FrancophonIA/ELRC3.0 huggingface dataset:
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).
Latvian: Kopumā 2 pētījumos, kuros novērtēja lenalidomīda uzturošo terapiju NDMM pacientiem, kam veikta ASCT, 4. pakāpes neitropēniju lenalidomīda uzturošās terapijas grupās novēroja biežāk, salīdzinot ar placebo uzturošās terapijas grupām (attiecīgi 32,1% un 26,7% [16,1% un 1,8% pēc uzturošās terapijas sākšanas] pētījumā CALGB 100104 un 16,4% un 0,7% pētījumā IFM 2005-02).
English: Rd vs MPT Rd vs Rd18 Rd18 vs MPT PFS2e (months) Mediana PFS2 time, months (95% CI)b HR [95% CI]c; p-valued
Latvian: Rd, salīdzinot ar MPT Rd, salīdzinot ar Rd18 Rd18, salīdzinot ar MPT PFS2e (mēneši)
English: Lenalidomide Accord 5 mg and Lenalidomide Accord 25 mg hard capsules Gelatin
Latvian: Lenalidomide Accord 5 mg un Lenalidomide Accord 25 mg cietās kapsulas Želatīns
English: Each capsule contains 10 mg of lenalidomide.
Latvian: Katra kapsula satur 10 mg lenalidomīda.
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.
Latvian: Ārstēšanu ar lenalidomīdu nedrīkst uzsākt, ja absolūtais neitrofilo leikocītu skaits (Absolute Neutrophil Count - ANC) ir < 1,0 x 109/l un/vai trombocītu skaits ir < 75 x 109/l.
English: Return to ≥ 25 x 109/L
Latvian: Atgriežas līmenī ≥ 25 x 109/l
English: Each capsule contains 2.5 mg of lenalidomide.
Latvian: Katra kapsula satur 2,5 mg lenalidomīda.
English: Common Hypothyroidism
Latvian: Bieži Hipotireoze
English: ªIf the subject has not been receiving G-CSF therapy, initiate G-CSF therapy.
Latvian: Atsāciet lenalidomīda lietošanu nākamajā zemākā devas līmenī vienu reizi dienā ªJa pacients nav saņēmis G-CSF terapiju, uzsāciet G-CSF terapiju.
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 7.5 mg hard capsules lenalidomide
Latvian: ZĀĻU NOSAUKUMS Lenalidomide Accord 7,5 mg cietās kapsulas lenalidomide
English: Lenalidomide Accord 25 mg hard capsules Each hard capsule contains 25 mg of lenalidomide.
Latvian: Lenalidomide Accord 25 mg cietās kapsulas Katra cietā kapsula satur 25 mg lenalidomīda (lenalidomide).
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.
Latvian: Ārstēšanu ar lenalidomīdu nedrīkst uzsākt, ja ANC ir < 1,5 x 109/l un/vai trombocītu skaits ir < 75 x 109/l.
English: Lenalidomide Accord 10 mg hard capsules
Latvian: Lenalidomide Accord 10 mg cietās kapsulas
English: Acute myeloid leukaemia Multiple myeloma
Latvian: Akūta mieloleikoze Multiplā mieloma
English: First fall to < 30 x 109/L
Latvian: Pirmo reizi samazinās līdz < 30 x 109/l
English: Overall response: CR, VGPR, or PR Duration of response (months) Mediana (95% CI)b
Latvian: Kopējā atbildes reakcija: CR, VGPR vai PR
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.
Latvian: Lenalidomide Accord 20 mg ir 1. izmēra cietas želatīna kapsulas, aptuveni 19,0 mm līdz 19,8 mm garas, ar necaurspīdīgu zaļu vāciņu un necaurspīdīgu baltu korpusu.
English: • Constipation, diarrhoea, nausea, redness of skin, rashes, vomiting, muscle cramps, muscle aches,
Latvian: • aizcietējums, caureja, slikta dūša, ādas apsārtums, izsitumi, vemšana, muskuļu krampji, muskuļu sāpes, kaulu sāpes, locītavu sāpes, nogurums, vispārējs pietūkums, ieskaitot roku un kāju pietūkumu;
English: • an immunosuppressant medicine called ‘prednisone'.
Latvian: • imūno sistēmu nomācošām zālēm - prednizonu.
English: Propylene glycol Iron oxide black (E172) Iron oxide yellow (E172) Potassium hydroxide Titanium dioxide (E171) Indigo carmine (E132)
Latvian: Melnais dzelzs oksīds (E172) Dzeltenais dzelzs oksīds (E172) Kālija hidroksīds Titāna dioksīds (E171) Indigokarmīns (E132)
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.
Latvian: Ārstēšanu ar lenalidomīdu nedrīkst uzsākt, ja ANC ir < 1,0 x 109/l un/vai trombocītu skaits ir < 50 x 109/l.
English: Fall to < 25 x 109/L
Latvian: Samazinās līdz < 25 x 109/l
English: ADRs reported in post-marketing use in patients treated with lenalidomide System Organ
Latvian: Nevēlamas blakusparādības, par kurām pēcreģistrācijas periodā ziņots pacientiem, kuri ārstēti ar lenalidomīdu Orgānu sistēmu klase/ vēlamais termins
English: Fall to < 0.5 x 109/L
Latvian: Samazinās līdz < 0,5 x 109/l
English: Lenalidomide Accord 5 mg hard capsules Each hard capsule contains 5 mg of lenalidomide.
Latvian: Lenalidomide Accord 5 mg cietās kapsulas Katra cietā kapsula satur 5 mg lenalidomīda (lenalidomide).
English: Common Abnormal liver function tests
Latvian: Izmainīti aknu funkciju testi Retāk
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 10 mg hard capsules lenalidomide
Latvian: ZĀĻU NOSAUKUMS Lenalidomide Accord 10 mg cietās kapsulas lenalidomide
English: First fall to < 0.5 x 109/Lª
Latvian: Pirmo reizi samazinās līdz < 0,5 x 109/lª
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.
Latvian: Lenalidomide Accord 7,5 mg ir 4. izmēra cietas želatīna kapsulas, aptuveni 14,0 mm līdz 14,8 mm garas, ar necaurspīdīgu lavandas krāsas vāciņu un necaurspīdīgu baltu korpusu.
English: Each capsule contains 15 mg of lenalidomide.
Latvian: Katra kapsula satur 15 mg lenalidomīda.
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 2.5 mg hard capsules lenalidomide
Latvian: ZĀĻU NOSAUKUMS Lenalidomide Accord 2,5 mg cietās kapsulas lenalidomide
English: Gastrointestinal perforations have been reported during treatment with lenalidomide.
Latvian: Ārstēšanas laikā ar lenalidomīdu ir saņemti ziņojumi par perforācijām kuņģa-zarnu traktā.
English: Lenalidomide Accord 15 mg hard capsules Each hard capsule contains 15 mg of lenalidomide.
Latvian: Lenalidomide Accord 15 mg cietās kapsulas Katra cietā kapsula satur 15 mg lenalidomīda (lenalidomide).
English: Each capsule contains 5 mg of lenalidomide.
Latvian: Katra kapsula satur 5 mg lenalidomīda.
English: Lenalidomide Accord 20 mg hard capsules EU/1/18/1316/010
Latvian: Lenalidomide Accord 20 mg cietās kapsulas EU/1/18/1316/010
English: Lenalidomide Accord 25 mg hard capsules
Latvian: Lenalidomide Accord 25 mg cietās kapsulas
English: Common (may affect up to 1 in 10 people):
Latvian: Bieži (var skart līdz 1 no 10 lietotājiem):
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).
Latvian: Pētījumos, kuros novērtēja lenalidomīda uzturošo terapiju NDMM pacientiem, kam veikta ASCT, 3. un 4. pakāpes trombocitopēniju lenalidomīda uzturošās terapijas grupās novēroja biežāk, salīdzinot ar placebo uzturošās terapijas grupām (attiecīgi 37,5% un 30,3% [17,9% un 4,1% pēc uzturošās terapijas sākšanas] pētījumā CALGB 100104 un 13,0% un 2,9% pētījumā IFM 2005-02).
English: Lenalidomide Accord 25 mg hard capsules EU/1/18/1316/011
Latvian: Lenalidomide Accord 25 mg cietās kapsulas EU/1/18/1316/011
English: Hypokalaemia◊, Hyperglycaemia, Hypocalcaemia◊, Decreased appetite, Weight decreased
Latvian: Hipokaliēmija◊, hiperglikēmija, hipokalciēmija◊, samazināta ēstgriba, samazināta ķermeņa masa
English: Diarrhoea◊, Constipation◊, Abdominal pain◊, Nausea, Vomiting
Latvian: Caureja◊, aizcietējums◊, sāpes vēderā◊, slikta dūša, vemšana
English: Lenalidomide Accord 2.5 mg hard capsules
Latvian: Lenalidomide Accord 2,5 mg cietās kapsulas
English: Excipient with known effect Each hard capsule contains100 mg of lactose.
Latvian: Palīgviela ar zināmu iedarbību Katra cietā kapsula satur 100 mg laktozes.
English: Fall to < 30 x 109/L
Latvian: Samazinās līdz < 30 x 109/l
English: CI = confidence interval; HR = hazard ratio; max = maximum; min = minimum; NE = not estimable; OS = overall survival; PFS = progression-free survival;
Latvian: NE = nav novērtējams; OS = kopējā dzīvildze; P = prednizons; PFS = dzīvildze bez slimības progresēšanas;
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.
Latvian: Lenalidomide Accord 10 mg ir 3. izmēra cietas želatīna kapsulas, aptuveni 15,4 mm līdz 16,2 mm garas, ar zaļu lapu krāsas vāciņu un necaurspīdīgu baltu korpusu.
English: Lenalidomide Accord 7.5 mg hard capsules:
Latvian: Lenalidomide Accord 7,5 mg cietās kapsulas:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 20 mg of lenalidomide.
Latvian: NOSAUKUMS(-I) UN DAUDZUMS(-I) Katra kapsula satur 20 mg lenalidomīda.
English: Overall survival Mediana OS time, months (95% CI)b
Latvian: Mediānaisa OS ilgums mēnešos (95% TI)b
English: Progression free survival Median [95% CI], weeks
Latvian: Dzīvildze bez slimības progresēšanas Mediāna [95% TI], nedēļas p < 0,001
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 25 mg hard capsules lenalidomide
Latvian: ZĀĻU NOSAUKUMS Lenalidomide Accord 25 mg cietās kapsulas lenalidomide
English: When neutrophils
Latvian: Ja neitrofilie leikocīti
English: MPp +p (N = 154)
Latvian: MPp+p
English: Lenalidomide Accord 7.5 mg hard capsules
Latvian: Lenalidomide Accord 7,5 mg cietās kapsulas
English: Lenalidomide Accord 10 mg hard capsules:
Latvian: Lenalidomide Accord 10 mg cietās kapsulas:
English: How Lenalidomide Accord works
Latvian: Kā Lenalidomide Accord darbojas
English: Return to ≥ 50 x 109/L
Latvian: Atgriežas līmenī ≥ 50 x 109/l
English: Excipientwith known effect Each hard capsule contains 67mg of lactose.
Latvian: Palīgviela ar zināmu iedarbību Katra cietā kapsula satur 67 mg laktozes.
English: First fall to < 0.5 x 109/L
Latvian: Pirmo reizi samazinās līdz < 0,5 x 109/l
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.
Latvian: Lenalidomide Accord 15 mg ir 2. izmēra cietas želatīna kapsulas, aptuveni 17,4 mm līdz 18,2 mm garas, ar necaurspīdīgu oranžas krāsas vāciņu un necaurspīdīgu baltu korpusu.
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).
Latvian: Lenalidomīda uzturošā terapija pēc ASCT ir saistīta ar biežāku 3. vai 4. pakāpes trombocitopēnijas sastopamību, salīdzinot ar placebo uzturošo terapiju (attiecīgi 37,5% un 30,3% pētījumā CALGB 100104 un 13,0% un 2,9% pētījumā IFM 2005-02).
English: Counselling
Latvian: Parestēzija
English: Lenalidomide Accord 10 mg hard capsules EU/1/18/1316/006
Latvian: Lenalidomide Accord 10 mg cietās kapsulas EU/1/18/1316/006
English: Lenalidomide Accord 7.5 mg hard capsules EU/1/18/1316/005
Latvian: Lenalidomide Accord 7,5 mg cietās kapsulas EU/1/18/1316/005
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 2.5 mg of lenalidomide.
Latvian: NOSAUKUMS(-I) UN DAUDZUMS(-I) Katra kapsula satur 2,5 mg lenalidomīda.
English: • Circulatory problems
Latvian: • nieru darbības traucējumi;
English: Lenalidomide Accord 5 mg hard capsules
Latvian: Lenalidomide Accord 5 mg cietās kapsulas
English: Return to ≥ 0.5 x 109/L
Latvian: Atgriežas līmenī ≥ 0,5 x 109/l
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 5 mg hard capsules lenalidomide
Latvian: ZĀĻU NOSAUKUMS Lenalidomide Accord 5 mg cietās kapsulas lenalidomide
English: Lenalidomide Accord 2.5 mg hard capsules EU/1/18/1316/001
Latvian: Lenalidomide Accord 2,5 mg cietās kapsulas EU/1/18/1316/001
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.
Latvian: Lai kontrolētu citopēnijas, uzsākot ārstēšanu, katru nedēļu pirmās 8 ārstēšanas ar lenalidomīdu nedēļas un pēc tam katru mēnesi jānosaka pilna asins aina, ieskaitot leikocītu skaitu un formulu, trombocītu skaitu, hemoglobīnu un hematokrītu.
English: Very Common Fatigue, Asthenia, Pyrexia
Latvian: Ļoti bieži Nogurums, astēnija, drudzis
English: Lenalidomide maintenance in patients who have undergone autologous stem cell transplantation (ASCT)
Latvian: Pirmo reizi diagnosticēta multiplā mieloma (newly diagnosed multiple myeloma − NDMM) Lenalidomīda uzturošā terapija pacientiem, kam veikta autologo cilmes šūnu transplantācija (ASCTautologous stem cell transplantation)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 25 mg of lenalidomide.
Latvian: NOSAUKUMS(-I) UN DAUDZUMS(-I) Katra kapsula satur 25 mg lenalidomīda.
English: For men taking lenalidomide
Latvian: Kā un kad lietot lenalidomīdu
English: Overall survival (months) Mediana OS time, months (95% CI)b
Latvian: Mediānaisª OS ilgums, mēneši (95% TI)
English: Resume lenalidomide at dose level -1 once daily
Latvian: Atsāciet lenalidomīda lietošanu vienu reizi dienā -1.
English: Common Sepsis◊, Sinusitis◊
Latvian: Bieži Sepse◊, sinusīts◊
English: EU/1/18/1316/010 21x1 hard capsules
Latvian: REĢISTRĀCIJAS APLIECĪBAS NUMURS(-I) EU/1/18/1316/010 21x1 cietā kapsula
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 10 mg of lenalidomide.
Latvian: NOSAUKUMS(-I) UN DAUDZUMS(-I) Katra kapsula satur 10 mg lenalidomīda.
English: EU/1/18/1316/005 21x1 hard capsules
Latvian: REĢISTRĀCIJAS APLIECĪBAS NUMURS(-I) EU/1/18/1316/005 21x1 cietā kapsula
English: Multiple myeloma
Latvian: Multiplā mieloma
English: Tumour flare reaction and tumour lysis syndrome
Latvian: Audzēja uzliesmojuma reakcija un audzēja sabrukšanas sindroms
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.
Latvian: Pacienti Rd un Rd18 grupās lietoja lenalidomīdu 25 mg vienu reizi dienā no 1. līdz 21. dienai 28 dienu ciklos atbilstoši protokola grupai.
English: ◊ Adverse reactions reported as serious in clinical trials in patients with NDMM who had undergone ASCT * Applies to serious adverse drug reactions only ^ See section 4.8 description of selected adverse reactions a “Pneumonias” combined AE term includes the following PTs: Bronchopneumonia, Lobar pneumonia, Pneumocystis jiroveci pneumonia, Pneumonia, Pneumonia klebsiella, Pneumonia legionella, Pneumonia mycoplasmal, Pneumonia pneumococcal, Pneumonia streptococcal, Pneumonia viral, Lung disorder, Pneumonitis b “Sepsis” combined AE term includes the following PTs: Bacterial sepsis, Pneumococcal sepsis, Septic shock, Staphylococcal sepsis c “Peripheral neuropathy” combined AE term includes the following preferred terms (PTs): Neuropathy peripheral, Peripheral sensory neuropathy, Polyneuropathy d “Deep vein thrombosis” combined AE term includes the following PTs: Deep vein thrombosis, Thrombosis, Venous thrombosis
Latvian: a Kopējais nevēlamas blakusparādības termins „pneimonijas” ietver šādus vēlamos terminus (PT - preferred term): bronhopneimonija, lobāra pneimonija, Pneumocystis jiroveci pneimonija, pneimonija, Kebsiella pneimonija, Legionella pneimonija, mikoplazmu pneimonija, pneimokoku pneimonija, streptokoku pneimonija, vīruspneimonija, plaušu slimības, pneimonīts.
English: HR [95% CI]c; p-valued Rd vs MPT
Latvian: HR [95% TI]c; p-vērtībad Kopējā dzīvildze
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.
Latvian: Lenalidomide Accord 25 mg ir 0. izmēra cietas želatīna kapsulas, aptuveni 21,0 mm līdz 21,8 mm garas, ar necaurspīdīgu baltu vāciņu un korpusu.
English: Common Deafness (Including Hypoacusis), Tinnitus
Latvian: Kurlums (ieskaitot hipoakūziju), troksnis ausīs
English: Congestive cardiac failure◊, Tachycardia, Cardiac failure◊, Myocardial ischemia◊
Latvian: Miokarda infarkts (ieskaitot akūtu)^,◊, priekškambaru mirdzēšana◊, sastrēguma sirds mazspēja◊, tahikardija, sirds mazspēja◊, miokarda išēmija◊
English: Lenalidomide Accord 15 mg hard capsules EU/1/18/1316/008
Latvian: Lenalidomide Accord 15 mg cietās kapsulas EU/1/18/1316/008
English: Lenalidomide Accord 15 mg hard capsules lenalidomide
Latvian: Lenalidomide Accord 15 mg cietās kapsulas Želatīns
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 7.5 mg of lenalidomide
Latvian: NOSAUKUMS(-I) UN DAUDZUMS(-I) Katra kapsula satur 7,5 mg lenalidomīda.
English: Lenalidomide Accord 15 mg hard capsules:
Latvian: Lenalidomide Accord 15 mg cietās kapsulas:
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.
Latvian: Mediānā kopējā PFS bija 44,4 mēneši (39,6; 52,0) lenalidomīda grupā un 23,8 mēneši (95% TI 21,2; 27,3) placebo grupā.
English: Infection◊, Urinary tract infection◊,*, Lower respiratory tract infection, Lung infection◊
Latvian: Bieži Infekcija◊, urīnceļu infekcija◊,*,
English: Lenalidomide Accord 5 mg hard capsules EU/1/18/1316/003
Latvian: Lenalidomide Accord 5 mg cietās kapsulas EU/1/18/1316/003
English: For men taking lenalidomide lenalidomide passes into human semen.
Latvian: Lenalidomīds nokļūst vīrieša spermā.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Latvian: Stabila slimības gaita (SD)
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.
Latvian: Lenalidomide Accord 5 mg ir 5. izmēra cietas želatīna kapsulas, aptuveni 11,0 mm līdz 11,8 mm garas, ar necaurspīdīgu baltu vāciņu un korpusu.
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.
Latvian: Lenalidomide Accord 2,5 mg ir 5. izmēra cietas želatīna kapsulas, aptuveni 11,0 mm līdz 11,8 mm garas, ar pelēku vāciņu un necaurspīdīgu baltu korpusu.
English: Each hard capsule contains167 mg of lactose.
Latvian: Palīgviela ar zināmu iedarbību Katra cietā kapsula satur 167 mg laktozes.
English: Excipient with known effect Each hard capsule contains 36 mg of lactose.
Latvian: Katra cietā kapsula satur 36 mg laktozes.
English: Lenalidomide Accord 15 mg hard capsules
Latvian: Lenalidomide Accord 15 mg cietās kapsulas
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 5 mg of lenalidomide.
Latvian: NOSAUKUMS(-I) UN DAUDZUMS(-I) Katra kapsula satur 5 mg lenalidomīda.
English: • Pregnancy test regime o Advice on suitable tests o Before commencing treatment o During treatment based on method of contraception o After finishing treatment
Latvian: pirms ārstēšanas uzsākšanas; atkarībā no kontracepcijas līdzekļa ārstēšanas laikā; pēc ārstēšanas beigām.
English: • Breathlessness
Latvian: • Trombocitopēnija
English: Lenalidomide Accord 2.5 mg hard capsules Gelatin
Latvian: Lenalidomide Accord 2,5 mg cietās kapsulas Želatīns
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.
Latvian: Uzraksts “LENALIDOMIDE” melnā krāsā uzdrukāts uz vāciņa, un uzraksts “25 mg” zaļā krāsā uzdrukāts uz korpusa.Kapsulas satur baltu vai gandrīz baltu pulveri.
English: Very Common Cough
Latvian: Ļoti bieži Klepus
English: EU/1/18/1316/008 7x1 hard capsules EU/1/18/1316/009 21x1 hard capsules
Latvian: REĢISTRĀCIJAS APLIECĪBAS NUMURS(-I) EU/1/18/1316/008 7x1 cietā kapsula EU/1/18/1316/009 21x1 cietā kapsula
English: • Pregnancy test regime o Before commencing treatment o During treatment, every 4 weeks except in case of confirmed tubal sterilisation o After finishing treatment
Latvian: • arstēšanas laikā ik pēc 4 nedēļām, izņemot gadījumus, kad ir apstiprināta olvadu sterilizācija.
English: Lenalidomide Accord 7.5 mg hard capsules Gelatin
Latvian: Lenalidomide Accord 7,5 mg cietās kapsulas Želatīns
English: • Women of childbearing potential unless all of the conditions of the Pregnancy Prevention
Latvian: • Sievietēm ar reproduktīvo potenciālu, ja vien nav izpildīti visi grūtniecības nepieļaušanas programmas nosacījumi (skatīt 4.4. un 4.6. apakšpunktu).
English: Cerebrovascular accident◊, Dizziness, Syncope
Latvian: reibonis, sinkope
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.
Latvian: Kad tika pārsniegts iepriekš ieplānotās PFS starpposmu analīzes slieksnis, saskaņā ar datu uzraudzības komitejas ieteikumiem pētījuma maskēšana tika atcelta.
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.
Latvian: 2. izmēra cietas želatīna kapsulas, aptuveni 17,4 mm līdz 18,2 mm garas, ar necaurspīdīgu oranžas krāsas vāciņu un necaurspīdīgu baltu korpusu.
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.
Latvian: 1. izmēra cietas želatīna kapsulas, aptuveni 19,0 mm līdz 19,8 mm garas, ar necaurspīdīgu zaļu vāciņu un necaurspīdīgu baltu korpusu.
English: Hepatic failure^
Latvian: • elpas trūkums.
English: Dose level- 4
Latvian: -4. devas līmenis
English: EU/1/18/1316/006 7x1 hard capsules EU/1/18/1316/007 21x1 hard capsules
Latvian: REĢISTRĀCIJAS APLIECĪBAS NUMURS(-I) EU/1/18/1316/006 7x1 cietā kapsula EU/1/18/1316/007 21x1 cietā kapsula
English: • Toothache
Latvian: Rabdomiolīze
English: EU/1/18/1316/003 7x1 hard capsules EU/1/18/1316/004 21x1 hard capsules
Latvian: REĢISTRĀCIJAS APLIECĪBAS NUMURS(-I) EU/1/18/1316/003 7x1 cietā kapsula EU/1/18/1316/004 21x1 cietā kapsula
English: Investigator-assessed PFS (months) Mediana PFS time, months (95% CI) HR [95% CI]; p-value
Latvian: Mediānaisª PFS ilgums, mēneši [95% TI]
English: NAME OF THE MEDICINAL PRODUCT Lenalidomide Accord 20 mg hard capsuleslenalidomide 2.
Latvian: ZĀĻU NOSAUKUMS Lenalidomide Accord 20 mg cietās kapsulas lenalidomide
English: Thrombocytopenia^,◊, Anaemia ,
Latvian: Neitropēnija^,◊, trombocitopēnija^,◊, anēmija◊, leikopēnijas
English: Very Common Diarrhoea, Constipation, Abdominal pain, Nausea
Latvian: Caureja, aizcietējums, sāpes vēderā, slikta dūša