FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you are prescribed intravenous iron, you should immediately tell your doctor if you have previously had an allergic reaction to intravenous iron preparations.
Slovenian: • Če so vam predpisali intravensko železo, morate nemudoma obvestiti zdravnika, če ste imeli v preteklosti alergijsko reakcijo na intravenske pripravke, ki vsebujejo železo.
English: The Agency's recommendations are based on a review of all available data on the risk of hypersensitivity as well as the benefits of intravenous iron medicines:
Slovenian: Priporočila agencije temeljijo na pregledu vseh razpoložljivih podatkov o tveganju za preobčutljivost in koristih intravenskih zdravil, ki vsebujejo železo:
English: In rare cases these injections can cause allergic reactions which can be serious.
Slovenian: Redko lahko tako injiciranje povzroči alergijske reakcije, ki so lahko resne.
English: • In view of the limitations of the data the Committee recommended further activities, including yearly reviews of allergic reaction reports and a study to confirm the safety of intravenous iron medicines.
Slovenian: • Na podlagi omejitev podatkov je odbor priporočil dodatne dejavnosti, vključno z letnimi pregledi poročil o alergijskih reakcijah in študijo za potrditev varnosti intravenskih zdravil, ki vsebujejo železo.
English: Treatment should be confined to the second or third trimester, provided the benefits of treatment clearly outweigh the potential serious risks to the foetus such as anoxia and foetal distress.
Slovenian: Zdravljenje je treba omejiti na drugo ali tretje trimesečje, če so koristi zdravljenja očitno večje od morebitnih resnih tveganj za plod, kot sta anoksija in fetalni distres.
English: Intravenous iron-containing products must also not be used in patients with serious hypersensitivity to other parenteral iron products.
Slovenian: Intravenska zdravila, ki vsebujejo železo, se prav tako ne smejo uporabljati pri bolnikih z resno preobčutljivostjo na druga parenteralna zdravila, ki vsebujejo železo.
English: Intravenous iron preparations are prescribed when iron supplements given by mouth cannot be used or do not work, especially in patients receiving dialysis for kidney failure, before and after operations, or in case of absorption disorders affecting the gut.
Slovenian: Intravenski pripravki železa se predpisujejo, kadar ni mogoče uporabiti peroralnih nadomestkov železa ali ti ne delujejo, predvsem pri bolnikih na dializi zaradi ledvične odpovedi, pred kirurškimi posegi in po njih ali v primeru motenj absorpcije, ki prizadenejo črevesje.
English: The Committee also recommended further activities, including yearly reviews of allergic reaction reports and a study to confirm the safety of intravenous iron medicines.
Slovenian: Odbor je priporočil tudi dodatne dejavnosti, vključno z letnimi pregledi poročil o alergijskih reakcijah in študijo za potrditev varnosti intravenskih zdravil, ki vsebujejo železo.
English: • In case of hypersensitivity reactions, healthcare professionals should immediately stop the iron administration and consider appropriate treatment for the hypersensitivity reaction.
Slovenian: • Če se pojavi preobčutljivostna reakcija, mora zdravstveno osebje takoj prekiniti dajanje železa in razmisliti o primernem zdravljenju preobčutljivostne reakcije.
English: All intravenous iron medicines have a small risk of causing allergic reactions which can be lifethreatening if not treated promptly.
Slovenian: Pri vseh intravenskih zdravilih, ki vsebujejo železo, obstaja majhno tveganje za alergijske reakcije, ki so lahko smrtno nevarne, če se ne zdravijo takoj.
English: • All intravenous iron preparations can cause serious hypersensitivity reactions which can be fatal.
Slovenian: • Vsi intravenski pripravki, ki vsebujejo železo, lahko povzročijo resne preobčutljivostne reakcije, ki so lahko smrtne.
English: • Intravenous iron medicines should only be administered when staff trained to evaluate and manage anaphylactic and anaphylactoid reactions are immediately available as well as resuscitation facilities.
Slovenian: • Intravenska zdravila, ki vsebujejo železo, se smejo dajati samo, kadar sta osebje, usposobljeno za ocenjevanje in obravnavo anafilaktičnih ter anafilaktoidnih reakcij, in oprema za oživljanje takoj na voljo.
English: Patients should be closely observed for signs and symptoms of hypersensitivity reactions during and for at least 30 minutes following each injection of an intravenous iron medicine.
Slovenian: Bolnike je treba skrbno opazovati in biti pozoren na znake in simptome preobčutljivosti med injiciranjem intravenskega zdravila, ki vsebuje železo, in vsaj še 30 minut po njem.
English: • Intravenous iron products should not be used during pregnancy unless clearly necessary.
Slovenian: • Intravenska zdravila, ki vsebujejo železo, se ne smejo uporabljati med nosečnostjo, razen če je to res nujno.
English: Intravenous iron medicines should therefore not be used during pregnancy unless clearly necessary.
Slovenian: Posledično se intravenska zdravila, ki vsebujejo železo, ne smejo uporabljati med nosečnostjo, razen če je to povsem nujno.
English: If you are receiving intravenous iron medicines your doctor will closely observe you for any allergic reactions during and for at least 30 minutes after the injection.
Slovenian: Če prejemate intravenska zdravila, ki vsebujejo železo, vas bo zdravnik med injiciranjem in vsaj 30 minut po njem pozorno opazoval zaradi morebitnega pojava alergijske reakcije.
English: A test dose is therefore no longer recommended but instead caution is warranted with every dose of intravenous iron that is given, even if previous administrations have been well tolerated.
Slovenian: Posledično testni odmerek ni več priporočljiv, temveč je pri vsakem danem odmerku intravenskega železa potrebna previdnost, tudi če je bolnik prejšnje odmerke dobro prenašal.
English: Instead caution is warranted with every dose of intravenous iron that is given, even if previous administrations have been well tolerated.
Slovenian: Namesto tega je potrebna previdnost pri vsakem danem odmerku intravenskega železa, tudi če je bolnik prejšnje odmerke dobro prenašal.
English: • Intravenous iron-containing products are contraindicated in patients with hypersensitivity to the active substance or excipients.
Slovenian: • Intravenska zdravila, ki vsebujejo železo, so kontraindicirana pri bolnikih s preobčutljivostjo na zdravilno učinkovino ali pomožne snovi.
English: • Intravenous iron medicines are a valuable alternative when iron supplements cannot be given by mouth or have not worked.
Slovenian: • Intravenska zdravila, ki vsebujejo železo, so koristna alternativa, kadar nadomestkov železa ni mogoče dajati peroralno (z zaužitjem) ali ta ne učinkujejo.
English: Intravenous iron medicines are used when iron supplements given by mouth cannot be used or do not work.
Slovenian: Intravenska zdravila, ki vsebujejo železo, se uporabljajo, če peroralnih nadomestkov železa ni mogoče uporabiti ali ne učinkujejo.
English: Strength Pharmaceutical Form
Slovenian: Številka EU zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: Packaging
Slovenian: velikost pakiranja o ā
English: (Invented) name Strength Pharmaceutical form Route of administration
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
English: Date of first authorisation: 17 April 2013
Slovenian: Datum prve odobritve: 17. april 2013
English: These include some types of cancer.
Slovenian: To vključuje nekatere vrste raka.
English: The adverse reactions were similar in all indications, with two exceptions.
Slovenian: Neželene reakcije so bile podobne pri vseh indikacijah, z dvema izjemama.
English: However, the mechanism of the observed interaction is presently unknown.
Slovenian: Vendar pa trenutno mehanizem opažene interakcije ni znan.
English: 1 Haematological response criteria (all responses to be confirmed after ≥ 4 weeks):
Slovenian: 1Kriteriji hematološkega odziva (vsi odzivi morajo biti potrjeni po ≥ 4 tednih):
English: Bilirubin elevation was below 3%.
Slovenian: Zvišanje bilirubina je bilo pod 3 %.
English: Follow all your doctor's instructions carefully, even if they differ from the general information contained in this leaflet.
Slovenian: Skrbno se ravnajte po vseh navodilih vašega zdravnika, tudi če se razlikujejo od splošnih informacij v tem navodilu za uporabo.
English: Currently available published data are summarised in section 5.1 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi objavljeni podatki so povzeti v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
English: These precautions are also applicable to children.
Slovenian: Te zaščitne ukrepe je treba upoštevati tudi pri otrocih.
English: You will also have blood tests and be weighed regularly.
Slovenian: Pri vas bodo tudi opravljali preiskave krvi in vas redno tehtali.
English: 220 Hafnarfjörður Iceland
Slovenian: 220 Hafnarfjörður Islandija
English: GI and tumoural bleeding may be serious and sometimes fatal.
Slovenian: Gastrointestinalne in tumorske krvavitve so lahko resne in včasih smrtne.
English: - If you forget a dose, take it as soon as you remember.
Slovenian: - Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Vendar pa mora imetnik dovoljenja za promet za to zdravilo predložiti redno posodobljena poročila o varnosti zdravila, če je zdravilo vključeno v seznam referenčnih datumov Unije (seznam EURD), opredeljen v členu 107c(7) Direktive 2001/83/ES in objavljen na evropskem spletnem portalu o zdravilih
English: Two intermediates of the manufacturing process, which are also present in the final product, are positive for mutagenesis in the Ames assay.
Slovenian: Dva od vmesnih produktov postopka izdelave, ki sta prisotna tudi v končnem izdelku, sta pozitivna za mutagenezo v Amesovem testu.
English: Prephase
Slovenian: predhodna faza
English: Treatment should be continued as long as the patient continues to benefit.
Slovenian: Z zdravljenjem je treba nadaljevati dokler to bolniku koristi.
English: However if it is nearly time for the next dose, skip the missed dose.
Slovenian: Če je že skoraj čas za naslednji odmerek, izpustite pozabljeni odmerek.
English: - Then continue with your normal schedule.
Slovenian: - Nato nadaljujte z jemanjem zdravila po običajnem razporedu.
English: The safety database for children with Ph+ALL is very limited though no new safety concerns have been identified.
Slovenian: Čeprav je baza podatkov za otroke s Ph+ ALL zelo majhna, zaenkrat niso odkrili nobenih novih pomislekov glede varnosti.
English: Use only as directed by a doctor.
Slovenian: Uporabljajte samo po zdravnikovih navodilih.
English: The current estimate of the median survival of the previously untreated and treated patients was 7.7 and 4.7 months, respectively.
Slovenian: Tekoča ocena medianega preživetja predhodno nezdravljenih in zdravljenih bolnikov je bila 7,7 in 4,7 meseca.
English: In the clinical study 38% of patients were ≥ 60 years of age and 12% of patients were ≥ 70 years of age.
Slovenian: V klinični študiji je bilo 38 % bolnikov starih ≥ 60 let, 12 % bolnikov pa je bilo starih ≥ 70 let.
English: The rate of haematological response was 70% with a duration of 2-3 months.
Slovenian: Stopnja hematološkega odziva je bila 70 %, njegovo trajanje pa 2-3 mesece.
English: Elderly patients: Imatinib pharmacokinetics have not been specifically studied in older people.
Slovenian: Starejši bolniki: Farmakokinetike imatiniba pri starejših osebah niso posebej proučili.
English: A major response combines both complete and partial responses: complete (0% Ph+ metaphases), partial (1-35%)
Slovenian: Pomemben odziv združuje tako popolne kot delne odzive: popoln (0 % Ph+ metafaz), delen (1-35 %)
English: The capsule contains light yellow powder.
Slovenian: Kapsule vsebujejo svetlo rumen prašek.
English: 9/L
Slovenian: 9/Ll
English: - Slowing of growth in children and adolescents.
Slovenian: - upočasnjena rast pri otrocih in mladostnikih.
English: This leaflet was last revised in Other source of information
Slovenian: Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
English: ANC = absolute neutrophil count a occurring after at least 1 month of treatment
Slovenian: ANC = absolutno število nevtrofilcev (absolute neutrophil count) a do katere pride po najmanj 1 mesecu zdravljenja
English: - If you are being treated for Ph-positive ALL:
Slovenian: - Če se zdravite zaradi Ph pozitivne ALL:
English: The amount of Imatinib Actavis given will depend on your child's condition, body weight and height.
Slovenian: Potrebna količina zdravila Imatinib Actavis bo odvisna od otrokovega stanja, telesne mase in višine.
English: - if you are taking the medicine levothyroxine because your thyroid has been removed.
Slovenian: - če jemljete zdravilo levotiroksin, ker so vam odstranili ščitnico.
English: - Dermatofibrosarcoma protuberans (DFSP).
Slovenian: - s protuberantnim dermatofibrosarkomom (DFSP).
English: Caution is therefore recommended.
Slovenian: Zato je potrebna previdnost.
English: You should wash your hands immediately after opening the capsules.
Slovenian: Takoj po odpiranju kapsul si umijte roke.
English: If you have any questions about how Imatinib Actavis works or why this medicine has been prescribed for you, ask your doctor.
Slovenian: Če imate kakšna vprašanja glede tega, kako zdravilo Imatinib Actavis deluje ali zakaj vam je bilo predpisano to zdravilo, vprašajte svojega zdravnika.
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 μmol/L, respectively.
Slovenian: Vrednosti Ki v mikrosomih človeških jeter so bile 27, 7,5 oziroma 7,9 μmol/L.
English: 2 Cytogenetic response criteria:
Slovenian: 2 Kriteriji citogenetičnega odziva:
English: One blister contains 10 tablets.
Slovenian: En pretisni omot vsebuje 10 tablet.
English: Some children and adolescents taking Imatinib Actavis may have slower than normal growth.
Slovenian: Pri nekaterih otrocih in mladostnikih, ki jemljejo zdravilo Imatinib Actavis, je lahko rast počasnejša od normalne.
English: Reykjavíkurvegur 76-78, Hafnarfjörður Iceland
Slovenian: Reykjavíkurvegur 76-78, Hafnarfjörður Islandija
English: Events that have been reported at different dose ranges are as follows:
Slovenian: Pri različnih obsegih odmerkov so poročali o naslednjih dogodkih:
English: very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John's Wort).
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta (na primer paracetamol), vključno z zdravili rastlinskega izvora (na primer šentjanževko).
English: The rate of response was also higher in the patients treated at 600 mg (33%) as compared to the patients treated at 400 mg (16%, p=0.0220).
Slovenian: Stopnja odziva je bila tudi večja pri bolnikih, zdravljenih s 600 mg (33 %), kot pri bolnikih, zdravljenih s 400 mg (16 %, p=0,0220).
English: Hypersensitivity to soya or peanut.
Slovenian: Preobčutljivost na sojo ali arašide.
English: As reported in a recent publication 21 of these 65 patients also achieved complete molecular remission with a median follow-up of 28 months (range 13-67 months).
Slovenian: Kot so nedavno objavili, je 21 od teh 65 bolnikov doseglo tudi popolno molekularno remisijo po mediano 28 mesecih spremljanja (od 13 do 67 mesecev).
English: - Stir with a spoon until the tablets have completely dissolved.
Slovenian: - Mešajte z žlico, dokler se tablete popolnoma ne raztopijo.
English: However, these oedemas were rarely severe and may be managed with diuretics, other supportive measures, or by reducing the dose of imatinib.
Slovenian: Vendar so bili ti edemi redko hudi in jih lahko zdravimo z diuretiki, drugimi podpornimi ukrepi ali z zmanjšanjem odmerka imatiniba.
English: 11 Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions.
Slovenian: 11 Poročali so o primerih s smrtnim izidom pri bolnikih z napredovalo boleznijo, s hudimi okužbami, hudo nevtropenijo in z drugimi resnimi spremljajočimi stanji.
English: Study AJP01
Slovenian: Študija AJP01
English: AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)
Slovenian: AST: > IULN (lahko je normalna ali < IULN, če je celotni bilirubin > IULN)
English: Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n=10).
Slovenian: Limfoidna blastna kriza: Omejeno število bolnikov so vključili v študije prve faze (n=10).
English: In this study, 31% of patients achieved a haematological response (36% in previously untreated patients and 22% in previously treated patients) (Table 2).
Slovenian: V tej študiji je 31 % bolnikov doseglo hematološki odziv (36 % pri predhodno nezdravljenih bolnikih in 22 % pri predhodno zdravljenih bolnikih) (Preglednica 2).
English: In a recent publication updated information from 6 of these 11 patients revealed that all these patients remained in cytogenetic remission (range 32-38 months).
Slovenian: Nedavno objavljeni dopolnjeni podatki za 6 od teh 11 bolnikov razkrivajo, da so vsi ti bolniki ostali v citogenetični remisiji (po 32 do 38 mesecih).
English: Study AAU02
Slovenian: Študija AAU02
English: - Swallow the capsules whole with a large glass of water.
Slovenian: - Kapsule pogoltnite cele z velikim kozarcem vode.
English: The duration of imatinib therapy can vary with the treatment programme selected, but generally longer exposures to imatinib have yielded better results.
Slovenian: Trajanje zdravljenja z zdravilom Imatinib Actavis je lahko različno glede na izbrani program zdravljenja, vendar pa je na splošno daljša izpostavljenost zdravilu Imatinib Actavis prinesla boljše rezultate.
English: Study 0102 38-month data Myeloid blast crisis (n=260) % of patients (CI95%)
Slovenian: Študija 0102 podatki pri 38 mesecih mieloidna blastna kriza (n=260) % bolnikov (IZ95 %)
English: Therefore, the use of imatinib in combination requires special precaution.
Slovenian: Zato je pri uporabi imatiniba v kombinaciji potrebna posebna previdnost.
English: 3 Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study.
Slovenian: 3Popoln citogenetični odziv, potrjen z drugo citogenetično oceno kostnega mozga, opravljeno vsaj en mesec po prvi študiji kostnega mozga.
English: Your doctor will discuss with you the possible risks of taking Imatinib Actavis during pregnancy.
Slovenian: Zdravnik se bo pogovoril z vami o možnih nevarnostih jemanja zdravila Imatinib Actavis v nosečnosti.
English: This medicine works by inhibiting the growth of abnormal cells in the diseases listed below.
Slovenian: Zdravilo deluje tako, da zavira rast nenormalnih celic pri boleznih navedenih spodaj.
English: Traces of the dissolved tablets may be left behind in the glass.
Slovenian: Sledove raztopljenih tablet lahko pustite v kozarcu.
English: - Once the tablet has dissolved, drink everything in the glass straight away.
Slovenian: - Ko se tableta raztopi, takoj popijte celotno vsebino kozarca.
English: Consolidation therapy II, IV
Slovenian: Dan konsolidacijska terapija II, IV
English: Study ADE04
Slovenian: Študija ADE04
English: Imatinib administration to patients without the genetic translocation generally results in no improvement.
Slovenian: Uporaba zdravila Imatinib Actavis pri bolnikih brez genetske translokacije večinoma ni povzročila izboljšanja.
English: Do not use any pack that is damaged or shows signs of tampering.
Slovenian: Ne uporabite škatle, če je poškodovana ali kaže znake, da je bila že odprta.
English: Al/PVC/Aclar blister.
Slovenian: Al/PVC/Aclar pretisni omot.
English: The decreases in white blood cell (WBC) and neutrophil counts occurred mainly during the first six weeks of therapy, with values remaining relatively stable thereafter.
Slovenian: Do zmanjšanja koncentracij belih krvničk (WBC - white blood cell) in nevtrofilcev je prišlo predvsem v prvih šestih tednih zdravljenja, zatem pa so vrednosti ostale relativno stabilne.
English: Mean absolute bioavailability for imatinib is 98%.
Slovenian: Absorpcija Povprečna absolutna biološka uporabnost imatiniba je 98 %.
English: If you are allergic to peanut or soya, do not use this medicinal product.
Slovenian: Če ste alergični na sojo ali arašide, ne jemljite tega zdravila.
English: In patients treated with metoprolol clinical monitoring should be considered.
Slovenian: Pri bolnikih, ki se zdravijo z metoprololom, je treba razmisliti o kliničnem spremljanju.
English: While you are taking Imatinib Actavis, your doctor will regularly check whether the medicine is working.
Slovenian: Med jemanjem zdravila Imatinib Actavis bo zdravnik redno spremljal, ali zdravilo deluje.
English: The safety and efficacy of imatinib in children with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Slovenian: Varnost in učinkovitost imatiniba pri otrocih, ki imajo MDS/MPD, DFSP ali HES/CEL in so stari manj kot 18 let, nista bili dokazani v kliničnih preskušanjih.
English: Studies in two breast-feeding women revealed that both imatinib and its active metabolite can be distributed into human milk.
Slovenian: Študije pri dveh doječih materah sta pokazali, da se tako imatinib kot njegov aktivni presnovek pri človeku lahko izločata v materino mleko.
English: Because of known increased risks of bleeding in conjunction with the use of imatinib (e.g. haemorrhage), patients who require anticoagulation should receive low-molecular-weight or standard heparin instead of coumarin derivatives such as warfarin.
Slovenian: Zaradi znanega povečanega tveganja za krvavitve v povezavi z uporabo imatiniba (na primer hemoragija) naj bolniki, pri katerih je potrebna antikoagulantna terapija, dobivajo nizkomolekularni ali standardni heparin namesto kumarinskih derivatov, kot je varfarin.
English: Treatment was discontinued permanently because of liver laboratory abnormalities in less than 1% of CML patients.
Slovenian: Zaradi jetrnih laboratorijskih nenormalnosti so zdravljenje trajno prekinili pri manj kot 1 % bolnikov s KML.
English: - if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na imatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Patients should be instructed to use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
Slovenian: Bolnikom je treba naročiti, naj se poslužujejo ukrepov, kot so zaščita z oblačili in uporaba zaščitne kreme z visokim zaščitnim faktorjem
English: Patients, who are allergic to peanut or soya, may not use this medicinal product.
Slovenian: Bolniki, ki so alergični na arašide ali sojo, ne smejo jemati tega zdravila.
English: 20 out of the 50 (40%) patients in cohort 5 received haematopoietic stem cell transplant.
Slovenian: 20 od 50 bolnikom (40 %) v 5. kohorti so presadili krvotvorne matične celice.
English: Ask your pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več se posvetujte s farmacevtom.
English: Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Slovenian: Blastno krizo opredeljuje ≥ 30 % blastov v krvi ali kostnem mozgu ali ekstramedularna bolezen, ki ni hepatosplenomegalija.
English: Complete (Confirmed3) [95% CI] Partial
Slovenian: Popoln (potrjen3) [95 %interval zaupanja]