkanjem zaviralca alfa1-proteinaze.
English: How does Respreeza work?
Slovenian: Kako zdravilo Respreeza deluje?
English: Respreeza has been shown to slow down lung damage in one main study involving 180 patients with lung damage due to alpha1-proteinase inhibitor deficiency.
Slovenian: V eni glavni študiji, ki je vključila 180 bolnikov s pljučno poškodbo zaradi pomanjkanja zaviralca alfa1-proteinaze, so pokazali, da je zdravilo Respreeza upočasnilo pljučno poškodbo.
English: It must not be used in patients with:
Slovenian: Ne smejo ga uporabljati bolniki z:
English: At the start of the studies, the patients had around 16 incontinence episodes per week.
Slovenian: Na začetku študije so imeli bolniki približno 16 epizod na teden.
English: The main measure of effectiveness was the change in the number of incontinence episodes per week.
Slovenian: Glavno merilo učinkovitosti je bila sprememba števila inkotinenčnih epizod na teden.
English: It blocks a receptor called the ‘muscarinic M3 receptor'.
Slovenian: Zavira receptor, imenovan „muskarinski receptor M3“.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emselex on 22 October 2004.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Emselex, veljavno po vsej Evropski uniji, odobrila dne 22. oktobra 2004.
English: ‘Prolonged-release' means that darifenacin is released slowly from the tablet over a few hours.
Slovenian: „Podaljšano sproščanje“ pomeni, da se darifenacin iz tablet počasi sprošča več ur.
English: EPAR summary for the public darifenacin
Slovenian: Povzetek EPAR za javnost darifenacin
English: After 12 weeks of treatment, patients receiving Emselex 7.5 mg or 15 mg had 8.8 (68%) or 10.6 (77%) fewer episodes of incontinence per week, respectively, and patients receiving placebo had 7 or 7.5 (54 or 58%) fewer episodes per week.
Slovenian: Po 12 tednih zdravljenja so imeli bolniki, ki so prejemali zdravilo Emselex v odmerku 7,5 mg, 8,8 (68 %), bolniki, ki so prejemali 15 mg zdravila, pa 10,6 (77 %) manj inkontinenčnih epizod na teden, medtem ko so bolniki, ki so prejemali placebo imeli 7 oziroma 7,5 (54 oziroma 58 %) manj epizod na teden.
English: The recommended starting dose of Emselex is 7.5 mg once a day.
Slovenian: Priporočeni začetni odmerek zdravila Emselex je 7,5 mg enkrat dnevno.
English: It is used to treat the urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) that are associated with the syndrome.
Slovenian: Uporablja se za zdravljenje urgentne inkontinence (nenadne izgube nadzora nad uriniranjem), povečane pogostosti mokrenja (potrebe po pogostem uriniranju) in urgence (nenadne močne nuje po uriniranju), ki so povezane s sindromom.
English: It is available as prolongedrelease tablets (7.5 mg and 15 mg).
Slovenian: Na voljo je v obliki tablet s prirejenim sproščanjem (7,5 mg in 15 mg).
English: This is a summary of the European public assessment report (EPAR) for Emselex.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Emselex.
English: The Committee decided that Emselex's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor je zaključil, da so koristi zdravila Emselex večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The most common side effects with Emselex (seen in more than 1 patient in 10) are dry mouth and constipation.
Slovenian: Najpogostejša neželena učinka zdravila Emselex (opažena pri več kot 1 od 10 bolnikov) sta suha usta in zaprtje.
English: Other information about Emselex
Slovenian: Druge informacije o zdravilu Emselex
English: Emselex must not be taken by patients who are also taking medicines that could affect the way that Emselex is broken down in the body, such as protease inhibitors (used to treat HIV infection, such as ritonavir), or ketoconazole or itraconazole (used to treat fungal infections).
Slovenian: Zdravila Emselex ne smejo jemati bolniki, ki jemljejo tudi zdravila, ki bi utegnila vplivati na način, na katerega se zdravilo Emselex presnavlja v telesu, kot so zaviralci proteaze (ki se uporabljajo za zdravljenje okužbe z virusom HIV, npr. ritonavir) ali ketokonazol oziroma itrakonazol (ki se uporabljata za zdravljenje glivičnih okužb).
English: Emselex has been studied in four main studies in a total of 2,078 male and female patients with symptoms of overactive bladder.
Slovenian: Zdravilo Emselex je bilo raziskano v štirih glavnih študijah pri skupno 2 078 moških in ženskih bolnikih s simptomi čezmerno aktivnega sečnega mehurja.
English: When the results from all four studies were combined, Emselex was more effective in reducing the number of incontinence episodes than placebo.
Slovenian: Primerjava rezultatov vseh štirih študij je pokazala, da je zdravilo Emselex učinkoviteje zmanjšalo število inkotinenčnih epizod kot placebo.
English: • toxic megacolon (a very serious complication of colitis).
Slovenian: • toksičnim megakolonom (zelo resnim zapletom kolitisa).
English: • urinary retention (difficulty passing urine);
Slovenian: • zastajanjem urina (težavami pri odvajanju urina);
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Emselex.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Emselex, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: • myasthenia gravis (a disease causing muscle weakness);
Slovenian: • miastenijo gravis (boleznijo, ki povzroča šibkost mišic);
English: This helps Emselex to prevent unwanted urination.
Slovenian: Na ta način zdravilo Emselex pomaga preprečiti neželeno mokrenje.
English: • gastric retention (when the stomach does not empty properly);
Slovenian: • zastojem v želodcu (želodec se ne prazni na ustrezen način);
English: What benefit has Emselex shown during the studies?
Slovenian: Kakšne koristi je zdravilo Emselex izkazalo med študijami?
English: • severe ulcerative colitis (severe inflammation of the gut causing ulcers and bleeding);
Slovenian: • hudim ulceroznim kolitisom (hudim vnetjem debelega črevesa, ki povzroča razjede in krvavitve);
English: Emselex must not be used in people who are hypersensitive (allergic) to darifenacin or any of the other ingredients.
Slovenian: Zdravila Emselex ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) darifenacin ali katero koli drugo sestavino zdravila.
English: The CHMP concluded that Emselex showed an effectiveness similar to that of other anticholinergic medicines used in overactive bladder syndrome.
Slovenian: CHMP je sklenil, da je zdravilo Emselex izkazalo podobno učinkovitost kot ostala antiholingerična zdravila, ki se uporabljajo za zdravljenje sindroma čezmerno aktivnega sečnega mehurja.