FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients; see section 4.8).
Slovenian: Epizod febrilne nevtropenije 4. stopnje niso opazili pogosto (0,6 % pri bolnikih, ki so prejemali lenalidomid/deksametazon, v primerjavi z 0,0 % pri bolnikih, ki so prejemali placebo/deksametazon; glejte poglavje 4.8).
English: In patients with multiple myeloma, the combination of lenalidomide with dexamethasone is associated with an increased risk of venous thromboembolism (predominantly deep vein thrombosis and pulmonary embolism) and was seen to a lesser extent with lenalidomide in combination with melphalan and prednisone.
Slovenian: Pri bolnikih z diseminiranim plazmocitomom je kombinacija lenalidomida in deksametazona povezana z zvečanim tveganjem venske trombembolije (predvsem globoke venske tromboze in pljučne embolije), ki so jo opazili v manjši meri pri lenalidomidu v kombinaciji z melfalanom in prednizonom.
English: The safety and efficacy of lenalidomide was assessed in a phase III, multicenter, randomised, openlabel, 3-arm study (MM-020) of patients who were at least 65 years of age or older or, if younger than 65 years of age, were not candidates for stem cell transplantation because they declined to undergo stem cell transplantation or stem cell transplantation is not available to the patient due to cost or other reason.The study (MM-020) compared lenalidomide and dexamethasone (Rd) given for 2 different durations of time (i.e., until progressive disease [Arm Rd] or for up to eighteen 28-day cycles [72 weeks, Arm Rd18]) to melphalan, prednisone and thalidomide (MPT) for a maximum of twelve 42-day cycles (72 weeks).
Slovenian: Varnost in učinkovitost lenalidomida so ocenili v multicentrični, randomizirani, odprti študiji faze III s 3 skupinami (MM-020) bolnikov, ki so bili stari vsaj 65 let ali več ali, če so bili mlajši od 65 let, niso bili kandidati za presaditev matičnih celic, ker so presaditev matičnih celic odklonili ali pa presaditev matičnih celic bolniku ni bila na voljo zaradi stroškov ali kakšnih drugih razlogov.
English: Severe cutaneous reactions including SJS, TEN and DRESS have been reported with the use of lenalidomide.
Slovenian: Pri uporabi lenalidomida so poročali o hudih kožnih reakcijah, vključno s SJS, TEN in DRESS.
English: Lenalidomide Accord 20 mg hard capsules Each hard capsule contains 20 mg of lenalidomide.
Slovenian: Lenalidomide Accord 20 mg trde kapsule Ena trda kapsula vsebuje 20 mg lenalidomida.
English: ADRs reported in post-marketing use in patients treated with lenalidomide System Organ
Slovenian: Neželeni učinki, o katerih so poročali v obdobju trženja zdravila pri bolnikih, zdravljenih z lenalidomidom
English: Lenalidomide in combination with melphalan and prednisone followed by maintenance therapy in patients who are not eligible for transplant
Slovenian: Lenalidomid v kombinaciji z melfalanom in prednizonom, ki jim sledi vzdrževalno zdravljenje, pri bolnikih, ki niso primerni za presaditev
English: Grade 4 febrile neutropenia was reported at similar frequencies in the lenalidomide maintenance arms compared to placebo maintenance arms in both studies (0.4% vs 0.5% [0.4% vs 0.5% after the start of maintenance treatment] in CALGB 100104 and 0.3% vs 0% in IFM 2005-02, respectively).
Slovenian: O febrilni nevtropeniji 4. stopnje so poročali s podobno pogostnostjo v skupinah z vzdrževalnim zdravljenjem z lenalidomidom v primerjavi s skupinami, ki so prejemale vzdrževalno zdravljenje s placebom v obeh študijah (0,4 % proti 0,5 % [0,4 % proti 0,5 % po začetku vzdrževalnega zdravljenja] v CALGB 100104 oziroma 0,3 % proti 0 % v IFM 2005-02).
English: Newly diagnosed multiple myelomaLenalidomide maintenance in patients who have undergone ASCT
Slovenian: Novo diagnosticirani diseminirani plazmocitom Vzdrževalno zdravljenje z lenalidomidom pri bolnikih, pri katerih je bila opravljena ASCT
English: • if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see section 2, ‘Pregnancy, breast-feeding and contraceptioninformation for women and men').
Slovenian: • če lahko zanosite, razen če upoštevate nujne ukrepe za preprečevanje nosečnosti (glejte 2. poglavje ‘Nosečnost, dojenje in kontracepcija - informacije za ženske in moške'); če lahko zanosite, bo zdravnik ob vsakem receptu preveril, ali upoštevate nujne ukrepe, in bo priložil potrdilo;
English: - capsule contents: lactose, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Slovenian: vsebina kapsule: laktoza, mikrokristalna celuloza, premreženi natrijev karmelozat, brezvodni koloidni silicijev dioksid, magnezijev stearat.
English: The following dose adjustments are recommended at the start of therapy and throughout treatment for patients with moderate or severe impaired renal function or end stage renal disease.
Slovenian: Pri bolnikih z zmerno ali hudo okvaro ledvic ali s končno odpovedjo ledvic so na začetku zdravljenja in ves čas zdravljenja priporočene naslednje prilagoditve odmerka.
English: The combination of lenalidomide with low dose dexamethasone in newly diagnosed multiple myeloma patients is associated with a lower frequency of grade 4 neutropenia (8.5% in Rd and Rd18, compared with MPT (15%).
Slovenian: Kombinacija lenalidomida z deksametazonom v majhnem odmerku pri bolnikih z novo diagnosticiranim diseminiranim plazmocitomom je povezana z manjšo pogostnostjo nevtropenije 4. stopnje (8,5 % pri Rd in Rd18) v primerjavi z MPT (15 %).
English: An increase of second primary malignancies (SPM) has been observed in clinical trials in previously treated myeloma patients receiving lenalidomide/dexamethasone (3.98 per 100 person-years) compared to controls (1.38 per 100 person-years).
Slovenian: V kliničnih preskušanjih predhodno zdravljenih bolnikov s plazmocitomom, ki so prejemali lenalidomid/deksametazon, so opazili povečanje drugih primarnih malignosti (SPM - second primary malignancies) (3,98 na 100 oseb-let) v primerjavi s kontrolnimi skupinami (1,38 na 100 oseb-let).
English: • The need to stop Lenalidomide Accord immediately upon suspicion of pregnancy
Slovenian: • potrebo po takojšnji prekinitvi zdravljenja z zdravilom Lenalidomide Accord pri sumu na nosečnost,
English: Lenalidomide in combination with melphalan and prednisone followed by lenalidomide maintenance in patients who are not eligible for transplant
Slovenian: Lenalidomid v kombinaciji z melfalanom in prednizonom, ki jim sledi vzdrževalno zdravljenje z lenalidomidom, pri bolnikih, ki niso primerni za presaditev
English: In the IFM 2005-02 study, the adverse reactions observed more frequently with lenalidomide maintenance than placebo were neutropenia (60.8%), bronchitis (47.4%), diarrhoea (38.9%), nasopharyngitis (34.8%), muscle spasms (33.4%), leucopenia (31.7%), asthenia (29.7%), cough (27.3%), thrombocytopenia (23.5%), gastroenteritis (22.5%) and pyrexia (20.5%).
Slovenian: V študiji IFM 2005-02 so bili neželeni učinki, ki so jih opazili pogosteje pri vzdrževalnem zdravljenju z lenalidomidom kot pri placebu, nevtropenija (60,8 %), bronhitis (47,4 %), driska (38,9 %), nazofaringitis (34,8 %), mišični spazmi (33,4 %), levkopenija (31,7 %), astenija (29,7 %), kašelj (27,3 %), trombocitopenija (23,5 %), gastroenteritis (22,5 %) in zvišana telesna temperatura (20,5 %).
English: Muscle spasms, Bone pain◊, Musculoskeletal and connective tissue pain and discomfort (including back pain◊), Arthralgia◊
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva zelo pogosti mišični spazmi, bolečina v kosteh◊, bolečina in nelagodje mišično-skeletnega sistema in vezivnega tkiva (vključno z bolečno v hrbtu◊), artralgija◊
English: Multiple myeloma with at least one prior therapy
Slovenian: Diseminirani plazmocitom z vsaj eno predhodno terapijo
English: • Instructions to stop Lenalidomide Accord immediately upon suspicion of pregnancy
Slovenian: • navodila za takojšnjo prekinitev zdravljenja z zdravilom Lenalidomide Accord v primeru suma na nosečnost,
English: Newly diagnosed multiple myeloma: patients who are not eligible for transplant treated with lenalidomide in combination with low dose dexamethasone
Slovenian: Novo diagnosticirani diseminirani plazmocitom: bolniki, ki niso primerni za presaditev, zdravljeni z lenalidomidom v kombinaciji z deksametazonom v majhnem odmerku
English: The combination of lenalidomide with melphalan and prednisone in newly diagnosed multiple myeloma patients is associated with a higher frequency of grade 4 neutropenia (34.1% in MPR+R/MPR+p) compared with MPp+p (7.8%).
Slovenian: Kombinacija lenalidomida z melfalanom in prednizonom pri bolnikih z novo diagnosticiranim diseminiranim plazmocitomom je povezana z večjo pogostnostjo nevtropenije 4. stopnje (34,1 % pri MPR+R/MPR+p) v primerjavi z MPp+p (7,8 %).
English: The combination of lenalidomide with melphalan and prednisone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (40.4% in MPR+R/MPR+p treated patients, compared with 13.7% in MPp+p-treated patients; see section 4.8).
Slovenian: Kombinacija lenalidomida z melfalanom in prednizonom pri bolnikih z diseminiranim plazmocitomom je povezana z večjo incidenco trombocitopenije 3. in 4. stopnje (40,4 % bolnikov, zdravljenih z MPR+R/MPR+p, v primerjavi s 13,7 % bolnikov, zdravljenih z MPp+p; glejte poglavje 4.8).
English: How to take Lenalidomide Accord
Slovenian: Kako jemati zdravilo Lenalidomide Accord
English: • The need to contact their doctor immediately upon suspicion of pregnancy Brochure for male patients
Slovenian: • potrebo po takojšnjem obveščanju zdravnika pri sumu na nosečnost.
English: How to store Lenalidomide Accord 6.
Slovenian: Shranjevanje zdravila Lenalidomide Accord 6.
English: • Muscle weakness
Slovenian: • šibkost mišic;
English: • Patients with hepatic impairment
Slovenian: • Bolniki z okvaro jeter
English: Lenalidomide treatment must not be started if the ANC < 1.0 x 109/L, and/or platelet counts < 75 x 109/L or, dependent on bone marrow infiltration by plasma cells, platelet counts < 30 x 109/L.
Slovenian: Zdravljenje z lenalidomidom se ne sme začeti, če je ANC < 1,0 x 109/l in/ali je število trombocitov < 75 x 109/l ali je, odvisno od infiltracije kostnega mozga s plazmatkami, število trombocitov < 30 x 109/l.
English: Newly diagnosed multiple myeloma: patients who are not eligible for transplant treated with lenalidomide in combination with melphalan and prednisone
Slovenian: Novo diagnosticirani diseminirani plazmocitom: bolniki, ki niso primerni za presaditev, zdravljeni z lenalidomidom v kombinaciji z melfalanom in prednizonom
English: The adverse reactions observed more frequently with Rd or Rd18 than MPT were: diarrhoea (45.5%), fatigue (32.8%), back pain (32.0%), asthenia (28.2%), insomnia (27.6%), rash (24.3%), decreased appetite (23.1%), cough (22.7%), pyrexia (21.4%), and muscle spasms (20.5%).
Slovenian: Neželeni učinki, ki so jih opazili pogosteje pri Rd ali Rd18 kot pri MPT, so bili driska (45,5 %), utrujenost (32,8 %), bolečina v hrbtu (32,0 %), astenija (28,2 %), nespečnost (27,6 %), izpuščaj (24,3 %), zmanjšan apetit (23,1 %), kašelj (22,7 %), zvišana telesna temperatura (21,4 %) in mišični spazmi (20,5 %).
English: • Newly diagnosed multiple myeloma: patients who are not eligible for transplant treated with lenalidomide in combination with low dose dexamethasone Grade 4 neutropenia was observed in the lenalidomide arms in combination with low dose dexamethasone to a lesser extent than in the comparator arm (8.5% in the Rd [continuous treatment] and Rd18 [treatment for 18 four-week cycles] compared with 15% in the melphalan/prednisone/thalidomide arm, see section 4.8).
Slovenian: zdravljeni z lenalidomidom v kombinaciji z deksametazonom v majhnem odmerku Nevtropenijo 4. stopnje so opazili v skupinah z lenalidomidom v kombinaciji z deksametazonom v majhnem odmerku v manjši meri kot v skupini s primerjalnim zdravilom (8,5 % v Rd [neprekinjeno zdravljenje] in Rd18 [zdravljenje v 18 štiritedenskih ciklih], v primerjavi s 15 % v skupini z melfalanom, prednizonom in talidomidom, glejte poglavje 4.8).
English: Each capsule contains 20 mg of lenalidomide.
Slovenian: Ena kapsula vsebuje 20 mg lenalidomida.
English: Cataract
Slovenian: Katarakta
English: • Stomach pain, bloating, or diarrhoea, which may be symptoms of inflammation in the large intestine (called colitis or caecitis)
Slovenian: • bolečina v želodcu, napenjanje ali driska, ki so lahko simptomi vnetja debelega črevesa (to se imenuje kolitis ali vnetje slepega črevesa);
English: Common Hyperthyroidism
Slovenian: Bolezni endokrinega sistema pogosti hipertiroidizem
English: • Tubal sterilisation
Slovenian: • sterilizacija jajcevodov;
English: The combination of lenalidomide with melphalan and prednisone in newly diagnosed multiple myeloma patients is associated with a higher frequency of grade 3 and grade 4 thrombocytopenia (40.4% in MPR+R/MPR+p) compared with MPp+p (13.7%).
Slovenian: Kombinacija lenalidomida z melfalanom in prednizonom pri bolnikih z novo diagnosticiranim diseminiranim plazmocitomom je povezana z večjo pogostnostjo trombocitopenije 3. in 4. stopnje (40,4 % pri MPR+R/MPR+p) v primerjavi z MPp+p (13,7 %).
English: Dose level -1
Slovenian: Raven odmerka -1
English: Dose level -3
Slovenian: Raven odmerka -3
English: MPR+R vs MPp+p MPR+R vs MPR+p MPR+p vs MPp +p PFS2 (months) ¤ Mediana PFS2 time, months (95% CI)
Slovenian: HR [95 % IZ]; vrednost p MPR+R proti MPp+p MPR+R proti MPR+p MPR+p proti MPp +p PFS2 (meseci) ¤ Medianaa časa PFS2, meseci (95 % IZ)
English: Neutropenia^,◊, Febrile neutropenia^,◊,
Slovenian: anemija◊, levkopenije pogosti febrilna nevtropenija^,◊,
English: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Slovenian: Vsebina kapsule laktoza mikrokristalna celuloza premreženi natrijev karmelozat brezvodni koloidni silicijev dioksid magnezijev stearat
English: The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared with 0.6% in placebo/dexamethasone-treated patients).
Slovenian: Pri bolnikih z diseminiranim plazmocitomom je kombinacija lenalidomida in deksametazona povezana s povečano incidenco nevtropenije 4. stopnje (5,1 % pri bolnikih, ki so prejemali lenalidomid/deksametazon, v primerjavi z 0,6 % pri bolnikih, ki so prejemali placebo/deksametazon).
English: The combination of lenalidomide with low dose dexamethasone in newly diagnosed multiple myeloma patients is associated with a lower frequency of grade 3 and 4 thrombocytopenia (8.1% in Rd and Rd18) compared with MPT (11%).
Slovenian: Kombinacija lenalidomida z deksametazonom v majhnem odmerku pri bolnikih z novo diagnosticiranim diseminiranim plazmocitomom je povezana z manjšo pogostnostjo trombocitopenije 3. in 4. stopnje (8,1 % pri Rd in Rd18) v primerjavi z MPT (11 %).
English: Each capsule contains 7.5 mg of lenalidomide.
Slovenian: Ena kapsula vsebuje 7,5 mg lenalidomida.
English: • Circulatory problems
Slovenian: • težave z obtočili;
English: Lenalidomide maintenance after ASCT is associated with a higher frequency of grade 4 neutropenia compared to placebo maintenance (32.1% vs 26.7% [16.1% vs 1.8% after the start of maintenance treatment] in CALGB 100104 and 16.4% vs 0.7% in IFM 2005-02, respectively).
Slovenian: Vzdrževalno zdravljenje z lenalidomidom po ASCT je povezano z večjo pogostnostjo nevtropenije 4. stopnje kot vzdrževalno zdravljenje s placebom (32,1 % proti 26,7 % [16,1 % proti 1,8 % po začetku vzdrževalnega zdravljenja] v študiji CALGB 100104 oziroma 16,4 % proti 0,7 % v študiji IFM 2005-02).
English: The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients; see section 4.8).
Slovenian: Pri bolnikih z diseminiranim plazmocitomom je kombinacija lenalidomida in deksametazona povezana s povečano incidenco trombocitopenije 3. in 4. stopnje (9,9 % 3. stopnje in 1,4 % 4. stopnje pri bolnikih, ki so prejemali lenalidomid/deksametazon, v primerjavi z 2,3 % 3. stopnje in 0,0 % 4. stopnje pri bolnikih, ki so prejemali placebo/deksametazon; glejte poglavje 4.8).
English: The median overall PFS2 was 69.9 months (95% CI 58.1, 80.0) in the lenalidomide arm versus 58.4 months (95% CI 51.1, 65.0) in the placebo arm. For OS, the observed HR was 0.90: (95% CI 0.72, 1.13; p = 0.355) for lenalidomide versus placebo.
Slovenian: Mediana celokupnega PFS2 je bila 69,9 meseca (95 % IZ 58,1; 80,0) v skupini z lenalidomidom in 58,4 meseca (95 % IZ 51,1; 65,0) v skupini s placebom.
English: Uncommon Hypersensitivity^
Slovenian: Bolezni imunskega sistema občasni preobčutljivost^
English: Lenalidomide Accord 7.5 mg hard capsules Each hard capsule contains 7.5 mg of lenalidomide.
Slovenian: Lenalidomide Accord 7,5 mg trde kapsule Ena trda kapsula vsebuje 7,5 mg lenalidomida.
English: ADRs reported in clinical studies in patients with multiple myeloma treated with lenalidomide in combination with dexamethasone, or with melphalan and prednisone System Organ
Slovenian: Neželeni učinki, o katerih so poročali v okviru kliničnih študij pri bolnikih z diseminiranim plazmocitomom, zdravljenih z lenalidomidom v kombinaciji z deksametazonom, ali z melfalanom in prednizonom
English: Lenalidomide Accord 2.5 mg hard capsules Lenalidomide Accord 5 mg hard capsules Lenalidomide Accord 7.5 mg hard capsules Lenalidomide Accord 10 mg hard capsules Lenalidomide Accord 15 mg hard capsules Lenalidomide Accord 20 mg hard capsules Lenalidomide Accord 25 mg hard capsules
Slovenian: Lenalidomide Accord 2,5 mg trde kapsule Lenalidomide Accord 5 mg trde kapsule Lenalidomide Accord 7,5 mg trde kapsule Lenalidomide Accord 10 mg trde kapsule Lenalidomide Accord 15 mg trde kapsule Lenalidomide Accord 20 mg trde kapsule Lenalidomide Accord 25 mg trde kapsule
English: The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients).
Slovenian: Pri bolnikih z diseminiranim plazmocitomom je kombinacija lenalidomida in deksametazona povezana s povečano incidenco trombocitopenije 3. in 4. stopnje (9,9 % 3. stopnje in 1,4 % 4. stopnje pri bolnikih, ki so prejemali lenalidomid/deksametazon, v primerjavi z 2,3 % 3. stopnje in 0,0 % 4. stopnje pri bolnikih, ki so prejemali placebo/deksametazon).
English: 23% and 29% in multiple myeloma patients and healthy volunteers, respectively.
Slovenian: Povprečna vezava na beljakovine v plazmi pri bolnikih z diseminiranim plazmocitomom je bila 23 %, pri zdravih prostovoljcih pa 29 %.
English: Uncommon Hypercoagulation, Coagulopathy
Slovenian: pancitopenija◊, hemolitična anemija občasni hiperkoagulacija, koagulopatija
English: Dose level -2
Slovenian: Raven odmerka -2
English: An embryofoetal development study has been conducted in monkeys administered lenalidomide at doses from 0.5 and up to 4 mg/kg/day.
Slovenian: Pri opicah, ki so jim dajali lenalidomid v odmerkih od 0,5 do 4 mg/kg/dan, so izvedli študijo embriofetalnega razvoja.
English: Propylene glycol Iron oxide black (E172) Iron oxide yellow (E172) Potassium hydroxide Titanium dioxide (E171) Indigo carmine (E132)
Slovenian: Tiskarsko črnilo šelak propilenglikol črni železov oksid (E172) rumeni železov oksid (E172) kalijev hidroksid titanov dioksid (E171) indigotin (E132)
English: • Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty and breathless,
Slovenian: • bolečina v prsnem košu, ki se širi v roke, vrat, čeljust, hrbet ali trebuh, občutek potenja in zasoplosti, občutek slabosti ali bruhanje, kar so lahko simptomi srčnega infarkta (miokardnega infarkta);
English: The DLT in these studies was essentially haematological.
Slovenian: V teh študijah so bili toksični učinki, ki so omejevali odmerjanje, predvsem hematološki.
English: Description of the PPP and categorisation of patients based on sex and childbearing potential
Slovenian: Opis PPN in razvrstitev bolnikov po spolu in zmožnosti zanositve: • algoritem izvajanja PPN,
English: Lenalidomide maintenance after ASCT is associated with a higher frequency of grade 3 or 4 thrombocytopenia compared to placebo maintenance (37.5% vs 30.3% [17.9% vs 4.1% after the start of maintenance treatment] in CALGB 100104 and 13.0% vs 2.9% in IFM 2005-02, respectively).
Slovenian: Vzdrževalno zdravljenje z lenalidomidom po ASCT je povezano z večjo pogostnostjo trombocitopenije 3 ali 4. stopnje kot vzdrževalno zdravljenje s placebom (37,5 % proti 30,3 % [17,9 % proti 4,1 % po začetku vzdrževalnega zdravljenja] v študiji CALGB 100104 oziroma 13,0 % proti 2,9 % v študiji IFM 2005-02).
English: Fatigue◊, Oedema (including peripheral oedema), Pyrexia◊, Asthenia, Influenza like illness syndrome (including pyrexia, cough, myalgia, musculoskeletal pain, headache and rigors)
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti utrujenost◊, edem (vključno s perifernim edemom), pireksija◊, astenija, sindrom gripi podobne bolezni (vključno s pireksijo, kašljem, mialgijo, mišično-skeletno bolečino, glavobolom in okorelostjo pogosti bolečina v prsih, letargija pogosti utrujenost◊, pireksija◊, astenija
English: Lenalidomide Accord 7.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lenalidomide Accord 7,5 mg
English: Each capsule contains 2.5 mg of lenalidomide.
Slovenian: Ena kapsula vsebuje 2,5 mg lenalidomida.
English: Injury, Poisoning and Procedural Complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih pogosti padci, kontuzija^
English: • You must not become pregnant while taking lenalidomide.
Slovenian: • Med jemanjem lenalidomida ne smete zanositi.
English: Lenalidomide Accord 10 mg hard capsules Each hard capsule contains 10 mg of lenalidomide.
Slovenian: Lenalidomide Accord 10 mg trde kapsule Ena trda kapsula vsebuje 10 mg lenalidomida.
English: Lenalidomide Accord 20 mg hard capsules
Slovenian: Lenalidomide Accord 20 mg trde kapsule
English: Lenalidomide Accord 2.5 mg hard capsules Lenalidomide Accord 5 mg hard capsules Lenalidomide Accord 7.5 mg hard capsules Lenalidomide Accord 10 mg hard capsules Lenalidomide Accord 15 mg hard capsules Lenalidomide Accord 20 mg hard capsules Lenalidomide Accord 25 mg hard capsules lenalidomide
Slovenian: Lenalidomide Accord 2,5 mg trde kapsule Lenalidomide Accord 5 mg trde kapsule Lenalidomide Accord 7,5 mg trde kapsule Lenalidomide Accord 10 mg trde kapsule Lenalidomide Accord 15 mg trde kapsule Lenalidomide Accord 20 mg trde kapsule Lenalidomide Accord 25 mg trde kapsule lenalidomid
English: HR [95% CI], p-value a
Slovenian: HR [95 % IZ], vrednost pa
English: Excipient with known effect Each hard capsule contains 33 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom Ena trda kapsula vsebuje 33 mg laktoze.
English: (95% CI 88.8, NE) in the lenalidomide arm versus 88.1 months (95% CI 80.7, 108.4) in the placebo arm.
Slovenian: Mediana celokupnega časa preživetja je bila 105,9 meseca (95 % IZ 88,8; NE) v skupini z lenalidomidom in 88,1 meseca (95 % IZ 80,7; 108,4) v skupini s placebom.
English: Lenalidomide must not be started if the Absolute Neutrophil Count (ANC) is < 1.0 x 109/L, and/or platelet counts are < 75 x 109/L.
Slovenian: Zdravljenje z lenalidomidom se ne sme začeti, če je absolutno število nevtrofilcev (ANC - Absolute Neutrophil Count) < 1,0 x 109/l in/ali število trombocitov < 75 x 109/l.
English: HR [95% CI]c; p-valued Rd vs MPT
Slovenian: HR [95 % IZ]c; vrednost pd
English: Lenalidomide Accord 2.5 mg hard capsules Each hard capsule contains 2.5 mg of lenalidomide.
Slovenian: Lenalidomide Accord 2,5 mg trde kapsule Ena trda kapsula vsebuje 2,5 mg lenalidomida.