FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Empliciti (which may affect more than 1 in 10 people) are headache, tiredness, fever, diarrhoea, sore throat, nose and throat infections, cough, pneumonia (lung infection), low levels of white blood cells and weight loss.
Slovenian: Najpogostejši neželeni učinki zdravila Empliciti (ki se lahko pojavijo pri več kot 1 bolniku od 10) so glavobol, utrujenost, povišana telesna temperatura, driska, vnetje žrela, okužbe nosu in žrela, kašelj, pljučnica (pljučna okužba), nizke ravni belih krvnih celic in zmanjšanje telesne mase.
English: Elotuzumab also attaches to SLAMF7 on the cancer cells, making them more vulnerable to attack by the immune cells.
Slovenian: Elotuzumab se veže tudi na SLAMF7 na rakavih celicah, ki tako postanejo bolj ranljive za napad imunskih celic.
English: For more information about using Empliciti, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Empliciti glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: In addition, the cancer cleared partially or completely in 79% of patients treated with the Empliciti combination compared with 66% of patients treated with the other two medicines.
Slovenian: Poleg tega je bil rak delno ali v celoti odpravljen pri 79 % bolnikov, zdravljenih z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom, v primerjavi s 66 % bolnikov, ki so bili zdravljeni z drugima dvema zdraviloma.
English: A second main study involved 117 multiple myeloma patients who had received at least two other treatments previously, including a proteasome inhibitor and lenalidomide.
Slovenian: V drugo glavno študijo je bilo vključenih 117 bolnikov z multiplim mielomom, ki so predhodno prejeli vsaj dve drugi zdravljenji, vključno z zaviralci proteazoma in lenalidomidom.
English: The active substance in Empliciti, elotuzumab, is a monoclonal antibody that attaches to SLAMF7, a protein on immune cells, causing the cells to attack the multiple myeloma cancer cells and thereby slow down the disease.
Slovenian: Učinkovina v zdravilu Empliciti, elotuzumab, je monoklonsko protitelo, ki se veže na SLAMF7, tj. beljakovino na površini imunskih celic, kar povzroči, da celice začnejo napadati rakave celice multiplega mieloma in tako upočasnijo napredovanje bolezni.
English: Adding Empliciti to lenalidomide and dexamethasone can delay the worsening of multiple myeloma and improve clearance of the cancer in patients whose disease did not improve with previous treatment or whose disease came back.
Slovenian: Dodajanje zdravila Empliciti k lenalidomidu in deksametazonu lahko upočasni slabšanje stanja multiplega mieloma in izboljša možnosti za odstranitev raka pri bolnikih, pri katerih se bolezen s prejšnjim zdravljenjem ni izboljšala ali se je ponovila.
English: To prevent infusion reactions, the patient is given an anti-inflammatory medicine, an antihistamine and paracetamol before every infusion.
Slovenian: Bolnik mora za preprečitev reakcij na infundiranje pred vsakim dajanjem zdravila prejeti protivnetno zdravilo, antihistaminik in paracetamol.
English: How is Empliciti used?
Slovenian: Kako se zdravilo Empliciti uporablja?
English: For the full list of side effects and restrictions of Empliciti, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Empliciti glejte navodilo za uporabo.
English: All patients had previously received other treatments but the treatments had not worked or the cancer had come back.
Slovenian: Vsi bolniki so pred tem že bili zdravljeni, vendar brez uspeha oziroma se je bolezen ponovila.
English: Treatment must be started and supervised by a doctor experienced in treating multiple myeloma, and the medicine can only be obtained with a prescription.
Slovenian: Zdravljenje mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem multiplega mieloma.
English: In patients who had already been treated with at least two treatments including a proteasome inhibitor and lenalidomide (and the treatment had not worked or the disease had come back), Empliciti plus pomalidomide and dexamethasone delayed worsening of the disease, compared with just pomalidomide and dexamethasone.
Slovenian: Pri bolnikih, ki so že bili zdravljeni z vsaj dvema drugima zdraviloma, vključno z zaviralcem proteazoma in lenalidomidom (vendar zdravljenje ni bilo uspešno ali pa se je bolezen ponovila), je zdravilo Empliciti v kombinaciji s pomalidomidom in deksametazonom podaljšalo čas do poslabšanja bolezni v primerjavi z zdravljenjem samo s pomalidomidom in deksametazonom.
English: Patients treated with a combination of Empliciti plus pomalidomide and dexamethasone lived on average for over 5.5 months longer without their disease getting worse compared with patients treated with pomalidomide and dexamethasone.
Slovenian: Bolniki, ki so se zdravili s kombinacijo zdravila Empliciti ter pomalidomida in deksametazona, so v povprečju živeli več kot 5,5 meseca dlje brez poslabšanja bolezni v primerjavi z bolniki, ki so se zdravili s pomalidomidom in deksametazonom.
English: In a main study of 646 multiple myeloma patients a combination of Empliciti plus lenalidomide and dexamethasone was compared with only lenalidomide and dexamethasone.
Slovenian: V glavni študiji s 646 bolniki z multiplim mielomom so zdravilo Empliciti v kombinaciji z lenalidomidom in deksametazonom primerjali s kombinacijo lenalidomida in deksametazona.
English: It is used together with two other medicines (lenalidomide and dexamethasone) and is given to adults who have received at least one previous cancer treatment.
Slovenian: Uporablja se v kombinaciji z dvema drugima zdraviloma (lenalidomidom in deksametazonom) pri odraslih bolnikih, ki so pred tem že prejemali vsaj eno drugo zdravilo za zdravljenje raka.
English: The average time before the disease got worse was 18.5 months in patients treated with the Empliciti combination compared with 14.3 months in those treated with just lenalidomide and dexamethasone.
Slovenian: Povprečni čas do poslabšanja bolezni je bil 18,5 meseca pri bolnikih, zdravljenih z zdravilom Empliciti v kombinaciji z lenalidomidom in deksametazonom, v primerjavi s 14,3 meseca pri bolnikih, zdravljenih samo z lenalidomidom in deksametazonom.
English: Patients' previous treatment should have included the multiple myeloma medicines lenalidomide and a class of medicines called proteasome inhibitors (e.g. bortezomib, carfilzomib and ixazomib).
Slovenian: Predhodno zdravljenje mora vključevati zdravilo lenalidomid in enega od zdravil iz razreda zaviralcev proteazoma (npr. bortezomib, karfilzomib in iksazomib), ki se uporabljajo za zdravljenje multiplega mieloma.
English: The patient is also given other cancer medicines (dexamethasone with either lenalidomide or pomalidomide) during each cycle.
Slovenian: Bolnik v vsakem ciklu zdravljenja prejme tudi druga zdravila za zdravljenje raka (deksametazon v kombinaciji z lenalidomidom ali pomalidomidom).
English: Empliciti is given as an infusion (drip) into a vein.
Slovenian: Zdravilo Empliciti se daje z infundiranjem (kapalno infuzijo) v veno.
English: Empliciti is also used together with the medicines pomalidomide and dexamethasone to treat multiple myeloma that was previously treated with at least two other treatments but the cancer had come back.
Slovenian: Zdravilo Empliciti se uporablja tudi v kombinaciji s pomalidomidom in deksametazonom za zdravljenje multiplega mieloma, ki je bil predhodno že zdravljen z vsaj dvema drugima zdraviloma, vendar se je rak ponovil.
English: Empliciti is a medicine for treating multiple myeloma (a cancer of the bone marrow).
Slovenian: Empliciti je zdravilo za zdravljenje multiplega mieloma (raka kostnega mozga).
English: Empliciti contains the active substance elotuzumab.
Slovenian: Zdravilo Empliciti vsebuje učinkovino elotuzumab.
English: How does Empliciti work?
Slovenian: Kako zdravilo Empliciti deluje?
English: If you see more than one drop:
Slovenian: Če vidite več kot eno kapljo:
English: What do the arrows mean?
Slovenian: Kaj pomenijo puščice?
English: This is normal.
Slovenian: To je običajno.
English: If it is not, do not use.
Slovenian: Če ni, je ne uporabite.
English: Date of first authorisation: 20 November 2006 Date of latest renewal: 22 July 2016
Slovenian: Datum prve odobritve: 20. november 2006 Datum zadnjega podaljšanja: 22. julij 2016
English: • unusual taste in the mouth
Slovenian: • nenavaden okus v ustih
English: The injection is complete when:
Slovenian: Injiciranje je končano, ko:
English: • No.
Slovenian: • Ne.
English: • loss of energy and strength
Slovenian: • izguba energije in moči
English: The arrows mean you are ready for the next step.
Slovenian: Puščice pomenijo, da ste pripravljeni za naslednji korak.
English: It is not known if this medicine may harm your unborn child.
Slovenian: Ni znano ali lahko to zdravilo škoduje vašemu nerojenemu otroku.
English: Continue to follow your food and exercise plan.
Slovenian: Nadaljujte s sledenjem vašega načrta prehranjevanja in telesne vadbe.
English: It will not harm you or affect your dose.
Slovenian: Ne bo vam škodoval ali vplival na vaš odmerek.
English: Twice daily
Slovenian: dvakrat dnevno
English: Replace the needle and repeat the step above.
Slovenian: Zamenjajte iglo in ponovite zgornji korak.
English: Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines).
Slovenian: Prosimo, imejte to možno težavo v mislih v vseh situacijah, v katerih lahko sebe ali druge izpostavite tveganju (npr. vožnja avtomobila ali uporaba strojev).
English: GETTING STARTED
Slovenian: KAKO ZAČETI
English: Then, move on to section 2 - getting started.
Slovenian: Nato nadaljujte s poglavjem 2 - kako začeti.
English: Do not give this medicine to children and adolescents less than 18 years as there is no experience with this medicine in this age group.
Slovenian: Tega zdravila ne dajajte otrokom in mladostnikom, mlajšim od 18 let, ker z uporabo tega zdravila v tej starostni skupini ni izkušenj.
English: A small drop of liquid may appear.
Slovenian: Lahko se pojavi majhna kaplja tekočine.
English: - How to inject this medicine.
Slovenian: - Kako si injicirati to zdravilo.
English: • You may not have received your full dose.
Slovenian: • Morda niste prejeli vašega celotnega odmerka.
English: Do not inject another dose.
Slovenian: Ne injicirajte si še enega odmerka.
English: Do not change your dose unless your doctor has told you to.
Slovenian: Vašega odmerka ne spreminjajte, razen če vam je to predpisal vaš zdravnik.
English: You should see your doctor immediately if you experience symptoms such as
Slovenian: Takoj se obrnite na svojega zdravnika, če imate simptome kot so
English: • Wash hands prior to use.
Slovenian: • Pred uporabo si umijte roke.
English: (See section 3 “How to use Byetta”).
Slovenian: (Glejte poglavje 3 “Kako uporabljati zdravilo Byetta”).
English: How do I throw away my needles?
Slovenian: Kako naj zavržem moje igle?
English: Lipid profiles should be monitored regularly.
Slovenian: Redno moramo nadzorovati profile maščob.
English: • You are now ready for your first dose of Byetta.
Slovenian: • Sedaj ste pripravljeni za vaš prvi odmerek zdravila Byetta.
English: Spontaneous reports data (unknown denominator)
Slovenian: Spontano prijavljeni podatki (neznan imenovalec).
English: COMMONLY ASKED QUESTIONS
Slovenian: POGOSTA VPRAŠANJA
English: Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare Ireland
Slovenian: Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare Irska
English: These reductions in HbA1c were generally observed at 12 weeks after initiation of treatment.
Slovenian: Ta zmanjšanja HbA1c so navadno opazili 12 tednov po začetku zdravljenja.
English: How can I tell when the injection is complete?
Slovenian: Kako vem, kdaj je injiciranje končano?
English: The mean age of subjects was 59 years and the mean duration of diabetes was 12.3 years.
Slovenian: Srednja starost je bila 59 let in srednje trajanje diabetesa 12,3 let.
English: These instructions do not take the place of talking with your healthcare professional about your medical condition or your treatment.
Slovenian: Ta navodila ne nadomeščajo odgovorov zdravstvenega delavca glede vašega zdravstvenega stanja ali vašega zdravljenja.
English: Use this medicine at any time within the 60 minutes (1 hour) before your meal.
Slovenian: To zdravilo uporabite kadarkoli v roku 60 minut (1 ure) pred vašim obrokom.
English: You may remove them with an alcohol wipe or alcohol swab.
Slovenian: Odstranite jih lahko z alkoholnim robčkom ali alkoholno krpico.
English: • This pen is not recommended for use by people who are blind or who cannot see well enough.
Slovenian: • Tega injekcijskega peresnika ne priporočamo uporabljati slepim ali osebam, ki ne vidijo dovolj dobro.
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: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Consult with your healthcare professional about how to handle a partial dose.
Slovenian: Posvetujte se s svojim zdravstvenim delavcem, kako ravnati v primeru delnega odmerka.
English: Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis.
Slovenian: Uporabo agonistov receptorjev GLP-1 povezujejo s tveganjem za razvoj akutnega pankreatitisa.
English: Also contains metacresol.
Slovenian: Vsebuje tudi metakrezol.
English: If you stop using this medicine this can affect your blood sugar levels.
Slovenian: Če prenehate uporabljati to zdravilo, lahko to vpliva na vašo raven sladkorja v krvi.
English: Hypoglycaemia may reduce your ability to concentrate.
Slovenian: Hipoglikemija lahko zmanjša vašo sposobnost za koncentracijo.
English: Animal studies did not indicate direct harmful effects with respect to fertility or pregnancy.
Slovenian: Študije na živalih niso pokazale neposrednih škodljivih učinkov glede plodnosti ali nosečnosti.
English: Read and follow the directions in this section only after you've read section 1-what you need to know about your Byetta pen.
Slovenian: Preberite in sledite navodilom v tem poglavju šele potem, ko ste prebrali poglavje 1 - kaj morate vedeti o vašem injekcijskem peresniku Byetta.
English: • Hives and difficulties to breathe
Slovenian: • izpuščaj in težave z dihanjem
English: • increased sweating
Slovenian: • povečano znojenje
English: An additional 6% of patients had higher titre antibodies at 30 weeks.
Slovenian: Dodatnih 6 % bolnikov je po 30 tednih imelo višje titre protiteles.
English: These arrows show the direction to pull or turn the dose knob in the next step.
Slovenian: Te puščice kažejo smer za izvlečenje ali obračanje gumba za odmerjanje v naslednjem koraku.
English: Exenatide should not be used during pregnancy and the use of insulin is recommended.
Slovenian: Eksenatida ne smemo uporabljati med nosečnostjo in priporoča se uporaba insulina.
English: There are no adequate data from the use of exenatide in pregnant women.
Slovenian: O uporabi eksenatida pri nosečih ženskah nimamo ustreznih podatkov.
English: What if I cannot pull, turn, or push the dose knob?
Slovenian: Kaj naj storim, če ne morem izvleči, obračati ali pritisniti gumba za odmerjanje?
English: The safety and efficacy of exenatide in children and adolescents under 18 years of age have not been established (see section 5.2).
Slovenian: Varnosti in učinkovitosti eksenatida pri otrocih in mladostnikih, mlajših od 18 let, niso ugotovili (glejte poglavje 5.2).
English: In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: • nausea, (nausea is most common when first starting this medicine, but decreases over time in most patients)
Slovenian: • slabost (slabost je najpogostejša, ko prvič začnete s tem zdravilom, vendar pri večini bolnikov s časom mine)
English: Frequencies are defined as: 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: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do  1/10), občasni ( 1/1.000 do < 1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neznana pogostnost (ni mogoče oceniti na podlagi razpoložljivih podatkov).
English: AstraZeneca UK Limited Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA United Kingdom
Slovenian: AstraZeneca UK Limited Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA Velika Britanija
English: Note: This needs to be done after each injection
Slovenian: Opomba: To je treba narediti po vsakem injiciranju.
English: In the event of overdose, appropriate supportive treatment (possibly given parenterally) should be initiated according to the patient's clinical signs and symptoms.
Slovenian: V primeru prevelikega odmerjanja je potrebno začeti z ustreznim podpornim zdravljenjem (če je mogoče, danim parenteralno) glede na bolnikove klinične znake in simptome.
English: • A small air bubble is normal.
Slovenian: • Majhen zračni mehurček je običajen.
English: No clinically relevant effects on Cmax or AUC were observed.
Slovenian: Klinično pomembnih učinkov na Cmax ali AUC niso opazili.
English: In most patients who develop antibodies, antibody titres diminish over time and remain low through 82 weeks.
Slovenian: Pri večini bolnikov, ki razvijejo protitelesa, se titri protiteles s časom zmanjšajo in ostanejo nizki v obdobju 82 tednov.
English: The clinical experience in patients > 75 years is very limited.
Slovenian: Klinične izkušnje pri bolnikih > 75 let so zelo omejene.
English: It should be injected under the skin and not into a vein or into the muscle.
Slovenian: Injicirajte si ga pod kožo in ne v veno ali v mišico.
English: When the pen is empty, you cannot use it again.
Slovenian: Ko je injekcijski peresnik prazen, ga ne morete ponovno uporabiti.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije pri živalih so pokazale reproduktivno toksičnost (glejte poglavje 5.3).
English: Do not use an extra dose or increase the amount of your next dose to make up for the one you missed.
Slovenian: Ne uporabite dodatnega odmerka in ne povečajte količine vašega naslednjega odmerka, da bi nadomestili odmerek, ki ste ga izpustili.
English: In addition some other side effects have been reported (frequency not known, cannot be estimated from the available data).
Slovenian: Dodatno so poročali tudi o nekaterih drugih neželenih učinkih (pogostnost ni znana in je ni mogoče oceniti na podlagi razpoložljivih podatkov):
English: Why are there air bubbles in the cartridge?
Slovenian: Zakaj so v vložku zračni mehurčki?
English: − Some antibiotics may need to be taken an hour before your Byetta injection.
Slovenian: - nekatere antibiotike bo morda treba vzeti eno uro pred injiciranjem zdravila Byetta.
English: Your doctor should tell you how to treat low blood sugar.
Slovenian: Vaš zdravnik naj vam pove, kako zdraviti nizek sladkor v krvi.
English: Now that you have done the New Pen Setup, follow Section 3 for all of your injections.
Slovenian: Sedaj ko ste zaključili pripravo novega injekcijskega peresnika, sledite Poglavju 3 za vse vaše nadaljnje injekcije.
English: Changes in LDL-C or total cholesterol are possible, however, no predetermined dose adjustment is required.
Slovenian: Spremembe v LDL-C ali skupnem holesterolu so možne, vendar vnaprejšnja prilagoditev odmerka ni potrebna.
English: Exenatide is not a substitute for insulin.
Slovenian: Eksenatid ni nadomestilo za insulin.
English: Do not use this medicine after your meal.
Slovenian: Ne uporabite tega zdravila po vašem obroku.
English: If you are using Byetta and an insulin you must make two separate injections.
Slovenian: Če uporabljate zdravilo Byetta in insulin, morate pripraviti dve ločeni injekciji.
English: Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.
Slovenian: Bolnike je potrebno obvestiti o značilnih simptomih akutnega pankreatitisa: vztrajni, hudi bolečini v trebuhu.
English: With continued therapy, the frequency and severity decreased in most patients who initially experienced nausea.
Slovenian: Z nadaljevanjem zdravljenja sta se pogostnost in resnost zmanjšali pri večini bolnikov, ki so na začetku občutili navzeo.
English: • The needle may be clogged, bent, or incorrectly attached.
Slovenian: • Igla je morda zamašena, zvita ali nepravilno pritrjena.
English: If you feel you should stop using this medicine, consult your doctor first.
Slovenian: Če menite, da bi prenehali uporabljati to zdravilo, se o tem najprej posvetujte s svojim zdravnikom.
English: Beta-cell function
Slovenian: Delovanje beta celic
English: - If you have type 1 diabetes or diabetic ketoacidosis (a dangerous condition that can occur in diabetes), as you should not use this medicine.
Slovenian: - Če imate sladkorno bolezen tipa 1 ali diabetično ketoacidozo (nevarno bolezensko stanje, ki se lahko pojavi pri sladkorni bolezni), ker ne smete uporabiti tega zdravila.
English: Instructions for use Byetta is for use by one person only.
Slovenian: Zdravilo Byetta je za uporabo le za eno osebo.
English: - If you are allergic to exenatide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - Če ste alergični na eksenatid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • New Pen Setup is now done.
Slovenian: • Priprava novega peresnika je sedaj zaključena.
English: This medicine may reduce your appetite, the amount of food you eat, and your weight.
Slovenian: To zdravilo lahko zmanjša vaš apetit, količino zaužite hrane in vašo telesno maso.
English: Patients receiving medicinal products of either a narrow therapeutic ratio or medicinal products that require careful clinical monitoring should be followed closely.
Slovenian: Bolnike, ki dobivajo zdravila z ozkim terapevtskim razmerjem ali zdravila, ki zahtevajo skrben klinični nadzor, moramo skrbno spremljati.
English: For this group, the level of glycaemic control (HbA1c) was generally comparable to that observed in those without antibody titres.
Slovenian: Za to skupino je bila stopnja glikemičnega nadzora (HbA1c) na splošno primerljiva s stopnjo, opazovano pri tistih brez titrov protiteles.
English: If you use more of this medicine than you should, talk to a doctor or go to a hospital right away.
Slovenian: Če ste uporabili večji odmerek tega zdravila, kot bi smeli, se takoj posvetujte z zdravnikom ali odidite v bolnišnico.
English: Table 2: Combined results of the 30-week placebo-controlled studies (intent to treat patients)
Slovenian: Preglednica 2: Kombinirani rezultati 30 tedenskih, s placebom nadzorovanih študij (na zdravljenje pripravljeni bolniki)
English: If is in the dose window:
Slovenian: Če je v okencu za odmerjanje :
English: Gender and race Gender and race have no clinically relevant influence on exenatide pharmacokinetics.
Slovenian: Spol in rasa Spol in rasa nimata klinično značilnega vpliva na farmakokinetiko eksenatida.
English: These medical conditions can increase your chance of getting pancreatitis, or getting it again, whether or not you are taking this medicine.
Slovenian: Te motnje namreč povečujejo možnost, da dobite (ali znova dobite) pankreatitis, ne glede na to, ali uporabljate to zdravilo ali ne.