FrancophonIA/ELRC3.0 huggingface dataset:
English: • High level of sugar in the blood (hyperglycaemia)
Slovenian: • visoka raven sladkorja v krvi (hiperglikemija)
English: In clinical studies and post-marketing spontaneous reports, everolimus has been associated with renal failure events (including fatal outcome) and proteinuria.
Slovenian: V poročilih iz kliničnih študij in spontanih poročilih na podlagi izkušenj po prihodu zdravila na trg so everolimus povezovali s primeri ledvične odpovedi (vključno s smrtnim izzidom) in s proteinurijo.
English: Includes (very common) pneumonitis, (common) interstitial lung disease, lung infiltration and (rare) pulmonary alveolar haemorrhage, pulmonary toxicity, and alveolitis d
Slovenian: b vključuje različne krvavitve na različnih delih telesa, ki niso navedene posamezno c vključno s pljučnico (zelo pogosta), intersticijsko boleznijo pljuč, infiltracijo pljuč (pogosti) in pljučno alveolarno krvavitvijo, toksičnimi učinki na pljuča in alveolitisom (redki)
English: • difficulty breathing or swallowing
Slovenian: • oteženo dihanje ali požiranje,
English: Hormone receptor-positive advanced breast cancer BOLERO-2 (study CRAD001Y2301), a randomised, double-blind, multicentre phase III study of Afinitor + exemestane versus placebo + exemestane, was conducted in postmenopausal women with oestrogen receptor-positive, HER2/neu negative advanced breast cancer with recurrence or progression following prior therapy with letrozole or anastrozole.
Slovenian: Napredovali rak dojke, pozitiven na hormonske receptorje V randomizirani, dvojno slepi, multicentrični študiji faze III BOLERO-2 (z oznako CRAD001Y2301) so primerjali kombinirano zdravljenje z zdravilom Afinitor in eksemestanom s kombinacijo placeba in eksemestana pri ženskah v pomenopavzi z napredovalim, na estrogenske receptorje pozitivnim in HER2/neu negativnim rakom dojke, pri katerih je prišlo do ponovitve ali napredovanja bolezni po predhodnem zdravljenju z letrozolom ali anastrozolom.
English: White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other.
Slovenian: Podolgovate tablete, bele do nekoliko rumenkaste barve, z zaobljenim robom in brez razdelilne zareze, z vtisnjenima oznakama “UHE” na eni strani in “NVR” na drugi.
English: The grades follow CTCAE Version 3.0 and 4.03.
Slovenian: Stopnje izraženosti so opredeljene po dokumentu Skupni terminološki kriteriji za neželene dogodke verzija 3.0 in 4.03 (Common Terminology Criteria for Adverse Events - CTCAE).
English: Absence of menstrual periods (amenorrhoea) has been observed in some female patients receiving Afinitor.
Slovenian: Pri nekaterih bolnicah, ki so prejemale zdravilo Afinitor, so opažali odsotnost menstrualnih krvavitev (amenoreja).
English: Mean oral clearance (CL/F) of everolimus after 10 mg daily dose in patients with advanced solid tumours was 24.5 l/h.
Slovenian: Pri bolnikih z napredovalim trdim tumorjem je bil povprečni peroralni očistek (CL/F) everolimusa po jemanju odmerka 10 mg na dan 24,5 l/h.
English: Butylhydroxytoluene Magnesium stearate Lactose monohydrate Hypromellose Crospovidone type A Lactose anhydrous
Slovenian: 6.1 Seznam pomožnih snovi butilhidroksitoluen magnezijev stearat laktoza monohidrat hipromeloza krospovidon (tipa A) brezvodna laktoza
English: Monitoring of fasting serum glucose is recommended prior to the start of Afinitor therapy and periodically thereafter.
Slovenian: Pred začetkom zdravljenja z zdravilom Afinitor in periodično med zdravljenjem je priporočeno spremljanje koncentracije glukoze v serumu na tešče.
English: Afinitor 5 mg and Afinitor 10 mg are available in blister packs containing 10, 30 or 90 tablets.
Slovenian: Zdravili Afinitor 5 mg in Afinitor 10 mg sta na voljo v pakiranjih, ki vsebujejo 10, 30 ali 90 tablet v pretisnih omotih.
English: Female fertility
Slovenian: Plodnost pri ženskah
English: Grade 3 Interrupt treatment until symptoms resolve to Grade 1.
Slovenian: Stopnja 3 Prekinite zdravljenje, dokler se simptomi ne popravijo na raven stopnje 1.
English: Talk to your doctor if you wish to father a child.
Slovenian: Če načrtujete otroka, se posvetujte z zdravnikom.
English: Hazard Ratio = 0.33 95% CI [0.25, 0.43]
Slovenian: razmerje tveganj = 0,33 95 % IZ [0,25, 0,43]
English: Afinitor 5 mg tablets everolimus
Slovenian: Afinitor 5 mg tablete everolimus
English: • Low level of phosphate in the blood (hypophosphataemia)
Slovenian: • znižana raven fosfatov v krvi (hipofosfatemija)
English: Afinitor 2.5 mg is available in blister packs containing 30 or 90 tablets.
Slovenian: Zdravilo Afinitor 2,5 mg je na voljo v pakiranjih, ki vsebujejo 30 ali 90 tablet v pretisnih omotih.
English: Afinitor 10 mg tablets Each tablet contains 10 mg everolimus.
Slovenian: Afinitor 10 mg tablete Ena tableta vsebuje 10 mg everolimusa.
English: Common Proteinuria*, blood creatinine increased, renal failure* Uncommon Increased daytime urination, acute renal failure* Reproductive system and breast disorders Common Menstruation irregular e
Slovenian: občasni povečano odvajanje urina čez dan, akutna ledvična odpoved* Motnje reprodukcije in dojk pogosti neredne menstrualne krvavitve e občasni amenoreja e*
English: Afinitor 10 mg tablets Packs containing 10, 30 or 90 tablets.
Slovenian: Afinitor 10 mg tablete Pakiranja vsebujejo 10, 30 ali 90 tablet.
English: • Fever, coughing, difficulty breathing, wheezing (signs of inflammation of the lung, also known as pneumonitis)
Slovenian: • zvišana telesna temperatura, kašelj, oteženo dihanje, piskajoče dihanje (znaki vnetja pljuč, ki ga imenujemo tudi pljučnica)
English: EU/1/09/538/009 30 tablets EU/1/09/538/010 90 tablets
Slovenian: EU/1/09/538/009 30 tablet EU/1/09/538/010 90 tablet
English: If toxicity recurs at Grade 2, interrupt treatment until recovery to Grade 1.
Slovenian: Če se škodljivi učinki ponovijo na ravni stopnje 2, prenehajte z zdravljenjem, dokler ne pride do izboljšanja na raven stopnje 1.
English: Afinitor 5 mg tablets EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
Slovenian: Afinitor 5 mg tablete EU/1/09/538/001 EU/1/09/538/003 EU/1/09/538/007
English: Afinitor 10 mg tablets are white to slightly yellowish, elongated tablets.
Slovenian: Tablete Afinitor 10 mg so podolgovate tablete, bele do nekoliko rumenkaste barve.
English: Afinitor 10 mg tablets EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/008
Slovenian: Afinitor 10 mg tablete EU/1/09/538/004 EU/1/09/538/006 EU/1/09/538/008
English: Includes (very common) stomatitis, (common) aphthous stomatitis, mouth and tongue ulceration and (uncommon) glossodynia, glossitis e
Slovenian: d vključno z vnetjem ustne sluznice (zelo pogost), aftoznim stomatitisom, razjedo v ustih in na jeziku (pogosti) ter pekočimi bolečinami v jeziku in vnetjem jezika (občasni)
English: Afinitor 2.5 mg tablets Each tablet contains 2.5 mg everolimus.
Slovenian: Afinitor 2,5 mg tablete Ena tableta vsebuje 2,5 mg everolimusa.
English: Afinitor 5 mg tablets are white to slightly yellowish, elongated tablets.
Slovenian: Tablete Afinitor 5 mg so podolgovate tablete, bele do nekoliko rumenkaste barve.
English: Figure 4 RADIANT-4 - Kaplan-Meier progression-free survival curves (independent radiological review)
Slovenian: Slika 4 Študija RADIANT-4 - Kaplan-Meierjevi krivulji preživetja brez napredovanja bolezni (po pregledu neodvisnih radiologov)
English: • High level of lipids (fats) in the blood (hypercholesterolaemia)
Slovenian: • visoka raven lipidov (maščob) v krvi (hiperholesterolemija)
English: The primary endpoint for the study was progression-free survival (PFS) evaluated by Response Evaluation Criteria in Solid Tumors (RECIST), based on independent radiology assessment.
Slovenian: Primarni cilj opazovanja v študiji je bilo preživetje brez napredovanja bolezni, ki so ga ocenjevali s pomočjo Kriterijev za ocenjevanje odziva pri solidnih tumorjih (RECIST, Response Evaluation Criteria in Solid Tumours) na osnovi ocene neodvisnih radiologov.
English: The key secondary objective was to estimate the HR of PFS for everolimus + exemestane versus capecitabine.
Slovenian: Ključni sekundarni cilj študije je bila ocena razmerja tveganj za preživetje brez napredovanja bolezni pri zdravljenju s kombinacijo everolimusa in eksemestana v primerjavi z zdravljenjem s kapecitabinom.
English: Cases of PJP/PCP, some with fatal outcome, have been reported in patients who received everolimus.
Slovenian: Pri bolnikih, ki so se zdravili z everolimusom, so poročali o pojavu PJP/PCP, ki se je pri nekaj bolnikih končala s smrtjo.
English: In rats, everolimus caused embryo/foetotoxicity at systemic exposure below the therapeutic level.
Slovenian: Pri podganah je bil everolimus pri sistemski izpostavljenosti pod terapevtsko toksičen za zarodek in plod, kar se je pokazalo s smrtjo in z zmanjšano telesno maso ploda.
English: Limited evidence of PFS benefit was reported in the subgroup of patients with ileum as primary tumour origin (see section 5.1).
Slovenian: Pri bolnikih z ileumom, kot primarnim mestom izvora tumorja, so na voljo omejeni dokazi o pozitivnih učinkih na preživetje brez napredovanja bolezni (glejte poglavje 5.1).
English: Afinitor 5 mg tablets Each tablet contains 5 mg everolimus.
Slovenian: Afinitor 5 mg tablete Ena tableta vsebuje 5 mg everolimusa.
English: Hazard Ratio = 0.48 95% CI [0.35, 0.67]
Slovenian: razmerje tveganj (HR) = 0,48 95% IZ [0,35, 0,67]
English: Musculoskeletal and connective tissue disorders Common Arthralgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti bolečine v sklepih
English: Afinitor 5 mg tablets Packs containing 10, 30 or 90 tablets.
Slovenian: Afinitor 5 mg tablete Pakiranja vsebujejo 10, 30 ali 90 tablet.
English: Prior chemotherapy Primary tumour origin
Slovenian: predhodna kemoterapija primarni izvor tumorja gradus tumorja breme tumorja v jetrih izhodiščna vrednost CgA izhodiščna vrednost NSE
English: Cmax is dose-proportional between 5 and 10 mg. tmax occurs at 1 to 2 hours post-dose.
Slovenian: Cmax je v okviru odmerkov od 5 do 10 mg sorazmerna z višino odmerka.
English: Progression-free survival, documented using RECIST (Response Evaluation Criteria in Solid Tumours) and assessed via a blinded, independent central review, was the primary endpoint.
Slovenian: Primarni cilj opazovanja je bilo preživetje brez napredovanja bolezni, ki so ga dokumentirali s pomočjo Kriterijev za ocenjevanje odziva pri trdih tumorjih (RECIST, Response Evaluation Criteria in Solid Tumours) in presodili s slepim neodvisnim centralnim pregledovanjem.
English: Elderly patients (≥65 years) No dose adjustment is required (see section 5.2).
Slovenian: Starejši bolniki (≥65 let)
English: • Mouth ulcers
Slovenian: • suha usta
English: The primary endpoint for the study was progression-free survival (PFS) evaluated by RECIST (Response Evaluation Criteria in Solid Tumors), based on the investigator's assessment (local radiology).
Slovenian: Primarni cilj opazovanja v študiji je bilo preživetje brez napredovanja bolezni, ki ga je raziskovalec (lokalni radiolog) ocenil s pomočjo Kriterijev za ocenjevanje odziva pri solidnih tumorjih (RECIST, Response Evaluation Criteria in Solid Tumours).
English: Use caution when co-administration of moderate CYP3A4 inhibitors or PgP inhibitors cannot be avoided.
Slovenian: Če se uporabi zdravila Afinitor v kombinaciji z zmernimi zaviralci CYP3A4 ali P-glikoproteina ne da izogniti, je potrebna previdnost.
English: Monitoring of complete blood count is recommended prior to the start of Afinitor therapy and periodically thereafter.
Slovenian: Pred začetkom zdravljenja z zdravilom Afinitor in periodično med zdravljenjem je priporočeno spremljanje celotne krvne slike.
English: Advanced neuroendocrine tumours of pancreatic origin (pNET) RADIANT-3 (study CRAD001C2324), a phase III, multicentre, randomised, double-blind study of Afinitor plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pNET, demonstrated a statistically significant clinical benefit of Afinitor over placebo by a 2.4-fold prolongation of median progression-free-survival (PFS) (11.04 months versus 4.6 months), (HR 0.35; 95% CI: 0.27, 0.45; p<0.0001) (see Table 5 and Figure 3).
Slovenian: Rezultati te študije kažejo, da je zdravilo Afinitor statistično značilno klinično bolj koristno kot placebo z 2,4-krat večjim medianim trajanjem preživetja brez napredovanja bolezni (11,04 meseca v primerjavi s 4,6 meseca), (z razmerjem tveganj (HR) 0,35; s 95-odstotnim IZ: 0,27, 0,45; p<0,0001) (glejte preglednico 5 in sliko 3).
English: Figure 3 RADIANT-3 - Kaplan-Meier progression-free survival curves (investigator radiological review)
Slovenian: Slika 3 Študija RADIANT-3 - Kaplan-Meierjevi krivulji preživetja brez napredovanja bolezni (ocena radiološkega izvida s strani raziskovalca)
English: EU/1/09/538/007 10 tablets EU/1/09/538/001 30 tablets EU/1/09/538/003 90 tablets
Slovenian: EU/1/09/538/007 10 tablet EU/1/09/538/001 30 tablet EU/1/09/538/003 90 tablet
English: *Non-ileum: stomach, colon, rectum, appendix, caecum, duodenum, jejunum, carcinoma of unknown primary origin and other gastrointestinal origin
Slovenian: WHO PS: stanje zmogljivosti po lestvici Svetovne zdravstvene organizacije SSA: analogi somatostatina (somatostatin analogues) *izven ileuma: želodec, kolon, danka, slepič, slepo črevo, dvanajstnik, jejunum, karcinom neznanega izvora in druga gastrointestinalna mesta izvora tumorja
English: Figure 2 BOLERO-6 Kaplan-Meier progression-free survival curves (investigator radiological review)
Slovenian: Slika 2 BOLERO-6 Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (ocena radiološkega izvida s strani raziskovalca)
English: Each tablet of Afinitor 2.5 mg contains 2.5 mg everolimus.
Slovenian: Ena tableta Afinitor 2,5 mg vsebuje 2,5 mg everolimusa.
English: However, the corresponding oestradiol levels at steady state (4 weeks) were not different between the two treatment arms.
Slovenian: Sočasna uporaba everolimusa in eksemestana je zvišala Cmin eksemestana za 45 %, njegovo C2h pa za 64 %, vendar pa se ustrezni koncentraciji estradiola v stanju dinamičnega ravnovesja (po 4 tednih) med obema zdravljenima skupinama nista razlikovali.
English: EU/1/09/538/008 10 tablets EU/1/09/538/004 30 tablets EU/1/09/538/006 90 tablets
Slovenian: EU/1/09/538/008 10 tablet EU/1/09/538/004 30 tablet EU/1/09/538/006 90 tablet
English: Each tablet of Afinitor 5 mg contains 5 mg everolimus.
Slovenian: Ena tableta Afinitor 5 mg vsebuje 5 mg everolimusa.
English: • Dry mouth
Slovenian: • vročinski oblivi
English: Figure 1 BOLERO-2 Kaplan-Meier progression-free survival curves (investigator radiological review)
Slovenian: Slika 1 BOLERO-2 Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (ocena radiološkega izvida s strani raziskovalca)
English: Each tablet of Afinitor 10 mg contains 10 mg everolimus.
Slovenian: Ena tableta Afinitor 10 mg vsebuje 10 mg everolimusa.
English: • Weakness, spontaneous bleeding or bruising and frequent infections with signs such as fever,
Slovenian: • šibkost, spontane krvavitve in pojavljanje modric ter pogoste okužbe z znaki, kot so zvišana telesna temperatura, mrazenje, vnetje grla oziroma žrela, razjede ustne sluznice (znaki zmanjšanega števila krvnih celic, kar imenujemo tudi pancitopenija)
English: • Coughing up blood (haemoptysis)
Slovenian: • izkašljevanje krvi (hemoptiza)
English: No increase in adverse reactions related to exemestane was observed in patients with hormone receptor-positive advanced breast cancer receiving the combination.
Slovenian: Pri bolnicah z napredovalim rakom dojke, pozitivnim na hormonske receptorje, ki so prejemale kombinacijo obeh zdravil, niso opažali povečanega obsega neželenih učinkov, ki bi bili povezani z eksemestanom.
English: • Mild loss of hair
Slovenian: • rahlo izpadanje las
English: • Low level of potassium in the blood (hypokalaemia)
Slovenian: • znižana raven kalija v krvi (hipokaliemija)
English: Median overall survival (months) (95% CI) Median overall survival
Slovenian: vrednost p mediana preživetja brez napredovanja bolezni (meseci) (95 % IZ) ocena radiološkega izvida s strani raziskovalca ocena radiološkega izvida s strani neodvisnega pregledovalca mediana celotnega preživetja (meseci) (95 % IZ) mediana celotnega preživetja
English: Grade 2 Temporary dose interruption until recovery to Grade 1.
Slovenian: Stopnja 2 Začasna prekinitev zdravljenja, dokler ne pride do izboljšanja na raven stopnje 1.
English: • Fever
Slovenian: • bruhanje
English: • Inflammation of the inner lining of the mouth, stomach, gut
Slovenian: • vnetje ustne, želodčne ali črevesne sluznice
English: Grade 3 Temporary dose interruption until recovery to Grade 1.
Slovenian: Stopnja 3 Začasno prekinite zdravljenje, dokler ne pride do izboljšanja na raven stopnje 1.
English: • Disturbed taste (dysgeusia)
Slovenian: • oteženo požiranje (disfagija)
English: In favour of
Slovenian: Uporabno do
English: • Breathlessness (dyspnoea)
Slovenian: • zadihanost (dispneja)
English: While taking Afinitor, be vigilant for symptoms and signs of infection; if a diagnosis of infection is made, institute appropriate treatment promptly and consider interruption or discontinuation of Afinitor.
Slovenian: Če ugotovijo okužbo, morajo takoj začeti z ustreznim zdravljenjem in razmisliti o prekinitvi zdravljenja z zdravilom Afinitor.
English: There are currently not sufficient data to allow dosing recommendations in this situation.
Slovenian: Zaenkrat ni dovolj podatkov, da bi lahko oblikovali priporočila za odmerjanje v takem primeru, zato sočasna uporaba zdravila Afinitor in močnih zaviralcev ni priporočena.
English: What Afinitor looks like and contents of the pack Afinitor 2.5 mg tablets are white to slightly yellowish, elongated tablets.
Slovenian: Tablete Afinitor 2,5 mg so podolgovate tablete, bele do nekoliko rumenkaste barve.
English: Diltiazem Dronedarone
Slovenian: Okvara jeter
English: Stomatitis, including mouth ulcerations and oral mucositis, is the most commonly reported adverse reaction in patients treated with Afinitor (see section 4.8).
Slovenian: Pri bolnikih, ki jemljejo zdravilo Afinitor, je najpogosteje poročan neželeni učinek stomatitis, ki vključuje razjede v ustni votlini in vnetje ustne sluznice (glejte poglavje 4.8).
English: Ciclosporin oral
Slovenian: • razjede ustne sluznice
English: All (N=302) <65 years (N=159) ≥65 years (N=143) 0 (N=216) 1 (N=86)
Slovenian: Študijo RECORD-1 (študijo CRAD001C2240), mednarodno multicentrično randomizirano dvojno slepo študijo faze III, v kateri so primerjali everolimus 10 mg/dan in placebo, oba so bolniki prejemali vsi (N=302) <65 let (N=159) ≥65 let (N=143) 0 (N=216) 1 (N=86) da (N=157) ne (N=145) da (N=77)
English: The primary endpoint for the study was PFS evaluated by RECIST (Response Evaluation Criteria in Solid Tumors).
Slovenian: Primarni cilj opazovanja je bilo preživetje brez napredovanja bolezni, ki so ga ocenjevali s pomočjo Kriterijev za ocenjevanje odziva pri solidnih tumorjih (RECIST, Response Evaluation Criteria in Solid Tumours).
English: Not applicable e p value is obtained from the exact Cochran-Mantel-Haenszel test using a stratified version of the Cochran-Armitage permutation test.
Slovenian: n/a d e a skupaj z eksemestanom b delež bolnic z objektivnim odzivom = delež bolnic s popolnim ali z delnim odzivom c delež bolnic s klinično koristjo = delež bolnic s popolnim ali z delnim odzivom ali s stabilno boleznijo ≥24 tednov d navedba smiselno ni potrebna e vrednost p je pridobljena na podlagi eksaktnega Cochran-Mantel-Haenszelovega testa z uporabo stratificirane verzije Cochran-Armitage permutacijskega testa.
English: Common Vomiting, dry mouth, abdominal pain, mucosal inflammation, oral pain, dyspepsia,
Slovenian: • zvišana telesna temperatura, vnetje grla oziroma žrela, razjede ustne sluznice zaradi okužbe
English: • Abnormal wound healing
Slovenian: • slabo celjenje ran
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: Izgled zdravila Afinitor in vsebina pakiranja
English: When possible optimal glycaemic control should be achieved before starting a patient on Afinitor.
Slovenian: Če se le da, je treba pred začetkom zdravljenja z zdravilom Afinitor urediti koncentracije glukoze v krvi.
English: Invented name Strength Pharmaceutical form Route of administration Immediate packaging
Slovenian: Stična ovojnina Vsebina Velikost pakiranja
English: Catherine Moraiti (Greece)
Slovenian: Catherine Moraiti (Grčija)
English: The European Commission issued a decision on 15 March 2010.
Slovenian: Evropska komisija je odločbo izdala dne 15. marca 2010.
English: Ref.: EMA/CHMP/736379/2009 rev.1 EMEA/H/A-30/1078
Slovenian: : EMA/CHMP/736379/2009 rev.1 EMEA/H/A-30/1078
English: The review was carried out under an ‘Article 30' referral1.
Slovenian: Pregled je bil opravljen v skladu z napotitvenim postopkom iz „člena 30“1.
English: The company that markets these medicines is Novartis.
Slovenian: Družba, ki trži ta zdravila, je Novartis.
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Slovenian: Člen 30 Direktive 2001/83/ES, kakor je bila spremenjena, napotitveni postopek na podlagi različnih odločitev držav članic.
English: Why was Lescol reviewed?
Slovenian: Zakaj je bilo zdravilo Lescol pregledano?
English: London, 15 March 2010 Doc.
Slovenian: London, 15. marca 2010 Sklic dok.
English: Lescol is authorised in the EU via national procedures.
Slovenian: Zdravilo Lescol je v EU odobreno z nacionalnimi postopki.
English: Questions and answers on the referral for Lescol and associated names Capsules containing 20 mg or 40 mg fluvastatin Prolonged-release tablets containing 80 mg fluvastatin
Slovenian: Vprašanja in odgovori v zvezi z napotitvenim postopkom za zdravilo Lescol in povezana imena kapsule, ki vsebujejo 20 mg ali 40 mg fluvastatina tablete s podaljšanim sproščanjem, ki vsebujejo 80 mg fluvastatina
English: Lescol is also available in the EU under other trade names: Canef, Cardiol, Cardiol XL, Cranoc, Digardil, Digaril Prolib, Fluvastatin Novartis, Fluvastatina, Fractal, Leposit Prolib, Lescol Depot, Lescol Exel, Lescol LP, Lescol MR, Lescol Prolib, Lescol XL, Lipaxan, Lipaxin, Liposit, Locol, Lymetel, Primesin, Vaditon and Vaditon Prolib.
Slovenian: Zdravilo Lescol je v EU na voljo tudi pod drugimi lastniškimi imeni: Canef, Cardiol, Cardiol XL, Cranoc, Digardil, Digaril Prolib, Fluvastatin Novartis, Fluvastatina, Fractal, Leposit Prolib, Lescol Depot, Lescol Exel, Lescol LP, Lescol MR, Lescol Prolib, Lescol XL, Lipaxan, Lipaxin, Liposit, Locol, Lymetel, Primesin, Vaditon in Vaditon Prolib.
English: The Committee concluded that initial dosing ranging from 20 to 80 mg/day is appropriate.
Slovenian: Odbor je menil, da so primerni začetni odmerki v razponu od 20 do 80 mg/dan.
English: The European Medicines Agency has completed a review of Lescol and associated names.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Lescol in povezanih imen.
English: The CHMP also agreed on a harmonised wording for the contra-indications (situations where the medicine must not be used):
Slovenian: CHMP se je uskladil tudi o usklajenem besedilu kontraindikacij (okoliščin, v katerih se zdravilo ne sme uporabiti):
English: The contra-indications that were removed were: use in children, in patients with myopathic disorders and patient with severe renal impairment, as warnings and cautionary statements are already included in sections 4.2 and 4.4.
Slovenian: Odstranjene kontraindikacije so: uporaba pri otrocih, pri bolnikih z miopatskimi boleznimi in bolnikih s hudo okvarjenim delovanjem ledvic, saj so opozorila in previdnostni stavki že vključeni v poglavji 4.2 in 4.4.
English: The dosage in specific populations, such as children and patients with kidney problems, was also harmonised.
Slovenian: Usklajeno je bilo tudi odmerjanje za specifične populacije, kot so otroci in bolniki s težavami z ledvicami.
English: “- in patients with known hypersensitivity to fluvastatin or any of the excipients;
Slovenian: „- pri bolnikih z znano preobčutljivostjo za fluvastatin ali katero koli pomožno snov;
English: HMG-CoA reductase is responsible for the production of cholesterol.
Slovenian: HMG-CoA-reduktaza je odgovorna za nastajanje holesterola.