FrancophonIA/ELRC3.0 huggingface dataset:
English: - Patients with strongly activated renin-angiotensin-aldosterone system
Slovenian: Pomembno aktivacijo sistema renin-angiotenzin-aldosteron je treba pričakovati npr. pri bolniki s:
English: Fatigue, asthenia Chest pain, pyrexia
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost, astenija bolečina v prsih, pireksija
English: Cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional), hepatic enzyme and /or bilirubin conjugated increased
Slovenian: Bolezni jeter, žolčnika in žolčevodov holestatski ali citolitični hepatitis (zelo redko s smrtnim izidom), zvišanje jetrnih encimov in/ali konjugiranega bilirubina akutna odpoved jeter, holestatska zlatenica, okvara jetrnih celic kalkulozni holecistitis zaradi hidroklorotiazida
English: PACKAGE LEAFLET
Slovenian: • zamegljen vid
English: Finland: Cardace Comp 2.5 mg/12.5 mg tabletit
Slovenian: Cardace Comp 2.5 mg/12.5 mg tabletit
English: Transient erectile impotence
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA
English: Read all of this leaflet carefully before you start taking this medicine.
Slovenian: Pred uporabo natančno preberite navodilo!
English: Patients with renal impairment (see section 4.2).
Slovenian: Bolniki z okvaro ledvic (glejte poglavje 4.2).
English: Patients with renal impairment (see section 4.2)
Slovenian: Bolniki z okvaro ledvic (glejte poglavje 4.2)
English: Norway
Slovenian: Norveška Poljska
English: Patients with liver impairment (see section 4.2)
Slovenian: Bolniki z okvaro jeter (glejte poglavje 4.2)
English: • Blood tests showing more potassium than usual in your blood.
Slovenian: • preiskave krvi, ki kažejo več kalija v krvi, kot po navadi
English: Check with your doctor or pharmacist before taking your medicine:
Slovenian: Preden vzamete to zdravilo, se posvetujte z zdravnikom ali farmacevtom:
English: Stop taking TRITAZIDE and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:
Slovenian: Če opazite katerega od naslednjih resnih neželenih učinkov, nehajte jemati zdravilo TRITAZIDE in nemudoma pojdite k zdravniku.
English: Slovak Republic: Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
Slovenian: Slovaška: Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
English: Ireland: Tritazide tablets 2.5 mg/12.5 g
Slovenian: Tritazide tablets 2.5 mg/12.5 g
English: Always take TRITAZIDE exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila TRITAZIDE natančno upoštevajte zdravnikova navodila.
English: Metabolism Hydrochlorothiazide undergoes negligible hepatic metabolism.
Slovenian: Presnova Presnova hidroklorotiazida v jetrih je zanemarljiva.
English: Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of ramipril to hydrochlorothiazide tends to reverse the potassium loss associated with these diuretics.
Slovenian: Sočasna uporaba ramiprila in hidroklorotiazid do neke mere odpravlja izgubljanje kalija, ki spremlja tiazidne diuretike - verjetno zaradi blokade sistema renin-angiotenzin-aldosteron.
English: Bulgaria: Tritace 2.5 Plus 2.5 mg/12.5 mg таблетки, Tritace 5 Plus 5 mg/25 mg таблетки
Slovenian: Tritace 2.5 Plus 2.5 mg/12.5 mg таблетки, Tritace 5 Plus 5 mg/25 mg таблетки Ciper:
English: Denmark: Triatec Comp 5 mg/25 mg tabletter
Slovenian: Triatec Comp 5 mg/25 mg tabletter
English: 2,5 mg /12,5 mg 5 mg/25mg
Slovenian: 2,5 mg /12,5 mg 5 mg/25mg tableta peroralna uporaba
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA tableta [Izpolni država članica]
English: RamiWin comp 5 mg/25 mg Tabletten
Slovenian: RamiWin comp 5 mg/25 mg
English: Cardace Comp 2.5 mg/12.5 mg tabletid Cardace Plus 5 mg/25 mg tabletid
Slovenian: Cardace Comp 2.5 mg/12.5 mg tabletid
English: • Chest pain
Slovenian: • izpadanje las
English: Insufficient information is available regarding the use of ramipril during breast-feeding and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Slovenian: Bolnice, ki nameravajo zanositi, morajo zdravilo zamenjati z alternativnim zdravilom proti hipertenziji, ki ima dokazan varnostni profil za uporabo med nosečnostjo, razen če je nadaljnje zdravljenje z zaviralcem ACE nujno.
English: Tablet [To be completed nationally]
Slovenian: NAČIN IZDAJANJA ZDRAVILA [Izpolni država članica]
English: Diuretic-treated patients
Slovenian: Bolniki, ki dobivajo diuretike
English: • Feeling dizzy.
Slovenian: • omotica.
English: Pharmacokinetics and Metabolism
Slovenian: Farmakokinetika in presnova
English: Nervous system disorders
Slovenian: - dekompenziranim kongestivnim srčnim popuščanjem
English: Belgium: Tritazide 5 mg/25 mg tabletten/comprimés/Tabletten
Slovenian: Tritazide 5 mg/25 mg tabletten/comprimés/Tabletten Bolgarija:
English: Czech Republic Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety
Slovenian: Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety Danska:
English: PHARMACOLOGICAL PROPERTIES
Slovenian: 5 FARMAKOLOŠKE LASTNOSTI
English: Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Slovenian: Pri določenih bolnikih, ki dobivajo tiazide, se lahko pojavi hiperurikemija ali se razvije protin.
English: Glycosuria, metabolic alkalosis, hypochloraemia, hypomagnesaemia, hypercalcaemia, dehydration due to hydrochlorothiazide
Slovenian: Očesne bolezni motnja vida, vključno z zamegljenim vidom, konjunktivitis ksantopsija, manjše solzenje zaradi hidroklorotiazida
English: White blood cell count decreased, red blood cell count decreased, haemoglobin decreased, haemolytic anaemia, platelet count decreased
Slovenian: Bolezni krvi in limfatičnega sistema zmanjšanje števila levkocitov, zmanjšanje števila eritrocitov, znižanje hemoglobina, hemolitična anemija, zmanjšanje števila trombocitov odpoved kostnega mozga, nevtropenija, vključno z agranulocitozo, pancitopenija, eozinofilija hemokoncentracija zaradi pomanjkanja tekočine
English: Austria:
Slovenian: Finska:
English: 2.5 mg /12.5mg 5 mg/25mg
Slovenian: 2.5 mg /12.5mg 5 mg/25mg tableta peroralna uporaba
English: OTHER Monday Tuesday Wednesday Thursday Friday Saturday Sunday
Slovenian: Ponedeljek Torek Sreda Četrtek Petek Sobota Nedelja
English: Especially tell your doctor:
Slovenian: Še zlasti obvestite zdravnika:
English: This will help get the best results for your health.
Slovenian: Tako boste dosegli najboljše izide za svoje zdravje.
English: • At the request of the European Medicines Agency;
Slovenian: • na zahtevo Evropske agencije za zdravila
English: • awakening from sleep at night to pass urine
Slovenian: • prebujanje iz spanja ponoči, da bi šli na vodo
English: A risk to the newborns/infants cannot be excluded.
Slovenian: Tveganja za novorojenčke/dojenčke ni mogoče izključiti.
English: This will help you to remember to take it.
Slovenian: Tako si boste lažje zapomnili jo vzeti.
English: The majority of these reactions were transient and reversible.
Slovenian: Večina teh primerov je bila prehodnih in reverzibilnih.
English: Take the medicine pack with you.
Slovenian: Vzemite s seboj pakiranje zdravila.
English: (95% CI)
Slovenian: (95 % IZ)
English: Similar reductions were observed up to 104 weeks.
Slovenian: Po obdobju do 104 tedne so opažali podobna znižanja.
English: These effects were sustained in longer-term trials.
Slovenian: Ti učinki so se ohranili v dolgoročnih preskušanjih.
English: These conditions can cause dehydration.
Slovenian: Ta stanja lahko povzročijo dehidracijo.
English: The increased/decreased risk was not statistically significant in any of the organ systems.
Slovenian: Povečanje/zmanjšanje tveganja ni bilo statistično značilno v nobenem od organskih sistemov.
English: Then take your next dose at the usual time.
Slovenian: Nato pa vzemite naslednji odmerek ob običajnem času.
English: Mean duration of diabetes ranged from 1.4 to 16.9 years.
Slovenian: Povprečno trajanje sladkorne bolezni je bilo od 1,4 do 16,9 let.
English: • The recommended dose is one 10 mg tablet each day.
Slovenian: • Priporočeni odmerek je ena 10-mg tableta vsak dan.
English: Subjects (%) achieving:
Slovenian: Preiskovanci (%), ki so dosegli:
English: Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Slovenian: Zdravnik vam bo povedal, kako zdraviti nizek krvni sladkor in kaj storiti, če se vam pojavi kateri od zgoraj opisanih znakov.
English: This effect was observed at Week 1 of treatment and maintained in studies extended through Week 104.
Slovenian: Ta učinek je bil opažen 1. teden zdravljenja in se je ohranil v študijah, podaljšanih do 104. tedne.
English: • Swallow the tablet whole with half a glass of water.
Slovenian: • Tableto zaužijte celo s pol kozarca vode.
English: The safety and efficacy of dapagliflozin in children aged 0 to < 18 years have not yet been established.
Slovenian: Varnost in učinkovitost dapagliflozina pri otrocih, starih 0 do < 18 let še nista bili ugotovljeni.
English: What to do if you forget to take a tablet depends on how long it is until your next dose.
Slovenian: Če ste pozabili vzeti tableto, je ukrepanje odvisno od tega, koliko časa je še do naslednjega odmerka.
English: • passing more water (urine) than usual or needing to pass water more often
Slovenian: • odvajanje več vode (urina) kot običajno ali potreba po pogostejšem odvajanju vode
English: Your blood sugar may increase without this medicine.
Slovenian: Količina sladkorja v vaši krvi se vam lahko brez tega zdravila poveča.
English: This leads to a high level of sugar in your blood.
Slovenian: To vodi do velikih količin sladkorja v vaši krvi.
English: Talk to your doctor about the best way to control your blood sugar while you are pregnant.
Slovenian: Posvetujte se z zdravnikom o tem, kako najbolje obvladati krvni sladkor med nosečnostjo.
English: • Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter
Slovenian: • Pred začetkom sočasnega zdravljenja z zdravili, ki lahko zmanjšajo delovanje ledvic in periodično potem.
English: • Your doctor will prescribe the strength that is right for you.
Slovenian: • Zdravnik vam bo predpisal jakost zdravila, ki je za vas primerna.
English: • For renal function approaching moderate renal impairment, at least 2 to 4 times per year.
Slovenian: • V primeru poslabšanega delovanja ledvic, ki se približuje zmerni okvari, vsaj 2 do 4-krat na leto.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse informacije o tem zdravilu se lahko obrnete na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom:
English: • You can take your tablet with or without food.
Slovenian: • Tableto lahko vzamete s hrano ali brez nje.
English: In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status.
Slovenian: V primeru prevelikega odmerjanja je treba uvesti ustrezno podporno zdravljenje kot ga narekuje bolnikovo klinično stanje.
English: A meta-analysis of cardiovascular events in the clinical program was performed.
Slovenian: Izvedli so meta-analizo kardiovaskularnih dogodkov v kliničnem programu.
English: How much to take
Slovenian: Koliko zdravila je treba vzeti
English: (A satellite study was conducted to assess dapagliflozin exposures in milk and pups.)
Slovenian: (Izvedena je bila satelitska študija za oceno izpostavljenosti dapagliflozinu v mleku in pri mladičih.)
English: It belongs to a group of medicines called “oral anti-diabetics”.
Slovenian: Spada v skupino zdravil, imenovanih "peroralni antidiabetiki".
English: Cardiovascular episodes were adjudicated by an independent adjudication committee.
Slovenian: Kardiovaskularne dogodke je presojal neodvisen odbor za presojo.
English: Fifty-one percent (51%) of the subjects were men, 84% were White, 9% were Asian, 3% were Black and 4% were of other racial groups.
Slovenian: Enainpetdeset odstotkov (51 %) preiskovancev je bilo moških, 84 % belcev, 9 % Azijcev, 3 % črncev in 4 % drugih rasnih skupin.
English: Tablets are to be swallowed whole.
Slovenian: Tablete je treba zaužiti cele.
English: Dapagliflozin is approximately 91% protein bound.
Slovenian: Dapagliflozin je približno 91 % vezan na beljakovine.
English: • changes in laboratory blood tests (for example creatinine or urea)
Slovenian: • spremembe izvidov laboratorijskih preiskav krvi (npr. za kreatinin ali sečnino)
English: Frequency categories are defined according to 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: Kategorije pogostosti so opredeljene 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Monitoring of renal function is recommended as follows:
Slovenian: Priporočljivo je redno spremljanje delovanja ledvic kot sledi:
English: In both cases, treatment with dapagliflozin may be restarted once the patient's condition has stabilised.
Slovenian: V obeh primerih je mogoče dapagliflozin znova uvesti, ko se bolnikovo stanje stabilizira.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: • If it is 12 hours or more until your next dose, take a dose of Forxiga as soon as you remember.
Slovenian: • Če je do naslednjega odmerka 12 ur ali več, vzemite odmerek zdravila Forxiga takoj, ko se spomnite.
English: Adverse reactions listed below are classified according to frequency and system organ class (SOC).
Slovenian: Spodaj našteti neželeni učinki so razvrščeni po pogostosti in organskem sistemu (SOC - system organ class).
English: Effect of dapagliflozin on other medicinal products
Slovenian: Vpliv dapagliflozina na druga zdravila
English: Forxiga is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Slovenian: Uporaba zdravila Forxiga ni priporočljiva pri otrocih in mladostnikih, starih manj kot 18 let, ker pri teh bolnikih zdravilo ni bilo raziskano.
English: Paediatric population Interaction studies have only been performed in adults.
Slovenian: Pediatrična populacija Študije medsebojnega delovanja so izvedli le pri odraslih.
English: • if you are 75 years old or older, you should not start taking Forxiga.
Slovenian: • če ste stari 75 let ali več, ne smete začeti z jemanjem zdravila Forxiga.
English: Since the numerical imbalance of breast, bladder and prostate tumours must be considered with caution, it will be further investigated in post-authorisation studies.
Slovenian: Ker je treba številčno neravnovesje tumorjev dojke, mehurja in prostate obravnavati previdno, bo slednje preučevano v študijah po pridobitvi dovoljenja za promet.
English: Elderly (≥ 65 years)
Slovenian: Starejši (≥ 65 let)
English: • if you have a history of serious heart disease or if you have had a stroke.
Slovenian: • če imate resno srčno bolezen ali ste kdaj doživeli možgansko kap.
English: • if you are taking a medicine used to remove water from the body (diuretic).
Slovenian: • če jemljete zdravilo, ki se uporablja za odvajanje vode iz telesa (diuretik).
English: Eighty percent (80%) of the subjects had a body mass index (BMI) ≥ 27.
Slovenian: Osemdeset odstotkov (80 %) preiskovancev je imelo indeks telesne mase (ITM)  27.
English: Although uncommon, if you see blood in your urine, tell your doctor immediately.
Slovenian: Običajno se kri v urinu ne pojavi, a če jo opazite, takoj obvestite zdravnika.
English: Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Slovenian: Zdravljenje je treba prekiniti pri bolnikih, sprejetih v bolnišnico zaradi večjega kirurškega posega ali akutne resne bolezni.
English: • if you are taking another medicine for diabetes that contains “pioglitazone”, you should not start taking Forxiga.
Slovenian: • če jemljete drugo zdravilo za zdravljenje sladkorne bolezni, ki vsebuje "pioglitazon", ne smete začeti z jemanjem zdravila Forxiga.
English: Forxiga can be taken orally once daily at any time of day with or without food.
Slovenian: Zdravilo Forxiga se jemlje peroralno, enkrat na dan, kadar koli tekom dneva, s hrano ali brez nje.
English: In general, no dosage adjustment is recommended based on age.
Slovenian: V splošnem ni priporočil glede prilagoditve odmerjanja, ki temelji na starosti.
English: This may occur regardless of blood glucose level.
Slovenian: To se lahko pojavi ne glede na količino glukoze v krvi.
English: Cardiovascular safety
Slovenian: Kardiovaskularna varnost
English: • They work by lowering the amount of sugar (glucose) in your blood.
Slovenian: • Delujejo tako, da zmanjšajo količino sladkorja (glukoze) v vaši krvi.
English: Forxiga has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Forxiga nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Parathyroid hormone (PTH)
Slovenian: Parathormon (PTH)
English: However, an increased exposure due to age-related decrease in renal function can be expected.
Slovenian: Vendar je mogoče pričakovati večjo izpostavljenost zaradi s starostjo povezanega zmanjšanja delovanja ledvic.
English: • if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Slovenian: • če jemljete druga zdravila, ki zmanjšujejo količino sladkorja v vaši krvi, npr. insulin ali kakšno ''sulfonilsečninsko'' zdravilo.
English: Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italy
Slovenian: Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italija
English: The increases in creatinine were generally transient during continuous treatment or reversible after discontinuation of treatment.
Slovenian: Zvišanja kreatinina so bila med stalnim zdravljenjem na splošno prehodna in po prenehanju zdravljenja reverzibilna.
English: What Forxiga is and what it is used for
Slovenian: Kaj je zdravilo Forxiga in za kaj ga uporabljamo
English: The incidence of hypoglycaemia was similar to placebo.
Slovenian: Pojavnost hipoglikemij je bila podobna kot pri placebu.
English: If you take more Forxiga tablets than you should, talk to a doctor or go to a hospital immediately.
Slovenian: Če ste vzeli več tablet zdravila Forxiga, kot bi smeli, se takoj posvetujte z zdravnikom ali pojdite v bolnišnico.
English: Twelve studies had a treatment period of 24 weeks duration, 8 with long-term extensions ranging from 24 to 80 weeks (up to a total study duration of 104 weeks), and one study was 52 weeks in duration with long-term extensions of 52 and 104 weeks (total study duration of 208 weeks).
Slovenian: V dvanajstih študijah je zdravljenje trajalo 24 tednov in 8 od teh študij je imelo dolgoročna podaljšanja, ki so trajala od 24 do 80 tednov (do celotnega trajanja študije 104 tedne); ena študija je trajala 52 tednov z dolgoročnima podaljšanjema 52 tednov in 104 tedne (celotno trajanje študije 208 tednov).
English: • if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink.
Slovenian: • če so se pri vas pojavili navzea (občutek siljenja na bruhanje), bruhanje ali vročina ali ne zmorete jesti ali piti.
English: Do not stop taking Forxiga without talking to your doctor first.
Slovenian: Ne prenehajte z jemanjem zdravila Forxiga, ne da bi se prej posvetovali z zdravnikom.
English: Therefore, the use of dapagliflozin is not recommended during the second and third trimesters of pregnancy.
Slovenian: Zato dapagliflozina ni priporočljivo uporabljati v drugem in tretjem trimesečju nosečnosti.
English: Maternal toxicity was evident only at the highest dose tested, and limited to transient reductions in body weight and food consumption at dose.
Slovenian: Maternalna toksičnost je bila opazna le pri največjemu preskušanemu odmerku in je bila omejena na prehodna zmanjšanja telesne mase in uživanje hrane pri tem odmerku.
English: Paediatric population Pharmacokinetics in the paediatric population have not been studied.
Slovenian: Pediatrična populacija Farmakokinetika pri pediatrični populaciji ni bila raziskana.
English: The increase in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Slovenian: Povečanje izpostavljenosti simvastatinu in simvastatinski kislini ne velja za klinično pomembno.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: It is not known if this medicine passes into human breast milk.
Slovenian: Ni znano, ali se to zdravilo izloča v materino mleko.
English: The effects of smoking, diet, herbal products and alcohol use on the pharmacokinetics of dapagliflozin have not been studied.
Slovenian: Vplivi kajenja, prehrane, pripravkov rastlinskega izvora in alkohola na farmakokinetiko dapagliflozina niso bili raziskani.
English: Patients should be alerted to the risk of hypoglycaemia when dapagliflozin is used in combination with a sulphonylurea or insulin.
Slovenian: Bolnike je treba opozoriti na tveganje za hipoglikemijo, če se dapagliflozin uporablja skupaj s sulfonilsečnino ali insulinom.
English: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
Slovenian: Kadar zgolj dieta in telesna dejavnost ne zagotavljata ustrezne urejenosti glikemije pri bolnikih, pri katerih uporaba metformina ni primerna zaradi intolerance.
English: The amount of glucose removed by the kidney through this mechanism is dependent upon the blood glucose concentration and GFR.
Slovenian: Količina glukoze, ki se s tem mehanizmom odstrani skozi ledvice, je odvisna od koncentracije glukoze v krvi in od GFR.
English: In patients with severe hepatic impairment, a starting dose of 5 mg is recommended.
Slovenian: Pri bolnikih s hudo okvaro jeter je priporočljiva uporaba začetnega odmerka 5 mg.
English: No dose adjustment is recommended.
Slovenian: Prilagoditev odmerjanja ni priporočljiva.
English: Considering the lack of tumour findings in non-clinical studies as well as the short latency between first drug exposure and tumour diagnosis, a causal relationship is considered unlikely.
Slovenian: Ob upoštevanju pomanjkanja ugotovitev glede tumorjev v pred-kliničnih študijah, kakor tudi kratke latence med prvo izpostavljenostjo in diagnozo tumorja, je vzročna povezanost malo verjetna.
English: A clinically relevant effect with other inducers (e.g. carbamazepine, phenytoin, phenobarbital) is not expected.
Slovenian: Klinično pomembnega učinka pri uporabi z drugimi induktorji (npr. karbamazepinom, fenitoinom, fenobarbitalom) ni pričakovati.
English: • Do not use this medicine after the expiry date, which is stated on the blister or carton after ‘EXP'.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu poleg oznake "EXP" ali škatli poleg oznake "Uporabno do".