FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted that the study site had been satisfactorily inspected and that the study was performed according to GCP guidelines.
Slovenian: CHMP je ugotovil, da je bilo mesto študije zadovoljivo pregledano in da je bila študija izpeljana v skladu s smernicami dobre klinične prakse.
English: Treatment phases were separated by a washout period of 21 days and subjects were administered a single oral dose as a 1 x 10 mg tablet and blood sampling was carried out prior to dosing (0) and at regular intervals post-dose.
Slovenian: Faze zdravljenja so bile prekinjene z obdobji izpiranja po 21 dni, osebe pa so prejele enojni peroralni odmerek v obliki 1 x 10 mg tablete, pred dajanjem odmerka (0) in ob rednih intervalih po odmerku pa so jim odvzeli vzorec krvi.
English: Loratadine and descarboethoxyloratadine concentrations in plasma were determined by s liquid chromatography assay with MS-MS detection.
Slovenian: Koncentracije loratadina in deskarboetoksiloratadina v plazmi so določili s tekočinsko kromatografijo z MS/MS detekcijo.
English: The samples were handled adequately and plausible reasons were presented for analysis repetition.
Slovenian: Z vzorci se je primerno ravnalo, za ponovitev analize pa so bili predstavljeni utemeljeni razlogi.
English: In the clinical setting, loratadine has been used for over 10 years in the treatment of allergic disorders such as conjunctivitis, atopic dermatitis, urticaria, asthma, and anaphylaxis.
Slovenian: Klinično se loratadin uporablja že več kot 10 let pri zdravljenju alergijskih obolenj, kot so konjunktivitis, atopični dermatitis, urtikarija, astma in anafilaksa.
English: The Applicant decided to perform a new BE study and submitted the full details of a single centre, randomised, single-dose, open-label, laboratory blinded 2-way crossover bioequivalence study comparing the rate and extent of absorption of Loratadine Sandoz 10 mg tablets versus the reference loratadine (Clarityne by ScheringPlough) under fasting conditions (Study SZ190/08).
Slovenian: Predlagatelj je sklenil izvesti novo študijo bioekvivalence in je predložil vse podrobnosti enocentrične, randomizirane, laboratorijske, slepe, dvosmerne, navzkrižne bioekvivalenčne študije enega odmerka in odprtega zdravljenja, v kateri so primerjali hitrost in obseg absorpcije zdravila Loratadine Sandoz 10 mg tablete z referenčnim loratadinom (zdravilom Clarityne družbe Schering-Plough) v teščem stanju (študija SZ190/08).
English: According to the current applicable guidelines, bioequivalence must be demonstrated for the parent compound for generic products.
Slovenian: V skladu s trenutno veljavnimi smernicami mora biti za generična zdravila bioekvivalenca dokazana za matično spojino.
English: Therefore, the products cannot be considered bioequivalent and the CHMP concluded that the benefit-risk of Loratadine Sandoz 10 is negative.
Slovenian: Zato zdravili ne moreta veljati kot bioekvivaletni, CHMP pa je zaključil, da je razmerje med koristmi in tveganji za zdravilo Loratadine Sandoz 10 negativno.
English: The CHMP concluded that the bioequivalence between Loratadine Sandoz 10 and the reference product was not sufficiently demonstrated and adopted a List of Outstanding Issues, requesting the Applicant to further substantiate bioequivalence.
Slovenian: CHMP je zaključil, da bioekvivalenca med zdravili Loratadine Sandoz 10 in referenčnim zdravilom ni bila zadostno dokazana in je sprejel seznam nerešenih vprašanj, v katerem poziva predlagatelja, naj dodatno podkrepi bioekvivalenco.
English: PRT Alameda da Beloura, Edifício 1, 2º - Escritório 15 2710-693 Sintra
Slovenian: PRT Alameda da Beloura, Edifício 1, 2º - Escritório 15
English: Loratadine is an antagonist of histamine at H1 receptor sites (competitive, reversible) leading to the relief of allergic symptoms.
Slovenian: Loratadin je (kompetitivni, reverzibilni) zaviralec histamina na mestih receptorjev H1, kar vodi v olajšanje simptomov alergije.
English: The study was considered acceptable for the estimation of PK parameters and properly designed in terms of wash-out, sampling periods and drug intake procedures.
Slovenian: Študija velja kot sprejemljiva za oceno farmakokinetičnih parametrov in primerno zasnovana v smislu obdobja izpiranja in vzorčenja ter postopkov vnosa zdravila.
English: the benefit-risk of the generic Loratadine Sandoz 10 is therefore considered to be negative,
Slovenian: razmerje med koristmi in tveganji za generično zdravilo Loratadine Sandoz 10 je zato negativno,
English: Loratadine Sandoz 10 is used for the long term treatment of allergies and both parent compound and metabolite contribute to the clinical efficacy.
Slovenian: Zdravilo Loratadine Sandoz 10 se uporablja za dolgotrajno zdravljenje alergij, h klinični učinkovitosti pa pripomoreta tako matična spojina kot tudi metabolit.
English: The sought indications for Loratadine Sandoz 10 were the relief of symptoms associated with seasonal and perennial allergic rhinitis and the treatment of the symptoms of chronic urticaria.
Slovenian: Indikacije za zdravilo Loratadine Sandoz 10, za katere je bila predložena vloga, so bile olajšanje simptomov, povezanih s sezonskim in celoletnim alergijskim rinitisom in zdravljenje simptomov kronične urtikarije.
English: While bioequivalence between Loratadine Sandoz 10 and the reference product was shown for the active metabolite, bioequivalence with regards to the parent compound was not demonstrated.
Slovenian: Medtem ko je bila bioekvivalenca med zdravilom Loratadine Sandoz 10 in referenčnim zdravilom dokazana za aktivni metabolit, pa bioekvivalenca z ozirom na matično spojino ni bila dokazana.
English: - bioequivalence between Loratadine Sandoz 10 and the reference product was not demonstrated for the parent compound,
Slovenian: - bioekvivalenca med zdravilom Loratadine Sandoz 10 in referenčnim zdravilom ni bila dokazana za matično spojino,
English: the CHMP has recommended the refusal of the granting of the Marketing Authorisations in the Concerned Member States and the suspension of the Marketing Authorisation in the Member States where the product is currently authorised, for Loratadine Sandoz 10 and associated names (see Annex I).
Slovenian: CHMP je za zdravilo Loratadine Sandoz 10 in z njim povezana imena (glejte Dodatek I) priporočil zavrnitev odobritve dovoljenja za promet z zdravilom v zadevnih državah članicah ter umik dovoljenja za promet z zdravilom v državah članicah, v katerih je zdravilo trenutno odobreno.
English: The calculated 90% CI for AUC0-t, AUCinf and Cmax for the metabolite descarboethoxyloratadine were within the 0.80- 1.25 acceptance range, but bioequivalence for loratadine tablets should also be based on parent compound data and because the 90% CI for Cmax and AUC of the parent compound were outside the standard 0.80 - 1.25 acceptance criterion, the objecting concerned member states considered that bioequivalence between Loratadine Sandoz 10 and the reference product could not be established.
Slovenian: Izračunani 90 % interval zaupanja za AUC0-t, AUCinf in Cmax za metabolit deskarboetoksiloratadin so bili znotraj razpona sprejemljivosti 0,80-1,25, vendar bi morala bioekvivalenca za tablete loratadina prav tako temeljiti na podatkih matičnih spojin.
English: LORATADINE 10 MG TABLETS10 mg Tablet
Slovenian: LORATADINE 10 mg TABLETS 10 mg Tableta
English: United Kingdom Sandoz Limited Woolmer way
Slovenian: Sandoz Limited Woolmer way Bordon, Hants, GU35 9 QE Velika Britanija
English: Loratadin Sandoz 10 mg tablety 10 mg Tablet
Slovenian: Loratadin Sandoz 10 mg tablety 10 mg Tableta
English: LORATADIN SANDOZ 10 MG 10 mg Tablet
Slovenian: LORATADIN SANDOZ 10 mg 10 mg Tableta
English: Prevalence %
Slovenian: Prevalenca %
English: African/Ethiopian African American
Slovenian: Afriška/Etiopska Afroameriška
English: Hungarian Northern European
Slovenian: Madžarska Severnoevropska
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Slovenian: To omogoča neprestano spremljanje razmerja koristi/tveganja zdravila.
English: “Children with compromised respiratory function
Slovenian: " Otroci z ogroženo respiratorno funkcijo
English: Estimates indicate that up to 7% of the Caucasian population may have this deficiency.
Slovenian: Ocenjujejo, da ima do 7 % kavkazijske populacije pomanjaknje omenjenega encima.
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: Informacije o zdravilu se lahko naknadno posodobijo s strani pristojnih organov držav članic, v povezavi z referenčno državo članico, kot je ustrezno, in v skladu s postopki določenimi v Poglavju 4 Naslova III Direktive 2001/83/ES .
English: By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: S poročanjem neželenih učinkov pomagate zagotoviti več informacij o varnosti tega zdravila.
English: These factors may worsen symptoms of morphine toxicity.”
Slovenian: Vsi ti dejavniki lahko poslabšajo simptome morfinske toksičnosti. "
English: “Paediatric population:
Slovenian: "Pediatrična populacija:
English: Some people have a variation of this enzyme and this can affect people in different ways.
Slovenian: Nekateri ljudje imajo spremenjen encim, kar lahko vpliva na ljudi na različne načine.
English: Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:
Slovenian: Ocene prevalenc zelo hitrih presnavljalcev različnih populacij so povzete spodaj:
English: “CYP2D6 metabolism
Slovenian: CYP2D6 metabolizem
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim <zdravnikom> <ali> <,> <farmacevtom> <ali medicinsko sestro>.
English: Annex III Amendments to relevant sections of the product information
Slovenian: Priloga III Dopolnitve ustreznih poglavij informacij o zdravilu
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Slovenian: Poročanje o domnevnih neželenih učinkih po registraciji zdravila je pomembno.
English: Codeine and morphine passes into breast milk.”
Slovenian: Kodein in morfin prehajata v materino mleko . "
English: Section 4.8 Undesirable effects
Slovenian: Poglavje 4.8 - Neželeni učinki
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Slovenian: Zdravstvene delavce se poziva, da poročajo o vseh domnevnih neželenih učinkih preko nacionalnega sistema poročanja, navedenega v Prilogi V *.
English: Greek
Slovenian: Grška
English: In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal.
Slovenian: V hudih primerih se lahko pojavi respiratorna in cirkulatorna depresija, ki je lahko življensko ogrožujoča in zelo redko smrtna.
English: Asian
Slovenian: Azijska
English: These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.
Slovenian: Ti bolniki hitro presnavljajo kodein v morfin, zaradi česa so serumske koncentracije morfina višje kot pričakovano.
English: Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
Slovenian: Kodein ni priporočljiv za uporabo pri otrocih, pri katerih je lahko ogrožena respiratorna funkcija, vključno z neuromuskulatornimi obolenji, hudimi kardiološkimi ali respiratornimi stanji, infekcijami zgornjega respiratornega trakta ali pljuč, večkratnimi poškodbami ali obsežnimi kirurškimi posegi.
English: • “In children below the age of 12 years due to an increased risk of developing serious and lifethreatening adverse reactions.
Slovenian: • "Pri otrocih, mlajših od 12 let, zaradi povečanega tveganja za razvoj resnih in smrtno nevarnih neželenih učinkov.
English: Morphine is the substance that produces the effects of codeine.
Slovenian: Morfin je snov, ki povzroča učinke kodeina.
English: PACKAGE LEAFLET (PL) [The following wording should be included in the package leaflet of the marketing authorisations:]
Slovenian: Navodilo za uporabo (PL) [Naslednje besedilo je potrebno vključiti v Navodilo za uporabo od dovoljenja za promet z zdravilom:]
English: Section 4 - Possible side effects
Slovenian: Poglavje 4 - Možni neželeni učinki
English: “Reporting of suspected adverse reactions
Slovenian: "Poročanje o domnevnih neželenih učinkih
English: These amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are the outcome of the referral procedure.
Slovenian: Dopolnitve ustreznih poglavij Povzetka glavnih značilnosti zdravila in Navodila za uporabo so rezultat napotitvnega postopka.
English: If a patient has a deficiency or is completely lacking this enzyme an adequate therapeutic effect will not be obtained.
Slovenian: Če ima bolnik pomanjkanje ali odsotnost jetrnega encima, se terapevtski učinek zdravila ne doseže.
English: At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.
Slovenian: Pri normalnih terapevtskih odmerkih sta kodein in njegov aktivni presnovek lahko prisotna v materinem mleku v zelo nizkih odmerkih, zaradi česa je malo verjetno, da bo prišlo do neželenih učinkov na dojenem otroku.
English: Caucasian
Slovenian: Kavkazijska
English: • “In women during breastfeeding (see section 4.6)”
Slovenian: • » Pri ženskah, ki dojijo (glejte poglavje 4.6)"
English: Morphine is the substance that produces the effects of codeine and relieves pain and symptoms of cough.
Slovenian: Morfin je snov, ki povzroča učinke kodeina in lajša bolečino ter simptome kašlja.
English: However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses.
Slovenian: V primeru, če ima bolnik obsežno ali zelo hitro presnovo, pa obstaja povečano tveganje za ravoj neželenih učinkov, povezanih z opioidno zastrupitvijo, že ob občajno predpisanih odmerkih.
English: If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
Slovenian: Če opazite katerega od naslednjih neželenih učinkov, morate prenehati jemati zdravilo in nemudoma poiskati zdravniško pomoč: počasno ali plitko dihanje, zmedenost, zaspanost, mioza, občutek slabosti ali bruhanje, zaprtje, pomanjkanje apetita.»
English: General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite.
Slovenian: Glavni simptomi zastupitve z opiodi vključujejo zmedenost, somnolenco, plitko dihanje, miozo, slabost, bruhanje, zaprtje in pomanjkanje apetita.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu za uporabo.
English: SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Slovenian: Povzetek glavnih značilnosti zdravila (SmPC) [Za vsa zdravila iz Priloge I se obstoječi podatki spremenijo (vstavijo, zamenjajo ali črtajo, kakor je ustrezno), da vsebujejo besedilo, določeno v nadaljevanju] Poglavje 4.2 - Odmerjanje in način uporabe [Opomba: Pri zdravilih, registriranih samo za uporabo pri kašlju in/ali prehladu:]
English: However, if the patient is an ultrarapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.”
Slovenian: Če pa ima bolnica zelo hitro presnovo z encimom CYP2D6, se lahko pojavijo povišane koncentracije aktivnega presnovka morfina v materinem mleku, kar v zelo redkih primerih lahko povzroči simptome opiodne zastrupitve pri dojenčku, ki je lahko smrtna.
English: “Do not take <codeine><Product name (if a combination product)> while you are breastfeeding.
Slovenian: "Ne jemljite "<Kodein><ime zdravila (če je kombinacija zdravilnih učinkovin)>, ko dojite.
English: Other people are more likely to get serious side effects because a very high amount of morphine is produced.
Slovenian: Pri drugih ljudeh pa se lahko pojavijo resni neželeni učinki, ker se jim veliko kodeina pretvori v morfin.
English: • “In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers”
Slovenian: • »Pri bolnikih, za katere je znano, da imajo zelo hiter metabolizem z encimom CYP2D6«
English: “Codeine is transformed to morphine in the liver by an enzyme.
Slovenian: " Kodein se pretvarja v jetrih z encimom v morfin.
English: “Reporting of side effects
Slovenian: " Poročanje o neželenih učinkih
English: [Note: For products authorised in the cough and/or cold and pain indications:]
Slovenian: [Opomba: Pri zdravilih, registriranih za uporabo pri kašlju in/ali prehladu in pri lajšanju bolečine:]
English: Section 4.3 - Contraindications [Note: For products authorised in the cough and/or cold indication only:]
Slovenian: Poglavje 4.3 - Kontraindikacije [Opomba: Pri zdravilih registriranih samo za uporabo pri kašlju in/ali prehladu:]
English: Do not <take> <use> <product name>: “If you are under 12 years old” “If you know that you metabolise very rapidly codeine into morphine” “If you are breastfeeding”
Slovenian: Poglavje 2 - Kaj morate vedeti, preden boste <vzeli> <uporabili> <ime zdravila > Ne <jemljite> <uporabite> zdravila <ime zdravila >: "Če ste mlajši od 12 let" "Če veste, da se vam kodein zelo hitro presnavlja v morfin" "Če dojite"
English: Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite.
Slovenian: Jetrni encim CYP2D6 presnavlja kodein v aktivni presnovek morfin.
English: “<Codeine><Product name (if a combination product)> is contraindicated in women during breastfeeding (see section 4.3).
Slovenian: "<Kodein><ime zdravila (če je kombinacija zdravilnih učinkovin)> je kontraindiciran za uporabo pri doječih ženskah (glejte poglavje 4.3).
English: In some people, morphine is not produced or produced in very small quantities, and it will not have an effect on their cough symptoms.
Slovenian: Pri nekaterih ljudeh se kodein ne pretvarja v morfin ali se pretvori v zelo majhnih količinah, kar ne zadošča za učinek na simptome kašlja.
English: In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief or relieve their cough.
Slovenian: Pri nekaterih ljudeh se kodein ne pretvarja v morfin ali se pretvori v zelo majhnih količinah, kar ne zadošča za učinek lajšanja bolečine ali na simptome kašlja.
English: Children aged less than 12 years: <Codeine><product name (if a combination products)> is contraindicated in children below the age of 12 years (see sections 4.3).
Slovenian: Otroci, stari manj kot 12 let: <Kodein><ime zdravila (če je kombinacija zdravilnih učinkovin)> je kontraindiciran za uporabo pri otrocih, mlajših od 12 let (glejte poglavje 4.3).
English: Children aged 12 years to 18 years <Codeine><Product name (if a combination product)> is not recommended for use in children aged 12 years to 18 years with compromised respiratory function for the symptomatic treatment of <cough><and/or><cold>1 (see section 4.4).”
Slovenian: Otroci, stari od 12 let do 18 let <Kodein><ime zdravila (če je kombinacija zdravilnih učinkovin)> ni priporočljiv za simptomatsko zdravljenje <kašlja> in/ali <prehlada>1 pri otrocih, starih od 12 let do 18 let, pri katerih je ogrožena respiratorna funkcija (glejte poglavje 4.4). "
English: <cough><and/or><cold>1 due to an increased risk of developing serious and life-threatening adverse reactions.
Slovenian: • " Pri otrocih, mlajših od 12 let, za simptomatsko zdravljenje <kašlja> <in/ali> <prehlada>1, zaradi povečanega tveganja za razvoj resnih in smrtno nevarnih neželenih učinkov.
English: Warnings and precautions [Note: For products authorised in the cough and/or cold indication only:]
Slovenian: [Opomba: Pri zdravilih, registriranih samo za uporabo pri kašlju in/ali prehladu:]
English: • “In women during breastfeeding (see section 4.6)” • “In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers”
Slovenian: • »Pri bolnikih, za katere je znano, da imajo zelo hitro presnovo z encimom CYP2D6«
English: Adolescents older than 12 years of age <Codeine><Product name (if a combination product)> is not recommended in adolescents with compromised respiratory function for the treatment of <cough><and/or><cold>1.
Slovenian: "<Kodein><ime zdravila (če je kombinacija zdravilnih učinkovin)> ni priporočljiv za za zdravljenje <kašlja> <in/ali> <prehlada>1 pri mladostnikih, pri katerih je ogroženo delovanje dihal.
English: • “In children below the age of 12 years for the symptomatic treatment of
Slovenian: Mladostniki, starejši od 12 let
English: In some cases the bleeding may not be obvious.
Slovenian: V nekaterih primerih te krvavitve niso očitne.
English: • Drug Utilisation and Outcome Studies in the UK, Germany, The Netherlands and Sweden
Slovenian: • Študije o uporabi in izsledkih zdravljenja v Združenem kraljestvu, Nemčiji, na Nizozemskem in Švedskem
English: Date of first authorisation: 30 September 2008 Date of latest renewal: 22 May 2018
Slovenian: Datum prve odobritve: 30. september 2008 Datum zadnjega podaljšanja: 22. maj 2018
English: Number of patients*
Slovenian: Število bolnikov*
English: The primary objective of PIONEER AF-PCI was to assess safety.
Slovenian: Primarni cilj študije PIONEER AF-PCI je bila ocena varnosti.
English: In case of emergency, please notify:
Slovenian: V nujnem primeru obvestite:
English: The Prescriber Guide should contain the following key safety messages:
Slovenian: Vodnik za predpisovanje mora vsebovati naslednja ključna sporočila o varnosti:
English: To be taken with food.
Slovenian: Jemanje skupaj s hrano.
English: • Interim analyses reports provided annually beginning Q4 2015 until completion of the study programme.
Slovenian: • Letna predložitev vmesnih poročil od začetka 4. četrtletja 2015 vse do zaključka programa študij.
English: Please also notify:
Slovenian: Obvestite tudi:
English: Data on efficacy (including thromboembolic events) in this population are limited.
Slovenian: Podatki o učinkovitosti (vključno s pojavom trombemboličnih dogodkov) pri tej populaciji so omejeni.
English: There is not enough information on its use in children and adolescents.
Slovenian: Na voljo ni dovolj podatkov o uporabi zdravila pri otrocih in mladostnikih.
English: SSRIs/SNRIs
Slovenian: SSRI/SNRI
English: Your doctor will decide how long you must continue treatment.
Slovenian: Zdravnik bo odločil, kako dolgo morate nadaljevati z zdravljenjem.
English: p-value b)
Slovenian: p-vrednost b)
English: DAY 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
Slovenian: 1. teden, 2. teden, 3. teden dan 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
English: You should not drive or use machines if you are affected by these symptoms.
Slovenian: Ne vozite in ne upravljajte strojev, če se vam pojavijo ti simptomi.
English: Excessive bleeding may lead to a sudden drop in blood pressure (shock).
Slovenian: Obsežna krvavitev lahko povzroči nenadno znižanje krvnega tlaka (šok).
English: The overall median study treatment duration was 504 days.
Slovenian: Celotna mediana trajanja študije je bila 504 dni.
English: Time period
Slovenian: Časovno obdobje
English: However, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.
Slovenian: Natančen čas, ko je dosežen zadosti majhen antikoagulacijski učinek pri posameznem bolniku, ni znan.