FrancophonIA/ELRC3.0 huggingface dataset:
English: It was to be available as prolonged-release tablets (50, 100 and 200 mg).
Slovenian: Zdravilo naj bi bilo v obliki tablet s podaljšanim sproščanjem (50, 100 in 200 mg).
English: International non-proprietary name (INN): desvenlafaxine
Slovenian: Mednarodno nelastniško ime (INN): desvenlafaksin
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če ste vključeni v klinično preskušanje in potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: In all of the studies, the effectiveness of the medicine was measured using standard questionnaires for depression.
Slovenian: V vseh teh študijah so učinkovitost zdravila merili s standardnimi vprašalniki za depresijo.
English: The CHMP was assessing the responses given by the company to a list of questions.
Slovenian: CHMP je ocenjeval odgovore, ki jih je družba podala na vprašanja s seznama vprašanj.
English: Two of the flexible-dose studies also included venlafaxine (however, the studies were not designed to compare the two medicines).
Slovenian: Dve od študij s prilagodljivimi odmerki zdravila sta vključevali tudi uporabo venlafaksina (vendar ti študiji nista bili zasnovani za primerjavo obeh zdravil).
English: The effects of Ellefore were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Ellefore so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: On 13 October 2008, Wyeth Europa Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ellefore, for the treatment of major depressive disorder.
Slovenian: Družba Wyeth Europa Ltd. je dne 13. oktobra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Ellefore, namenjenim zdravljenju hudih depresivnih motenj.
English: In these short-term studies, the main measure of effectiveness was the change in depressive symptoms over the eight weeks of treatment.
Slovenian: V teh kratkoročnih študijah je bilo glavno merilo učinkovitosti sprememba simptomov depresije v osmih tednih zdravljenja.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Slovenian: Nevrotransmiterji so kemične spojine, ki živčnim celicam omogočajo medsebojno komunikacijo.
English: Ellefore was compared with placebo (a dummy treatment) in nine main studies involving a total of over 3,000 adults with major depression.
Slovenian: Zdravilo Ellefore so primerjali s placebom (zdravilom brez zdravilne učinkovine) v devetih glavnih študijah, ki so vključevale vsega skupaj več kot 3 000 odraslih s hudo depresijo.
English: Information on the short and long-term effectiveness of Ellefore was also considered to be insufficient, because too few patients in the studies took the doses of Ellefore that were intended for use and because the studies' results were inconsistent.
Slovenian: Zaradi tega so podatke o kratkoročni in dolgoročni učinkovitosti zdravila Ellefore prav tako označili za nezadostne, saj je premalo bolnikov v študijah vzelo odmerke zdravila Ellefore, ki so bili namenjeni za uporabo, in ker rezultati študij niso bili dosledni.
English: The substance has been slightly modified with the aim of reducing side effects in patients who have problems breaking venlafaxine down.
Slovenian: Spojino so malce spremenili, da bi zmanjšali neželene učinke pri bolnikih, ki imajo težave z razgrajanjem venlafaksina.
English: Questions and answers on the withdrawal of the marketing application for Ellefore
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Ellefore
English: Desvenlafaxine is derived from venlafaxine, an SNRI that has been used as an antidepressant since the 1990s.
Slovenian: Desvenlafaksin se pridobiva iz venlafaksina, SNRI, ki so ga uporabljali kot zdravilo proti depresiji od 1990-ih.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Ellefore?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih ali programih sočutne uporabe zdravila Ellefore?
English: It works by preventing the neurotransmitters 5-hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain.
Slovenian: Deluje tako, da preprečuje ponovno privzemanje nevrotransmiterjev 5hidroksitriptamina (imenovanega tudi serotonin) in noradrenalina v možganske celice.
English: What documentation did the company present to support its application to the CHMP?
Slovenian: Katero dokumentacijo je družba predstavila CHMP v podporo svoji vlogi?
English: The application was at day 166 when the company withdrew.
Slovenian: Družba je vlogo umaknila na 166. dan postopka.
English: ‘Prolonged release' means that the active substance is released from the tablets over a few hours.
Slovenian: Izraz podaljšano sproščanje pomeni, da se zdravilna učinkovina iz tablet sprošča več ur.
English: Four of the studies involving 1,814 patients used a fixed dose of Ellefore, and another four involving 1,229 patients used doses of Ellefore that could be adjusted.
Slovenian: V štirih študijah, ki so vključevale 1 814 bolnikov, so uporabljali stalni odmerek zdravila Ellefore, v drugih štirih študijah, ki so vključevale 1 229 bolnikov, pa so uporabljali prilagodljive odmerke zdravila Ellefore.
English: Ellefore was expected to be used to treat major depression in adults.
Slovenian: Zdravilo Ellefore naj bi se bilo uporabljalo za zdravljenje hudih depresivnih motenj pri odraslih.
English: Since these neurotransmitters are involved in the control of mood, blocking their re-uptake into nerve cells is expected to improve the symptoms of major depression.
Slovenian: Ker omenjena nevrotransmiterja sodelujeta pri nadzorovanju razpoloženja, je bilo pričakovati, da se bodo z blokado njihovega ponovnega privzema v živčne celice izboljšali simptomi hude depresije.
English: By blocking their re-uptake, desvenlafaxine increases the amount of these neurotransmitters in the spaces between certain nerve cells, increasing the level of communication between the cells.
Slovenian: Desvenlafaksin z blokiranjem ponovnega privzemanja poveča količino teh nevrotransmiterjev v prostorih med posameznimi živčnimi celicami, zaradi česar se poveča raven komunikacije med celicami.
English: In relation to its parent substance, venlafaxine, desvenlafaxine seemed to be less effective with no advantages in terms of safety and tolerability.
Slovenian: Videti je, da je desvenlafaksin v primerjavi s starševsko učinkovino, venelafaksinom, manj učinkovit in brez prednosti glede varnosti in prenašanja pri bolnikih.
English: Ellefore is a medicine that contains the active substance desvenlafaxine.
Slovenian: Ellefore je zdravilo, ki vsebuje zdravilno učinkovino desvenlafaksin.
English: What is Ellefore?
Slovenian: Kaj je zdravilo Ellefore?
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ellefore could not have been approved for the treatment of major depressive disorder.
Slovenian: Na podlagi pregleda podatkov je CHMP v času umika vloge izrazil določene zadržke in je začasno menil, da zdravilo Ellefore ne more biti odobreno za zdravljenje hude depresivne motnje.
English: The CHMP was concerned that, overall, the effectiveness of Ellefore had not been shown convincingly.
Slovenian: CHMP je menil, da učinkovitost zdravila Ellefore ni bila prepričljivo dokazana.
English: The active substance in Ellefore, desvenlafaxine, is a ‘serotonin-noradrenaline re-uptake inhibitor' (SNRI).
Slovenian: Zdravilna učinkovina v zdravilu Ellefore, desvenlafaksin, je inhibitor ponovnega privzema serotonina in noradrenalina (SNRI).
English: One long-term study looked at how long it took for symptoms to return in a total of 376 patients who had already shown a response to an initial 12 weeks of Ellefore treatment.
Slovenian: V eni od dolgoročnih študij so pri vsega skupaj 376 bolnikih, ki so se že odzvali na začetno 12tedensko zdravljenje z zdravilom Ellefore, opazovali čas, potreben za ponoven pojav simptomov.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Ellefore and that there are no compassionate use programmes ongoing.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Ellefore.
English: What was Ellefore expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Ellefore bilo uporabljalo?
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Ellefore had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: CHMP je v času umika menil, da koristi zdravila Ellefore niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
English: How is Ellefore expected to work?
Slovenian: Kako naj bi zdravilo Ellefore delovalo?
English: • if you are taking medicines for high blood pressure.
Slovenian: · če jemljete zdravila za visok krvni tlak.
English: In-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Čas in pogoji shranjevanja pred uporabo so odgovornost uporabnika.
English: Median TTP:
Slovenian: mediana TTP:
English: • if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries.
Slovenian: · če menite, da boste v kratkem potrebovali katero koli cepljenje, vključno s cepljenji, ki bi jih potrebovali za potovanje v druge države.
English: • Keep this card with you all the time - such as in your wallet or purse.
Slovenian: · Kartico imejte vedno pri sebi, na primer v denarnici ali torbici.
English: If not used immediately, preparation should take place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljeno takoj, mora priprava potekati v kontroliranih in preverjenih aseptičnih pogojih.
English: • What to do if you think you might be getting an infection.
Slovenian: · Kaj storite, če menite, da imate morda okužbo
English: In total: 8 cycles.
Slovenian: Skupaj: 8 ciklov.
English: The corresponding AUCτ ratios were 1.66, 1.17 and 1.32.
Slovenian: Ustrezna razmerja AUCτ so bila 1,66, 1,17 in 1,32.
English: † Outcome at 24 weeks
Slovenian: † Izid po 24 tednih
English: Three cases had no reported adverse event.
Slovenian: treh primerih niso poročali o nobenem neželenem dogodku.
English: How much and how often you will receive your treatment
Slovenian: Koliko zdravila boste dobili in kako pogosto
English: In addition, central volume was slightly (9%) lower in females compared to males.
Slovenian: Poleg tega je bil centralni volumen nekoliko (9 %) nižji pri ženskah kot pri moških.
English: The most frequent reported or observed serious adverse drug reactions were:
Slovenian: Najpogosteje zabeleženi ali opaženi resni neželeni učinki so bili:
English: Date of latest renewal: 2 June 2008
Slovenian: Datum prve odobritve: 2. junij 1998 Datum zadnjega podaljšanja: 2. junij 2008
English: • Changes in laboratory tests carried out by your doctor.
Slovenian: · spremembe rezultatov laboratorijskih preiskav, ki jih naroči vaš zdravnik.
English: If an injection is interrupted it can be resumed at the same site or another location may be used, if appropriate.
Slovenian: Če se injiciranje prekine, ga je mogoče nadaljevati na istem mestu, lahko pa se uporabi tudi drugo mesto, če je to primerno.
English: Proportion with PFS event
Slovenian: Delež z dogodkom PFS
English: Overall survival
Slovenian: celokupno preživetje
English: 1 Antibody Way Oceanside, CA 92056 5802 USA
Slovenian: 1 Antibody Way Oceanside, CA 92056 5802 ZDA
English: • Additional risk minimisation measures
Slovenian: · Dodatni ukrepi za zmanjševanje tveganj
English: Available data suggest that clinical response is usually achieved within 16 - 24 weeks of an initial treatment course.
Slovenian: Podatki, ki so na voljo, kažejo, da je klinični odziv ponavadi dosežen v roku 16-24 tednov po začetnem ciklu zdravljenja.
English: All IRRs were CTC Grade 1 or 2.
Slovenian: Vse IRR so bile 1. ali 2. stopnje po CTC.
English: This is usually given every 3 weeks up to 8 times.
Slovenian: Ta se po navadi daje na 3 tedne, do 8-krat.
English: You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant.
Slovenian: Zdravniku ali medicinski sestri morate povedati, če ste noseči, menite, da ste noseči, ali načrtujete zanositev.
English: Proportion of patients with no radiographic change
Slovenian: Delež bolnikov brez radioloških sprememb
English: Do not have MabThera if you have an active infection or a serious problem with your immune system.
Slovenian: Zdravila MabThera ne smete prejeti, če imate aktivno okužbo ali resno težavo s svojim imunskim sistemom.
English: Take this into account if you are on a low-sodium diet.
Slovenian: To količino upoštevajte, če ste na dieti z nizkim vnosom natrija.
English: All patients n=99
Slovenian: Vsi bolniki n = 99
English: 95.1%b CI (−3.2%, 24.3%) a
Slovenian: 95,1 %b IZ (-3,2 %, 24,3 %) a
English: Results from trial BP22333 are presented in section 5.2.
Slovenian: Izsledki preskušanja BP22333 so predstavljeni v poglavju 5.2.
English: Date of most recent infusion: ____________ Date of first infusion: ___________________ Patient's Name:________________________ Doctor's Name:________________________ Doctor's contact details:_________________
Slovenian: Bolnikovo ime:________________________ Zdravnikovo ime:______________________ Zdravnikov telefon:_________________
English: Your doctor may decide to treat you longer with MabThera (up to 5 years), depending on how you respond to the medicine.
Slovenian: Zdravnik se lahko odloči, da vas bo z zdravilom MabThera zdravil dlje (do 5 let), odvisno od tega, kako se odzovete na zdravilo.
English: +myocardial infarction4 and 6,
Slovenian: +miokardni infarkt4 in 6,
English: The gender- related pharmacokinetic differences are not considered to be clinically relevant and dose adjustment is not required.
Slovenian: S spolom povezane razlike v farmakokinetiki ne štejemo za klinično pomembne in prilagajanje odmerkov ni potrebno.
English: − CI = confidence interval.
Slovenian: IZ = interval zaupanja.
English: Your doctor may decide to stop your MabThera treatment if these reactions are serious.
Slovenian: Zdravnik se lahko odloči za prenehanje zdravljenja z zdravilom MabThera, če so te reakcije resne.
English: Binet stage A Binet stage B Binet stage C
Slovenian: stopnja po Binetu A stopnja po Binetu B stopnja po Binetu C
English: 9/L as clinical experience in this population is limited.
Slovenian: Kliničnih izkušenj v tej populaciji je namreč malo.
English: Trial BO22334 (SABRINA)
Slovenian: Preskušanje BO22334 (SABRINA)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če je ne uporabimo takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik; čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C, razen če je bila raztopina pripravljena v nadzorovanih in validiranih aseptičnih pogojih.
English: Figure 3: Cumulative incidence over time of first major relapse
Slovenian: Slika 3: Kumulativna incidenca glede na čas prvega hujšega recidiva
English: • if you have ever taken medicines which affect your immune system - such as chemotherapy or immune-suppressive medicines.
Slovenian: · če ste kdaj jemali zdravila, ki vplivajo na imunski sistem - na primer kemoterapijo ali imunosupresivna zdravila.
English: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your MabThera.
Slovenian: · Pokažite jo vsem zdravnikom, medicinskim sestram in zobozdravnikom, ki jih obiščete - ne samo specialistu, ki vam predpiše zdravilo MabThera.
English: Treatment, N
Slovenian: Zdravljenje (n)
English: Twenty nine (0.48%) post-dose observations (all from trial BP22333) were below the quantification limit.
Slovenian: Devetindvajset (0,48 %) vrednosti po odmerku (vse iz preskušanja BP22333) je bilo pod mejo kvantifikacije.
English: MabThera will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Slovenian: Zdravilo MabThera vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje z uporabo takšnih zdravil.
English: It remains unknown if early detection of PML and suspension of MabThera therapy may lead to similar stabilisation or improved outcome.
Slovenian: Ni znano, ali lahko zgodnje odkritje PML in ukinitev zdravljenja z zdravilom MabThera doseže podobno stabilizacijo ali izboljšanje izida.
English: Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection
Slovenian: Bolnike, ki so kdaj imeli okužbo z virusom hepatitisa B, bo zdravnik skrbno spremljal glede znakov te okužbe;
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Slovenian: Kadar predložitev PSUR in posodobitev RMP sovpadata, se ju lahko predloži istočasno.
English: Patients should receive MabThera for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Slovenian: MabThera prejemati vsaj 24 mesecev po doseženi remisiji (odsotnost kliničnih znakov in simptomov).
English: No data are available on performing the injection in other sites of the body, therefore injections should be restricted to the abdominal wall.
Slovenian: Podatkov o injiciranju v druge dele telesa ni, zato mora biti injiciranje omejeno na trebušno steno.
English: If you can get pregnant, you and your partner must use an effective method of contraception while using MabThera.
Slovenian: Če bi lahko zanosili, morate vi in vaš partner med uporabo zdravila MabThera uporabljati učinkovito kontracepcijsko zaščito.
English: The risk of disease progression was reduced by 46 % and the risk of relapse by 51 %.
Slovenian: Tveganje za napredovanje bolezni je bilo manjše za 46 %, tveganje za ponovitev bolezni pa za 51 %.
English: Your doctor will decide when to start MabThera injections.
Slovenian: Vaš zdravnik bo presodil, kdaj začeti z injekcijami zdravila MabThera.
English: • if you think you may have an infection, even a mild one like a cold.
Slovenian: · če menite, da bi lahko imeli okužbo, četudi blago, kot je prehlad.
English: Non-oncology indications:
Slovenian: Neonkološke indikacije:
English: Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more MabThera.
Slovenian: Glede na znake in simptome vaše bolezni se bo zdravnik odločil, kdaj boste ponovno zdravljeni z zdravilom MabThera.
English: The “primary” statistical test for “response” was the trend test of CR versus PR versus non-response (p < 0.0001)
Slovenian: “Primarni” statistični test za “odgovor” je bil test trenda CR v primerjavi s PR v primerjavi z neodzivnimi (p < 0,0001).
English: MabThera may also cause changes in laboratory tests carried out by your doctor.
Slovenian: Zdravilo MabThera lahko vpliva tudi na spremembe laboratorijskih preiskav, ki jih naroči vaš zdravnik.
English: You may be asked not to take these other medicines 12 hours before you are given MabThera.
Slovenian: Morda vam bo naročil, da ne jemljite teh drugih zdravil 12 ur, preden boste dobili zdravilo MabThera.
English: The information provided in this section pertains to the use of MabThera in oncology.
Slovenian: Informacije v tem poglavju se nanašajo na uporabo zdravila MabThera v onkologiji.
English: The Physician information, Patient information and Patient Alert Card must be agreed with the National Competent Authorities prior to distribution.
Slovenian: Vsebina in oblika izobraževalnega gradiva za zdravnike in bolnike ter opozorilne kartice za bolnika morata biti pred razdeljevanjem dogovorjeni s pristojnim nacionalnim organom.
English: • painful joints or back
Slovenian: · boleči sklepi ali hrbet,
English: The overall proportion of patients found to have anti-rHuPH20 antibodies remained generally constant over the follow-up period in both cohorts.
Slovenian: Celotni delež bolnikov, pri katerih so ugotovili protitelesa proti rHuPH20, je ostal med obdobjem spremljanja v obeh kohortah na splošno stalen.
English: In clinical trials more than 3100 patients received at least one treatment course and were followed for periods ranging from 6 months to over 5 years; approximately 2400 patients received two or more courses of treatment with over 1000 having received 5 or more courses.
Slovenian: V kliničnih preskušanjih je več kot 3100 bolnikov prejelo najmanj en cikel zdravljenja, po tem so jih spremljali od 6 mesecev do več kot 5 let; približno 2400 bolnikov je prejelo dva ali več ciklov zdravljenja, od teh pa več kot 1000 bolnikov 5 ali več ciklov zdravljenja.
English: • tremors (shakiness, often in the hands)
Slovenian: · tremor (tresenje, pogosto tresenje rok),
English: • The need for close supervision during administration in an environment where full resuscitation facilities are immediately available
Slovenian: · informacije o nujnosti skrbnega nadzora med aplikacijo v okolju, kjer so nemudoma na voljo vsi pripomočki za oživljanje,
English: At minimum this should include HBsAg-status and HBcAb-status.These can be complemented with other appropriate markers as per local guidelines.
Slovenian: To vključuje najmanj določanje statusa HBsAg in HBcAb, ki ju lahko dopolnimo z ostalimi primernimi označevalci v skladu z lokalnimi smernicami.
English: For storage conditions after first opening see section 6.3.
Slovenian: Za pogoje shranjevanja po prvem odprtju glejte poglavje 6.3.
English: ACR20 ACR50 ACR70 EULAR Response (Good/Moderate) Mean Change in DAS
Slovenian: ACR20 ACR50 ACR70 Odziv po EULAR (dober/zmeren)
English: Based on popPK analysis an absolute bioavailability of 71% was estimated.
Slovenian: Na podlagi populacijske farmakokinetične analize je bila ocenjena absolutna biološka uporabnost 71 %.
English: The incidence of infections that were serious or required IV antibiotics was approximately 4 per 100 patient years.
Slovenian: Incidenca okužb, ki so bile resne ali so zahtevale uporabo intravenskega antibiotika, je bila približno 4 na 100 bolnik-let.
English: Based on popPK analysis of study BO25341 (SAWYER) an absolute bioavailability of 68.4% was estimated.
Slovenian: Na podlagi populacijske farmakokinetične analize študije BO25341 (SAWYER) je bila ocenjena absolutna biološka uporabnost 68,4 %.
English: • What the signs of an infection are
Slovenian: · Kateri so znaki okužbe
English: Higher time-dependenet clearance in subjects with higher disease burden would lead to lower initial exposure and longer time needed to achieve the same exposure as in subjects with lower burden of the disease.
Slovenian: Večji od-časa-odvisen-očistek pri bolnikih z višjim bremenom bolezni je povzročil nižjo začetno izpostavljenost zdravilu in podaljšanje časa, potrebnega za doseganje enake izpostavljenosti kot pri bolnikih z nižjim bremenom bolezni.
English: For these reasons MabThera should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Slovenian: Zato nosečnice ne smejo prejemati zdravila MabThera, razen če je pričakovana korist večja od možnega tveganja.
English: The response rates for the analysis of 176 patients in SAWYER Part 2 are shown in Table 2.
Slovenian: Deleži odgovorov analize 176 bolnikov v 2. delu preskušanja SAWYER so prikazani v preglednici 2.
English: When should I not have MabThera?
Slovenian: Kdaj ne smete prejeti zdravila MabThera?
English: Treatment Difference (MabTheraCyclophosphamide)
Slovenian: razlika zdravljenj (MabTheraciklofosfamid)