FrancophonIA/ELRC3.0 huggingface dataset:
English: Enhanced clinical response Corticosteroid-free clinical remission§ Durable clinical remission¶
Slovenian: Klinična remisija Okrepljen klinični odziv Klinična remisija brez uporabe kortikosteroidov§
English: Patients should be given the package leaflet and the Patient Alert Card. Posology
Slovenian: Bolniki morajo prejeti navodilo za uporabo in opozorilno kartico.
English: For the first two infusions, they should also be observed for approximately 2 hours following completion of the infusion for signs and symptoms of acute hypersensitivity reactions.
Slovenian: Pri prvih 2 infundiranjih je treba bolnike glede pojava znakov in simptomov akutnih preobčutljivostnih reakcij nadzirati še približno dve uri po koncu infundiranja, pri vseh nadaljnjih infundiranjih pa še približno 1 uro po koncu infundiranja.
English: How to store Entyvio
Slovenian: Kako boste prejeli zdravilo Entyvio
English: Vedolizumab Every 8 weeks n = 154
Slovenian: Vedolizumab vsakih 8 tednov n = 154
English: In patients with ulcerative colitis, mean steady-state serum trough concentrations were 11.2 mcg/mL (SD ± 7.24) and 38.3 mcg/mL (SD ± 24.43), respectively.
Slovenian: Pri bolnikih z ulceroznim kolitisom, ki so vedolizumab prejemali na vsakih osem tednov, je povprečna najmanjša serumska koncentracija v stanju dinamičnega ravnovesja znašala 11,2 μg/ml (SD ± 7,24), pri bolnikih, ki so vedolizumab prejemali na vsake štiri tedne, pa 38,3 μg/ml (SD ± 24,43).
English: Patients who lost response to vedolizumab when treated every eight weeks in GEMINI II were allowed to enter an open-label extension study and received vedolizumab every four weeks.
Slovenian: Bolniki, ki so pri zdravljenju z vedolizumabom na vsakih osem tednov izgubili odziv, so se v študiji GEMINI II lahko vključili v odprto podaljšano študijo in so vedolizumab prejemali na vsake štiri tedne.
English: In-use stability of the diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection in infusion bag has been demonstrated for 12 hours at 20°C-25°C or 24 hours at 2°C-8°C.
Slovenian: Razredčeno raztopino, z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje, lahko v infuzijski vrečki hranite 12 ur pri temperaturi 20 °C-25 °C ali 24 ur pri temperaturi 2 °C-8 °C.
English: Takeda Austria GmbH St. Peter-Straße 25 4020 Linz
Slovenian: A-4020 Linz Avstrija
English: §Clinical remission: Complete Mayo score of ≤ 2 points and no individual subscore > 1 point
Slovenian: * p < 0,0001 † p ≤ 0,001 ‡ p < 0,05 § Klinična remisija: celotna ocena Mayo ≤ 2 točk, nobena posamezna podocena > 1 točke ¶ Celjenje sluznice: endoskopska podocena Mayo ≤ 1 točke
English: Most patients continued on vedolizumab after the infection resolved.
Slovenian: Po ozdravitvi okužbe se je zdravljenje z vedolizumabom pri večini bolnikov nadaljevalo.
English: In patients with Crohn's disease mean steady-state serum trough concentrations were 13.0 mcg/mL (SD ± 9.08) and 34.8 mcg/mL (SD ± 22.55), respectively.
Slovenian: Pri bolnikih s Crohnovo boleznijo, ki so vedolizumab prejemali na vsakih osem tednov, je povprečna najmanjša serumska koncentracija v stanju dinamičnega ravnovesja znašala 13,0 μg/ml (SD ± 9,08), pri bolnikih, ki so vedolizumab prejemali na vsake štiri tedne, pa 34,8 μg/ml (SD ± 22,55).
English: In these patients, clinical remission was achieved in 45% of patients by 28 weeks and 36% of patients by 52 weeks.
Slovenian: Pri teh bolnikih je bila klinična remisija v 28. tednu dosežena pri 45 % bolnikov, v 52. tednu pa pri 36 % bolnikov.
English: Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab
Slovenian: Entyvio 300 mg prašek za koncentrat za raztopino za infundiranje vedolizumab
English: Beginning at week 6, patients who had achieved clinical response and were receiving corticosteroids were required to begin a corticosteroid-tapering regimen.
Slovenian: ki so dosegli klinični odziv, in so se zdravili s kortikosteroidi, so v 6. tednu morali začeti z režimom zmanjševanja odmerka kortikosteroida.
English: Unopened vial: Store in a refrigerator (2 °C-8 °C).
Slovenian: Zaprta viala: Shranjujte v hladilniku (2 °C-8 °C).
English: Enhanced clinical response was achieved in 29%, 38%, 21%, respectively, and corticosteriod-free clinical remission was achieved in 24%, 16%, 0%, respectively.
Slovenian: Okrepljen klinični odziv je bil dosežen pri 29 %, 38 %
English: Caution should be exercised when considering the use of vedolizumab in patients with a controlled chronic severe infection or a history of recurring severe infections.
Slovenian: Pri bolnikih z nadzorovano hudo kronično okužbo ali anamnezo ponavljajočih se hudih okužb se je treba za zdravljenje z vedolizumabom odločiti po posebej skrbnem in previdnem razmisleku.
English: Anal Abscess, Anal fissure, Nausea, Dyspepsia, Constipation, Abdominal distension, Flatulence, Haemorrhoids
Slovenian: Bolezni prebavil pogosti absces zadnjika, fisura ob zadnjiku, navzea, dispepsija, zaprtost, napihnjenost trebuha, flatulenca, hemoroidi
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Entyvio 300 mg powder for concentrate for solution for infusion vedolizumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Entyvio 300 mg prašek za koncentrat za raztopino za infundiranje vedolizumab
English: Entyvio is given by a doctor or nurse and patients should not need to store or handle Entyvio.
Slovenian: Bolnikom zdravila Entyvio ni treba shranjevati ali kakor koli z njim rokovati.
English: In these patients, clinical remission was achieved in 23% of patients at week 28 and 32% of patients at week 52.
Slovenian: Klinična remisija v 28. tednu je bila dosežena pri 23 % takšnih bolnikov, v 52. tednu pa pri 32 % bolnikov.
English: Vedolizumab should be administered in a healthcare setting equipped to allow management of acute hypersensitivity reactions including anaphylaxis, if they occur.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Vedolizumab je treba uporabljati v ustrezno opremljenih zdravstvenih ustanovah, kjer je v primeru pojava akutnih preobčutljivostnih reakcij, vključno z anafilaksijo, mogoče nemudoma uvesti ustrezne ukrepe.
English: Treatment 2
Slovenian: Drugo zdravljenje
English: Entyvio treatment is not to be initiated in patients with active, severe infections until the infections are controlled, and physicians should consider withholding treatment in patients who develop a severe infection while on chronic treatment with Entyvio.
Slovenian: Pri bolnikih s hudimi aktivnimi okužbami se zdravljenja z zdravilom Entyvio ne sme uvesti vse dokler okužbe niso ustrezno nadzorovane.
English: Infusion site reaction (including: Infusion site pain and Infusion site irritation), Infusion related reaction, Chills, Feeling cold
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti zvišana telesna temperatura občasni reakcija na mestu infundiranja (vključno z bolečino na mestu infundiranja in iritacijo na mestu infundiranja), reakcija, povezana z infundiranjem, mrzlica, občutek mraza
English: approximately half of patients had previously failed TNFα antagonist therapy.
Slovenian: GEMINI II se približno polovica bolnikov ni odzvala na predhodno zdravljenje z zaviralcem TNFα.
English: • Patient alert card,
Slovenian: • izobraževalno gradivo za zdravnike, • opozorilno kartico za bolnika.
English: Health-related quality of life (HRQOL) was assessed by Inflammatory Bowel Disease Questionnaire (IBDQ), a disease specific instrument, and SF-36 and EQ-5D, which are general measures.
Slovenian: Z zdravjem povezano kakovost življenja (HRQOL-“Health-related quality of life”) so ovrednotili z za vnetno bolezen črevesa specifičnim vprašalnikom IBDQ (“Inflammatory Bowel Disease
English: • prickling or tingling
Slovenian: • mrzlica ali drgetanje,
English: The risk of malignancy is increased in patients with ulcerative colitis and Crohn's disease.
Slovenian: Pri bolnikih z ulceroznim kolitisom in s Crohnovo boleznijo je tveganje za novotvorbe večje.
English: In GEMINI I, two cohorts of patients received vedolizumab at week 0 and week 2: cohort 1 patients were randomised to receive either vedolizumab 300 mg or placebo in a double-blind fashion, and cohort 2 patients were treated with open-label vedolizumab 300 mg. To evaluate efficacy at week 52, 373 patients from cohort 1 and 2 who were treated with vedolizumab and had achieved clinical response at week 6 were randomised in a double-blind fashion (1:1:1) to one of the following regimens beginning at week 6: vedolizumab 300 mg every eight weeks, vedolizumab 300 mg every four weeks, or placebo every four weeks.
Slovenian: Za oceno učinkovitosti v 52. tednu so 373 bolnikov iz 1. in 2. kohorte, ki so pri zdravljenju z vedolizumabom dosegli klinični odziv, v 6. tednu randomizirali na dvojno slep način (1:1:1) na enega od naslednjih režimov, ki se je začel v 6. tednu: vedolizumab v odmerku 300 mg na vsakih osem tednov, vedolizumab v odmerku 300 mg na vsake štiri tedne ali placebo na vsake štiri tedne.
English: Injection site reactions (with symptoms such as dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) have also been reported in patients treated with vedolizumab.
Slovenian: Pri bolnikih, zdravljenih z vedolizumabom, so poročali tudi o reakcijah na mestu injiciranja (s simptomi kot so dispneja, bronhospazem, urtikarija, vročinski oblivi, izpuščaj, zvišan krvni tlak in srčni utrip).
English: ≥ 3 points and ≥ 30% from baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point) at week 6.
Slovenian: Primarni opazovani dogodek je bil delež bolnikov s kliničnim odzivom (opredeljeno kot zmanjšanje celotne oceno Mayo za ≥ 3 točke in ≥ 30 % od izhodiščne vrednosti ob sočasnem zmanjšanju podocene krvavitve iz danke za ≥ 1 točko ali absolutna podocena krvavitve iz danke ≤ 1 točke) v 6. tednu.
English: NAME OF THE MEDICINAL PRODUCT Entyvio 300 mg powder for concentrate for solution for infusion
Slovenian: IME ZDRAVILA Entyvio 300 mg prašek za koncentrat za raztopino za infundiranje
English: In GEMINI III at week 6 and 10 the respective clinical remission rates were 18% (difference from placebo 3%, 95% CI: -7, 13) and 22% (difference from placebo 8%, 95% CI: -3, 19) when administered without corticosteroids compared to 20% (difference from placebo 11%, 95% CI: 2, 20) and 35% (difference from placebo 23%, 95% CI: 12, 33) respectively when administered with concomitant corticosteroids.
Slovenian: V študiji GEMINI III je delež klinične remisije pri uporabi brez kortikosteroidov v 6. tednu znašal 18 % (razlika v primerjavi s placebom 3 %, 95 % IZ: -7, 13), v 10. tednu pa 22 % (razlika v primerjavi s placebom 8 %, 95 % IZ: -3, 19).
English: • haemorrhoids
Slovenian: • koprivnica,
English: Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Slovenian: Zdravilo Entyvio je indicirano za zdravljenje zmerno do močno aktivne Crohnove bolezni pri odraslih bolnikih, če pri predhodnem ustaljenem zdravljenju ali zdravljenju z zaviralcem tumorje nekrotizirajočega faktorja alfa (TNFα) odziv na zdravljenje ni bil zadosten, je izzvenel ali pa bolniki takšnega zdravljenja niso prenašali.
English: Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.
Slovenian: Zdravilo Entyvio je indicirano za zdravljenje zmerno do močno aktivnega ulceroznega kolitisa pri odraslih bolnikih, če pri predhodnem ustaljenem zdravljenju ali zdravljenju z zaviralcem tumorje nekrotizirajočega faktorja alfa (TNFα) odziv na zdravljenje ni bil zadosten, je izzvenel ali pa bolniki takšnega zdravljenja niso prenašali.
English: including corticosteroids, immunomodulators, and/or TNFα antagonists (including primary non-responders).
Slovenian: Vključeni bolniki se niso odzivali na vsaj eno ustaljeno zdravljenje, vključno s kortikosteroidi, imunomodulatorji in/ali zaviralci TNFα (vključno s primarnim neodzivom).
English: 28% receiving vedolizumab every eight weeks, 27% receiving vedolizumab every four weeks, and 13% receiving placebo achieved clinical remission at week 52.
Slovenian: Od teh bolnikov je bila klinična remisija v 52. tednu dosežena pri 28 % bolnikov, ki so vedolizumab prejemali na vsakih osem tednov, 27 % bolnikov, ki so vedolizumab prejemali na vsake štiri tedne, in 13 % bolnikov, ki so prejemali placebo.
English: No dose-limiting toxicity was seen in clinical trials.
Slovenian: V kliničnih preskušanjih niso opazili toksičnih učinkov, ki bi omejevali velikost odmerka.
English: Treatment 1
Slovenian: Prvo zdravljenje
English: Corticosteroid-free clinical remission♠
Slovenian: Trajna klinična remisija# Klinična remisija brez uporabe kortikosteroidov♠
English: Furthermore, no effects were found of vedolizumab on the proliferative rate or cytotoxicity of a human tumour cell line expressing the α4β7 integrin in vitro.
Slovenian: Razen tega pa tudi in vitro na tumorskih celičnih linijah človeškega izvora z izraženim integrinom α4β7 niso ugotovili učinkov vedolizumaba na delež proliferacij ali citotoksičnih učinkov.
English: • bloated stomach
Slovenian: • mišični krči,
English: • stomach flu
Slovenian: • trebušna gripa,
English: Immune System Disorders
Slovenian: Organski sistem
English: Week 52 Efficacy Results of GEMINI I
Slovenian: Rezultati učinkovitosti v 52. tednu v študiji GEMINI I Opazovani dogodek
English: Vedolizumab
Slovenian: Celokupno
English: • pneumonia
Slovenian: • hemoroidi,
English: Rash, Pruritus, Eczema, Erythema, Night sweats, Acne
Slovenian: Bolezni kože in podkožja pogosti izpuščaj, srbenje, ekcem, rdečina, nočno znojenje, akna občasni folikulitis
English: The murine precursor of vedolizumab alleviated gastrointestinal inflammation in colitic cotton-top tamarins, a model of ulcerative colitis.
Slovenian: Pri tamarinkah ali lisztovih opicah (Saguinus oedipus) s kolitisom, modelu ulceroznega kolitisa, mišji prekurzor vedolizumaba omili gastrointestinalno vnetje.
English: Vedolizumab does not pass the blood brain barrier after intravenous administration.
Slovenian: Vedolizumab po intravenski aplikaciji ne prehaja skozi krvno-možgansko pregrado.
English: Entyvio contains the active substance vedolizumab.
Slovenian: Učinkovina zdravila Entyvio je vedolizumab.
English: One serious adverse reaction of IRR was reported in a Crohn's disease patient during the second infusion (symptoms reported were dyspnoea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) and was successfully managed with discontinuation of infusion and treatment with antihistamine and intravenous hydrocortisone.
Slovenian: koprivnica, pordelost, izpuščaj in zvišan krvni tlak ter pospešen srčni utrip) in so ga uspešno obvladali s prekinitvijo infundiranja in z zdravljenjem z antihistaminikom in intravenskim hidrokortizonom.
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Week 6 Efficacy Results of GEMINI I
Slovenian: Rezultati učinkovitosti v 6. tednu v študiji GEMINI I Opazovani dogodek
English: • pain in the limb
Slovenian: • bolečina v žrelu,
English: *p < 0.05 †not statistically significant ‡secondary endpoint to be viewed as exploratory by pre-specified statistical testing procedure §not statistically significant, the other endpoints were therefore not tested statistically ¶n = 157 for placebo and n = 158 for vedolizumab #Sustained clinical remission: clinical remission at weeks 6 and 10 ^Exploratory Endpoint
Slovenian: † ni statistično pomembno ‡ sekundarni opazovani dogodek, eksplorativno po vnaprej določenem statističnem postopku testiranja § ni statistično pomembno, drugi opazovani dogodki zato niso bili statistično obdelani
English: If you forget or miss your Entyvio infusion
Slovenian: Če ste prenehali uporabljati zdravilo Entyvio
English: In these patients, clinical remission was achieved in 25% of patients at week 28 and week 52.
Slovenian: Klinična remisija v 28. tednu in 52. tednu je bila dosežena pri 25 % teh bolnikov.
English: Sustained clinical remission#,¶ Overall
Slovenian: Ohranitev klinične remisije#¶
English: Use aseptic technique when preparing Entyvio solution for intravenous infusion.
Slovenian: Entyvio raztopino za intravensko infundiranje morate pripraviti v aseptičnih pogojih.
English: • throat and mouth yeast infection
Slovenian: • glivična okužba žrela in ustne votline,
English: No vedolizumab clinical trial data are available for patients previously treated with natalizumab or rituximab.
Slovenian: Pri bolnikih, ki so se predhodno zdravili z natalizumabom ali rituksimabom, podatki iz kliničnega preskušanja vedolizumaba niso na voljo.
English: Crohn's disease is an inflammatory disease of the gastrointestinal tract.
Slovenian: Pri bolnikih z ulceroznim kolitisom in Crohnovo boleznijo vedolizumab zmanjša gastrointestinalno vnetje.
English: Age does not impact the vedolizumab clearance in ulcerative colitis and Crohn's disease patients based on the population pharmacokinetic analyses.
Slovenian: Analize populacijske farmakokinetike kažejo, da pri bolnikih z ulceroznim kolitisom ali s Crohnovo boleznijo starost ne vpliva na očistek vedolizumaba.
English: trafficking into the CNS as evidenced by the lack of change in the ratio of CD4 +/CD8
Slovenian: Vedolizumab ni vplival na cirkulacijo celic CD4+ in celic CD8+ v osrednje živčevje, kot je razvidno iz nespremenjenega razmerja CD4+/CD8+ v cerebrospinalni tekočini pred uporabo in po uporabi vedolizumaba pri zdravih prostovoljcih.
English: Very rare side effects (may affect up to 1 in 10,000 people)
Slovenian: Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): • pljučnica,
English: Bronchitis, Gastroenteritis, Upper respiratory tract infection, Influenza, Sinusitis, Pharyngitis
Slovenian: Infekcijske in parazitske bolezni zelo pogosti nazofaringitis pogosti bronhitis, gastroenteritis, okužba zgornjih dihal, gripa, sinuzitis, faringitis občasni okužba dihal, kandidoza vulve in nožnice, kandidoza ustne sluznice, herpes zoster zelo redki pljučnica
English: TNFα Antagonist(s) Failure¶,‡
Slovenian: Neodziv na zaviralec (zaviralce) TNFα¶,‡
English: Very common Headache Common
Slovenian: Bolezni živčevja zelo pogosti glavobol pogosti parestezija
English: TNFα Antagonist(s) Failure¶
Slovenian: Neodziv na zaviralec (zaviralce) TNFα
English: • pain at the infusion site
Slovenian: • bolečina v okončini,
English: • chills or shivering
Slovenian: • zbadanje ali mravljinčenje,
English: TNFα Antagonist(s) Naïve^
Slovenian: (zaviralci) TNFα^
English: • swelling
Slovenian: • zgaga,
English: • rash and redness
Slovenian: • izpuščaj in rdečina,
English: Concomitant stable doses of oral corticosteroids, immunomodulators, and antibiotics were permitted.
Slovenian: Dovoljena je bila sočasna uporaba peroralnih kortikosteroidov,
English: GEMINI II contained two cohorts of patients that received vedolizumab at weeks 0 and 2: cohort 1 patients were randomised to receive either vedolizumab 300 mg or placebo in a double-blind fashion, and cohort 2 patients were treated with open-label vedolizumab 300 mg. To evaluate efficacy at week 52, 461 patients from cohorts 1 and 2, who were treated with vedolizumab and had achieved clinical response (defined as a ≥ 70-point decrease in CDAI score from baseline) at week 6, were randomised in a double-blind fashion (1:1:1) to one of the following regimens beginning at week 6: vedolizumab 300 mg every eight weeks, vedolizumab 300 mg every four weeks, or placebo every four weeks.
Slovenian: ≥ 70 točk od izhodišča), v 6. tednu randomizirani na dvojno slep način (1:1:1) na enega od naslednjih režimov, ki se je začel v 6. tednu: vedolizumab v odmerku 300 mg na vsakih osem tednov, vedolizumab v odmerku 300 mg na vsake štiri tedne ali placebo na vsake štiri tedne.
English: Takeda Italia S.p.A. Tel.: +39 06 502601
Slovenian: Tel.: +39 06 502601
English: Powder for concentrate for solution for infusion in Type 1 glass vial (20 mL) fitted with rubber stopper and aluminium crimp protected by a plastic cap.
Slovenian: 6.5 Vrsta ovojnine in vsebina Prašek za koncentrat za raztopino za infundiranje je na voljo v 20 ml stekleni viali (steklo tipa 1),
English: • heart burn
Slovenian: • glavobol.
English: Oropharyngeal pain, Nasal congestion, Cough
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti bolečina v ustih in žrelu, kongestija nosne sluznice, kašelj
English: Fre que ncy
Slovenian: (zaviralci) TNFα
English: • muscle weakness
Slovenian: • oslabelost mišic,
English: Respiratory, thoracic and mediastinal disorders
Slovenian: razredčena raztopina z natrijevim kloridom
English: It is to be reconstituted and further diluted prior to intravenous administration
Slovenian: Pred intravenskim infundiranjem je treba zdravilo rekonstituirati in nadalje razredčiti.
English: Inspect the reconstituted solution visually for particulate matter and discolouration prior to dilution.
Slovenian: Po rekonstituciji in pred redčenjem raztopino preglejte glede morebitne prisotnosti trdnih delcev in spremembe barve.
English: Population pharmacokinetic analyses indicate that vedolizumab has a total body clearance of approximately 0.157 L/day and a serum half-life of 25 days.
Slovenian: 0,157 l/dan, razpolovni čas v serumu pa 25 dni.
English: Clinical remission
Slovenian: Ponovna uvedba zdravljenja
English: Musculoskeletal and connective tissue disorders
Slovenian: Razredčena raztopina z natrijevim kloridom
English: • chest infection
Slovenian: • okužba v prsnem košu,
English: • throat pain
Slovenian: • trdo blato,
English: The combined in-use stability of Entyvio in the vial and infusion bag with sodium chloride 9 mg/mL (0.9%) solution for injection is a total of 12 hours at 20°C-25°C or 24 hours at 2°C-8°C.
Slovenian: (0,9 %) raztopino za injiciranje, je skupno 12 ur pri temperaturi 20 °C-25 °C ali 24 ur pri temperaturi 2 °C-8 °C.
English: 2 This time assumes the reconstituted solution is immediately diluted in the sodium chloride 9 mg/mL (0.9%) solution for injection and held in the infusion bag only.
Slovenian: 5 ml (300 mg) rekonstituirane raztopine zdravila Entyvio dodajte v 250 ml sterilne raztopine za injiciranje natrijevega klorida 9 mg/ml (0,9 %) in vsebino infuzijske vrečke nežno premešajte
English: Clinical response Clinical remission§ Mucosal healing¶
Slovenian: Klinični odziv Klinična remisija§
English: TNFα Antagonist(s) Naïve
Slovenian: Crohnova bole ze n
English: Exploratory analysis showed clinically meaningful improvements were observed for the vedolizumab every four weeks and every eight weeks groups in GEMINI II and the improvements were significantly greater as compared with the placebo group from baseline to week 52 on EQ-5D and EQ-5D VAS scores, total IBDQ score, and IBDQ subscales of bowel symptoms and systemic function.
Slovenian: Eksplorativna analiza je pokazala klinično pomembno izboljšanje pri uporabi vedolizumaba na vsake štiri tedne in na vsakih osem tednov v študiji GEMINI II.
English: World Health Organization.
Slovenian: 1Svetovna zdravstvena organizacija.
English: The CHMP concluded
Slovenian: je CHMP sklenil
English: Available on http://www.who.int/wer/2011/wer8629.pdf 29(86) Ref Type: Internet Communication
Slovenian: Dostopno na http://www.who.int/wer/2011/wer8629.pdf
English: There is an estimated theoretical risk of severe malformations attributed to the rubella containing vaccine that varies between 0.5% and 1.3%.
Slovenian: Ocenjeno teoretično tveganje hudih okvar, ki jih je mogoče pripisati cepivu, ki vsebuje virus rdečk, znaša od 0,5 % do 1,3 %.