FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to take a dose of Clopidogrel BGR, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Slovenian: Če ste pozabili vzeti zdravilo Clopidogrel BGR Če ste pozabili vzeti odmerek in od tega ni minilo več kot 12 ur, ga vzemite takoj, ko se spomnite.
English: For bottle 30 film-coated tablets: EU/1/09/558/011
Slovenian: Za vsebnik 30 filmsko obloženih tablet: EU/1/09/558/011
English: Fertility Clopidogrel was not shown to alter fertility in animal studies.
Slovenian: Plodnost Študije na živalih niso pokazale, da bi klopidogrel vplival na plodnost.
English: How to take Clopidogrel BGR
Slovenian: Kako jemati zdravilo Clopidogrel BGR
English: For blister Store in the original package in order to protect from moisture and light.
Slovenian: Za pretisni omot Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago in svetlobo.
English: Clopidogrel BGR is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Slovenian: Zdravilo Clopidogrel BGR jemljejo odrasli za preprečevanje nastanka krvnih strdkov (trombov) v otrdelih krvnih žilah (arterijah).
English: Blister Store in the original package in order to protect from moisture and light.
Slovenian: Pretisni omot Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago in svetobo.
English: Do not stop the treatment unless your doctor tells you so.
Slovenian: Če ste prenehali jemati zdravilo Clopidogrel BGR Ne prekinite zdravljenja razen, če tako odloči zdravnik.
English: How to take Clopidogrel BGR 4.
Slovenian: Shranjevanje zdravila Clopidogrel BGR 6.
English: Secondary prevention of atherothrombotic events
Slovenian: Sekundarno preprečevanje aterotrombotičnih dogodkov Klopidogrel je indiciran pri:
English: CARTON/for blisters and bottle
Slovenian: ŠKATLA/za pretisne omote in vsebnik
English: For bottle
Slovenian: Za pretisni omot
English: - signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions').
Slovenian: Pri manjših vrezninah ali poškodbah, npr. če se urežete ali brijete, navadno ni razloga za skrb, če pa ste glede krvavitve v kakršnihkoli dvomih, se morate takoj posvetovati s svojim zdravnikom, (glejte poglavje 2 "Opozorila in previdnostni ukrepi").
English: - swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
Slovenian: "Opozorila in previdnostni ukrepi"); - otekanje ust ali bolezni kože, kot so izpuščaj, srbenje in mehurji na koži, kar so lahko znaki - alergijske reakcije.
English: Do not take Clopidogrel BGR
Slovenian: Shranjevanje zdravila Clopidogrel BGR
English: 23 May 2011
Slovenian: 23. maj 2011
English: The European Commission issued a decision on this opinion on 23 May 2011.
Slovenian: Evropska komisija je odločbo v zvezi s tem mnenjem izdala dne 23. maja 2011.
English: It is authorised in Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom.
Slovenian: Odobreno je v Avstriji, Belgiji, Bolgariji, na Cipru, Češkem, Danskem, v Estoniji, na Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Islandiji, v Italiji, Latviji, Litvi, Luksemburgu, na Malti, Nizozemskem, Norveškem, Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji, Španiji, na Švedskem in v Združenem kraljestvu.
English: The suspension will remain in place until the problem has been rectified.
Slovenian: Začasni umik bo veljal, dokler težave ne bodo odpravljene.
English: • Patients who have any questions should speak to their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo z zdravnikom ali s farmacevtom.
English: • Doctors should stop using Octagam and switch their patients to the most appropriate alternative treatment.
Slovenian: • Zdravniki naj prenehajo uporabljati zdravilo Octagam in bolnikom predpišejo najustreznejše nadomestno zdravljenje.
English: In September 2010, the German and Swedish medicines regulatory agencies suspended marketing authorisations for Octagam.
Slovenian: Septembra 2010 sta nemška in švedska regulativna agencija za zdravila začasno umaknili dovoljenje za promet z zdravilom Octagam.
English: As required by Article 107, the German and Swedish agencies informed the CHMP of their actions so that the Committee could prepare an opinion on whether the marketing authorisations for Octagam should be maintained, changed, suspended or withdrawn across the EU.
Slovenian: Nemška in švedska agencija sta v skladu s členom 107 obvestili CHMP o svojih ukrepih, tako da bi lahko Odbor pripravil mnenje o tem, ali je treba dovoljenja za promet z zdravilom Octagam po vsej EU ohraniti, dopolniti, začasno umakniti ali preklicati.
English: Octagam is made by Octopharma.
Slovenian: Zdravilo Octagam izdeluje družba Octopharma.
English: Human normal immunoglobulins are antibodies (types of protein) normally found in the blood that help the body to fight infections and other diseases.
Slovenian: Humani normalni imunoglobulini so protitelesa (vrsta beljakovin), ki jih običajno najdemo v krvi ter pomagajo telesu pri premagovanju okužb in drugih bolezni.
English: The CHMP noted that, based on the available information, there was clear evidence of a recent increase in thromboembolic events associated with Octagam but that the exact cause of the problems could not be identified with certainty.
Slovenian: CHMP je na podlagi razpoložljivih informacij menil, da obstajajo jasni dokazi o nedavnem povečanju števila tromboemboličnih dogodkov, povezanih z uporabo zdravila Octagam, vendar pa natančnega vzroka težav ni mogoče z gotovostjo določiti.
English: Questions and answers on the suspension of the marketing authorisations for Octagam (human normal immunoglobulin 5% and 10%) EMA/588737/2010 rev.1
Slovenian: Vprašanja in odgovori v zvezi z začasnim umikom dovoljenj za promet z zdravilom Octagam (humani normalni imunoglobulin 5 % in 10 %) EMA/588737/2010 rev.1
English: The European Medicines Agency has completed a review of Octagam triggered by reports of serious thromboembolic events.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Octagam, ki so ga sprožila poročila o hudih tromboemboličnih dogodkih.
English: Questions and answers on the suspension of the marketing authorisations for Octagam (human normal immunoglobulin 5% and 10%)
Slovenian: Vprašanja in odgovori v zvezi z začasnim umikom dovoljenj za promet z zdravilom Octagam (humani normalni imunoglobulin 5 % in 10 %)
English: This follows an unexpectedly high number of reports of serious thromboembolic events (problems due to the formation of blood clots in the blood vessels) in patients taking the medicine.
Slovenian: Do tega je prišlo po nepričakovano visokem številu poročil o hudih tromboemboličnih dogodkih (težave zaradi nastajanja krvnih strdkov v žilah) pri bolnikih, ki so jemali zdravilo.
English: The CHMP reviewed the reported thromboembolic events and looked at evidence related to the medicine's safety.
Slovenian: CHMP je pregledal poročila o tromboemboličnih dogodkih in preučil dokaze glede varnosti zdravila.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that all marketing authorisations for the medicine be suspended throughout the European Union (EU) and that Octagam currently on the market be recalled.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je priporočil začasni umik dovoljenj za promet z zdravilom in odpoklic zdravila Octagam s tržišč po vsej Evropski uniji (EU).
English: The CHMP therefore recommended that, because of the safety concerns with Octagam, the marketing authorisations for the medicine be suspended in the EU.
Slovenian: CHMP je zato priporočil, da je treba zaradi varnostnih zadržkov v povezavi z zdravilom Octagam dovoljenja za promet z zdravilom v EU začasno umakniti.
English: While the marketing authorisations are suspended, Octagam will not be available.
Slovenian: Med začasnim umikom dovoljenj za promet z zdravilom zdravilo Octagam ne bo na voljo.
English: Its effect may improve further for up to six months.
Slovenian: Njegov učinek se lahko dodatno povečuje še do šest mesecev.
English: EMA/CHMP/328573/2014 EMEA/H/C/001227
Slovenian: EMA/265372/2014 EMEA/H/C/001227
English: It is available as tablets (10, 15 and 20 mg).
Slovenian: Na voljo je v obliki tablet (10, 15 in 20 mg).
English: The medicine usually starts to have an effect after four to six weeks.
Slovenian: Zdravilo navadno začne učinkovati po štirih do šestih tednih.
English: Leflunomide medac leflunomide
Slovenian: Leflunomide medac leflunomid
English: The full EPAR for Leflunomide medac 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 Leflunomide medac je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide medac on 27 July 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Leflunomide medac, veljavno po vsej Evropski uniji, izdala 27. julija 2010.
English: The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Slovenian: Priporočeni vzdrževalni odmerek je od 10 do 20 mg enkrat na dan za bolnike z revmatoidnim artritisom in 20 mg enkrat na dan za bolnike s psoriatičnim artritisom.
English: This document is a summary of the European public assessment report (EPAR) for Leflunomide medac.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Leflunomide medac.
English: Leflunomide medac treatment usually starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Slovenian: Zdravljenje z zdravilom Leflunomide medac se običajno začne z „udarnim odmerkom“ v višini 100 mg enkrat na dan tri dni zapored, čemur sledi vzdrževalni odmerek.
English: What measures are being taken to ensure the safe and effective use of Leflunomide medac ?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Leflunomide medac?
English: Leflunomide medac is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Slovenian: Zdravilo Leflunomide medac se uporablja za zdravljenje odraslih z aktivnim revmatoidnim artritisom (boleznijo imunskega sistema, ki povzroča vnetje sklepov) ali aktivnim psoriatičnim artritisom (boleznijo, ki povzroča rdeče, luskaste površine na koži in vnetje sklepov).
English: For more information about treatment with Leflunomide medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Leflunomide medac preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This means that Leflunomide medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Arava.
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Slovenian: Zaradi manjšega števila limfocitov je vnetje manjše, kar pripomore k nadziranju simptomov artritisa.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide medac, and regularly during treatment.
Slovenian: Zdravnik mora pri bolniku opraviti krvne preiskave za pregled delovanja jeter, števila belih krvničk in krvnih ploščic, preden predpiše zdravilo Leflunomide medac in nato v rednih presledkih med zdravljenjem.
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 Leflunomide medac.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Other information about Leflunomide medac:
Slovenian: Druge informacije o zdravilu Leflunomide medac:
English: Because Leflunomide medac is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Leflunomide medac generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Leflunomide medac treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Slovenian: Zdravljenje z zdravilom Leflunomide medac mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem revmatoidnega artritisa in psoriatičnega artritisa.
English: The CHMP concluded that, in accordance with EU requirements, Leflunomide medac has been shown to have comparable quality and to be bioequivalent to Arava.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Leflunomide medac primerljivo raven kakovosti kot zdravilo Arava ter da mu je biološko enakovredno.
English: A risk management plan has been developed to ensure that Leflunomide medac is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Leflunomide medac je bil pripravljen načrt obvladovanja tveganj.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Leflunomide medac, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Leflunomide medac in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Slovenian: Leflunomid deluje tako, da zavira encim, imenovan „dihidroorotat dehidrogenaza“, ki je potreben za delitev limfocitov.
English: It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Slovenian: Zdravilo ublaži vnetje z zmanjšanjem tvorjenja imunskih celic, imenovanih „limfociti“, ki povzročajo vnetje.
English: Leflunomide medac is a ‘generic medicine'.
Slovenian: Leflunomide medac je „generično zdravilo“.
English: What are the benefit and risk of Leflunomide medac?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Leflunomide medac?
English: Therefore, the CHMP's view was that, as for Arava, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi tako kot pri zdravilu Arava odtehtajo znana tveganja.
English: Because Leflunomide medac is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Slovenian: Ker je zdravilo Leflunomide medac generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Arava.
English: The Committee recommended that Leflunomide medac be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Leflunomide medac izda dovoljenje za promet.
English: Leflunomide medac is a medicine that contains the active substance leflunomide.
Slovenian: Leflunomide medac je zdravilo, ki vsebuje zdravilno učinkovino leflunomid.
English: Why has Leflunomide medac been approved?
Slovenian: Zakaj je bilo zdravilo Leflunomide medac odobreno?
English: The active substance in Leflunomide medac, leflunomide, is an immunosuppressant.
Slovenian: Zdravilna učinkovina zdravila Leflunomide medac, leflunomid, je zdravilo za zaviranje imunskega odziva.
English: How has Leflunomide medac been studied?
Slovenian: Kako je bilo zdravilo Leflunomide medac raziskano?
English: What is Leflunomide medac?
Slovenian: Kaj je zdravilo Leflunomide medac?
English: What is Leflunomide medac used for?
Slovenian: Za kaj se zdravilo Leflunomide medac uporablja?
English: How does Leflunomide medac work?
Slovenian: Kako zdravilo Leflunomide medac deluje?
English: How is Leflunomide medac used?
Slovenian: Kako se zdravilo Leflunomide medac uporablja?
English: 3 x 28 tablets
Slovenian: 3 x 28 tablet
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Z mikrobiološkega vidika je treba izdelek uporabiti nemudoma.
English: It is available in packs of:
Slovenian: Na voljo v pakiranjih:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 September 2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 14. september 2015
English: * Definition of frequency terms: Very common - ≥ 10 %; Common - > 5 % and < 10 %.
Slovenian: * Definicija pogostnosti: Zelo pogosto - > 10 %; Pogosto - > 5 % in < 10 %.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor.
Slovenian: Če ste noseči, mislite, da bi lahko bili noseči, ali načrtujete nosečnost, to povejte zdravniku.
English: If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Slovenian: Če niste prepričani, vprašajte zdravnika ali farmacevta, ali so katera od vaših zdravil NSAIDi.
English: Frequency estimate: 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) and not known (cannot be estimated from available data).
Slovenian: Pogostnosti so določene kot: zelo pogosto (≥ 1/10), pogosto ( 1/100 do < 1/10), občasno (≥ 1/1000 do < 1/100), redko (≥ 1/10.000 do < 1/1000), zelo redko (<1/10.000) in ni znano (ni mogoče oceniti iz razpoložljivih podatkov).
English: Based on the planned date of your infusion of Pemetrexed Lilly and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Slovenian: Na podlagi načrtovanega datuma vaše infuzije zdravila Pemetreksed Lilly in/ali glede na delovanje vaših ledvic vam mora zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
English: It is unknown whether pemetrexed is excreted in human milk and adverse reactions on the suckling child cannot be excluded.
Slovenian: Ni znano, ali se pemetreksed izloča v materino mleko, in neželenih reakcij za dojenčka ne moremo izključiti.
English: Not known: frequency cannot be estimated from the available data Lower limb swelling with pain and redness Increased urine output
Slovenian: Ni znano: pogostnosti ni mogoče oceniti na podlagi razpoložljivih podatkov Otekanje spodnjih okončin z bolečino in rdečino Povečano izločanje urina
English: Driving and using machines Pemetrexed Lilly may make you feel tired.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Pemetreksed Lilly lahko povzroči, da se boste počutili utrujene.
English: Very common (may affect more than 1 in 10 people) Low white blood cells
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) Nizko število belih krvnih celic
English: Creatinine clearance decreased**
Slovenian: Povišan kreatinin Znižan očistek kreatinina**
English: Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor's prescription (such as ibuprofen).
Slovenian: Prosimo, povejte zdravniku, če jemljete kaka zdravila proti bolečinam ali vnetju (oteklinam), denimo zdravila, imenovana “nesteroidna protivnetna zdravila” (NSAID-i), vključno z zdravili, ki ste jih dobili brez recepta (kot denimo, ibuprofen).
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing pemetrexed in all subsets of the paediatric population in the granted indications (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje pemetreksed, za vse podskupine pediatrične populacije za odobrene indikacije zdravila (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2 °C to 8 °C.
Slovenian: Če zdravila, pripravljenega za uporabo, ne uporabimo takoj, je za čase shranjevanja in pogoje pred uporabo odgovoren uporabnik, in naj bi ne presegali 24 ur pri 2 do 8 C.
English: In vitro studies indicate that pemetrexed is actively secreted by OAT3 (organic anion transporter.
Slovenian: In vitro študije so pokazale, da se pemetreksed aktivno izloča z OAT3 (prenašalcem organskih anionov).
English: Calculate the dose and the number of Pemetrexed Lilly vials needed.
Slovenian: Izračunajte odmerek in število potrebnih vial zdravila Pemetreksed Lilly.
English: Lilly France Zone Industrielle 2 Rue du Colonel Lilly 67640 Fegersheim France
Slovenian: Lilly France Zone Industrielle 2 Rue du Colonel Lilly 67640 Fegersheim Francija
English: Safety was assessed for patients who were randomised to receive pemetrexed (N = 800).
Slovenian: Varnost je bila ocenjena pri bolnikih, ki so bili naključno izbrani za prejemanje pemetrekseda (N = 800).
English: ** In the pemetrexed/cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Slovenian: **V veji zdravljenja s pemetreksedom/cisplatinom, randomizirani in zdravljeni (N = 225) ter s popolnim dopolnjevanjem (N = 167).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o tem zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive Pemetrexed Lilly.
Slovenian: Pred vsako infuzijo vam bomo odvzeli vzorce krvi za vrednotenje delovanja vaših ledvic in jeter ter oceno, ali imate dovolj krvnih celic za prejemanje zdravila Pemetreksed Lilly.
English: Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) should be ≤ 3 times upper limit of normal.
Slovenian: Alkalna fosfataza (AF), aspartatna aminotransferaza (AST ali SGOT) in alaninska aminotransferaza (ALT ali SGPT) morajo biti  3-kratnik zgornje meje normalnih vrednosti.
English: Creatinine clearance should be ≥ 45 mL/min.
Slovenian: Očistek kreatinina mora biti  45 ml/min.
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: Priloga IV Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj(a) za promet z zdravilom