FrancophonIA/ELRC3.0 huggingface dataset:
English: If a patient vomits or misses a dose of Verzenios, the patient should be instructed to take the next dose at its scheduled time; an additional dose should not be taken.
Slovenian: Če bolnica bruha ali izpusti odmerek zdravila Verzenios, ji je treba naročiti, da naj naslednji odmerek vzame ob predvidenem času; dodatnega odmerka ne sme vzeti.
English: Effects in lung and skeletal muscle occurred only in rats at exposure levels approximately 2-fold higher than human exposure levels and effects in kidney occurred only in rats at exposure levels approximately 6fold higher than human exposure levels.
Slovenian: Učinki na pljuča in skeletne mišice so se pojavili samo pri podganah pri izpostavljenosti, približno 2krat večji od izpostavljenosti pri človeku, učinki na ledvice pa so se pojavili samo pri podganah pri izpostavljenosti, približno 6-krat večji od izpostavljenosti pri človeku.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Slovenian: Bolnice z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malapsorpcijo glukoze/galaktoze, ne smejo jemati tega zdravila.
English: Verzenios is a cancer medicine containing the active substance abemaciclib.
Slovenian: Verzenios je zdravilo za zdravljenje raka, ki vsebuje učinkovino abemaciklib.
English: These proteins are abnormally active in some cancer cells and make them grow out of control.
Slovenian: Ti proteini so v nekaterih rakavih celicah nenormalno aktivni, zato te celice nenadzorovano rastejo.
English: However, cytotoxic effects to the male reproductive tract in rats and dogs indicate that abemaciclib may impair fertility in males (see section 5.3).
Slovenian: Citotoksični učinki na moški reproduktivni sistem pri podganah in psih pa kažejo, da abemaciklib lahko škoduje plodnosti pri moških (glejte poglavje 5.3).
English: Patients with prior (neo)adjuvant endocrine therapy must have completed this therapy at least 12 months before study randomisation.
Slovenian: Bolnice s predhodnim (neo)adjuvantnim endokrinim zdravljenjem so morale to zdravljenje zaključiti vsaj 12 mesecev pred randomizacijo v študiji.
English: Read the package leaflet before use.
Slovenian: Pred uporabo preberite navodilo za uporabo!
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred začetkom jemanja tega zdravila posvetujte s svojim zdravnikom.
English: Other medicines and Verzenios
Slovenian: Druga zdravila in zdravilo Verzenios
English: Abemaciclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), and most active against Cyclin D1/CDK4 in enzymatic assays.
Slovenian: Abemaciklib je močan in selektiven zaviralec od ciklina odvisnih kinaz 4 in 6 (CDK4 in CDK6) ter v encimskih testih najaktivnejši proti ciklinu D1/CDK4.
English: If you get certain side effects while you are taking Verzenios your doctor may lower your dose or stop treatment temporarily or permanently.
Slovenian: Če se med jemanjem zdravila Verzenios pojavijo določeni neželeni učinki, vam bo zdravnik mogoče zmanjšal odmerek ali prekinil zdravljenje, začasno ali trajno.
English: PCTFE/PE/PVC blisters sealed with an aluminium foil in a calendar blister card, in packs of 14, 28, 42, 56, 70 or 168 film-coated tablets.
Slovenian: Pretisni omoti iz PCTFE/PE/PVC, zaprti z aluminijasto folijo v koledarskem pretisnem omotu v pakiranjih po 14, 28, 42, 56, 70 ali 168 filmsko obloženih tablet.
English: A high-fat meal increased combined AUC of abemaciclib and its active metabolites by 9% and increased Cmax by 26%.
Slovenian: Obrok z veliko vsebnostjo maščob je povečal kombiniran AUC abemacikliba in njegovih aktivnih presnovkov za 9 %, Cmax pa za 26 %.
English: Diarrhoea was the most commonly reported adverse reaction (see Table 6).
Slovenian: Driska je bila neželeni učinek, o katerem so najpogosteje poročali (glejte preglednico 6).
English: Overall survival was not mature at the final PFS analysis (133 events observed across the two arms).
Slovenian: Podatki za celokupno preživetje ob končni analizi PFS niso bili zreli (133 dogodkov v obeh skupinah).
English: What Verzenios is and what it is used for
Slovenian: Kaj je zdravilo Verzenios in za kaj ga uporabljamo
English: It is not known if Verzenios passes into breast milk.
Slovenian: Ni znano, ali zdravilo Verzenios prehaja v materino mleko.
English: It should not be taken with grapefruit or grapefruit juice (see section 4.5).
Slovenian: Zdravilo se ne sme jemati z grenivko ali grenivkinim sokom (glejte poglavje 4.5).
English: Morning Evening
Slovenian: Zjutraj
English: It is given together with hormonal therapies, such as aromatase inhibitors or fulvestrant.
Slovenian: Dajemo ga skupaj s hormonskim zdravilom, kot so zaviralci aromataze ali fulvestrant.
English: These results correspond to a clinically meaningful reduction in the risk of disease progression or death of 44.7% and a 7.2 month improvement in median PFS for patients treated with Verzenios plus fulvestrant.
Slovenian: Ti rezultati ustrezajo klinično pomembnemu zmanjšanju tveganja za napredovanje bolezni ali smrt za 44,7 % in izboljšanju medianega PFS za 7,2 meseca pri bolnicah, zdravljenih z zdravilom Verzenios in s fulvestrantom.
English: Approximately 22% of patients had bone-only disease, and 53% patients had visceral metastases.
Slovenian: Približno 22 % bolnic je imelo bolezen samo v kosteh, 53 % bolnic pa metastaze v visceralnih organih.
English: Other side effects with Verzenios may include:
Slovenian: Drugi neželeni učinki zdravila Verzenios lahko vključujejo:
English: In patients with severe (Child Pugh C) hepatic impairment, a decrease in dosing frequency to once daily is recommended (see section 5.2).
Slovenian: Pri bolnicah s hudo (Child Pugh C) jetrno okvaro se priporoča zmanjšanje pogostnosti odmerjanja na enkrat na dan (glejte poglavje 5.2).
English: Take Verzenios continuously for as long as your doctor tells you to.
Slovenian: Zdravilo Verzenios jemljite neprekinjeno in tako dolgo, kot vam naroči zdravnik.
English: Frequency gradings are: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Slovenian: pogosti (≥1/100 to <1/10), občasni (≥1/1,000 to <1/100), redki (≥1/10,000 to <1/1,000), zelo redki
English: Approximately 39% of patients had received chemotherapy and 44% had received antihormonal therapy in the (neo)adjuvant setting.
Slovenian: Približno 39 % bolnic je prejemalo kemoterapijo, 44 % pa hormonsko zdravljenje v okviru (neo)adjuvantnega zdravljenja.
English: In patients receiving an aromatase inhibitor or fulvestrant alone, 78.4% reported an increase in serum creatinine (all laboratory grades).
Slovenian: Pri bolnicah, ki prejemajo samo zaviralec aromataze ali fulvestrant, so o povišanju vrednosti kreatinina v serumu (vseh laboratorijskih stopenj) poročali pri 78,4 %.
English: In breast cancer xenograft models, abemaciclib dosed daily without interruption at clinically relevant concentrations alone or in combination with anti-oestrogens resulted in reduction of tumour size.
Slovenian: V modelih ksenogenskega presadka raka dojk je abemaciklib z dnevnim odmerkom brez prekinitve pri klinično pomembnih koncentracijah sam ali v kombinaciji z antiestrogeni povzročil zmanjšanje velikosti tumorja.
English: Concomitant use of strong CYP3A4 inducers (including, but not limited to: carbamazepine, phenytoin, rifampicin and St. John's wort) should be avoided due to the risk of decreased efficacy of abemaciclib.
Slovenian: Sočasni uporabi močnih induktorjev CYP3A4 (vključno, vendar ne omejeno na: karbamazepin, fenitoin, rifampicin in šentjanževko) se je treba izogibati zaradi tveganja za manjšo učinkovitost abemacikliba.
English: • Inflamation of the mouth and lips, nausea (feeling sick), vomiting,
Slovenian: • vnetje ust in ustnic, siljenje na bruhanje (slabost), bruhanje
English: Age, gender, and body weight had no effect on the exposure of abemaciclib in a population pharmacokinetic analysis in patients with cancer (135 males and 859 females; age range 24-91 years; and body weight range 36-175 kg).
Slovenian: Starost, spol in telesna masa niso imeli vpliva na izpostavljenost abemaciklibu v analizi populacijske farmakokinetike pri bolnikih z rakom (135 moških in 859 žensk; starostni razpon 24-91 let, razpon telesne mase 36-175 kg).
English: In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Slovenian: Pri ženskah v pred- in perimenopavzi je treba endokrino zdravljenje kombinirati z agonistom gonadoliberina (LHRH - Luteinizing Hormone-Releasing Hormone).
English: The geometric mean hepatic clearance (CL) of abemaciclib was 21.8 L/h (39.8% CV), and the mean plasma elimination half-life for abemaciclib in patients was 24.8 hours (52.1% CV).
Slovenian: Srednja geometrijska vrednost jetrnega izločanja (CL) abemacikliba je bila 21,8 l/h (39,8 % CV) in povprečni razpolovni čas izločanja abemacikliba iz plazme pri bolnicah 24,8 ure (52,1 % CV).
English: The median age of patients enrolled was 63 years (range 32-88).
Slovenian: Mediana starost vključenih bolnic je bila 63 let (razpon 32-88).
English: Show the Verzenios carton and this leaflet.
Slovenian: Pokažite škatlo zdravila Verzenios in to navodilo.
English: Steady state was achieved within 5 days following repeated twice daily dosing, and abemaciclib accumulated with a geometric mean accumulation ratio of 3.7 (58% CV) and 5.8 (65% CV) based on Cmax and AUC, respectively.
Slovenian: Stanje dinamičnega ravnovesja je bilo doseženo po 5 dneh po ponavljajočem se dvakratnem dnevnem odmerjanju, abemaciklib pa se je kopičil z razmerjem geometrijskih srednjih vrednosti 3,7 (58 % CV) na podlagi Cmax in 5,8 (65 % CV) na podlagi AUC.
English: Alternatively, the abemaciclib dose may be reduced to 50 mg once daily or discontinued.
Slovenian: Alternativno je mogoče odmerek abemacikliba znižati na 50 mg enkrat na dan ali prekiniti dajanje abemacikliba.
English: Common Lacrimation increased
Slovenian: Povečano solzenje
English: In a clinical study in patients with breast cancer, there was no clinically-relevant pharmacokinetic drug interaction between abemaciclib and anastrozole, fulvestrant, exemestane, letrozole or tamoxifen.
Slovenian: V klinični študiji pri bolnicah z rakom dojke ni bilo klinično pomembnih farmakokinetičnih interakcij med abemaciklibom in anastrozolom, fulvestrantom, eksemestanom, letrozolom ali tamoksifenom.
English: Overall survival was not mature at the final PFS analysis (93 events observed across the two arms).
Slovenian: Podatki za celokupno preživetje ob končni analizi PFS niso bili zreli (93 dogodkov v obeh skupinah).
English: This was found to be due to reduced renal secretion with unaffected glomerular filtration.
Slovenian: Ugotovili so, da je to posledica zmanjšanega ledvičnega izločanja z neprizadeto glomerulno filtracijo.
English: Verzenios plus fulvestrant prolonged progression-free survival with neither a clinically meaningful or significant detriment to health-related quality of life.
Slovenian: Zdravilo Verzenios in fulvestrant sta podaljšala preživetje brez napredovanja, pri čemer ni prišlo do klinično pomembnega ali značilnega poslabšanja kakovosti življenja.
English: Alanine aminotransferase (ALT) and aspartate aminostransferase (AST) should be monitored prior to the start of Verzenios therapy, every two weeks for the first two months, monthly for the next two months, and as clinically indicated.
Slovenian: Alanin-aminotransferaze (ALT) in aspartat-aminotransferaze (AST) je treba spremljati, in sicer pred začetkom zdravljenja z zdravilom Verzenios, prva dva meseca vsaka dva tedna, enkrat mesečno naslednja dva meseca in v nadaljevanju kot je klinično indicirano.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: In a clinical drug interaction study with metformin (substrate of OCT2, MATE1 and 2) co-administered with 400 mg abemaciclib, a small but not clinically relevant increase (37%) in metformin plasma exposure was observed.
Slovenian: V klinični študiji medsebojnega delovanja zdravil z metforminom (substrat za OCT2, MATE1 in 2), ki so ga dajali sočasno s 400 mg abemacikliba, so opazili majhno, a ne klinično pomembno povečanje (37 %) izpostavljenosti metforminu v plazmi.
English: Developmental toxicity
Slovenian: Razvojna toksičnost
English: Take Verzenios twice daily, at about the same time every day, preferably in the morning and evening, so there is enough medicine in your body all the time.
Slovenian: Kdaj in kako jemati zdravilo Verzenios Zdravilo Verzenios jemljite dvakrat na dan, vsak dan ob približno istem času, najbolje zjutraj in zvečer, tako da bo v telesu ves čas dovolj zdravila.
English: Approximately 56% patients had visceral metastases.
Slovenian: Približno 56 % bolnic je imelo metastaze v visceralnih organih.
English: Grade 4 (>20.0 x ULN)
Slovenian: Stopnja 4 (> 20,0 x ZMN)
English: Aluminium/aluminium perforated unit dose blisters of 28 x 1 film-coated tablets.
Slovenian: Aluminij/aluminij perforirani enoodmerni pretisni omoti z 28 x 1 filmsko obloženo tableto.
English: Lilly S.A., Avda.
Slovenian: Proizvajalec Lilly S.A., Avda.
English: Refer to Section 2 for more information on any of the possible effects listed above.
Slovenian: Za več informacij o morebitnih učinkih, navedenih zgoraj, glejte poglavje 2.
English: Not all the pack sizes may be marketed.
Slovenian: Na trgu morda ni vseh navedenih pakiranj.
English: The primary biotransformation is hydroxylation to a metabolite that circulates with an AUC that is 77% of parent drug.
Slovenian: Primarna biotransformacija je hidroksilacija v presnovek, ki kroži in predstavlja 77 % AUC prvotnega zdravila.
English: In the event of an abemaciclib overdose, fatigue and diarrhoea may occur.
Slovenian: Ob prevelikem odmerjanju abemacikliba se lahko pojavita utrujenost in driska.
English: Verzenios therapy should be initiated and supervised by physicians experienced in the use of anti-cancer therapies.
Slovenian: Zdravljenje z zdravilom Verzenios mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih bolezni.
English: Elevation in AST and/or ALT >3 x ULN WITH total bilirubin >2 x ULN, in the absence of cholestasis
Slovenian: Povišanje vrednosti AST in/ali ALT >3 x ZMN SKUPAJ s celokupnim bilirubinom > 2,0 x ZMN v odsotnosti holestaze
English: Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Slovenian: b Okužbe so vključevale vse priporočene izraze, ki spadajo v organski sistem Infekcijske in parazitske bolezni.
English: How long to take Verzenios
Slovenian: Kako dolgo jemati zdravilo Verzenios
English: Serious or life-threatening infections are uncommon (may affect up to 1 in 100 people).
Slovenian: Resne ali življenjsko nevarne okužbe so redke (pojavijo se lahko pri največ 1 od 100 bolnikov);
English: Verzenios film-coated tablets come in different strengths:
Slovenian: Filmsko obložene tablete zdravila Verzenios so na voljo v različnih jakostih:
English: • Abnormalities in liver blood tests
Slovenian: • nenormalni rezultati krvnih jetrnih preiskav
English: You will have regular blood tests before and during treatment to check whether Verzenios affects your blood (white blood cells, red blood cells, platelets) or the concentration in your blood of enzymes from your liver.
Slovenian: Kaj bo zdravnik preverjal pred zdravljenjem in med njim Pred zdravljenjem in med njim boste redno opravljali krvne preiskave, s katerimi se ugotavlja, ali zdravilo Verzenios vpliva na vašo kri (bele krvne celice, rdeče krvne celice, trombocite), in kakšna je v vaši krvi koncentracija encimov, ki prihajajo iz jeter.
English: Placebo plus fulvestrant
Slovenian: Placebo in fulvestrant
English: The majority of the dose eliminated in faeces was metabolites.
Slovenian: Večina odmerka, izločenega v blatu, so bili presnovki.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinases inhibitors, ATC code: L01XE50
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, zaviralci proteinskih kinaz; oznaka ATC: L01XE50
English: These results correspond to a clinically meaningful reduction in the risk of disease progression or death of 46% for patients treated with abemaciclib plus an aromatase inhibitor.
Slovenian: Ti rezultati ustrezajo klinično pomembnemu zmanjšanju tveganja za napredovanje bolezni ali smrt pri 46 % bolnic, zdravljenih z abemaciklibom in zaviralcem aromataze.
English: In patients receiving abemaciclib in combination with aromatase inhibitors or fulvestrant, ALT and AST elevations were reported frequently (15.1% and 14.2%, respectively).
Slovenian: Pri bolnicah, ki so prejemale abemaciklib v kombinaciji z zaviralci aromataze ali fulvestrantom, so pogosto (15,1 % in 14, 2 %) poročali o povišanih vrednostih ALT in AST.
English: Grade 1 or 2
Slovenian: Stopnja 1 ali 2
English: Verzenios is not recommended during pregnancy and in women of child-bearing potential not using contraception.
Slovenian: Zdravila Verzenios ne uporabljate pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: a NCI Common Terminology Criteria for Adverse Events (CTCAE) b ANC: Grade 1: ANC < LLN - 1500/mm3; Grade 2: ANC 1000 - <1500/mm3; Grade 3: ANC 500 - <1000/mm3; Grade 4: ANC <500/mm3
Slovenian: a merila NCI za poenoteno terminologijo neželenih dogodkov (CTCAE - NCI Common Terminology Criteria for Adverse Events) b ANC: Stopnja 1: ANC < SMN - 1.500/mm3 Stopnja 2: ANC 1000 - < 1.500/mm3;
English: In oestrogen receptor-positive breast cancer cell lines, sustained target inhibition with abemaciclib prevented rebound of Rb phosphorylation resulting in cell senescence and apoptosis.
Slovenian: V celičnih linijah raka dojk, pozitivnega na estrogenske receptorje, je trajno zaviranje tarč z abemaciklibom preprečilo ponovno fosforilacijo Rb, kar je pripeljalo do celične senescence in apoptoze.
English: Genotoxicity
Slovenian: Genotoksičnost
English: If you are able to have children, you should use adequate contraceptive methods (e.g., double -barrier contraception such as condom and diaphragm) during therapy and for at least 3 weeks after completing therapy.
Slovenian: Če lahko zanosite, morate med zdravljenjem in še vsaj 3 tedne po koncu zdravljenja uporabljati ustrezno kontracepcijsko metodo (npr. dvojno mehansko kontracepcijo, kot sta kondom in diafragma).
English: Tel: + 40 21 4023000
Slovenian: Tel. št.: + 40 21 4023000
English: Effects of other medicinal products on the pharmacokinetics of abemaciclib
Slovenian: Učinki drugih zdravil na farmakokinetiko abemacikliba
English: The median age of patients enrolled was 60 years (range, 32-91 years).
Slovenian: Mediana starost vključenih bolnic je bila 60 let (razpon 32-91 let).
English: In a sub-population with locally advanced or metastatic disease that had not received prior endocrine therapy, the PFS was also consistent.
Slovenian: Tudi v podskupini bolnic z lokalno napredovalim ali metastatskim rakom, ki pred tem niso prejemale endokrinega zdravljenja, je bil PFS skladen.
English: Patients should be monitored for signs and symptoms of deep vein thrombosis and pulmonary embolism and treated as medically appropriate.
Slovenian: Bolnice je treba spremljati glede znakov in simptomov globoke venske tromboze in pljučne embolije ter jih ustrezno zdraviti.
English: Elderly No dose adjustment is required based on age (see section 5.2).
Slovenian: Prilagajanje odmerka glede na starost ni potrebno (glejte poglavje 5.2).
English: Mild (Child Pugh A) and moderate (Child Pugh B) hepatic impairment had no effect on the exposure of abemaciclib.
Slovenian: Blaga (Child Pugh A) in zmerna (Child Pugh B) jetrna okvara nista imeli učinka na izpostavljenost abemaciklibu.
English: Randomised Phase 3 Study MONARCH 3: Verzenios in combination with aromatase inhibitors
Slovenian: Randomizirana študija III. faze MONARCH 3: Zdravilo Verzenios v kombinaciji z zaviralci aromataze
English: Tel: +371 67364000
Slovenian: Tel. št.: +371 67364000
English: Patients receiving abemaciclib should not breast-feed.
Slovenian: Bolnice, ki prejemajo abemaciklib, ne smejo dojiti.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Management recommendations for increased aminotransferases
Slovenian: Priporočila za obvladovanje pri povečanih vrednostih aminotransferaz
English: Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600
Slovenian: Lilly Portugal Produtos Farmacêuticos, Lda Tel. št.: + 351-21-4126600
English: Discontinue abemaciclib.
Slovenian: Prekinite zdravljenje z abemaciklibom.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene na seznamu referenčnih datumov EU (seznam EURD), opredeljenem v členu 107c(7)
English: Venous thromboembolic events were reported in 5.3% of patients treated with abemaciclib plus fulvestrant or aromatase inhibitors, compared to 0.8% of patients treated with placebo plus fulvestrant or aromatase inhibitors.
Slovenian: O venskih trombembolijah so poročali pri 5,3 % bolnic, zdravljenih z abemaciklibom in fulvestrantom ali zaviralci aromataz, v primerjavi z 0,8 % bolnic, zdravljenih s placebom in fulvestrantom ali zaviralci aromataz.
English: Charles de Giorgio Ltd. Tel: + 356 25600 500
Slovenian: Charles de Giorgio Ltd. Tel. št.: + 356 25600 500
English: Abemaciclib prevents retinoblastoma protein (Rb) phosphorylation, blocking cell cycle progression from the G1 to the S-phase of cell division, leading to suppression of tumour growth.
Slovenian: Abemaciklib preprečuje fosforilacijo proteina retinoblastoma (Rb) in zavira napredovanje celičnega cikla iz faze G1 v fazo S celične delitve, kar pripelje do supresije rasti tumorja.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom,
English: If strong CYP3A4 inhibitors cannot be avoided, the abemaciclib dose should be reduced to 100 mg twice daily.
Slovenian: Če se uporabi močnih zaviralcev CYP3A4 ni mogoče izogniti, je treba odmerek abemacikliba znižati na 100 mg dvakrat na dan.
English: Abemaciclib has been shown to increase serum creatinine due to inhibition of renal tubular secretion transporters without affecting glomerular function (as measured by iohexol clearance) (see section 4.5).
Slovenian: Pokazali so, da abemaciklib poviša vrednost kreatinina v serumu zaradi zaviranja prenašalcev pri ledvični tubulni sekreciji, ne da bi pri tem prizadel glomerulno funkcijo (izmerjeno z očistkom ioheksola) (glejte poglavje 4.5).
English: 14 film-coated tablets 168 film-coated tablets 28 x 1 film-coated tablets 28 film-coated tablets 56 film-coated tablets 42 film-coated tablets 70 film-coated tablets
Slovenian: 14 filmsko obloženih tablet 168 filmsko obloženih tablet 28 x 1 filmsko obložena tableta 28 filmsko obloženih tablet 56 filmsko obloženih tablet 42 filmsko obloženih tablet 70 filmsko obloženih tablet
English: Tel: +48 22 440 33 00
Slovenian: Tel. št.: +48 22 440 33 00