FrancophonIA/ELRC3.0 huggingface dataset:
English: In the olaparib and placebo arms, 6% and 5% of patients had prior bevacizumab, respectively.
Slovenian: Bevacizumab je predhodno prejemalo 6 % bolnic v skupini z olaparibom in 5 % bolnic v skupini s placebom.
English: Distribution The in vitro plasma protein binding is approximately 82% at 10 µg/mL which is approximately Cmax.
Slovenian: Porazdelitev Ob koncentraciji 10 µg/ml, ki je približna vrednost Cmax, je vezava na beljakovine in vitro približno
English: Anaemia includes preferred terms (PTs) of anaemia, anaemia macrocytic, erythropenia, haematocrit decreased, haemoglobin decreased, normochromic anaemia, normochromic normocytic anaemia, normocytic anaemia and red blood cell count decreased; Neutropenia includes PTs of agranulocytosis, febrile neutropenia, granulocyte count decreased, granulocytopenia, idiopathic neutropenia, neutropenia, neutropenic infection, neutropenic sepsis and neutrophil count decreased; Thrombocytopenia includes PTs of platelet count decreased, platelet production decreased, plateletcrit decrease and thrombocytopenia; Leukopenia includes PTs of leukopenia and white blood cell count decreased;
Slovenian: Anemija obsega prednostne izraze (Preferred Terms) anemija, makrocitna anemija, eritropenija, znižanje hematokrita, znižanje hemoglobina, normokromna anemija, normokromna normocitna anemija, normocitna anemija in zmanjšano število eritrocitov.
English: The primary endpoint was PFS based on investigator assessment using RECIST 1.0.
Slovenian: Primarni cilj študije je bilo preživetje brez napredovanja bolezni (PFS) na podlagi raziskovalčeve ocene in z uporabo RECIST 1.0.
English: Patient-reported outcome (PRO) data indicate no difference for the olaparib-treated patients as compared to placebo as measured by improvement and worsening rates in the TOI and FACT-O total.
Slovenian: Podatki o izidu po navedbi bolnic (PRO) merjeni z deleži izboljšanja oziroma poslabšanja indeksa TOI lestvice FACT-O ne kažejo razlik med prejemnicami olapariba in prejemnicami placeba.
English: Lynparza 100 mg film-coated tablets
Slovenian: Lynparza 100 mg filmsko obložene tablete
English: Do not breast-feed if you are taking Lynparza and for 1 month after taking the last dose of Lynparza.
Slovenian: Med jemanjem zdravila Lynparza in še en mesec po vzetju zadnjega odmerka zdravila Lynparza ne smete dojiti.
English: Lynparza 150 mg film-coated tablets
Slovenian: Lynparza 150 mg filmsko obložene tablete
English: Do not eat preferably for up to 2 hours after taking Lynparza.
Slovenian: Potem, ko ste vzeli zdravilo Lynparza, po možnosti do 2 uri ne jejte.
English: Olaparib 300 mg bd
Slovenian: olaparib 300 mg 2x/dan kemoterapija
English: Lynparza 100 mg film-coated tablets olaparib
Slovenian: Lynparza 100 mg filmsko obložene tablete olaparib
English: Uncommon Increase in blood creatinine
Slovenian: Preiskave pogosti zvišanje kreatinina v krvi občasni povečanje povprečnega volumna eritrocitov občasni zvišanje kreatinina v krvi
English: Patients must have confirmation of a deleterious or suspected deleterious breast cancer susceptibility gene (BRCA) mutation (either germline or tumour) before Lynparza treatment is initiated.
Slovenian: Pred uvedbo zdravljenja z zdravilom Lynparza morajo imeti bolnice potrjeno škodljivo ali domnevno škodljivo mutacijo gena BRCA (gen dovzetnosti za raka dojk), bodisi germinalno bodisi v tumorju.
English: Lynparza 150 mg film-coated tablets olaparib
Slovenian: Lynparza 150 mg filmsko obložene tablete olaparib
English: Table 5 Summary of primary objective outcome for all patients and patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19
Slovenian: Povzetek izida primarnega cilja za vse bolnice in PSR bolnice z rakom jajčnikov z mutacijo gena BRCA1/2 in BRCA1/2 wt/VUS v študiji 19
English: Tabulated list of adverse reactions
Slovenian: Seznam neželenih učinkov v preglednici Neželeni učinki
English: You will be asked to take 200 mg (2 x 100 mg tablets)
Slovenian: Jemati boste morali 200 mg (dve 100 mg tableti) dvakrat na danskupaj 4 tablete vsak dan,
English: Table 3 Summary of primary objective outcome for patients with gBRCA1/2m PSR ovarian cancer in SOLO2
Slovenian: Povzetek izida primarnega cilja pri PSR bolnicah z rakom jajčnikov in gBRCA1/2m v študiji SOLO2.
English: Race (%) White Asian Other
Slovenian: Rasa (%)
English: • You must use a condom when having sex with a female partner, even if she is pregnant, while taking Lynparza and for 3 months after taking the last dose.
Slovenian: • Medtem ko jemljete zdravilo Lynparza in še 3 mesece po uporabi zadnjega odmerka tega zdravila morate med spolnimi odnosi s partnerko uporabljati kondom, in sicer tudi če je partnerka noseča.
English: Placebo Olaparib 400 mg capsule bd
Slovenian: olaparib kapsule 400 mg dvakrat na dan placebo olaparib kapsule 400 mg dvakrat na dan olaparib kapsule 400 mg dvakrat na dan placebo
English: The recommended dose reduction is to 200 mg twice daily (equivalent to a total daily dose of 400 mg).
Slovenian: V primeru potrebe po zmanjšanju odmerka je priporočeno zmanjšanje odmerka na 200 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 400 mg).
English: Lymphopenia includes PTs of B-lymphocyte count decreased, lymphocyte count decreased, lymphopenia and T-lymphocyte count decreased; Cough includes PTs of cough and productive cough; Rash includes PTs of exfoliative rash, generalised erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular and rash pruritic; Hypersensitivity includes PTs of drug hypersensitivity and hypersensitivity; Dermatitis includes PTs of dermatitis, dermatitis allergic and dermatitis exfoliative.
Slovenian: Izpuščaj obsega prednostne izraze eksfoliativni izpuščaj, generaliziran eritem, izpuščaj, eritematozen izpuščaj, generaliziran izpuščaj, makularen izpuščaj, makulo-papulozen izpuščaj, papulozen izpuščaj in pruritičen izpuščaj.
English: PAES: In order to further define the efficacy of olaparib in patients with platinum sensitive relapsed (PSR) non-germline BRCA mutated high grade ovarian cancer in the maintenance setting and investigate predictive biomarkers within this patient group, the MAH should submit the results of study D0816C00020 (OPINION), a phase IIIb single-arm, open-label, multicentre study of maintenance therapy in PSR non-germline BRCA mutated ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
Slovenian: PAES: Za dodatno opredelitev učinkovitosti olapariba med vzdrževalnim zdravljenjem bolnic z recidivom slabo diferenciranega raka jajčnikov, občutljivega za platino (PSR), z negerminalno mutacijo gena BRCA ter za proučitev napovednih bioloških označevalcev v tej skupini bolnic mora imetnik dovoljenja za promet z zdravilom predložiti rezultate študije D0816C00020 (OPINION).
English: The primary endpoint was PFS determined by investigator assessment using RECIST 1.1.
Slovenian: Primarni cilj študije je bilo preživetje brez napredovanja bolezni (PFS) po raziskovalčevi oceni na podlagi meril RECIST 1.1.
English: o A test is used to find out whether you have BRCA-mutated ovarian cancer.
Slovenian: o Za ugotavljanje tega, ali imate raka jajčnikov z mutacijo gena BRCA, se uporablja posebna preiskava.
English: Preplanned subgroup analysis identified patients with BRCA1/2-mutated ovarian cancer (n=136,
Slovenian: Vnaprej načrtovana analiza podskupin je pokazala, da je vzdrževalna monoterapija z olaparibom klinično najbolj koristila podskupini bolnic z rakom jajčnikov in z mutacijo gena BRCA1/2 (n = 136, 51,3 %, vključno z 20 bolnicami z identificirano somatsko tumorsko mutacijo gena BRCA1/2).
English: Tablet coating
Slovenian: Izpuščeni odmerek
English: Common Lymphopenia
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: Gastrointestinal toxicities
Slovenian: Toksični učinki na prebavilih
English: Vomiting, Diarrhoea, Nausea, Dyspepsia, Upper abdominal pain
Slovenian: Bolezni živčevja zelo pogosti omotica, glavobol, spremenjen okus občasni omotica, glavobol
English: bd Twice daily; NR not reached; CI confidence interval; PFS2 time from randomisation to second progression or death;
Slovenian: ND = ni doseženo, IZ = interval zaupanja, PFS2 = čas od randomizacije do drugega napredovanja bolezni, TSST = čas od randomizacije do začetka drugega nadaljnjega zdravljenja ali smrti.
English: It can affect the way the medicine works.
Slovenian: Grenivkin sok namreč lahko vpliva na delovanje tega zdravila.
English: 14 Capsules
Slovenian: 14 kapsul
English: Blister(Alu/Alu)
Slovenian: Pretisni omot (Alu/Alu)
English: 200 mg Powder for concentrate for solution for infusion
Slovenian: EU/1/15/1036/001 Zdravilo Cresemba 200 mg Prašek za koncentrat za raztopino za infundiranje
English: Intravenous use vial (glass)
Slovenian: Intravenska uporaba viala (steklena) 10 ml
English: 100 mg Capsule, hard Oral use
Slovenian: EU/1/15/1036/002 Zdravilo Cresemba 100 mg Kapsula, trda
English: If it is taken with food, it may take longer to work.
Slovenian: Če se zdravilo jemlje s hrano, bo morda preteklo več časa, preden bo delovalo.
English: What measures are being taken to ensure the safe and effective use of Spedra?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Spedra?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Spedra on 21 June 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Spedra, veljavno po vsej Evropski uniji, izdala 21. junija 2013.
English: Spedra may be taken with or without food.
Slovenian: Zdravilo Spedra se lahko jemlje s hrano ali brez nje.
English: The full EPAR for Spedra 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 Spedra je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The dose may be adjusted if necessary; lower doses may be needed in patients with liver problems or who are taking certain other medicines.
Slovenian: Odmerek se lahko po potrebi prilagodi; nižji odmerki bodo morda potrebni pri bolnikih z jetrnimi obolenji ali pri tistih, ki jemljejo druga zdravila.
English: What benefits of Spedra have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Spedra izkazalo v študijah?
English: This is a summary of the European public assessment report (EPAR) for Spedra.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Spedra.
English: The main measures of effectiveness in all three studies were the percentage of erections that lasted long enough for successful intercourse, the percentage of successful vaginal penetrations, and the change in an assessment score for erectile function.
Slovenian: Glavna merila učinkovitosti v vseh treh študijah so bila odstotek erekcij, ki so trajale dovolj dolgo za uspešen spolni odnos, odstotek uspešnih vaginalnih penetracij in sprememba v rezultatu ocene erektilne funkcije.
English: The medicine also produced about 20% more successful vaginal penetrations than placebo.
Slovenian: Zdravilo je povzročilo tudi približno 20 % več uspešnih vaginalnih penetracij kot placebo.
English: What are the risks associated with Spedra?
Slovenian: Kakšna tveganja so povezana z zdravilom Spedra?
English: A risk management plan has been developed to ensure that Spedra is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Spedra je bil pripravljen načrt obvladovanja tveganj.
English: What is Spedra and what is it used for?
Slovenian: Kaj je zdravilo Spedra in za kaj se uporablja?
English: Spedra is available as tablets (50, 100 and 200 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Spedra je na voljo v obliki tablet (50 mg, 100 mg in 200 mg) in se izdaja le na recept.
English: It is not intended to provide practical advice on how to use Spedra.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Spedra has been studied in three main studies involving over 3,400 men with erectile dysfunction.
Slovenian: Zdravilo Spedra so proučevali v treh glavnih študijah, v katere je bilo vključenih 3 400 moških z erektilno disfunkcijo.
English: Other information about Spedra
Slovenian: Druge informacije o zdravilu Spedra
English: Doctors should consider the potential risks of sexual activity for the heart in men who have heart disease before prescribing Spedra.
Slovenian: Zdravniki naj pri moških, ki imajo srčno obolenje, pred predpisovanjem zdravila Spedra upoštevajo možna tveganja spolne dejavnosti za srce.
English: Spedra was more effective than placebo in all studies.
Slovenian: Zdravilo Spedra je bilo v vseh študijah učinkovitejše od placeba.
English: Why is Spedra approved?
Slovenian: Zakaj je bilo zdravilo Spedra odobreno?
English: The Committee therefore considered that Spedra's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor je zato zaključil, da so koristi zdravila Spedra večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Regarding its safety, side effects were similar to other medicines of its class.
Slovenian: Glede njegove varnosti so bili neželeni učinki podobni neželenim učinkom drugih zdravil iz te skupine.
English: The improvement in assessment score was about 5 to 7 points more than with placebo.
Slovenian: Izboljšanje rezultata ocene erektilne funkcije je znašalo približno od 5 do 7 točk več kot pri placebu.
English: The active ingredient in Spedra, avanafil, belongs to a group of medicines called phosphodiesterasetype-5 (PDE5) inhibitors.
Slovenian: Zdravilna učinkovina v zdravilu Spedra, avanafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5).
English: The recommended dose is 100 mg, taken approximately 15 to 30 minutes before sexual activity; patients should not take more than one dose a day.
Slovenian: Priporočeni odmerek je 100 mg, ki se vzame približno od 15 do 30 minut pred spolnim odnosom, pri čemer bolniki ne smejo vzeti več kot en odmerek na dan.
English: Spedra must not be taken with certain other medicines including nitrates (a type of medicine used for angina) or medicines that strongly reduce the breakdown of Spedra in the body.
Slovenian: Zdravilo Spedra se ne sme jemati skupaj z določenimi drugimi zdravili, vključno z nitrati (vrsto zdravil za zdravljenje angine pektoris), ali zdravili, ki močno zmanjšajo razgradnjo zdravila Spedra v telesu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Spedra, 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 in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Spedra is a medicine used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Slovenian: Zdravilo Spedra se uporablja za zdravljenje erektilne disfunkcije (imenovane tudi impotenca) pri odraslih moških, ki ne zmorejo doseči ali ohraniti dovolj čvrstega penisa (erekcije) za zadovoljiv spolni odnos.
English: An additional study involving 440 adults with erectile dysfunction was also carried out, where Spedra was taken approximately 15 minutes before sexual activity.
Slovenian: Izvedena je bila tudi dodatna študija, v katero je bilo vključenih 440 odraslih z erektilno disfunkcijo, ki so zdravilo Spedra vzeli približno 15 minut pred spolnim odnosom.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Spedra was more effective than placebo in allowing successful intercourse.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo zdravilo Spedra pri omogočanju uspešnega spolnega odnosa učinkovitejše od placeba.
English: The percentage of successful attempts was about 28% with Spedra at a dose of 200 mg and about 25% with a dose of 100 mg, compared with 14% with placebo.
Slovenian: Odstotek uspešnih poskusov je bil približno 28 % pri jemanju zdravila Spedra v odmerku 200 mg in okoli 25 % v odmerku 100 mg v primerjavi s 14 % pri jemanju placeba.
English: The most common side effects with Spedra (which may affect up to 1 in 10 people) are headache, flushing (reddening of the skin) and nasal congestion; back pain has also been reported and may affect up to 1 in 100 people.
Slovenian: Najpogostejši neželeni učinki zdravila Spedra (ki se lahko pojavijo pri največ 1 bolniku od 10) so glavobol, zardevanje (pordelost kože) in zamašenost nosu, poročali pa so tudi o bolečinah v hrbtu, ki se lahko pojavi pri največ 1 bolniku od 100.
English: The medicine must not be used by patients with certain serious heart or circulatory problems, including those who have had a heart attack, stroke, or serious arrhythmia (irregularity of the heart rhythm) in the last six months and those who have unstable angina (a severe type of chest pain), angina during sexual intercourse, heart failure, or high or low blood pressure.
Slovenian: Zdravila ne smejo uporabljati bolniki z določenimi resnimi težavami s srcem ali ožiljem, vključno z bolniki, ki so v zadnjih šestih mesecih doživeli srčni infarkt, kap ali hudo aritmijo (motnje srčnega ritma), in bolniki z nestabilno angino pektoris (hudo obliko bolečine v prsnem košu), angino pektoris med spolnim odnosom, srčnim popuščanjem ter visokim ali nizkim krvnim tlakom.
English: The first study involved men from the general population, but because certain conditions associated with erectile dysfunction might affect response to treatment the second study looked mainly at men who had erectile dysfunction and diabetes, and the third was in men who had erectile dysfunction after surgery on the prostate gland.
Slovenian: V prvo študijo so bili vključeni moški iz splošne populacije, ker pa bi lahko določena stanja, povezana z erektilno disfunkcijo, vplivala na odziv na zdravljenje, so v drugi študiji opazovali predvsem moške, ki so imeli erektilno disfunkcijo in sladkorno bolezen.
English: For practical information about using Spedra, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Spedra naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For more information about treatment with Spedra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Spedra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: However, the fact that it was not compared directly with other medicines in its class made it hard to evaluate its potential place in treating erectile dysfunction.
Slovenian: Ker pa zdravila Spedra niso neposredno primerjali z drugimi zdravili iz te skupine, je težko oceniti njegovo primernost pri zdravljenju erektilne disfunkcije.
English: It must also not be used by patients who have severely reduced liver or kidney function, or who have had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischaemic optic neuropathy, NAION) that can be triggered by this class of medicines.
Slovenian: Prav tako ga ne smejo uporabljati bolniki z močno okrnjenim delovanjem jeter ali ledvic ali bolniki, ki so izgubili vid zaradi težav z dotokom krvi v očesni živec (nearteritična anteriorna ishemična optična nevropatija - NAION), ki jih lahko sproži ta skupina zdravil.
English: The results of the first study showed that Spedra taken approximately 30 minutes before sexual activity at a dose of 100 or 200 mg increased the percentage of successful attempts at intercourse from about 13% before treatment to about 57%, whereas placebo only increased it to 27%.
Slovenian: Rezultati prve študije so pokazali, da je zdravilo Spedra v odmerku 100 mg ali 200 mg, ki se vzame približno 30 minut pred spolnim odnosom, povečalo odstotek uspešnih poskusov spolnih odnosov s 13 % pred zdravljenjem na približno 57 %, medtem ko je placebo odstotek povečal samo na 27 %.
English: In these studies, which lasted for 12 weeks, different doses of Spedra taken approximately 30 minutes before sexual activity were compared with placebo (a dummy tablet).
Slovenian: V teh študijah, ki so trajale 12 tednov, so primerjali različne odmerke zdravila Spedra, ki so ga bolniki vzeli približno 30 minut pred spolnim odnosom, s placebom (tableto brez zdravilne učinkovine).
English: For the full list of all side effects reported with Spedra, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Spedra, glejte navodilo za uporabo.
English: By blocking the breakdown of cGMP, Spedra enhances its effect on erectile function.
Slovenian: Z zaviranjem razgradnje cGMP zdravilo Spedra ponovno vzpostavi erektilno funkcijo.
English: How is Spedra used?
Slovenian: Kako se zdravilo Spedra uporablja?
English: Spedra contains the active substance avanafil.
Slovenian: Vsebuje zdravilno učinkovino avanafil.
English: For Spedra to be effective, sexual stimulation is required.
Slovenian: Zdravilo je učinkovito le ob spolnem vzburjenju.
English: The safety was considered sufficiently shown.
Slovenian: Varnost se šteje za zadostno dokazano.
English: Your symptoms may reoccur.
Slovenian: Vaši simptomi se lahko ponovno pojavijo.
English: - If you suffer from asthma.
Slovenian: - če trpite za astmo.
English: Pharmacovigilance reporting, mainly from Sweden and Spain, does not indicate any new safety issues.
Slovenian: Poročila farmakovigilance, v glavnem iz Švedske in Španije, ne kažejo novih varnostnih vprašanj.
English: ATC code: M01AX05
Slovenian: ATC oznaka: M01AX05
English: This was considered appropriate.
Slovenian: To se je zdelo ustrezno.
English: The applicant provided bibliographical data from a number of studies.
Slovenian: Vlagatelj je predložil bibliografske podatke iz številnih raziskav.
English: Approximately 38% of an intravenous dose is excreted in the urine as unchanged substance.
Slovenian: Približno 38% intravensko danega odmerka se izloči z urinom v nespremenjeni obliki.
English: Children and Adolescents
Slovenian: Otroci in mladostniki
English: The open, comparative study by Qiu 2005 did not identify any efficacy differences between the two formulations.
Slovenian: V odprti primerjalni raziskavi Qiu 2005 ni bilo opaženih nobenih razlik v učinkovitosti med obema formulacijama.
English: Two Cochrane reviews indicate efficacy but in the second review the conclusion are more hesitant.
Slovenian: Dva Cochranova pregleda nakazujeta učinkovitost, vendar je drugi pregled bolj nedoločen v zaključkih.
English: The distribution volume is approximately 5 litres and the half-life after intravenous administration is approximately 2 hours.
Slovenian: Volumen porazdelitve je približno 5 litrov, razpolovni čas po intravenski uporabi je približno 2 uri.
English: The clinical relevance is unknown.
Slovenian: Klinični pomen ni znan.
English: The period to onset of response cannot be assessed.
Slovenian: Čas začetka delovanja ni mogoče oceniti.
English: The tablets should be swallowed together with some water or other suitable liquid.
Slovenian: Tablete pogoltnite skupaj z nekaj vode ali z drugo primerno tekočino.
English: D-glucosamine has low acute toxicity.
Slovenian: D-glukozamin ima nizko akutno toksičnost.
English: Tablets can be taken with or without food.
Slovenian: Tablete se lahko zaužije skupaj s hrano ali brez nje.
English: For a full list of excipients, see section 6.1
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1
English: Additional information on special populations.
Slovenian: Dodatne informacije o posebnih skupinah bolnikov.