FrancophonIA/ELRC3.0 huggingface dataset:
English: Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo.
Slovenian: 18 % in njegovo povprečno AUC za 55 %; to kaže, da A771726 in vivo morda šibko inducira CYP1A2.
English: Common side effects (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (prizadenejo lahko največ 1 od 10 bolnikov)
English: If a patient taking leflunomide develops a peripheral neuropathy, consider discontinuing leflunomide therapy and performing the drug elimination procedure (see section 4.4).
Slovenian: Če bolnik med jemanjem zdravila Leflunomid ratiopharm razvije periferno nevopatijo, je potrebno razmisliti o ukinitvi terapije z zdravilom Leflunomid ratiopharm in o izvajanju postopka za eliminacijo zdravila.
English: Leflunomide ratiopharm contains soya lecithin
Slovenian: Zdravilo Leflunomid ratiopharm vsebuje sojin lecitin.
English: Each tablet contains 10 mg of leflunomide.
Slovenian: Ena tableta vsebuje 10 mg leflunomida.
English: other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable, - warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - teriflunomide for multiple sclerosis - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinence or in kidney disease in diabetics - alosetron for the management of severe diarrhoea - theophylline for asthma - tizanidine, a muscle relaxant - oral contraceptives (containing ethinylestradiol and levonorgestrel) - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indomethacin, ketoprofen for pain or inflammation - furosemide for heart disease (diuretic, water pill) - zidovudine for HIV infection
Slovenian: - teriflunomid za multiplo sklerozo, - repaglinid, pioglitazon, nateglinid, ali rosiglitazon za sladkorno bolezen, - daunorubicin, doksorubicin, paklitaksel, ali topotekan za raka, - duloksetin za depresijo, inkontinenco urina ali bolezen ledvic pri sladkornih bolnikih, - alosetron za obvladovanje hude driske,
English: • In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for
Slovenian: • Pri psoriatičnem artritisu: zdravljenje z leflunomidom se začne z začetnim odmerkom
English: Effect of leflunomide on other medicinal products:
Slovenian: Vpliv leflunomida na druga zdravila: Peroralni kontraceptivi
English: - a marked decrease of some white blood cells (agranulocytosis), - severe and potentially severe allergic reactions, - inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis), - inflammation of the pancreas (pancreatitis), - severe liver injury such as liver failure or necrosis which may be fatal,
Slovenian: • izrazito zmanjšanje nekaterih belih krvnih celic (agranulocitoza), • hude in potencialno hude alergijske reakcije,
English: Leflunomide ratiopharm 10 mg film-coated tablets
Slovenian: Leflunomid ratiopharm 10 mg filmsko obložene tablete
English: tendon rupture
Slovenian: pretrganje tetive
English: In vitro inhibition studies in human liver microsomes suggest that cytochrome P450 (CYP) 1A2, 2C19 and 3A4 are involved in leflunomide metabolism.
Slovenian: 1A2, 2C19 in 3A4 citokroma P450 (CYP).
English: Leflunomide ratiopharm 20 mg film-coated tablets
Slovenian: Leflunomid ratiopharm 20 mg filmsko obložene tablete
English: - if you are male and wish to father a child. As it can not be excluded that Leflunomide ratiopharm passes into semen, reliable contraception should be used during treatment with Leflunomide ratiopharm.
Slovenian: Obstaja možnost, da se zdravilo Leflunomid ratiopharm izloča v semensko tekočino, zato mora bolnik med zdravljenjem z zdravilom Leflunomid ratiopharm uporabljati zanesljivo kontracepcijo.
English: Leflunomide ratiopharm contains lactose
Slovenian: Shranjevanje zdravila Leflunomid ratiopharm
English: 35 μg/ml.
Slovenian: 0,02 mg/l):
English: Leflunomide ratiopharm 10 mg film-coated tablets Leflunomide
Slovenian: Leflunomid ratiopharm 10 mg filmsko obložene tablete leflunomid
English: Leflunomide ratiopharm 20 mg film-coated tablets Leflunomide
Slovenian: Leflunomid ratiopharm 20 mg filmsko obložene tablete leflunomid
English: • Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis.
Slovenian: nevtropenijo ali trombocitopenijo, katerih vzrok ni revmatoidni ali psoriatični artritis.
English: • Physician Leaflet
Slovenian: • pred uvedbo leflunomida
English: If you forget to take Leflunomide ratiopharm
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Leflunomid ratiopharm Ne jemljite zdravila Leflunomid ratiopharm
English: (pancytopenia), - severe increase in blood pressure, - inflammation of the lung (interstitial lung disease), - an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice, - severe infections called sepsis which may be fatal, - an increase of certain enzymes in the blood (lactate dehydrogenase).
Slovenian: • utrujenost, bolečine v trebuhu ali zlatenico (porumenelost oči ali kože), ki so lahko znak resnih bolezni, kot je bolezen jeter, ki je lahko smrtna,
English: Cardiac disorders Common:
Slovenian: Psihiatrične motnje Občasni:
English: a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia), - a decrease in the levels of potassium in the blood, - anxiety, - taste disturbances, - urticaria (nettle rash), - tendon rupture, - an increase in the levels of fat in the blood (cholesterol and triglycerides), - a decrease in the levels of phosphate in the blood.
Slovenian: Redki neželeni učinki (prizadenejo lahko največ 1 od 1.000 bolnikov) • zvečanje števila krvnih celic imenovanih eozinofilci (eozinofilija); blago zmanjšanje števila belih krvnih celic (levkopenija); zmanjšanje števila vseh krvnih celic (pancitopenija), • resno zvišanje krvnega tlaka,
English: • Patients with severe immunodeficiency states, e.g. AIDS,
Slovenian: • če kakršnakoli težava vpliva na vaš imunskisistem (npr. AIDS),
English: Invented name
Slovenian: EU Številka Izmišljeno ime
English: United Kingdom Teva Uk Limited
Slovenian: Združeno kraljestvo Teva Uk Limited
English: S.P.A. Italiana Laboratori Bouty
Slovenian: Italiana Laboratori Bouty
English: United Kingdom Pronova Biopharma Norge As
Slovenian: Združeno kraljestvo Pronova Biopharma Norge As
English: United Kingdom Mercury Pharmaceuticals Ltd.
Slovenian: Združeno kraljestvo Mercury Pharmaceuticals Ltd.
English: 1000mg Capsule
Slovenian: 1000 mg kapsula
English: Fish Oil 1000mg Capsule
Slovenian: ribje olje 1000 mg kapsula
English: Ratiopharm Gmbh Omega-3 Ratiopharm Omega-3-Acid Ethyl Esters 90 1000mg
Slovenian: Ratiopharm Gmbh Omega-3 Ratiopharm omega-3-kislinski etilestri 90 1000 mg kapsula
English: United Kingdom Strides Arcolab International Limited
Slovenian: Združeno kraljestvo Strides Arcolab International Limited
English: Esters Of Unsaturated Fatty Acids 500mg Capsule
Slovenian: Esapent estri nenasičenih maščobnih kislin 500 mg kapsula
English: Triglycerides Medium Chain 1qs Capsule, Lecithin Soya 1qs Capsule, Omega-3-Acid Ethyl Esters 90 1000mg Capsule
Slovenian: Romunija srednjeverižni trigliceridi 1qs kapsula, sojin lecitin 1qs kapsula, omega-3kislinski etilestri 90
English: Ácidos Omega 3 Aristo Omega-3-Acid Ethyl Esters 1000mg Capsule
Slovenian: Ácidos Omega 3 Aristo omega-3-kislinski etilestri 1000 mg kapsula
English: Docosahexaenoic Acid 60mg Capsule, Eicosapentaenoic Acid 90mg Capsule
Slovenian: Prolipid dokozaheksaenojska kislina 60 mg kapsula, eikozanpentanojska kislina 90 mg kapsula
English: Docosahexaenoic Acid 115mg Capsule, Eicosapentanoic Acid/Docosahexaenoic Acid 170mg Capsule
Slovenian: Pazeril dokozaheksaenojska kislina 115 mg kapsula, eikozanpentanojska kislina/dokozaheksaenoj ska kislina 170 mg kapsula
English: Acidos Omega 3 Stada Omega-3-Acid Ethyl Esters 90 1000mg
Slovenian: Acidos Omega 3 Stada omega-3-kislinski etilestri 90 1000 mg kapsula
English: Omega-3-Acid Ethyl Esters 90 With A Specific Composition For Epa And Dha Not Lower Than 85%.
Slovenian: Eskim omega-3-kislinski etilestri 90 s specifično sestavo EPA in DHA nad 85 % 500mg kapsula
English: Omega-3 Fatty Acids 1000mg Capsule
Slovenian: Tevocor omega-3 maščobne kisline 1000 mg kapsula
English: Esters Of Unsaturated Fatty Acids 1000mg Capsule
Slovenian: Esapent estri nenasičenih maščobnih kislin 1000 mg kapsula
English: Docosahexaenoic Acid 120mg Capsule, Eicosapentaenoic Acid 180mg Capsule
Slovenian: Prolipid dokozaheksaenojska kislina 120 mg kapsula, eikozanpentanojska kislina 180 mg kapsula
English: Ácidos Omega 3 Tarbis Docosahexaenoic Acid 380mg Capsule,
Slovenian: Ácidos Omega 3 Kern Pharma etilester eikozapentaenojske kisline 460 mg kapsula, etilester dokozaheksaenojske kisline 380 mg kapsula
English: Docosahexaenoic Acid 527mg/5ml, Eicosapentaenoic Acid 791mg/5ml
Slovenian: Farlipid dokozaheksaenojska kislina 527 mg/5 ml, eikozapentaenojska kislina 791 mg/5 ml peroralna raztopina
English: Docosahexaenoic Acid 115mg Capsule, Vitamin D 10 I.U.G,
Slovenian: Maxepa dokozaheksaenojska kislina 115 mg kapsula, vitamin D 10 i.e./g, eikozanpentanojska kislina 170 mg kapsula, vitamin A 100 i.e./g
English: Docosahexaenoic Acid 527mg/5ml, Eicosapentanoic Acid/Docosahexaenoic Acid 791mg/5ml
Slovenian: Pazeril dokozaheksaenojska kislina 527 mg/5 ml, eikozanpentanojska kislina/dokozaheksaenoj ska kislina 791 mg/5 ml peroralna raztopina
English: Eicosapentaenoic Acid 170mg Capsule, Vitamin A 1 I.U.G
Slovenian: Farlipid dokozaheksaenojska kislina 115 mg kapsula, vitamin D 1 i.e./g, eikozapentaenojska kislina 170 mg kapsula, vitamin A 1 i.e./g
English: Verisfield (Uk) Ltd Lipemia
Slovenian: Verisfield (Uk) Ltd Lipemia ribje olje 0,5 ml/ml peroralna emulzija
English: Docosahexaenoic Acid 265mg/5ml, Eicosapentaenoic Acid 390mg/5ml
Slovenian: Farlipid dokozaheksaenojska kislina 265 mg/5 ml, eikozapentaenojska kislina 390 mg/5 ml peroralna emulzija
English: Eicosapentaenoic Acid 791mg/5ml, Vitamin A 100 I.U.G
Slovenian: Maxepa dokozaheksaenojska kislina 527 mg/5 ml, vitamin D 10 i.e./g, eikozapentaenojska kislina 791 mg/5 ml, vitamin A 100 i.e./g peroralna raztopina
English: Docosahexaenoic Acid Ethyl Ester 437mg Capsule
Slovenian: Tropolipid etilester eikozapentaenojske kisline 430 mg kapsula, etilester dokozaheksaenojske kisline 437 mg kapsula
English: Pharmaceutical Form Route of administration
Slovenian: Številka (EU) dovoljenja za promet zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
English: Treatment with Pioglitazone Actavis should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Slovenian: Zdravljenje z zdravilom Pioglitazon Actavis je treba ponovno oceniti po treh do šest mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, prekiniti.
English: The full EPAR for Pioglitazone Actavis 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 Pioglitazon Actavis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Actavis on 15 March 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pioglitazon Actavis, veljavno po vsej Evropski uniji, izdala 15. marca 2012.
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Actavis.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pioglitazon Actavis.
English: Pioglitazone Actavis is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Slovenian: Zdravilo Pioglitazon Actavis se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih (starejših od 18 let), zlasti tistih s prekomerno telesno maso.
English: The company that markets Pioglitazone Actavis will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Slovenian: Družba, ki trži zdravilo Pioglitazon Actavis, bo za zdravnike, ki bodo predpisovali zdravilo, pripravila izobraževalno gradivo, ki bo vključevalo možno tveganje za srčno popuščanje in rak sečnega mehurja pri zdravljenju s pioglitazonom, merila za izbiro bolnikov in potrebo po redni oceni zdravljenja ter njegovi prekinitvi, če to bolnikom ne koristi več.
English: Pioglitazone Actavis
Slovenian: Pioglitazon Actavis pioglitazon
English: The active substance in Pioglitazone Actavis, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Slovenian: Zdravilna učinkovina v zdravilu Pioglitazon Actavis, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
English: The Committee recommended that Pioglitazone Actavis be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Pioglitazon Actavis odobri za uporabo v EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pioglitazone Actavis has been shown to have comparable quality and to be bioequivalent to Actos.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pioglitazon Actavis primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
English: What measures are being taken to ensure the safe and effective use of Pioglitazone Actavis?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pioglitazon Actavis?
English: This means that Pioglitazone Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Actos.
English: Because Pioglitazone Actavis 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 Pioglitazon Actavis generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What are the benefits and risks of Pioglitazone Actavis?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Pioglitazon Actavis?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pioglitazone Actavis have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pioglitazon Actavis upoštevati zdravstveni delavci in bolniki, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: For more information about treatment with Pioglitazone Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pioglitazon Actavis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Pioglitazone Actavis
Slovenian: Druge informacije o zdravilu Pioglitazon Actavis
English: Pioglitazone Actavis is a ‘generic medicine'.
Slovenian: Zdravilo Pioglitazon Actavis je „generično zdravilo“.
English: Because Pioglitazone Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Slovenian: Ker je zdravilo Pioglitazon Actavis generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Actos.
English: For practical information about using Pioglitazone Actavis, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Pioglitazon Actavis naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: • in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;
Slovenian: • v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče zadovoljivo uravnati bolezni, ali v kombinaciji s sulfonilsečnino (drugo vrsto zdravila za zdravljenje sladkorne bolezni), če metformin ni primeren, pri bolnikih, pri katerih sladkorna bolezen zgolj s sulfonilsečnino ni zadovoljivo uravnana;
English: What is Pioglitazone Actavis and what is it used for?
Slovenian: Kaj je zdravilo Pioglitazon Actavis in za kaj se uporablja?
English: Why is Pioglitazone Actavis approved?
Slovenian: Zakaj je bilo zdravilo Pioglitazon Actavis odobreno?
English: Pioglitazone Actavis contains the active substance pioglitazone.
Slovenian: Zdravilo Pioglitazon Actavis vsebuje zdravilno učinkovino pioglitazon.
English: It is not intended to provide practical advice on how to use Pioglitazone Actavis.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Pioglitazone Actavis can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Pioglitazon Actavis je le na recept.
English: How has Pioglitazone Actavis been studied?
Slovenian: Kako je bilo zdravilo Pioglitazon Actavis raziskano?
English: How is Pioglitazone Actavis used?
Slovenian: Kako se zdravilo Pioglitazon Actavis uporablja?
English: How does Pioglitazone Actavis work?
Slovenian: Kako zdravilo Pioglitazon Actavis deluje?
English: Date of first authorisation: 13 March 2013 Date of latest renewal:
Slovenian: Datum prve odobritve: 13. marec 2013 Datum zadnjega podaljšanja:
English: Contains desiccant, do not eat.
Slovenian: Vsebuje sušilo, ne jejte.
English: Avoid taking alcohol until you have talked to your doctor.
Slovenian: Izogibajte se pitju alkohola, dokler se o tem ne pogovorite z zdravnikom.
English: - Calcium supplements and/or vitamin D supplements.
Slovenian: - dodatki kalcija in/ali dodatki vitamina D;
English: About 60% of the oral dose is eliminated within 48 hours.
Slovenian: Približno 60 % peroralnega odmerka se izloči v 48 urah.
English: You may notice this as dizziness when standing up.
Slovenian: Pojavi se vam lahko omotica, ko vstanete.
English: The event may be a chance finding or related to a mechanism currently not known (see section 5.1).
Slovenian: Dogodek je lahko naključen ali povezan s še neznanim mehanizmom (glejte poglavje 5.1).
English: A. LABELLING
Slovenian: A: OZNAČEVANJE
English: Renal clearance is about 250-300 ml/min.
Slovenian: Ledvični očistek je približno 250 do 300 ml/min.
English: - Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Slovenian: - Drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6).
English: This applies especially to the medicines listed below taken at the same time with Actelsar HCT:
Slovenian: To velja zlasti za spodaj našteta zdravila, ki jih jemljete hkrati z zdravilom Actelsar HCT:
English: - Medicines to increase blood pressure, such as noradrenaline.
Slovenian: - zdravila za zvišanje krvnega tlaka, kot je noradrenalin;
English: Your doctor will normally advise you to stop taking Actelsar HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Actelsar HCT.
Slovenian: Zdravnik vam bo praviloma svetoval, da zdravilo Actelsar HCT prenehate jemati, preden boste zanosili ali takoj, ko boste vedeli, da ste noseči, in vam svetoval, da namesto zdravila Actelsar HCT jemljete drugo zdravilo.
English: Actelsar HCT can have influence on the ability to drive and use machines.
Slovenian: Zdravilo Actelsar HCT lahko vpliva na sposobnost vožnje in upravljanja strojev.
English: *The event may have happened by chance or could be related to a mechanism currently not known.
Slovenian: *Morebiti gre za naključje ali pa je pojav povezan z mehanizmom, ki še ni znan.
English: The safety and efficacy of Actelsar HCT in children and adolescents aged below 18 have not been established.
Slovenian: Varnost in učinkovitost zdravila Actelsar HCT pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
English: See also information under the heading “Do not take Actelsar HCT”.
Slovenian: Glejte tudi informacije pod naslovom “Ne jemljite zdravila Actelsar HCT''.
English: - Amantadine (medicine used to treat Parkinson's disease and also used to treat or prevent certain illnesses caused by viruses).
Slovenian: - amantadin (zdravilo za zdravljenje Parkinsonove bolezni, s katerim zdravijo ali preprečujejo tudi nekatere bolezni, ki jih povzročajo virusi);
English: Do not use this medicine after the expiry date which is stated on the carton, blister or bottle label after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake »EXP«.
English: Telmisartan is highly bound to plasma proteins (>99.5%) mainly albumin and alpha l-acid glycoprotein.
Slovenian: Telmisartan se obsežno veže na plazemske beljakovine (> 99,5 %), predvsem albumin in kisli glikoprotein alfa-1.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: Magnesium stearate (E470b) Potassium hydroxide Meglumine
Slovenian: Magnezijev stearat (E470b) Kalijev hidroksid
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Slovenian: - Preobčutljivost na katero koli učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Slovenian: Hidroklorotiazid sproži diurezo v 2 urah, največji učinek doseže približno po 4 urah, njegovo delovanje pa traja približno 6 do 12 ur.
English: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed.
Slovenian: Če je bil telmisartan uporabljen sočasno z digoksinom, so opažali mediano povečanje največje koncentracije digoksina (49 %) in njegove najmanjše koncentracije (20 %).
English: Very rare (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): napredujoče brazgotinjenje pljučnega tkiva (intersticijska pljučna bolezen)**
English: Actelsar HCT with food and alcohol
Slovenian: Zdravilo Actelsar HCT skupaj s hrano in alkoholom