FrancophonIA/ELRC3.0 huggingface dataset:
English: Erlotinib is metabolised in the liver by the hepatic cytochromes in humans, primarily CYP3A4 and to a lesser extent by CYP1A2.
Croatian: Erlotinib se metabolizira u jetri pomoću jetrenih citokroma u ljudi, prije svega CYP3A4 te nešto manje
English: Rash and diarrhoea resulted in discontinuation of Tarceva in 1% and <1% of patients, respectively, in study BO18192, while no patients discontinued for rash or diarrhoea in BO25460.
Croatian: Ni u jednom od ta dva ispitivanja nisu primijećeni osip ni proljev stupnja 4. Osip i proljev doveli su do prekida liječenja lijekom Tarceva u 1% odnosno < 1% bolesnika u ispitivanju BO18192, dok u ispitivanju BO25460 nijedan bolesnik nije prekinuo liječenje zbog osipa ili proljeva.
English: • The active substance of Tarceva is erlotinib.
Croatian: Što Tarceva sadrži · Djelatna tvar lijeka Tarceva je erlotinib.
English: In the pancreatic cancer study in combination with gemcitabine, the incidence of ILD-like events was 2.5% in the Tarceva plus gemcitabine group versus 0.4% in the placebo plus gemcitabine treated group.
Croatian: U ispitivanju provedenom u bolesnika s rakom gušterače, incidencija pojave simptoma nalik intersticijskoj bolesti pluća iznosila je 2,5% u grupi koja je primala lijek Tarceva u kombinaciji s gemcitabinom, odnosno 0,4% u grupi liječenoj placebom u kombinaciji s gemcitabinom.
English: LIST OF EXCIPIENTS Contains lactose monohydrate.
Croatian: Sadrži laktoza hidrat.
English: Tarceva 25 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 25' engraved on one side and is available in pack sizes of 30 tablets.
Croatian: Tarceva 25 mg su bijele do žućkaste okrugle filmom obložene tablete s utisnutim natpisom "T 25" na jednoj strani, a dostupne su u pakiranju od 30 tableta.
English: Erlotinib and Capecitabine
Croatian: Erlotinib i kapecitabin
English: The primary endpoint was overall survival.
Croatian: Primarna mjera ishoda bila je ukupno preživljenje (OS).
English: In the pivotal study BR.21 in NSCLC, the incidence of ILD (0.8%) was the same in both the placebo and Tarceva groups.
Croatian: U pivotalnom ispitivanju BR.21 za rak pluća nemalih stanica, incidencija intersticijske bolesti pluća (0,8%) bila je jednaka u skupini koja je primala placebo i skupini koja je primala lijek Tarceva.
English: Rigors very common very common very common
Croatian: Kašalj vrlo često vrlo često
English: Diarrhoea, dehydration, electrolyte imbalance and renal failure Diarrhoea (including very rare cases with a fatal outcome) has occurred in approximately 50% of patients on Tarceva and moderate or severe diarrhoea should be treated with e.g. loperamide.
Croatian: Proljev (uključujući vrlo rijetko slučajeve sa smrtnim ishodom) se pojavio u otprilike 50% bolesnika koji su koristili lijek Tarceva, a umjereni ili težak proljev bilo je potrebno liječiti npr. loperamidom.
English: Name and address of the manufacturer responsible for batch release
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Roche Pharma AG
English: There were no significant effects of carboplatin or paclitaxel on the pharmacokinetics of erlotinib.
Croatian: Nisu uočeni značajni učinci karboplatina ili paklitaksela na farmakokinetiku erlotiniba.
English: Glucuronidation disorder like Gilbert's syndrome Your doctor must treat you with caution if you have a glucuronidation disorder like Gilbert's syndrome.
Croatian: Ako patite od poremećaja glukuronidacije, kao što je Gilbertov sindrom, liječnik Vas mora liječiti uz povećani oprez.
English: Dermatitis acneiform -Skin fissures
Croatian: - paronihija - folikulitis - akne/ akneiformni dermatitis - kožne fisure
English: The 300 mg dose did not show improved efficacy in second line treatment after failure of chemotherapy compared to the recommended 150 mg dose in patients who continue to smoke cigarettes.
Croatian: U bolesnika koji nastave pušiti cigarete, doza od 300 mg u usporedbi s preporučenom dozom od 150 mg nije pokazala bolju djelotvornost u drugoj liniji liječenja nakon neuspješne kemoterapije.
English: In a phase I dose escalation study in NSCLC patients who were current smokers, pharmacokinetic analyses at steady-state indicated a dose proportional increase in erlotinib exposure when the Tarceva dose was increased from 150 mg to the maximum tolerated dose of 300 mg. Steady-state trough plasma concentrations at a 300 mg dose in current smokers in this study was 1.22 µg/mL (n=17).
Croatian: I povećavanja doze u bolesnika pušača s rakom pluća nemalih stanica, farmakokinetička analiza u stanju dinamičke ravnoteže pokazala je proporcionalno povećanje u izloženosti erlotinibu kada je doza lijeka Tarceva povećana sa 150 mg do maksimalno podnošljive doze od 300 mg.
English: Ninety-three percent and 92% of all patients in the Tarceva and placebo groups, respectively, had received a prior platinum-containing regimen and 36% and 37% of all patients, respectively, had received a prior taxane therapy.
Croatian: već je bilo primilo terapijski protokol s platinom, a 36% odnosno 37% svih bolesnika prethodno je bilo liječeno taksanima.
English: Each 25 mg film-coated tablet contains 27.43 mg Lactose monohydrate.
Croatian: Tarceva 25 mg filmom obložene tablete Jedna filmom obložena tableta od 25 mg sadrži 27,43 mg laktoza hidrata.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2)
English: The most frequent ADRs seen in patients treated with Tarceva in study ML20650 were rash and diarrhoea (any Grade 80% and 57%, respectively), most were Grade 1/2 in severity and manageable without intervention.
Croatian: bile su osip i proljev (bilo kojeg stupnja u 80% odnosno 57% bolesnika), koji su većinom bili stupnja težine 1/2 i mogli su se zbrinuti bez medicinske intervencije.
English: Δ
Croatian: U
English: - NSCLC treatment after failure of at least one prior chemotherapy regimen (Tarceva administered as monotherapy)
Croatian: - Liječenje raka pluća nemalih stanica nakon neuspjeha primjene barem jednog kemoterapijskog protokola (Tarceva primijenjena kao monoterapija)
English: The usual dose is one tablet of Tarceva 100 mg each day if you have metastatic pancreatic cancer.
Croatian: Ako imate metastatski rak gušterače, uobičajena doza je jedna Tarceva tableta od 100 mg dnevno.
English: Cut-off date: Aug 2010
Croatian: Podaci do: kolovoz 2010.
English: NAME OF THE MEDICINAL PRODUCT Tarceva 25 mg film-coated tablets Tarceva 100 mg film-coated tablets Tarceva 150 mg film-coated tablets
Croatian: Tarceva 25 mg filmom obložene tablete Tarceva 100 mg filmom obložene tablete Tarceva 150 mg filmom obložene tablete
English: Erlotinib is primarily cleared by the liver.
Croatian: Najvećim dijelom erlotinib se uklanja putem jetre.
English: The efficacy and safety of Tarceva in combination with gemcitabine as a first-line treatment was assessed in a randomised, double-blind, placebo-controlled trial in patients with locally advanced, unresectable or metastatic pancreatic cancer.
Croatian: Rak gušterače (primjena lijeka Tarceva u kombinaciji s gemcitabinom u ispitivanju PA.3) Djelotvornost i sigurnost primjene lijeka Tarceva u kombinaciji s gemcitabinom u prvoj liniji liječenja ispitivana je u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju u bolesnika s lokalno uznapredovalim, neoperabilnim ili metastatskim rakom gušterače.
English: N.V. Roche S.A. Tél/Tel: +32 (0) 2 525 82 11
Croatian: Tél/Tel: +32 (0) 2 525 82 11
English: In a post-hoc analysis, patients with favourable clinical status at baseline (low pain intensity, good QoL and good PS) may derive more benefit from Tarceva.
Croatian: (slab intenzitet boli, dobra kvaliteta života i dobrim funkcionalnim stanjem) imali više koristi od lijeka Tarceva.
English: Suomi/Finland
Croatian: Suomi/Finland Roche Oy
English: • Bleeding from the nose
Croatian: Za primjenu kroz usta
English: If a diagnosis of ulcerative keratitis is confirmed, treatment with Tarceva should be interrupted or discontinued.
Croatian: Potvrdi li se dijagnoza ulceroznog keratitisa, liječenje lijekom
English: - Maintenance NSCLC therapy after first-line chemotherapy (Tarceva administered as monotherapy)
Croatian: - Terapija održavanja u raku pluća nemalih stanica nakon prve linije kemoterapije (Tarceva primijenjena kao monoterapija)
English: Including in-growing eyelashes, excessive growth and thickening of the eyelashes.
Croatian: u kliničkom ispitivanju PA.3. 2 uključujući rast trepavica prema oku, pojačan rast i zadebljanje trepavica.
English: Cut-off date: Jan 2011
Croatian: Podaci do: siječanj 2011.
English: Alopecia very common very common very common very common
Croatian: Pireksija Tresavica vrlo često vrlo često vrlo često
English: demonstrating a substantial PFS benefit (HR=0.10, 95% CI, 0.04 to 0.25; p<0.0001) and an overall survival HR of 0.83 (95% CI, 0.34 to 2.02).
Croatian: najveća je korist opažena u unaprijed definiranoj eksploracijskoj analizi provedenoj u bolesnika s aktivirajućim mutacijama EGFR-a (n = 49), koja je pokazala znatnu korist u smislu PFS-a (HR = 0,10, 95% CI: 0,04 - 0,25; p < 0,0001) i omjera hazarda (HR) za ukupno preživljenje od 0,83 (95% CI: 0,34 - 2,02).
English: Gastrointestinal perforations have been observed (uncommon: may affect up to 1 in 100 people).
Croatian: Opažena su puknuća (perforacije) u probavnom sustavu (manje često: mogu se javiti kod manje od 1 na 100 osoba).
English: Results of a pharmacokinetic interaction study indicated a significant 2.8-, 1.5- and 9-fold reduced AUCinf, Cmax and plasma concentration at 24 hours, respectively, after administration of Tarceva in smokers as compared to non-smokers.
Croatian: Erlotinib i pušači Rezultati ispitivanja farmakokinetičkih interakcija u pušača i nepušača ukazuju na to da pušenje značajno smanjuje AUCinf , Cmax i koncentracije u plazmi mjereno 24 sata nakon primjene lijeka Tarceva (2,8 puta, 1,5 puta odnosno 9 puta).
English: • Eyebrow changes
Croatian: 1 - promjene na trepavicama
English: ADRs occurring in ≥ 10% of patients in BR.21 (treated with Tarceva) and PA.3 (treated with Tarceva plus gemcitabine) studies and ADRs occurring more frequently (≥ 3%) than placebo in BR.21 (treated with Tarceva) and PA.3 (treated with Tarceva plus gemcitabine) studies Tarceva (BR.21) N = 485
Croatian: (≥ 3%) nego uz placebo u ispitivanjima BR.21 (liječenje lijekom Tarceva) i PA.3 (liječenje lijekom Tarceva i gemcitabinom)
English: Common side effects (may affect up to 1 in 10 people):
Croatian: Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba):
English: Confounding or contributing factors such as concomitant or prior chemotherapy, prior radiotherapy, pre-existing parenchymal lung disease, metastatic lung disease, or pulmonary infections were frequent.
Croatian: Učestali su bili i šumovi ili neki potpomažući faktori, poput istovremene ili prethodne kemoterapije, prethodne terapije zračenjem,
English: -Hepatic failure 6
Croatian: - zatajenje jetre 6
English: • if you are also taking a statin and experience unexplained muscle pain, tenderness, weakness or cramps.
Croatian: Vam se neobjašnjiva bol u mišićima, osjetljivost, slabost mišića ili grčevi.
English: Cases were mainly mild to moderate in severity, transient in nature or associated with liver metastases.
Croatian: Ona su bila vrlo česta u kliničkom ispitivanju PA.3 i česta u ispitivanju BR.21.Uglavnom su bile blagog ili umjerenog intenziteta, prolazne ili povezane s metastazama u jetri.
English: In a clinical study, the concomitant use of erlotinib with ketoconazole (200 mg orally twice daily for 5 days), a potent CYP3A4 inhibitor, resulted in an increase of erlotinib exposure (86% of AUC and 69% of Cmax).
Croatian: U kliničkom ispitivanju pokazalo se da istovremena primjena erlotiniba s ketokonazolom (200 mg peroralno, dvaput dnevno, tijekom 5 dana), jakim CYP3A4 inhibitorom,
English: If you experience more severe or persistent diarrhoea contact your doctor immediately as your doctor may need to treat you in the hospital.
Croatian: Ako imate težak ili dugotrajan proljev, odmah se obratite svom liječniku jer
English: Extrahepatic metabolism by CYP3A4 in intestine, CYP1A1 in lung, and CYP1B1 in tumour tissue also potentially contribute to the metabolic clearance of erlotinib.
Croatian: Metabolizmu erlotiniba potencijalno pridonosi i metabolizam izvan jetre, putem CYP3A4 u crijevu, CYP1A1 u plućima i CYP1B1 u tumorskom tkivu.
English: p=0.003
Croatian: p<0,0001 p=0,003
English: Patients with Non-Small Cell Lung Cancer EGFR mutation testing should be performed in accordance with the approved indications (see section
Croatian: Treba provesti testiranje na mutacije EGFR-a sukladno odobrenim indikacijama (vidjeti dio 4.1).
English: Concomitant treatment with these types of agents should be avoided (see section 4.5).
Croatian: Stoga je potrebno izbjegavati njihovu istovremenu primjenu s lijekom Tarceva (vidjeti dio 4.5).
English: The geometric mean of the Cmax was 1056 ng/mL in the non-smokers and 689 ng/mL in the smokers with a mean ratio for smokers to non-smokers of 65.2% (95% CI: 44.3 to 95.9, p = 0.031).
Croatian: 689 ng/ml u pušača, uz srednji omjer vrijednosti u pušača prema nepušačima od 65,2% (95% CI:
English: Assessment of EGFR mutation status
Croatian: DATUM REVIZIJE TEKSTA
English: NAME OF THE MEDICINAL PRODUCT Tarceva 25 mg film-coated tablets Erlotinib
Croatian: Tarceva 25 mg filmom obložene tablete erlotinib
English: In the event of severe or persistent diarrhoea, nausea, anorexia, or vomiting associated with dehydration, Tarceva therapy should be interrupted and appropriate measures should be taken to treat the dehydration (see section 4.8).
Croatian: U slučaju teškog ili dugotrajnog proljeva, mučnine, anoreksije ili povraćanja uz dehidraciju, potrebno je obustaviti terapiju lijekom
English: Hypersensitivity to erlotinib or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na erlotinib ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Procjena statusa EGFR mutacija
English: Both rash and diarrhoea resulted in discontinuation of Tarceva in 1% of patients.
Croatian: Nije zabilježen osip ni proljev stupnja 4. I osip i proljev doveli su do prekida liječenja lijekom Tarceva u 1% bolesnika.
English: Pre-planned Interim Analysis (35% OS maturity) (n=153)
Croatian: (sa 35% podataka za OS) (n=153)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/311/001
English: Contact your doctor as soon as possible if you suffer from any of the below side effects.
Croatian: Ako patite od bilo koje od niže navedenih nuspojava obratite se liječniku što je moguće prije.
English: - First-line Non-Small Cell Lung Cancer (NSCLC) therapy for patients with EGFR activating mutations (Tarceva administered as monotherapy)
Croatian: Klinička djelotvornost - Prva linija liječenja raka pluća nemalih stanica (NSCLC-a) u bolesnika s aktivirajućim mutacijama
English: When erlotinib was co-administered with ciprofloxacin, a moderate CYP1A2 inhibitor, the erlotinib exposure [AUC] increased significantly by 39%, while no statistically significant change in Cmax was found.
Croatian: raspoloživost erlotiniba (AUC) značajno se povećala za 39%, dok nije uočena statistički značajna promjena vrijednosti Cmax.
English: Erlotinib and Carboplatin/Paclitaxel
Croatian: Erlotinib i karboplatin/paklitaksel
English: Medicinal products that alter the pH of the upper Gastro-Intestinal (GI) tract may alter the solubility of erlotinib and hence its bioavailability.
Croatian: Karakteristika je erlotiniba smanjena topivost pri pH vrijednost iznad 5. Lijekovi koji mijenjaju pH vrijednost u gornjem dijelu probavnog trakta mogu promijeniti topivost erlotiniba pa tako i njegovu bioraspoloživost.
English: CI of HR
Croatian: CI za D HR CI za HR pvrijednost
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/311/002
English: There were treatment-related increases in ALT, AST and bilirubin.
Croatian: Kao posljedica liječenja došlo je i do povećanja ALT, AST te bilirubina.
English: Rash and diarrhoea each resulted in dose reductions in 2% of patients, and resulted in study discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine.
Croatian: U bolesnika koji su primali lijek Tarceva u kombinaciji s gemcitabinom,doza se morala smanjiti u 2% bolesnika zbog osipa i 2% zbog proljeva, koji su doveli do prekida ispitivanja u do 1% bolesnika.
English: NAME OF THE MEDICINAL PRODUCT Tarceva 150 mg film-coated tablets Erlotinib
Croatian: Tarceva 150 mg filmom obložene tablete erlotinib
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/05/311/003
English: Renal and urinary disorders insufficiency1 -Nephritis1 -Proteinuria1
Croatian: - nefritis1 - proteinurija1
English: The usual dose is one tablet of Tarceva 150 mg each day if you have non-small cell lung cancer.
Croatian: Ako imate rak pluća nemalih stanica, uobičajena doza je jedna Tarceva tableta od 150 mg dnevno.
English: NAME OF THE MEDICINAL PRODUCT Tarceva 100 mg film-coated tablets Erlotinib
Croatian: Tarceva 100 mg filmom obložene tablete erlotinib
English: Interaction with coumarin-derived anticoagulants including warfarin leading to increased International Normalized Ratio (INR) and bleeding events, which in some cases were fatal, have been reported in patients receiving Tarceva.
Croatian: U bolesnika koji su primali lijek Tarceva prijavljene su interakcije s kumarinskim antikoagulansima uključujući varfarin, koje su dovele do porasta INR-a (engl.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 25 mg erlotiniba (u obliku erlotinibklorida).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 150 mg of erlotinib (as erlotinib hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 150 mg erlotiniba (u obliku erlotinibklorida).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg of erlotinib (as erlotinib hydrochloride).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 100 mg erlotiniba (u obliku erlotinibklorida).
English: -Rash
Croatian: - osip
English: • If you get any side effects, talk to your doctor or pharmacist.
Croatian: · Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: 5.3 Preclinical safety data
Croatian: Podaci o sigurnosti za doze od
English: White to yellowish, round, biconvex tablets with ‘T 100' engraved on one side.
Croatian: Tarceva 100 mg filmom obložene tablete Bijele do žućkaste, okrugle, bikonveksne tablete s utisnutim natpisom "T 100" na jednoj strani.
English: Dose reduction or interruption of Tarceva should be considered if severe adverse reactions occur.
Croatian: Ako se pojave teške nuspojave, treba razmotriti smanjenje doze ili prekid liječenja lijekom Tarceva.
English: Tarceva 150 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 150' engraved on one side and is available in pack sizes of 30 tablets.
Croatian: Tarceva 150 mg filmom obložene tablete Bijele do žućkaste, okrugle, bikonveksne tablete s utisnutim natpisom "T 150" na jednoj strani.
English: Hepatic impairment
Croatian: Mučnina Povraćanje
English: White to yellowish, round, biconvex tablets with ‘T 25' engraved on one side.
Croatian: Tarceva 25 mg filmom obložene tablete Bijele do žućkaste, okrugle, bikonveksne tablete s utisnutim natpisom "T 25" na jednoj strani.
English: Tarceva 100 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 100' engraved on one side and is available in pack sizes of 30 tablets.
Croatian: Tarceva 100 mg su bijele do žućkaste okrugle filmom obložene tablete s utisnutim natpisom "T 100"
English: Vomiting
Croatian: Anoreksija
English: -Eyelash changes 2
Croatian: - proljev 7
English: Stomach pain, indigestion and flatulence
Croatian: Dijareja, dehidracija, neravnoteža elektrolita, zatajenje bubrega
English: Renal impairment
Croatian: - renalna insuficijencija1
English: [This section should be amended to reflect the following wording]
Croatian: [Ovaj dio treba prilagoditi kako bi odražavao sljedeći tekst]
English: What is alfacalcidol?
Croatian: Što je alfakalcidiol?
English: Combination of alendronic acid and alfacalcidol (Valebo):
Croatian: Kombinacija alendronatne kiseline i alfakalcidiola (Valebo):
English: Section 4.1: Therapeutic indications [The wording of this section should be read as below] Treatment of postmenopausal osteoporosis.
Croatian: Dio 4.1: Terapijske indikacije [Tekst ovog dijela treba glasiti kako je niže navedeno] Liječenje postmenopauzalne osteoporoze.
English: [The following wording should be deleted] “whilst alfacalcidol significantly reduces the frequency of falls in the elderly” [The following wording should be added]
Croatian: [Sljedeći tekst treba izbrisati] “istovremeno alfakalcidiol značajno smanjuje učestalost padova u starijih” [Sljedeći tekst treba dodati]
English: In some clinical studies, alfacalcidol has been shown to reduce the risk of falls in the elderly.
Croatian: Neka klinička ispitivanja su pokazala da alfakalcidiol snižava rizik od padova u starijih.
English: WHAT VALEBO IS AND WHAT IT IS USED FOR
Croatian: ŠTO JE VALEBO
English: Alendronic acid reduces the risk of vertebral and hip fractures.
Croatian: Alendronatna kiselina smanjuje rizik od fraktura kralješaka i kuka.
English: The valid package leaflet is the final version achieved during the Coordination group procedure with the following amendments:
Croatian: Važeća uputa o lijeku je završna verzija postignuta tijekom postupka pod nadzorom Koordinacijske grupe uz sljedeće dopune:
English: The valid summary of product characteristics is the final version achieved during the Coordination group procedure with the following amendments:
Croatian: Važeći sažetak opisa svojstava lijeka je završna verzija postignuta tijekom postupka pod nadzorom Koordinacijske grupe uz sljedeće dopune:
English: Summary of product characteristic
Croatian: Sažetak opisa svojstava lijeka
English: Amendments to be included in the relevant sections of the summary of product characteristic and package leaflet
Croatian: Dopune koje je potrebno primijeniti u odgovarajućim odlomcima sažetka opisa svojstava lijeka i upute o lijeku
English: Section 5.1: Pharmacodynamic properties [This section should be amended to reflect the following wording]
Croatian: Dio 5.1: Farmakodinamička svojstva
English: Try to take a tablet at the same time each day.
Croatian: Pokušajte uzimati tabletu u isto vrijeme svaki dan.
English: Sepsis including fatal outcome
Croatian: sepsa uključujući fatalan ishod
English: Therefore the combination should be administered with caution, especially in the elderly.
Croatian: Stoga se ova kombinacija mora primjenjivati s oprezom, osobito kod starijih osoba.
English: Both of these substances help to control high blood pressure.
Croatian: Obje tvari pomažu u kontroli visokog krvnog tlaka.
English: About 60 % of the oral dose is eliminated within 48 hours.
Croatian: Oko 60% oralne doze se eliminira unutar 48 sati.
English: It is important that you take Tolucombi every day until your doctor tells you otherwise.
Croatian: Važno je da uzimate Tolucombi svaki dan dok Vam liječnik ne propiše drugačije.
English: You should see your doctor immediately if you experience any of the following symptoms:
Croatian: Morate se odmah javiti liječniku ako imate neki od sljedećih simptoma:
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u prometa: