FrancophonIA/ELRC3.0 huggingface dataset:
English: Ulipristal acetate has a specific pharmacodynamic action on the endometrium: Changes in the histology of the endometrium may be observed in patients treated with ulipristal acetate.
Slovenian: Ulipristalacetat ima specifično farmakodinamično delovanje na endometrij.
English: Endometrial thickening
Slovenian: Odebelitev endometrija
English: Therefore, do not breast-feed your baby while taking Esmya.
Slovenian: Zato med jemanjem zdravila Esmya ne dojite.
English: These changes return to normal after treatment is stopped and your periods restart.
Slovenian: Po koncu zdravljenja te spremembe izginejo, menstruacija pa se povrne.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v mišicah in skeletu bolečine v hrbtu
English: Hot flush* Pelvic pain Ovarian cyst* Breast tenderness/pain
Slovenian: Bolezni prebavil bolečina v trebuhu navzea suha usta obstipacija dispepsija flatulenca
English: Study 2
Slovenian: Druga študija
English: Pituitary
Slovenian: omotica
English: Patient card
Slovenian: OPOZORILNA KARTICA ZA BOLNICO
English: PATIENT CARD
Slovenian: Opozorilna kartica za bolnico
English: breast discomfort - swelling due to fluid retention (oedema) - extreme tiredness (asthenia) - increase in blood cholesterol seen in blood tests, increase in blood fats (triglycerides) seen in blood tests.
Slovenian: itrakonazol), - zeliščni pripravki, ki vsebujejo šentjanževko (Hypericum perforatum), za zdravljenje depresije ali tesnobe, - nekatera zdravila za zdravljenje depresije (npr. nefazodon), - nekatera zdravila za zdravljenje visokega krvnega tlaka (npr. verapamil).
English: Musculoskeletal pain
Slovenian: Bolezni živčevja glavobol*
English: Pre-operative use:
Slovenian: Uporaba pred kirurškim posegom:
English: Do not take Esmya - if you are allergic to ulipristal acetate or any of the other ingredients of Esmya (listed in section 6).
Slovenian: Ne jemljite zdravila Esmya - če ste alergični na ulipristalacetat ali katero koli sestavino zdravila Esmya, (navedeno v poglavju 6); - če imate osnovno bolezen jeter; - če ste noseči ali če dojite; - če imate krvavitve iz spolovil, ki niso posledica materničnih leiomiomov; - če imate rak maternice, materničnega vratu, jajčnikov ali dojke.
English: • At the request of the European Medicines Agency;
Slovenian: • na zahtevo Evropske agencije za zdravila,
English: The majority of the population enrolled was Asian.
Slovenian: Večina vključene populacije je bila azijske rase.
English: Take care not to infect other people
Slovenian: Pazite, da ne okužite drugih ljudi
English: • Risk Management plan (RMP)
Slovenian: • Načrt za obvladovanje tveganj (RMP)
English: Date of first authorisation: 24 April 2007 Date of latest renewal: 16 December 2016
Slovenian: Datum prve odobritve: 24. april 2007 Datum zadnjega podaljšanja: 16. december 2016
English: Elderly (age above 65 years)
Slovenian: Starostniki (starost nad 65 let)
English: Talk to your doctor.
Slovenian: Pogovorite se z zdravnikom.
English: Your doctor will decide which treatment is most appropriate for you.
Slovenian: Zdravnik bo določil, katero zdravljenje je za vas najbolj primerno.
English: Treatment discontinuation should be considered as follows:
Slovenian: Pri odločanju o prenehanju zdravljenja je treba upoštevati naslednje:
English: This medicine is intended for long-term treatment, possibly lasting for months or years.
Slovenian: To zdravilo je namenjeno za dolgotrajno zdravljenje, ki lahko traja več mesecev ali let.
English: Results at 208 weeks
Slovenian: Rezultati po 208 tednih
English: Never share needles.
Slovenian: Nikoli si ne izmenjujte igel.
English: < 30 (not requiring dialysis)
Slovenian: <30 (dializa ni potrebna)
English: This may increase the chance of you getting unwanted side effects.
Slovenian: To bi lahko povečalo možnost, da pride do neželenih stranskih učinkov.
English: Telbivudine did not show any carcinogenic potential.
Slovenian: Telbivudin ni pokazal kancerogenega potenciala.
English: These mutations most likely are compensatory mutations.
Slovenian: Po vsej verjetnosti so navedene mutacije kompenzacijske.
English: The proposed dose modifications are based on extrapolation and may not be optimal.
Slovenian: Predlagane spremembe odmerjanja temeljijo na ekstrapolaciji in niso nujno optimalne.
English: Use within 2 months of opening the bottle.
Slovenian: Raztopino porabite v 2 mesecih po odprtju steklenice.
English: The median treatment duration was 104 weeks.
Slovenian: Mediana vrednost trajanja zdravljenja je znašala 104 tedne.
English: A vaccine is available to prevent infection with HBV.
Slovenian: Za preprečevanje okužbe s HBV je na voljo cepivo.
English: Please read these instructions carefully so that you know how to use the solution correctly.
Slovenian: Pazljivo preberite ta navodila, da boste vedeli, kako raztopino pravilno uporabljati.
English: The next dose should be taken at the usual time.
Slovenian: Naslednji odmerek mora vzeti ob običajnem času.
English: Duration of therapy The optimal treatment duration is unknown.
Slovenian: Trajanje zdravljenja Optimalno trajanje zdravljenja ni znano.
English: The combination of telbivudine with these medicinal products should be used with caution.
Slovenian: Pri uporabi kombinacij telbivudina s temi zdravili je potrebna previdnost.
English: - If you have hepatitis B and become pregnant, talk to your doctor about how you can best protect your baby.
Slovenian: - Če imate hepatitis B in zanosite, se z zdravnikom pogovorite, kako lahko kar najbolje zaščitite svojega otroka.
English: Genotypic mutation pattern and cross-resistance
Slovenian: Vzorec genotipskih mutacij in navzkrižna rezistenca
English: This effect was considered to be secondary to maternal toxicity.
Slovenian: Ta učinek naj bi bil sekundaren zaradi toksičnosti za mater.
English: Haemodialysis (up to 4 hours) reduces systemic telbivudine exposure by approximately 23%.
Slovenian: Hemodializa (v trajanju do 4 ure) zmanjša sistemsko izpostavljenost telbivudina za približno 23%.
English: SEM: Standard error of mean Roche COBAS Amplicor
Slovenian: SEM: standardna napaka ocene srednje vrednosti Roche COBAS Amplicor
English: The primary data analysis was conducted after all patients had reached week 52.
Slovenian: Primarno analizo podatkov so opravili po tem, ko so bili vsi bolniki zdravljeni vsaj 52 tednov.
English: Close the bottle firmly.
Slovenian: Steklenico trdno zaprite.
English: The most common HBV genotypes were B (26%) and C (51%).
Slovenian: Najbolj pogosta genotipa virusa hepatitisa B sta bila B (26%) in C (51%).
English: Also contains sodium.
Slovenian: Vsebuje tudi natrij.
English: Optimal therapy should be guided by resistance testing.
Slovenian: Izbira optimalnega zdravljenja naj temelji na testiranju rezistence.
English: Sebivo should be used during pregnancy only if the benefit to the mother outweighs the potential risk to the foetus.
Slovenian: Sebivo se sme uporabljati v nosečnosti samo, če koristi za mater presegajo potencialno tveganje za plod.
English: If you feel dizzy while taking this medicine, do not drive a vehicle or use any tools or machines.
Slovenian: Če ste v času jemanja tega zdravila omotični, ne vozite in ne uporabljajte naprav in strojev.
English: Do not pour it back into the bottle.
Slovenian: Ne zlivajte ga nazaj v steklenico.
English: Fertility was assessed in conventional studies performed in adult rats, and as part of a juvenile toxicology study.
Slovenian: Plodnost so ocenjevali v konvencionalnih študijah na odraslih podganah in v sklopu toksikološke študije na mladih podganah.
English: Normal
Slovenian: normalno
English: Response parameter
Slovenian: parameter odziva
English: Patients with previous exposure to nucleoside/nucleotide analogues
Slovenian: Bolniki, ki so bili že prej izpostavljeni zdravljenju z analogi nukleozidov/nukleotidov
English: Pregnancy and breast-feeding - Do not use Sebivo during pregnancy unless your doctor recommends it.
Slovenian: Nosečnost in dojenje - Zdravila Sebivo ne uporabljajte v nosečnosti, če vam tega ni priporočil zdravnik.
English: Creatine kinase elevation
Slovenian: Zvišanje kreatin kinaze
English: Clinical studies of telbivudine did not include sufficient numbers of patients  65 years of age to determine whether they respond differently from younger subjects.
Slovenian: V klinične študije telbivudina ni bilo vključeno dovolj veliko število bolnikov, starih 65 let ali več, da bi lahko ugotovili, če se odzivajo drugače kot mlajše osebe.
English: Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment.
Slovenian: Zdravnika takoj obvestite o kakršnihkoli novih ali nenavadnih simptomih, ki bi jih opazili po zaključku zdravljenja.
English: Children and adolescents Sebivo is not recommended for use in children and adolescents.
Slovenian: Otroci in mladostniki Uporaba zdravila Sebivo ni priporočljiva pri otrocih in mladostnikih.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije na živalih ne kažejo na neposredne škodljive vplive na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: With prolonged treatment for more than 2 years, regular reassessment is recommended to confirm that continuation of the selected therapy remains appropriate for the patient.
Slovenian: Pri dolgotrajnem zdravljenju, ki traja več kot 2 leti, je priporočeno, da zdravnik redno ponovno presoja, ali je nadaljevanje izbranega zdravljenja še vedno primerno za bolnika.
English: How much Sebivo to take
Slovenian: Koliko zdravila Sebivo vzeti
English: Therefore, close clinical monitoring is recommended in these patients.
Slovenian: Zato je pri teh bolnikih priporočeno skrbno klinično spremljanje.
English: If any of these applies to you, tell your doctor before you take Sebivo.
Slovenian: Če kaj od navedenega velja za vas, povejte to svojemu zdravniku, še preden boste vzeli Sebivo.
English: Such patients should, therefore, be closely monitored.
Slovenian: Zato je treba take bolnike skrbno spremljati.
English: Some people may get very serious hepatitis symptoms when they stop taking medicines like Sebivo.
Slovenian: Pri nekaterih ljudeh lahko pride od hudih simptomov hepatitisa, ko prenehajo jemati zdravila, kot je Sebivo.
English: Other side effects of this type of medicine
Slovenian: Drugi neželeni učinki te vrste zdravil
English: What Sebivo is and what it is used for
Slovenian: Kaj je zdravilo Sebivo in za kaj ga uporabljamo
English: Due to the limited data available (about 3% of patients enrolled had cirrhosis), telbivudine should be used with particular caution in cirrhotic patients.
Slovenian: Zaradi majhnega števila razpoložljivih podatkov (približno 3% vključenih bolnikov je imelo cirozo) je pri uporabi telbivudina pri bolnikih s cirozo potrebna posebna previdnost.
English: Tell your doctor or pharmacist if you are being treated with interferon.
Slovenian: Svojemu zdravniku ali farmacevtu povejte, če se zdravite z interferonom.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to telbivudine in clinical trials (n = 8,914).
Slovenian: Kategorijo pogostnosti so določili na podlagi statističnega izračuna glede na skupno število bolnikov, ki so prejemali telbivudin v kliničnih preskušanjih (n = 8.914).
English: If you forget to take Sebivo - If you forget to take Sebivo, take it as soon as you remember and then take your next dose at its regular time.
Slovenian: Če ste pozabili vzeti zdravilo Sebivo - Če ste pozabili vzeti zdravilo Sebivo, ga vzemite takoj, ko se spomnite, naslednji odmerek pa vzemite ob običajnem času.
English: Patients should be followed closely.
Slovenian: Bolnike je treba skrbno spremljati.
English: No novel mutation was reported.
Slovenian: O kakršnikoli novi mutaciji niso poročali.
English: Effect of food on oral absorption
Slovenian: Vpliv hrane na absorpcijo peroralnega odmerka
English: Remove the dosing cup and open the bottle.
Slovenian: Odstranite odmerno posodico in odprite steklenico.
English: Metabolism and nutrition disorders Rare*
Slovenian: Presnovne in prehranske motnje redki*
English: Your doctor will discuss with you the potential risks of taking Sebivo during pregnancy.
Slovenian: Z zdravnikom se pogovorite o možnih tveganjih jemanja zdravila Sebivo med nosečnostjo.
English: Take the pack with you and show it to the doctor.
Slovenian: Škatlico vzemite s seboj in jo pokažite zdravniku.
English: Week 52 Week 104 Week 156 Week 208
Slovenian: po 52 tednih po 104 tednih po 156 tednih po 208 tednih
English: The absence of activity of telbivudine against HIV has not been evaluated in clinical trials.
Slovenian: Odsotnosti delovanja telbivudina proti HIV v kliničnih preskušanjih niso ocenjevali.
English: The mechanism behind these events is not known (see section 4.4).
Slovenian: Mehanizem teh pojavov ni znan (glejte poglavje 4.4).
English: Telbivudine is eliminated primarily by urinary excretion of unchanged substance.
Slovenian: Telbivudin se izloča predvsem z urinom kot nespremenjena učinkovina.
English: Cmax (g/ml) AUC0-∞ (g•h/ml) CLRENAL (ml/min)
Slovenian: Cmax (g/ml) AUC0-∞ (g•h/ml) CLLEDVIC (ml/min)
English: Monitoring during treatment
Slovenian: Spremljanje odziva med zdravljenjem
English: Sebivo belongs to a group of medicines called antiviral medicines, which are used to treat infections caused by viruses.
Slovenian: Sebivo sodi v skupino zdravil, ki jih imenujemo protivirusna zdravila in jih uporabljamo za zdravljenje okužb z virusi.
English: HBV DNA at week 24
Slovenian: HBV DNA po 24 tednih
English: EU/1/07/388/001 28 film-coated tablets EU/1/07/388/002 98 film-coated tablets
Slovenian: EU/1/07/388/001 28 filmsko obloženih tablet EU/1/07/388/002 98 filmsko obloženih tablet
English: Table 2 lists the adverse reactions according to MedDRA system organ class and frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: V preglednici 2 so po organskih sistemih klasifikacije MedDRA in pogostnosti našteti neželeni učinki, in sicer po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Changes in Knodell necroinflammatory and Ishak scores were similar for HBeAg-positive and HBeAg-negative patients.
Slovenian: Spremembe ocen na Knodellovi nekroinflamatorni lestvici in na Ishakovi lestvici so bile podobne pri HBeAg-pozitivnih in HBeAg-negativnih bolnikih.
English: Telbivudine is excreted in the milk of rats.
Slovenian: Telbivudin se pri podganah izloča v mleko.
English: Do not change your dose or stop taking Sebivo without talking to your doctor.
Slovenian: Ne spreminjajte odmerka in ne prenehajte jemati zdravila Sebivo, ne da bi se prej pogovorili z zdravnikom.
English: If you have sexual intercourse with a partner who is not immune against hepatitis B, always use condoms and avoid any other exchange of body fluids.
Slovenian: Pri spolnih odnosih s partnerjem, ki ni imun na virus hepatitisa B, vedno uporabljajte kondom in se izogibajte kakršnikoli izmenjavi telesnih tekočin.
English: Tested doses up to 1,800 mg/day, three times greater than the recommended daily dose, have been well tolerated.
Slovenian: Poskusne odmerke do 1.800 mg/dan, ki so trikrat večji od priporočenega dnevnega odmerka, so preiskovanci dobro prenašali.
English: The renal clearance of telbivudine approaches normal glomerular filtration rate, suggesting that filtration is the main mechanism of excretion.
Slovenian: Ledvični očistek telbivudina je skoraj enak normalni hitrosti glomerulne filtracije, kar kaže na to, da je filtracija glavni način izločanja.
English: Inter-subject variability (CV%) for measures of systemic exposures (Cmax, AUC) was typically approximately 30%.
Slovenian: Variabilnost med posamezniki (interindividualna variabilnost - CV%) za parametre sistemske izpostavljenosti (Cmax, AUC) je bila karakteristično približno 30%.
English: If patients test positive for HBV DNA at any time after their initial response, treatment modification should be considered.
Slovenian: Če pri bolniku kadarkoli po začetnem odzivu pride do pozitivnega izida testa HBV DNA, je treba razmisliti o spremembi zdravljenja.
English: Clinical results at week 104
Slovenian: Klinični rezultati po 104 tednih
English: Therefore, the potential for CYP450-mediated drug interactions involving Sebivo is low.
Slovenian: Zato je možnost medsebojnih interakcij z zdravili preko CYP450 majhna.
English: In vitro binding of telbivudine to human plasma proteins is low (3.3%).
Slovenian: In vitro se telbivudin le malo veže na humane proteine v plazmi (3,3%).
English: In the 104-week clinical studies, reported adverse reactions were usually classified as mild or moderate in severity.
Slovenian: V 104-tedenskih kliničnih študijah so neželene učinke, o katerih so poročali, po jakosti običajno opredelili kot blage ali zmerne.
English: If a dose is missed, the patient may take the missed dose only up to 4 hours prior to the next scheduled dose.
Slovenian: Če bolnik pozabi vzeti odmerek, lahko pozabljeni odmerek vzame le v primeru, da je do naslednjega predvidenega odmerka več kot 4 ure.
English: It is not known whether the risk of myopathy during treatment with telbivudine is increased with concurrent administration of other medicinal products associated with myopathy (e.g. statins, fibrates, or ciclosporin).
Slovenian: Ni znano, ali je tveganje za miopatijo med zdravljenjem s telbivudinom povečano ob sočasni uporabi drugih zdravil, ki so povezana z miopatijo (npr. statinov, fibratov ali ciklosporina).
English: Cumulative genotypic resistance rates were also assessed by applying a mathematical model where only patients with undetectable HBV DNA at the beginning of the respective year are considered.
Slovenian: Kumulativne deleže genotipske rezistence so ocenili tudi s pomočjo matematičnega modela, v katerega so vključili samo podatke bolnikov z nemerljivo vrednostjo HBV DNA na začetku posameznega leta.
English: Predictability at week 24
Slovenian: Možnosti napovedovanja po 24 tednih
English: Lactic acidosis is a rare but serious side effect which can occasionally be fatal.
Slovenian: Laktacidoza je redek, a resen neželen učinek, ki se v posameznih primerih lahko konča smrtno.
English: Detailed instructions on how to use this are given in the section “Instructions for use”.
Slovenian: Podrobna navodila za uporabo te brizge so navedena v poglavju “Navodila za jemanje zdravila”.
English: Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment (see “If you stop taking Sebivo” in section 3 of this leaflet).
Slovenian: Zdravnika takoj obvestite o kakršnihkoli novih ali nenavadnih simptomih, ki bi jih opazili po zaključku zdravljenja (glejte odstavek z naslovom “Če ste prenehali jemati zdravilo Sebivo” v poglavju 3 tega navodila za uporabo).
English: Cases were more often secondary to other serious conditions (e.g. rhabdomyolysis) and/or associated with muscle-related events (e.g. myopathy, myositis).
Slovenian: Ti primeri so se pogosto pojavljali sekundarno pri drugih resnih stanjih (npr. pri rabdomiolizi) in/ali v povezavi z dogodki, ki so bili povezani z mišicami (npr. z miopatijo ali miozitisom).
English: On-treatment response at week 24 has been shown to be predictive of longer-term response (see Table 7 in section 5.1).
Slovenian: Pokazalo se je, da odziv po 24 tednih zdravljenja lahko napove dolgoročen odziv (glejte preglednico 7 v poglavju 5.1).
English: In the event of an overdose, Sebivo should be discontinued and appropriate general supportive treatment applied as necessary.
Slovenian: V primeru prevelikega odmerjanja je treba zdravljenje z zdravilom Sebivo prekiniti in po potrebi poskrbeti za ustrezne splošne ukrepe podpornega zdravljenja.
English: Bottle containing the oral solution.
Slovenian: Steklenica, ki vsebuje peroralno raztopino.
English: Sebivo film-coated tablets are supplied in packs of 28 or 98 tablets.
Slovenian: Sebivo filmsko obložene tablete so na voljo v pakiranju po 28 ali 98 tablet.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Slovenian: Vaš zdravnik bo redno spremljal vaše stanje in tako preverjal, ali ima zdravljenje pri vas želen učinek.
English: Do not take Sebivo if you are using pegylated or standard interferon alfa (see “Do not take Sebivo”), because the combination of these medicines may increase your risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensations in the arms and/or legs).
Slovenian: Ne jemljite zdravila Sebivo, če uporabljate pegilirani ali standardni interferon alfa (glejte "Ne jemljite zdravila Sebivo"), ker kombinacija teh zdravil lahko poveča tveganje za razvoj periferne nevropatije (odrevenelosti, mravljinčenja in/ali pekočega občutka v rokah in/ali nogah).
English: Pharmacotherapeutic group: Antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF11
Slovenian: Farmakoterapevtska skupina: protivirusna zdravila za sistemsko zdravljenje, zaviralci nukleozidne in nukleotidne reverzne transkriptaze, oznaka ATC: J05AF11
English: Do not share personal items that could have blood or body fluids on them, such as toothbrushes or razor blades.
Slovenian: Ne dovolite, da bi drugi uporabljali vaše osebne predmete, na katerih bi lahko bila kri ali druge telesne tekočine, na primer zobne krtačke ali britvice.
English: Conversions at position 80, 180 and polymorphic positions 91, 229 were always detected in sequences that harboured the M204I mutation that confers genotypic resistance.
Slovenian: Konverzije na mestih 80, 180 in polimorfnih mestih 91, 229 so vedno odkrivali v zaporedjih, ki so nosila mutacijo M204I, ta pa prinaša genotipsko rezistenco.
English: Rare (may affect up to 1 in 1,000 people) - Excess of lactic acid in the blood (lactic acidosis) - Muscle breakdown (rhabdomyolysis)
Slovenian: Redki (lahko prizadenejo do 1 od 1.000 ljudi) - čezmerno kopičenje mlečne kisline v krvi (laktacidoza) - razgradnja mišic (rabdomioliza).
English: Baseline to week 24 Week 24 to end of study
Slovenian: skupaj od izhodišča do 24. tedna od 24. tedna do konca študije
English: Paediatrics and elderly (65 years age and above) Pharmacokinetic studies have not been conducted in paediatric or elderly subjects.
Slovenian: Otroci in starostniki (stari 65 let ali več) Farmakokinetičnih študij pri otrocih in starostnikih niso opravili.
English: The clinical significance of these reductions has not been determined.
Slovenian: Ni še ugotovljeno, kakšen je klinični pomen navedenega znižanja.
English: Muscular effects
Slovenian: Vpliv na mišice
English: Studies in pregnant rabbits showed early delivery and/or abortion secondary to maternal toxicity.
Slovenian: V študiji na brejih kuncih je prišlo do prezgodnje skotitve in/ali splava sekundarno zaradi toksičnosti pri materi.
English: Take the pack of tablets with you and show it to your doctor.
Slovenian: Škatlico tablet vzemite s seboj in jo pokažite zdravniku.
English: The tablet should not be chewed, split or crushed.
Slovenian: Tablet se ne sme žvečiti, lomiti ali drobiti.
English: Clinical results at week 52
Slovenian: Klinični rezultati po 52 tednih
English: Overall
Slovenian: Splošno
English: No data are available to support a specific dose recommendation for patients over the age of 65 years (see section 4.4).
Slovenian: Ni razpoložljivih podatkov, na katerih bi temeljila posebna priporočila za odmerjanje pri ljudeh, starih več kot 65 let (glejte poglavje 4.4).