FrancophonIA/ELRC3.0 huggingface dataset:
English: Lenalidomide treatment must not be started if the ANC is < 1.5 x 109/L, and/or platelet counts are < 75 x 109/L.
Slovenian: Zdravljenje z lenalidomidom se ne sme začeti, če je ANC < 1,5 x 109/l in/ali je število trombocitov < 75 x 109/l.
English: A complete blood cell count, including white blood cell count with differential count, platelet count, haemoglobin, and haematocrit should be performed at baseline, every week for the first 8 weeks of lenalidomide treatment and monthly thereafter to monitor for cytopenias.
Slovenian: Za spremljanje citopenij je treba na začetku odmerjanja, prvih 8 tednov zdravljenja z lenalidomidom vsak teden in nato vsak mesec opraviti celotno krvno sliko, vključno s številom limfocitov in diferencialno krvno sliko, številom trombocitov, hemoglobinom in hematokritom.
English: What Lenalidomide Accord contains
Slovenian: Kaj vsebuje zdravilo Lenalidomide Accord
English: Lenalidomide Accord 25 mg hard capsules Each hard capsule contains 25 mg of lenalidomide.
Slovenian: Lenalidomide Accord 25 mg trde kapsule Ena trda kapsula vsebuje 25 mg lenalidomida.
English: The study was unblinded upon the recommendations of the data monitoring committee after surpassing the threshold for a preplanned interim analysis of PFS. After unblinding, patients receiving placebo were not crossed over to lenalidomide therapy prior to progressive disease.
Slovenian: Dvojno slepi del študije je bil po priporočilu odbora za spremljanje podatkov prekinjen po prekoračitvi praga za vnaprej načrtovano vmesno analizo PFS.
English: A 1.3-fold increase in incidence rate of solid tumour SPM has been observed in patients receiving lenalidomide in combination with dexamethasone until progression or for 18 months (1.58 per 100 person-years) compared to thalidomide in combination with melphalan and prednisone (1.19 per 100 person-years).
Slovenian: Pri bolnikih, ki so prejemali lenalidomid v kombinaciji z deksametazonom do napredovanja bolezni ali 18 mesecev dolgo, so opazili 1,3-kratno zvečanje incidence SPM s čvrstimi tumorji (1,58 na 100 oseblet) v primerjavi s talidomidom v kombinaciji z melfalanom in prednizonom (1,19 na 100 oseb-let).
English: No dose adjustments are required for patients with mild renal impairment and multiple myeloma.
Slovenian: Pri bolnikih z blago okvaro ledvic in diseminiranim plazmocitomom niso potrebne prilagoditve odmerka.
English: Each capsule contains 25 mg of lenalidomide.
Slovenian: Ena kapsula vsebuje 25 mg lenalidomida.
English: Grade 3 or 4 thrombocytopenia was observed at a higher frequency in the lenalidomide maintenance arms compared to the placebo maintenance arms in studies evaluating lenalidomide maintenance in NDMM patients who have undergone ASCT (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: Trombocitopenijo 3. in 4. stopnje so v študijah, v katerih so ocenjevali vzdrževalno zdravljenje z lenalidomidom pri bolnikih z NDDP, pri katerih je bila opravljena ASCT, opazili pogosteje v skupinah z vzdrževalnim zdravljenjem z lenalidomidom kot v skupinah, ki so prejemale vzdrževalno zdravljenje s placebom (37,5 % proti 30,3 % [17,9 % proti 4,1 % po začetku vzdrževalnega zdravljenja] v CALGB 100104 oziroma 13,0 % proti 2,9 % v IFM 2005-02).
English: Grade 3-4 ADRs/Frequency
Slovenian: - 4. stopnje / pogostnost
English: Lenalidomide Accord
Slovenian: Shranjevanje zdravila Lenalidomide Accord
English: Lenalidomide Accord 10 mg hard capsules
Slovenian: Lenalidomide Accord 10 mg trde kapsule
English: Patients with renal impairment
Slovenian: • Bolniki z okvaro ledvic
English: A 2.12-fold increase in incidence rate of solid tumour SPM has been observed in patients receiving lenalidomide (9 cycles) in combination with melphalan and prednisone (1.57 per 100 person-years) compared with melphalan in combination with prednisone (0.74 per 100 person-years).
Slovenian: Pri bolnikih, ki so prejemali lenalidomid (9 ciklov) v kombinaciji z melfalanom in prednizonom, so opazili 2,12-kratno zvečanje incidence SPM s čvrstimi tumorji (1,57 na 100 oseb-let), v primerjavi z melfalanom v kombinaciji s prednizonom (0,74 na 100 oseb-let).
English: Lenalidomide treatment must not be started if the ANC is < 1.0 x 109/L, and/or platelet counts are < 50 x 109/L.
Slovenian: Zdravljenje z lenalidomidom se ne sme začeti, če je ANC < 1,0 x 109/l in/ali je število trombocitov < 50 x 109/l.
English: • Constipation, diarrhoea, nausea, redness of skin, rashes, vomiting, muscle cramps, muscle aches,
Slovenian: • zaprtje, driska, slabost, rdečina kože, izpuščaji, bruhanje, mišični krči, mišične bolečine, boleče kosti, bolečina v sklepih, utrujenost, splošno otekanje vključno z otekanjem rok in nog;
English: Lenalidomide Accord 2.5 mg hard capsules
Slovenian: Lenalidomide Accord 2,5 mg trde kapsule
English: Lenalidomide Accord 10 mg hard capsules:
Slovenian: Lenalidomide Accord 10 mg trde kapsule:
English: Lenalidomide Accord 7.5 mg hard capsules
Slovenian: Lenalidomide Accord 7,5 mg trde kapsule
English: What Lenalidomide Accord is
Slovenian: Kaj je zdravilo Lenalidomide Accord
English: Excipient with known effect Each hard capsule contains 36 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom Ena trda kapsula vsebuje 36 mg laktoze.
English: Patients were randomised 1:1 to receive either lenalidomide or placebo maintenance (10 mg once daily on days 1-28 of repeated 28day cycles increased up to 15 mg once daily after 3 months in the absence of dose-limiting toxicity) following 2 courses of lenalidomide consolidation (25 mg/day, days 1-21 of a 28-day cycle).
Slovenian: Po 2 ciklih konsolidacije z lenalidomidom (25 mg/dan, od 1. do 21. dne v 28-dnevnem ciklu) je bil vzdrževalni odmerek 10 mg enkrat na dan od 1. do 28. dne v ponavljajočih se 28-dnevnih ciklih (zvečan na do 15 mg enkrat na dan po 3 mesecih, če ni bilo toksičnosti, ki bi omejevala odmerek), zdravljenje se je nadaljevalo do napredovanja bolezni.
English: The study was unblinded upon the recommendations of the data monitoring committee after surpassing the threshold for a preplanned interim analysis of PFS. After unblinding, patients in the placebo arm were allowed to cross over to receive lenalidomide before disease progression.
Slovenian: Dvojno slepi del študije je bil po priporočilu odbora za spremljanje podatkov prekinjen ob prekoračitvi praga za vnaprej načrtovano vmesno analizo PFS.
English: Leucopenia◊, Lymphopenia
Slovenian: levkopenija◊, limfopenija pogosti pancitopenija◊
English: Lenalidomide Accord 20 mg hard capsules EU/1/18/1316/010
Slovenian: Lenalidomide Accord 20 mg trde kapsule EU/1/18/1316/010
English: Very Common Pneumonias◊,a, Upper respiratory tract infection, Neutropenic infection, Bronchitis◊, Influenza◊, Gastroenteritis◊, Sinusitis, Nasopharyngitis, Rhinitis
Slovenian: Infekcijske in parazitske bolezni zelo pogosti pljučnice◊, a, okužbe zgornjih dihal, nevtropenična okužba, bronhitis◊, gripa◊, gastroenteritis◊, sinusitis, nazofaringitis, rinitis pogosti okužba◊, okužba sečil◊,*, okužba spodnjih dihal, okužba pljuč◊
English: Acute myeloid leukaemia Multiple myeloma
Slovenian: Akutna mieloična levkemija Diseminirani plazmocitom
English: • Breathlessness
Slovenian: • Trombocitopenija
English: Each capsule contains 10 mg of lenalidomide.
Slovenian: Ena kapsula vsebuje 10 mg lenalidomida.
English: Lenalidomide Accord 5 mg hard capsules Each hard capsule contains 5 mg of lenalidomide.
Slovenian: Lenalidomide Accord 5 mg trde kapsule Ena trda kapsula vsebuje 5 mg lenalidomida.
English: Lenalidomide Accord 2.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lenalidomide Accord 2,5 mg
English: Lenalidomide Accord 15 mg hard capsules Each hard capsule contains 15 mg of lenalidomide.
Slovenian: Lenalidomide Accord 15 mg trde kapsule Ena trda kapsula vsebuje 15 mg lenalidomida.
English: Each capsule contains 5 mg of lenalidomide.
Slovenian: Ena kapsula vsebuje 5 mg lenalidomida.
English: Lenalidomide Accord 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lenalidomide Accord 10 mg
English: Excipient with known effect Each hard capsule contains134 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom Ena trda kapsula vsebuje 134 mg laktoze.
English: Lenalidomide Accord 25 mg hard capsules EU/1/18/1316/011
Slovenian: Lenalidomide Accord 25 mg trde kapsule EU/1/18/1316/011
English: Psychiatric Disorders
Slovenian: Bolezni ščitnice
English: Each capsule contains 15 mg of lenalidomide.
Slovenian: Ena kapsula vsebuje 15 mg lenalidomida.
English: • The need to use condoms if sexual partner is pregnant or a WCBP not using effective contraceptions (even if man has had a vasectomy)
Slovenian: • potrebo po uporabi kondomov, če je spolna partnerica noseča ali ŽRD, ki ne uporablja zanesljive kontracepcije (tudi, če je moški imel vazektomijo): o med zdravljenjem z zdravilom Lenalidomide Accord, o še en teden po zadnjem odmerku;
English: Lenalidomide Accord 15 mg hard capsules:
Slovenian: Lenalidomide Accord 15 mg trde kapsule:
English: Endocrine Disorders
Slovenian: Trombocitopenija
English: Lenalidomide Accord 25 mg hard capsules
Slovenian: Lenalidomide Accord 25 mg trde kapsule
English: Lenalidomide Accord 20 mg are gelatin hard capsules size “1” approximately 19.0 mm to 19.8 mm in length, opaque green cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “20 mg” printed on body in green, containing white to off white coloured powder.
Slovenian: Lenalidomide Accord 20 mg trde kapsule so trde želatinske kapsule velikosti »1«, dolge približno 19,0 mm do 19,8 mm, z neprozornim zelenim pokrovčkom in neprozornim belim telesom, ki imajo na pokrovčku v črni barvi natisnjeno »LENALIDOMIDE«, na telesu pa v zeleni barvi »20 mg« in vsebujejo prašek bele do belkaste barve.
English: Lenalidomide Accord 5 mg hard capsules
Slovenian: Lenalidomide Accord 5 mg trde kapsule
English: If lenalidomide makes contact with the mucous membranes, they should be thoroughly flushed with water.
Slovenian: V primeru stika lenalidomida s sluznico, jo morate temeljito sprati z obilico vode.
English: Lenalidomide Accord 25 mg are gelatin hard capsules size “0” approximately 21.0 mm to 21.8 mm in length, white opaque cap and body with “LENALIDOMIDE” printed on cap in black and “25 mg” printed on body in green, containing white to off white coloured powder.
Slovenian: Lenalidomide Accord 25 mg trde kapsule so trde želatinske kapsule velikosti »0«, dolge približno 21,0 mm do 21,8 mm, z neprozornim belim pokrovčkom in telesom, ki imajo na pokrovčku v črni barvi natisnjeno »LENALIDOMIDE«, na telesu pa v zeleni barvi »25 mg« in vsebujejo prašek bele do belkaste barve.
English: Fatal instances of TLS have been reported during treatment with lenalidomide.
Slovenian: Med zdravljenjem z lenalidomidom so poročali o smrtnih primerih zaradi sindroma tumorske lize.
English: Lenalidomide Accord 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lenalidomide Accord 20 mg
English: Time to progression Median [95% CI], weeks
Slovenian: Mediana časa do napredovanja bolezni [95 % IZ], tedni p < 0,001
English: CI = confidence interval; HR = hazard ratio; max = maximum; min = minimum; NE = not estimable; OS = overall survival; PFS = progression-free survival;
Slovenian: IZ = interval zaupanja; HR = razmerje tveganja; maks = maksimum; min = minimum; NE = ni mogoče oceniti; OS = celokupno preživetje; PFS = obdobje brez napredovanja bolezni; SE = standardna napaka a Mediana temelji na Kaplan-Meierjevi oceni b 95 % IZ okrog mediane.
English: Lenalidomide Accord 7.5 mg are gelatin hard capsules size “4” approximately 14.0 mm to 14.8 mm in length, opaque lavender cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “7.5 mg” printed on body in green, containing white to off white coloured powder.
Slovenian: Lenalidomide Accord 7,5 mg trde kapsule so trde želatinske kapsule velikosti »4«, dolge približno 14,0 mm do 14,8 mm, z neprozornim svetlovijoličastim pokrovčkom in neprozornim belim telesom, ki imajo na pokrovčku v črni barvi natisnjeno »LENALIDOMIDE«, na telesu pa v zeleni barvi »7,5 mg« in vsebujejo prašek bele do belkaste barve.
English: Lenalidomide Accord 10 mg hard capsules EU/1/18/1316/006
Slovenian: Lenalidomide Accord 10 mg trde kapsule EU/1/18/1316/006
English: Patients in the Rd and Rd18 arms took lenalidomide 25 mg once daily on days 1 to 21 of 28-day cycles according to protocol arm. Dexamethasone 40 mg was dosed once daily on days 1, 8, 15, and 22 of each 28-day cycle.
Slovenian: Bolniki v skupinah Rd in Rd18 so jemali lenalidomid 25 mg enkrat na dan od 1. do 21. dne 28-dnevnih ciklov v skladu s protokolom skupine.
English: For men taking lenalidomide
Slovenian: Za moške, ki jemljejo lenalidomid
English: How Lenalidomide Accord works
Slovenian: Kako zdravilo Lenalidomide Accord deluje
English: Resume lenalidomide and melphalan at dose level -1
Slovenian: • Koraki za zmanjšanje odmerka lenalidomid melfalan prednizon
English: Lenalidomide Accord 7.5 mg hard capsules EU/1/18/1316/005
Slovenian: Lenalidomide Accord 7,5 mg trde kapsule EU/1/18/1316/005
English: Excipient with known effect Each hard capsule contains100 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom Ena trda kapsula vsebuje 100 mg laktoze.
English: Hepatic disorders
Slovenian: Diseminirani plazmocitom
English: Lenalidomide Accord 15 mg hard capsules
Slovenian: Lenalidomide Accord 15 mg trde kapsule
English: Common Respiratory distress◊, Dyspnoea◊
Slovenian: pogosti dihalna stiska◊, dispneja◊
English: Lenalidomide Accord 25 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lenalidomide Accord 25 mg
English: Gelatin hard capsules size “0” approximately 21.0 mm to 21.8 mm in length, white opaque cap and body with “LENALIDOMIDE” printed on cap in black and “25 mg” printed on body in green, containing white to off white coloured powder.
Slovenian: Trde želatinske kapsule velikosti »0«, dolge približno 21,0 mm do 21,8 mm, z neprozornim belim pokrovčkom in telesom, ki imajo na pokrovčku v črni barvi natisnjeno »LENALIDOMIDE«, na telesu pa v zeleni barvi »25 mg« in vsebujejo prašek bele do belkaste barve.
English: Lenalidomide Accord 2.5 mg hard capsules EU/1/18/1316/001
Slovenian: Lenalidomide Accord 2,5 mg trde kapsule EU/1/18/1316/001
English: capsule shell: gelatin, iron oxide red (E172), titanium dioxide (E171), indigo carmine (E132) printing ink: black and green ink (which contains shellac, propylene glycol, iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide)
Slovenian: ovojnica kapsule: želatina, rdeči železov oksid (E172), titanov dioksid (E171), indigotin (E132) tiskarsko črnilo: črno in zeleno črnilo (ki vsebuje šelak, propilenglikol, črni železov oksid (E172), rumeni železov oksid (E172), titanov dioksid (E171), indigotin (E132) in kalijev hidroksid)
English: Lenalidomide Accord 15 mg are gelatin hard capsules size “2” approximately 17.4 mm to 18.2 mm in length, opaque orange cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “15 mg” printed on body in green, containing white to off white coloured powder.
Slovenian: Lenalidomide Accord 15 mg trde kapsule so trde želatinske kapsule velikosti »2«, dolge približno 17,4 mm do 18,2 mm, z neprozornim oranžnim pokrovčkom in neprozornim belim telesom, ki imajo na pokrovčku v črni barvi natisnjeno »LENALIDOMIDE«, na telesu pa v zeleni barvi »15 mg« in vsebujejo prašek bele do belkaste barve.
English: Excipientwith known effect Each hard capsule contains 67mg of lactose.
Slovenian: Pomožna snov z znanim učinkom Ena trda kapsula vsebuje 67 mg laktoze.
English: Excipient with known effect Each hard capsule contains50 mg of lactose.
Slovenian: Pomožna snov z znanim učinkom Ena trda kapsula vsebuje 50 mg laktoze.
English: The active substance is lenalidomide.
Slovenian: Učinkovina je lenalidomid.
English: Gelatin hard capsules size “4” approximately 14.0 mm to 14.8 mm in length, opaque lavender cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “7.5 mg” printed on body in green, containing white to off white coloured powder.
Slovenian: Trde želatinske kapsule velikosti »4«, dolge približno 14,0 mm do 14,8 mm, z neprozornim svetlovijoličastim pokrovčkom in neprozornim belim telesom, ki imajo na pokrovčku v črni barvi natisnjeno »LENALIDOMIDE«, na telesu pa v zeleni barvi »7,5 mg« in vsebujejo prašek bele do belkaste barve.
English: Very Common Diarrhoea, Constipation, Abdominal pain, Nausea
Slovenian: Bolezni prebavil zelo pogosti driska, zaprtje, bolečine v trebuhu, navzea pogosti bruhanje, bolečina v zgornjem delu trebuha pogosti driska, bruhanje, navzea
English: • That Lenalidomide Accord may cause neutropenia and thrombocytopenia and the need for regular blood tests
Slovenian: • opozorilo, da lahko zdravilo Lenalidomide Accord povzroči nevtropenijo in trombocitopenijo,
English: Lenalidomide Accord 10 mg are gelatin hard capsules size “3” approximately 15.4 mm to 16.2 mm in length, leaf green cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “10 mg” printed on body in green, containing white to off white coloured powder.
Slovenian: Lenalidomide Accord 10 mg trde kapsule so trde želatinske kapsule velikosti »3«, dolge približno 15,4 mm do 16,2 mm, s pokrovčkom listnato zelene barve in neprozornim belim telesom, ki imajo na pokrovčku v črni barvi natisnjeno »LENALIDOMIDE«, na telesu pa v zeleni barvi »10 mg« in vsebujejo prašek bele do belkaste barve.
English: Skin and Subcutaneous Tissue Disorders
Slovenian: Bolezni kože in podkožja občasni angioedema redki
English: Gelatin hard capsules size “2” approximately 17.4 mm to 18.2 mm in length, opaque orange cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “15 mg” printed on body in green, containing white to off white coloured powder.
Slovenian: Trde želatinske kapsule velikosti »2«, dolge približno 17,4 mm do 18,2 mm, z neprozornim oranžnim pokrovčkom in neprozornim belim telesom, ki imajo na pokrovčku v črni barvi natisnjeno »LENALIDOMIDE«, na telesu pa v zeleni barvi »15 mg« in vsebujejo prašek bele do belkaste barve.
English: Lenalidomide Accord 15 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lenalidomide Accord 15 mg
English: capsule shell: gelatin, iron oxide black (E172), titanium dioxide (E171) printing ink: black and green ink (which contains shellac, propylene glycol, iron oxide black (E172), iron oxide yellow (E172), titanium dioxide (E171), indigo carmine (E132) and potassium hydroxide)
Slovenian: ovojnica kapsule: želatina, črni železov oksid (E172), titanov dioksid (E171) tiskarsko črnilo: črno in zeleno črnilo (ki vsebuje šelak, propilenglikol, črni železov oksid (E172), rumeni železov oksid (E172), titanov dioksid (E171), indigotin (E132) in kalijev hidroksid)
English: Haematuria^, Urinary retention, Urinary incontinence
Slovenian: pogosti hematurija^, zastajanje urina, urinska inkontinenca občasni pridobljen Fanconijev sindrom občasni ledvična tubularna nekroza
English: The median overall PFS was 44.4 months (39.6, 52.0) in the lenalidomide arm versus 23.8 months (95% CI 21.2, 27.3) in the placebo arm. For PFS2, the observed HR was 0.80 (95% CI 0.66, 0.98; p = 0.026) for lenalidomide versus placebo.
Slovenian: Mediana celokupnega PFS je bila 44,4 meseca (39,6; 52,0) v skupini z lenalidomidom in 23,8 meseca (95 % IZ 21,2; 27,3) v skupini s placebom.
English: Mediana PFS2 time, months (95% CI) b HR [95% CI]c ; p-valued
Slovenian: Medianaa časa PFS2, meseci (95 % IZ)b
English: Lenalidomide Accord 15 mg hard capsules EU/1/18/1316/008
Slovenian: Lenalidomide Accord 15 mg trde kapsule EU/1/18/1316/008
English: Gelatin hard capsules size “1” approximately 19.0 mm to 19.8 mm in length, opaque green cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “20 mg” printed on body in green, containing white to off white coloured powder.
Slovenian: Trde želatinske kapsule velikosti »1«, dolge približno 19,0 mm do 19,8 mm, z neprozornim zelenim pokrovčkom in neprozornim belim telesom, ki imajo na pokrovčku v črni barvi natisnjeno »LENALIDOMIDE«, na telesu pa v zeleni barvi »20 mg« in vsebujejo prašek bele do belkaste barve.
English: Respiratory, Thoracic and Mediastinal Disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora neznana pogostnost intersticijski pnevmonitis
English: Lenalidomide Accord 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Lenalidomide Accord 5 mg
English: EU/1/18/1316/011 21x1 hard capsules
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1316/011 21x1 trda kapsula
English: Resume lenalidomide at next lower dose level (dose level -2 or -3) once daily.
Slovenian: za vsako nadaljnje zmanjšanje pod 30 x 109/l prekinite zdravljenje z lenalidomidom vrne na ≥ 30 x 109/l nadaljujte zdravljenje z lenalidomidom na naslednji nižji ravni odmerka (raven odmerka -2 ali -3) enkrat na dan.
English: Blood and Lymphatic System Disorders
Slovenian: Bolezni krvi in limfatičnega sistema neznana pogostnost pridobljena hemofilija
English: Overall, grade 4 neutropenia was observed at a higher frequency in the lenalidomide maintenance arms compared to the placebo maintenance arms in the 2 studies evaluating lenalidomide maintenance in NDMM patients who have undergone ASCT (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: To so opazili v 2 študijah, v katerih so ocenjevali vzdrževalno zdravljenje z lenalidomidom pri bolnikih z NDDP, pri katerih je bila opravljena ASCT (32,1 % proti 26,7 % [16,1 % proti 1,8 % po začetku vzdrževalnega zdravljenja] v CALGB 100104 oziroma 16,4 % proti 0,7 % v IFM 2005-02).
English: Iron oxide red (E172) Iron oxide yellow (E172) Titanium dioxide (E171)
Slovenian: Lenalidomide Accord 15 mg trde kapsule želatina rdeči železov oksid (E172) rumeni železov oksid (E172) titanov dioksid (E171)
English: Lenalidomide Accord 2.5 mg are gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in length, grey cap and opaque white body with “LENALIDOMIDE” printed on cap in black and “2.5 mg” printed on body in green, containing white to off white coloured powder.
Slovenian: Lenalidomide Accord 2,5 mg trde kapsule so trde želatinske kapsule velikosti »5«, dolge približno 11,0 mm do 11,8 mm, s sivim pokrovčkom in neprozornim belim telesom, ki imajo na pokrovčku v črni barvi natisnjeno »LENALIDOMIDE«, na telesu pa v zeleni barvi »2,5 mg« in vsebujejo prašek bele do belkaste barve.
English: Common Febrile neutropenia^,◊, Pancytopenia◊
Slovenian: hemoragične bolezni^, levkopenije pogosti febrilna nevtropenija^,◊, pancitopenija◊
English: How and when to take lenalidomide swallow the capsules whole, preferably with water.
Slovenian: • Kapsule pogoltnite cele, po možnosti z vodo.
English: Lenalidomide Accord 5 mg hard capsules EU/1/18/1316/003
Slovenian: Lenalidomide Accord 5 mg trde kapsule EU/1/18/1316/003
English: Lenalidomide Accord 5 mg are gelatin hard capsules size “5” approximately 11.0 mm to 11.8 mm in length, opaque white cap and body with “LENALIDOMIDE” printed on cap in black and “5 mg” printed on body in green, containing white to off white coloured powder.
Slovenian: Lenalidomide Accord 5 mg trde kapsule so trde želatinske kapsule velikosti »5«, dolge približno 11,0 mm do 11,8 mm, z neprozornim belim pokrovčkom telesom, ki imajo na pokrovčku v črni barvi natisnjeno »LENALIDOMIDE«, na telesu pa v zeleni barvi »5 mg« in vsebujejo prašek bele do belkaste barve.
English: EU/1/18/1316/010 21x1 hard capsules
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1316/010 21x1 trda kapsula
English: EU/1/18/1316/005 21x1 hard capsules
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1316/005 21x1 trda kapsula
English: WARNING: Risk of severe birth defects.
Slovenian: če obstaja tveganje za zanositev;