FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric subjects who had completed a prior romiplostim study (including study S4) were allowed to enroll in study S6 (340), an open-label extension study evaluating the safety and efficacy of long-term dosing of romiplostim in thrombocytopenic paediatric subjects with ITP.
Maltese: Individwi pedjatriċi li kienu temmew studju preċedenti ta' romiplostim (inkluż studju S4) tħallew jirreġistraw fl-istudju S6 (340), studju ta' estensjoni open-label li evalwa s-sigurtà u l-effikaċja ta' dożaġġ fit-tul ta' romiplostim f'individwu pedjatriċi tromboċitopeniċi b'ITP.
English: In the Phase 3 paediatric study, the mean (SD) number of composite bleeding episodes (see section 5.1) was 1.9 (4.2) for the romiplostim arm and 4.0 (6.9) for the placebo arm.
Maltese: Fl-istudju pedjatriku ta' Fażi 3, l-għadd medju (SD) ta' episodji ta' fsada komposti (ara sezzjoni 5.1) kien 1.9 (4.2) għall-grupp ta' romiplostim u 4.0 (6.9) għall-grupp tal-plaċebo.
English: Example:
Maltese: Tel:
English: Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1).
Maltese: L-użu ta' kortikosterojdi, danazol, u azathioprine jista' jiġi mnaqqas jew imwaqqaf meta dawn jingħataw flimkien ma' romiplostim (ara sezzjoni 5.1).
English: + 0.44 mL = 125 mcg in 0.25 mL 500 mcg/mL
Maltese: + 0.44 mL = 125 mcg f'0.25 mL 500 mcg/mL
English: Home Administration Training (HAT) pack
Maltese: Taħriġ ta' amministrazzjoni fid-dar (Home Administration Training - HAT)
English: Platelet counts should be monitored in patients receiving Nplate (see sections 4.2, 4.4 and 4.9).
Maltese: L-għadd tal-plejtlits għandu jiġu ssorveljat f'pazjenti li qed jirċievu Nplate (ara sezzjonijiet 4.2, 4.4 u 4.9).
English: Platelet counts above the normal range present a risk for thrombotic/thromboembolic complications.
Maltese: Għadd ta' plejtlits 'l fuq mill-firxa normali jfisser riskju għal komplikazzjonijiet trombotiċi/tromboemboliċi.
English: In pre-clinical and clinical trials no anti-romiplostim antibodies cross reacted with endogenous TPO.
Maltese: Fi provi prekliniċi u kliniċi l-ebda antikorp kontra romiplostim ma rreaġixxa ma' TPO endoġenu.
English: It is very important that you prepare Nplate properly and take the correct dose (see section 7.
Maltese: Huwa importanti ħafna li tipprepara Nplate sew u li tieħu d-doża korretta (ara sezzjoni 7.
English: • chills;
Maltese: • tqalligħ;
English: The mean (SD) number of composite bleeding episodes was 1.9 (4.2) for the romiplostim arm and 4.0 (6.9) for the placebo arm with a median (Q1, Q3) number of bleeding events of 0.0 (0, 2) for the romiplostim arm and 0.5 (0, 4.5) in the placebo arm.
Maltese: In-numru medju (SD) ta' episodji ta' fsada komposta kien ta' 1.9 (4.2) għall-grupp ta' romiplostim u 4.0 (6.9) għall-grupp talplaċebo b'numru medjan (Q1, Q3) ta' avvenimenti ta' fsada ta' 0,0 (0, 2) għall-grupp ta' romiplostim u 0.5
English: • blood clot in a lung artery (pulmonary embolism);
Maltese: • demm magħqud f'arterja tal-pulmun (emboliżmu pulmonari);
English: Study S3 (131) was an open-label randomised 52 week trial in subjects who received romiplostim or medical standard of care (SOC) treatment.
Maltese: Studju S3 (131) kienet prova open-label u randomised ta' 52 ġimgħa f'individwi li rċevew romiplostim jew trattament mediku ta' standard ta' kura (SOC - standard of care).
English: The safety and efficacy of romiplostim was evaluated in two placebo-controlled, double-blind studies.
Maltese: Is-sigurtà u l-effikaċja ta' romiplostim kienu evalwati f'żewġ studji double-blind u kkontrollati bilplaċebo.
English: In study S4, 62 subjects were randomised in a 2:1 ratio to receive romiplostim (n = 42) or placebo (n = 20) and stratified into 1 of 3 age cohorts.
Maltese: Fl-istudju S4, 62 individwi kienu randomised fi proporzjon ta' 2:1 biex jirċievu romiplostim (n = 42) jew plaċebo (n = 20) u stratifikati fi grupp wieħed minn 3 gruppi ta' età.
English: Patients (≥ 18 years) were randomised in a 2:1 ratio to receive a starting dose of romiplostim 1 mcg/kg or placebo.
Maltese: Il-pazjenti (≥ 18 sena) kienu randomised fi proporzjon ta' 2:1 biex jingħataw doża tal-bidu ta' romiplostim ta' 1 mcg/kg jew plaċebo.
English: In another ITP clinical trial, no accumulation in serum concentrations was observed after 6 weekly doses of romiplostim (3 mcg/kg).
Maltese: Fi prova klinika oħra dwar ITP, ma kienet osservata lebda akkumulazzjoni fil-konċentrazzjonijiet fis-serum wara 6 dożi ta' kull ġimgħa ta' romiplostim (3 mcg/kg).
English: Vial containing 125 micrograms of romiplostim.
Maltese: Kunjett fih 125 mikrogramma ta' romiplostim.
English: Of these, 65 subjects (98.5%) received at least 1 dose of romiplostim.
Maltese: Minn dawn, 65 individwu (98.5%) irċevew mill-inqas doża waħda ta' romiplostim.
English: Vial Content:
Maltese: Kontenut tal-Kunjett:
English: Romiplostim is an Fc-peptide fusion protein (peptibody) that signals and activates intracellular transcriptional pathways via the TPO receptor (also known as cMpl) to increase platelet production.
Maltese: Romiplostim huwa proteina Fc-peptide tal-irbit (peptibody) li jagħti sinjal u jattiva rotot ta' traskrizzjoni ġewwa ċ-ċelluli permezz tar-riċettur ta' TPO (magħruf ukoll bħala cMpl) biex iżidu lproduzzjoni tal-plejtlits.
English: Multiple myeloma Myelofibrosis
Maltese: Emorraġija mill-vaġina
English: = 500 mcg in 1.00 mL 500 mcg/mL
Maltese: = 500 mcg f'1.00 mL 500 mcg/mL
English: Study S2 (105) evaluated patients who were splenectomised and continued to have thrombocytopenia.
Maltese: Studju S2 (105) evalwa pazjenti li kellhom tneħħija tal-milsa u komplew ikollhom tromboċitopenija.
English: In the subset of subjects with ITP > 12 months of duration, the overall subject incidence of platelet response was 93.7% (n = 59) and was similar across age groups.
Maltese: Fis-sottogrupp ta' individwi b'ITP li kienet ilha > 12-il xahar, l-inċidenza globali fl-individwi ta' rispons tal-plejtlits kienet ta' 93.7% (n = 59) u kienet simili matul il-gruppi ta' età.
English: A total of 3.2% (9/282) subjects had binding antibodies to TPO at any time during romiplostim treatment.
Maltese: Total ta' 3.2% (9/282) tal-individwi kellhom antikorpi li jeħlu għal TPO fi kwalunkwe ħin waqt it-trattament b'romiplostim.
English: In an ongoing paediatric clinical trial, of the subjects with an evaluable on-study bone marrow biopsy, 5 out of 27 subjects (18.5%) developed increased reticulin in cohort 1 and 2 out of 4 subjects (50.0%) developed increased reticulin in cohort 2.
Maltese: Fi prova klinika pedjatrika li għadha għaddejja, mill-individwi b'bijopsija tal-mudullun li setgħet tiġi evalwata fl-istudju, 5 minn 27 individwu (18.5%) żviluppaw żieda ta' reticulin fi grupp 1 u 2 minn 4 individwi (50.0%) żviluppaw żieda ta' reticulin fi grupp 2.
English: Immediately discard syringe and needle into an approved Sharps Container.
Maltese: Armi s-siringa u l-labra minnufih ġo kontenitur għallabar approvat.
English: = 125 mcg in 0.25 mL 500 mcg/mL
Maltese: = 125 mcg f'0.25 mL 500 mcg/mL
English: Romiplostim has no amino acid sequence homology to endogenous TPO.
Maltese: Romiplostim m'għandux effett osservat fuq ilfertilità tal-firien.
English: Pharmacokinetic data of romiplostim were collected from two studies in 21 paediatric subjects with ITP.
Maltese: Data farmakokinetiku ta' romiplostim inġabret minn żewġ studji fuq 21 individwu pedjatriku b'ITP.
English: All (100%) splenectomised patients who were receiving romiplostim were able to reduce the dose by more than 25% or discontinue the concurrent ITP medical therapies by the end of the treatment period compared to 17% of placebo treated patients.
Maltese: Il-pazjenti kollha (100%) li tneħħitilhom il-milsa li kienu qed jirċievu romiplostim kienu kapaċi jnaqqsu d-doża b'aktar minn 25% jew iwaqqfu it-terapiji mediċinali ta' ITP fl-istess waqt sat-tmiem tal-perjodu ta' trattament meta mqabbel ma' 17% tal-pazjenti ttrattati bil-plaċebo.
English: The subject prevalence of rescue medication use showed a trend towards a reduction over the course of the study: from 24.6% (weeks 1 to 12) to < 13.0% (weeks 13 to 216), then 0% after week 216 until the end of the study.
Maltese: Il-prevalenza fl-individwi ta' użu ta' medikazzjoni ta' salvataġġ uriet tendenza lejn tnaqqis matul ilkors tal-istudju: minn 24.6% (ġimgħat 1 sa 12) sa < 13.0% (ġimgħat 13 sa 216), imbagħad 0% wara ġimgħa 216 sat-tmiem tal-istudju.
English: Remove 1 mL administration syringe from package.
Maltese: Neħħi siringa għall-għoti ta' 1 mL mill-pakkett.
English: Bleeding events that were grade 2 or higher were reported by 15% of patients treated with romiplostim and 34% of patients treated with placebo (Odds Ratio; [romiplostim/placebo] = 0.35; 95% CI = (0.14, 0.85)).
Maltese: Avvenimenti ta' fsada li kienu ta' grad 2 jew ogħla kienu rrappurtati minn 15% tal-pazjenti ittrattati b'romiplostim u 34% tal-pazjenti ittrattati bi plaċebo (Proporzjon ta' Probabbiltà; [romiplostim/placebo] = 0.35; 95% CI = (0.14, 0.85)).
English: After reconstitution, a deliverable volume of 0.25 mL solution contains 125 mcg of romiplostim (500 mcg/mL).
Maltese: Wara r-rikostituzzjoni, volum li jista' jingħata ta' 0.25 mL ta' soluzzjoni fih 125 mcg ta' romiplostim (500 mcg/mL).
English: • bruising (contusion);
Maltese: • tbenġil (kontużjoni);
English: Keep the Nplate self injection kit refrigerated at 2ºC to 8ºC.
Maltese: Żomm il-kit biex tinjetta lilek innifsek ta' Nplate filfriġġ f'temperatura ta' 2°C sa 8°C.
English: Each vial of Nplate 500 micrograms powder for solution for injection contains a total of 625 micrograms of romiplostim.
Maltese: Kull kunjett ta' Nplate 500 mikrogramma trab għal soluzzjoni għall-injezzjoni fih total ta' 625 mikrogramma ta' romiplostim.
English: The maximum deliverable volume for the 250 microgram vial is 0.5 mL and for the 500 microgram vial is 1 mL.
Maltese: Il-volum massimu li jista' jingħata għall-kunjett ta' 250 mikrogramma huwa ta' 0.5 mL u għall-kunjett ta' 500 mikrogramma huwa ta' 1 mL.
English: Arthralgia Myalgia
Maltese: Tqalligħ Dijarea
English: Add this volume of preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection to the reconstituted vial
Maltese: Żid dan il-volum ta' soluzzjoni għallinjezzjoni mingħajr preservattivi u sterili ta' 9 mg/mL (0.9%) sodium chloride malkunjett rikostitwit
English: • higher than normal platelet counts (thrombocytosis);
Maltese: • għadd ta' plejtlits ogħla min-normal (tromboċitosi);
English: The most serious adverse reactions that may occur during Nplate treatment include: reoccurrence of thrombocytopenia and bleeding after cessation of treatment, increased bone marrow reticulin, thrombotic/thromboembolic complications, medication errors and progression of existing MDS to AML.
Maltese: L-aktar reazzjonijiet avversi serji li jistgħu jseħħu waqt it-trattament b'Nplate jinkludu: terġa tfiġġ ittromboċitopenija u fsada wara l-waqfien tat-trattament, żieda fir-retikulin tal-mudullun, kumplikazzjonijiet trombotiċi/tromboemboliċi, żbalji fl-għoti tal-mediċina u l-progressjoni ta' MDS eżistenti għal AML.
English: Manufacturer Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Maltese: Manifattur Amgen NV Arianelaan 5 1200 Brussel Il-Belġju
English: Each vial of Nplate 250 micrograms powder for solution for injection contains a total of 375 micrograms of romiplostim.
Maltese: Kull kunjett ta' Nplate 250 mikrogramma trab għal soluzzjoni għall-injezzjoni fih total ta' 375 mikrogramma ta' romiplostim.
English: Portal vein thrombosis Increase in transaminase
Maltese: Trombożi fil-vina portali Żieda fit-transaminase
English: Dextrose (5%) in water or sterile water for injection should not be used for the dilution.
Maltese: Dextrose (5%) fl-ilma jew ilma sterili għall-injezzjoni m'għandhomx jintużaw għad-dilwizzjoni.
English: Protein urine present
Maltese: Proteina preżenti flawrina
English: Deep vein thrombosis Hypotension Peripheral embolism Peripheral ischaemia Phlebitis
Maltese: Trombożi fil-vini tal-fond Pressjoni baxxa Emboliżmu periferali
English: • Remove red (250 micrograms) or blue (500 micrograms) plastic cap from vial.
Maltese: • Neħħi l-għatu tal-plastik aħmar (250 mikrogramma) jew blu (500 mikrogramma) mill-kunjett.
English: Localised infection Nasopharyngitis
Maltese: Influwenza Infezzjoni lokalizzata Nażofarinġite
English: 1 pre-filled syringe containing 0.72 mL of solvent.
Maltese: 72 mL ta' solvent.
English: = 250 mcg in 0.50 mL 500 mcg/mL
Maltese: = 250 mcg f'0.50 mL 500 mcg/mL
English: Nplate 250 µg powder for injection romiplostim
Maltese: Nplate 250 µg trab għall-injezzjoni romiplostim
English: Seventy-three percent of non-splenectomised patients receiving romiplostim were able to reduce the dose by more than 25% or discontinue concurrent ITP medical therapies by the end of the study compared to 50% of placebo treated patients (see section 4.5).
Maltese: Tlieta u sebgħin fil-mija tal-pazjenti li ma tneħħitilhomx il-milsa li kienu qed jirċievu romiplostim kienu kapaċi jnaqqsu d-doża b'aktar minn 25% jew iwaqqfu it-terapiji mediċinali ta' ITP fl-istess waqt sat-tmiem tal-istudju meta mqabbel ma' 50% tal-pazjenti ttrattati bil-plaċebo (ara sezzjoni 4.5).
English: No. (%) patients with overall platelet response b
Maltese: valur p Numru (%) ta' pazjenti b'rispons globali talplejtlits b
English: Across all subjects, the median (Q1, Q3) percentage of months with platelet response was 93.33% (67.57%, 100.00%) and was similar across age groups.
Maltese: Tul l-individwi kollha, il-perċentwali medjan (Q1, Q3) ta' xhur b'rispons tal-plejtlits kien ta' 93.33% (67.57%, 100.
English: The median duration of exposure was 65.4 weeks.
Maltese: It-tul medjan ta' esponiment kien ta' 65.4 ġimgħat.
English: Each vial of Nplate 125 micrograms powder for solution for injection contains a total of 230 micrograms of romiplostim.
Maltese: Kull kunjett ta' Nplate 125 mikrogramma trab għal soluzzjoni għall-injezzjoni fih total ta' 230 mikrogramma ta' romiplostim.
English: In the two adult placebo-controlled studies, 9 patients reported a bleeding event that was considered serious (5 [6.0%] romiplostim, 4 [9.8%] placebo; Odds Ratio [romiplostim/placebo] = 0.59; 95% CI = (0.15, 2.31)).
Maltese: Fiż-żewġ studji kkontrollati bil-plaċebo fl-adulti, 9 pazjenti rrappurtaw avveniment ta' fsada li kien ikkunsidrat serju (5 [6.0%] romiplostim, 4 [9.8%] plaċebo; Proporzjon ta' Probabbiltà [romiplostim/placebo] = 0.59; 95% CI = (0.15, 2.31)).
English: No. (%) patients with durable platelet response a
Maltese: Numru (%) ta' pazjenti b'rispons tal-plejtlits li jdum a
English: 10 kg patient is initiated at 1 mcg/kg of romiplostim.
Maltese: Pazjent ta' 10 kg se jinbeda b'1 mcg/kg ta' romiplostim.
English: Dilution Guidelines:
Maltese: Wara d-dilwizzjoni:
English: Nplate 250 micrograms powder and solvent for solution for injection Nplate 500 micrograms powder and solvent for solution for injection
Maltese: Nplate 250 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni Nplate 500 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni
English: • muscle spasm;
Maltese: • uġigħ fid-dahar;
English: Front
Maltese: Linji
English: Nplate's active ingredient is romiplostim, which is a protein used to treat low platelet counts in patients with immune (idiopathic) thrombocytopenic purpura (called ITP).
Maltese: Is-sustanza attiva ta' Nplate hija romiplostim, li hija proteina wżata għat-trattament ta' għadd baxx ta' plejtlits f'pazjenti b'purpura tromboċitopenika immuni (idjopatika) (msejħa ITP).
English: Twenty-one non-splenectomised and 18 splenectomised patients received on-study ITP medical treatments (primarily corticosteroids) at the start of study.
Maltese: Fil-bidu talistudju, wieħed u għoxrin pazjent li ma tneħħitilhomx il-milsa u 18 li tneħħitilhom il-milsa rċevew trattamenti mediċinali ta' ITP waqt l-istudju (primarjament kortikosterojdi).
English: Of those 62 subjects, 48 subjects had ITP > 12 months of duration (32 subjects received romiplostim and 16 subjects received placebo).
Maltese: Minn dawk it-62 individwu, 48 individwu kellhom ITP li kienet ilha > 12-il xahar (32 individwu rċevew romiplostim u 16-il individwu irċevew plaċebo).
English: Vial containing 500 micrograms of romiplostim.
Maltese: Kunjett fih 500 mikrogramma ta' romiplostim.
English: Of the cases of MDS disease progression to AML that were observed, patients with RAEB-1 classification of MDS at baseline were more likely to have disease progression to AML (see section 4.4).
Maltese: Mill-każijiet ta' MDS li pprogressaw għal AML, li kienu osservati, pazjenti bi klassifikazzjoni RAEB-1 ta' MDS fil-linja bazi kellhom aktar ċans li jkollhom progressjoni tal-marda għal AML (ara sezzjoni 4.4).
English: • low blood platelet count (thrombocytopenia) and low blood platelet count (thrombocytopenia)
Maltese: • jew kanċer taċ-ċelluli bojod tad-demm (majeloma multipla);
English: Plunger rod for pre-filled sterile water syringe x1 Pre-filled sterile water syringe x1
Maltese: Bastun tal-planġer għas-siringa mimlija għal-lest b'ilma sterili x1
English: Volume to administer (mL) = Individual patient dose (mcg) / 500 mcg/mL (Round volume to the nearest hundredth mL)
Maltese: Volum li għandu jingħata (mL) = Doża tal-pazjent individwali (mcg) / 500 mcg/mL (Żid/naqqas il-volum sa l-eqreb mitt mL)
English: Both studies enrolled paediatric subjects (≥ 1 year to < 18 years of age) with thrombocytopenia (defined by a mean of 2 platelet counts ≤ 30 x 109/L with neither count > 35 x 109/L in both studies) with ITP, regardless of splenectomy status.
Maltese: Iż-żewġ studji rreġistraw individwi pedjatriċi (età ta' ≥ sena sa < 18-il sena) bi tromboċitopenija (definita b'medja ta' żewġ għadd tal-plejtlits ta' ≤ 30 x 10
English: Using: 2 alcohol swab packages, 1 vial, and 1 vial adapter package.
Maltese: 2 pakketti ta' imsielaħ tal-alkoħol, kunjett wieħed, u pakkett ta' adattatur tal-kunjett wieħed.
English: + 0.72 mL = 250 mcg in 0.50 mL 500 mcg/mL
Maltese: 72 mL = 250 mcg f'0.50 mL 500 mcg/mL
English: Flushing
Maltese: Flebite
English: • changes in some blood tests (increase in transaminase; blood lactate dehydrogenase increased);
Maltese: • bidliet f'xi testijiet tad-demm (żieda fit-transaminase; żieda f'lactate dehydrogenase fid-demm);
English: The composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period.
Maltese: L-episodju ta' fsada komposta kien definit bħala avvenimenti ta' fsada klinikament sinifikanti jew lużu ta' medikazzjoni ta' salvataġġ biex tipprevjeni avveniment ta' fsada klinikament sinifikanti matul ġimgħa 2 sa 25 tal-perjodu ta' trattament.
English: • swelling in the limbs/hands/feet;
Maltese: • nefħa fir-riġlejn/idejn/saqajn;
English: Carton containing 1 or 4 vials of romiplostim.
Maltese: Kartuna fiha kunjett wieħed 1 jew 4 kunjetti ta' romiplostim.
English: In the subset of subjects with ITP > 12 months of duration, the mean (SD) number of composite bleeding episodes was 2.1 (4.7) for the romiplostim arm and 4.2 (7.5) for the placebo arm with a median (Q1, Q3) number of bleeding events of 0.0 (0, 2) for the romiplostim arm and 0.0 (0, 4) in the placebo arm. Because the statistical testing for the incidence of rescue medication use was not significant, no statistical test was done for the number of composite bleeding episodes endpoint.
Maltese: Fis-sottogrupp ta' individwu b'ITP li kienet ilha > 12-il xahar, innumru medju (SD) ta' episodji ta' fsada komposta kien ta' 2.1 (4.7) għall-grupp ta' romiplostim u 4.2 (7.5) għall-grupp tal-plaċebo b'numru medjan (Q1, Q3) ta' avvenimenti ta' fsada ta' 0.0
English: The platelet counts of ITP patients who received 6 weekly doses of 1 or 3 mcg/kg of romiplostim were within the range of 50 to 450 x 10
Maltese: L-għadd tal-plejtlits ta' pazjenti b'ITP li rċevew 6 dożi darba fil-ġimgħa ta' 1 mcg/kg jew 3 mcg/kg ta' romiplostim kien fil-firxa ta' 50 sa 450 x 10
English: • dizziness or a spinning sensation (vertigo);
Maltese: • sturdament jew sensazzjoni li kollox qed idur bik (vertigo);
English: Of the 157 subjects randomised to the romiplostim group, three subjects did not receive romiplostim.
Maltese: Mill-157 individwu randomised għall-grupp b'romiplostim, tlieta ma ngħatawx romiplostim.
English: • pain;
Maltese: • deni;
English: After reconstitution, a deliverable volume of 0.5 mL solution contains 250 mcg of romiplostim (500 mcg/mL).
Maltese: Wara r-rikostituzzjoni, volum li jista' jingħata ta' 0.5 mL ta' soluzzjoni fih 250 mcg ta' romiplostim (500 mcg/mL).
English: The subject prevalence of concurrent ITP medication use showed a trend towards a reduction over the course of the study: from 31.7% (weeks 1 to 12) to < 20.0% (weeks 13 to 240), and then 0% from week 240 to the end of the study.
Maltese: Ilprevalenza fl-individwi ta' użu ta' medikazzjoni għal ITP fl-istess waqt uriet tendenza lejn tnaqqis matul il-kors tal-istudju: minn 31.7% (ġimgħat 1 sa 12) għal < 20.0% (ġimgħat 13 sa 240), u mbagħad 0% minn ġimgħa 240 sat-tmiem tal-istudju.
English: Each pack contains: 1 vial of 500 micrograms romiplostim.
Maltese: Kull pakkett fih: Kunjett wieħed b'500 mikrogramma romiplostim.
English: • problems with your nervous system including involuntary muscle contractions (clonus); distorted sense of taste (dysgeusia); decrease in sense of taste (hypogeusia); decreased feeling of sensitivity, especially in the skin (hypoaesthesia); alteration in the nerve functions in the arms and legs (neuropathy peripheral); blood clot in the transverse sinus (transverse sinus thrombosis);
Maltese: • problemi fis-sistema nervuża tiegħek inklużi kontrazzjonijiet mhux volontarji tal-muskoli (klonus); bidla fit-togħma (disġewżja); tnaqqis fis-sens tat-togħma (ipoġewżja); sensazzjoni ta' sensittività mnaqqsa, speċjalment fil-ġilda (ipoesteżja); bidla fil-funzjonijiet tan-nervituri fiddirgħajn u r-riġlejn (newropatija periferali); embolu fis-sinus trasversali (trombożi fis-sinus trasversali);
English: Vial containing 250 micrograms of romiplostim.
Maltese: Kunjett fih 250 mikrogramma ta' romiplostim.
English: Pharmacotherapeutic group: Antihaemorrhagics, other systemic haemostatics, ATC code: B02BX04
Maltese: Sustanzi kontra l-emorraġija, emostatiċi sistemiċi oħrajn, Kodiċi ATC:
English: Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, 3 events of thrombocytosis were reported, n = 271.
Maltese: Ibbażat fuq analiżi tal-pazjenti adulti b'ITP kollha li ngħataw romiplostim f'4 provi kliniċi kkontrollati u 5 mhux ikkontrollati, kienu rrappurtati 3 każi ta' tromboċitosi, n = 271.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Maltese: Kif jista'jiġri bil-proteini terapewtiċi kollha, hemm potenzjal ta' immunoġeniċità.
English: Overdose may result in an excessive increase in platelet counts associated with thrombotic/thromboembolic complications.
Maltese: Doża eċċessiva tista' tirriżulta f'żieda eċċessiva fl-għadd tal-plejtlits assoċjata ma' komplikazzjonijiet trombotiċi/tromboemboliċi.
English: Other medicines and Nplate
Maltese: Mediċini oħra u Nplate
English: or
Maltese: e
English: (95% CI) (35%, 67%) (0%, 16%) (18%, 47%) (0%, 16%) (30%, 52%) (0%, 8%) p-value a Durable platelet response was defined as weekly platelet count ≥ 50 x 109/L for 6 or more times for study weeks 18-25 in the absence of rescue therapies any time during the treatment period.
Maltese: (CI ta' valur p a Rispons tal-plejtlits li jdum kien definit bħala għadd tal-plejtlits ta' kull ġimgħa ta' ≥ 50 x 109/L għal 6 darbiet jew aktar għall-ġimgħat 18-25 tal-istudju fin-nuqqas ta' terapiji ta' salvataġġ f'xi ħin waqt il-perijodu ta' trattament.
English: EU/1/08/497/009 EU/1/08/497/010 EU/1/08/497/001 EU/1/08/497/003 EU/1/08/497/002 EU/1/08/497/004
Maltese: EU/1/08/497/001 EU/1/08/497/003 EU/1/08/497/002 EU/1/08/497/004
English: All clinically significant (≥ grade 3) bleeding events occurred at platelet counts < 30 x 10
Maltese: L-avvenimenti ta' fsada klinikament sinifikanti (≥ grad 3) kollha seħħew f'għadd ta' plejtlits ta' < 30 x 10
English: Each pack contains: 1 vial of 250 micrograms romiplostim.
Maltese: Kull pakkett fih: Kunjett wieħed b'250 mikrogramma romiplostim.