FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric patients who start on 0.25 mg capsules and subsequently reach a stable body weight above 40 kg should be switched to 0.5 mg capsules.
Slovenian: Pediatrični bolniki, ki začnejo odmerjanje z 0,25-miligramskimi kapsulami in kasneje dosežejo stabilno telesno maso, ki presega 40 kg, naj preidejo na jemanje 0,5-miligramskih kapsul.
English: Due to risk to the foetus, fingolimod is contraindicated during pregnancy and in women of childbearing potential not using effective contraception.
Slovenian: Zaradi tveganja za plod je uporaba fingolimoda kontraindicirana v času nosečnosti in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: If myocardial ischaemia is suspected, it is recommended to seek advice from a cardiologist.
Slovenian: Če obstaja sum na ishemijo miokarda, se je treba posvetovati s kardiologom.
English: Although most patients did not require medical intervention, one patient on Gilenya 0.5 mg received isoprenaline for asymptomatic second-degree Mobitz I atrioventricular block.
Slovenian: Posebno zdravljenje pri večini bolnikov sicer ni bilo potrebno, en bolnik, ki je prejel zdravilo Gilenya 0,5 mg, pa je zaradi asimptomatskega atrioventrikularnega bloka druge stopnje tipa Mobitz I prejel izoprenalin.
English: Caution should also be exercised when switching patients from long-acting therapies with immune effects such as natalizumab, teriflunomide or mitoxantrone (see section 4.4).
Slovenian: Prav tako je potrebna previdnost pri prehajanju bolnikov z dolgodelujočih zdravil, ki delujejo na imunski sistem, kot so natalizumab, teriflunomid ali mitoksantron (glejte poglavje 4.4).
English: What Gilenya is and what it is used for
Slovenian: Kaj je zdravilo Gilenya in za kaj ga uporabljamo
English: Co-administration of carbamazepine 600 mg twice daily at steady-state and a single dose of fingolimod 2 mg reduced the AUC of fingolimod and its metabolite by approximately 40%.
Slovenian: Pri odmerjanju karbamazepina 600 mg dvakrat na dan je v stanju dinamičnega ravnovesja ob sočasni uporabi enkratnega odmerka fingolimoda 2 mg prišlo do zmanjšanja AUC fingolimoda in njegovega metabolita za približno 40 %.
English: Pharmacokinetic interactions of other substances on fingolimod
Slovenian: Farmakokinetični vpliv drugih učinkovin na fingolimod
English: Co-administration of fingolimod with ketoconazole resulted in a 1.7-fold increase in fingolimod and fingolimod phosphate exposure (AUC) by inhibition of CYP4F2.
Slovenian: Pri sočasni uporabi fingolimoda in ketokonazola je prišlo do 1,7-kratnega povečanja izpostavljenosti fingolimodu in fingolimodijevemu fosfatu (AUC) zaradi zaviranja CYP4F2.
English: Additional PML cases have occurred in patients who had been treated previously with natalizumab, which has a known association with PML.
Slovenian: Primeri PML so se pojavljali tudi pri bolnikih, ki so se predhodno zdravili z natalizumabom, za katerega je znano, da je povezan s PML.
English: The symptoms of PML may be similar to an MS relapse.
Slovenian: Simptomi PML so lahko podobni kot pri zagonu multiple skleroze.
English: To open: While pressing tab 1 firmly, pull on tab 2.
Slovenian: Navodilo za odpiranje: močno pritisnite na zavihek 1 in hkrati povlecite za zavihek 2.
English: Peripheral lymphocyte count increases are evident within days of stopping fingolimod treatment and typically normal counts are reached within one to two months.
Slovenian: V nekaj dneh po prekinitvi zdravljenja s fingolimodom se pokaže zvišanje števila perifernih limfocitov, normalno število pa limfociti praviloma dosežejo v enem do dveh mesecih.
English: • Depression and anxiety are known to occur with increased frequency in the multiple sclerosis population and have been reported also in pediatric patients treated with GILENYA;
Slovenian: • znano je, da se depresija in tesnoba pogosteje pojavljata v populaciji bolnikov z multiplo sklerozo, o njiju so poročali tudi pri pediatričnih bolnikih, ki so prejemali zdravilo GILENYA;
English: Gilenya 0.25 mg capsules are available in packs containing 7 or 28 capsules.
Slovenian: 0,25-miligramske kapsule zdravila Gilenya so na voljo v pakiranjih, ki vsebujejo 7 ali 28 kapsul.
English: Drug exposure in rats at this dose was similar to that in patients at the therapeutic dose (0.5 mg).
Slovenian: Pri takem odmerjanju je bila izpostavljenost zdravilu pri podganah približno tolikšna kot pri bolnikih, ki prejemajo terapevtski odmerek (0,5 mg).
English: When fingolimod was used with atenolol in an interaction study in healthy volunteers, there was an additional 15% reduction of heart rate at fingolimod treatment initiation, an effect not seen with diltiazem.
Slovenian: Pri uporabi fingolimoda z atenololom je v študiji medsebojnega delovanja pri zdravih prostovoljcih na začetku zdravljenja s fingolimodom prišlo do znižanja srčne frekvence za dodatnih 15 %, medtem ko z diltiazemom do tega ne pride.
English: Respiratory effects
Slovenian: Vpliv na dihanje
English: The teratogenic potential in rabbits could not be fully assessed, however an increased embryo-foetal mortality was seen at doses of 1.5 mg/kg and higher, and a decrease in viable foetuses as well as foetal growth retardation was seen at 5 mg/kg.
Slovenian: Pri kuncih niso mogli v celoti oceniti teratogenega potenciala, vendar so pri odmerkih 1,5 mg/kg in več opažali večjo embriofetalno umrljivost, pri odmerkih 5 mg/kg pa zmanjšano število za življenje sposobnih plodov in zastoj rasti pri plodu.
English: Autonomic responses of the heart, including diurnal variation of heart rate and response to exercise are not affected by fingolimod treatment.
Slovenian: Tudi na odziv srca na avtonomno živčevje, vključno z dnevnim nihanjem srčne frekvence in z odzivom na obremenitev, zdravljenje s fingolimodom ne vpliva.
English: In particular, the following should be noted when prescribing Gilenya to paediatric patients: - Precautions should be followed at the time of the first dose (see “Bradyarrhythmia” above).
Slovenian: Pri predpisovanju zdravila Gilenya pediatričnim bolnikom je treba zlasti paziti na naslednje: - Pri prejemu prvega odmerka je treba upoštevati previdnostne ukrepe (glejte zgoraj pod naslovom “Bradiaritmija”).
English: If you have to restart Gilenya more than 2 weeks after you stop taking it, the effect on heart rate normally seen when treatment is first started may re-occur and you will need to be monitored at the doctor's surgery or clinic for re-initiation of treatment.
Slovenian: Če morate zdravilo Gilenya ponovno začeti jemati več kot 2 tedna po tem, ko ste z jemanjem prekinili, lahko ponovno pride do učinka na hitrost bitja srca, ki ga običajno opažamo po prvi uvedbi zdravila, zato vas bodo v zdravnikovi ordinaciji ali v bolnišnici ob ponovni uvedbi zdravljenja morali spet opazovati.
English: Uncommon (may affect up to 1 in 100 people): - Low level of certain white blood cells (neutrophils) - Depressed mood - Nausea
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 ljudi): - znižano število določenih krvnih celic (nevtrofilcev), - depresivno razpoloženje, - občutek siljenja na bruhanje.
English: Fingolimod is eliminated by oxidative biotransformation catalysed mainly via CYP4F2 and possibly other isoenzymes and subsequent fatty acid-like degradation to inactive metabolites.
Slovenian: Fingolimod se izloča z oksidativno biotransformacijo, ki jo katalizira pretežno izoencim CYP4F2 in verjetno ostali izoencimi, nato pa z degradacijo kot pri maščobnih kislinah na neaktivne metabolite.
English: Fingolimod was neither mutagenic nor clastogenic in animal studies.
Slovenian: V študijah na živalih ni bil fingolimod niti mutagen niti klastogen.
English: If this risk is suspected, discontinuation of treatment should be considered by the physician on a case-bycase basis (see also section 4.4 “Infections” and “Cutaneous neoplasms” and section 4.8 “Lymphomas”).
Slovenian: Pri sumu na takšno tveganje je treba pri vsakem bolniku posebej pretehtati možnost prekinitve zdravljenja (glejte tudi “Okužbe” in “Kožni tumorji” v poglavju 4.4 in poglavje 4.8 “Limfomi”).
English: What Gilenya is and what it is used for What you need to know before you take Gilenya How to take Gilenya
Slovenian: Kaj je zdravilo Gilenya in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Gilenya Kako jemati zdravilo Gilenya Možni neželeni učinki
English: Continuous (real time) ECG monitoring during this 6 hour period is recommended.
Slovenian: V navedenem 6-urnem obdobju je priporočeno neprekinjeno spremljanje EKG (v realnem času).
English: In a thorough QT interval study of doses of 1.25 or 2.5 mg fingolimod at steady-state, when a negative chronotropic effect of fingolimod was still present, fingolimod treatment resulted in a prolongation of QTcI, with the upper limit of the 90% CI ≤13.0 ms.
Slovenian: V podrobni študiji intervala QT z odmerki 1,25 oziroma 2,5 mg fingolimoda je v stacionarnem stanju v času, ko je bil še vedno prisoten negativni kronotropni učinek zdravila, zdravljenje s fingolimodom povzročilo podaljšanje intervala QTcI (individualno korigiranega intervala QT) z zgornjo mejo 90odstotnega intervala zaupanja ≤13,0 ms.
English: Children and adolescents who start on one 0.25 mg capsule per day and later reach a stable body weight above 40 kg will be instructed by their doctor to switch to one 0.5 mg capsule per day.
Slovenian: Otrokom in mladostnikom, ki začnejo odmerjanje z eno 0,25-miligramsko kapsulo na dan in kasneje dosežejo stabilno telesno maso nad 40 kg, bo zdravnik naročil, naj preidejo na jemanje ene 0,5-miligramske kapsule na dan.
English: In adults, the recommended dose of Gilenya is one 0.5 mg capsule taken orally once daily.
Slovenian: Pri odraslih je priporočeni odmerek zdravila Gilenya ena 0,5-miligramska kapsula, ki jo bolnik vzame peroralno enkrat na dan.
English: If the overdose constitutes first exposure to Gilenya, it is important to monitor patients with a continuous (real time) ECG and hourly measurement of heart rate and blood pressure, at least during the first 6 hours (see section 4.4).
Slovenian: Če do prevelikega odmerjanja pride pri prvi izpostavljenosti zdravilu Gilenya, je pomembno bolniku najmanj prvih 6 ur po odmerjanju neprekinjeno spremljati EKG (v realnem času) in vsako uro meriti srčno frekvenco in krvni tlak (glejte poglavje 4.4).
English: When switching from a 0.25 mg to a 0.5 mg daily dose, it is recommended to repeat the same first dose monitoring as for treatment initiation.
Slovenian: Pri prehodu z odmerjanja 0,25 mg na 0,5 mg dnevno je ob prvem prejemu novega odmerka priporočljivo izvesti enak postopek spremljanja kot ob prvi uvedbi zdravljenja.
English: This could be serious (see “If you stop taking Gilenya” in section 3, and also section 4, “Possible side effects”).
Slovenian: Lahko gre za resno stanje (glejte poglavje 3 pod naslovom “Če ste prenehali jemati zdravilo Gilenya” in poglavje 4 pod naslovom “Možni neželeni učinki”).
English: o Vigilance for basal cell carcinoma and other cutaneous neoplasms including malignant melanoma, squamous cell carcinoma, Kaposi's sarcoma and Merkel cell carcinoma is recommended, with skin examination prior to treatment initiation and then every 6 to 12 months taking into consideration clinical judgement.
Slovenian: o Priporočeno je pozorno spremljanje bolnikov glede pojava bazalnoceličnega karcinoma ali drugih kožnih tumorjev, kar vključuje maligni melanom, ploščatocelični karcinom, Kaposijev sarkom in karcinom Merklovih celic, s pregledom kože pred začetkom zdravljenja in nato vsakih 6 do 12 mesecev glede na klinično presojo.
English: Patients should inform their doctor immediately if any skin nodules (e.g., shiny, pearly nodules), patches or open sores that do not heal within weeks are noted.
Slovenian: Bolniki morajo takoj obvestiti svojega zdravnika, če na koži opazijo vozličke (npr. s svetlečo, biserno površino), lise ali odprte ranice, ki se ne pozdravijo več tednov.
English: • Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone or sotalol.
Slovenian: • zdravila za nepravilen srčni ritem, kot so kinidin, dizopiramid, amiodaron ali sotalol.
English: In multiple sclerosis clinical studies the concomitant treatment of relapses with a short course of corticosteroids was not associated with an increased rate of infection.
Slovenian: V kliničnih študijah multiple skleroze sočasno kratkotrajno jemanje kortikosteroidov za zdravljenje zagonov ni bilo povezano s povečano pogostnostjo okužb.
English: The apparent elimination half-life of fingolimod is unchanged in subjects with mild hepatic impairment, but is prolonged by about 50% in patients with moderate or severe hepatic impairment.
Slovenian: Pri bolnikih z blago okvaro jeter ostane navidezni razpolovni čas izločanja nespremenjen, pri bolnikih z zmerno ali hudo okvaro jeter pa se podaljša za približno 50 %.
English: Vigilance for skin lesions is warranted and a medical evaluation of the skin is recommended at initiation, and then every 6 to 12 months taking into consideration clinical judgement.
Slovenian: Bolnike velja pozorno spremljati glede morebitnega razvoja kožnih sprememb, pregled kože pa je priporočen na začetku zdravljenja in nato vsakih 6 do 12 mesecev po klinični presoji.
English: In a small number of patients (N=10 on 1.25 mg, N=2 on 0.5 mg) who experienced ALT elevations ≥5x ULN and who continued on Gilenya therapy, the ALT levels returned to normal within approximately 5 months (see also section 4.4, Liver function).
Slovenian: Pri manjšem številu bolnikov (N=10 z odmerkom 1,25 mg, N=2 z odmerkom 0,5 mg), pri katerih je prišlo do zvišanja vrednosti alanin-aminotransferaze na ≥5x ZMN in ki so nadaljevali z jemanjem zdravila Gilenya, so se vrednosti alanin-aminotransferaze vrnile na normalne v približno 5 mesecih (glejte tudi poglavje 4.4 Jetrna funkcija).
English: If patients report visual disturbances at any time while on therapy, evaluation of the fundus, including the macula, should be carried out.
Slovenian: Če bolnik kadarkoli v času zdravljenja toži o motnjah vida, mu je treba pregledati očesno ozadje, vključno z makulo.
English: In the post-marketing setting, severe exacerbation of disease has been observed rarely in some patients stopping fingolimod.
Slovenian: V okviru uporabe zdravila po njegovem prihodu na trg so v redkih primerih opažali hudo poslabšanje bolezni pri nekaterih bolnikih, ki so prenehali uporabljati fingolimod.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for fingolimod, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za fingolimod je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Caution is needed in this subgroup due to very limited knowledge available from the clinical study.
Slovenian: Pri tej podskupini je potrebna previdnost, ker je poznavanje uporabe zdravila na osnovi klinične študije zelo omejeno.
English: After stopping Gilenya you may have to wait for 6-8 weeks before starting a new MS treatment.
Slovenian: Po prenehanju jemanja zdravila Gilenya boste morali počakati 6-8 tednov, preden boste lahko začeli uporabljati novo zdravilo za multiplo sklerozo.
English: Your ability to drive and use machines may be impaired during and potentially after this time period.
Slovenian: V tem času in morda tudi kasneje je lahko vaša sposobnost za vožnjo in upravljanje s stroji zmanjšana.
English: Anti-neoplastic, immunomodulatory or immunosuppressive therapies
Slovenian: Antineoplastična, imunomodulatorna ali imunosupresivna zdravila
English: The treatment should be initiated and supervised by a physician experienced in multiple sclerosis.
Slovenian: Zdravljenje sme uvesti in nadzorovati samo zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.
English: If you experience any of these, tell your doctor straight away.
Slovenian: Če pride do česa od navedenega, takoj obvestite zdravnika.
English: Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms that reflect inflammation within the CNS.
Slovenian: Za recidivno-remitentno multiplo sklerozo so značilni ponavljajoči se napadi (zagoni) simptomov s strani centralnega živčevja, ki odražajo vnetje v centralnem živčevju.
English: Chronic fingolimod dosing leads to a mild decrease in the neutrophil count to approximately 80% of baseline.
Slovenian: Kronično odmerjanje fingolimoda povzroča blago znižanje števila nevtrofilcev na približno 80 % izhodiščne vrednosti.
English: The patient/parents/caregiver guide shall contain the following key messages:
Slovenian: Vodnik za bolnika/starše/skrbnika mora vsebovati naslednja ključna sporočila:
English: Gilenya should be used with caution in patients with severe respiratory disease, pulmonary fibrosis and chronic obstructive pulmonary disease (see also section 4.8).
Slovenian: Pri uporabi zdravila Gilenya pri bolnikih s hudo boleznijo dihal, s pljučno fibrozo ali s kronično obstruktivno pljučno boleznijo je potrebna previdnost (glejte tudi poglavje 4.8).
English: Physician's checklist The physician's checklist shall contain the following key messages:
Slovenian: Kontrolni seznam za zdravnika mora vsebovati naslednja ključna sporočila:
English: Multipack: 84 (3 packs of 28) hard capsules.
Slovenian: Skupno pakiranje: 84 (3 pakiranja po 28) trdih kapsul.
English: Lymphoma*** Squamous cell carcinoma****
Slovenian: limfom*** ploščatocelični karcinom****
English: Hepatic enzyme increased (increased ALT, Gamma glutamyltransferase, Aspartate transaminase)
Slovenian: zvišane vrednosti jetrnih encimov (zvišane vrednosti alanin-aminotransferaze, gama-glutamiltransferaze in aspartat-aminotransferaze)
English: If you are taking medicines that can cause your heart rate to decrease, Gilenya may not be appropriate for you.
Slovenian: Če jemljete zdravila, ki lahko povzročijo upočasnitev bitja srca, zdravilo Gilenya morda ni primerno za vas.
English: o Treatment initiation in patients with severe active infection should be delayed until the infection is resolved.
Slovenian: o Pri bolnikih s hudo aktivno okužbo je treba odložiti začetek zdravljenja do ozdravitve.
English: • One case with very suggestive chronology of the event with compatible outcome then dechallenge and re-challenge positive
Slovenian: • Pri enem primeru je povezavo močno nakazoval kronološki potek dogodka s skladnim izidom, ki sta mu sledila izboljšanje po prekinitvi zdravljenja (de-challenge) in poslabšanje po ponovni uvedbi zdravljenja (positive re-challenge).
English: Fingolimod treatment with single or multiple doses of 0.5 and 1.25 mg for two weeks is not associated with a detectable increase in airway resistance as measured by FEV1 and forced expiratory flow rate (FEF) 25-75.
Slovenian: Zdravljenje z enkratnimi ali večkratnimi odmerki 0,5 in 1,25 mg fingolimoda v dveh tednih ne povzroča merljivega povečanja upora v dihalnih poteh, izmerjenega s FEV1,in forsiranim ekspiratornim pretokom (FEF) 25-75.
English: A decision on whether or not Gilenya therapy should be re-initiated after resolution of macular oedema needs to take into account the potential benefits and risks for the individual patient.
Slovenian: Pri odločanju glede ponovne uvedbe zdravljenja z zdravilom Gilenya po izzvenetju makularnega edema je treba upoštevati možne koristi in tveganja za posameznega bolnika.
English: Macular oedema with or without visual symptoms has been reported in 0.5% of patients treated with fingolimod 0.5 mg, occurring predominantly in the first 3-4 months of therapy (see section 4.8).
Slovenian: Pri 0,5 % bolnikov, ki so jemali fingolimod 0,5 mg, so opisovali makularni edem s simptomi motenj vida ali brez njih, do česar je prišlo večinoma v prvih 3-4 mesecih zdravljenja (glejte poglavje 4.8).
English: Gilenya is used in adults and in children and adolescents (10 years of age and above) to treat relapsing-remitting multiple sclerosis (MS), more specifically in: - Patients who have failed to respond despite treatment with an MS treatment.
Slovenian: Zdravilo Gilenya uporabljamo za zdravljenje odraslih, otrok in mladostnikov (starih 10 let ali več), ki imajo recidivno-remitentno multiplo sklerozo, bolj natančno: - pri bolnikih, pri katerih ni prišlo do odziva kljub zdravljenju z zdravilom za multiplo sklerozo, oziroma - pri bolnikih s hitro razvijajočo se hudo multiplo sklerozo.
English: If you take more Gilenya than you should If you have taken too much Gilenya, call your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Gilenya, kot bi smeli Če ste vzeli preveč zdravila Gilenya, takoj obvestite zdravnika.
English: Anti-neoplastic, immunomodulatory or immunosuppressive therapies should not be co-administered due to the risk of additive immune system effects.
Slovenian: Antineoplastičnih, imunomodulatornih oziroma imunosupresivnih zdravil se ne sme odmerjati sočasno zaradi tveganja za aditivno delovanje na imunski sistem.
English: What Gilenya contains - The active substance is fingolimod.
Slovenian: Kaj vsebuje zdravilo Gilenya - Učinkovina je fingolimod.
English: • What GILENYA is and how it works;
Slovenian: • Pojasnilo, kaj je zdravilo GILENYA in kako deluje.
English: The most common foetal visceral malformations included persistent truncus arteriosus and ventricular septum defect.
Slovenian: Med najbolj pogostimi visceralnimi malformacijami ploda sta bila persistenten arteriozni trunkus in defekt interventrikularnega septuma.
English: Fingolimod is contraindicated in women of childbearing potential not using effective contraception (see section 4.3).
Slovenian: Uporaba fingolimoda je kontraindicirana pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije (glejte poglavje 4.3).
English: • Patients should have a baseline ECG and blood pressure measurement prior to receiving the first dose of GILENYA;
Slovenian: • Bolniku je treba posneti izhodiščni EKG in mu izmeriti krvni tlak pred prejemom prvega odmerka zdravila GILENYA.
English: Your doctor will decide to stop treatment (see “If you stop taking Gilenya” in section 3, and also section 4, “Possible side effects”).
Slovenian: Zdravnik bo določil, da prekinete zdravljenje (glejte poglavje 3 pod naslovom “Če ste prenehali jemati zdravilo Gilenya” in poglavje 4 pod naslovom “Možni neželeni učinki”).
English: Patients who completed the 24-month core FREEDOMS study could enter a dose-blinded extension study (D2301E1) and receive fingolimod.
Slovenian: Bolniki, ki so zaključili 24-mesečno osnovno študijo FREEDOMS, so lahko vstopili v podaljšanje študije (D2301E1) s slepim odmerjanjem (s prikrito višino odmerka), v katerem so prejemali fingolimod.
English: - There are very limited data available in children between 10-12 years old, less than 40 kg or at Tanner stage <2 (see sections 4.8 and 5.1).
Slovenian: - O uporabi zdravila pri otrocih, ki so stari od 10 do 12 let in imajo telesno maso manjšo od 40 kg ali oceno stopnje razvoja po Tannerju manj kot 2, je na voljo zelo malo podatkov (glejte poglavji 4.8 in 5.1).
English: - The first time you take Gilenya, or when you switch from a 0.25 mg daily dose to a 0.5 mg daily dose, your doctor will monitor your heart rate and heartbeat (see “Slow heart rate (bradycardia)
Slovenian: - Ko prvič prejmete zdravilo Gilenya oziroma ko preidete z odmerka 0,25 mg na dan na 0,5 mg na dan, mora zdravnik opazovati in meriti hitrost bitja srca in srčni utrip (glejte zgoraj “Počasno bitje srca (bradikardija) in nepravilno bitje srca”).
English: Should post-dose bradyarrhythmia-related symptoms occur, appropriate clinical management should be initiated and monitoring should be continued until the symptoms have resolved.
Slovenian: Če pride do simptomov bradiaritmije po odmerjanju, je treba začeti z ustreznim kliničnim zdravljenjem in bolnika spremljati, dokler simptomi ne izzvenijo.
English: Merkel cell carcinoma can also present as a firm painless nodule or mass.
Slovenian: Karcinom Merklovih celic je lahko tudi čvrst neboleč vozliček ali tvorba.
English: • Cardiac monitoring guidance;
Slovenian: • navodila za spremljanja delovanja srca;