FrancophonIA/ELRC3.0 huggingface dataset:
English: If individual patient dose is < 23 mcg
Maltese: Jekk id-doża individwali tal-pazjent hija < 23 mcg
English: Contents of the pack and other information Instructions for preparing and giving an injection of Nplate
Maltese: Kontenut tal-pakkett u informazzjoni oħra Istruzzjonijiet għall-preparazzjoni u l-għoti ta' injezzjoni ta' Nplate
English: Nplate 125 µg powder for injection romiplostim
Maltese: Nplate 125 µg trab għall-injezzjoni romiplostim
English: Some of the adverse reactions seen in adults were reported more frequently in paediatric subjects such as cough, diarrhoea, rash, pyrexia and contusion reported very commonly (≥ 1/10) in paediatric subjects and purpura and urticaria were reported commonly (≥ 1/100 to < 1/10) in paediatric subjects.
Maltese: Xi wħud mir-reazzjonijiet avversi osservati fl-adulti kienu irrappurtati b'mod aktar frekwenti f'individwi pedjatriċi bħal sogħla, dijarea, raxx, deni u tbenġil irrappurtati b'mod komuni ħafna (≥ 1/10) f'individwi pedjatriċi u purpura u urtikarja li kienu rrappurtati b'mod komuni (≥ 1/100 sa < 1/10) f'individwi pedjatriċi.
English: • Nplate 125 micrograms powder for solution for injection should be reconstituted with 0.44 mL sterile water for injections, yielding a deliverable volume of 0.25 mL.
Maltese: • Nplate 125 mikrogramma trab għal soluzzjoni għall-injezzjoni għandu jiġi rikostitwit b'0.44 mL ta' ilma sterili għall-injezzjoni, li jirriżulta f'volum li jista' jingħata ta' 0.25 mL.
English: This non-linear decrease in volume of distribution is in line with the (megakaryocyte and platelet) target-mediated binding of romiplostim, which may be saturated at the higher doses applied.
Maltese: Dan it-tnaqqis mhux lineari fil-volum ta' distribuzzjoni, huwa konsistenti mat-twaħħil ta' romiplostim medjat mit-targit (megakarjoċiti u plejtlits), li jista' jkun saturat fl-ogħla dożi mogħtija.
English: EU/1/08/497/005 - 1 pack EU/1/08/497/006 - 4 pack
Maltese: EU/1/08/497/005 - pakkett wieħed EU/1/08/497/006 - 4 pakketti
English: Rhinitis***
Maltese: Sensittività eċċessiva**
English: • diarrhoea;
Maltese: • emigranja;
English: In the two 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, 9 pazjenti rrappurtaw avveniment ta' fsada li kien ikkunsidrat serju (5 [6.0%] b'romiplostim, 4 [9.8%] bi plaċebo; Proporzjon ta' Probabbiltà [romiplostim/plaċebo] = 0.59; CI ta' 95% = (0.15, 2.31)).
English: Thrombosis Erythromelalgia
Maltese: Tromboflebite superfiċjali Tromobożi Eritromelalġja
English: After reconstitution, a deliverable volume of 1 mL solution contains 500 mcg of romiplostim (500 mcg/mL).
Maltese: Wara r-rikostituzzjoni, volum ta' 1 mL ta' soluzzjoni li jista' jingħata fih 500 mcg ta' romiplostim (500 mcg/mL).
English: All bleeding events ≥ grade 2 occurred at platelet counts < 50 x 10
Maltese: L-avvenimenti ta' fsada ta' ≥ grad 2 kollha seħħew f'għadd ta' plejtlits ta' < 50 x 10
English: After reconstitution, a deliverable volume of 0.25 mL solution contains 125 micrograms of romiplostim (500 micrograms/mL).
Maltese: Wara r-rikostituzzjoni, volum ta' soluzzjoni li jista' jingħata ta' 0.25 ml fih 125 mikrogramma ta' romiplostim (500 mikrogramma/mL).
English: The reoccurrence of thrombocytopenia is likely upon discontinuation of treatment (see section 4.4).
Maltese: Id-dehra mill-ġdid ta' tromboċitopenija hija probabbli mal-waqfien tat-trattament (ara sezzjoni 4.4).
English: • joint pain (arthralgia);
Maltese: • uġigħ fil-ġogi (artralġja);
English: Dizziness Migraine Paraesthesia
Maltese: Sturdament Emigranja Parasteżija
English: Volume to administer (mL) = Individual patient dose (mcg) / 125 mcg/mL (Round volume to the nearest hundredth mL)
Maltese: Volum li għandu jingħata (mL) = Doża tal-pazjent individwali (mcg) / 125 mcg/mL (Żid/naqqas il-volum sal-eqreb mitt mL)
English: Nplate 125 micrograms powder for solution for injection romiplostim
Maltese: Nplate 125 mikrogramma trab għal soluzzjoni għall-injezzjoni romiplostim
English: 1 pre-filled syringe containing 1.2 mL of solvent.
Maltese: Siringa mimlija għal-lest waħda li fiha 1.2 mL ta' solvent.
English: The starting dose of romiplostim 1 mcg/kg and doses were adjusted to maintain (50 to 200 x 10
Maltese: Id-doża tal-bidu ta' romiplostim 1 mcg/kg u d-dożi kienu aġġustati biex jinżamm l-għadd tal-plejtlits (50 sa 200 x 109/L).
English: • Make sure you have the following items: Alcohol swab package x4
Maltese: Pakkett ta' imsielaħ tal-alkoħol x4
English: Romiplostim was administered to 157 subjects by subcutaneous (SC) injection once weekly starting at a dose of 3 mcg/kg, and adjusted throughout the study within a range of 1-10 mcg/kg in order to maintain platelet counts between 50 and 200 x 10
Maltese: Romiplostim ingħata lil 157 individwu permezz ta' injezzjoni taħt il-ġilda (SC - subcutaneous) darba fil-ġimgħa b'doża tal-bidu ta' 3 mcg/kg, u din kienet aġġustata matul l-istudju fuq firxa ta' 1-10 mcg/kg sabiex l-għadd ta' plejtlits jinżamm bejn 50 u 200 x 10
English: If the calculated individual patient dose is less than 23 mcg (see section 4.2), an additional dilution step to 125 mcg/mL with preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection is required to ensure accurate volume (see table below).
Maltese: Jekk id-doża kkalkulata tal-pazjent individwali hija anqas minn 23 mcg (ara sezzjoni 4.2), huwa meħtieġ pass ieħor ta' dilwizzjoni għal 125 mcg/mL b'soluzzjoni għall-injezzjoni mingħajr preservattivi u sterili ta' 9 mg/mL (0.9%) sodium chloride biex jiġi żgurat volum preċiż (ara t-tabella hawn taħt).
English: Injection safety needle x1
Maltese: Labra sikura biex tinjetta x1
English: 230 mcg
Maltese: 125 mcg 230 mcg
English: Photosensitivity reaction Acne
Maltese: Reazzjoni ta' fotosensittività Akne
English: Across all subjects, the median (Q1, Q3) number of months with platelet response was 30.0 months (13.0 months, 43.0 months) and the median (Q1, Q3) time on study was 35.0 months (23.0 months, 47.0 months).
Maltese: Fost l-individwi kollha, in-numru medjan (Q1, Q3) ta' xhur b'rispons tal-plejtlits kien ta' 30.0 xahar (13.0-il xahar, 43.0 xahar) u ż-żmien medjan (Q1, Q3) tal-istudju kien ta' 35.0 xahar (23.0 xahar, 47.
English: The primary endpoint was the incidence of durable response, defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10
Maltese: Il-punt finali primarju kien l-inċidenza ta' rispons li jdum fit-tul, definit bħala li jinkiseb mill-inqas għadd ta' plejtlits ta' kull ġimgħa għal 6 ġimgħat ta' ≥ 50 x 10
English: • heart attack (myocardial infarction); increased heart rate;
Maltese: • attakk tal-qalb (infart mijokardijaku); il-qalb tħabbat aktar mis-soltu;
English: • painful swollen joints caused by uric acid (food breakdown product) (gout);
Maltese: • ġogi minfuħin u juġgħu ikkawżati minn uric acid (sustanza ffurmata meta l-ikel jiġi mmetabolizzat) (gotta);
English: Nplate 500 micrograms powder and solvent for solution for injection romiplostim
Maltese: Nplate 500 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni romiplostim
English: Instructions for preparing and giving an injection of Nplate
Maltese: Istruzzjonijiet għall-preparazzjoni u l-għoti ta' injezzjoni ta' Nplate
English: Nplate 125 micrograms powder for solution for injection should be reconstituted with 0.44 mL sterile water for injections, yielding a deliverable volume of 0.25 mL.
Maltese: Nplate 125 mikrogramma trab għal soluzzjoni għall-injezzjoni għandu jiġi rikostitwit b'0.44 mL ta' ilma sterili għall-injezzjoni, li jirriżulta f'volum li jista' jingħata ta' 0.25 mL.
English: While 5.8% and 3.9% of the subjects were positive for developing binding antibodies to romiplostim and TPO respectively, only 2 subjects (0.4%) were positive for neutralising antibodies to romiplostim but these antibodies did not cross react with endogenous TPO.
Maltese: Filwaqt li 5.8% u 3.9% tal-individwi kienu pożittivi għall-iżvilupp ta' antikorpi li jeħlu għal romiplostim u TPO rispettivament, żewġ individwi (0.4%) biss kienu pożittivi għall-antikorpi newtralizzanti għal romiplostim iżda dawn l-antikorpi ma rreaġixxewx ma' TPO endoġenu.
English: Cases of thromboembolic events (TEEs), including portal vein thrombosis, have been reported in patients with chronic liver disease receiving romiplostim.
Maltese: F'pazjenti b'mard kroniku tal-fwied li kienu qed jingħataw romiplostim kienu rrappurtati każi ta' avvenimenti tromboemboliċi (TEES - thromboembolic events), inklużi trombożi fil-vini portali.
English: EU/1/08/497/007 - 1 pack EU/1/08/497/008 - 4 pack
Maltese: EU/1/08/497/007 - pakkett wieħed EU/1/08/497/008 - 4 pakketti
English: Amgen NV Telecomlaan 5-7 1831 Diegem Belgium
Maltese: Amgen NV Arianelaan 5 1200 Brussel Il-Belġju
English: • Draw air into syringe to 1 mL marking.
Maltese: • Tiġbidx il-planġer lura aktar minn 1 mL.
English: If the calculated individual patient dose is less than 23 mcg, an additional dilution step to 125 mcg/mL with preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection is required to ensure accurate volume (see table below).
Maltese: Jekk id-doża kkalkulata tal-pazjent individwali hija anqas minn 23 mcg, huwa meħtieġ pass ieħor ta' dilwizzjoni għal 125 mcg/mL b'soluzzjoni għall-injezzjoni mingħajr preservattivi u sterili ta' 9 mg/mL (0.9%) sodium chloride biex jiġi żgurat volum preċiż (ara t-tabella hawn taħt).
English: 184 confirmed adult patients were included in this study; for these patients, the incidence of binding antibody post treatment was 3.8% (7/184) to romiplostim, of which 0.5% (1/184) was positive for neutralising antibodies to romiplostim.
Maltese: Ma kienu osservati l-ebda antikorpi għal TPO. 184 pazjent adult ikkonfermat ġew inklużi f'dan l-istudju; għal dawn il-pazjenti, linċidenza ta' antikorpi li jeħlu wara t-trattament kienet ta' 3.8% (7/184) għal romiplostim, li minnhom 0.5% (1/184) kienu pożittivi għal antikorpi newtralizzanti għal romiplostim.
English: Toxicokinetic studies showed no interaction of the antibodies with the measured concentrations.
Maltese: Studji tossikokinetiċi ma wrew lebda interazzjoni tal-antikorpi bil-konċentrazzjonijiet imkejla.
English: Pruritus Ecchymosis Rash
Maltese: Tħawwadx il-kunjett
English: Of the 77 subjects randomised to the SOC group, two subjects did not receive any SOC.
Maltese: Mis-77 individwu randomised għall-grupp b'SOC, żewġ individwi ma ngħatawx kwalunkwe SOC.
English: Nplate 500 µg powder for injection romiplostim
Maltese: Nplate 500 µg trab għall-injezzjoni romiplostim
English: Injection site haemorrhage Chest pain Irritability Malaise Face oedema Feeling hot Feeling jittery
Maltese: ITP hija marda fejn is-sistema immuni tal-ġisem tiegħek tiddistruġġi l-plejtlits tagħha stess. Plejtlits huma ċ-ċelluli fiddemm tiegħek li jgħinu jagħlqu feriti u jiffurmaw demm magħqud.
English: Nplate 125 micrograms powder for solution for injection
Maltese: Nplate 125 mikrogramma trab għal soluzzjoni għall-injezzjoni
English: Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 mL sterile water for injections, yielding a deliverable volume of 1 mL.
Maltese: Nplate 500 mikrogramma trab għal soluzzjoni għall-injezzjoni għandu jiġi rrikostitwit b'1.2 ml ilma sterili għall-injezzjonijiet, li jirriżulta f'volum li jista' jingħata ta' 1 mL.
English: May be removed from the refrigerator for a period of 30 days at room temperature (up to 25ºC) when stored in the original carton.
Maltese: Jista' jitneħħa mill-friġġ għal perijodu ta' 30 ġurnata f'temperatura tal-kamra (sa 25ºC) meta maħżun fil-kartuna oriġinali.
English: The most common adverse reactions observed include hypersensitivity reactions (including cases of rash, urticaria and angioedema) and headache.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni osservati jinkludu reazzjonijiet ta' sensittività eċċessiva (li jinkludu każijiet ta' raxx, urtikarja u anġjoedima) u uġigħ ta' ras.
English: Initial reconstitution of romiplostim with designated volumes of sterile water for injections results in a concentration of 500 mcg/mL in all vial sizes.
Maltese: Ir-rikostituzzjoni inizjali ta' romiplostim b'volumi indikati ta' ilma għal injezzjonijiet sterili tagħti konċentrazzjoni ta' 500 mcg/mL f'kull daqs ta' kunjett.
English: • Nplate 500 micrograms powder for solution for injection should be reconstituted with 1.2 mL sterile water for injections, yielding a deliverable volume of 1 mL.
Maltese: • Nplate 500 mikrogramma trab għal soluzzjoni għall-injezzjoni għandu jiġi rrikostitwit b'1.2 mL ta' ilma sterili għall-injezzjoni, li jirriżulta f'volum li jista' jingħata ta' 1 mL.
English: 9/L) platelet counts.
Maltese: 9/L għall-biċċa l-kbira tal-pazjenti.
English: • contusion;
Maltese: • uġigħ;
English: 1 vial.
Maltese: It-Tieni Pass.
English: In all developmental studies neutralising antibodies were formed, which may have inhibited romiplostim effects.
Maltese: Fl-istudji kollha tal-iżvilupp kienu ffurmati antikorpi newtralizzanti li setgħu jinibixxu l-effetti ta' romiplostim.
English: Malaise
Maltese: Prurigo
English: Rectal haemorrhage Breath odour Dysphagia Gastro-oesophageal reflux disease Haematochezia Mouth haemorrhage Stomach discomfort Stomatitis
Maltese: Marda ta' rifluss gastro-esofagali Ematokeżja Emorraġija mill-ħalq Skumdità fl-istonku Stomatite
English: Mannitol (E421), sucrose, l-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Maltese: Mannitol (E421), sucrose, l-histidine, hydrochloric acid (għall-aġġustmament tal-pH) u polysorbate 20.
English: For 500 µg kit
Maltese: Għall-kit ta' 500 µg
English: • problems with the digestive system including: vomiting; bad breath (breath odour); difficulty swallowing (dysphagia); indigestion or heartburn (gastro-oesophageal reflux disease); blood in the stools (haematochezia); stomach discomfort; mouth ulcers or mouth blistering (stomatitis); discoloured teeth (tooth discolouration);
Maltese: • problemi fis-sistema diġestiva inklużi: rimettar; riħa fil-ħalq; diffikultà biex tibla (disfaġija); indiġestjoni jew ħruq fl-istonku (marda ta' rifluss gastro-esofagali); demm fl-ippurgar (ematokeżja); skumdità fl-istonku; ulċeri fil-ħalq jew infafet fil-ħalq (stomatite); bidla fil-kulur tas-snien;
English: Romiplostim pharmacokinetics appear not affected by age, weight and gender to a clinically significant extent.
Maltese: Il-farmakokinetika ta' romiplostim tidher li mhix affettwata minn età, piż u sess b'mod klinikament sinifikanti.
English: • weight decreased; weight increased; intolerance of alcohol; loss of appetite (anorexia or decreased appetite); dehydration;
Maltese: • tnaqqis fil-piż; żieda fil-piż; intolleranza għall-alkoħol; telf t'aptit (anoreksja jew nuqqas ta' aptit); deidrazzjoni;
English: • Nplate 250 micrograms powder for solution for injection should be reconstituted with 0.72 mL sterile water for injections, yielding a deliverable volume of 0.5 mL.
Maltese: • Nplate 250 mikrogramma trab għal soluzzjoni għall-injezzjoni għandu jiġi rrikostitwit b'0.72 mL ta' ilma sterili għall-injezzjoni, li jirriżulta f'volum li jista' jingħata ta' 0.5 mL.
English: After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25ºC and for 24 hours at 2ºC - 8ºC, when protected from light and kept in the original vial.
Maltese: Stabbiltà kimika u fiżika waqt l-użu kienet murija għal 24 siegħa f'25ºC u għal 24 siegħa f'2ºC - 8ºC, meta protett mid-dawl u miżmum fil-kunjett oriġinali.
English: After reconstitution, a deliverable volume of 0.5 mL solution contains 250 micrograms of romiplostim (500 micrograms/mL).
Maltese: Wara r-rikostituzzjoni, volum ta' soluzzjoni li jista' jingħata ta' 0.5 mL fih 250 mikrogramma ta' romiplostim (500 mikrogramma/mL).
English: Following the first 4-weeks of study romiplostim maintained platelet counts ≥ 50 x 10
Maltese: Pazjenti li jkollhom għadd ta' plejtlits stabbli ta' ≥ 50 x 10
English: Treatment with romiplostim should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of romiplostim therapy at the highest weekly dose of 10 mcg/kg.
Maltese: Trattament b'romiplostim għandu jitwaqqaf jekk l-għadd tal-plejtlits ma jiżdiedx għal-livell suffiċjenti biex tiġi evitata fsada' klinikament importanti wara erba' ġimgħat ta' terapija b'romiplostim bl-ogħla doża ta' 10 mcg/kg darba fil-ġimgħa.
English: EU/1/08/497/005 EU/1/08/497/006 EU/1/08/497/007 EU/1/08/497/008
Maltese: EU/1/08/497/006 EU/1/08/497/007 EU/1/08/497/008
English: Treatment discontinuation
Maltese: Disġewżja
English: In a randomised placebo-controlled trial in MDS adult subjects treatment with romiplostim was prematurely stopped due to a numerical increase in cases of MDS disease progression to AML and transient increases in blast cell counts in patients treated with romiplostim compared to placebo.
Maltese: Fi studji kliniċi fl-adulti ta' trattament b'romiplostim f'pazjenti b'MDS, kienu osservati każijiet ta' żidiet temporanji fl-għadd ta' ċelluli blast u kienu rrappurtati każijiet ta' progressjoni tal-marda MDS għal lewkimja majelojda akuta (AML - acute myeloid leukemia).
English: If the calculated individual patient dose is less than 23 mcg, dilution with preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection is required to ensure accurate dosing (see section 6.6).
Maltese: Jekk id-doża talpazjent individwali ikkalkulata hija inqas minn 23 mcg, biex jiġi żgurat dożaġġ preċiż hija meħtieġa dilwizzjoni ma' soluzzjoni għall-injezzjoni mingħajr preservattivi u sterili, ta' 9 mg/mL (0.9%) sodium chloride (ara sezzjoni 6.6).
English: Feeling hot
Maltese: Żieda fil-piż
English: • Do dispose of the used needle and syringe in a puncture-resistant container.
Maltese: • Kun ċert li l-materjal l-ieħor kollu jintrema f'kontenituri adattati.
English: • fever (pyrexia);
Maltese: • ħmura fil-ġilda (fwawar);
English: A total of 31 subjects (47.7%) used concurrent ITP therapy during the study including 23 subjects (35.4%) who used rescue medication and 5 subjects (7.7%) who used concurrent ITP medication at baseline.
Maltese: Total ta' 31 individwu (47.7%) użaw terapiji differenti għal ITP fl-istess waqt matul l-istudju inklużi 23 individwu (35.
English: Do not use Nplate:
Maltese: Bżieżaq tal-arja:
English: After reconstitution, a deliverable volume of 1 mL solution contains 500 micrograms of romiplostim (500 micrograms/mL).
Maltese: Wara r-rikostituzzjoni, volum ta' soluzzjoni li jista' jingħata ta' 1 mL fih 500 mikrogramma ta' romiplostim (500 mikrogramma/mL).
English: For 250 µg kit
Maltese: Għal kit ta' 250 µg
English: Reduction in permitted concurrent ITP medical therapies
Maltese: Tnaqqis fit-terapiji mediċi ta' ITP permessi flimkien
English: Eye disorder
Maltese: Disturbi fil-vista
English: Of those 22 subjects, 17 subjects had ITP > 12 months of duration (14 subjects received romiplostim and 3 subjects received placebo).
Maltese: Minn dawk it22 individwu, 17-il individwu kellhom ITP li kienet ilha > 12-il xahar (14-il individwu irċevew romiplostim u 3 individwi rċevew plaċebo).
English: Nplate 250 micrograms powder and solvent for solution for injection romiplostim
Maltese: Nplate 250 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni romiplostim
English: Conjunctival haemorrhage Accommodation disorder
Maltese: Majeloma multipla Majelofibrożi
English: 1 pre-filled syringe containing 0.72 or 1.2 mL of water for injections.
Maltese: 72 jew 1.2 mL ta' ilma għall-injezzjonijiet għarrikostituzzjoni.
English: Each pack contains: 1 vial of 250 micrograms or 500 micrograms of romiplostim.
Maltese: Kull pakkett fih: Kunjett wieħed b'250 mikrogramma jew b'500 mikrogramma ta' romiplostim.
English: 75 kg patient is initiated at 1 mcg/kg of romiplostim.
Maltese: Pażjent b'piż ta' 75 kg jinbeda b'1 mcg/kg ta' romiplostim.
English: Powder: Mannitol (E421), sucrose, l-histidine, hydrochloric acid (for pH adjustment) and polysorbate 20.
Maltese: Trab: mannitol (E421), sucrose, L-histidine, hydrochloric acid (għal aġġustament tal-pH) u polysorbate 20.
English: • upper respiratory tract infection;
Maltese: • infezzjoni fl-apparat respiratorju ta' fuq;
English: The resulting concentration is 500 mcg/mL.
Maltese: Ilkonċentrazzjoni li tirriżulta hija 500 mcg/mL.
English: (24.0 months, 46.0 months).
Maltese: (ara sezzjoni 4.2).
English: Aplastic anaemia Bone marrow failure Leucocytosis Splenomegaly Thrombocythaemia Platelet count increased Platelet count abnormal
Maltese: Imbotta l-planġer 'l fuq bil-mod biex timbotta l-bżieżaq tal-arja barra missiringa.
English: Nplate 500 micrograms powder for solution for injection romiplostim
Maltese: Nplate 500 mikrogramma trab għal soluzzjoni għall-injezzjoni romiplostim
English: Increased bone marrow reticulin
Maltese: Żieda fir-reticulin tal-mudullun
English: Dermatitis contact Dry skin
Maltese: Dermatite tal-kuntatt Ġilda xotta
English: Nplate 500 micrograms powder and solvent for solution for injection
Maltese: Nplate 500 mikrogramma trab u solvent għal soluzzjoni għall-injezzjoni
English: Nplate 250 micrograms powder for solution for injection romiplostim
Maltese: Nplate 250 mikrogramma trab għal soluzzjoni għall-injezzjoni romiplostim
English: Aplastic anaemia Bone marrow failure Leucocytosis Splenomegaly Thrombocythaemia Platelet count increased
Maltese: Waqt li żżomm il-kunjett fuq il-bank, imbotta ladattatur tal-kunjett l-isfel ġoċ-ċentru tal-kunjett sakemm jeħel sew f'postu.
English: • itchy, runny or blocked nose (rhinitis);
Maltese: • ħakk fl-imnieħer, imnieħer iqattar jew imblukkat (rinite);
English: Dose calculator
Maltese: DATA TA' SKADENZA
English: Uncommon: may affect up to 1 in 100 people • higher than normal platelet counts (thrombocytosis).
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna waħda minn kull 100 • għadd tal-plejtlits ogħla min-normal (tromboċitosi).
English: • problems with the circulation including blood clot in the vein in the liver (portal vein thrombosis); deep vein thrombosis; low blood pressure (hypotension); increased blood pressure; blocking of a blood vessel or (peripheral embolism); reduced blood flow in the hands, ankles or feet (peripheral ischaemia); swelling and clotting in a vein, which may be extremely tender when touched (phlebitis or thrombophlebitis superficial); blood clot (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 fil-sinus trasversali (trombożi fis-sinus trasversali);
English: The 125 mcg vial cap is beige, the 250 mcg vial cap is red and the 500 mcg vial cap is blue.
Maltese: L-għatu tal-kunjett ta' 125 mcg huwa kannella fl-isfar, l-għatu tal-kunjett ta' 250 mcg huwa aħmar u l-għatu tal-kunjett ta' 500 mcg huwa blu.
English: In both adult placebo-controlled, double-blind studies, patients already receiving ITP medical therapies at a constant dosing schedule were allowed to continue receiving these medical treatments throughout the study (corticosteroids, danazol and/or azathioprine).
Maltese: Fiż-żewġ studji double-blind u kkontrollati bil-plaċebo, il-pazjenti li diġà kienu qed jirċievu terapiji mediċinali għal ITP fi programm kostanti ta' dożaġġ tħallew jibqgħu jirċievu dawn it-trattamenti mediċinali matul l-istudju (kortikosterojdi, danazol u/jew azathioprine).
English: A bone marrow aspirate and biopsy should normally have been done over the course of the disease and treatment, particularly in patients over 60 years of age, for those with systemic symptoms or abnormal signs such as increased peripheral blast cells.
Maltese: Normalment għandhom isiru aspirazzjoni u bijopsija tal-mudullun matul il-kors tal-marda u tattrattament, speċjalment f'pazjenti b'età 'l fuq minn 60 sena, u għal dawk b'sintomi sistemiċi jew sinjali mhux normali bħal żieda fiċ-ċelluli blast periferali.