FrancophonIA/ELRC3.0 huggingface dataset:
English: Taltz was efficacious in biologic-naive, biologic-exposed and biologic-failure patients.
Slovenian: Zdravilo Taltz je bilo učinkovito pri bolnikih, ki predhodno niso bili zdravljeni z biološkim zdravilom, pri bolnikih, ki so bili izpostavljeni biološkemu zdravilu in pri bolnikih, pri katerih zdravljenje z biološkim zdravilom ni bilo uspešno.
English: Then gently let go of your skin.
Slovenian: Nežno izpustite kožno gubo.
English: Always use this medicine exactly as your doctor or nurse has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika ali medicinske sestre.
English: The efficacy and safety of Taltz were also evaluated versus etanercept (UNCOVER-2 and UNCOVER-3).
Slovenian: Učinkovitost in varnost zdravila Taltz so ovrednotili tudi v primerjavi z etanerceptom
English: 53% of patients had concomitant use of MTX at a mean weekly dose of 15.8 mg. 67% of patients who had concomitant use of MTX had a dose of 15 mg or greater.
Slovenian: bolnikov, od katerih je 41 % sočasno uporabljalo MTX v povprečnem tedenskem odmerku 16,1 mg. 73,2 % bolnikov, ki so sočasno uporabljali MTX, je prejemalo odmerek 15 mg ali več.
English: (neutropenia).
Slovenian: (čisto)
English: • The pre-filled pen must not be shaken.
Slovenian: • Napolnjenega injekcijskega peresnika ne smete stresati.
English: The instructions for using the syringe, included with the package leaflet, must be followed carefully.
Slovenian: Skrbno upoštevajte navodila za uporabo brizge, ki so priložena navodilu za uporabo zdravila.
English: The increased frequency of injection site reactions in the combined Q2W and Q4W groups did not result in an increase in discontinuations in either the plaque psoriasis or the psoriatic arthritis studies g Based on reported adverse events h Based on postmarketing reports i Adverse drug reactions in patients treated with ixekizumab in the plaque psoriasis and psoriatic arthritis clinical trials were similar with the exception of the frequencies of influenza (common) and conjunctivitis (common) in the psoriatic arthritis clinical trials
Slovenian: Povečana pogostnost reakcij na mestu injiciranja v kombiniranih skupinah Q2W in Q4W ni povzročila povečanega števila prekinitev zdravljenja v študijah psoriaze s plaki ali v študijah psoriatičnega artritisa.
English: Comprehensive instructions for administration are given in the package leaflet.
Slovenian: V navodilu za uporabo so podana obsežnejša navodila za dajanje zdravila.
English: The pre-filled syringe is for single use only.
Slovenian: Napolnjena injekcijska brizga je namenjena samo za enkratno uporabo.
English: Efficacy results at Week 12 in UNCOVER-3
Slovenian: Rezultati učinkovitosti v 12. tednu študije UNCOVER-3
English: Before using your pre-filled pen:
Slovenian: Pred uporabo napolnjenega injekcijskega peresnika:
English: EU/1/15/1085/001 1 pre-filled pen EU/1/15/1085/002 2 pre-filled pens EU/1/15/1085/003 3 pre-filled pens
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1085/001 1 napolnjeni injekcijski peresnik EU/1/15/1085/002 2 napolnjena injekcijska peresnika EU/1/15/1085/003 3 napolnjeni injekcijski peresniki
English: Very common
Slovenian: Pogosti navzea
English: Efficacy results at Week 12 in UNCOVER-1
Slovenian: Rezultati učinkovitosti v 12. tednu študije UNCOVER-1
English: EU/1/15/1085/004 1 pre-filled syringe EU/1/15/1085/005 2 pre-filled syringes EU/1/15/1085/006 3 pre-filled syringes
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1085/004 1 napolnjena injekcijska brizga EU/1/15/1085/005 2 napolnjeni injekcijski brizgi EU/1/15/1085/006 3 napolnjene injekcijske brizge
English: Read the “Instructions for Use” for the syringe carefully before using Taltz.
Slovenian: Pred uporabo zdravila Taltz natančno preberite „Navodila za uporabo“ brizge.
English: ≥ 4d
Slovenian: NRS ≥ 4d
English: Nausea
Slovenian: Stegno
English: • DO NOT share or reuse your Taltz pre-filled syringe.
Slovenian: • Napolnjene injekcijske brizge Taltz NE delite z nikomer drugim in je ne uporabite znova.
English: Inspect the pre-filled pen.
Slovenian: Preglejte napolnjeni injekcijski peresnik.
English: Radiographic joint damage progression was inhibited by Taltz (Table 9) at Week 24, and the percentage of patients with no radiographic joint damage progression (defined as a change from baseline in mTSS of ≤0.5) from randomisation to Week 24 was 94.8% for Taltz Q2W(p<0.001),
Slovenian: Zdravilo Taltz je zavrlo rentgenografsko napredovanje poškodb sklepov (Preglednica 9) v 24. tednu in odstotek bolnikov brez rentgenografskega napredovanja poškodb sklepov (definiranih kot sprememba od izhodišča v mTSS ≤ 0,5) od randomizacije do 24. tedna je znašal 94,8 % za Taltz Q2W (p<0,001), 89,0 % za Taltz Q4W (p=0,026), 95,8 % za adalimumab (p<0,001), vsakokrat v primerjavi s 77,4 % za placebo.
English: Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo b p < 0.001 compared with etanercept c Patients with Itch NRS >= 4 at baseline: placebo N = 158, Taltz 80 mg Q4W N = 313, Taltz 80 mg Q2W N = 320, Etanercept N = 312
Slovenian: a p < 0,001 v primerjavi s placebom b p < 0,001 v primerjavi z etanerceptom c Bolniki z oceno srbenja na lestvici NRS > = 4 v izhodišču: placebo N = 158, zdravilo Taltz 80 mg Q4W N = 313, zdravilo Taltz 80 mg Q2W N = 320, etanercept N = 312
English: • Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.
Slovenian: • O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte z zdravnikom,
English: Solution for injection in pre-filled pen.
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje v napolnjenem injekcijskem peresniku.
English: Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo b Patients with Itch NRS >= 4 at baseline: placebo N = 374, Taltz 80 mg Q4W N = 379, Taltz 80 mg Q2W N = 391
Slovenian: a p < 0,001 v primerjavi s placebom b Bolniki z oceno srbenja na lestvici NRS >= 4 v izhodišču: placebo N = 374, zdravilo Taltz 80 mg Q4W N = 379, zdravilo Taltz 80 mg Q2W N = 391
English: Efficacy results at Week 12 in UNCOVER-2
Slovenian: Rezultati učinkovitosti v 12. tednu študije UNCOVER-2
English: Taltz is given by injection under your skin (subcutaneous injection).
Slovenian: Zdravilo Taltz dajemo s podkožno injekcijo (imenovano subkutana injekcija).
English: reduction ≥ 4b
Slovenian: NRS ≥ 4b
English: Taltz 80 mg Q2W (N = 351)
Slovenian: zdravilo Taltz 80 mg Q2W (N = 351)
English: Pack sizes of 1, 2, or 3 pre-filled syringes.
Slovenian: Pakiranja vsebujejo 1, 2 ali 3 napolnjene injekcijske brizge.
English: The pen must not be shaken.
Slovenian: Brizge ne smete stresati.
English: You should see the green plunger rod showing through the syringe body when the injection is complete.
Slovenian: Ko je injiciranje končano, mora biti zeleni potisni bat viden skozi ohišje brizge.
English: Sodium citrate Citric acid, anhydrous Sodium chloride Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi natrijev citrat brezvodna citronska kislina natrijev klorid polisorbat 80 voda za injekcije
English: The syringe is encased in a disposable, single-dose pen.
Slovenian: Brizga je vstavljena v enoodmerni peresnik za enkratno uporabo.
English: Taltz is injected under the skin (subcutaneous injection).
Slovenian: Zdravilo Taltz se injicira podkožno (subkutano injiciranje).
English: You must look out for signs of these conditions while you are using Taltz.
Slovenian: Med uporabo zdravila Taltz bodite pozorni na znake teh bolezni.
English: Patients were randomised (1:2:2:2) to receive either placebo, or Taltz (80 mg every two or four weeks [Q2W or Q4W] following a 160 mg starting dose) or etanercept 50 mg twice weekly for 12 weeks.
Slovenian: Bolniki so bili randomizirani (1:2:2:2) za prejemanje placeba ali zdravila Taltz (80 mg vsaka dva ali štiri tedne [Q2W ali Q4W] po 160
English: 80 mg Q4W (induction) / 80 mg Q4W (maintenance)
Slovenian: 80 mg Q4W (indukcijsko zdravljenje) / 80 mg Q4W (vzdrževalno zdravljenje) (N=195)
English: • Before you use the Taltz pre-filled syringe, read and carefully follow all the step-by-step instructions.
Slovenian: • Preden uporabite napolnjeno injekcijsko brizgo zdravila Taltz, preberite in natančno upoštevajte podrobna navodila.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI NAPOLNJENE INJEKCIJSKE BRIZGE
English: The syringe is for ONE-TIME USE ONLY.
Slovenian: Brizga je namenjena SAMO ZA ENKRATNO UPORABO.
English: Back of arm
Slovenian: Blazinica za palec
English: - Keep this leaflet.
Slovenian: Zavrzite brizgo.
English: Taltz 80 mg Q4W (N = 386)
Slovenian: zdravilo Taltz 80 mg Q4W (N = 386)
English: Taltz 80 mg Q2W (N = 385)
Slovenian: zdravilo Taltz 80 mg Q2W (N = 385)
English: Instructions for use Taltz 80 mg solution for injection in pre-filled syringe
Slovenian: Navodila za uporabo Taltz 80 mg raztopina za injiciranje v napolnjeni injekcijski brizgi iksekizumab
English: Each pre-filled syringe contains 80 mg ixekizumab in 1 ml.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 80 mg iksekizumaba v 1 ml raztopine.
English: Commonly asked questions Q. What if I see air bubbles in the pre-filled pen?
Slovenian: V: Kaj moram narediti, če v napolnjenem injekcijskem peresniku opazim zračne mehurčke?
English: Before you use the TALTZ pre-filled syringe, read and carefully follow all the step-by-step instructions.
Slovenian: Preden uporabite napolnjeno injekcijsko brizgo zdravila TALTZ, preberite in natančno upoštevajte podrobna navodila.
English: Stop using Taltz and tell your doctor or seek medical help immediately if you get any of the following side effects.
Slovenian: Če opazite katerega koli od naslednjih neželenih učinkov, takoj prenehajte z uporabo zdravila Taltz in se posvetujte z zdravnikom ali poiščite nujno medicinsko pomoč.
English: The instructions for using the pen, included with the leaflet, must be followed carefully.
Slovenian: Navodila za uporabo Skrbno upoštevajte navodila za uporabo peresnika, ki so priložena navodilu za uporabo zdravila.
English: Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or nurse.
Slovenian: Brizgo zavrzite v vsebnik za odlaganje igel oziroma po navodilih zdravnika, farmacevta ali medicinske sestre.
English: Taltz 80 mg solution for injection in pre-filled syringe ixekizumab
Slovenian: Taltz 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku iksekizumab
English: BSA≥10 and sPGA≥3).
Slovenian: Genitalno srbenje GPSS (izboljšanje za ≥ 3
English: Endpoints
Slovenian: točke)
English: Taltz contains the active substance ixekizumab.
Slovenian: Zdravilo Taltz vsebuje zdravilno učinkovino iksekizumab.
English: Taltz 80 mg Q2W (N = 433)
Slovenian: zdravilo Taltz 80 mg Q2W (N = 433)
English: Ixekizumab is a recombinant humanised monoclonal antibody produced in CHO cells.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 80 mg iksekizumaba v 1 ml. Iksekizumab je rekombinantno humanizirano monoklonsko protitelo, izdelano v ovarijskih celicah kitajskega hrčka (Chinese Hamster Ovary - CHO).
English: Taltz 80 mg Q4W (N = 347)
Slovenian: zdravilo Taltz 80 mg Q4W (N = 347)
English: EU/1/15/1085/004 EU/1/15/1085/005 EU/1/15/1085/006
Slovenian: EU/1/15/1085/006
English: Taltz 80 mg solution for injection in pre-filled syringe.
Slovenian: Taltz 80 mg raztopina za injiciranje v napolnjeni injekcijski brizgi iksekizumab
English: Taltz 80 mg Q4W (N = 432)
Slovenian: zdravilo Taltz 80 mg Q4W (N = 432)
English: Expiration date
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: - bacterial skin infection.
Slovenian: danih s subkutanim injiciranjem.
English: Each pre-filled pen contains 80 mg ixekizumab in 1 ml.
Slovenian: En napolnjen injekcijski peresnik vsebuje 80 mg iksekizumaba v 1 ml raztopine.
English: • Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or nurse.
Slovenian: • Peresnik zavrzite v zbiralnik za ostre predmete oziroma po navodilih zdravnika, farmacevta ali medicinske sestre.
English: • 1 cotton ball or piece of gauze
Slovenian: • 1 kroglico vate ali kos gaze
English: Elderly
Slovenian: Nadlaket
English: N with baseline GPSS Itch NRS Score ≥3 N=62 N=60 GPSS Genital Itch (≥3 point improvement) N with baseline SFQ Item 2 Score ≥2
Slovenian: N z izhodiščno oceno postavke 2 vprašalnika SFQ ≥ 2
English: • Dispose of the pen in a sharps container or as directed by your doctor, pharmacist or nurse.
Slovenian: • Brizgo zavrzite v zbiralnik za ostre predmete oziroma po navodilih zdravnika, farmacevta ali medicinske sestre.
English: Twist-off base cap
Slovenian: Odstotno izboljšanje PASI od izhodišča
English: Instructions for use Taltz 80 mg solution for injection in pre-filled pen
Slovenian: Navodila za uporabo Taltz 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku iksekizumab
English: Grey syringe plunger
Slovenian: Sivi bat sec
English: 1 ml solution in a type I clear glass syringe.
Slovenian: 1 ml raztopine v brizgi iz prozornega stekla tipa I. Brizga je vstavljena v enoodmerni peresnik za enkratno uporabo.
English: Table 4.
Slovenian: Preglednica 4
English: - hives.
Slovenian: - ekcem,
English: You may have slight bleeding.
Slovenian: Morda bo iz mesta injiciranja priteklo nekaj kapelj krvi.
English: Taltz 80 mg injection ixekizumab Subcutaneous use
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Taltz 80 mg raztopina za injiciranje iksekizumab subkutana uporaba
English: Talk to your doctor, nurse or pharmacist before using Taltz:
Slovenian: Pred začetkom uporabe zdravila Taltz se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom: - če imate trenutno okužbo ali če imate dolgotrajne ali ponavljajoče se okužbe.
English: 97 (49.7)a 127 (57.5)a
Slovenian: 97 (49,7)a 127 (57,5)a 48,2 (40,9; Razlaga kratic: N = število bolnikov v populaciji za analizo
English: The pre-filled pen is for single use only.
Slovenian: Napolnjeni injekcijski peresnik je namenjen samo za enkratno uporabo.
English: The solution/the syringe must not be shaken.
Slovenian: Raztopine/injekcijske brizge ne smete stresati.
English: Repso leflunomide
Slovenian: Repso leflunomid
English: The medicine usually starts to have an effect after four to six weeks.
Slovenian: Zdravilo navadno prične učinkovati po štirih do šestih tednih.
English: What are the benefits and risks of Repso?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Repso?
English: The full EPAR for Repso 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 Repso je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (white and round: 10 mg; dark beige and triangular: 20 mg).
Slovenian: Na voljo je v obliki okroglih tablet (belih in okroglih: 10 mg; temno bež in trikotnih: 20 mg).
English: This means that Repso is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Arava.
English: For more information about treatment with Repso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Repso preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Slovenian: Priporočeni vzdrževalni odmerek je 10 do 20 mg enkrat na dan za bolnike z revmatoidnim artritisom in 20 mg enkrat na dan za bolnike s psoriatičnim artritisom.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Repso.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Repso, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Its effect may improve further for up to six months.
Slovenian: Učinki zdravila se lahko nato v nadaljnjih šestih mesecih še izboljšajo.
English: Repso is a ‘generic medicine'.
Slovenian: Zdravilo Repso je „generično zdravilo“.
English: Repso treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Slovenian: Zdravljenje z zdravilom Repso se začne z začetnim odmerkom 100 mg enkrat na dan prve tri dni, čemur sledi vzdrževalni odmerek.
English: Because Repso is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Repso generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: This is a summary of the European public assessment report (EPAR) for Repso.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Repso.
English: Repso is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Slovenian: Zdravilo Repso se uporablja za zdravljenje odraslih z aktivnim revmatoidnim artritisom (boleznijo imunskega sistema, ki povzroča vnetje sklepov) ali aktivnim psoriatičnim artritisom (boleznijo, ki povzroča rdeče in luskinaste zaplate na koži ter vnetje sklepov).
English: Repso treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Slovenian: Zdravljenje z zdravilom Repso mora uvesti in nadzorovati zdravnik specialist, ki ima izkušnje z zdravljenjem revmatoidnega artritisa in psoriatičnega artritisa.
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Slovenian: Zaradi manjšega števila prisotnih limfocitov je manjše tudi vnetje, kar pomaga pri obvladovanju simptomov artritisa.
English: Therefore, the CHMP's view was that, as for Arava, the benefit outweighs the identified risk.
Slovenian: Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Arava, odtehtajo znana tveganja.
English: Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Slovenian: Leflunomid to doseže z zaviranjem encima, imenovanega „dihidroorotatdehidrogenaza“, ki je potreben za razmnoževanje limfocitov.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Repso to TEVA Pharma B.V. on 14 March 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Repso, veljavno po vsej Evropski uniji, odobrila družbi TEVA Pharma B.V.
English: Because Repso is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Slovenian: Ker je zdravilo Respo generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Arava.
English: The Committee recommended that Repso be given marketing authorisation.
Slovenian: Odbor je zato priporočil, da se za zdravilo Repso odobri dovoljenje za promet.
English: The CHMP concluded that, in accordance with EU requirements, Repso has been shown to have comparable quality and to be bioequivalent to Arava.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Repso primerljivo raven kakovosti kot zdravilo Arava ter da mu je biološko enakovredno.
English: Repso is a medicine that contains the active substance leflunomide.
Slovenian: Repso je zdravilo, ki vsebuje zdravilno učinkovino leflunomid.
English: It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Slovenian: Zdravilo zmanjšuje vnetje tako, da zmanjša tvorjenje imunskih celic, imenovanih „limfociti“, ki povzročajo vnetje.
English: Why has Repso been approved?
Slovenian: Zakaj je bilo zdravilo Repso odobreno?
English: How has Repso been studied?
Slovenian: Kako je bilo zdravilo Repso raziskano?
English: The active substance in Repso, leflunomide, is an immunosuppressant.
Slovenian: Zdravilna učinkovina v zdravilu Respo, leflunomid, je sredstvo za zaviranje imunske odzivnosti.
English: What is Repso used for?
Slovenian: Za kaj se zdravilo Repso uporablja?
English: How is Repso used?
Slovenian: Kako se zdravilo Repso uporablja?
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Repso, and regularly during treatment.
Slovenian: Zdravnik mora, preden predpiše zdravilo Repso in nato v rednih intervalih med zdravljenjem, opraviti krvne preiskave, s katerimi preveri delovanje bolnikovih jeter ter število belih krvnih celic in krvnih ploščic, .
English: What is Repso?
Slovenian: Kaj je zdravilo Repso?
English: Other information about Repso
Slovenian: Druge informacije o zdravilu Respo:
English: These studies included nearly 2,500 patients, of whom over 1,400 received valproate.
Slovenian: Te študije so vključevale skoraj 2 500 bolnikov, izmed katerih jih je več kot 1 400 prejemalo valproat.
English: In addition there is a considerable risk due to the narrow therapeutic window of this substance.
Slovenian: Poleg tega je prisotno precejšnje tveganje zaradi ozkega terapevtskega okna te snovi.
English: Method and duration of administration:
Slovenian: Način in trajanje uporabe:
English: 4.1 Therapeutic indications
Slovenian: 4.1 TERAPEVTSKE INDIKACIJE
English: 1.1 Mania
Slovenian: 1.1 Manija
English: 1.2 Prevention of Recurrence of mood episodes
Slovenian: 1.2 Preprečevanje ponovitev razpoloženjskih epizod
English: Anticonvulsants are increasingly becoming an alternative.
Slovenian: Antikonvulzivi se čedalje pogosteje uporabljajo kot nadomestna možnost.
English: In adults:
Slovenian: Pri odraslih:
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for <active substance>.
Slovenian: Mehanizem tega tveganja ni znan, razpoložljivi podatki pa ne izključujejo možnosti povečanega tveganja pri <zdravilni učinkovini>.
English: If at any time you have these thoughts, immediately contact your doctor.
Slovenian: Če imate take misli, se takoj posvetujte z zdravnikom.
English: Post-hoc analyses were done of the large Bowden study.
Slovenian: Naknadne analize so temeljile na obsežni Bowdenovi študiji.
English: The prolonged-release tablets should preferably be taken 1 hour before meals (on an empty stomach in the morning).
Slovenian: Najbolje je, da se tablete s podaljšanim sproščanjem vzamejo eno uro pred obrokom (zjutraj na prazen želodec).
English: The two recurrence prevention studies are of sufficient duration and have an active comparator as requested by European guidelines.
Slovenian: Obe študiji preprečevanja ponovitev sta trajali dovolj dolgo in vključujeta aktivno primerjalno zdravilo, kot to zahtevajo evropske smernice.
English: Patients receiving daily doses higher than 45mg/kg/day body weight should be carefully monitored.
Slovenian: Bolnike, ki prejemajo dnevne odmerke, večje od 45 mg/kg telesne mase/dan, je treba skrbno spremljati.
English: Please follow his/her instructions, otherwise you will not fully benefit from your medicine.
Slovenian: Upoštevajte zdravnikova navodila, sicer ne boste v celoti uživali prednosti tega zdravila.
English: 2.2 Risk Management Plan
Slovenian: 2.2 Načrt za obvladovanje tveganja