FrancophonIA/ELRC3.0 huggingface dataset:
English: • Serious allergic reactions which may include:
Slovenian: • Resne alergijske reakcije, ki lahko vključujejo:
English: To give yourself an injection you will need:
Slovenian: Da si boste dali injekcijo, potrebujete:
English: Please discuss this with your doctor.
Slovenian: Prosimo, da se o tem posvetujete z zdravnikom.
English: A risk to the suckling child cannot be excluded.
Slovenian: Tveganja za dojenčka ne moremo izključiti.
English: In some cases, your doctor may recommend that you take iron supplements.
Slovenian: V nekaterih primerih vam zdravnik lahko svetuje jemanje dodatkov železa.
English: Equipment:
Slovenian: Oprema:
English: • think you may be pregnant; or
Slovenian: • mislite, da ste noseči; ali
English: 30 minutes
Slovenian: 30 minut
English: Do not administer more than one dose.
Slovenian: Ne aplicirajte več kot enega odmerka.
English: No alteration of fertility was detected.
Slovenian: Sprememb plodnosti niso odkrili.
English: The instructions for use, handling and disposal are given in section 6.6.
Slovenian: Navodila za uporabo, ravnanje z zdravilom in odlaganje so navedena v poglavju 6.6.
English: A reticulocyte count should be considered as part of the evaluation.
Slovenian: Določanje števila retikulocitov mora biti del ocenjevanja.
English: Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.
Slovenian: Redno vam bo preverjal tudi krvni tlak, še posebej na začetku zdravljenja.
English: If it is cloudy or there are particles in it, you must not use it.
Slovenian: Če je motna ali so v njej delci, je ne smete uporabiti.
English: Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect.
Slovenian: Ker telo za nastanek več rdečih krvnih celic potrebuje nekaj časa, bodo minili približno štirje tedni, preden boste opazili kakšen učinek.
English: • Allergic reactions
Slovenian: • alergijske reakcije
English: Guidance is given separately for adult and paediatric patients.
Slovenian: Smernice so navedene ločeno za odrasle in pediatrične bolnike.
English: Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of ESAs and should therefore be corrected.
Slovenian: Pomanjkanje železa, folne kisline ali vitamina B12 zmanjša učinkovitost ESA in jih je zato treba korigirati.
English: Placental transfer was minimal.
Slovenian: Prehajanje skozi placento je bilo minimalno.
English: 15 seconds
Slovenian: 15 sekund
English: It is important to tell your doctor if you:
Slovenian: Zdravniku morate povedati, če:
English: “click”
Slovenian: “klik”
English: - if you have been diagnosed with high blood pressure which is not being controlled with other medicines prescribed by your doctor.
Slovenian: - če imate ugotovljen visok krvni tlak in ta ni obvladan z drugimi zdravili, ki vam jih je predpisal zdravnik.
English: Correction phase:
Slovenian: Obdobje korekcije:
English: Important: Do not touch the red start button yet.
Slovenian: Pomembno: Ne dotikajte se še rdečega sprožilnega gumba.
English: Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose.
Slovenian: Pomembno: Ko boste napolnjeni injekcijski peresnik odmaknili od kože in če okence ni postalo rumeno, ali če izgleda, kot da se zdravilo še vedno injicira, to pomeni, da niste prejeli celotnega odmerka.
English: 2 Frequency cannot be estimated from the available data.
Slovenian: 2 Pogostnosti iz razpoložljivih podatkov ni mogoče oceniti.
English: Do not use Aranesp if you think it has been frozen.
Slovenian: Ne uporabite zdravila Aranesp, če mislite, da je bilo zamrznjeno.
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Slovenian: Epoetini niso odobreni za obvladovanje anemije, povezane s hepatitisom C.
English: Do not use Aranesp: - if you are allergic to darbepoetin alfa or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Aranesp: - če ste alergični na darbepoetin alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Poorly controlled hypertension.
Slovenian: Slabo urejena hipertenzija.
English: It is important to tell your doctor if you are taking either of these medicines.
Slovenian: Pomembno je, da zdravniku poveste, če jemljete katero od njiju.
English: J Keep pushing down on your skin.
Slovenian: J Še naprej pritiskajte ob kožo.
English: The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
Slovenian: Kancerogenega potenciala darbepoetina alfa niso ocenili v dolgoročnih študijah na živalih.
English: Important: Follow your healthcare provider's instructions about selecting sites for injection appropriate to you and about changing the site for each injection.
Slovenian: Pomembno: Upoštevajte navodila zdravstvenega delavca o izbiri mest za injiciranje, ki vam ustrezajo, in o spremembi mesta za vsako injiciranje.
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Slovenian: Tako kot pri vseh rastnih dejavnikih tudi pri epoetinih obstaja skrb, da bi lahko spodbudili rast tumorjev.
English: Dose increases must not be made more frequently than once every four weeks.
Slovenian: Odmerka ne smete povečati pogosteje kot enkrat na štiri tedne.
English: In preclinical studies it has been shown that renal clearance is minimal (up to 2% of total clearance), and does not affect the serum half-life.
Slovenian: Predklinične študije so pokazale, da je ledvični očistek minimalen (do 2 % celotnega očistka) in ne vpliva na razpolovni čas v serumu.
English: C Gather all the materials needed for your injection.
Slovenian: C Pripravite ves material, potreben za injiciranje.
English: Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
Slovenian: Kljub tem molekulskim spremembam darbepoetin alfa ohranja zelo ozko specifičnost za eritropoetinski receptor.
English: Amgen Manufacturing Limited PO Box 4060, Road 31 km 24.6 Juncos, PR 00777-4060
Slovenian: Amgen Manufacturing Limited PO Box 4060, Road 31 km 24.6 Juncos, PR 00777-4060 Portoriko
English: Depending on your individual situation a blood transfusion may be preferable.
Slovenian: Odvisno od vašega osebnega stanja je lahko primernejši ukrep transfuzija krvi.
English: Only use each syringe for one injection.
Slovenian: Vsako brizgo uporabite le za eno injiciranje.
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Slovenian: Receptorji za eritropoetin so lahko izraženi na površini različnih tumorskih celic.
English: If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective.
Slovenian: Če bolnikov klinični odziv (utrujenost, odziv hemoglobina) po devetih tednih ni zadosten, nadaljnje zdravljenje morda ne bo učinkovito.
English: Important: Needle is inside
Slovenian: Pomembno: Znotraj je igla.
English: • Alcohol wipes
Slovenian: • alkoholne zložence
English: The injections will be given by a healthcare professional.
Slovenian: Injekcije vam bo dal zdravstveni delavec.
English: • High blood pressure (hypertension)
Slovenian: • visok krvni tlak (hipertenzija)
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsaki spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki bi lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Before you inject Aranesp you must do the following:
Slovenian: Pred injiciranjem zdravila Aranesp, morate narediti naslednje:
English: Date of latest renewal: 19 May 2006
Slovenian: Datum prve odobritve: 8. junij 2001 Datum zadnjega podaljšanja: 19. maj 2006
English: Maintenance phase:
Slovenian: Obdobje vzdrževanja:
English: A systematic review has also been performed involving more than 9,000 cancer patients participating in 57 clinical trials.
Slovenian: Sistematično so pregledali tudi podatke o več kot 9.000 bolnikih z rakom, ki so sodelovali v 57 kliničnih preskušanjih.
English: It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
Slovenian: Normalno je, da se na koncu igle ali rumenega varnostnega ščitnika pokaže kapljica tekočine.
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Za razvrstitev pogostnosti je uporabljen naslednji dogovor: 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), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: For intravenous or subcutaneous use.
Slovenian: Za intravensko ali subkutano uporabo.
English: Important: You must push all the way down but do not touch the red start button until you are ready to inject.
Slovenian: Pomembno: Potisniti morate do konca dol, vendar se ne dotikajte rdečega sprožilnega gumba, dokler niste pripravljeni na injiciranje.
English: Treatment with Aranesp is divided into two stages, correction and maintenance phase.
Slovenian: Zdravljenje z zdravilom Aranesp delimo na dve obdobji - obdobje korekcije in obdobje vzdrževanja.
English: If you are pregnant or breast-feeding, 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 ali dojite, menite, da bi bili lahko noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: The primary efficacy endpoint [change in haemoglobin between baseline and the evaluation period (week 21-28)] was comparable between the two groups.
Slovenian: Primarni opazovani dogodek učinkovitosti [sprememba hemoglobina od izhodišča do obdobja ovrednotenja (21. do 28. teden)] je bil med skupinama primerljiv.
English: • Tell your doctor if you have an allergy to latex.
Slovenian: • Zdravniku morate povedati, če ste alergični na lateks.
English: I When you are ready to inject, pressthe red start button.
Slovenian: I Ko ste pripravljeni na injiciranje, pritisnite rdeči sprožilni gumb.
English: Bioavailability is 37% with subcutaneous administration.
Slovenian: Biološka uporabnost po subkutani uporabi je 37 %.
English: In the chronic toxicity studies no tumourigenic or unexpected mitogenic responses were observed in any tissue type.
Slovenian: V študijah kronične toksičnosti niso v nobeni vrsti tkiva opazili tumorigenosti ali nepričakovanega mitogenega odziva.
English: In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or stated) in the patient file.
Slovenian: Z namenom izboljšanja sledljivosti zdravil za stimulacijo eritropoeze (ESA) je treba v bolnikovi dokumentaciji jasno zabeležiti (ali navesti) trgovsko ime uporabljenega ESA.
English: • Shortness of breath (allergic bronchospasm)
Slovenian: • težko dihanje (alergijski bronhospazem)
English: There are no adequate and well-controlled studies with Aranesp in pregnant women.
Slovenian: Pri nosečnicah ni ustreznih in dobro kontroliranih študij z zdravilom Aranesp.
English: - If you are a cancer patient you should be aware that Aranesp may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Slovenian: - Če ste bolnik z rakom, morate vedeti, da lahko zdravilo Aranesp deluje kot rastni dejavnik za krvne celice in lahko v nekaterih okoliščinah neugodno vpliva na vašo bolezen.
English: • Outer area of upper arm (only if someone else is giving you the injection) Clean the injection site with an alcohol wipe.
Slovenian: • zunanji del nadlakta (le če vam injekcijo da kdo drug) Očistite mesto injiciranja z alkoholnim zložencem.
English: Your doctor will tell you exactly when to stop taking Aranesp.
Slovenian: Zdravnik vam bo povedal, kdaj natančno morate nehati uporabljati zdravilo Aranesp.
English: Not known: frequency cannot be estimated from available data • Pure red cell aplasia (PRCA) - (anaemia, unusual tiredness, lack of energy)
Slovenian: Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti • čista aplazija rdečih celic (PRCA) - (anemija, nenavadna utrujenost, pomanjkanje energije)
English: • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
Slovenian: • oteklost obraza, ustnic, ust, jezika ali žrela, ki lahko povzroči težave pri požiranju ali dihanju (angioedem)
English: Patients < 6 years of age may need higher doses for maintenance of haemoglobin than patients above that age.
Slovenian: Bolniki, stari < 6 let, lahko za vzdrževanje hemoglobina potrebujejo večje odmerke kot bolniki nad to starostjo.
English: - Take special care with other products that stimulate red blood cell production: Aranesp is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Slovenian: - Bodite posebno pozorni pri jemanju drugih zdravil, ki spodbujajo nastajanje rdečih krvnih celic: zdravilo Aranesp spada v skupino zdravil, ki spodbujajo nastajanje rdečih krvnih celic tako, kot ga spodbuja človeška beljakovina eritropoetin.
English: • Do not put the cap back on used needles, as you may accidentally prick yourself.
Slovenian: • Ne nameščajte pokrovčka nazaj na uporabljene igle, ker se lahko po nesreči zbodete.
English: To avoid bending the needle, gently pull the cap from the needle without twisting as shown in pictures 1 and 2.
Slovenian: Da ne boste zvili igle, previdno snemite pokrovček z igle, ne da bi ga upogibali, tako kot prikazujeta sliki 1 in 2.
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Slovenian: Primeri so bili opisani pri bolnikih s hepatitisom C, zdravljenih z interferonom in ribavirinom, če so sočasno uporabljeni epoetini.
English: Your treatment will continue until approximately four weeks after the end of your chemotherapy.
Slovenian: Zdravljenje boste končali približno štiri tedne po koncu kemoterapije.
English: Using Aranesp with food and drink
Slovenian: Uporaba zdravila Aranesp skupaj s hrano in pijačo
English: If you are unable to inject, please contact your healthcare provider immediately.
Slovenian: Če ne morete injicirati, nemudoma kontaktirajte zdravstvenega delavca.
English: Contact your healthcare provider immediately.
Slovenian: Takoj pokličite zdravstvenega delavca.
English: Because of individual variability, titration to optimal therapeutic doses is expected for individual patients.
Slovenian: Zaradi individualne variabilnosti je treba pričakovati, da bo pri posameznem bolniku potrebno titriranje do optimalnega terapevtskega odmerka.
English: In controlled clinical studies, use of Aranesp and other ESAs have shown:
Slovenian: V kontroliranih kliničnih študijah je uporaba zdravila Aranesp in drugih ESA:
English: Food and drink do not affect Aranesp.
Slovenian: Hrana in pijača ne vplivata na zdravilo Aranesp.
English: Do not try to inject yourself if you have not been trained.
Slovenian: Ne poskušajte si ga injicirati, če vas tega niso naučili.
English: Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Slovenian: Simptomi in posledice anemije se lahko razlikujejo glede na starost, spol in celotno breme bolezni; zdravnik mora oceniti klinični potek in stanje pri posameznem bolniku.
English: Check that it is the correct dose that your doctor has prescribed.
Slovenian: Preverite, da imate pravi odmerek, ki ga je predpisal zdravnik.
English: Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life-expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1).
Slovenian: Med dejavniki, ki jih je treba upoštevati pri takšni oceni, so vrsta in stadij tumorja, stopnja anemije, pričakovana življenjska doba, okolje, v katerem poteka bolnikovo zdravljenje in bolnikove želje (glejte poglavje 5.1).
English: Not known: frequency cannot be estimated from available data
Slovenian: Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
English: If you experience these symptoms you should contact your doctor who will determine the best course of action to treat your anaemia.
Slovenian: Če se vam pojavijo takšni simptomi, se morate posvetovati z zdravnikom, ki bo določil najustreznejše ukrepanje za zdravljenje vaše anemije.
English: In the absence of incompatibility studies, this medicinal product must not be mixed or administered as an infusion with other medicinal products.
Slovenian: V primeru pomanjkanja študij kompatibilnosti tega zdravila ne smete mešati ali aplicirati v infuziji z drugimi zdravili.
English: The clinical results obtained so far do not indicate any interaction of darbepoetin alfa with other substances.
Slovenian: Dosedanji klinični rezultati ne kažejo, da bi darbepoetin alfa medsebojno deloval z drugimi snovmi.
English: Any medicinal product remaining should be disposed of.
Slovenian: Ostanek zdravila morate zavreči.
English: If needed, you may cover the injection site with a plaster.
Slovenian: Če je treba, lahko mesto injiciranja pokrijete z obližem.
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Slovenian: Ob času predpisovanja zdravila je treba bolnike seznaniti z znaki in simptomi kožnih reakcij in jih glede takšnih reakcij skrbno spremljati.
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Slovenian: V štirih študijah, kontroliranih s placebom, je bilo razmerje ogroženosti za celotno preživetje med 1,25 in 2,47 v korist bolnikov v kontrolnih skupinah.
English: The carton contains a package leaflet with the full instructions for use and handling.
Slovenian: V škatli je priloženo Navodilo za uporabo s celotnimi navodili za uporabo in ravnanje z zdravilom.
English: Aranesp works in exactly the same way as the natural hormone erythropoietin.
Slovenian: Zdravilo Aranesp deluje popolnoma enako kot naravni hormon eritropoetin.
English: Towards the end of your chemotherapy course, particularly if you have had a lot of chemotherapy, your red blood cell count may fall making you anaemic.
Slovenian: Proti koncu ciklusa kemoterapije (še posebej, če ste dobili veliko kemoterapije) pa se vam lahko število rdečih krvnih celic zmanjša in tako postanete anemični.
English: Your doctor may decide to change the way that your injection is given (either under the skin or into a vein).
Slovenian: Zdravnik se lahko odloči za spremembo načina injiciranja (pod kožo ali v veno).
English: Do not touch the cleaned area of the skin
Slovenian: Ne dotikajte se očiščenega predela kože.
English: The maximum amount of Aranesp that can be safely administered in single or multiple doses has not been determined.
Slovenian: Največja količina zdravila Aranesp, ki jo je mogoče varno injicirati v enem ali več odmerkih, ni določena.
English: If blood pressure is difficult to control by initiation of appropriate measures, the haemoglobin may be reduced by decreasing or withholding the dose of Aranesp (see section 4.2).
Slovenian: Če je krvni tlak po uvedbi ustreznih ukrepov težko obvladovati, lahko hemoglobin znižate z zmanjšanjem ali zadržanjem odmerka zdravila Aranesp (glejte poglavje 4.2).
English: For the purpose of ambulatory use, Aranesp may be removed from storage once for a maximum single period of seven days at room temperature (up to 25ºC).
Slovenian: Za ambulantno rabo je zdravilo Aranesp mogoče vzeti iz prostora za shranjevanje enkrat za največ eno sedemdnevno obdobje pri sobni temperaturi (do 25 °C).
English: This may be associated with life-threatening complications of the cardiovascular system.
Slovenian: To je lahko povezano s smrtno nevarnimi zapleti na srčno-žilnem sistemu.
English: • Check that it is the correct dose that your healthcare provider has prescribed.
Slovenian: • Preverite, da imate pravilen odmerek, ki vam ga je predpisal zdravstveni delavec.
English: If someone else is injecting for you, they can also use the back of your arms.
Slovenian: Če vam zdravilo injicira kdo drug, vam ga lahko da tudi v zadnjo stran nadlakta.
English: Aranesp has not been tested in pregnant women.
Slovenian: Zdravilo Aranesp ni preizkušeno pri nosečnicah.
English: Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.
Slovenian: Anemija (slabokrvnost) je stanje, pri katerem v krvi ni dovolj rdečih krvnih celic; simptomi so lahko utrujenost, šibkost in težko dihanje.
English: The rashes may progress to widespread peeling of the skin and life-threatening complications.
Slovenian: Izpuščaji lahko napredujejo v razširjeno lupljenje kože in smrtno nevarne zaplete.
English: Adverse events at very high doses were all considered to be related to an exaggerated pharmacological effect (decreased tissue perfusion due to increased blood viscosity).
Slovenian: Vse neželene učinke ob zelo velikih odmerkih so ocenili za posledice pretiranega farmakološkega delovanja (manjša perfuzija tkiva zaradi večje viskoznosti krvi).
English: The additional sugar residues are molecularly indistinct from those on the endogenous hormone.
Slovenian: Dodatne sladkorne skupine se molekulsko ne ločijo od tistih na endogenem hormonu.
English: Blood pressure should be monitored in all patients, particularly during initiation of Aranesp therapy.
Slovenian: Vsem bolnikom morate kontrolirati krvni tlak, zlasti med začetkom zdravljenja z zdravilom Aranesp.
English: However, there is potential for an interaction with substances that are highly bound to red blood cells e.g. cyclosporin, tacrolimus.
Slovenian: Obstaja pa možnost za interakcije s snovmi, ki so v veliki meri vezane na rdeče krvne celice, npr. s ciklosporinom ali takrolimusom.
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Slovenian: Zdravnik bo uporabil najmanjši učinkoviti odmerek za obvladovanje simptomov anemije.
English: For more information or help, contact your healthcare provider.
Slovenian: Za več informacij ali pomoč kontaktirajte zdravstvenega delavca.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
English: Darbepoetin alfa stimulates erythropoiesis by the same mechanism as the endogenous hormone.
Slovenian: Darbepoetin alfa spodbuja eritropoezo prek istih mehanizmov kot endogeni hormon.
English: • 0.45 micrograms once weekly.
Slovenian: • 0,45 mikrogramov enkrat na teden.
English: Data are presented separately for CRF and cancer patients reflecting the different adverse reaction profile in these populations.
Slovenian: Podatki so predstavljeni ločeno za bolnike s kronično odpovedjo ledvic in bolnike z rakom; to odraža različen profil neželenih reakcij v teh populacijah.