natgillin/translations-raw huggingface dataset:
Uncommon These may affect up to 1 in 100 people − reduction in the number of platelets (blood cells necessary for blood clotting) − reduced blood flow to the brain.
zmanjšanje števila trombocitov (krvnih celic, ki so potrebne za strjevanje krvi) zmanjšana prekrvavitev možganov.
Very rare These may affect less than 1 in 10,000 people − serious bleeding (for example, bleeding inside the abdomen, inside the brain, and into the lungs) − fatal bleeding − severe reduction in the number of platelets (blood cells necessary for blood clotting) − skin rash (such as hives) − sudden, severe allergic reaction.
Zelo redki Pojavijo se lahko pri manj kot 1 od 10. 000 oseb
If you notice any signs of bleeding, notify your doctor or nurse immediately.
Če opazite kakršnekoli znake krvavitve, to nemudoma povejte zdravniku ali medicinski sestri.
If you develop severe allergic reaction or hives, notify your doctor or nurse immediately.
Če se pojavi huda alergijska reakcija ali koprivnica, to nemudoma povejte zdravniku ali medicinski sestri.
Other events that may occur in patients who require this type of treatment, include those that are related to the condition you are having treated, such as rapid or irregular heart beat, low blood pressure, shock or cardiac arrest.
Drugi neželeni učinki, ki se lahko pojavijo pri bolnikih, ki potrebujejo tovrstno zdravljenje, vključujejo tiste, ki so povezani z zdravstvenim stanjem, ki se zdravi, npr. hiter ali nepravilen srčni utrip, nizek krvni tlak, šok ali srčni zastoj.
HOW TO STORE INTEGRILIN
SHRANJEVANJE ZDRAVILA INTEGRILIN
However, protection of INTEGRILIN solution from light is not necessary during administration.
Zaščita raztopine INTEGRILIN pred svetlobo med uporabo ni potrebna.
INTEGRILIN should not be used if it is noticed that particulate matter or discoloration is present.
Ne uporabljajte zdravila INTEGRILIN, če ste opazili delce ali obarvanje vsebine.
Any unused material after opening should be discarded.
Neporabljeno raztopino po odprtju morate zavreči.
What INTEGRILIN contains − The active substance is 0.75 mg/ ml eptifibatide. − The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.
Kaj vsebuje zdravilo INTEGRILIN − Zdravilna učinkovina je 0, 75 mg/ ml eptifibatida. − Pomožne snovi so: citronska kislina monohidrat, natrijev hidroksid in voda za injekcije.
What INTEGRILIN looks like and contents of the pack INTEGRILIN solution for infusion:
Izgled zdravila INTEGRILIN in vsebina pakiranja INTEGRILIN raztopina za infundiranje:
100 ml vial, pack of one vial (to be used with INTEGRILIN solution for injection).
100 ml viala, pakiranje po ena viala (za uporabo skupaj z INTEGRILIN raztopino za injiciranje).
The clear, colourless solution is contained in a 100 ml glass vial, which is closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
43 Bistra brezbarvna raztopina v 100- ml stekleni viali, ki je zaprta z zamaškom iz butilne gume in zapečatena z aluminijskim pokrovčkom.
Marketing Authorisation Holder and manufacturer
Imetnik dovoljenja za promet z zdravilom in izdelovalec
UB6 0NN, United Kingdom
UB6 0NN, Velika Britanija
SP Labo N. V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium
SP Labo N. V., Industriepark 30, B- 2220 Heist- op- den- Berg, Belgija
Glaxo Operations UK Ltd., (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, Co. Durham, DL12 8DT, United Kingdom
Glaxo Operations UK Ltd., (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, Co. Durham, DL12 8DT, Velika Britanija
44 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
44 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
België/ Belgique/ Belgien GlaxoSmithKline s. a. / n. v.
België/ Belgique / Belgien GlaxoSmithKline s. a. / n. v.
47 Take special care with INTEGRILIN: − INTEGRILIN is recommended for use only in adult, hospitalized patients in coronary care units. − INTEGRILIN is not intended for use in children or adolescents less than 18 years of age. − Before and during your treatment with INTEGRILIN, samples of your blood will be tested as a safety measure to limit the possibility of unexpected bleeding. − During use of INTEGRILIN, you will be checked carefully for any signs of unusual or unexpected bleeding.
Bodite posebno pozorni pri uporabi zdravila INTEGRILIN − INTEGRILIN priporočamo za uporabo le pri odraslih bolnikih, hospitaliziranih na bolnišničnih koronarnih oddelkih. − INTEGRILIN ni namenjen za uporabo pri otrocih in mladostnikih do 18. leta starosti.
48 Common side effects These may affect up to 1 in 10 people − inflammation of a vein
Pogosti neželeni učinki Pojavijo se lahko pri do 1 od 10 oseb
Uncommon These may affect up to 1 in 100 people − reduction in the number of platelets (blood cells necessary for blood clotting) − reduced blood flow to the brain
zmanjšanje števila trombocitov (krvnih celic, ki so potrebne za strjevanje krvi) zmanjšana prekrvavitev možganov.
Other events that may occur in patients who require this type of treatment include those that are related to the condition you are having treated, such as rapid or irregular heart beat, low blood pressure, shock or cardiac arrest.
Drugi neželeni učinki, ki se lahko pojavijo pri bolnikih, ki potrebujejo tovrstno zdravljenje, vključujejo tiste, ki so povezani z zdravstvenim stanjem, ki se zdravi, npr. hiter ali nepravilen srčni utrip, nizek krvni tlak, šok ali srčni zastoj.
What INTEGRILIN contains − The active substance is 2 mg/ ml eptifibatide. − The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.
Kaj vsebuje zdravilo INTEGRILIN − Zdravilna učinkovina je 2 mg/ ml eptifibatida. − Pomožne snovi so: citronska kislina monohidrat, natrijev hidroksid in voda za injekcije.
What INTEGRILIN looks like and contents of the pack INTEGRILIN solution for injection:
Izgled zdravila INTEGRILIN in vsebina pakiranja INTEGRILIN raztopina za injiciranje:
10 ml vial, pack of one vial (to be used with INTEGRILIN solution for infusion).
10 ml viala, pakiranje po ena viala (za uporabo skupaj z INTEGRILIN raztopino za infundiranje).
The clear, colourless solution is contained in a 10 ml glass vial, which is closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
49 Bistra brezbarvna raztopina v 10- ml stekleni viali, ki je zaprta z zamaškom iz butilne gume in zapečatena z aluminijskim pokrovčkom.
50 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
50 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
EPAR summary for the public
EPAR POVZETEK JAVNEGA POROČILA
Intelence is a medicine containing the active substance etravirine.
Intelence je zdravilo, ki vsebuje zdravilno učinkovino etravirin.
It is available as white, oval tablets (100 mg).
Na voljo je v obliki belih, ovalnih tablet (100 mg).
Intelence is an antiviral medicine.
Zdravilo Intelence je protivirusno zdravilo.
It is used to treat adults who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Uporablja se za zdravljenje odraslih, ki so okuženi z virusom človeške imunske pomanjkljivosti tipa 1 (HIV- 1), virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
Intelence is only used in patients who have been treated for their HIV infection before.
Zdravilo Intelence se uporablja le pri bolnikih, ki so se že zdravili zaradi okužbe s HIV.
Intelence must be used together with other antiviral medicines which have to include a ‘ boosted protease inhibitor’.
Zdravilo Intelence se mora uporabljati le skupaj z drugimi protivirusnimi zdravili, ki morajo vključevati „ okrepljeni zaviralec proteaze “.
Treatment with Intelence should be started by a doctor who has experience in the treatment of HIV infection.
Zdravljenje z zdravilom Intelence sme uvesti zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
The recommended dose of Intelence is two tablets twice a day taken after a meal.
Priporočeni odmerek zdravila Intelence sta dve tableti dvakrat na dan, po jedi.
For patients who are unable to swallow the tablets, Intelence tablets can be dispersed by stirring them in a glass of water to form a milky solution, which has to be drunk immediately.
Bolniki, ki tablet zdravila Intelence ne morejo pogoltniti celih, jih lahko raztopijo v kozarcu vode, premešajo, da nastane mlečna raztopina in jo nemudoma popijejo.
Intelence should be used with caution in patients who have moderate problems with their liver.
Pri bolnikih z zmernimi okvarami jeter je treba zdravilo Intelence uporabljati posebej previdno.
It is not recommended for use in patients with severe liver problems or in patients under 18 years of age because of a lack of information on safety and effectiveness in these groups.
Uporaba zdravila Intelence se ne priporoča pri bolnikih s hudimi težavami z jetri ali pri bolnikih, mlajših od 18 let, zaradi pomanjkanja podatkov o varnosti in učinkovitosti pri teh starostnih skupinah.
It should be used with caution in patients over 65 years of age because there is limited information on its use in this age group.
Podatki o uporabi zdravila Intelence pri bolnikih, starejših od 65 let, so omejeni, zato je pri uporabi v tej starostni skupini potrebna previdnost.
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Zavira delovanje reverzne transkriptaze, encima, na nastanek katerega vpliva HIV in ki okuži druge celice telesa ter proizvaja več virusov.
By blocking this enzyme, Intelence, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Intelence v kombinaciji z drugimi protivirusnimi zdravili z zaviranjem tega encima zmanjšuje količino HIV v krvi in ohranja njegovo nizko raven.
Intelence does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Intelence ne zdravi okužbe z virusom HIV niti AIDS- a, ampak le zavira njegovo poškodovanje imunskega sistema ter razvoj okužb in bolezni, povezanih z AIDS- som.
Intelence has been studied in two main studies involving a total of 1,203 HIV-infected adults who had been taking anti-HIV therapy that was not working any longer and who had few or no treatment options remaining.
Učinki zdravila Intelence so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh. Zdravilo Intelence je bilo raziskano v dveh glavnih študijah, v katerih je sodelovalo 1203 odraslih bolnikov, okuženih z virusom HIV, ki so že bili zdravljeni s terapijo proti HIV, vendar ta ni več ustrezno delovala in pri katerih ni več veliko drugih ali nobenih možnosti zdravljenja.
Both studies compared the effectiveness of Intelence with that of placebo (a dummy treatment), when they were taken with boosted darunavir (a protease inhibitor), as well as at least two other antiviral medicines that were chosen for each patient as they had the best chances of reducing the levels of HIV in the blood.
V obeh študijah so primerjali učinkovitost zdravila Intelence z učinkovitostjo placeba (zdravila brez zdravilne učinkovine), kadar se je jemalo skupaj z okrepljenim darunavirjem (zaviralcem proteaze) in z vsaj dvema drugima protivirusnima zdraviloma, izbranima za vsakega posameznega bolnika, s čimer se je doseglo optimalno zmanjšanje ravni HIV v krvi.
The main measure of effectiveness was the number of patients with a level of HIV in the blood (viral load) that was below 50 copies/ ml after 24 weeks of treatment.
Glavno merilo učinkovitosti je bilo število bolnikov, okuženih z HIV, pri katerih je bila raven HIV v krvi (virusno breme) po 24 tednih zdravljenja pod 50 kopij/ ml.
Intelence was more effective than placebo at reducing viral load.
Zdravilo Intelence je bilo učinkovitejše od placeba pri zmanjševanju virusnega bremena.
Looking at the two studies taken together, the average patients’ viral load was 70,000 copies/ ml at the start of the studies.
Ob upoštevanju obeh študij skupaj je bilo ob začetku študije povprečno virusno breme pri bolnikih 70. 000 kopij/ ml.
After 24 weeks, 59% of the patients taking Intelence in combination with other anti-HIV medicines (353 out of 599) had a viral load below 50 copies/ ml, compared with 41% of the patients taking placebo in combination with other anti-HIV medicines (248 out of 604).
Po 24 tednih zdravljenja je bilo pri 59% bolnikov, ki so uporabljali zdravilo Intelence v kombinaciji z drugimi zdravili proti HIV (353 od 599), bilo virusno breme manjše od 50 kopij/ ml, v primerjavi z 41% bolnikov, ki so jemali placebo v kombinaciji z drugimi zdravili proti HIV (248 od 604).
The most common side effects with Intelence (seen in between 1 and 10 patients in 100) are rash, diarrhoea, nausea (feeling sick), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), peripheral neuropathy (nerve damage in the hands and feet), headache, gastro-oesophageal reflux disease (acid reflux into the gullet), vomiting, abdominal (tummy) pain, flatulence (wind), gastritis (inflammation of the stomach lining), kidney failure, diabetes, hyperglycaemia (high blood glucose levels), hypertension (high blood pressure), fatigue (tiredness), anxiety, and insomnia (difficuly sleeping), abnormal levels of fat in the blood, increases in blood levels of some proteins and decreases in neutrophils (a type of white blood cell).
Najpogostejši neželeni učinki zdravila Intelence (opaženi pri 1 do 10 bolnikih izmed 100) so izpuščaji, driska, navzeja (občutek slabosti), trombocitopenija (nizko število trombocitov v krvi), anemija (nizko število rdečih krvnih celic), periferna nevropatija (poškodovani živci v dlaneh in stopalih), glavobol, gastroezofagealni refluks (vračanje kisline v požiralnik), bruhanje, bolečine v trebuhu, napenjanje (vetrovi), gastritis (vnetje potrebušnice), ledvična odpoved, sladkorna bolezen, hiperglikemija (visoka raven glukoze v krvi), hipertenzija (visok krvni tlak), utrujenost, anksioznost in nespečnost (težave s spanjem), nenormalna raven maščobe v krvi, povečanje ravni nekaterih beljakovin v krvi in zmanjšanje nevtrofilcev (vrste belih krvnih celic).
For the full list of all side effects reported with Intelence, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Intelence, glejte navodilo za uporabo.
Intelence should not be used in people who may be hypersensitive (allergic) to etravirine or any of the other ingredients.
Zdravila Intelence ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) etravirin ali na katero koli drugo sestavino zdravila.
Severe skin reactions have been reported with Intelence (rash with blisters typically on lips, mouth and eyes, sometimes with skin peeling), and treatment with Intelence should be stopped if a severe skin reaction develops.
Pri uporabi zdravila Intelence so se pojavile tudi hude kožne reakcije (izpuščaj z mehurčki, najpogosteje na ustnicah, v ustih in na očeh, včasih luščenje kože), pri hujših reakcijah na koži pa je treba zdravljenje z zdravilom Intelence prekiniti.
As with other anti-HIV medicines, patients taking Intelence may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Podobno kot pri uporabi drugih zdravil proti HIV obstaja pri bolnikih, ki jemljejo zdravilo Intelence, tveganje za pojav lipodistrofije (sprememb v porazdelitvi telesnega maščevja), osteonekroze (odmiranje kostnega tkiva) ali sindroma imunske reaktivacije (simptomov okužbe, ki jih povzroči imunski sistem med okrevanjem).
Patients who have hepatitis B or C infection may be at an elevated risk of liver damage when taking Intelence.
Bolniki, okuženi s hepatitisom B ali C, so lahko pri jemanju zdravila Intelence izpostavljeni večjemu tveganju okvare jeter.
The Committee for Medicinal Products for Human Use (CHMP) decided that Intelence’ s benefits are greater than its risks when used in combination with a boosted protease inhibitor and other antiretroviral medicines for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients.
Odbor za zdravila za uporabo v humani medicini je zaključil, da so koristi zdravila Intelence pri uporabi v kombinaciji z okrepljenim zaviralcem proteaze in drugimi protiretrovirusnimi zdravili za zdravljenje okužb z virusom HIV tipa 1 pri odraslih bolnikih, ki so že bili predhodno zdravljeni z drugimi protiretrovirusnimi zdravili, večje od z njim povezanih tveganj.
This indication is based on the results of two 24-week studies of Intelence taken in combination with other anti-HIV medicines including darunavir boosted with ritonavir, which were carried out in patients with virus that was not responding to NNRTIs or protease inhibitors.
Ta indikacija temelji na rezultatih dveh 24- tedenskih študijah uporabe zdravila Intelence v kombinaciji z drugimi zdravili proti HIV, vključno z okrepljenim darunavirjem z ritonavirjem, ki so bile izvedene pri bolnikih z virusom, ki se ni odzival na nenukleozidne zaviralce reverzne transkriptaze (NNRTI) ali zaviralce proteaze.
The Committee recommended that Intelence be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Intelence odobri dovoljenje za promet.
Intelence has been given ‘ Conditional Approval’.
Za zdravilo Intelence je bila sprejeta „ pogojna odobritev “.
This means that there is more evidence to come about the medicine, in particular further information on its effectiveness and safety.
To pomeni, da pričakujemo še več dokazov o zdravilu, zlasti o njegovi učinkovitosti in varnosti.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available, and this summary will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto ponovno pregledala vse razpoložljive nove informacije in po potrebi posodobila ta povzetek.
What information is still awaited for Intelence?
Katere informacije o zdravilu Intelence še pričakujemo?
The company that makes Intelence will supply the final 48-week results of the two main studies with Intelence, and will conduct an additional study to demonstrate that similar results are also seen in patients taking protease inhibitors other than boosted darunavir.
Družba, ki proizvaja zdravilo Intelence, bo posredovala končne rezultate dveh 48- tedenskih glavnih študij z zdravilom Intelence, prav tako pa bo izvedla dodatno študijo, s katero bo dokazala, da se tudi 2/ 3 pri bolnikih, ki namesto okrepljenega darunavirja jemljejo zaviralce proteaze, kažejo podobni rezultati.
2/ 3 Other information about Intelence:
Druge informacije o zdravilu Intelence:
The European Commission granted a marketing authorisation valid throughout the European Union for Intelence to Janssen-Cilag International NV on 28 August 2008.
Evropska Komisija je dovoljenje za promet z zdravilom Intelence, veljavno po vsej Evropski uniji, odobrila družbi Janssen- Cilag International NV dne 28. avgusta 2008.
The full EPAR for Intelence can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Intelence je na voljo tukaj.
EU/ 1/ 08/ 468/ 001
Številka EU EU/ 1/ 08/ 468/ 001
INTELENCE
Izmišljeno ime INTELENCE
Tablet
farmacevtska oblika tableta
Oral use
pot uporabe peroralna uporaba
Bottle (HDPE)
ovojnina plastenka (HDPE)
120 tablets
velikost pakiranja 120 tablet
Each tablet contains 100 mg of etravirine.
Ena tableta vsebuje 100 mg etravirina.
Each tablet contains 160 mg lactose.
Pomožne snovi: ena tableta vsebuje 160 mg laktoze.
White to off-white, oval tablet, debossed with “ T125” on one side and “ 100” on the other side.
Bela do belkasta ovalna tableta z vtisnjeno oznako “ T125 ” na eni strani in “ 100 ” na drugi.
INTELENCE, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients (see sections 4.4, 4.5 and 5.1).
Zdravilo INTELENCE je v kombinaciji z okrepljenim zaviralcem proteaze in drugimi protiretrovirusnimi zdravili indicirano za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti tipa 1 (HIV- 1) pri odraslih bolnikih, ki so se že zdravili s protiretrovirusnimi zdravili (glejte poglavja 4. 4, 4. 5 in 5. 1).
This indication is based on week 24 analyses from 2 randomised, double-blind, placebo-controlled Phase III trials in highly pre-treated patients with viral strains harbouring mutations of resistance to non-nucleoside reverse transcriptase inhibitors and protease inhibitors, where INTELENCE was investigated in combination with an optimised background regimen (OBR) which included darunavir/ ritonavir (see section 5.1).
V teh preskušanjih so zdravilo INTELENCE raziskovali v kombinaciji z optimirano osnovno shemo zdravljenja (optimised background regimen - OBR), ki je vsebovala darunavir oz. ritonavir (glejte poglavje 5. 1).
Therapy should be initiated by a physician experienced in the management of HIV infection.
Zdravljenje mora uvesti zdravnik, ki je izkušen v zdravljenju okužbe s HIV.
Adults The recommended dose of INTELENCE is 200 mg (two 100 mg tablets) taken orally twice daily (b. i. d.), following a meal (see section 5.2).
Bolniki naj ga jemljejo peroralno dvakrat na dan (b. i. d.), po jedi (glejte poglavje 5. 2).
Patients who are unable to swallow INTELENCE tablets whole may disperse the tablets in a glass of water.
Bolniki, ki ne morejo pogoltniti celih tablet zdravila INTELENCE, jih lahko dispergirajo v kozarcu vode.
Once dispersed, patients should stir the dispersion well and drink it immediately.
Po dispergiranju tablete naj dobro premešajo tekočino in jo takoj popijejo.
The glass should be rinsed with water several times and each rinse completely swallowed to ensure the entire dose is consumed.
Potem naj kozarec večkrat sperejo z vodo in vsakič popijejo tudi vso vodo, s katero so sprali kozarec, da bodo prejeli celotni odmerek zdravila.
Paediatric population INTELENCE is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see section 5.2).
Pediatrična populacija Zdravilo INTELENCE ni priporočljivo za uporabo pri otrocih in mladostnikih zaradi nezadostnih podatkov o njegovi varnosti in učinkovitosti (glejte poglavje 5. 2).
Elderly There is limited information regarding the use of INTELENCE in patients > 65 years of age (see section 5.2), therefore caution should be used in this population.
Starostniki Podatki o uporabi zdravila INTELENCE pri bolnikih, starih > 65 let, so omejeni (glejte poglavje 5. 2), zato je pri uporabi v tej populaciji bolnikov potrebna previdnost.
2 impairment.
2 Jetrna okvara Pri bolnikih z blago do zmerno jetrno okvaro (razred A ali B po klasifikaciji Child- Pugh) ni potrebna prilagoditev odmerka.
The pharmacokinetics of etravirine have not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Zdravilo INTELENCE je treba previdno uporabljati pri bolnikih z zmerno jetrno okvaro.
Therefore, INTELENCE is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Farmakokinetike etravirina pri bolnikih s hudo jetrno okvaro (razred C po klasifikaciji Child- Pugh) niso proučevali, zato uporaba zdravila INTELENCE pri njih ni priporočena (glejte poglavji 4. 4 in 5. 2).
Renal impairment No dose adjustment is required in patients with renal impairment (see section 5.2).
Ledvična okvara Pri bolnikih z ledvično okvaro ni potrebna prilagoditev odmerka (glejte poglavje 5. 2).