FrancophonIA/ELRC3.0 huggingface dataset:
English: Fatigue/ weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Slovenian: Splošne teţave in spremembe na mestu aplikacije astenija (S3/4: 3 %), pireksija (S3/4: 1 %), utrujenost/šibkost (S3/4: 5 %), periferni edem (S3/4: 1 %)
English: Docetaxel in combination with platinum agents in chemotherapy-naïve patients
Slovenian: Zdravilo Docetaxel Teva Pharma v kombinaciji s platinskimi zdravili pri bolnikih, ki se še niso zdravili s kemoterapijo
English: Tabulated list of adverse reactions in head and neck cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neţelenih učinkov zdravljenja z zdravilom Docetaxel Teva Pharma 75 mg/m pri raku glave in vratu v kombinaciji s cisplatinom in 5-fluorouracilom
English: This vial contains 2.88 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/3.40 ml).
Slovenian: Ta viala vsebuje 2,88 ml raztopine docetaksela 27,73 mg/ml v polisorbatu 80 (polnilni volumen: 94,4 mg/3,40 ml).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docetaxel Teva Pharma 20 mg
Slovenian: Vehikel za Docetaxel Teva Pharma 20 mg
English: Metabolism and nutrition disorders Nervous system disorders
Slovenian: Presnovne in prehranske motnje anoreksija
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docetaxel Teva Pharma 80 mg
Slovenian: Vehikel za Docetaxel Teva Pharma 80 mg
English: Post-marketing experience
Slovenian: Izkušnje iz obdobja trţenja
English: Anorexia (G3/4: 11.7%)
Slovenian: Presnovne in prehranske motnje anoreksija (S3/4: 11,7 %)
English: Contracteption in males and females
Slovenian: Bolezni koţe in podkoţja
English: G3/4 Blood bilirubin increased (2.1%);
Slovenian: Preiskave povišanje ravni bilirubina v krvi S3/4 (< 2,1 %), povišanje ravni ALT S3/4 (1,3 %)
English: Each single-dose vial of Docetaxel Teva Pharma concentrate contains 20 mg docetaxel (anhydrous).
Slovenian: Vsaka enoodmerna viala koncentrata Docetaxel Teva Pharma vsebuje 20 mg docetaksela (brezvodnega).
English: min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Slovenian: Druga je na 3 tedne dobivala docetaksel 75 mg/m v enourni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml.min) v 30-60 minutah, tretja pa na 4 tedne vinorelbin (VCis) 25 mg/m v 6-10 minutah 1., 8.,
English: • stomach upsets including nausea, vomiting and diarrhoea, constipation
Slovenian: Bolezni prebavil navzeja, driska, bruhanje, zaprtost, stomatitis, dispepsija, bolečine v trebuhu
English: Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel
Slovenian: Pri bolnikih zdravljenih z docetakselom so bili opisani primeri cistoidnega makularnega edema (CMO).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.72 ml (Fill: 0.88 ml)
Slovenian: 0,72 ml (napolnjena: 0,88 ml)
English: Asthenia (G3/4: 3%);
Slovenian: Bolezni prebavil navzeja (S3/4: 5 %),
English: Hypotension (G3/4: 0.7%)
Slovenian: Ţilne bolezni hipotenzija (S3/4: 0,7 %)
English: Dyspepsia (G3/4: 0.8%); Gastrointestinal pain (G3/4: 1.2%);
Slovenian: dispepsija (S3/4: 0,8 %), bolečine v prebavilih (S3/4: 1,2 %), krvavitev v prebavilih (S3/4: 0,4 %)
English: Nail disorders (severe 0.4%); Skin reaction (no severe)
Slovenian: Bolezni koţe in podkoţja alopecija, spremembe nohtov (hude 0,4 %), koţna reakcija (ne huda)
English: Hypersensitivity (G3/4: 5.3%)
Slovenian: Bolezni imunskega sistema preobčutljivost (S3/4: 5,3 %)
English: Solvent for Docetaxel Teva Pharma 80 mg vial 15 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Slovenian: Zdravilo Docetaxel Teva Pharma 80 mg viala 15 ml viala tipa I iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - CONCENTRATE 20 mg
Slovenian: NALEPKA NA VIALI - KONCENTRAT 20 mg
English: • Each vial contains 20 mg/0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml).
Slovenian: Ena viala vsebuje 20 mg/0,72 ml raztopine docetaksela 27,73 mg/ml v polisorbatu 80 (polnilni volumen: 24,4 mg/0,88 ml).
English: Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%);
Slovenian: Bolezni prebavil navzeja (S3/4: 9,6 %), bruhanje (S3/4: 7,6 %), driska (S3/4: 6,4 %), stomatitis (S3/4: 2 %)
English: Somnolence (G3/4: 0%)
Slovenian: hipotenzija (S3/4: 0 %)
English: Peripheral sensory neuropathy (G3/4: 1.2%)
Slovenian: Bolezni ţivčevja periferna senzorična nevropatija (S3/4: 1,2 %) disgevzija (S3/4: 0 %)
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Slovenian: Opis izbranih neţelenih učinkov zdravljenja z zdravilom Docetaxel Teva Pharma 75 mg/m v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom ţelodca
English: Statistical Analysis
Slovenian: FARMACEVTSKI PODATKI
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.88 ml (Fill: 3.40 ml)
Slovenian: 2,88 ml (napolnjena: 3,40 ml)
English: Musculoskeletal, connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija
English: Peripheral sensory neuropathy (G3: 4.1%);
Slovenian: Bolezni ţivčevja periferna senzorična nevropatija (S 3: 4,1 %), periferna motorična
English: Venous disorder (G3/4: 0.6%)
Slovenian: Ţilne bolezni venska bolezen (S3/4: 0,6 %)
English: Docetaxel Teva Pharma 80 mg concentrate and solvent for solution for infusion docetaxel
Slovenian: Docetaxel Teva Pharma 80 mg koncentrat za raztopino za infundiranje docetaksel
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Slovenian: Infekcijske in parazitske bolezni okuţba (S3/4: 3,6 %)
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with cisplatin
Slovenian: Tabelarični prikaz neţelenih učinkov zdravljenja z zdravilom Docetaxel Teva Pharma 75 mg/m pri raku dojke v kombinaciji s cisplatinom
English: Asthenia (severe 9.9%); Fluid retention (severe 0.7%);
Slovenian: zaprtost (huda 0,2 %), bolečine v trebuhu vnetje poţiralnika (hudo: 0,4 %)
English: Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 in combination with trastuzumab
Slovenian: Preiskave povečanje telesne mase Opis izbranih neţelenih učinkov zdravljenja z zdravilom Docetaxel Teva Pharma 100 mg/m pri raku dojke v kombinaciji s trastuzumabom
English: Hypersensitivity (G3/4: 1.7%)
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije (S3/4: 1,7 %)
English: Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Slovenian: srbeč izpuščaj (S3/4: 0,7 %), spremembe nohtov (S3/4:
English: • The Docetaxel 80 mg vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Slovenian: Viala z 80 mg docetaksela je 15 ml viala iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neţelenih učinkov zdravljenja z zdravilom Docetaxel Teva Pharma 75 mg/m v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom ţelodca
English: Nausea (G3/4: 5%); Stomatitis (G3/4: 7.8%);
Slovenian: Bolezni prebavil navzeja (S3/4: 3,3 %), stomatitis (S3/4: 1,7 %), bruhanje (S3/4: 0,8 %), driska (S3/4: 1,7 %)
English: • The solvent for Docetaxel 20 mg vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Slovenian: Vehikel za vialo z 20 mg docetaksela je 6 ml viala iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
English: Docetaxel Teva Pharma 20 mg concentrate and solvent for solution for infusion docetaxel
Slovenian: Docetaxel Teva Pharma 20 mg koncentrat za raztopino za infundiranje docetaksel
English: Constipation (G3/4: 1.0 %); Gastrointestinal pain (G3/4: 1.0%);
Slovenian: zaprtost (S3/4: 1,0 %), bolečine v prebavilih (S3/4: 1,0 %), ezofagitis / disfagija / odinofagija (S3/4: 0,7 %)
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin
Slovenian: Tabelarični prikaz neţelenih učinkov zdravljenja z zdravilom Docetaxel Teva Pharma 75 mg/m pri raku dojke v kombinaciji z doksorubicinom
English: • The Docetaxel 20 mg vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Slovenian: Viala z 20 mg docetaksela je 6 ml viala iz prozornega stekla z zaporko iz brombutilne gume in pokrovčkom Flip Off.
English: Eye disorders Respiratory, thoracic and mediastinal disorders
Slovenian: Očesne bolezni močnejše solzenje, konjunktivitis
English: Dyspepsia;
Slovenian: faze.
English: Psychiatric disorders Nervous system disorders
Slovenian: Bolezni imunskega sistema preobčutljivost
English: Abdominal pain (severe 1%);
Slovenian: zastajanje tekočine (hudo/smrtno nevarno: 1 %)
English: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva Pharma 80 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Slovenian: Dodatek celotne vsebine viale z vehiklom vsebini viale zdravila Docetaxel Teva Pharma 80 mg koncentrata za raztopino za infundiranje zagotavlja koncentracijo 10 mg/ml docetaksela v osnovni raztopini.
English: ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007-0
Slovenian: ratiopharm Arzneimittel Vertriebs-GmbH
English: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva Pharma 20 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Slovenian: Dodatek celotne vsebine viale z vehiklom vsebini viale z 20 mg zdravila Docetaxel Teva Pharma koncentrata za raztopino za infundiranje zagotavlja koncentracijo 10 mg/ml docetaksela v osnovni raztopini.
English: Esophagitis/dysphagia/ odynophagia (G3/4: 0.6%);
Slovenian: Presnovne in prehranske motnje anoreksija (S3/4: 0,6 %)
English: Epistaxis (G3/4: 0%);
Slovenian: flebitis (S3/4: 0 %),
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² single agent
Slovenian: Tabelarnični prikaz neţelenih učinkov monoterapije z zdravilom Docetaxel Teva Pharma 100 mg/m2 pri raku dojke
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with capecitabine
Slovenian: Tabelarični prikaz neţelenih učinkov zdravljenja z zdravilom Docetaxel Teva Pharma 75 mg/m pri raku dojke v kombinaciji s kapecitabinom
English: Ear and labyrinth disorders Cardiac disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta okvara sluha
English: Dyspnoea (severe 2.7%)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja (huda 2,7 %)
English: Epistaxis (G3/4: <1%)
Slovenian: Preiskave povišanje ravni AST S3/4 (< 1 %), povišanje ravni ALT S3/4 (< 1 %)
English: Cases of persisting alopecia have been reported.
Slovenian: Opisani so bili primeri dolgotrajne plešavosti.
English: Frequency unknown:
Slovenian: Pogosti neželeni učinki
English: Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Slovenian: stomatitis (S3/4: 7,8 %), driska (S3/4: 6,2 %), bruhanje (S3/4: 5 %), zaprtost
English: 2.2 Solvent for Docetaxel 80 mg vial:
Slovenian: 2.2 Viala z vehiklom za 80 mg docetaksela
English: Infection (G3/4: 3.3%)
Slovenian: Infekcijske in parazitske bolezni okuţba (S3/4: 3,3 %)
English: Vascular disorders Respiratory, thoracic and mediastinal disorders
Slovenian: Psihiatrične motnje Bolezni ţivčevja parestezije, glavobol, disgevzija,
English: In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.
Slovenian: V preskušanju III. faze so 1218 bolnikov z neresektabilnim nedrobnoceličnim pljučnim rakom v stadiju IIIB ali IV, ki so imeli zmogljivost po Karnofskem 70 % ali več in za to bolezen predhodno niso dobivali kemoterapije, naključno razvrstili v tri skupine.
English: • one vial (2.88 ml) of concentrate (80 mg of docetaxel),
Slovenian: Vsaka škatla vsebuje: eno vialo (2,88 ml) s koncentratom (80 mg docetaksela), eno vialo (5,12 ml) z vehiklom (voda za injekcije).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 80 mg
Slovenian: NALEPKA NA VIALI - VEHIKEL ZA 80 mg
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa (S3/4: 0 %), dispneja (S3/4: 0,6 %), kašelj (S3/4: 0 %)
English: Neutropenia (G4: 54.2%); Anaemia (G3/4: 10.8%);
Slovenian: Infekcijske in parazitske bolezni okuţbe (S3/4: 5 %) Bolezni krvi in limfatičnega sistema nevtropenija (S4: 54,2 %), anemija (S3/4: 10,8 %), trombocitopenija (S4: 1,7 %)
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Teva Pharma 80 mg concentrate and solvent for solution for infusion
Slovenian: Docetaxel Teva Pharma 80 mg koncentrat in vehikel za raztopino za infundiranje
English: • difficulty or painful swallowing
Slovenian: letargija, bolečina
English: What is in this leaflet
Slovenian: Kaj vsebuje viala z vehiklom
English: Gastrointestinal Haemorrhage (severe 0.3%)
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija (huda: 0,5 %)
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Teva Pharma 20 mg concentrate and solvent for solution for infusion
Slovenian: Docetaxel Teva Pharma 20 mg koncentrat in vehikel za raztopino za infundiranje
English: Peripheral sensory neuropathy (G3/4: <0.1%)
Slovenian: Bolezni ţivčevja disgevzija (S3/4: 0,6 %), periferna senzorična nevropatija (S3/4: <0,1 %)
English: There are no active patients;
Slovenian: V njej ni aktivnih bolnikov;
English: It was noted that three Clinical studies are currently ongoing:
Slovenian: Ugotovljeno je bilo, da trenutno potekajo tri klinične študije:
English: This is potentially a plausible mechanism which needs to be further investigated.
Slovenian: To bi lahko bil verjeten mehanizem, ki ga je treba nadalje raziskati.
English: It is ongoing in 9 countries with more than 400 patients.
Slovenian: Izvaja se v devetih državah, v njej pa sodeluje več kot 400 bolnikov.
English: It is administered as 150 mg dose subcutaneously once a month.
Slovenian: Daje se subkutano v 150-miligramskem odmerku enkrat mesečno.
English: National competent authorities competent for the regulatory oversight of these clinical studies should act accordingly.
Slovenian: Nacionalni organi, pristojni za regulativni nadzor nad temi kliničnimi študijami, bi morali ustrezno ukrepati.
English: In addition, the European Commission requested the Agency to give its opinion, as soon as possible, as to whether provisional measures were necessary to protect public health
Slovenian: Poleg tega je agencijo prosila, naj čim prej izrazi mnenje o tem, ali so potrebni začasni ukrepi za zaščito javnega zdravja.
English: ZEUS: non-interventional study in Germany with 609 patients enrolled currently.
Slovenian: ZEUS: neintervencijska študija v Nemčiji, v kateri trenutno sodeluje 609 bolnikov.
English: This adverse reaction appears unpredictable and no measure to minimize the risk has been identified at this stage.
Slovenian: Ta neželeni učinek se zdi nepredvidljiv, v tej fazi pa ni bil opredeljen noben ukrep za zmanjšanje tveganja.
English: In the European Union, as of 30 November 2017, daclizumab beta has been marketed in Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Norway, Poland, Slovenia, Sweden and United Kingdom.
Slovenian: V Evropski uniji je bil daklizumab beta od 30. novembra 2017 na trgu v Avstriji, Belgiji, na Danskem, Finskem, v Nemčiji, na Irskem, v Italiji, na Nizozemskem, Norveškem, Poljskem, v Sloveniji, na Švedskem in v Združenem kraljestvu.
English: Zinbryta (daclizumab beta) has been authorised in the European Union (EU) since 1 July 2016.
Slovenian: Zdravilo Zinbryta (daklizumab beta) je v Evropski uniji (EU) odobreno od 1. julija 2016.
English: EXTEND: extension study to assess efficacy and safety in patients from the pivotal studies.
Slovenian: EXTEND: podaljšana študija za oceno učinkovitosti in varnosti, v katero so vključeni bolniki iz ključnih študij.
English: The postmarketing exposure in the European Economic Area (EEA) is estimated at 3,290 patients (of which around 2,890 patients in Germany) and worldwide at 5,086 patients.
Slovenian: Izpostavljenost po pridobitvi dovoljenja za promet je ocenjena na 3 290 bolnikov (od tega približno 2 890 v Nemčiji) v Evropskem gospodarskem prostoru in 5 086 bolnikov po svetu.
English: The PRAC considered the alternative treatment options for the different stages or manifestations of the disease.
Slovenian: Odbor PRAC je preučil druge možnosti zdravljenja za različne stopnje ali manifestacije bolezni.
English: These cases concerned 10 females, 1 male (and 1 unknown), aged between 30 and 69 years-old; 9 cases occurred in Germany, 2 in USA and 1 in Spain.
Slovenian: Ti primeri so bili ugotovljeni pri desetih ženskah in enem moškem (in eni osebi neznanega spola) v starostni skupini 30-69 let; devet primerov je bilo ugotovljenih v Nemčiji, dva v ZDA, en pa v Španiji.
English: Due to the conclusion of the previous referral and based on the clinical characteristics of the patients, the MAH has already decided in January 2018 to stop this trial by 30 March 2018;
Slovenian: Zaradi zaključkov iz prejšnjega postopka napotitve in na podlagi kliničnih značilnosti bolnikov se je imetnik dovoljenja za promet z zdravilom januarja 2018 že odločil, da bo do 30. marca 2018 prekinil to študijo;
English: Patients stopping treatment must be followed up for at least 6 months, as symptoms may appear after discontinuation of Zinbryta treatment.
Slovenian: Bolnike, ki bodo zdravljenje prenehali, je treba spremljati še najmanj šest mesecev, saj se lahko simptomi pojavijo po prekinitvi zdravljenja z zdravilom Zinbryta.
English: As of November 2017, 2,251 patients had received Zinbryta in the clinical development program.
Slovenian: Od novembra 2017 je zdravilo Zinbryta prejelo 2 251 bolnikov v programu kliničnega razvoja.
English: SUSTAIN: A phase 3b open label study to assess efficacy and safety of daclizumab beta in patients switching from natalizumab in 5 countries, 3 in EU (DE, IT and UK).
Slovenian: SUSTAIN: odprta študija faze 3b za oceno učinkovitosti in varnosti zdravljenja z daklizumabom beta pri bolnikih, ki so prej jemali natalizumab; ta študija se izvaja v petih državah, vključno s tremi državami EU (Nemčija, Italija in Združeno kraljestvo).
English: These cases are characterized by torpid progression and potentially fatal or disabling outcome.
Slovenian: Za te primere je značilno počasno napredovanje in potencialno smrten ali onesposabljajoč izid.
English: On 20 February 2018, the Paul Ehrlich Institute (PEI) informed the EMA about five patients who were treated in 2016 and 2017 with daclizumab beta in Germany, and experienced worsening of disease after initiation of therapy.
Slovenian: Inštitut Paula Ehrlicha je 20. februarja 2018 agencijo EMA obvestil o petih bolnikih, ki so se v Nemčiji v letih 2016 in 2017 zdravili z daklizumabom beta in pri katerih se je bolezen po začetku terapije poslabšala.
English: On 26 February 2018, pursuant to Article 20 of Regulation (EC) No 726/2004, the European Commission requested the opinion of the Agency on whether the marketing authorisation of Zinbryta should be maintained, varied, suspended or revoked.
Slovenian: Evropska komisija je 26. februarja 2018 v skladu s členom 20 Uredbe (ES) št. 726/2004 agencijo zaprosila za mnenje o tem, ali je treba ohraniti, spremeniti, začasno odvzeti ali razveljaviti dovoljenje za promet z zdravilom Zinbryta.
English: • In view of the above, the PRAC considered that the benefit-risk balance of Zinbryta is no longer favourable and that urgent measures are needed to protect patients.
Slovenian: • Odbor PRAC glede na navedeno meni, da razmerje med tveganji in koristmi zdravila Zinbryta ni več ugodno in da so potrebni nujni ukrepi za zaščito bolnikov.
English: In light of all of the above and having carefully assessed all available data, PRAC considered at this stage that the benefit-risk balance of the product is no longer favourable and that urgent measures in accordance with Article 20(3) of Regulation (EC) No 726/2004, taking into account the grounds set out in Articles 116 and 117 of Directive 2001/83/EC, are needed to protect patients.
Slovenian: Glede na zgoraj navedeno in po skrbni preučitvi vseh razpoložljivih podatkov v tej fazi meni, da razmerje med tveganji in koristmi zdravila ni več ugodno ter da je treba v skladu s členom 20(3) Uredbe (ES) št. 726/2004 ob upoštevanju razlogov iz členov 116 in 117 Direktive 2001/83/ES sprejeti nujne ukrepe za zaščito bolnikov.
English: From the third PSUR (period from 27 May 2017 - 26 November 2017), there have also been some cases of unexpected deaths, attributed to cerebrovascular accidents, but with no detailed information on them that would conclusive allow for the exclusion of encephalitis.
Slovenian: V tretjem rednem poročilu o varnosti zdravila (za obdobje od 27. maja 2017 do 26. novembra 2017) je bilo navedenih tudi nekaj primerov nepričakovanih smrti zaradi cerebrovaskularnih nesreč, vendar v zvezi z njimi ni bilo podrobnih informacij, ki bi omogočile dokončno izključitev encefalitisa.
English: Healthcare professionals should contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives as a matter of urgency.
Slovenian: Zdravstveni delavci bi morali stopiti v stik z bolniki, ki se trenutno zdravijo z zdravilom Zinbryta, ter takoj prekiniti zdravljenje in razmisliti o drugih možnostih zdravljenja.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Zinbryta, in particular the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004, taking into account the grounds set out in Articles 116 and 117 of Directive 2001/83/EC.
Slovenian: • odbor PRAC je upošteval postopek iz člena 20 Uredbe (ES) št. 726/2004, ki je bil v zvezi z zdravilom Zinbryta začet na podlagi farmakovigilančnih podatkov, zlasti zaradi potrebe po uvedbi začasnih ukrepov v skladu s členom 20(3) Uredbe (ES) št. 726/2004, ob upoštevanju razlogov iz členov 116 in 117 Direktive 2001/83/ES.
English: It was acknowledged that the mechanism of action of daclizumab beta is complex.
Slovenian: Priznal je, da je mehanizem delovanja daklizumaba beta zapleten.
English: The number of doses received before the event was reported in all but two cases; it ranged between 1 and 8 doses, except for the Spanish patient who had received daclizumab beta for 4 years.
Slovenian: V vseh primerih razen dveh je bilo sporočeno število odmerkov, prejetih pred dogodkom, in sicer so bolniki prejeli od enega do osem odmerkov, razen španskega bolnika, ki je daklizumab beta prejemal štiri leta.
English: A PRAC review concluded on 31 October 2017 (due to cases of immune-mediated liver injury) led to the restriction of indication to the treatment of adult patients with relapsing forms of multiple sclerosis who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable.
Slovenian: Pregled odbora PRAC, opravljen 31. oktobra 2017 (zaradi primerov imunsko posredovane poškodbe jeter), je privedel do omejitve indikacije za zdravljenje odraslih bolnikov z recidivno obliko multiple skleroze, ki so se neustrezno odvali na vsaj dve zdravili, ki spreminjata potek bolezni (DMT), in za katere je zdravljenje s katerim koli drugim zdravilom DMT kontraindicirano ali kako drugače neprimerno.