FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT VeraSeal solutions for sealant human fibrinogen / human thrombin
Slovenian: Navodilo za uporabo VeraSeal raztopine za lepilo za tkiva humani fibrinogen/humani trombin Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Component 1: 2 ml of human fibrinogen (80 mg/ml) Component 2: 2 ml of human thrombin (500 IU/ml)
Slovenian: Komponenta 1: 2 ml humanega fibrinogena (80 mg/ml) Komponenta 2: 2 ml humanega trombina (500 i.e./ml)
English: The use of VeraSeal is restricted to experienced surgeons who have been trained in the use of VeraSeal.
Slovenian: Kako se uporablja zdravilo VeraSeal Zdravilo VeraSeal smejo uporabljati samo izkušeni kirurgi, ki so se izurili za uporabo zdravila
English: Sodium citrate dihydrated Sodium chloride Arginine
Slovenian: Injekcijska brizga s humanim fibrinogenom natrijev citrat dihidrat, natrijev klorid, arginin, izolevcin,
English: Your surgeon must not treat you with VeraSeal
Slovenian: Kaj morate vedeti, preden boste zdravljeni z zdravilom VeraSeal Kirurg vas ne sme zdraviti z zdravilom VeraSeal
English: Calcium chloride Human albumin Sodium chloride Glycine
Slovenian: Injekcijska brizga s humanim trombinom kalcijev klorid,
English: Constipation, flatulence, ileus, retroperitoneal haematoma, vomiting
Slovenian: retroperitonealni hematom, bruhanje občasni
English: Glutamic acid monosodium Water for injections
Slovenian: natrijev klorid, glicin, voda za injekcije.
English: Patients and healthcare professionals are advised of the following:
Slovenian: Bolnikom in zdravstvenim delavcem svetujemo naslednje:
English: 22 May 2015 EMA/324341/2015
Slovenian: 16 July 2015 EMA/466132/2015
English: • Patients should continue to take their medicines as prescribed and contact their doctor or pharmacist if they have any questions.
Slovenian: • Bolniki morajo še naprej jemati svoja zdravila, kot jim je bilo predpisano, in se posvetovati z zdravnikom ali farmacevtom, če imajo kakršna koli vprašanja.
English: For around 300 other pharmaceutical forms and strengths, sufficient supporting data from other sources had been provided; these medicines will therefore remain on the market in the EU.
Slovenian: Za približno 300 drugih farmacevtskih oblik in jakosti so bili predloženi zadostni podporni podatki iz drugih virov; ta zdravila bodo zato ostala na trgu v EU.
English: This is the outcome of a re-examination requested by marketing authorisation holders for seven of the medicines concerned.
Slovenian: To je rezultat ponovne preiskave, ki so jo zahtevali imetniki dovoljenj za promet z zdravilom za sedem zadevnih zdravil.
English: 1 Bivolet (nebivolol) 5 mg tablets (marketing authorisation holder: Neo Balkanika EOOD); the product has now been removed from the list of medicines recommended for suspension.
Slovenian: 1 Bivolet (nebivolol) 5 mg tablete (imetnik dovoljenja za promet z zdravilom: Neo Balkanika EOOD); zdravilo so zdaj odstranili s seznama zdravil, priporočenih za začasni umik.
English: National authorities will decide if some of the medicines recommended for suspension are critical in their countries.
Slovenian: Nacionalni organi bodo odločali, ali so nekatera od zdravil, priporočenih za začasni umik, kritično pomembna v njihovih državah.
English: Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials at the site generally and on the reliability of data generated.
Slovenian: Zaradi sistematskega značaja, dolgega obdobja, ko se je to dogajalo, in števila članov udeleženega osebja sta neoporečnost izvajanja preskušanj v obratu in zanesljivost ustvarjenih podatkov na splošno dvomljivi.
English: • National authorities in the EU will consider how critical individual medicines are in their countries and make final decisions on whether to suspend or allow them to remain available, while new data are generated.
Slovenian: • Nacionalni organi v EU bodo presodili, kako kritično pomembna so posamezna zdravila v njihovih državah, in podali končne odločitve o začasnem umiku ali ohranitvi dovoljenja za promet z zdravilom, medtem ko se bodo ustvarjali novi podatki.
English: Some of these medicines may remain on the market in some countries if they are of critical importance for patients because alternatives cannot meet patients' needs.
Slovenian: Nekatera od teh zdravil lahko ostanejo na trgu v nekaterih državah, če so kritično pomembna za bolnike in če druga zdravila ne morejo zadostiti potrebam bolnikov.
English: The updated list of medicines for which the CHMP recommends suspension is available on the EMA website.
Slovenian: Posodobljen seznam zdravil, za katera je odbor CHMP priporočil začasen umik, je na voljo na spletni strani agencije EMA.
English: This is with the exception of one medicine included in the re-examination for which concerns about studies were addressed.
Slovenian: Izjema je eno zdravilo, vključeno v ponovno preiskavo, v kateri so se obravnavali pomisleke glede študij.
English: This decision will apply to all Member States irrespective of whether or not they have taken interim measures to suspend medicines.
Slovenian: Komisija je izdala svojo odločbo, ki velja za vse države članice, ne glede na to, ali so uvedle vmesne ukrepe za začasen umik zdravil ali ne.
English: EMA and national authorities work closely with international partners to ensure that studies underpinning marketing authorisations in the EU are carried out to the highest standards and that the companies involved comply fully with all aspects of Good Clinical Practice (GCP).
Slovenian: Agencija EMA in nacionalni organi tesno sodelujejo z mednarodnimi partnerji, s čimer zagotavljajo, da se študije, ki podpirajo dovoljenja za promet z zdravilom EU, izvajajo skladno z najvišjimi standardi in da vpletene družbe delujejo skladno z vsemi vidiki dobre klinične prakse (DKP).
English: For medicines that are considered critical, companies are given 12 months to submit additional data.
Slovenian: Za zdravila, ki so kritično pomembna, morajo družbe v 12 mesecih predložiti dodatne podatke.
English: The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years.
Slovenian: Pri inšpekciji so ugotovili prirejanje podatkov elektrokardiogramov (EKG) med izvajanjem nekaterih študij z generičnimi zdravili, kar se je dogajalo v obdobju vsaj petih let.
English: The CHMP's recommendation will now be sent to the European Commission for a legally binding decision.
Slovenian: Priporočilo odbora CHMP so posredovali Evropski komisiji, ki je oblikovala pravno zavezujočo odločbo.
English: During the re-examination, the CHMP concluded that concerns about reliability of the clinical studies remain and therefore maintained its recommendation of January 2015 to suspend medicines for which no supporting data from other studies were available.
Slovenian: Med ponovno preiskavo je odbor CHMP zaključil, da so še vedno prisotni pomisleki glede zanesljivosti kliničnih študij, zato je potrdil svoje priporočilo, podano januarja 2015 glede začasnega umika zdravil, za katera niso na voljo nobeni podporni podatki iz drugih študij.
English: Medicines considered critically important for patients to remain available
Slovenian: Zdravila, kritično pomembna za bolnike, bodo še vedno na voljo
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted in January 2015 an opinion on the marketing authorisation of these medicines.
Slovenian: Pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP), pristojen za vprašanja, povezana z zdravili za uporabo v humani medicini, ki je januarja 2015 sprejel mnenje glede dovoljenj za promet z zdravilom za ta zdravila.
English: Following a request from some marketing authorisation holders, the CHMP re-examined its January 2015 opinion.
Slovenian: Skladno s prošnjo nekaterih imetnikov dovoljenj za promet z zdravilom je odbor CHMP januarja 2015 ponovno pregledal svoje mnenje.
English: The CHMP noted that there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad.
Slovenian: Odbor CHMP je ugotovil, da ni dokazov o škodi ali pomanjkanju učinkovitosti, povezanih z izvajanjem študij družbe GVL Biosciences iz Hyderabada.
English: This medicine is now no longer recommended for suspension.1
Slovenian: To zdravilo je bilo odstranjeno s seznama zdravil, priporočenih za začasni umik.1
English: As a result of the CHMP's January 2015 opinion and the re-examination, around 700 pharmaceutical forms and strengths of medicines studied at the Hyderabad site remain recommended for suspension.
Slovenian: Kot posledica mnenja odbora CHMP, podanega januarja 2015, in ponovne preiskave so priporočili začasen umik približno 700 farmacevtskih oblik in jakosti zdravil, preučevanih v obratu v Hyderabadu.
English: The review covered nationally authorised medicines whose marketing authorisation applications included clinical data from studies conducted by GVK Biosciences at its Hyderabad site.
Slovenian: Pregled je vključil nacionalno odobrena zdravila, katerih vloge za pridobitev dovoljenja za promet z zdravilom so vsebovale klinične podatke iz študij, ki jih je družba GVK Biosciences izvedla v svojem obratu v Hyderabadu.
English: EMA's Committee for Medicinal Products for Human Use (CHMP) had adopted its original recommendation in January 2015 following an inspection of GVK Biosciences' site at Hyderabad by the French medicines agency (ANSM) that raised concerns about how GVK Biosciences conducted studies at the site on behalf of marketing authorisation holders.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila je svoje izvirno priporočilo sprejel januarja 2015 po inšpekcijskem pregledu obrata družbe GVK Biosciences v Hyderabadu, ki ga je opravila Francoska agencija za zdravila (ANSM) in med katerim so se pojavili pomisleki glede načina izvajanja študij družbe GVK Biosciences v obratu v imenu imetnikov dovoljenj za promet z zdravilom.
English: The CHMP has now adopted its final opinion, which will be forwarded to the European Commission, for a legally binding decision applicable in all EU Member States.
Slovenian: Končno mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 16. julija 2015 izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
English: The review was initiated on 25 September 2014 at the request of the European Commission, under Article 31 of Directive 2001/83/EC, in relation to findings by the French medicines agency (ANSM) of non-compliance with Good Clinical Practice (GCP) at the GVK Biosciences' site in Hyderabad, India.
Slovenian: Direktive 2001/83/ES sprožila pregled zaradi ugotovitev Francoske agencije za zdravila (ANSM) glede neupoštevanja dobre klinične prakse (DKP) v obratu družbe GVK Biosciences v Hyderabadu, v Indiji.
English: The European Medicines Agency (EMA) has confirmed its recommendation to suspend a number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India.
Slovenian: Evropska agencija za zdravila (EMA) je 21. maja 2015 potrdila svoje priporočilo glede začasnega umika številnih zdravil, katerih dovoljenja za promet z zdravilom v Evropski uniji (EU) so prvotno temeljila na kliničnih študijah, ki jih je družba GVK Biosciences izvedla v Hyderabadu, Indiji.
English: • Some medicines considered critical for patients will remain on the market in some countries pending the submission of new data.
Slovenian: • Nekatera zdravila, ki so kritično pomembna za bolnike, bodo v nekaterih državah ostala v prometu,
English: The decision on whether a medicine is critical for patients lies with the national authorities of EU Member States depending on the situation in their country.
Slovenian: Za odločitev, ali je zdravilo kritično pomembno za bolnike, so odgovorni nacionalni organi držav članic EU.
English: • There is no evidence of harm or lack of effectiveness with any of the medicines linked to studies conducted by GVK Biosciences.
Slovenian: • Pri nobenih zdravilih, povezanih s študijami, izvedenimi v družbi GVK Biosciences, ni dokazov o škodi ali zmanjšani učinkovitosti.
English: Information to patients and healthcare professionals A number of medicines are being considered for suspension in EU countries following concerns about how studies had been conducted at GVK Biosciences' site in Hyderabad, India.
Slovenian: Ko so se pojavili pomisleki glede izvajanja študij družbe GVK Biosciences v obratu v Hyderabadu, v Indiji, so bila številna zdravila izpostavljena začasnemu umiku v državah EU.
English: Within 2 years after Commission Decision
Slovenian: V dveh letih po sprejetju sklepa Komisije
English: Elderly (age 65 years or over)
Slovenian: Starejši bolniki (starost 65 let in več)
English: Distribution: Volume of distribution is approximately 21 L/kg.
Slovenian: Porazdelitev: Volumen porazdelitve je približno 21 l/kg.
English: 117 Allée des parcs 69800 Saint Priest France
Slovenian: 117 Allée des parcs 69800 Saint Priest Francija
English: Mylan Hungary Kft. Mylan utca 1, Komárom - 2900 Hungary
Slovenian: Mylan Hungary Kft. Mylan utca 1, Komárom - 2900 Madžarska
English: Absolute bioavailability has been calculated as between 64 % and 80 %.
Slovenian: Izračunana absolutna biološka uporabnost je med 64 in 80 %.
English: Package leaflet: Information for the patient
Slovenian: Navodilo za uporabo: Informacije za bolnika
English: 1) Limits for NDMA and NDEA outlined below should be implemented for a transitional period of 2 years:
Slovenian: 1) Spodaj navedene meje za NDMA in NDEA je treba uvesti za dveletno prehodno obdobje:
English: If any of these cause you problems or if they last for more than one week, you should contact your doctor.
Slovenian: Če vam katerikoli od teh povzroča težave ali traja dlje kot 1 teden, pokličite zdravnika.
English: Mean absolute bioavailability is 23 %.
Slovenian: Povprečna absolutna biološka uporabnost je 23 %.
English: Swelling of the tongue and throat which causes great difficulty breathing.
Slovenian: otekanje jezika in grla, ki zelo oteži dihanje.
English: Paediatric population (age below 18 years) No pharmacokinetic data are available in the paediatric population.
Slovenian: Pediatrična populacija (starost manj kot 18 let) Farmakokinetičnih podatkov za pediatrično populacijo ni.
English: if you have severe low blood pressure (hypotension).
Slovenian: imate zelo znižan krvni tlak (hipotenzijo).
English: The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 - 7%, with a maximum of 15%.
Slovenian: Ocenjujejo, da je delež materinega odmerka, ki ga prejme otrok, v interkvartilnem razponu 3-7 %, najvišji delež pa je 15 %.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednih posodobljenih poročil o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh kasnejših posodobitvah objavljenih na evropskem spletnem portalu o zdravilih.
English: In two long-term follow-up studies the effect of amlodipine/valsartan was maintained for over one year.
Slovenian: V dveh dolgoročnih spremljevalnih študijah se je učinek amlodipina/valsartana ohranil več kot eno leto.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Slovenian: Na natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
English: The expiry date refers to the last day of that month.
Slovenian: Rok uporabnosti se izteče na zadnji dan nevedenega meseca.
English: Exceptional cases of extrapyramidal syndrome have been reported.
Slovenian: Izjemoma so poročali o primerih ekstrapiramidnega sindroma.
English: Rare (may affect up to 1 in 1,000 people): Confusion.
Slovenian: Redki (pojavijo se pri največ 1 od 1.000 bolnikov): zmedenost.
English: Mean systemic AUC of valsartan is higher by 70 % in the elderly than in the young, therefore caution is required when increasing the dosage.
Slovenian: Povprečna sistemska AUC valsartana je pri starejših za 70 % večja kot pri mladih, zato je pri večanju odmerka potrebna previdnost.
English: Stevens-Johnson syndrome
Slovenian: Stevens-Johnson sindrom zelo redki
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na zdravilne učinkovine, na dihidropiridinske derivate ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Valsartan is highly bound to serum proteins (94-97 %), mainly serum albumin.
Slovenian: Valsartan je močno vezan na beljakovine v serumu (94-97 %), predvsem na albumin v serumu.
English: Clarithromycin is an inhibitor of CYP3A4.
Slovenian: Klaritromicin je zaviralec CYP3A4.
English: Follow your doctor's instructions for the starting dose carefully.
Slovenian: Natančno upoštevajte navodila zdravnika glede začetnega odmerka.
English: Elimination: Valsartan shows multiexponential decay kinetics (t½α <1 h and t½ß about 9 h).
Slovenian: Izločanje: Valsartan kaže multieksponentno kinetiko upadanja (t½α < 1 uro in t½ß približno 9 ur).
English: Depending on how you respond to the treatment, your doctor may suggest a higher or lower strength.
Slovenian: Glede na vaš odziv na zdravilo vam bo zdravnik nato morda svetoval večjo ali manjšo jakost.
English: Do not stop taking your medicine unless your doctor tells you to.
Slovenian: Ne prenehajte jemati zdravila, če vam tega ni naročil zdravnik.
English: Valsartan is primarily eliminated in faeces (about 83 % of dose) and urine (about 13 % of dose), mainly as unchanged drug.
Slovenian: Valsartan se v prvi vrsti izloči v blato (okrog 83 % odmerka) in urinu (okrog 13 % odmerka), v glavnem v obliki nespremenjenega zdravila.
English: Date of first authorisation: 22 March 2016
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 22. 3. 2016
English: This may involve itching, reddening of the skin or difficulty in breathing.
Slovenian: To lahko vključuje srbenje, pordelost kože ali oteženo dihanje.
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to amlodipine/valsartan.
Slovenian: Starost, spol, rasa ali indeks telesne mase (≥ 30 kg/m2, < 30 kg/m2) niso vplivali na odziv na amlodipin/valsartan.
English: Adverse reactions have been ranked under headings of frequency using 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: Neželeni učinki so razvrščeni po oznakah pogostnosti upoštevaje naslednji dogovor: 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: if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6).
Slovenian: ste alergični na valsartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu za oznako ''EXP''.
English: (calculations assume an oral dose of 320 mg/day and a 60 kg patient).
Slovenian: (izračun predvideva peroralni odmerek 320 mg/dan in 60-kg bolnika).
English: Swelling of eyelids, face or lips.
Slovenian: otekanje očesnih vek, obraza ali ustnic.
English: Patients with hepatic impairment have decreased clearance of amlodipine with resulting increase of approximately 40-60 % in AUC.
Slovenian: Bolniki z okvaro jeter imajo znižan očistek amlodipina; posledica je zvišanje AUC za približno 40-60 %.
English: The safety of amlodipine/valsartan has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Slovenian: Varnost amlodipina/valsartana so ocenjevali v petih kontroliranih kliničnih študijah s 5.175 bolniki, od katerih jih je 2.613 prejemalo valsartan v kombinaciji z amlodipinom.
English: Patients taking amlodipine/valsartan and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur.
Slovenian: Bolniki, ki jemljejo amlodipin/valsartan in vozijo motorna vozila ali uporabljajo stroje, morajo upoštevati, da se lahko občasno pojavita omotica ali utrujenost.
English: Biotransformation: Valsartan is not transformed to a high extent as only about 20 % of dose is recovered as metabolites.
Slovenian: Biotransformacija: Valsartan se ne spremeni v veliki meri, kajti le okrog 20 % odmerka se pojavi v obliki presnovkov.
English: A hydroxy metabolite has been identified in plasma at low concentrations (less than 10 % of the valsartan AUC).
Slovenian: V plazmi so ugotovili majhno koncentracijo hidroksipresnovka (manj kot 10 % AUC valsartana).
English: In vitro studies with amlodipine have shown that approximately 97.5 % of circulating drug is bound to plasma proteins.
Slovenian: Študije amlodipina in vitro so pokazale, da je na beljakovine v plazmi vezanega približno 97,5 % zdravila v obtoku.
English: if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).
Slovenian: imate zoženje aortne zaklopke (aortno stenozo) ali kardiogeni šok (stanje, v katerem srce ne more črpati dovolj močno, da bi oskrbelo telo s krvjo).
English: Your doctor will normally advise you to stop taking Amlodipine/Valsartan Mylan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Amlodipine/Valsartan Mylan.
Slovenian: Zdravnik vam bo praviloma svetoval, da prenehate z jemanjem zdravila Amlodipin/valsartan Mylan še preden zanosite oziroma takoj, ko ugotovite da ste noseči in vam bo svetoval jemanje drugega zdravila namesto zdravila Amlodipin/valsartan Mylan.
English: Following intravenous administration, plasma clearance of valsartan is about 2 L/h and its renal clearance is 0.62 L/h (about 30 % of total clearance).
Slovenian: Po intravenski uporabi je plazemski očistek valsartana okrog 2 l/uro, njegov ledvični očistek pa je 0,62 l/uro (okrog 30 % celotnega očistka).
English: You must tell your doctor if you think you are (or might become) pregnant.
Slovenian: Zdravniku morate povedati, če mislite da ste noseči ali (bi lahko bili noseči).
English: Biotransformation: Amlodipine is extensively (approximately 90 %) metabolised in the liver to inactive metabolites.
Slovenian: Biotransformacija: Amlodipin se v jetrih v veliki meri (približno 90 %) presnovi v neaktivne presnovke.
English: Pack sizes: 28, 56 or 98 film-coated tablets.
Slovenian: Velikosti pakiranj: 28, 56 ali 98 filmsko obloženih tablet.
English: Amlodipine/Valsartan Mylan is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Slovenian: Jemanje zdravila Amlodipin/valsartan Mylan v zgodnjem obdobju nosečnosti (v prvih 3 mesecih) ni priporočljivo, če pa ste noseči več kot 3 mesece, ga ne smete jemati, ker lahko uporaba po tretjem mesecu nosečnosti resno škoduje vašemu nerojenemu otroku.