FrancophonIA/ELRC3.0 huggingface dataset:
English: 50 ml (20 mg/ml) 1 vial l t o r
Slovenian: Velikost pakiranja viala (steklo) 5 ml (20 mg/ml) 3 viale + 2 razširitvena seta viala (steklo) 50 ml (20 mg/ml) 1 viala + 2 razširitvena seta o č
English: 196 (2 x 98) tablets l t o r
Slovenian: 196 (2 x 98) tablet o ā
English: It can be used for up to 7 consecutive days.
Slovenian: Uporablja se lahko največ sedem zaporednih dni.
English: In both studies the patients were also receiving G-CSF.
Slovenian: V obeh študijah so bolniki prejemali tudi G-CSF.
English: Mozobil (plerixafor)
Slovenian: Mozobil (pleriksafor)
English: The patients who are given Mozobil are:
Slovenian: Bolniki, ki prejmejo zdravilo Mozobil, so:
English: What measures are being taken to ensure the safe and effective use of Mozobil?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mozobil?
English: Further information on the orphan designation can be found on here: ema.europa.eu/medicines/human/orphan-designations/eu304227.
Slovenian: Nadaljnje informacije glede določitve zdravila sirote so na voljo tukaj: ema.europa.eu/medicines/human/orphan-designations/eu304227.
English: • children from 1 year of age who have lymphoma or solid tumours.
Slovenian: • otroci, starejši od enega leta, ki imajo limfom ali trdne tumorje.
English: The European Medicines Agency decided that Mozobil's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Mozobil večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Because of this, treatment should be carried out in collaboration with a specialised centre that has experience with this type of procedure and can monitor the stem cells.
Slovenian: Zato je treba zdravljenje izvesti v sodelovanju s specializirano ustanovo, ki ima izkušnje s tovrstnimi postopki in v kateri lahko nadzorujejo matične celice.
English: Mozobil received a marketing authorisation valid throughout the EU on 31 July 2009.
Slovenian: Za zdravilo Mozobil je bilo 31. julija 2009 izdano dovoljenje za promet, veljavno po vsej EU.
English: • adults with lymphoma or multiple myeloma (types of blood cancer);
Slovenian: • odrasli z limfomom ali multiplim mielomom (vrstama krvnega raka);
English: Further information on Mozobil can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/mozobil.
Slovenian: Nadaljnje informacije za zdravilo Mozobil so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/mozobil.
English: What are the risks associated with Mozobil?
Slovenian: Kakšna tveganja so povezana z zdravilom Mozobil?
English: Mozobil is used together with G-CSF.
Slovenian: Mozobil se uporablja skupaj z G-CSF.
English: As for all medicines, data on the use of Mozobil is continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Mozobil stalno spremljajo.
English: What benefits of Mozobil have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Mozobil izkazalo v študijah?
English: G-CSF is used on its own for 4 days before Mozobil is added.
Slovenian: G-CSF se uporablja kot samostojno zdravilo štiri dni pred dodajanjem zdravila Mozobil.
English: The active substance in Mozobil, plerixafor, works by blocking the activity of a protein called the ‘CXCR4 chemokine receptor'.
Slovenian: Učinkovina zdravila Mozobil, pleriksafor, deluje z zaviranjem dejavnosti beljakovine, imenovane „kemokinski receptor CXCR4“.
English: This protein normally helps to keep stem cells within the bone marrow.
Slovenian: Ta beljakovina običajno pomaga zadržati matične celice znotraj kostnega mozga.
English: The medicine can only be obtained with a prescription and treatment should only be started and supervised by a doctor who has experience in treating cancer or blood disorders.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik z izkušnjami z zdravljenjem raka ali krvnih motenj.
English: An overview of Mozobil and why it is authorised in the EU
Slovenian: Pregled zdravila Mozobil in zakaj je odobreno v EU
English: Mozobil is used together with the hormone granulocyte-colony stimulating factor (G-CSF) and is only for patients in whom collection of stem cells is difficult.
Slovenian: Zdravilo Mozobil se uporablja skupaj z granulocitne kolonije stimulirajočim faktorjem (G-CSF), in je namenjeno samo bolnikom, pri katerih je zbiranje matičnih celic težko.
English: Side effects reported with Mozobil are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Mozobil, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Mozobil authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Mozobil odobreno v EU?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mozobil have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Mozobil upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Other information about Mozobil
Slovenian: Druge informacije o zdravilu Mozobil
English: The most common side effects with Mozobil (which may affect more than 1 patient in 10) are diarrhoea, nausea (feeling sick) and reactions at the site of injection.
Slovenian: Najpogostejši neželeni učinki zdravila Mozobil (ki se lahko pojavijo pri več kot 1 bolniku od 10) so driska, navzeja (siljenje na bruhanje) in reakcije na mestu injiciranja.
English: For more information about using Mozobil, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Mozobil glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Mozobil and what is it used for?
Slovenian: Kaj je zdravilo Mozobil in za kaj se uporablja?
English: The number of patients that need mobilisation and collection of haematopoietic stem cells for transplantation is low and Mozobil was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 October 2004.
Slovenian: Ker je bolnikov, ki potrebujejo mobilizacijo in zbiranje krvotvornih matičnih celic za presaditev, malo, velja ta bolezen za redko, zato je bilo zdravilo Mozobil 20. oktobra 2004 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: In two main studies involving 298 adults with non-Hodgkin's lymphoma and 302 adults with multiple myeloma, more patients who received Mozobil achieved the target number of stem cells and had successful engraftment of stem cells (the cells started growing and producing normal blood cells after transplantation) than patients who received placebo (a dummy treatment).
Slovenian: V dveh glavnih študijah, v katere je bilo vključenih 298 odraslih z ne-Hodgkinovim limfomom in 302 odrasla z multiplim mielomom, je več bolnikov, ki so prejeli zdravilo Mozobil, doseglo ciljno število matičnih celic in imelo uspešno vsaditev matičnih celic (celice so začele rasti in po presaditvi proizvajati normalne krvne celice) kot bolniki, ki so prejemali placebo (zdravilo brez učinkovine).
English: Mozobil is given 6 to 11 hours before the patient's blood is taken and the stem cells are extracted.
Slovenian: Zdravilo Mozobil se daje 6 do 11 ur pred odvzemom krvi in ekstrahiranjem matičnih celic.
English: Mozobil contains the active substance plerixafor.
Slovenian: Zdravilo Mozobil vsebuje učinkovino pleriksafor.
English: Mozobil is a medicine used to mobilise blood stem cells from a patient's bone marrow so that they can be collected and used later for transplantation in the same patient.
Slovenian: Mozobil je zdravilo, ki se uporablja za mobilizacijo krvotvornih matičnih celic iz kostnega mozga bolnika, tako da jih je mogoče zbrati in uporabiti kasneje za presaditev pri istem bolniku.
English: Mozobil is given as an injection under the skin.
Slovenian: Zdravilo Mozobil se daje z injiciranjem pod kožo.
English: How is Mozobil used?
Slovenian: Kako se zdravilo Mozobil uporablja?
English: In a main study involving 45 children with lymphoma or solid tumours, 80% (24 out of 30) of patients who received Mozobil had at least a doubling of the number of stem cells in the blood, compared with 29% (4 out of 14) patients who received standard mobilisation treatment alone.
Slovenian: V glavni študiji, v katero je bilo vključenih 45 otrok s limfomom ali trdnimi tumorji, je 80 % (24 od 30) bolnikov, ki so prejemali zdravilo Mozobil, vsaj podvojilo število matičnih celic v krvi v primerjavi z 29 % (4 od 14) bolnikov, ki so prejemali samo standardno zdravljenje za mobilizacijo.
English: For the full list of side effects and restrictions with Mozobil, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Mozobil glejte navodilo za uporabo.
English: After the patient has been given Mozobil, the patient's stem cells are extracted from the blood and stored before transplantation.
Slovenian: Po prejemu zdravila Mozobil je treba bolnikove matične celice pridobiti iz krvi in jih pred presaditvijo shraniti.
English: How does Mozobil work?
Slovenian: Kako zdravilo Mozobil deluje?
English: By blocking its activity, Mozobil allows the stem cells to be released into the blood, so that they can be collected.
Slovenian: Z zaviranjem njene dejavnosti zdravilo Mozobil omogoča matičnim celicam, da se sprostijo v kri in so na voljo za zbiranje.
English: Among the adults with multiple myeloma, 72% (106 out of 148) of those receiving Mozobil achieved the target number of stem cells within 4 collection days, compared with 34% (53 out of 154) of the patients receiving placebo.
Slovenian: Med odraslimi z multiplim mielomom je ciljno število matičnih celic doseglo 72 % (106 od 148) bolnikov, ki so prejemali zdravilo Mozobil, v primerjavi z 34 % (53 od 154) bolnikov, ki so prejemali placebo.
English: Among the adults with lymphoma, 59% (89 out of 150) of those receiving Mozobil achieved the target number of stem cells within 4 collection days, compared with 20% (29 out of 148) of the patients receiving placebo.
Slovenian: Pri odraslih z limfomom je 59 % (89 od 150) tistih, ki so prejemali zdravilo Mozobil, v štirih dneh zbiranja doseglo ciljno število matičnih celic, pri bolnikih, ki so prejemali placebo, pa jih je bilo 20 % (29 od 148).
English: Mozobil is used to mobilise the stem cells from the bone marrow so they can be released into the blood.
Slovenian: Zdravilo Mozobil se uporablja za mobilizacijo matičnih celic iz kostnega mozga, tako da se lahko sproščajo v kri.
English: 20 November 2013
Slovenian: 20. novembra 2013
English: The European Commission issued a decision on 20 November 2013.
Slovenian: Evropska komisija je izdala odločbo dne 20. novembra 2013.
English: Why was Didanosine reviewed?
Slovenian: Zakaj je bilo zdravilo Didanosine pregledano?
English: It is available as gastroresistant tablets.
Slovenian: Na voljo je v obliki gastrorezistentnih tablet.
English: Two medicines are bioequivalent if they produce the same levels of the active substance in the body.
Slovenian: Dve zdravili sta biološko enakovredni, če dosegata enake ravni zdravilne učinkovine v telesu.
English: What is Didanosine?
Slovenian: Kaj je zdravilo Didanosine?
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 4 March 2013.
Slovenian: Vendar države članice niso mogle doseči soglasja, zato je regulativna agencija Združenega kraljestva za zdravila 4. marca 2013 zadevo napotila na CHMP v arbitražo.
English: On 19 September 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Didanosine.
Slovenian: Evropska agencija za zdravila je dne 19. septembra 2013 zaključila arbitražni postopek, potem ko so države članice Evropske unije (EU) izrazile nestrinjanje glede odobritve zdravila Didanosine.
English: authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance France, Germany, Italy, Netherlands, Portugal, Romania and Spain).
Slovenian: zdravilo zato, da se izda dovoljenje za promet, ki bo veljalo v tej državi in drugih državah članicah („zadevne države članice“, v tem primeru Francija, Nemčija, Italija, Nizozemska, Portugalska, Romunija in Španija).
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing
Slovenian: To je postopek, v katerem ena država članica („referenčna država članica“, v tem primeru Združeno kraljestvo) oceni
English: Didanosine is a hybrid medicine which means that it is similar to a ‘reference medicine' already authorised in the EU called Videx EC.
Slovenian: Didanosine je hibridno zdravilo, kar pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v EU in se imenuje Videx EC.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Didanosine outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the EU: France, Germany, Italy, the Netherlands, Portugal, Romania and Spain.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Didanosine odtehtajo z njim povezana tveganja in da se dovoljenje za promet lahko odobri v Združenem kraljestvu in naslednjih državah članicah EU: v Franciji, Nemčiji, Italiji, na Nizozemskem, Portugalskem, v Romuniji in Španiji.
English: Didanosine does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Didanozin ne ozdravi okužbe z virusom HIV ali aidsa, vendar lahko upočasni slabšanje imunskega sistema in razvoj okužb ter bolezni, povezanih z aidsom.
English: ‘Gastroresistant' means that the tablet's contents pass through the stomach without being broken down until they reach the intestine.
Slovenian: „Gastrorezistentne“ pomeni, da vsebina tablet preide skozi želodec v črevesje, ne da bi se pri tem razgradila.
English: Aurobindo Pharma (Malta) Limited submitted Didanosine to the UK medicines regulatory agency for a decentralised procedure.
Slovenian: Družba Aurobindo Pharma (Malta) Limited je regulativni agenciji Združenega kraljestva za zdravila predložila vlogo za začetek decentraliziranega postopka za zdravilo Didanosine.
English: The CHMP therefore concluded that the benefits of Didanosine outweigh its risks and recommended that the marketing authorisation be granted in the concerned Member States.
Slovenian: Odbor CHMP je zato zaključil, da so koristi zdravila Didanosine večje od z njim povezanih tveganj, in priporočil, da se odobri dovoljenje za promet z zdravilom v zadevnih državah članicah.
English: Questions and answers on Didanosine and associated names (didanosine, gastro-resistant capsules, 200, 250 and 400 mg)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Didanosine in povezanimi imeni (didanozin, gastrorezistentne kapsule, 200, 250 in 400 mg)
English: Didanosine is an antiviral medicine used in combination with other medicines to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Didanosine je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje bolnikov, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: Questions and answers on Didanosine and associated names (didanosine, gastroresistant capsules, 200, 250 and 400 mg) EMA/562334/2013 rev.1
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Didanosine in povezanimi imeni (didanozin, gastrorezistentne kapsule, 200, 250 in 400 mg) EMA/562334/2013 rev.1
English: Although the Committee noted that the maximum concentrations of active substance in the blood when taken with food were somewhat higher after Didanosine than after the reference medicine, it considered that the difference was not clinically relevant since the medicine should be taken on an empty stomach, which produces much higher concentrations, and these small variations in the concentration of the active substance in the blood would therefore not increase the risks.
Slovenian: Čeprav je odbor upošteval, da so bile največje koncentracije zdravilne učinkovine v krvi po zaužitju s hrano nekoliko večje po zaužitju zdravila Didanosine kot po zaužitju referenčnega zdravila, je menil, da razlika ni bila klinično pomembna, ker je zdravilo namenjeno zaužitju na prazen želodec, kar povzroči veliko večje koncentracije, zato te majhne razlike v koncentraciji zdravilne učinkovine v krvi ne bi povečale tveganj.
English: By blocking this enzyme, didanosine, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Z zaviranjem tega encima didanozin, uporabljen v kombinaciji z drugimi protivirusnimi zdravili, zmanjša količino virusa HIV v krvi in jo ohranja na nizki ravni.
English: This prevents the active substance from being destroyed by the acid in the stomach.
Slovenian: Na ta način se prepreči, da bi kislina v želodcu uničila zdravilno učinkovino.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicine has been shown when taken on an empty stomach, and under fed conditions when considering the overall exposure to the active substance (a measure known as AUC).
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave znotraj odbora je CHMP zaključil, da je bila biološka enakovrednost z referenčnim zdravilom dokazana pri zaužitju na prazen želodec in po obroku, če se upošteva skupna izpostavljenost zdravilni učinkovini (parameter, znan pod imenom AUC).
English: The grounds for the referral were objections raised by France and the Netherlands that the bioequivalence study carried out under fed conditions did not show that Didanosine was bioequivalent to its reference medicine, Videx EC.
Slovenian: Podlaga za napotitveni postopek so bili ugovori Francije in Nizozemske, ki sta trdili, da študija biološke enakovrednosti, opravljena pri zaužitju po obroku, ni pokazala, da je zdravilo Didanosine biološko enakovredno referenčnemu zdravilu Videx EC.
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to make more viruses in the cells it has infected.
Slovenian: Zdravilo zavira delovanje reverzne transkriptaze, tj. encima, ki ga proizvaja virus HIV-1 in ki omogoča nastajanje novih virusov v okuženih celicah.
English: Although the presence of food in the stomach lowers the amount of active substance that can be absorbed and these medicines should therefore be taken on an empty stomach, as Didanosine is a gastro-resistant preparation bioequivalence in fed conditions must be shown to grant the marketing authorisation.
Slovenian: Čeprav prisotnost hrane v želodcu zmanjša količino zdravilne učinkovine, ki se lahko absorbira, in je zato ta zdravila treba jemati na prazen želodec, je zaradi dejstva, da je zdravilo Didanosine gastrorezistenten pripravek, za odobritev dovoljenja za promet treba dokazati biološko enakovrednost pri zaužitju po obroku.
English: Didanosine belongs to a class of medicines called nucleoside analogues or nucleoside reversetranscriptase inhibitors (NRTIs).
Slovenian: Zdravilo Didanosine spada v skupino zdravil, imenovanih nukleozidni analogi ali nukleozidni zaviralci reverzne transkriptaze (NRTI).
English: 66 months.
Slovenian: 66 mesecev.
English: Day 7 or 8 or 9:
Slovenian: 7., 8. ali 9. dan:
English: Please ask your doctor how this may affect you, especially if you are planning on having children in the future.
Slovenian: Vprašajte svojega zdravnika, kako vas to lahko prizadene, zlasti če v prihodnosti načrtujete imeti otroke.
English: The onset of the reactions varied from days to months.
Slovenian: Pojavnost reakcij se je po dneh in mesecih spreminjala.
English: These usually decrease around two months after start of treatment.
Slovenian: Te začnejo običajno padati približno dva meseca po začetku zdravljenja.
English: Table 1 summarizes efficacy data from this study.
Slovenian: Preglednica 1 povzema podatke o učinkovitosti iz te študije.
English: Average % RCP =
Slovenian: 6) Povprečna % RCP =
English: These persons will take special care for the safe use of this product and will keep you informed of their actions.
Slovenian: Te osebe bodo posebej poskrbele za varno uporabo tega zdravila in vas bodo obveščale o svojih ukrepih.
English: Your doctor will immediately stop the treatment.
Slovenian: Vaš zdravnik bo takoj ustavil zdravljenje.
English: Please be cautious until you are sure you are not affected.
Slovenian: Prosimo, bodite previdni, dokler niste prepričani, da nimate teh neželenih učinkov.
English: This results in the ability to kill both targeted and neighbouring cells.
Slovenian: Zato ima sposobnost uničiti tako ciljne kot tudi sosednje celice.
English: Expected haematological toxicity was observed, including grade 3 or 4.
Slovenian: Opažena hematološka toksičnost je bila pričakovana, vključno s 3. ali 4. stopnjo.
English: Tell your doctor immediately if you notice symptoms of any of the following:
Slovenian: Takoj obvestite svojega zdravnika, če opazite karkoli od naslednjega:
English: HCl concentration
Slovenian: Koncentracija HCl
English: In all cases it is necessary to ensure that the risks of the radiation are less than from the disease itself.
Slovenian: V vseh primerih je potrebno zagotoviti, da je tveganje zaradi sevanja manj ogrožajoče kot bolezen sama.
English: Y] was 28 h.
Slovenian: Y] 28 ur.
English: Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če uporabljate ali ste pred kratkim uporabljali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: Labelling time longer than six minutes or shorter than four minutes will result in inadequate radioincorporation.
Slovenian: Če je čas označevanja daljši od 6 minut ali krajši od 4 minut, radiooznačevanje ne bo ustrezno.
English: Empty reaction vial (10 ml)
Slovenian: Prazna reakcijska viala (10 ml)
English: * Needs to be included as release test or controlled through process validation if above limit of quantitation
Slovenian: * Mora biti vključeno kot test sproščanja ali se kontrolira z validacijo postopka, če so vrednosti nad mejo kvantifikacije.
English: • Treatment with growth factors
Slovenian: • Zdravljenje z rastnimi faktorji
English: Date of first authorisation: 16 January 2004
Slovenian: Datum prve odobritve: 16. januar 2004 Datum zadnjega podaljšanja: 16. januar 2009
English: Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.
Slovenian: Vaš zdravnik in zdravnik specialist nuklearne medicine sta presodila, da klinična korist, ki jo boste imeli od postopka z radiofarmakom, odtehta tveganje zaradi sevanja.
English: Depending on the kind/severity of reaction your doctor will decide if treatment must be stopped immediately.
Slovenian: Glede na vrsto/resnost reakcije se bo vaš zdravnik odločil, ali je treba z zdravljenjem takoj prekiniti.
English: Most radioactivity will decay within the body, but a small part will be eliminated through your urine.
Slovenian: Večina radioaktivnosti razpade znotraj telesa, vendar se majhen del iz vašega telesa izloči z urinom.
English: Individual metals*
Slovenian: Posamezne kovine*