FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity/infusion reactions (including some life-threatening and rare fatal reactions), including and not limited to flushing, chest pain, dyspnoea, hypotension, apnoea, loss of consciousness, hypersensitivity and anaphylaxis, have been associated with the administration of temsirolimus (see section 4.8).
Slovenian: Uporaba temsirolimusa je povezana s preobčutljivostnimi reakcijami/reakcijami na infuzijo (vključno z nekaterimi življenjsko ogrožajočimi in redkimi smrtnimi reakcijami), ki med drugim vključujejo rdečico, bolečino v prsih, dispnejo, hipotenzijo, apnejo, izgubo zavesti, preobčutljivost in anafilaksijo (glejte poglavje 4.8).
English: For mantle cell lymphoma, the recommended dose is 175 mg infused (as a drip) over a 30- to 60-minute period once weekly for 3 weeks followed by single weekly doses of 75 mg infused (as a drip) over a 30- to 60-minute period.
Slovenian: Pri limfomu plaščnih celic je priporočeni odmerek 175 mg v infuziji (kot kapalna infuzija), ki teče od 30 do 60 minut, in sicer prve 3 tedne enkrat na teden, nato sledijo enkratni tedenski odmerki po 75 mg v infuziji (kot kapalna infuzija), ki teče od 30 do 60 minut.
English: The required amount of concentrate-solvent mixture from each vial must be combined in one syringe for rapid injection into 250 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Potrebno količino mešanice koncentrata in vehikla iz vsake viale morate zmešati v eni injekcijski brizgi za hitro injiciranje v 250 ml raztopine (9 mg/ml; 0,9 %) natrijevega klorida za injiciranje.
English: Rare side effects (may affect up to 1 in 1,000 people):
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, angioedema, exfoliative dermatitis and hypersensitivity vasculitis, have been associated with the oral administration of sirolimus.
Slovenian: S peroralno uporabo sirolimusa so bile povezane preobčutljivostne reakcije, vključno z anafilaktičnimi/anafilaktoidnimi reakcijami, angioedemom, eksfoliativnim dermatitisom in preobčutljivostnim vaskulitisom.
English: Reductions in testicular weights and/or histological lesions (e.g., tubular atrophy and tubular giant cells) were observed in mice, rats, and monkeys.
Slovenian: Pri miših, podganah in opicah so opazili zmanjšanje teže mod in/ali histološke lezije (npr. tubulno atrofijo in tubulne celice velikanke).
English: The concentrate-solvent mixture may only be administered in sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Mešanico koncentrata in vehikla smemo uporabiti samo v raztopini natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
English: You should seek medical advice immediately if you have acute abdominal pain, high fever, nausea and vomiting, or blood in the stools.
Slovenian: Če imate akutno bolečino v trebuhu, visoko vročino, vam je slabo in bruhate ali imate kri v blatu, nemudoma poiščite zdravniško pomoč.
English: Prophylaxis of PCP should be considered for patients who require concomitant use of corticosteroids or other immunosuppressive agents based upon current standard of care.
Slovenian: Pri bolnikih, ki sočasno uporabljajo kortikosteroide ali druge imunosupresivne učinkovine, je treba v skladu z veljavnimi smernicami razmisliti o profilaksi proti PCP.
English: Administration in infusion.
Slovenian: - Navodilo shranite.
English: Talk to your doctor, pharmacist or nurse before receiving Torisel:
Slovenian: Pred začetkom prejemanja zdravila Torisel se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva neznana rabdomioliza
English: Agents inhibiting CYP3A metabolism
Slovenian: Zdravila, ki zavirajo presnovo preko CYP3A
English: For MCL, multiple vials will be required for each dose over 25 mg.
Slovenian: Pri MCL bo za vsak odmerek, večji od 25 mg, potrebnih več vial.
English: For mantle cell lymphoma, multiple vials will be required for each dose over 25 mg.
Slovenian: Pri limfomu plaščnih celic bo za vsak odmerek, večji od 25 mg, potrebnih več vial.
English: The solution should be a clear to slightly turbid, colourless to light-yellow to yellow solution, essentially free from visual particulates.
Slovenian: Raztopina mora biti bistra do rahlo motna, brezbarvna do svetlo rumena do rumena raztopina, praktično brez vidnih delcev.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: An increased risk of angioneurotic oedema (including delayed reactions occurring two months following initiation of therapy) is possible in patients who receive temsirolimus concomitantly with an ACE inhibitor and/or a calcium channel blocker (see sections 4.5 and 4.8).
Slovenian: Pri bolnikih, ki dobivajo temsirolimus sočasno z zaviralcem ACE in/ali zaviralcem kalcijevih kanalčkov, je možno povečano tveganje za angionevrotični edem (vključno z zapoznelimi reakcijami, ki se pojavijo dva meseca po uvedbi zdravljenja) (glejte poglavji 4.5 in 4.8).
English: Temsirolimus should be used with caution in patients with severe renal impairment (see section 4.4).
Slovenian: Pri bolnikih s hudo okvaro ledvic je treba temsirolimus uporabljati previdno (glejte poglavje 4.4).
English: An increased incidence of angioneurotic oedema (including delayed reactions occurring two months following initiation of therapy) has been observed in patients who received temsirolimus or other mTOR inhibitors in combination with an ACE inhibitor (e.g. ramipril) and/or a calcium channel blocker (e.g. amlodipine) (see sections 4.4 and 4.8).
Slovenian: Pri bolnikih, ki so dobivali temsirolimus ali druge zaviralce mTOR v kombinaciji z zaviralcem ACE (npr. ramipril) in/ali zaviralcem kalcijevih kanalčkov (npr. amlodipin), so opazili zvečano incidenco angionevrotičnega edema (vključno z zapoznelimi reakcijami, ki se pojavijo dva meseca po uvedbi zdravljenja) (glejte poglavji 4.4 in 4.8).
English: Wound healing complications
Slovenian: Zapleti pri celjenju ran
English: The Torisel concentrate must first be diluted with 1.8 ml of the supplied solvent to achieve a concentration of 10 mg/ml before administration in sodium chloride 9 mg/ml (0.9%) solution for injection (see dilution instructions at the end of the package leaflet).
Slovenian: Pred dodajanjem v raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje je treba zdravilo Torisel koncentrat najprej razredčiti z 1,8 ml priloženega vehikla, da doseže koncentracijo 10 mg/ml (glejte navodila za redčenje na koncu navodila za uporabo).
English: if you have or have had kidney problems.
Slovenian: - če imate ali ste kdaj imeli težave z ledvicami.
English: Median overall survival, Months (95% CI) Median progression-free survival by independent assessment
Slovenian: Mediano preživetje brez napredovanja bolezni po neodvisni oceni meseci (95 % IZ) Mediano preživetje brez napredovanja bolezni po oceni raziskovalca meseci (95 % IZ) Celokupni odziv po neodvisni oceni % (95 % IZ)
English: Cataracts have been observed in some patients who received the combination of temsirolimus and IFN-α.
Slovenian: Pri nekaterih bolnikih, ki so prejemali kombinacijo temsirolimusa in IFN-, so opazili katarakte.
English: STEP 2: ADMINISTRATION OF CONCENTRATE FOR SOLUTION FOR INFUSION SOLVENT MIXTURE IN SODIUM CHLORIDE 9 MG/ML (0.9%) SOLUTION FOR INJECTION
Slovenian: KORAK: DODAJANJE MEŠANICE KONCENTRATA ZA RAZTOPINO ZA INFUNDIRANJE IN VEHIKLA V RAZTOPINO NATRIJEVEGA KLORIDA 9 MG/ML (0,9 %) ZA INJICIRANJE
English: For patients with RCC and severe hepatic impairment (total bilirubin >3 times ULN with any abnormality of AST, or as defined by Child-Pugh Class C), the recommended dose for patients who have baseline platelets 100 x 109/l is 10 mg intravenous once a week infused over a 30-60 minute period (see section 4.2).
Slovenian: Za bolnike z RCC in hudo okvaro jeter (celokupni bilirubin več kot trikrat višji od zgornje meje normalnih vrednosti in s kakršnokoli nenormalnostjo AST, ali razred C po Child-Pughovi lestvici) je priporočeni odmerek za bolnike, ki imajo izhodiščno koncentracijo trombocitov  100 x 10
English: The concentrate is a clear, colourless to light-yellow solution, free from visible particulates.
Slovenian: Koncentrat je bistra, brezbarvna do svetlo rumena raztopina brez vidnih delcev.
English: The solvent contains: polysorbate 80 (E 433), macrogol 400 and anhydrous ethanol.
Slovenian: Vehikel vsebuje: polisorbat 80 (E433), makrogol 400 in brezvodni etanol.
English: Previously treated mantle cell lymphoma, a type of cancer affecting the lymph nodes.
Slovenian: - napredovali rak ledvic; - predhodno zdravljen limfom plaščnih celic, vrsta raka bezgavk.
English: After first dilution of the concentrate with 1.8 ml of the supplied solvent, the concentration of temsirolimus is 10 mg/ml.
Slovenian: Po prvem redčenju koncentrata z 1,8 ml priloženega vehikla je koncentracija temsirolimusa 10 mg/ml.
English: Always dilute Torisel 30 mg concentrate with 1.8 ml of the supplied solvent before adding to the infusion solution.
Slovenian: Zdravilo Torisel 30 mg koncentrat pred dodajanjem raztopini za infundiranje vedno razredčimo z 1,8 ml vehikla, odvzetega iz priložene viale.
English: Based on the Phase 1 study, no dose adjustment of temsirolimus is recommended for RCC patients with baseline platelet counts 100 x 109/l and mild to moderate hepatic impairment (total bilirubin up to 3 times upper limit of normal [ULN] with any abnormality of AST, or as defined by Child-Pugh Class A or B).
Slovenian: 9/l ter blago do zmerno okvaro jeter (celokupni bilirubin do trikrat višji od zgornje meje normalnih vrednosti [ZMN] in s kakršnokoli nenormalnostjo AST, ali razred A ali B po Child-Pughovi lestvici).
English: A.
Slovenian: O
English: Temsirolimus should be used with caution in patients with hepatic impairment (see section 4.4).
Slovenian: Okvara jeter Pri bolnikih z okvaro jeter je treba temsirolimus uporabljati previdno (glejte poglavje 4.4).
English: This may result in the need for insulin and/or oral antidiabetic agent therapy.
Slovenian: Zato lahko postane potrebno zdravljenje z insulinom ali s peroralnimi antidiabetičnimi zdravili.
English: Co-administration of temsirolimus with rifampicin, a potent CYP3A4/5 inducer, had no significant effect on temsirolimus maximum concentration (Cmax) and area under the concentration vs. time curve
Slovenian: Sočasna intravenska uporaba temsirolimusa z rifampicinom, ki je močan induktor CYP3A4/5, ni pomembno vplivala na maksimalno koncentracijo (Cmax) in površino pod krivuljo koncentracije v odvisnosti od časa (AUC) temsirolimusa, vendar pa je v primerjavi z zdravljenjem samo s temsirolimusom zmanjšala Cmax sirolimusa za 65 % in AUC za 56 %.
English: a Hazard ratio IFN-α n = 207 P-value (95% CI)
Slovenian: IFN- n = 207
English: The temsirolimus arm showed a 49% increase in median OS compared with the IFN-α arm. Temsirolimus also was associated with statistically significant advantages over IFN-α in the secondary endpoints of PFS, TTF, and clinical benefit rate.
Slovenian: Temsirolimus je bil statistično pomembno boljši od IFN- tudi glede sekundarnih opazovanih dogodkov PFS, TTF in stopnje klinične koristnosti.
English: The solvent is a clear to slightly turbid, light-yellow to yellow solution, free from visible particulates.
Slovenian: Vehikel je bistra do rahlo motna, svetlo rumena do rumena raztopina brez vidnih delcev.
English: You should seek medical advice immediately if you experience shortness of breath, chest pain, coughing up blood, fast heartbeat, nausea, fainting, sweating, wheezing, and clammy or bluish skin.
Slovenian: Če se pri vas pojavi kratka sapa, bolečina v prsih, izkašljevanje krvi, hiter srčni utrip, slabost s siljenjem na bruhanje, omedlevica, potenje, piskanje pri dihanju ter sivkasta ali modrikasta koža, nemudoma poiščite zdravniško pomoč.
English: Polysorbate 80 (E 433) Macrogol 400
Slovenian: Vehikel polisorbat 80 (E433) makrogol 400 brezvodni etanol
English: Objective response rateb % (95% CI)
Slovenian: Razmerje ogroženosti (95 % IZ)
English: No dose adjustment is recommended in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic prilagajanje odmerka ni priporočljivo.
English: Rhinitis
Slovenian: Redčenje
English: If you get any side effect, talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: No clinically significant effect is anticipated when temsirolimus is co-administered with agents that are metabolised by CYP2D6.
Slovenian: Pri sočasni uporabi temsirolimusa z učinkovinami, ki se presnavljajo preko CYP2D6, ni pričakovati klinično pomembnega vpliva.
English: After further dilution of the concentrate-solvent mixture with sodium chloride 9 mg/ml (0.9%) solution for injection
Slovenian: Po nadaljnjem redčenju mešanice koncentrata in vehikla z raztopino natrijevega klorida za injiciranje v koncentraciji 9 mg/ml (0,9 %)
English: For renal cancer, the recommended dose is 25 mg infused (as a drip) over a 30 to 60 minute period once weekly.
Slovenian: Priporočeni odmerek pri raku ledvic je 25 mg, ki ga dobite s kapalno infuzijo, ki teče od 30 do 60 minut, enkrat na teden.
English: Uncommon Impaired wound healing
Slovenian: Bolezni sečil pogosti odpoved ledvic
English: Angioneurotic oedema-type reactions have been reported in some patients who received temsirolimus and ACE-inhibitors concomitantly.
Slovenian: Pri nekaterih bolnikih, ki so sočasno dobivali temsirolimus in zaviralce ACE, so poročali o reakcijah tipa angionevrotičnega edema.
English: You should tell your doctor or nurse immediately if you have symptoms of angioedema, such as swollen face, tongue or pharynx, and difficulty in breathing.
Slovenian: Če se vam pojavijo simptomi angioedema, na primer otekel obraz, jezik ali žrelo in težko dihanje, nemudoma obvestite zdravnika ali medicinsko sestro.
English: A benefit-risk assessment should be done prior to the continuation of temsirolimus therapy in patients with severe or life-threatening reactions.
Slovenian: Pri bolnikih s hudimi ali življenjsko ogrožajočimi reakcijami je treba pred nadaljevanjem zdravljenja s temsirolimusom oceniti koristi in tveganja nadaljnjega zdravljenja.
English: 1 vial of concentrate contains 474 mg of anhydrous ethanol 1.8 ml of the solvent provided contains 358 mg anhydrous ethanol For the full list of excipients, see section 6.1.
Slovenian: 1,8 ml priloženega vehikla vsebuje 358 mg brezvodnega etanola.
English: Cataracts
Slovenian: Katarakte
English: Stomatitis
Slovenian: Trombociti
English: Excipient with known effect
Slovenian: Pomožna(e) snov(i) z znanim učinkom:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of concentrate for solution for infusion contains 30 mg temsirolimus.
Slovenian: Ena viala koncentrata za raztopino za infundiranje vsebuje 30 mg temsirolimusa.
English: Mantle cell lymphoma
Slovenian: Limfom plaščnih celic
English: Very common Nausea Diarrhoea
Slovenian: Srčne bolezni občasni perikardialni izliv
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic: handle with caution.
Slovenian: Citotoksično: ravnajte previdno.
English: Monitoring of complete blood count is recommended prior to initiating temsirolimus therapy and peridically thereafter.
Slovenian: Pred začetkom zdravljenja s temsirolimusom ter v rednih intervalih med njim je priporočljivo spremljanje celotne krvne slike.
English: These symptoms might be caused by a perforation in your gut.
Slovenian: Ti simptomi so morda posledica predrtja črevesa.
English: Hepatic impairment
Slovenian: Znotrajmožganska krvavitev
English: Hypersensitivity reactions / drug hypersensitiviy
Slovenian: Bolezni imunskega sistema pogosti preobčutljivostne reakcije / preobčutljivost na zdravilo
English: Note: For mantle cell lymphoma, multiple vials will be required for each dose over 25 mg. Each vial of Torisel must be diluted according to the instructions below.
Slovenian: Opozorilo: Pri limfomu plaščnih celic bo za vsak odmerek, večji od 25 mg, potrebnih več vial.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Torisel 30 mg sterile concentrate temsirolimus
Slovenian: Torisel 30 mg sterilni koncentrat temsirolimus intravenska uporaba
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.2 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: Nail disorder Ecchymosis*** Petechiae***
Slovenian: občasni očesna krvavitev***
English: No dose adjustment is recommended for patients with MCL and mild hepatic impairment.
Slovenian: Pri bolnikih z MCL in blago okvaro jeter prilagajanje odmerka ni priporočljivo.
English: Note: For MCL, multiple vials will be required for each dose over 25 mg. Each vial of Torisel must be diluted according to the instructions below.
Slovenian: Opozorilo: Pri MCL bo za vsak odmerek, večji od 25 mg, potrebnih več vial.
English: This may require initiation, or increase, in the dose of lipid-lowering agents.
Slovenian: Zaradi hiperlipemije je včasih treba uvesti zdravila za zniževanje ravni lipidov ali zvečati njihove odmerke.
English: Very common Fatigue Oedema (including generalised oedema, facial oedema, peripheral oedema, scrotal oedema, genital oedema)
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti utrujenost edem (vključno z generaliziranim edemom, edemom obraza, perifernim edemom, edemom skrotuma, edemom spolovil) astenija vnetje sluznic pireksija bolečina mrzlica bolečina v prsih občasni slabše celjenje ran
English: Dizziness
Slovenian: Dojenje
English: One vial of 2.2 ml solvent.
Slovenian: 2,2 ml
English: Dilution
Slovenian: Odmerjanje
English: For patients with RCC and severe hepatic impairment, the recommended dose for patients who have baseline platelets 100 x 109/l is 10 mg intravenous once a week infused over a 30-60 minute period (see section 5.2).
Slovenian: Pri bolnikih z RCC in hudo okvaro jeter je priporočeni odmerek za bolnike, ki imajo izhodiščno koncentracijo trombocitov  100 x 10
English: Nervous system disorders
Slovenian: Organski sistem Pogostnost
English: Abdominal pain
Slovenian: Pljučna embolija
English: There are also links to other websites about rare diseases and treatments.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: Gastrointestinal haemorrhage (including anal, rectal, haemorrhoidal, lip, and mouth haemorrhage, gingival bleeding)
Slovenian: Bolezni prebavil zelo pogosti navzea diareja stomatitis bruhanje zaprtje bolečina v trebuhu pogosti gastrointestinalna krvavitev (vključno z analno, rektalno, hemoroidalno krvavitvijo, krvavitvijo iz ustnic in ust, krvavitvijo dlesni) gastritis** disfagija napihnjenost trebuha aftozni stomatitis bolečina v ustih gingivitis občasni perforacija črevesa a/dvanajstnika
English: One vial of 1.2 ml concentrate.
Slovenian: koncentrat in vehikel za raztopino za infundiranje ena viala z 1,2 ml koncentrata ena viala z 2,2 ml vehikla
English: Kidney failure
Slovenian: Okvara jeter
English: The concentrate for solution for infusion must be diluted with the supplied solvent before administration in sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Preden se koncentrat za raztopino za infundiranje doda v raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, ga je treba razredčiti s priloženim vehiklom.
English: In order to address the uncertainties with regards to the efficacy and safety of Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names in the treatment of irritable bowel syndrome in adult patients, the MAH should conduct and submit the results of a well-designed and adequately powered multicentre double blind randomised placebo controlled post approval efficacy study allowing for relevant subpopulation analyses, in accordance with an agreed protocol to assess the efficacy of Symbioflor 2 in the treatment of IBS in general versus subtypes of the disease such as IBS C and IBS D, both gender, disease severity and address the sustainability of efficacy The final study report should be submitted to the relevant National Competent Authorities.
Slovenian: Za preučitev negotovosti v zvezi z učinkovitostjo in varnostjo zdravila Symbioflor 2 (bakterije Escherichia coli (celice in avtolizat)) in povezanih imen pri zdravljenju sindroma razdražljivega črevesa pri odraslih bolnikih mora imetnik dovoljenja za promet z zdravilom opraviti (in nato predložiti njene rezultate) dobro zasnovano multicentrično, dvojno slepo, randomizirano, s placebom nadzorovano študijo učinkovitosti po odobritvi z zadostno statistično močjo, ki bo omogočila primerne analize podpopulacij, v skladu z dogovorjenim protokolom za oceno učinkovitosti zdravila Symbioflor 2 pri zdravljenju sindroma razdražljivega črevesa na splošno v primerjavi s podtipi bolezni, kot so sindrom razdražljivega črevesa C in D, oba spola, resnost bolezni, ter za preučitev trajnosti učinkovitosti.
English: Submission of the final study results by March
Slovenian: Predložitev končnih rezultatov študije do marca 2022.
English: Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names
Slovenian: Symbioflor 2 (bakterije Escherichia coli (celice in avtolizat)) in povezana imena
English: Annex IV Conditions to the marketing authorisation(s)
Slovenian: Priloga IV Pogoji dovoljenja (dovoljenj) za promet z zdravilom
English: Conditions to the marketing authorisation(s)
Slovenian: Pogoji dovoljenja (dovoljenj) za promet z zdravilom
English: 15 January 2015 EMA/35715/2015
Slovenian: 15. januar 2015 EMA/35715/2015
English: Contact our press officer Monika Benstetter
Slovenian: Stopite v stik z našim tiskovnim predstavnikom Monika Benstetter
English: Healthcare professionals should follow these recommendations:
Slovenian: Zdravstveni delavci morajo upoštevati naslednja priporočila:
English: • If you have any questions or concerns, you should consult your doctor or another healthcare professional.
Slovenian: • Če imate kakršna koli vprašanja ali pomisleke, se posvetujte s svojim zdravnikom ali drugim zdravstvenim delavcem.
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Slovenian: Tel. +44 (0)20 3660 8427 E-pošta: press@ema.europa.eu
English: Information to patients
Slovenian: Informacije za bolnike
English: Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1406430 (accessed 14/11/14).
Slovenian: Na voljo na spletni strani: http://www.nejm.org/doi/full/10.1056/NEJMoa1406430 (dostop 14.11.14).
English: Your doctor will regularly measure your heart rate particularly before starting treatment and when adjusting the dose.
Slovenian: Vaš zdravnik bo redno meril vaš srčni utrip, zlasti pred začetkom zdravljenja in ob prilagajanju odmerka.
English: The review of Procoralan/Corlentor was initiated on 8 May 2014 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Slovenian: Pregled zdravila Procoralan/Corlentor se je pričel 8. maja 2014 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: • Healthcare professionals have been informed in writing of these new recommendations, and the product information for Corlentor/Procoralan has been updated accordingly.
Slovenian: • Zdravstveni delavci so bili pisno obveščeni o teh novih priporočilih, informacije o zdravilu Corlentor/Procoralan pa so bile ustrezno posodobljene.
English: In addition, discontinuation should be considered if the improvement is only limited and if there is no clinically relevant reduction in resting heart rate within 3 months.
Slovenian: Poleg tega je treba razmisliti o ukinitvi zdravljenja, če je izboljšanje le omejeno in če v 3 mesecih ni opaziti klinično pomembnega znižanja srčnega utripa v mirovanju.
English: Regular monitoring for the occurrence of atrial fibrillation is recommended.
Slovenian: Priporočljivo je redno spremljanje z namenom zaznave atrijske fibrilacije.