natgillin/translations-raw huggingface dataset:
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.
Didanozin ne ozdravi okužbe z virusom HIV ali aidsa, vendar lahko upočasni slabšanje imunskega sistema in razvoj okužb ter bolezni, povezanih z aidsom.
‘Gastroresistant' means that the tablet's contents pass through the stomach without being broken down until they reach the intestine.
„Gastrorezistentne“ pomeni, da vsebina tablet preide skozi želodec v črevesje, ne da bi se pri tem razgradila.
Aurobindo Pharma (Malta) Limited submitted Didanosine to the UK medicines regulatory agency for a decentralised procedure.
Družba Aurobindo Pharma (Malta) Limited je regulativni agenciji Združenega kraljestva za zdravila predložila vlogo za začetek decentraliziranega postopka za zdravilo Didanosine.
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.
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.
Questions and answers on Didanosine and associated names (didanosine, gastro-resistant capsules, 200, 250 and 400 mg)
Vprašanja in odgovori v zvezi z zdravilom Didanosine in povezanimi imeni (didanozin, gastrorezistentne kapsule, 200, 250 in 400 mg)
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).
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).
Questions and answers on Didanosine and associated names (didanosine, gastroresistant capsules, 200, 250 and 400 mg) EMA/562334/2013 rev.1
Vprašanja in odgovori v zvezi z zdravilom Didanosine in povezanimi imeni (didanozin, gastrorezistentne kapsule, 200, 250 in 400 mg) EMA/562334/2013 rev.1
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.
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.
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.
Z zaviranjem tega encima didanozin, uporabljen v kombinaciji z drugimi protivirusnimi zdravili, zmanjša količino virusa HIV v krvi in jo ohranja na nizki ravni.
This prevents the active substance from being destroyed by the acid in the stomach.
Na ta način se prepreči, da bi kislina v želodcu uničila zdravilno učinkovino.
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).
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).
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.
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.
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.
Zdravilo zavira delovanje reverzne transkriptaze, tj. encima, ki ga proizvaja virus HIV-1 in ki omogoča nastajanje novih virusov v okuženih celicah.
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.
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.
Didanosine belongs to a class of medicines called nucleoside analogues or nucleoside reversetranscriptase inhibitors (NRTIs).
Zdravilo Didanosine spada v skupino zdravil, imenovanih nukleozidni analogi ali nukleozidni zaviralci reverzne transkriptaze (NRTI).
66 months.
66 mesecev.
Day 7 or 8 or 9:
7., 8. ali 9. dan:
Please ask your doctor how this may affect you, especially if you are planning on having children in the future.
Vprašajte svojega zdravnika, kako vas to lahko prizadene, zlasti če v prihodnosti načrtujete imeti otroke.
The onset of the reactions varied from days to months.
Pojavnost reakcij se je po dneh in mesecih spreminjala.
These usually decrease around two months after start of treatment.
Te začnejo običajno padati približno dva meseca po začetku zdravljenja.
Table 1 summarizes efficacy data from this study.
Preglednica 1 povzema podatke o učinkovitosti iz te študije.
Average % RCP =
6) Povprečna % RCP =
These persons will take special care for the safe use of this product and will keep you informed of their actions.
Te osebe bodo posebej poskrbele za varno uporabo tega zdravila in vas bodo obveščale o svojih ukrepih.
Your doctor will immediately stop the treatment.
Vaš zdravnik bo takoj ustavil zdravljenje.
Please be cautious until you are sure you are not affected.
Prosimo, bodite previdni, dokler niste prepričani, da nimate teh neželenih učinkov.
This results in the ability to kill both targeted and neighbouring cells.
Zato ima sposobnost uničiti tako ciljne kot tudi sosednje celice.
Expected haematological toxicity was observed, including grade 3 or 4.
Opažena hematološka toksičnost je bila pričakovana, vključno s 3. ali 4. stopnjo.
Tell your doctor immediately if you notice symptoms of any of the following:
Takoj obvestite svojega zdravnika, če opazite karkoli od naslednjega:
In all cases it is necessary to ensure that the risks of the radiation are less than from the disease itself.
V vseh primerih je potrebno zagotoviti, da je tveganje zaradi sevanja manj ogrožajoče kot bolezen sama.
Y] was 28 h.
Y] 28 ur.
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če uporabljate ali ste pred kratkim uporabljali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Labelling time longer than six minutes or shorter than four minutes will result in inadequate radioincorporation.
Če je čas označevanja daljši od 6 minut ali krajši od 4 minut, radiooznačevanje ne bo ustrezno.
Empty reaction vial (10 ml)
Prazna reakcijska viala (10 ml)
* Needs to be included as release test or controlled through process validation if above limit of quantitation
* Mora biti vključeno kot test sproščanja ali se kontrolira z validacijo postopka, če so vrednosti nad mejo kvantifikacije.
• Treatment with growth factors
• Zdravljenje z rastnimi faktorji
Date of first authorisation: 16 January 2004
Datum prve odobritve: 16. januar 2004 Datum zadnjega podaljšanja: 16. januar 2009
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.
Vaš zdravnik in zdravnik specialist nuklearne medicine sta presodila, da klinična korist, ki jo boste imeli od postopka z radiofarmakom, odtehta tveganje zaradi sevanja.
Depending on the kind/severity of reaction your doctor will decide if treatment must be stopped immediately.
Glede na vrsto/resnost reakcije se bo vaš zdravnik odločil, ali je treba z zdravljenjem takoj prekiniti.
Most radioactivity will decay within the body, but a small part will be eliminated through your urine.
Večina radioaktivnosti razpade znotraj telesa, vendar se majhen del iz vašega telesa izloči z urinom.
Individual metals*
Posamezne kovine*
There is a potential risk that [
Obstaja možno tveganje, da povzroča z [
There is a potential risk that ionizing radiation by [
Obstaja potencialno tveganje, da lahko ionizirajoče sevanje z [
This product will only be handled and given to you by people who are trained and qualified to use it safely.
S tem zdravilom bodo rokovali in vam ga dajali ljudje, ki so izobraženi in usposobljeni za njegovo varno uporabo.
Frequency groupings are defined according to the following convention: (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).
Skupine pogostnosti so opredeljene v skladu z naslednjim dogovorom: (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).
Refractory or relapsed NHL:
Neodzivni ali relapsni NHL:
Below limit of quantitation*
pod mejo kvantifikacije*
N = 70
Rituksimab n = 70
Patients recovered from these toxicity signs, and overdoses were not associated with serious or fatal outcome.
Bolniki so si od teh toksičnih znakov opomogli, preveliki odmerki pa niso povzročili resnih ali usodnih posledic.
Zevalin contains 1 of each of the following:
Zdravilo Zevalin vsebuje po 1 od naslednjega:
In total, 87% of patients were in CR(u); 76% in CR and 11% in CRu.
V celoti je bilo v CR(u) 87 % bolnikov; 76 % v CR in 11 % v Cru.
You can report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
The binding pattern is very restricted, with no cross-reactivity to other leukocytes or to other types of human tissue.
Vzorec vezave je zelo omejen, brez navzkrižne reaktivnosti nasproti drugim levkocitom ali drugim vrstam človeškega tkiva.
You will be given a total of 3 infusions in the course of two visits to a medical facility, 7 to 9 days apart.
Prejeli boste skupaj 3 infuzije v teku dveh obiskov bolnišnice, v razmaku 7 do 9 dni.
There are no known interactions with other medicinal products.
Interakcije z drugimi zdravili niso znane.
No overall differences in safety or efficacy were observed between these patients and younger patients.
Splošnih razlik v varnosti ali učinkovitosti med to skupino bolnikov in mlajšimi bolniki niso opazili.
This medicine will be stored by a healthcare professional.
To zdravilo bo shranil zdravstveni delavec.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significang change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki 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).
Infections may be bacterial, fungal, viral including reactivation of latent viruses.
Okužbe so lahko bakterijske, glivične in virusne, vključno z reaktivacijo latentnih virusov.
Process residuals (e.g. ammonia, nitrate)
Ostanki pri predelavi (npr. amoniak, nitrat)
 10 ppm each * Metals to be included need to be based on the specific manufacturing process.
 10 ppm vsaka * Pri kovinah, ki naj bi bile navedene, mora biti upoštevan specifičen proizvodni postopek.
Median progression free survival (PFS) was calculated at a median follow-up of 2.9 years.
Mediano preživetje brez napredovanja bolezni (PFS) so izračunali po medianem 2,9-letnem spremljanju.
It is used as a consolidation therapy to improve the reduction in the number of lymphoma cells (remission) achieved with the initial chemotherapy regimen.
Uporablja se kot konsolidacijska terapija za izboljšanje zmanjšanja števila celic limfoma (remisija), ki se doseže z začetnim režimom kemoterapije.
• Mucocutaneous reactions, including Stevens-Johnson Syndrome
• mukokutane reakcije, vključno s Stevens-Johnsonovim sindromom
The estimated radiation-absorbed doses to normal organs were substantially below recognised upper safety limits.
Ocenjene absorbirane doze sevanja, ki jih prejmejo normalni organi, so bile precej pod dovoljeno zgornjo varnostno mejo.
Pregnancy must be excluded before the start of treatment in women.
Pred začetkom zdravljenja pri ženskah je treba izključiti nosečnost.
Name and address of the manufacturer of the biological active substance Biogen IDEC, Inc.
Ime in naslov izdelovalca biološke učinkovine Biogen IDEC, Inc.
Median TTP (Months) [Range
Mediana TTP (meseci) [razpon
1.67 to 3.34 GBq/ml
1,67 do 3,34 GBq/ml
Studies on reproductive and developmental toxicity have not been performed.
Študij reproduktivne in razvojne toksičnosti niso izvedli.
Total other Beta impurities (non-strontium-90)
Skupne druge nečistote beta (ne-stroncij-90)
Mix completely by coating the entire inner surface of the reaction vial.
Temeljito premešajte, tako da bo prekrita celotna notranja površina reakcijske viale.
• infections of the lung (pneumonia): breathing difficulties
• okužbe pljuč (pljučnice): težave z dihanjem
Therefore, for one week after the Zevalin infusion you must wash your hands thoroughly each time after urinating.
Zato si morate en teden po infuziji zdravila Zevalin po vsakem uriniranju skrbno umivati roke.
If any signs or symptoms of extravasation have occurred, the infusion must be immediately terminated and restarted in another vein.
Če se pojavi kakršenkoli znak ali simptom ekstravazacije, je treba infundiranje takoj ustaviti in ga ponovno začeti v drugi veni.
net CPM bottom half x 100 net CPM top half + net CPM bottom half
neto CPM spodnja polovica x 100 neto CPM zgornja polovica + neto CPM spodnja polovica
Zevalin will only be used in special controlled areas.
Zdravilo Zevalin se sme uporabljati samo v posebnih nadzorovanih prostorih.
The safety and efficacy of the Zevalin therapeutic regimen were evaluated in two multi-center trials enrolling a total of 197 subjects.
Varnost in učinkovitost zdravljenja z zdravilom Zevalin so ocenjevali v dveh multicentričnih študijah, v kateri je bilo vključenih skupno 197 oseb.
The final formulation after radiolabelling contains 2.08 mg [
Končna formulacija po označitvi z radioizotopom vsebuje 2,08 mg [
This medicine is a radiopharmaceutical product for therapy only.
To zdravilo je radiofarmacevtski izdelek, namenjen samo za zdravljenje.
The prepared solution must be given as a slow intravenous infusion over 10 minutes.
Pripravljeno raztopino je treba dati v obliki počasne intravenske infuzije, ki teče 10 minut.
Repeated use: Data on the re-treatment of patients with Zevalin are not available.
Ponovna uporaba: Podatki o ponovnem zdravljenju bolnikov z zdravilom Zevalin niso na voljo.
Patients should be advised that fertility may be affected and that male patients may wish to consider semen cryopreservation.
Bolnike je treba poučiti, da zdravilo lahko vpliva na plodnost in da bodo moški bolniki morda želeli svoja semenčeca shraniti z globokim zamrzovanjem.
The side effects marked with two asterisks (**) were observed additionally under consolidation therapy.
Neželene učinke, označene z dvema zvezdicama (**), so dodatno opazili v konsolidacijski terapiji.
For storage conditions of the radiolabelled product, see section 6.3.
Za pogoje shranjevanja radioaktivnega zdravila glejte poglavje 6.3.
Yttrium-90 decays by the emission of high-energy beta particles, with a physical half-life of 64.1 hours (2.67 days).
Itrij-90 razpada z oddajanjem visokoenergijskih delcev beta, njegov fizikalni razpolovni čas pa je 64,1 h (2,67 dneva).
If you have been treated with other proteins (especially mouse-derived) before Zevalin treatment, you may be more likely to have an allergic reaction.
Če ste bili zdravljeni z drugimi beljakovinami (zlasti pridobljenimi iz miši) pred zdravljenjem z zdravilom Zevalin, so pri vas alergijske reakcije bolj verjetne.
Women must not breast-feed during treatment and for 12 months following the treatment.
Ženske ne smejo dojiti med zdravljenjem in še 12 mesecev po zdravljenju.
Pharmacotherapeutic group: Various therapeutic radiopharmaceuticals, ATC code: V10XX02
Farmakoterapevtska skupina: Razni radioterapevtiki, oznaka ATC: V10XX02
In the following cases, Zevalin use is not recommended since its safety and efficacy have not been established:
V naslednjih primerih se uporaba zdravila Zevalin ne priporoča, saj varnosti in učinkovitosti niso ugotavljali:
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZEVALIN
KAJ MORATE VEDETI, PREDEN VAM BODO DALI ZDRAVILO ZEVALIN
Zevalin is not used directly, but must be prepared by your healthcare professional first.
Zdravilo Zevalin se ne uporablja neposredno, temveč ga najprej pripravi zdravstveni delavec.
The maximum dose must not exceed 1200 MBq (‘megabecquerel', a unit to measure radioactivity).
Največji odmerek ne sme preseči 1200 MBq ("megabekerelov", merske enote za radioaktivnost).
It is not shed from the cell surface and does not internalise on antibody binding.
Ne loči se s celične površine in se po vezavi protitelesa ne internalizira.
(monotherapy) and <150,000/mm
(monoterapija) in < 150.000/mm
Secondary efficacy endpoints included time to disease progression (TTP) and duration of response (DR).
Sekundarna kriterija učinkovitosti sta bila čas do napredovanja bolezni (TTP) in trajanje odgovora (DR-duration of response).
Reporting suspected adverse reactions afterauthorisation of the medicinal product is important.
Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
- On day 1 you will be given one rituximab infusion - On day 7, 8, or 9 you will be given one rituximab infusion, followed by one Zevalin infusion shortly afterwards (within 4 hours).
- 1. dan boste prejeli eno infuzijo rituksimaba - 7., 8. ali 9 dan boste prejeli eno infuzijo rituksimaba, ki ji bo kmalu zatem sledila ena infuzija zdravila Zevalin (v roku 4 ur).
The amount of radiation that your body will be exposed to due to Zevalin is smaller than with radiotherapy.
Količina sevanja, ki mu bo izpostavljeno vaše telo zaradi zdravila Zevalin, je manjša kot bi bila tista pri radioterapiji.
If the average radiochemical purity is less than 95%, the preparation must not be administered.
Če je povprečna radiokemična čistost manj kot 95 %, se pripravka ne sme dati.
Although it is not known whether ibritumomab tiuxetan is excreted in human milk, maternal IgGs are known to be excreted in human milk.
Čeprav ni znano ali se ibritumomab tiuksetan pri ljudeh izloča v materino mleko, je znano, da se IgG matere izloča v materino mleko.
91192 Gif-sur-Yvette Cedex France
91192 Gif-sur-Yvette Cedex Francija
Zevalin may be infused directly by stopping the flow from an infusion bag and administering it directly into the line.
Zdravilo Zevalin se lahko infundira neposredno z ustavitvijo toka iz infuzijske vrečke in aplikacijo neposredno v linijo.
After the 5-minute incubation period, withdraw from the reaction vial the same volume of air as the formulation buffer to be added in order to normalise pressure and immediately thereafter gently add the formulation buffer down the side of the reaction vial to terminate incubation.
Po 5-minutni inkubaciji izvlecite iz reakcijske viale enako količino zraka kot je pufer za pripravo formulacije, ki ga boste dodali za normalizacijo pritiska in takoj nato previdno dodajte pufer za pripravo formulacije v reakcijsko vialo in s tem končajte inkubacijo.
Calculate the average Radiochemical Purity (RCP) as follows:
5) Izračunajte povprečno radiokemijsko čistoto (RCP - radiochemical purity), kot sledi:
• Additional testing that might be required for suitability assessment: Process-specific impurities:
• Pri ocenjevanju primernosti bo morda treba opraviti naslednje dodatne teste: Za postopek značilne nečistote:
If you are given Zevalin less than 4 months after chemotherapy containing the active substance fludarabine, you may have a higher risk of having a reduced number of blood cells.
Če dobivate zdravilo Zevalin manj kot 4 mesece po kemoterapiji, ki je vključevala zdravilno učinkovino fludarabin, je morda pri vas tveganje zmanjšanega števila krvnih celic večje.
If available, autologous stem cell support must be administered to manage haematological toxicity.
Če so na razpolago avtologne matične celice, jih je treba uporabiti kot podporo pri obvladovanju hematološke toksičnosti.
The primary efficacy endpoint of the study was to determine the ORR using the IWRC (see Table 2).
Primarni kriterij učinkovitosti v študiji je bil določitev ORR po kriterijih IWRC (glejte preglednico 2).
During the first 13 weeks after treatment with Zevalin, patients very commonly developed infections.
V prvih 13 tednih po zdravljenju z zdravilom Zevalin se je pri bolnikih pogosto pojavila okužba.
However, after Yttrium-90 is added, adequate shielding of the final preparation must be maintained.
Po dodatku itrija-90 pa je obvezna ustrezna zaščita končnega pripravka.
Metal impurities Total metals*
Kovinske nečistote Skupne kovine*
Based upon dosimetry studies with [
Na podlagi dozimetričnih študij z [
Radiation protection precaution in accordance with local regulations must be taken, since administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc..
Potrebno je izvesti ukrepe za zaščito pred sevanjem, saj pomeni dajanje radiofarmakov tveganje za druge ljudi zaradi zunanjega sevanja ali kontaminacijo zaradi razlitega urina, bruhanja, itd.
Blood samples, used to calculate residence times for red marrow, were drawn up to eight time-points.
Krvne vzorce za izračun rezidenčnih časov v rdečem kostnem mozgu so jemali v ustreznih časovnih presledkih do 8-krat.
If at any time in the preparation of this product the integrity of the containers is compromised it should not be used.
Če se kadarkoli med pripravljanjem tega zdravila poškoduje kak vsebnik, zdravila ne smete uporabiti.
 0.74 MBq strontium-90 / 37 GBq yttrium-90
 0,74 MBq stroncij-90/ 37 GBq itrij-90
Your doctor will immediately stop the infusion and restart it using another vein.
Vaš zdravnik bo takoj ustavil infuzijo in jo prestavil na drugo žilo
Special caution is required with respect to bone marrow depletion.
Posebna previdnost je potrebna glede na zmanjšan kostni mozeg.
Your doctor will perform tests to exclude pregnancy before you start the treatment.
Vaš zdravnik bo pred začetkom zdravljenja opravil teste za izključitev nosečnosti.