FrancophonIA/ELRC3.0 huggingface dataset:
English: Tenofovir disoproxil should not be administered concomitantly with adefovir dipivoxil.
Croatian: Tenofovirdizoproksil se ne smije istovremeno primjenjivati s adefovirdipivoksilom.
English: The following side effects are uncommon (these can affect up to 1 in every 100 patients):
Croatian: Sljedeće nuspojave su manje česte (mogu se javiti u do 1 na svakih 100 bolesnika):
English: In addition 55% (29/53) of patients treated with tenofovir disoproxil had undetectable HBV DNA (< 169 copies/ml [< 29 IU/ml]; the limit of quantification of the Roche Cobas TaqMan HBV assay) versus 60% (31/52) of patients treated with emtricitabine plus tenofovir disoproxil (p = 0.504).
Croatian: J./ml]; limit kvantifikacije testa na HBV Roche Cobas TaqMan) nasuprot 60% (31/52) bolesnika liječenih emtricitabinom u kombinaciji s tenofovirdizoproksilom (p = 0,504).
English: Mechanism of action and pharmacodynamic effects Tenofovir disoproxil maleate is the maleate salt of the prodrug tenofovir disoproxil.
Croatian: Tenofovirdizoproksilmaleat jest maleatna sol predlijeka tenofovirdizoproksila.
English: Tenofovir disoproxil 245 mg n = 176
Croatian: Tenofovirdizoproks il 245 mg n = 176
English: What you need to know before you take Tenofovir disoproxil Mylan
Croatian: Što morate znati prije nego počnete uzimati Tenofovir disoproxil Mylan Nemojte uzimati Tenofovir disoproxil Mylan:
English: Each Tenofovir disoproxil Mylan tablet contains 245 mg of tenofovir disoproxil (as maleate).
Croatian: Jedna tableta lijeka Tenofovir disoproxil Mylan sadrži 245 mg tenofovirdizoproksila (u obliku tenofovirdizoproksilmaleata).
English: In study GS-US-104-0352, 8 out of 89 paediatric patients (9.0%) exposed to tenofovir disoproxil (median tenofovir disoproxil exposure 331 weeks) discontinued study drug due to renal adverse events.
Croatian: U ispitivanju GS-US-104-0352, 8 od 89 pedijatrijskih bolesnika (9,0%) izloženih tenofovirdizoproksilu (medijan izloženosti tenofovirdizoproksilu: 331 tjedan) prekinulo je uzimanje ispitivanog lijeka zbog štetnih događaja povezanih s bubrezima.Pet ispitanika (5,6 %) imalo je laboratorijske nalaze koji klinički odgovaraju proksimalnoj bubrežnoj tubulopatiji, od kojih je njih 4 prekinulo liječenje tenofovirdizoproksilom.
English: How to store Tenofovir disoproxil Mylan
Croatian: Kako čuvati Tenofovir disoproxil Mylan
English: After an initial decline of approximately -4.9 ml/min (using Cockcroft-Gault equation) or -3.9 ml/min/1.73 m2 (using modification of diet in renal disease
Croatian: (prema Cockcroft-Gaultovoj jednadžbi) ili -3,9 ml/min/1,73 m
English: NA = Not Applicable a BMD Z-scores not adjusted for height and weight b Primary safety endpoint through week 72
Croatian: BMD Z rezultat nije prilagođen za tjelesnu visinu i težinu b
English: Tenofovir disoproxil Mylan 245 mg film-coated tablets tenofovir disoproxil
Croatian: Tenofovir disoproxil Mylan 245 mg filmom obložene tablete tenofovirdizoproksil
English: Sofosbuvir: AUC: ↔ Cmax: ↓ 30% Cmin: N/A
Croatian: Sofosbuvir: AUC: ↔ Cmax: ↓ 30% Cmin: NP
English: Whole body BMD at least 6% decreaseb
Croatian: Smanjenje BMD-a cijelog tijela za najmanje b
English: Lumbar spine mean (SD) BMD Z-score a
Croatian: BMD Z rezultata umbalne kralježnic e
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures) , myopathy Renal and urinary disorders: Uncommon:
Croatian: osteomalacija (koja se očituje bolovima u kostima i rijetko pridonosi prijelomima)
English: Medicinal product by therapeutic areas (dose in mg)
Croatian: Lijek po terapijskim područjima
English: Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see sections 4.4 and 5.2).
Croatian: Zato je u tih bolesnika nužno pažljivo pratiti klinički odgovor na liječenje i funkciju bubrega (vidjeti dijelove 4.4 i
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 90
Croatian: Adefovirdipivoksil 10 mg prebacivanje na tenofovirdizoproksil 245 mg n = 90d
English: Tenofovir disoproxil Mylan 245 mg
Croatian: tenofovirdizoproksil mylan 245 mg
English: tenofovir disoproxil mylan 245 mg
Croatian: Tenofovirdizoproksil Mylan 245 mg
English: Tenofovir disoproxil 245 mg n = 250
Croatian: Tenofovirdizoproks il 245 mg n = 250
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section
Croatian: Tijekom antivirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi (vidjeti dio 4.4).
English: b 48 weeks of double-blind tenofovir disoproxil followed by 48 weeks open-label.
Croatian: b 48 tjedana dvostruko slijepog ispitivanja tenofovirdizoproksila nakon čega slijedi 48 tjedana otvorenog ispitivanja.
English: HBV DNA (%)
Croatian: HBV DNK
English: Monitoring of renal function is recommended for patients receiving tenofovir disoproxil (see section
Croatian: Preporučuje se praćenje funkcije bubrega u bolesnika koji primaju tenofovirdizoproksil (vidjeti dio 4.4).
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Croatian: Sigurnost tenofovirdizoproksila prilikom istovremene primjene sa sofosbuvirom/velpatasvir om i farmakokinetičkim pojačivačem (npr. ritonavirom ili kobicistatom) nije ustanovljena.
English: 48 weeks of double-blind tenofovir disoproxil followed by 96 weeks open-label.
Croatian: 48 tjedana dvostruko slijepog ispitivanja tenofovirdizoproksila nakon čega je slijedilo 96 tjedana otvorenog ispitivanja.
English: 48 weeks of double-blind tenofovir disoproxil followed by 336 weeks open-label.
Croatian: 48 tjedana dvostruko slijepog ispitivanja tenofovirdizoproksila nakon čega slijedi 336 tjedana otvorenog ispitivanja.
English: + Efavirenz/Emtricitabine/ Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Croatian: efavirenz/emtricitabin/tenof ovirdizoproksil (600 mg/200 mg/245 mg q.d.)
English: There are limited data on the safety and efficacy of tenofovir disoproxil in patients with impaired renal function.
Croatian: Sigurnost i djelotvornost tenofovirdizoproksila istraživana je samo u vrlo ograničenoj mjeri kod bolesnika s oštećenjem funkcije bubrega.
English: f 48 weeks of double-blind adefovir dipivoxil followed by 96 weeks open-label tenofovir disoproxil.
Croatian: f 48 tjedana dvostruko slijepog ispitivanja adefovirdipivoksila nakon čega je slijedilo 96 tjedana otvorenog ispitivanja tenofovirdizoproksila.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Srednja vrijednost (SD)
English: Serology (%)
Croatian: Serologija (%) HBeAg nestanak/ serokonverzija
English: Renally eliminated medicinal products
Croatian: Ispitivanja provedena s drugim lijekovima
English: This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Croatian: 1 Ova nuspojava može nastati kao posljedica proksimalne bubrežne tubulopatije.
English: • adolescents aged 12 to less than 18 years who have already been treated with other HIV
Croatian: • adolescenata u dobi od 12 do manje od 18 godina koji su već bili liječeni drugim lijekovima protiv HIV-a koji više nisu potpuno djelotvorni zbog razvoja rezistencije ili su prouzročili nuspojave.
English: 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
Croatian: 48 tjedana dvostruko slijepog tenofovirdizoproksila nakon čega je slijedilo 144 tjedna otvorenog liječenja.
English: c 48 weeks of double-blind adefovir dipivoxil followed by 48 weeks open-label tenofovir disoproxil.
Croatian: c 48 tjedana dvostruko slijepog ispitivanja adefovirdipivoksila nakon čega slijedi 48 tjedana otvorenog ispitivanja tenofovirdizoproksila.
English: Entecavir
Croatian: pankreatitis
English: 48 weeks of double-blind tenofovir disoproxil followed by 48 weeks open-label.
Croatian: 48 tjedana dvostruko slijepog ispitivanja tenofovirdizoproksila nakon čega slijedi 48 tjedana otvorenog ispitivanja.
English: The increased exposure of tenofovir could potentiate tenofovirassociated adverse events, including renal disorders.
Croatian: Povećano izlaganje tenofoviru moglo bi pojačati nuspojave povezane s tenofovirdizoproksilom, uključujući poremećaje bubrega.
English: (log10 copies/ml) HBV DNA (%)
Croatian: (log10 kopija/ml) HBV DNK (%) < 400 kopija/ml (< 69 IU/ml) ALT (%) Normaliziran ALT
English: 48 weeks of double-blind adefovir dipivoxil followed by 96 weeks open-label tenofovir disoproxil.
Croatian: 48 tjedana dvostruko slijepog ispitivanja adefovirdipivoksila nakon čega je slijedilo 96 tjedana otvorenog ispitivanja tenofovirdizoproksila.
English: 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil.
Croatian: 48 tjedana dvostruko slijepog adefovirdipivoksila nakon čega je slijedilo 144 tjedana otvorenog liječenja tenofovirdizoproksilom.
English: 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label.
Croatian: 48 tjedana dvostruko slijepog tenofovirdizoproksila nakon čega je slijedilo 192 tjedna otvorenog liječenja.
English: 48 weeks of double-blind tenofovir disoproxil followed by 240 weeks open-label.
Croatian: 48 tjedana dvostruko slijepog ispitivanja tenofovirdizoproksila nakon čega slijedi 240 tjedana otvorenog ispitivanja.
English: You do not have to have HIV to be treated with Tenofovir disoproxil Mylan for HBV.
Croatian: Da biste se liječili lijekom Tenofovir disoproxil Mylan zbog infekcije HBV-om, ne morate biti zaraženi HIV-om.
English: Bone Mineral Density (BMD) data from Study GS-US-174-0115 are summarized in Table 8: Table 8: Bone Mineral Density Evaluation at Baseline, Week 72 and 192
Croatian: Podaci ispitivanja GS-US-174-0115 o mineralnoj gustoći kosti (BMD, eng.
English: 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil.
Croatian: 48 tjedana dvostruko slijepog ispitivanja adefovirdipivoksila nakon čega slijedi 240 tjedana otvorenog ispitivanja tenofovirdizoproksila.
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Srednja vrijednost promjene (SD)
English: 48 weeks of double-blind adefovir dipivoxil followed by 48 weeks open-label tenofovir disoproxil.
Croatian: 48 tjedana dvostruko slijepog ispitivanja adefovirdipivoksila nakon čega slijedi 48 tjedana otvorenog ispitivanja tenofovirdizoproksila.
English: headache Gastrointestinal disorders: Very common:
Croatian: Poremećaji probavnog sustava: Vrlo često:
English: The safety of tenofovir disoproxil when used with sofosbuvir/velpatasvir/vox ilaprevir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Croatian: Sigurnost tenofovirdizoproksila prilikom istovremene primjene s sofosbuvirom/velpatasvir om/voksilaprevirom i farmakokinetičkim pojačivačem (npr. ritonavirom ili kobicistatom) nije ustanovljena.
English: + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Croatian: tenofovirdizoproksil (200 mg/25 mg/245 mg q.d.)
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet: Mylan S.A.S
English: Paediatrics
Croatian: angioedem
English: Study GS-US-174-0103 was conducted in 266 (randomised and treated) HBeAg positive patients while study GS-US-174-0102 was conducted in 375 (randomised and treated) patients negative for HBeAg and positive for HBeAb.
Croatian: Rezultati dobiveni tijekom 48 tjedana iz dva randomizirana, dvostruko slijepa ispitivanja faze III u kojima se uspoređivao tenofovirdizoproksil s adefovirdipivoksilom u odraslih bolesnika s kompenziranom bolešću jetre prikazani su u tablici 3. Ispitivanje GS-US-174-0103 provodilo se na 266 (randomiziranih i liječenih) bolesnika pozitivnih na HbeAg, a ispitivanje GS-US-174-0102 provodilo se na 375 (randomiziranih i liječenih) bolesnika negativnih na HbeAg i pozitivnih na HBeAb.
English: 48 weeks of double-blind adefovir dipivoxil followed by 336 weeks open-label tenofovir disoproxil.
Croatian: 48 tjedana dvostruko slijepog ispitivanja adefovirdipivoksila nakon čega slijedi 336 tjedana otvorenog ispitivanja tenofovirdizoproksila. n/p = nije primjenjivo.
English: + Raltegravir (400 mg b.i.d) + Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Croatian: Sofosbuvir (400 mg q.d.) + efavirenz/emtricitabin/ tenofovirdizoproksil (600 mg/200 mg/245 mg q.d.)
English: 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Croatian: 48 tjedana dvostruko slijepog adefovirdipivoksila nakon čega je slijedilo 192 tjedna otvorenog liječenja tenofovirdizoproksilom.
English: l 48 weeks of double-blind tenofovir disoproxil followed by 240 weeks open-label.
Croatian: m 48 tjedana dvostruko slijepog ispitivanja tenofovirdizoproksila nakon čega slijedi 240 tjedana otvorenog ispitivanja.
English: GS-331007 AUC: ↔ Cmax:↔ Cmin: N/A
Croatian: GS-331007 AUC: ↔ Cmax:↔ Cmin: NP
English: BMD Z-scorea
Croatian: Tablični prikaz nuspojava
English: j 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil.
Croatian: d 48 tjedana dvostruko slijepog adefovirdipivoksila nakon čega je slijedilo 192 tjedna otvorenog liječenja tenofovirdizoproksilom.
English: + Ritonavir (100 mg q.d.)
Croatian: (90 mg/400 mg q.d.) +
English: 1/1n a Based upon Long Term Evaluation algorithm (LTE Analysis) - Patients who discontinued the study at any time prior to week 384
Croatian: Serologija (%) nestanak HBeAg/ serokonverzija nestanak HBsAg/ serokonverzija g g l l l g g l l l a Temelji se na algoritmu dugoročne promjene (LTE analiza) - Bolesnici koji su prekinuli sudjelovanje u ispitivanju bilo kada prije 384. tjedna zbog postizanja protokolom definirane mjere ishoda i oni koji su dovršili 384 tjedna liječenja uključeni su u nazivnik.
English: Don't stop any anti-HIV medicines prescribed by your doctor when you start Tenofovir disoproxil Mylan if you have both HBV and HIV.
Croatian: Ako ste istovremeno zaraženi HIV-om i HBV-om, nemojte prestati uzimati lijekove protiv HIV-a koje vam je propisao vaš liječnik kad započnete terapiju lijekom Tenofovir disoproxil Mylan.
English: After week 72, virologic suppression was maintained for those receiving double-blind tenofovir disoproxil followed by open-label tenofovir disoproxil (tenofovir disoproxil-tenofovir disoproxil group): 86.5% (45/52) of subjects in the tenofovir disoproxiltenofovir disoproxil group had HBV DNA < 400 copies/ml at week 192.
Croatian: Nakon 72. tjedna održana je virološka supresija u bolesnika koji su primali dvostruko slijepo tenofovirdizoproksil nakon čega je slijedilo otvoreno liječenje tenofovirdizoproksilom (skupina tenofovirdizoproksil-tenofovirdizoproksil).
English: There is insufficient information on the effects of tenofovir in newborns/infants.
Croatian: Nema dovoljno podataka o učinku tenofovira na novorođenčad/dojenčad, stoga se Tenofovir disoproxil Mylan ne bi trebao primjenjivati tijekom dojenja.
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, sofosbuvir/velpatasvir/vox ilaprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Croatian: Povećane koncentracije tenofovira u plazmi zbog istovremene primjene tenofovirdizoproksila, sofosbuvira/velpatasvira/ voksilaprevira i darunavira/ritonavira mogu pojačati nuspojave vezane uz tenofovirdizoproksil, uključujući poremećaje bubrega.
English: NRTIs
Croatian: NP
English: Satis-Radioisótopos E Protecções Contra Sobretensões Eléctricas Unipessoal, Lda
Croatian: E Protecções Contra Sobretensões Eléctricas Unipessoal, Lda
English: A. Martins & Fernandes, S.A.
Croatian: Martins & Fernandes, S.A.
English: Nationally authorised medicinal products Member state
Croatian: Popis nacionalno odobrenih lijekova
English: Bulgaria дотарем
Croatian: Bugarska дотарем
English: Netherlands Guerbet Nederland Bv
Croatian: Guerbet Nederland BV
English: Belgium Ge Healthcare Bvba
Croatian: GE Healthcare Bvba
English: Ge Healthcare Buchler Gmbh & Co. Kg
Croatian: GE Healthcare Buchler GmbH & Co.
English: Belgium Bayer Sa Nv
Croatian: Bayer SA NV
English: Jenapharm Gmbh & Co Kg
Croatian: Jenapharm GmbH & Co Kg Dotagraf
English: Belgium Agfa Healthcare Imaging Agents Gmbh
Croatian: Ujedinjeno Kraljevstvo Agfa Healthcare Imaging Agents GmbH
English: Solution for injection/infusion
Croatian: otopina za injekciju / infuziju
English: Ge Healthcare Handels Gmbh
Croatian: GE Healthcare Handels GmbH Omniscan
English: Solution for injection in cartridge | solution for injection in pre-filled syringe
Croatian: otopina za injekciju u ulošku | otopina za injekciju u napunjenoj štrcaljki
English: Netherlands Bayer Bv
Croatian: Bayer BV
English: Dotarem Arthro
Croatian: Dotarem Arthro u zglob
English: Netherlands Ge Healthcare B.V.
Croatian: GE Healthcare B.V.
English: Omniscan
Croatian: омнискен
English: Belgium Guerbet
Croatian: Ujedinjeno Kraljevstvo Guerbet
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
Croatian: Prilog I.B - lijekovi koji sadržavaju gadodiamid, gadopentetičnu kiselinu i gadoversetamid za intravensku primjenu
English: Gadoteric Acid 0.5 Milli Molar / Ml Solution for injection Intravenous use
Croatian: Gadoteric Acid 0.0025mmol/Ml otopina za injekciju u zglob
English: Bayer Spa
Croatian: Bayer S.p.A.
English: 90 (3 x 30) tablets (multipack)
Croatian: 90 (3 x 30) tableta (višestruko pakiranje)
English: Date of first authorisation: 19 September 2016
Croatian: Datum prvog odobrenja: 19. rujna 2016
English: The study designs were identical through the first 26 weeks.
Croatian: Dizajni ispitivanja bili su jednaki tijekom prvih 26 tjedana.
English: The pain may feel like it is moving through to your back or shoulder;
Croatian: Može se činiti kao da se bol pomiče kroz leđa ili rame;
English: Do not take Truberzi with any of the above medicines.
Croatian: Nemojte uzimati Truberzi s bilo kojim od gore navedenih lijekova.
English: Other medicines and Truberzi
Croatian: Drugi lijekovi i Truberzi
English: You may feel pain on the right side of your belly or the upper area of the belly, right below the ribs.
Croatian: Možete osjetiti bol na desnoj strani trbuha ili u gornjem dijelu trbuha, odmah ispod rebara.
English: Component of a multipack, can't be sold separately
Croatian: Dio višestrukog pakiranja, ne može se prodavati zasebno.
English: The safety and efficacy of eluxadoline in children aged 0 to18 years have not yet been established.
Croatian: Sigurnost i djelotvornost eluksadolina u djece u dobi od 0 do 18 godina nisu još ustanovljene.
English: There were no efficacy differences according to gender.
Croatian: 1. Nije bilo razlika u djelotvornosti vezano uz spol.
English: Caution should therefore be exercised in patients receiving such medicinal products especially with high doses.
Croatian: Stoga je potreban oprez u bolesnika koji dobivaju takve lijekove, naročito pri visokim dozama.
English: Gender, age, ethnicity
Croatian: Dob, spol, etnička pripadnost
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.
Croatian: Truberzi se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina jer nema informacija o njegovoj primjeni u toj dobnoj skupini.
English: If you are pregnant or breast-feeding or you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Take special care if you are 65 years of age or older, as there is a higher risk that you may have certain side effects (see section 4).
Croatian: Budite posebno oprezni ako imate 65 godina ili više, jer postoji veći rizik da nastupe određene nuspojave (pogledajte dio 4.).
English: Do not drive or use machines while taking this medicine until you know how it affects you.
Croatian: Nemojte upravljati vozilima ili strojevima za vrijeme uzimanja ovog lijeka dok ne doznate kako on utječe na
English: Serious allergic reactions have happened in some people after taking 1 or 2 doses of Truberzi.
Croatian: Ozbiljne alergijske reakcije pojavile su se u nekih osoba nakon uzimanja 1 ili 2 doze lijeka Truberzi.
English: Study 2 (IBS 3002)
Croatian: Ispitivanje 2 (IBS 3002)
English: The tablets should be taken orally with food in the morning and in the evening.
Croatian: Tablete treba uzimati kroz usta s hranom, ujutro i navečer.
English: Take the next dose at the next scheduled time and continue as normal.
Croatian: Uzmite sljedeću dozu u predviđeno vrijeme i nastavite uobičajeno uzimati lijek.
English: Drug dependence and potential for abuse
Croatian: Ovisnost o lijeku i mogućnost zlouporabe
English: The tablets should be taken with food in the morning and in the evening (see section 5.2).
Croatian: Tablete treba uzimati uz hranu, ujutro i navečer (vidjeti dio 5.2).
English: • Alcoholism, alcohol abuse, alcohol addiction or chronic or acute excessive alcohol use.
Croatian: • Alkoholizam, zlouporaba alkohola, ovisnost o alkoholu, ili kronično ili akutno pretjerano konzumiranje alkohola.
English: What Truberzi is and what it is used for
Croatian: Što je Truberzi i za što se koristi
English: • an average daily stool consistency score (BSS) of ≥5.5 and at least 5 days with a BSS score ≥5
Croatian: • prosječni dnevni bodovi konzistencije stolice (BSS) od ≥5,5 i najmanje 5 dana s BSS bodovima
English: Pharmacotherapeutic group: antipropulsives, ATC code: A07DA06 Mechanism of action
Croatian: Farmakoterapijska skupina: antipropulzivi, ATK oznaka: A07DA06 Mehanizam djelovanja
English: Contents of the pack and other information What Truberzi contains
Croatian: Sadržaj pakiranja i druge informacije Što Truberzi sadrži
English: Benefits and risks of the treatment should be periodically assessed in the context of patient symptoms severity.
Croatian: Potrebno je povremeno procijeniti koristi i rizike liječenja u kontekstu težine bolesnikovih simptoma.
English: The treatment should be initiated and supervised by a physician experienced in diagnosis and management of gastrointestinal disorders.
Croatian: Liječenje treba započeti i nadzirati liječnik s iskustvom u dijagnosticiranju i liječenju gastrointestinalnih poremećaja.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala, reproduktivne i razvojne toksičnosti.
English: Approximately 50% of constipation events occurred within the first 2 weeks of treatment.
Croatian: Približno 50% događaja konstipacije javilo se unutar prva 2 tjedna liječenja.
English: In principle, general dose recommendations also apply to patients aged 65 years and above.
Croatian: U principu, općenite preporuke za doziranje također se odnose na bolesnike u dobi od 65 i više godina.
English: Following a 1,000 mg oral dose in healthy male volunteers, M11 was detected in urine but not in systemic circulation.
Croatian: Nakon oralne doze od 1000 mg u zdravih muških dobrovoljaca, M11 je otkriven u urinu, ali ne i u sistemskoj cirkulaciji.
English: Global Symptom Response
Croatian: Odgovor u pogledu globalnih simptoma
English: • an average global symptom score >2.0 on a 0-4 scale (0 corresponds to no symptoms, 1 corresponds to mild symptoms, 2 corresponds to moderate symptoms, 3 corresponds to severe symptoms and 4 corresponds to very severe symptoms) over the week prior to randomization
Croatian: • prosječni bodovi globalnog simptoma >2,0 na ljestvici od 0 do 4 (0 odgovara stanju bez simptoma, 1 odgovara blagim simptomima, 2 odgovara umjerenim simptomima, 3 odgovara teškim simptomima, a 4 odgovara vrlo teškim simptomima) u tjednu prije randomizacije