FrancophonIA/ELRC3.0 huggingface dataset:
English: Dark brownish purple, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm).
Slovenian: Temno rjavkasto vijoličasta, ovalna, bikonveksna filmsko obložena tableta z oznako “S12” in logotipom podjetja Boehringer Ingelheim na eni strani ter oznako “1000” na drugi strani (dolžina tablete: 21,1 mm, širina tablete: 9,7 mm).
English: * p-value <0.0001 for non-inferiority, and p-value = 0.0153 for superiority ** p-value <0.0001
Slovenian: Statistična značilnost ni bila ocenjena zaradi zaporednega potrditvenega postopka testiranja 3 LOCF, vrednosti po cenzuriranju antihipertenzivnega reševanja * vrednost p < 0,0001 za enakovrednost, in vrednost p = 0,0153 za superiornost ** vrednost p < 0,0001
English: • changes the way things taste
Slovenian: • spremembe v okušanju
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.
Slovenian: metformin znižuje ravni skupnega holesterola, LDL holesterola in ravni trigliceridov.
English: (97.5% CI) a Subgroup analysis for patients on additional background of metformin (FAS, LOCF) b Subgroup analysis for patients on additional background of metformin (PPS-Completers, LOCF) 1 Mean adjusted for baseline value
Slovenian: Razlika glede na placebo1 (97,5-odstotni IZ) a Analiza pri podskupinah bolnikov ob dodatni prisotnosti metformina (FAS, LOCF)
English: • a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034,
Slovenian: (43,3 dogodka/1.000 bolnikov-let), p = 0,0023, in v primerjavi z obema skupinama s sulfonilsečnino ali insulinom v monoterapiji (40,1 dogodka/1.000 bolnikov-let), p = 0,0034;
English: Major hypoglycaemic events occurred in 0.5%, 0% and 0.5% of patients treated with empagliflozin 10 mg, empagliflozin 25 mg and placebo when added on to metformin and insulin, respectively.
Slovenian: Pri 0,5 % bolnikov, ki so kot dodatek k metforminu in insulinu prejemali empagliflozin 10 mg, 0 % bolnikov, ki so prejemali empagliflozin
English: Empagliflozin twice daily versus once daily as add on to metformin therapy The efficacy and safety of empagliflozin twice daily versus once daily (daily dose of 10 mg and 25 mg) as add-on therapy in patients with in sufficient glycemic control on metformin monotherapy was evaluated in a double blind placebo-controlled study of 16 weeks duration.
Slovenian: (dnevni odmerek 10 mg in 25 mg) kot dodatnim zdravljenjem k metforminu pri bolnikih z nezadostno urejeno glikemijo, ki prejemajo metformin v monoterapiji, so ocenili v dvojno slepi, s placebom nadzorovani študiji, ki je trajala 16 tednov.
English: No patient had a major hypoglycaemic event in the combination with metformin and a sulphonylurea.
Slovenian: Pri kombinaciji z metforminom in sulfonilsečnino se pri nobenem od bolnikov ni pojavil hud hipoglikemični dogodek.
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post marketing in patients treated with SGLT2 inhibitors, including empagliflozin.
Slovenian: V kliničnih preskušanjih in v obdobju trženja so pri bolnikih, ki so bili zdravljeni z zaviralci SGLT2,
English: The overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) in metformin-treated patients who received empagliflozin was low: 0.6% for empagliflozin 10 mg, 0.3% for empagliflozin 25 mg and 0.1% for placebo.
Slovenian: hipovolemija, ortostatska hipotenzija in sinkopa) je bila pri bolnikih, zdravljenih z metforminom, ki so prejemali empagliflozin nizka: 0,6 % za empagliflozin 10 mg, 0,3 % za empagliflozin 25 mg in 0,1 %
English: • itching
Slovenian: (NSAID).
English: • excessive hunger, headache
Slovenian: • bruhanje, trebušne bolečine • mišični krči
English: In a pre-specified pooled analysis of 4 placebo-controlled studies, treatment with empagliflozin (68% of all patients were on metformin background) resulted in a reduction in systolic blood pressure (empagliflozin 10 mg: -3.9 mmHg, empagliflozin 25 mg: -4.3 mmHg) compared with placebo (-0.5 mmHg), and in diastolic blood pressure (empagliflozin 10 mg: -1.8 mmHg, empagliflozin 25 mg: -2.0 mmHg) compared with placebo (-0.5 mmHg), at week 24, that were maintained up to week 52.
Slovenian: V predhodno specificirani analizi zbranih podatkov iz 4 s placebom nadzorovanih študij je zdravljenje z empagliflozinom (68 % vseh bolnikov je ob tem prejemalo metformin) v 24. tednu povzročilo znižanje sistoličnega krvnega tlaka (empagliflozin 10 mg: -3,9 mmHg; empagliflozin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovenian: Ena tableta vsebuje 12,5 mg empagliflozina in 850 mg metforminijevega klorida.
English: Therefore, serum creatinine levels should be determined before initiating treatment and regularly thereafter:
Slovenian: Ker se metformin izloča skozi ledvice, je treba pred začetkom zdravljenja in redno med zdravljenjem meriti raven kreatinina v serumu: • vsaj enkrat letno pri bolnikih z normalnim delovanjem ledvic,
English: A greater proportion of patients with a baseline HbA1c ≥7.0% and treated with empagliflozin plus linagliptin achieved a target
Slovenian: V primerjavi z linagliptinom 5 mg je večji delež bolnikov, zdravljenih z empagliflozinom z linagliptinom in z izhodiščno vrednostjo HbA1c ≥ 7,0 %, dosegel ciljno vrednost HbA1c < 7 %.
English: The results of bioequivalence studies in healthy subjects demonstrated that Synjardy (empagliflozin/metformin hydrochloride) 5 mg/850 mg, 5 mg/1,000 mg, 12.5 mg/850 mg, and 12.5 mg/1,000 mg combination tablets are bioequivalent to co-administration of corresponding doses of empagliflozin and metformin as individual tablets.
Slovenian: Rezultati bioekvivalenčnih študij pri zdravih prostovoljcih so pokazali, da so kombinirane tablete zdravila Synjardy (empagliflozin/metforminijev klorid) 5 mg/850 mg, 5 mg/1.000 mg,
English: * p-value <0.0001 ** p-value ≤0.025
Slovenian: ** vrednost p ≤ 0,025
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovenian: Ena tableta vsebuje 5 mg empagliflozina in 850 mg metforminijevega klorida.
English: • in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin (see sections 4.5 and 5.1 for available data on different combinations)
Slovenian: 18 let in več, za izboljšanje urejenosti glikemije kot dopolnilo k dieti in telesni aktivnosti: • pri bolnikih z nezadostno urejeno boleznijo pri jemanju največjega odmerka metformina, ki ga še prenašajo, v monoterapiji; • pri bolnikih z nezadostno urejeno boleznijo pri jemanju metformina v kombinaciji z drugimi zdravili, ki nižajo raven glukoze, vključno z insulinom (glejte poglavji 4.5 in 5.1 za podatke o različnih kombinacijah);
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovenian: Ena tableta vsebuje 12,5 mg empagliflozina in 1.000 mg metforminijevega klorida.
English: Patients with baseline HbA1c ≥9% In a pre-specified analysis of subjects with baseline HbA1c ≥9.0%, treatment with empagliflozin
Slovenian: Bolniki z izhodiščno vrednostjo HbA1c ≥ 9 %
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Slovenian: Ena tableta vsebuje 5 mg empagliflozina in 1.000 mg metforminijevega klorida.
English: Synjardy 12.5 mg/1,000 mg film-coated tablets are dark brownish purple, oval, biconvex.
Slovenian: Synjardy 12,5 mg/1000 mg filmsko obložene tablete so temno rjavkasto vijoličaste, ovalne,
English: Treatment with empagliflozin as add-on to metformin or metformin plus sulfonylurea resulted in clinically meaningful improvement of 2-hour post-prandial glucose (meal tolerance test) at 24 weeks (add-on to metformin, placebo: +5.9 mg/dl, empagliflozin 10 mg: -46.0 mg/dl, empagliflozin 25 mg: -44.6 mg/dl; add-on to metformin plus sulphonylurea, placebo: -2.3 mg/dl, empagliflozin 10 mg: -35.7 mg/dl, empagliflozin 25 mg: -36.6 mg/dl).
Slovenian: 24. tednu (dodatno zdravljenje k metforminu, placebo +5,9 mg/dl, empagliflozin 10 mg: -46,0 mg/dl,
English: In male rats, treatment-related benign vascular proliferative lesions (haemangiomas) of the mesenteric lymph node were observed at the highest dose, but not at 300 mg/kg/day, which corresponds to approximately 26-times the maximal clinical exposure to empagliflozin.
Slovenian: Pri podganjih samcih so pri najvišjih odmerkih, ne pa tudi pri 300 mg/kg/dan, kar ustreza približno 26-kratni največji klinični izpostavljenosti empagliflozinu,
English: At exposures sufficiently in excess of exposure in humans after therapeutic doses, empagliflozin had no adverse effects on fertility or early embryonic development.
Slovenian: empagliflozin ni imel neželenih učinkov na sposobnost razmnoževanja ali zgodnji razvoj zarodka.
English: Vascular disorders
Slovenian: Po peroralnem zaužitju raztopine
English: Baseline (mean) Change from baseline1
Slovenian: Izhodišče (povprečje) Sprememba od izhodišča1
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Synjardy 5 mg/850 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Slovenian: Synjardy 5 mg/850 mg filmsko obložene tablete Ena tableta vsebuje 5 mg empagliflozina in 850 mg metforminijevega klorida.
English: • severe tiredness
Slovenian: • srbečica
English: PHARMACEUTICAL FORM AND CONTENTS 60 x 1 film-coated tablets.
Slovenian: 60 x 1 filmsko obložena tableta.
English: SBP (mmHg)2, 3
Slovenian: Razlika glede na placebo1 (97,5-odstotni IZ) N Vrednost SBP (mmHg)2, 3
English: Symptoms of lactic acidosis are non-specific such as feeling or being very sick, vomiting, stomach ache with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing.
Slovenian: trebušne bolečine z mišičnimi krči, splošno slabo počutje z izrazito utrujenostjo in oteženo dihanje.
English: 24 hour SBP at week 123
Slovenian: 24-urni diastolični krvni tlak v 12. tednu3 Izhodišče (povprečje)
English: 200 mg (1 mg/ml) after reconstitution
Slovenian: 200 mg (1 mg/ml) po rekonstituciji
English: 1 Bottle
Slovenian: 1 plastenka
English: 200 mg Powder for oral solution Oral use
Slovenian: 200 mg prašek za peroralno raztopino
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Slovenian: številka EU ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: 20 mg Gastro-resistant capsule, hard
Slovenian: 20 mg gastrorezistentna kapsula, trda peroralna uporaba plastenka (HDPE)
English: (Invented) name Strength Pharmaceutical form Route of administration
Slovenian: Jakost Farmacevtska oblika Pot uporabe
English: Bottle (HDPE) 14 capsules
Slovenian: 14 kapsul
English: As a result, levodopa remains active for longer.
Slovenian: Posledično ostane levodopa aktivna dlje.
English: It can be taken with or without food.
Slovenian: Zdravilo se lahko jemlje s hrano ali brez nje.
English: The marketing authorisation was renewed on 16 September 2003 and on 16 September 2008.
Slovenian: Dovoljenje za promet z zdravilom je bilo obnovljeno dne 16. septembra 2003 in 16. septembra 2008.
English: The patients then lose their ability to control their movements reliably.
Slovenian: Bolniki zatem izgubijo zmožnost zanesljivega nadzora nad svojimi gibi.
English: It is available as brown-orange tablets (200 mg).
Slovenian: Na voljo je v obliki rjavkastooranžnih tablet (200 mg).
English: Other information about Comtess:
Slovenian: Druge informacije o zdravilu Comtess:
English: It should not be used with combinations that are ‘modified release' (when the levodopa is released slowly over a few hours).
Slovenian: Ne sme se ga uporabljati v kombinacijah s „prilagojenim sproščanjem“ (kjer se levodopa počasi sprošča v obdobju več ur).
English: What benefit has Comtess shown during the studies?
Slovenian: Kakšne koristi je zdravilo Comtess izkazalo med študijami?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Comtess on 16 September 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Comtess, veljavno po vsej Evropski uniji, odobrila dne 16. septembra 1998.
English: The Committee recommended that Comtess be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Comtess odobri dovoljenje za promet.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) COMTESS EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) COMTESS Povzetek EPAR za javnost
English: Comtess is used to treat patients with Parkinson's disease.
Slovenian: Zdravilo Comtess se uporablja za zdravljenje bolnikov s Parkinsonovo boleznijo.
English: When patients first add Comtess to their existing medication, they may need to take a lower daily dose of levodopa, either by changing how often they take it, or by reducing the amount of levodopa taken in each dose.
Slovenian: Ko bolnik prvič doda zdravilo Comtess svojim obstoječim zdravilom, bo morda moral vzeti manjši dnevni odmerek levodope, kar lahko doseže tako, da bodisi spremeni pogostost jemanja levodope ali pa zmanjša količino levodope, zaužite v vsakem odmerku.
English: Comtess should not be used in patients with:
Slovenian: Zdravila Comtess ne smejo uporabljati bolniki:
English: • liver disease;
Slovenian: • z obolenji jeter,
English: • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Slovenian: • ki so imeli v preteklosti nevroleptični maligni sindrom (nevarno obolenje živčnega sistema, ki ga običajno povzročijo antipsihotična zdravila) ali rabdomiolizo (razgradnjo mišičnih vlaken).
English: Fluctuations happen when the effects of the medication wear off and symptoms re-emerge.
Slovenian: Do nihanj pride, ko začnejo učinki zdravil popuščati in se ponovno pojavijo značilni simptomi.
English: The main measure of effectiveness was the time spent in the ‘on' state (the time when levodopa is controlling the symptoms of Parkinson's disease) after the first levodopa dose of the morning in the first study, and over one day in the second study.
Slovenian: Glavno merilo učinkoitosti je bil čas, ko je bilo bolnikovo stanje dobro (stanje „vklopa“, ko je levodopa nadzorovala simptome Parkinsonove bolezni), in sicer po prvem jutranjem odmerku levodope v prvi študiji in v teku celega dne v drugi študiji.
English: What is the risk associated with Comtess?
Slovenian: Kakšna tveganja so povezana z zdravilom Comtess?
English: Comtess is a medicine that contains the active substance entacapone.
Slovenian: Comtess je zdravilo, ki vsebuje zdravilno učinkovino entakapon.
English: Comtess should not be used in people who may be hypersensitive (allergic) to entacapone or any of the other ingredients.
Slovenian: Zdravila Comtess ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) entakapon ali katero koli drugo sestavino zdravila.
English: Comtess was more effective than placebo in both studies.
Slovenian: V obeh študijah je bilo zdravilo Comtess učinkovitejše od placeba.
English: It is taken as one tablet with each dose of the other medicine, up to a maximum of 10 tablets a day.
Slovenian: Bolnik zaužije eno tableto zdravila Comtess skupaj z vsakim odmerkom drugega zdravila, vendar največ 10 tablet na dan.
English: In the first study, adding Comtess increased the ‘on' time by 1 hour and 18 minutes more than adding placebo.
Slovenian: V prvi študiji je dodajanje zdravila Comtess podaljšalo trajanje stanja „vklopa“ za 1 uro in 18 minut v primerjavi s placebom.
English: In the second study, the ‘on' time was increased by 35 minutes compared with placebo.
Slovenian: V drugi študiji je bil v primerjavi s placebom ta čas daljši za 35 minut.
English: Why has Comtess been approved?
Slovenian: Zakaj je bilo zdravilo Comtess odobreno?
English: The most common side effects with Comtess (seen in between 1 and 10 patients in 100) are dyskinesia (uncontrollable movements), nausea (feeling sick) and harmless urine discoloration.
Slovenian: Najpogostejši neželeni učinki zdravila Comtess (opaženi pri 1 do 10 bolnikih izmed 100) so diskinezija (nekontrolirani gibi), navzeja (občutek slabosti) in nenevarna sprememba barve urina.
English: It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Slovenian: Deluje samo pri uporabi skupaj z levodopo, kopijo živčnega prenašalca dopamina, ki se jo lahko jemlje peroralno.
English: Comtess has been studied in a total of 376 patients with Parkinson's disease, in two six-month studies that measured the effects of adding Comtess or placebo (a dummy medicine) to the patient's combination of levodopa and carbidopa or levodopa and benserazide.
Slovenian: Zdravilo Comtess so preučevali pri skupno 376 bolnikih s Parkinsonovo boleznijo v dveh šestmesečnih študijah, v katerih so merili učinke dodajanja zdravila Comtess ali placeba (zdravila brez zdravilne učinkovine) bolnikovi kombinaciji levodope in karbidope oziroma levodope in benserazida.
English: For the full list of all side effects reported with Comtess, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Comtess, glejte navodilo za uporabo.
English: • phaeochromocytoma (a tumour of the adrenal gland);
Slovenian: • s feokromocitomom (tumorjem nadledvične žleze),
English: The active substance in Comtess, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Slovenian: Zdravilna učinkovina v zdravilu Comtess, entakapon, deluje tako, da ponovno vzpostavi ravni dopamina v delih možganov, ki nadzorujejo gibe in njihovo usklajenost.
English: They are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulties moving about.
Slovenian: Nihanja so povezana z zmanjšanjem učinka levodope, ko bolnik doživlja nenadne preskoke med stanjem, ko se lahko giblje (stanje „vklopa“), in med stanjem, ko ima z gibanjem težave (stanje „izklopa“).
English: Comtess should not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Slovenian: Zdravilo Comtess se ne sme jemati hkrati z drugimi zdravili, ki spadajo v skupino zaviralcev monoaminooksidaze (vrste antidepresivov).
English: Comtess can only be used with conventional combinations of levodopa.
Slovenian: Zdravilo Comtess se lahko uporablja le s standardnimi kombinacijami levodope.
English: The full EPAR for Comtess is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Comtess je na voljo tukaj.
English: See the Summary of Product Characteristics (also part of the EPAR) for full details.
Slovenian: Za podrobne informacije glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Comtess is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘fluctuations' towards the end of the period between two doses of their medication.
Slovenian: Zdravilo Comtess se uporablja skupaj z levodopo (bodisi v kombinaciji z levodopo in benserazidom ali kombinaciji z levodopo in karbidopo), kadar bolnik doživlja „nihanja“ proti koncu obdobja med dvema odmerkoma zdravil.
English: Comtess is used when these fluctuations cannot be treated with the standard levodopacontaining combination alone.
Slovenian: Zdravilo Comtess se uporablja, kadar nihanj ne moremo zdraviti samo s standardno kombinacijo, ki vsebuje levodopo.
English: Comtess is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Slovenian: Zdravilo Comtess se uporablja samo v kombinaciji z levodopo in benserazidom oziroma levodopo in karbidopo.
English: This helps to improve the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Slovenian: To olajša simptome Parkinsonove bolezni, kot sta otrdelost mišic in upočasnjeno izvajanje gibov.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Comtess's benefits are greater than its risks as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Comtess kot dodatka k standardnima kombinacijama levodope/benserazida oziroma levodope/karbidope za zdravljenje bolnikov s Parkinsonovo boleznijo in motoričnimi nihanji ob koncu delovanja odmerka, ki jih ne moremo stabilizirati z navedenimi kombinacijami, večje od z njim povezanih tveganj.
English: Entacapone blocks an enzyme that is involved in the breakdown of levodopa in the body called
Slovenian: Entakapon blokira encim, imenovan katehol-O-metiltransferaza (COMT), ki sodeluje pri razgradnji levodope v telesu.
English: How does Comtess work?
Slovenian: Kako zdravilo Comtess deluje?
English: How has Comtess been studied?
Slovenian: Kako je bilo zdravilo Comtess raziskano?
English: What is Comtess used for?
Slovenian: Za kaj se zdravilo Comtess uporablja?
English: How is Comtess used?
Slovenian: Kako se zdravilo Comtess uporablja?
English: What is Comtess?
Slovenian: Kaj je zdravilo Comtess?
English: Patients under 18 years of age.
Slovenian: Bolniki, mlajši od 18 let.
English: These beneficial effects were maintained for up to 52 weeks.
Slovenian: Ti koristni učinki so se vzdrževali do 52 tednov dolgo.
English: Further to the assessment of:
Slovenian: v zvezi z vrednotenjem:
English: On 23 June 2005, the CHMP concluded that:
Slovenian: Dne 23. junija je CHMP zaključil, da:
English: The volume of distribution (Vss) is 9 L.
Slovenian: Porazdelitveni prostor (Vss) je 9 l.
English: Patients should not exceed this dose.
Slovenian: Bolniki ne smejo prekoračiti tega odmerka.
English: The undesirable effects profile was generally similar to that reported in the OA and RA studies.
Slovenian: Profil neželenih učinkov je bil na splošno podoben tistemu, o katerem so poročali v študijah OA in RA.
English: However, exposure is limited to clinical trials.
Slovenian: Vendar pa je izpostavljenost omejena na klinična preizkušanja.
English: The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 and requested further changes.
Slovenian: CHMP je potrdil spremembe Informacij o zdravilu, že vnešene z variacijo tipa II, sprejeto maja 2005 in zahteval še nadaljne spremembe.
English: [Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Rare (>1/10,000, <1/1,000) Very rare
Slovenian: [pogosti (>1/100, <1/10) občasni (>1/1.000, <1/100) redki (>1/10.000, <1/1.000) zelo redki
English: Median tmax is about 2 hours post dose.
Slovenian: Mediani tmax je okrog 2 uri po odmerku.
English: Dosage adjustment in the elderly is not necessary.
Slovenian: Prilagajanje odmerjanja pri starejših osebah ni potrebno.
English: Plasma clearance is 7.7 L/h.
Slovenian: Plazemski očistek je 7,7 l/h.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE IN IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILI V DRŽAVAH ČLANICAH TER NA NORVEŠKEM IN ISLANDIJI