FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the provisions under Article 107(2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) prepared an opinion on 18 October 2007 recommending the revocation of the Marketing Authorisations for all clobutinol containing medicinal products in Annex I. The CHMP also recommended that temporary measures are needed in view of the potentially life-threatening risk associated with QT prolongation and therefore recommends to the European Commission that the marketing and the use of clobutinol containing medicinal products be suspended forthwith in all concerned EU Member States awaiting the adoption of final measures.
Slovenian: V skladu z določbami člena 107(2) Direktive 2001/83/ES, kakor je bila spremenjena, je Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje v okviru Agencije, 18. oktobra 2007 pripravil mnenje, v katerem je priporočil razveljavitev dovoljenj za promet za vsa zdravila iz Dodatka I, ki vsebujejo klobutinol.
English: Potentially life-threatening torsades de pointes may be caused by QT prolongation.
Slovenian: Koristi/tveganja Podaljšanje intervala QT lahko povzroči potencialno smrtno nevarne „torsades de pointes“.
English: Bottle (HDPE)
Slovenian: Peroralna uporaba Steklenika (HDPE)
English: Capsule, soft
Slovenian: 75mg Kapsula, mehka
English: Oral use
Slovenian: Ovojnina
English: Package size
Slovenian: Vsebina (koncentracija) Velikost pakiranja
English: This summary was last updated in 10-2013.
Slovenian: Povzetek je bil nazadnje posodobljen 10-2013.
English: Its use during the first three months of pregnancy is also not recommended.
Slovenian: Njegova uporaba v prvih treh mesecih nosečnosti prav tako ni priporočljiva.
English: ‘Essential' means that the hypertension has no obvious cause.
Slovenian: Izraz esencialna pomeni, da za hipertenzijo ni jasnega vzroka.
English: Edarbi must not be used in women who are more than three months pregnant.
Slovenian: Zdravila Edarbi ne smejo uporabljati ženske, ki so noseče več kot tri mesece.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Edarbi on 07 December 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Edarbi, veljavno po vsej Evropski uniji, odobrila 7. decembra 2011.
English: What measures are being taken to ensure the safe and effective use of Edarbi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Edarbi?
English: The full EPAR for Edarbi 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 Edarbi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (20, 40 and 80 mg).
Slovenian: Na voljo je v obliki tablet (20 mg, 40 mg in 80 mg).
English: The studies lasted between six and 56 weeks and the main measure of effectiveness was the change in the systolic blood pressure (blood pressure when the heart is contracting).
Slovenian: Študije so trajale od šest do 56 tednov, glavno merilo učinkovitosti pa je bila sprememba sistoličnega krvnega tlaka (krvnega tlaka pri krčenju srca).
English: This allows the blood pressure to fall towards normal, thus reducing the risks associated with high blood pressure, such as having a stroke.
Slovenian: Posledica tega je znižanje krvnega tlaka na normalno raven in s tem zmanjšanje tveganj, povezanih z visokim krvnim tlakom, kot je denimo tveganje kapi.
English: This is a summary of the European public assessment report (EPAR) for Edarbi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Edarbi.
English: A risk management plan has been developed to ensure that Edarbi is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Edarbi je bil pripravljen načrt obvladovanja tveganj.
English: Edarbi is taken by mouth and the usual recommended dose is 40 mg once a day.
Slovenian: Zdravilo Edarbi se jemlje peroralno, običajni priporočeni odmerek pa je 40 mg enkrat na dan.
English: Edarbi is used in adults who have essential hypertension (high blood pressure).
Slovenian: Zdravilo Edarbi se uporablja pri odraslih, ki imajo esencialno hipertenzijo (visok krvni tlak).
English: What benefit has Edarbi shown during the studies?
Slovenian: Kakšne koristi je zdravilo Edarbi izkazalo med študijami?
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 80 mg, or another medicine for hypertension, such as chlortalidone or hydrochlorothiazide, can be added.
Slovenian: Če krvni tlak ni ustrezno uravnan, se lahko odmerek poveča na 80 mg ali pa se doda drugo zdravilo za zdravljenje povišanega krvnega tlaka, na primer klortalidon ali hidroklorotiazid.
English: For more information about treatment with Edarbi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Edarbi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Edarbi
Slovenian: Druge informacije o zdravilu Edarbi:
English: The studies also showed that Edarbi, when taken in combination with other medicines, can produce additional decreases in blood pressure compared with when these medicines are taken without Edarbi.
Slovenian: Študije so tudi pokazale, da lahko zdravilo Edarbi v kombinaciji z drugimi zdravili krvni tlak še dodatno zniža v primerjavi z znižanjem tlaka, ki ga ta zdravila dosežejo brez kombiniranja z njim.
English: The patients in these studies had mild to moderate hypertension.
Slovenian: Bolniki v teh študijah so imeli blago do zmerno hipertenzijo.
English: What is the risk associated with Edarbi?
Slovenian: Kakšna tveganja so povezana z zdravilom Edarbi?
English: Edarbi 40 and 80 mg was also more effective than ramipril (10 mg).
Slovenian: Zdravilo Edarbi v odmerkih 40 mg in 80 mg je bilo učinkovitejše tudi od ramiprila (10 mg).
English: The CHMP concluded that Edarbi belongs to an established class of medicines in the treatment of hypertension and its risks are similar to others within this class.
Slovenian: CHMP je zaključil, da spada zdravilo Edarbi v skupino uveljavljenih zdravil za zdravljenje hipertenzije ter da so njegova tveganja podobna tveganju pri drugih zdravilih v tej skupini.
English: The Committee decided that the benefits of Edarbi are greater than its risks in patients with essential hypertension and recommended that it be given marketing authorisation.
Slovenian: Zaključil je, da so koristi zdravila Edarbi večje od z njim povezanih tveganj pri bolnikih z esencialno hipertenzijo, in priporočil, naj se zanj odobri dovoljenje za promet.
English: Eight main studies involving over 6,000 patients with essential hypertension were carried out with Edarbi.
Slovenian: Z zdravilom Edarbi je bilo izvedenih osem glavnih študij, v katerih je sodelovalo več kot 6 000 bolnikov z esencialno hipertenzijo.
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 Edarbi.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Edarbi, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: EPAR summary for the public
Slovenian: Povzetek EPAR za javnost medoksomilazilsartanat
English: Edarbi on its own was more effective than placebo.
Slovenian: Zdravilo Edarbi je bilo pri samostojni uporabi učinkovitejše od placeba.
English: Side effects with Edarbi are generally mild or moderate, with the most common side effect being dizziness.
Slovenian: Neželeni učinki zdravila Edarbi so na splošno blagi ali zmerni, najpogostejši med njimi pa je omotica.
English: The active substance in Edarbi, azilsartan medoxomil, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Zdravilna učinkovina v zdravilu Edarbi, medoksomilazilsartanat, ki je antagonist receptorjev angiotenzina II, kar pomeni, da v telesu preprečuje delovanje hormona, imenovanega angiotenzin II.
English: Three studies investigated the effects of Edarbi in combination with other antihypertensive medicines (chlortalidone, amlodipine, and hydrochlorothiazide).
Slovenian: V treh študijah so proučevali učinke zdravila Edarbi v kombinaciji z drugim zdravili proti hipertenziji (klortalidonom, amlodipinom in hidroklorotiazidom).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Edarbi, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu z njim so bile v povzetek glavnih značilnosti zdravila Edarbi in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: In the two studies with Edarbi taken alone compared with placebo, patients had an average fall in systolic blood pressure of about 13.5 mmHg on Edarbi 40 mg and a fall of about 14.5 mmHg on Edarbi 80 mg after 6 weeks.
Slovenian: V dveh študijah, v katerih so ga kot samostojno zdravilo primerjali s placebom, se je pri bolnikih, ki so jemali 40-miligramski odmerek zdravila Edarbi, po šestih tednih sistolični krvni tlak v povprečju znižal za okoli 13,5 mmHg, pri bolnikih, ki so jemali 80-miligramski odmerek tega zdravila, pa za okoli 14,5 mmHg.
English: Edarbi is a medicine that contains the active substance azilsartan medoxomil.
Slovenian: Edarbi je zdravilo, ki vsebuje zdravilno učinkovino medoksomilazilsartanat.
English: The patients in the combination studies had moderate to severe hypertension.
Slovenian: Bolniki v študijah z jemanjem kombinacije zdravil so imeli zmerno do hudo hipertenzijo.
English: For the full list of all side effects reported with Edarbi, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Edarbi, glejte navodilo za uporabo.
English: When Edarbi alone was compared with other medicines, 80 mg of Edarbi was more effective in lowering blood pressure than the highest approved dose of valsartan (320 mg) and olmesartan medoxomil (40 mg).
Slovenian: Pri primerjavi samostojne uporabe zdravila Edarbi z drugimi zdravili je bil njegov 80-miligramski odmerek učinkovitejši pri zniževanju krvnega tlaka kot največji odobreni odmerek valsartana (320 mg) in medoksomilolmesartanata (40 mg).
English: Edarbi must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with diabetes or in patients with moderate or severe kidney impairment.
Slovenian: Zdravilo Edarbi se v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), ne sme uporabljati pri bolnikih s sladkorno boleznijo ali zmerno do hudo ledvično okvaro.
English: Why has Edarbi been approved?
Slovenian: Zakaj je bilo zdravilo Edarbi odobreno?
English: By blocking the receptors to which angiotensin II normally attaches, azilsartan medoxomil stops the hormone from having an effect,
Slovenian: Medoksomilazilsartanat z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, zaustavlja delovanje tega hormona, zaradi česar se krvne žile razširijo.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Slovenian: Ta je močan vazokonstriktor (snov, ki zožuje krvne žile).
English: Five studies investigated the effects of Edarbi taken alone, comparing it with placebo (a dummy treatment) or with other antihypertensive medicines (ramipril, valsartan and olmesartan medoxomil).
Slovenian: V petih študijah so proučevali učinke pri samostojni uporabi tega zdravila v primerjavi s placebom (zdravilom brez zdravilne učinkovine) ali z drugimi zdravili proti hipertenziji (ramiprilom, valsartanom in medoksomilolmesartanatom).
English: This compares with a fall of 0.3 to 1.4 mmHg in the patients taking placebo.
Slovenian: Pri bolnikih, ki so jemali placebo, se je v primerjavi s tem krvni tlak znižal za 0,3 do 1,4 mmHg.
English: What is Edarbi used for?
Slovenian: Za kaj se zdravilo Edarbi uporablja?
English: How has Edarbi been studied?
Slovenian: Kako je bilo zdravilo Edarbi raziskano?
English: How does Edarbi work?
Slovenian: Kako zdravilo Edarbi deluje?
English: How is Edarbi used?
Slovenian: Kako se zdravilo Edarbi uporablja?
English: What is Edarbi?
Slovenian: Kaj je zdravilo Edarbi?
English: Consequently, to preserve the efficacy of this drug:
Slovenian: Da bi ohranili učinkovitost tega zdravila:
English: The safety profile is generally consistent among children and adult patients.
Slovenian: Varnostni profil je na splošno konsistenten pri otrocih in odraslih bolnikih.
English: [to be completed nationally]
Slovenian: [Se dopolni na nacionalni ravni]
English: Advice/medical education
Slovenian: Svetovanje/zdravstveno izobraževanje
English: Several genetic elements and multiple mutations are required.
Slovenian: Potrebno je več genskih elementov in mutacij.
English: - your hearing ability, - any other medicines you may be taking.
Slovenian: - vašega sluha - drugih zdravil, ki jih morda jemljete.
English: In addition, appropriate information should be given under Method of administration and in section 6.6.]
Slovenian: Poleg tega je treba dodati ustrezne informacije pod Način uporabe in v poglavju 6.6.]
English: Summary of the Safety profile
Slovenian: Povzetek varnostnega profila
English: Note: The existing package leaflet shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the wording below.
Slovenian: Opomba: obstoječe navodila za uporabo je treba spremeniti (vstaviti, zamenjai ali izbrisati besedilo, kot je ustrezno), da bo odražalo spodnje besedilo.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Podatki o zdravilu so lahko naknadno posodobljeni s strani pristojnih organov držav članic, v dogovoru z referenčno državo članico, v kolikor je to ustrezno, v skladu s postopki, navedenimi v poglavju 4 naslova III Direktive 2001/83/EC.
English: Careful observation of the patient is essential.
Slovenian: Nujno je skrbno spremljanje bolnika.
English: This phenomenon is called resistance: some antibiotic treatments become ineffective.
Slovenian: Ta pojav imenujemo odpornost: nekateri antibioitiki postanejo neučinkoviti.
English: The maximum daily dose should not exceed 2 g.
Slovenian: Največji dnevni odmerek ne sme preseči 2 g.
English: Your doctor will decide how much of this medicine you should receive each day and how long the treatment will last.
Slovenian: Zdravnik vam bo predpisal, koliko zdravila boste dobili vsak dan in kako dolgo bo trajalo zdravljenje.
English: The capsule should not be open and should be taken with plenty of water.
Slovenian: Kapsul ne smemo odpreti in treba jih je vzeti z veliko vode.
English: If your doctor has prescribed antibiotics, you need them precisely for your current illness.
Slovenian: Če vam je zdravnik predpisal antibiotike, jih morate uporabiti izključno za svojo trenutno bolezen.
English: 10 to 21 days
Slovenian: 10 do 21 dni
English: Swallow the capsules whole with water.
Slovenian: Kapsule pogoltnite z vodo.
English: This preparation is for oral use only and is not systemically absorbed.
Slovenian: To zdravilo je samo za peroralno uporabo in se ne absorbira sistemsko.
English: For information about the preparation of the solution, please see section 6.6.
Slovenian: Za informacije o pripravi raztopine glejte poglavje 6.6.
English: Potential for Systemic Absorption
Slovenian: Potencial za sistemsko absorpcijo
English: Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist.
Slovenian: Za otroke so morda primernejše druge oblike tega zdravila; posvetujte se z zdravnikom ali farmacevtom.
English: The length of treatment depends on the infection you have and may last a number of weeks.
Slovenian: Trajanje zdravljenja je odvisno od vrste okužbe, ki jo imate, in lahko traja več tednov.
English: Biliary excretion is insignificant (less than 5% of a dose).
Slovenian: Izločanje z žolčem je zanemarljivo (manj kot 5 % odmerka).
English: Your doctor, or nurse, will always give vancomycin into your blood and not in the muscle.
Slovenian: Zdravnik ali sestra vam bosta vankomicin vedno dala v kri, ne v mišico.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Slovenian: Nasvet strokovnjaka je nujno potreben, če je lokalna prevalenca odpornosti tolikšna, da je koristnost uporabe učinkovine pri vsaj nekaterih vrstah okužb vprašljiva.
English: Adults and children
Slovenian: Odrasli in otroci
English: Intravenous infusion means that the medicinal product flows from an infusion bottle or bag through a tube to one of your blood vessels and into your body.
Slovenian: Intravenska infuzija pomeni, da zdravilo teče iz steklenice ali vrečke po cevki v eno vaših krvnih žil in v vaše telo.
English: Suggested treatment duration is shown in table below.
Slovenian: Trajanje zdravljenja je prikazano v spodnji preglednici.
English: Vancomycin concentration generally increases proportionally with increasing dose.
Slovenian: Koncentracija vankomicina običajno narašča sorazmerno s povečanjem odmerka.
English: Subsequently, optimal dose should be calculated in line with dosing recommendations provided in section 4.2.
Slovenian: Posledično je treba izračunati optimalni odmerek v skladu s priporočili za odmerjanje zdravila, navedenimi v poglavju 4.2.
English: In any case, the duration of treatment should be tailored to the type and severity of infection and the individual clinical response.
Slovenian: V vsakem primeru je treba trajanje zdravljenja prilagoditi vrsti in resnosti okužbe in kliničnemu odzivu posameznika.
English: Despite antibiotics, some bacteria may survive or grow.
Slovenian: Navkljub jemanju antibiotikov lahko nekatere bakterije preživijo ali se namnožijo.
English: They are ineffective against viral infections.
Slovenian: Pri virusnih okužbah so neučinkoviti.
English: 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: Pogostosti pojavljanja so: 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 pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Whenever possible the antibacterial suspected to have caused CDI should be discontinued.
Slovenian: Kadarkoli je mogoče, je uporabo antibiotika, za katerega se sumi, da je povzročil CDI, treba prekiniti.
English: Contents of the pack and other information Other sources of information
Slovenian: Vsebina pakiranja in dodatne informacije Drugi viri informacij
English: The volume of distribution is about 60 L/1.73 m2 body surface.
Slovenian: Volumen porazdelitve je približno 60 l/1,73 m2 telesne površine.
English: Acute bacterial meningitis (For parenteral formulations authorised for Acute bacterial meningitis)
Slovenian: Akutni bakterijski meningitis (za parenteralna zdravila, odobrena za akutni bakterijski meningitis)
English: During the treatment, you might have blood tests, be asked to provide urine samples and possibly have hearing tests to look for signs of possible side effects.
Slovenian: Med zdravljenjem boste morda imeli krvne preiskave, lahko vas prosijo, da prinesete vzorce urina in morda boste opravili preizkuse sluha, da bi ugotovili morebitne neželene učinke.
English: The emergence of resistance towards vancomycin differs from one hospital to another and a local microbiological laboratory should therefore be contacted for relevant local information.
Slovenian: Pojav odpornosti na vankomicin se razlikuje od bolnišnice do bolnišnice, zato se je treba obrniti na krajevni mikrobiološki laboratorij za relevantne informacije.
English: Capsules
Slovenian: Kapsule
English: 7 to 14 days
Slovenian: 7 do 14 dni
English: In the first 24 hours, approximately 80 % of an administered dose of vancomycin is excreted in the urine through glomerular filtration.
Slovenian: V prvih 24 urah se približno 80 % odmerka vankomicina izloči z urinom skozi glomerulno filtracijo.
English: Half-life varies between 3.5 and 10 h and is longer than in adults, reflecting the usual lower values for clearance in the neonate.
Slovenian: Razpolovni čas je med 3,5 do 10 ur in je daljši kot pri odraslih, kar se običajno odraža v nižjih vrednostih očistka pri novorojenčkih.
English: Infective endocarditis
Slovenian: Infekcijski endokarditis
English: 5 - After completion of treatment, return all unused drugs to your chemist's shop to ensure they will be disposed of correctly.
Slovenian: 5 - po končanem zdravljenju vsa neuporabljena zdravila vrnite v lekarno, ker jih bodo primerno zavrgli.
English: Gram positive anaerobes
Slovenian: Po Gramu pozitivni anaerobi
English: In anephric patients, the mean half-life is 7.5 days.
Slovenian: Pri ledvičnih bolnikih je povprečni razpolovni čas 7,5 dni.
English: The elderly are particularly susceptible to auditory damage.
Slovenian: Starejši so še posebej dovzetni za poškodbe sluha.
English: You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate: - dosage - schedules - duration of treatment
Slovenian: K odpornosti bakterij lahko prispevate in s tem podaljšate čas svojega zdravljenja zaradi zmanjšanja učinkovitosti antibiotikov, če ne upoštevate: - odmerka - razporeda jemanja zdravila - trajanja zdravljenja
English: Superinfection
Slovenian: Superokužba
English: 3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
Slovenian: 3 - ne začnite ponovno jemati antibiotikov, če vam jih ne predpiše zdravnik, tudi če želite zdraviti podobno bolezen
English: Specimens for bacterial cultures should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to vancomycin.
Slovenian: Treba je pridobiti vzorce bakterijskih kultur, da bi izolirali in določili mikroorganizme povzročitelje ter opredelili njihovo občutljivost na vankomicin.
English: Experience with other antibiotics suggests that deafness may be progressive despite cessation of treatment.
Slovenian: Izkušnje z drugimi antibiotiki kažejo, da se lahko sluh še naprej slabša kljub prekinitvi terapije.
English: The elderly, pregnant women and patients with a kidney disorder, including those on dialysis, may need a different dose.
Slovenian: Starejši, nosečnice in bolniki z motnjo v delovanju ledvic, tudi tisti na dializi, bodo morda potrebovali drugačne odmerke.
English: This information only provides approximate guidance on the chance whether micro-organisms are susceptible to vancomycin.
Slovenian: Ti podatki so le približno vodilo o tem, ali so mikroorganizmi občutljivi na vankomicin.
English: The adverse reactions listed below are defined using the following MedDRA convention and system organ class database:
Slovenian: Spodaj navedeni neželeni učinki so opredeljeni v skladu z naslednjo konvencijo MedDRA in bazo podatkov razredov organskih sistemov.
English: However, the safety of increased vancomycin dosing has not been properly assessed and higher doses than 60 mg/kg/day cannot be generally recommended.
Slovenian: Vendar pa primerna ocena o varnosti pri večjem odmerjanju še ni bila opravljena, zato odmerkov, večjih od 60 mg/kg/dan, ni mogoče splošno priporočiti.