FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of tenofovir disoproxil and didanosine is not recommended (see section 4.4).
Slovenian: Sočasna uporaba dizoproksiltenofovirata in didanozina ni priporočljiva (glejte poglavje 4.4).
English: Lumbar spine BMD mean % increase
Slovenian: Povprečno zvišanje MGK ledvene hrbtenice v %
English: Each Tenofovir disoproxil Mylan tablet contains 245 mg of tenofovir disoproxil (as maleate).
Slovenian: Ena tableta zdravila Dizoproksiltenofovirat Mylan vsebuje 245 mg dizoproksiltenofovirata (v obliki maleata).
English: Tenofovir disoproxil Mylan contains the active substance tenofovir disoproxil.
Slovenian: Zdravilo Dizoproksiltenofovirat Mylan vsebuje učinkovino dizoproksiltenofovirat.
English: Figures presented are cumulative percentages based upon a Kaplan Meier analysis excluding data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-tenofovir disoproxil).
Slovenian: l Prikazane številke so kumulativni odstotki na podlagi Kaplan-Meierjeve analize, brez podatkov zbranih po dodajanju emtricitabina k odprtemu zdravljenju z dizoproksiltenofoviratom (KM-dizoproksiltenofovirat).
English: Tenofovir disoproxil should not be administered concomitantly with adefovir dipivoxil.
Slovenian: Dizoproksiltenofovirata se ne sme uporabljati sočasno z dipivoksiladefoviratom.
English: Tenofovir disoproxil should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide.
Slovenian: Sočasna uporaba z drugimi zdravili, ki ni priporočljiva Dizoproksiltenofovirata se ne sme uporabljati sočasno z drugimi zdravili, ki vsebujejo dizoproksiltenofovirat ali tenofoviralafenamid.
English: Pharmacokinetic parameters of tenofovir were determined following administration of a single dose of tenofovir disoproxil 245 mg to 40 non-HIV, non-HBV infected adult patients with varying degrees of renal impairment defined according to baseline creatinine clearance (CrCl) (normal renal function when CrCl > 80 ml/min; mild with CrCl = 50-79 ml/min; moderate with CrCl = 30-49 ml/min and severe with CrCl = 10-29 ml/min).
Slovenian: Stopnja ledvične okvare je bila določena glede na začetno vrednost očistka kreatinina (CLCR) (normalna ledvična funkcija je pri CLCR > 80 ml/min; blaga ledvična okvara pri CLCR = 50 - 79 ml/min, zmerna pri CLCR = 30 - 49 ml/min in huda pri CLCR = 10 - 29 ml/min).
English: - Tenofovir disoproxil Mylan should not be administered concomitantly with adefovir dipivoxil.
Slovenian: - Zdravila Dizoproksiltenofovirat Mylan se ne sme uporabljati sočasno z dipivoksiladefoviratom.
English: Entecavir
Slovenian: pankreatitis
English: For bottles: after first opening the bottle use within 90 days.
Slovenian: Za plastenke: Po prvem odprtju plastenke tablete uporabite v 90 dneh.
English: Tenofovir disoproxil Mylan 245 mg film-coated tablets tenofovir disoproxil
Slovenian: Dizoproksiltenofovirat Mylan 245 mg filmsko obložene tablete dizoproksiltenofovirat
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/ 100 mg+100 mg q.d.)
Slovenian: Priporočilo glede sočasne uporabe z 245 mg dizoproksiltenofovirata sofosbuvir/velpatasvir/ voksilaprevir (400 mg/100 mg/ 100 mg+100 mg enkrat dnevno)
English: week 144 (n = 7), and week 192(n = 8).
Slovenian: (n = 24), 144.
English: Normalised ALT
Slovenian: Jetrna okvara
English: Genotypic evaluations were performed on all patients within this group with HBV DNA > 400 copies/ml at week 96 (n = 17),
Slovenian: Genotipsko ocenitev so opravili pri vseh bolnikih v tej skupini s koncentracijo HBV DNA > 400 kopij/ml v 96. tednu (n = 17), 144. tednu (n = 7) in 192. tednu (n = 8).
English: Tenofovir disoproxil Mylan 245 mg film-coated tablets
Slovenian: Dizoproksiltenofovirat Mylan 245 mg filmsko obložene tablete
English: These include:
Slovenian: Med ta zdravila spadajo:
English: • pancreas problems
Slovenian: • težave s trebušno slinavko
English: Given that tacrolimus can affect renal function, close monitoring is recommended when it is coadministered with tenofovir disoproxil.
Slovenian: Takrolimus lahko vpliva na delovanje ledvic, zato je ob sočasni uporabi takrolimusa in dizoproksiltenofovirata priporočeno skrbno nadzorovati bolnika.
English: Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together.
Slovenian: Pri sočasnem jemanju zdravil, ki vsebujejo dizoproksiltenofovirat in didanozin, so redko poročali o vnetju trebušne slinavke in laktacidozi (zvišanje mlečne kisline v krvi), ki je bila včasih smrtna.
English: • adefovir dipivoxil (for HBV),
Slovenian: • dipivoksiladefovirat (za okužbo z virusom HBV);
English: AUC: ↑ 40% Cmax: ↔ Cmin: ↑ 91%
Slovenian: AUC: ↑ 40% Cmax: ↔ C min: ↑ 91%
English: Voxilaprevir: AUC: ↑ 143% Cmax:↑ 72% Cmin: ↑ 300%
Slovenian: AUC: ↑ 143 % Cmax:↑ 72 % Cmin: ↑ 300 %
English: • pain in the tummy (abdomen) caused by inflammation of the liver
Slovenian: • bolečine v trebuhu zaradi vnetja jeter
English: Lopinavir/Ritonavir (400 b.i.d./100 b.i.d.)
Slovenian: lopinavir/ritonavir (400 dvakrat dnevno/100 dvakrat dnevno)
English: Administration of tenofovir disoproxil 33 mg/g granules to provide a reduced daily dose of tenofovir disoproxil is recommended for adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients.
Slovenian: Odraslim bolnikom, ki imajo očistek kreatinina < 50 ml/min, vključno z bolniki na hemodializi, je priporočljivo dizoproksiltenofovirat dajati v obliki 33 mg/g zrnc, da se omogoči manjši dnevni odmerek dizoproksiltenofovirata.
English: Tenofovir disoproxil 245 mg (n = 45)
Slovenian: Dizoproksiltenofo -virat 245 mg (n = 45)
English: p 48 weeks of double-blind adefovir dipivoxil followed by 336 weeks open-label tenofovir disoproxil.
Slovenian: p 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 336-tedensko odprto zdravljenje z dizoproksiltenofoviratom.
English: • Try to avoid getting pregnant during treatment with Tenofovir disoproxil Mylan.
Slovenian: • Med zdravljenjem z zdravilom Dizoproksiltenofovirat Mylan poskusite preprečiti nosečnost.
English: NA = Not Applicable a BMD Z-scores not adjusted for height and weight b Primary safety endpoint through week 72
Slovenian: Z-indeks MGK ni prilagojen za telesno višino in maso b
English: GS-331007 AUC: ↔ Cmax:↔ Cmin: N/A
Slovenian: GS-331007 AUC: ↔ Cmax:↔ Cmin: N/V
English: Tenofovir disoproxil Mylan contains lactose
Slovenian: Shranjevanje zdravila Dizoproksiltenofovirat Mylan
English: • fatty liver
Slovenian: • zamaščena jetra
English: What Tenofovir disoproxil Mylan contains - The active substance is tenofovir disoproxil.
Slovenian: Kaj vsebuje zdravilo Dizoproksiltenofovirat Mylan - Učinkovina je dizoproksiltenofovirat.
English: c 48 weeks of double-blind adefovir dipivoxil followed by 48 weeks open-label tenofovir disoproxil.
Slovenian: c 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 48-tedensko odprto zdravljenje z dizoproksiltenofoviratom.
English: A higher risk of renal impairment has been reported in patients receiving tenofovir disoproxil in combination with a ritonavir or cobicistat boosted protease inhibitor.
Slovenian: Pri bolnikih, ki so dizoproksiltenofovirat prejemali v kombinaciji z zaviralcem proteaze, okrepljenim z ritonavirjem ali kobicistatom, so poročali o večjem tveganju za ledvično okvaro.
English: Concomitant use not recommended
Slovenian: navedba smiselno ni potrebna navedba smiselno ni potrebna
English: f 48 weeks of double-blind adefovir dipivoxil followed by 96 weeks open-label tenofovir disoproxil.
Slovenian: f 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 96-tedensko odprto zdravljenje z dizoproksiltenofoviratom.
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 90
Slovenian: 10 mg dipivoksiladefovirata prehod na 245 mg dizoproksiltenofovirata n = 90
English: b 48 weeks of double-blind tenofovir disoproxil followed by 48 weeks open-label.
Slovenian: b 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 48-tedensko odprto zdravljenje.
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Slovenian: Varnost dizoproksiltenofovirata, kadar se uporablja sočasno s sofosbuvirjem/velpatasvirjem in s farmakokinetičnim ojačevalcem (npr. ritonavirjem ali kobicistatom) ni bila potrjena.
English: • adolescents aged 12 to less than 18 years who have already been treated with other HIV
Slovenian: • mladostnike, stare od 12 do manj kot 18 let, predhodno že zdravljene z drugimi zdravili proti HIV, ki niso več polno učinkovita zaradi nastanka odpornosti ali so povzročala neželene učinke.
English: A consistent response to treatment with tenofovir disoproxil 245 mg was seen regardless of baseline HIV-1 RNA and CD4 count.
Slovenian: Ne glede na začetno vrednost HIV-1 RNA in števila CD4 je bil odziv na zdravljenje z 245 mg dizoproksiltenofovirata enak.
English: m 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Slovenian: m 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 240-tedensko odprto zdravljenje z dizoproksiltenofoviratom.
English: Lumbar spine mean (SD) BMD Z-score a
Slovenian: Povprečni (SD) Z-indeks MGK ledvene hrbtenicea
English: + Efavirenz/Emtricitabine/ Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Slovenian: sofosbuvir (400 mg enkrat dnevno) + efavirenz/emtricitabin/ dizoproksiltenofovirat (600 mg/200 mg/245 mg enkrat dnevno)
English: The safety of tenofovir disoproxil when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Slovenian: Varnost dizoproksiltenofovirata, kadar se uporablja sočasno z ledipasvirjem/sofosbuvirjem in s pospeševalcem farmakokinetike (npr. ritonavirjam ali kobicistatom) ni bila potrjena.
English: lactic acidosis Nervous system disorders:
Slovenian: NRTI (Nukleozidni in nukleotidni zaviralci reverzne transkriptaze) didanozin
English: Whole body BMD at least 6% decreaseb
Slovenian: Najmanj 6-% zmanjšanje MGK za celo telo b navedba smiselno ni potrebna navedba smiselno ni potrebna
English: e 48 weeks of double-blind tenofovir disoproxil followed by 96 weeks open-label.
Slovenian: e 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 96-tedensko odprto zdravljenje.
English: o 48 weeks of double-blind tenofovir disoproxil followed by 336 weeks open-label.
Slovenian: o 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 336-tedensko odprto zdravljenje.
English: • Contact your doctor before you restart taking Tenofovir disoproxil Mylan tablets.
Slovenian: • Preden začnete ponovno jemati zdravilo Dizoproksiltenofovirat Mylan, se posvetujte z zdravnikom.
English: 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Slovenian: i 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 144-tedensko odprto zdravljenje z dizoproksiltenofoviratom.
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV, non-HBV infected adult patients with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Slovenian: Farmakokinetične parametre za tenofovir so določili po uporabi enkratnega odmerka 245 mg dizoproksiltenofovirata pri 40 odraslih bolnikih, ki niso bili okuženi s HIV ali z virusom HBV, z različnimi stopnjami ledvične okvare.
English: h 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Slovenian: h 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 144-tedensko odprto zdravljenje z dizoproksiltenofoviratom.
English: j 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Slovenian: j 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 192-tedensko odprto zdravljenje z dizoproksiltenofoviratom.
English: 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Slovenian: n 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 240-tedensko odprto zdravljenje z dizoproksiltenofoviratom.
English: Histology
Slovenian: Serologija
English: Paediatrics
Slovenian: angioedem
English: 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Slovenian: k 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 192-tedensko odprto zdravljenje z dizoproksiltenofoviratom.
English: g 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
Slovenian: g 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 144-tedensko odprto zdravljenje.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Tenofovir disoproxil Mylan
Slovenian: Pred začetkom jemanja zdravila Dizoproksiltenofovirat Mylan se posvetujte z zdravnikom ali farmacevtom.
English: + Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Slovenian: ledipasvir/sofosbuvir (90 mg/400 mg enkrat dnevno) + emtricitabin/rilpivirin/dizo proksiltenofovirat (200 mg/25 mg/245 mg enkrat dnevno)
English: + Raltegravir (400 mg b.i.d) + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Slovenian: + darunavir (800 mg enkrat dnevno) + ritonavir (100 mg enkrat dnevno) + emtricitabin/ dizoproksiltenofovirat (200 mg/245 mg enkrat dnevno)
English: No clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with entecavir.
Slovenian: Ob sočasni uporabi dizoproksiltenofovirata z entekavirjem ni klinično pomembnih farmakokinetičnih interakcij.
English: NRTIs
Slovenian: Spol
English: Adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients:
Slovenian: Odrasli bolniki z očistkom kreatinina < 50 ml/min, vključno z bolniki na hemodializi Podatki o varnosti in učinkovitosti dizoproksiltenofovirata pri bolnikih z oslabljenim delovanjem ledvic so pomanjkljivi.
English: • pain in the tummy (abdomen) caused by inflammation of the pancreas
Slovenian: • bolečine v trebuhu zaradi vnetja trebušne slinavke
English: 48 weeks of double-blind adefovir dipivoxil followed by up to 192 weeks open-label tenofovir disoproxil.
Slovenian: d 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi do 192-tedensko odprto zdravljenje z dizoproksiltenofoviratom.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane plazemske koncentracije tenofovirja zaradi sočasne uporabe dizoproksiltenofovirata, sofosbuvirja/velpatasvirja in atazanavirja/ritonavirja lahko povečajo neželene učinke, povezane z dizoproksiltenofoviratom, vključno z boleznimi ledvic.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasnega dajanja dizoproksiltenofovirata, sofosbuvirja/velpatasvirja/voksila previrja in darunavirja/ritonavirja lahko povečajo neželene učinke, povezane z dizoproksiltenofoviratom, vključno z motnjami delovanja ledvic.
English: l 48 weeks of double-blind tenofovir disoproxil followed by 240 weeks open-label.
Slovenian: l 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 240-tedensko odprto zdravljenje.
English: 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label.
Slovenian: i 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 192-tedensko odprto zdravljenje.
English: Bulgaria дотарем
Slovenian: Bolgarija дотарем
English: A. Martins & Fernandes, S.A.
Slovenian: A. Martins & Fernandes, S.A. Dotarem
English: Netherlands Guerbet Nederland Bv
Slovenian: Guerbet Nederland BV
English: Luxembourg Guerbet
Slovenian: Luksemburg Guerbet
English: Intraarticular use
Slovenian: intraartikularna uporaba
English: Injection
Slovenian: injiciranje
English: Belgium Ge Healthcare Bvba
Slovenian: GE Healthcare Bvba
English: Ge Healthcare Buchler Gmbh & Co. Kg
Slovenian: GE Healthcare Buchler GmbH & Co.
English: Nationally authorised medicinal products Member state
Slovenian: Priloga I Seznam nacionalno odobrenih zdravil
English: Luxembourg Bayer Sa Nv
Slovenian: Luksemburg Bayer SA NV
English: Solution for injection/infusion
Slovenian: raztopina za injiciranje/infuzijo
English: Bracco Imaging Italia Srl
Slovenian: Bracco Imaging Italia SRL Prohance
English: Belgium Agfa Healthcare Imaging Agents Gmbh
Slovenian: Velika Britanija Agfa Healthcare Imaging Agents GmbH
English: Jenapharm Gmbh & Co Kg
Slovenian: Jenapharm GmbH & Co Kg Dotagraf
English: Belgium Bayer Sa Nv
Slovenian: Bayer SA NV
English: Solution for injection in cartridge | solution for injection in pre-filled syringe
Slovenian: raztopina za injiciranje v vložku | raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Mallinckrodt Deutschland Gmbh Optimark
Slovenian: Mallinckrodt Deutschland GmbH
English: Ge Healthcare Handels Gmbh
Slovenian: GE Healthcare Handels GmbH Omniscan
English: Sanochemia Pharmazeutika Ag Gadotersäure Sanochemia
Slovenian: Sanochemia Pharmazeutika AG
English: Netherlands Bayer Bv
Slovenian: Bayer BV
English: Solution for injection Intraarticular use
Slovenian: Artirem intraartikularna uporaba
English: Luxembourg Bracco Imaging Deutschland Gmbh
Slovenian: Luksemburg Bracco Imaging Deutschland GmbH
English: Omniscan
Slovenian: омнискен
English: Belgium Guerbet
Slovenian: Velika Britanija Guerbet
English: Sanochemia Pharmazeutika Ag Cyclolux Rep
Slovenian: Cyclolux Rep
English: Netherlands Ge Healthcare B.V.
Slovenian: GE Healthcare B.V.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States for gadolinium containing medicinal products
Slovenian: Priloga IA - zdravila, ki vsebujejo gadobensko kislino, gadobutrol, gadotersko kislino, gadoteridol, gadoksetno kislino za intravensko uporabo ter gadopentetsko kislino in gadotersko kislino za intraartikularno uporabo
English: Sanochemia Pharmazeutika Ag Cyclolux Multi
Slovenian: Cyclolux Multi
English: Sanochemia Pharmazeutika Ag Gadoteric Acid Gadotersäure
Slovenian: Gadotersäure Sanochemia
English: Gadopentat
Slovenian: гадовист
English: Sanochemia Pharmazeutika Ag Cyclolux
Slovenian: Velika Britanija Sanochemia Pharmazeutika AG
English: Gadoteric Acid 0.5 Milli Molar / Ml Solution for injection Intravenous use
Slovenian: Gadoteric Acid Gadotersäure Sanochemia 0,5 Mmol/Ml Injektionslösung
English: Conpharm Gmbh
Slovenian: Conpharm GmbH Gadopentat
English: Bayer Spa
Slovenian: Bayer S.p.A.
English: Gadodiamide 14.35g/50 Ml
Slovenian: Gadoteridol 13965mg/50 Ml
English: 90 (3 x 30) tablets (multipack)
Slovenian: Pot uporabe Stična ovojnina Velikost pakiranja plastenka (HDPE) 30 tablet plastenka (HDPE) 90 (3 x 30) tablet (skupna pakiranja)
English: Date of first authorisation: 19 September 2016
Slovenian: Datum prve odobritve: 19. september 2016
English: There were no efficacy differences according to gender.
Slovenian: Razlik v učinkovitosti glede na spol ni bilo.
English: Take the next dose at the next scheduled time and continue as normal.
Slovenian: Vzemite naslednji odmerek ob naslednjem načrtovanem času in nadaljujte kot ponavadi.
English: BSS <5 Response
Slovenian: Odziv BSS < 5
English: The study designs were identical through the first 26 weeks.
Slovenian: Prvih 26 tednov sta bili študiji enako zasnovani.
English: All patients met Rome III criteria for IBS and were required to meet the following criteria:
Slovenian: Vsi bolniki so ustrezali merilom Rome III za IBS in so morali izpolnjevati naslednja pogoja:
English: Caution should therefore be exercised in patients receiving such medicinal products especially with high doses.
Slovenian: Zato je potrebna previdnost pri bolnikih, ki prejemajo taka zdravila, zlasti v velikih odmerkih.
English: The pain may feel like it is moving through to your back or shoulder;
Slovenian: Čutite lahko, da se bolečina premika v hrbet in rame;
English: The tablets should be taken orally with food in the morning and in the evening.
Slovenian: Tablete je treba pogoltniti s hrano, zjutraj in zvečer.
English: Truberzi should not be given to children and adolescents less than 18 years old as there is no information about its use in this age group.
Slovenian: Zdravilo Truberzi se ne sme dajati otrokom in mladostnikom, mlajšim od 18 let, saj ni na voljo podatkov o njegovi uporabi v tej starostni skupini.
English: Benefits and risks of the treatment should be periodically assessed in the context of patient symptoms severity.
Slovenian: Koristi in tveganja zdravljenja je treba redno ocenjevati v okviru resnosti simptomov.
English: Study 2 (IBS 3002)
Slovenian: Študija 2 (IBS 3002)
English: In principle, general dose recommendations also apply to patients aged 65 years and above.
Slovenian: Splošna priporočila za odmerjanje načeloma veljajo tudi za bolnike, stare 65 let in več.
English: inhibitory concentration [IC50] of approximately 20 µM [11 µg/mL]), although this is not expected to result in any clinically meaningful interactions.
Slovenian: [IC50] za približno 20 µM [11 µg/ml]), čeprav ni pričakovati, da bo to povzročilo kakršne koli klinično pomembne interakcije.
English: You may feel pain on the right side of your belly or the upper area of the belly, right below the ribs.
Slovenian: Morda boste čutili bolečino na desni strani trebuha ali v zgornjem delu trebuha, tik pod rebri.
English: Global Symptom Response
Slovenian: Odziv globalnih simptomov
English: Approximately 50% of constipation events occurred within the first 2 weeks of treatment.
Slovenian: Približno 50 % primerov zaprtosti je nastopilo v prvih 2 tednih zdravljenja.
English: Gender, age, ethnicity
Slovenian: Spol, starost in etnična pripadnost
English: • Alcoholism, alcohol abuse, alcohol addiction or chronic or acute excessive alcohol use.
Slovenian: • Alkoholizem, zloraba alkohola, odvisnost od alkohola ali kronično ali akutno čezmerno uživanje alkohola.
English: In the event of acute overdose, the patient should be carefully observed and given standard supportive treatment as required.
Slovenian: Pri akutnem prevelikem odmerjanju je treba bolnika skrbno opazovati in mu po potrebi nuditi standardno podporno zdravljenje.
English: Do not drive or use machines while taking this medicine until you know how it affects you.
Slovenian: Med jemanjem tega zdravila ne vozite in ne upravljajte strojev, dokler ne veste, kako zdravilo vpliva na vas.
English: • pain may begin soon after you start Truberzi.
Slovenian: • bolečina lahko nastopi kmalu po začetku jemanja zdravila Truberzi.
English: The tablets should be taken with food in the morning and in the evening (see section 5.2).
Slovenian: Tablete je treba vzeti s hrano zjutraj in zvečer (glejte poglavje 5.2).
English: Component of a multipack, can't be sold separately
Slovenian: Del velikega pakiranja; ne sme se prodajati ločeno
English: All patients should be instructed not to use alcohol while on treatment with eluxadoline.
Slovenian: Vsem bolnikom je treba naročiti, da med zdravljenjem z eluksadolinom ne uživajo alkohola.
English: 80% (8/10) of sphincter of Oddi spasm events presented within the first week of treatment.
Slovenian: 80 % (8/10) spazmov Oddijevega sfinktra je nastopilo v prvem tednu zdravljenja.
English: Mean plasma elimination half-life is 5 hours with high inter-subject variability.
Slovenian: Srednji razpolovni čas izločanja iz plazme je 5 ur, z visoko variabilnostjo med posamezniki.