FrancophonIA/ELRC3.0 huggingface dataset:
English: This prevents sustained activation of the renin-angiotensin-aldosterone system that would result in vasoconstriction, renal sodium and fluid retention, activation of cellular growth and proliferation, and subsequent maladaptive cardiovascular remodelling.
Maltese: Dan jipprevjeni attivazzjoni kontinwa tas-sistema renin-anġjotensina-aldosterone li tirriżulta f'vażokostrizzjoni, sodju renali u żamma ta' fluwidi, attivazzjoni ta' tkabbir u proliferazzjoni ċellulari u rimudellar kardjovaskulari maladattiv sussegwenti.
English: BNP is not a suitable biomarker of heart failure in patients treated with Neparvis because BNP is a neprilysin substrate (see section 4.4).
Maltese: BNP mhuwiex bijomarkatur adegwat ta' insuffiċjenza tal-qalb f'pazjenti kkurati b' Neparvis minħabba li BNP huwa sottostrat tan-neprilysin (ara sezzjoni 4.4).
English: • if you or a member of your family have ever had a reaction called angioedema (swelling of the face, lips, tongue and/or throat, difficulties in breathing) when taking an ACE inhibitor or an angiotensin receptor blocker (ARB) (such as valsartan, telmisartan or irbesartan).
Maltese: • jekk inti jew membru tal-familja tiegħek qatt kelkom reazzjoni msejħa anġjoedima (nefħa talwiċċ, tax-xufftejn, tal-ilsien u/jew tal-gerżuma, diffikultajiet fit-teħid tan-nifs) meta ħadt inibitur ta' ACE jew imblokkatur tar-riċettur tal-anġjotensina (ARB - angiotensin receptor blocker) (bħal valsartan, telmisartan jew irbesartan).
English: Iron oxide black (E172)
Maltese: Ossidu tal-ħadid aħmar (E172) Ossidu tal-ħadid iswed (E172)
English: If you have been taking an ACE inhibitor, wait 36 hours after taking the last dose of the ACE inhibitor before starting to take Neparvis (see “Do not take Neparvis”).
Maltese: Jekk kont qed tieħu inibitur ta' ACE, stenna 36 siegħa wara li tieħu l-aħħar doża qabel ma tibda tieħu Neparvis (ara “Mediċini oħra u Neparvis”).
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Maltese: (INKLUŻA L-KAXXA BLU)
English: What Neparvis looks like and contents of the pack Neparvis 24 mg/26 mg film-coated tablets are violet-white oval tablets with “NVR” on one side and “LZ” on the other side.
Maltese: Il-pilloli miksija b'rita Neparvis 24 mg/26 mg huma pilloli ovali ta' lewn vjola u abjad b'“NVR” fuq naħa waħda u “LZ” fuq in-naħa l-oħra.
English: Monitoring of serum potassium is recommended, especially in patients who have risk factors such as renal impairment, diabetes mellitus or hypoaldosteronism or who are on a high potassium diet or on mineralocorticoid antagonists (see section 4.2).
Maltese: Il-monitoraġġ tal-potassju fis-serum huwa rrakkomandat, speċjalment f'pazjenti li għandhom fatturi ta' riskju bħal indeboliment renali, dijabete mellitus jew hypoaldosteronism jew li qegħdin fuq dieta b'livelli għolja ta' potassju jew fuq antagonisti ta' mineralokortikojdi (ara sezzjoni 4.2).
English: Dizziness
Maltese: Pożoloġija
English: Multipack: 196 (7 packs of 28) film-coated tablets
Maltese: Pillola miksija b'rita Pakkett b'ħafna: 196 (7 pakketti ta' 28) pilloli miksija b'rita
English: Candesartan 32 * These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected.
Maltese: Candesartan 32 * Dawn il-limiti mhumiex applikabbli għal lottijiet fejn aktar minn wieħed millN-nitrosamini ta' hawn fuq ġew identifikati simultanjament; dawn il-lottijiet għandhom jiġu miċħuda.
English: Neparvis must not be started until 36 hours after taking the last dose of ACE inhibitor therapy.
Maltese: Neparvis m'għandux jinbeda sa 36 siegħa wara li tittieħed l-aħħar doża ta' terapija b'inibitur ta' ACE.
English: It is teratogenic based on a low incidence of foetal hydrocephaly, associated with maternally toxic doses, which was observed in rabbits at an Neparvis dose of ≥4.9 mg sacubitril/5.1 mg valsartan/kg/day.
Maltese: Huwa teratoġeniku bbażat fuq inċidenza baxxa ta' idroċefalija tal-fetu, assoċjata ma' dożi tossiċi għall-omm, li kienet osservata fil-fniek f'doża ta' Neparvis ta' ≥4.9 mg sacubitril/5.1 mg valsartan/kg/jum.
English: The concomitant use of Neparvis with ACE inhibitors is contraindicated, as the concomitant inhibition of neprilysin (NEP) and ACE may increase the risk of angioedema.
Maltese: L-użu konkomitanti ta' Neparvis ma' inibituri ta' ACE huwa kontraindikat, billi l-inibizzjoni konkomitanti ta' neprilysin (NEP) u ACE tista' żżid ir-riskju ta' anġjoedima.
English: The use of Neparvis is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Maltese: L-użu ta' Neparvis mhux rakkomandat waqt l-ewwel trimestru tat-tqala u huwa kontraindikat waqt ittieni u t-tielet trimestri tat-tqala (ara sezzjoni 4.3).
English: Discontinuation of therapy due to an adverse reaction in the double-blind period of the PARADIGM-HF study occurred in 450 Neparvis-treated patients (10.7%) and 516 enalapril-treated patients (12.2%).
Maltese: It-twaqqif tat-terapija minħabba reazzjoni avversa fil-perjodu double-blind tal-istudju PARADIGM-HF seħħ f'450 pazjent ikkurati b' Neparvis (10.
English: The complementary cardiovascular benefits of Neparvis in heart failure patients are attributed to the enhancement of peptides that are degraded by neprilysin, such as natriuretic peptides (NP), by LBQ657 and the simultaneous inhibition of the effects of angiotensin II by valsartan.
Maltese: Il-benefiċċji kardjovaskulari kumplimentarji ta' Neparvis f'pazjenti b'insuffiċjenza tal-qalb huma attribwiti għat-titjib tal-peptidi li huma ddegradati permezz ta' neprilysin, bħal peptidi natrijuretiċi (NP), permezz ta' LBQ657 u l-inibizzjoni simultanja tal-effetti talanġjotensina II permezz ta' valsartan.
English: In the PARADIGM-HF study, subjects were previously treated with ACE inhibitors and/or ARBs and also had to successfully complete sequential enalapril and Neparvis run-in periods (median drug exposure of 15 and 29 days, respectively) prior to the randomised double-blind period.
Maltese: Fl-istudju PARADIGM-HF, l-individwi kienu ttrattati minn qabel b'inibituri ta' ACE u/jew ARBs u wkoll kellhom jikkompletaw b'suċċess il-perjodi inizjali sekwenzjali ta' enalapril u Neparvis (tul medju ta' espożizzjoni għall-mediċina ta' 15-il jum u 29 jum, rispettivament) qabel il-perjodu doubleblind magħżul b'mod każwali.
English: Each film-coated tablet contains 48.6 mg sacubitril and 51.4 mg valsartan (as sacubitril valsartan sodium salt complex).
Maltese: Kull pillola miksija b'rita fiha 48.6 mg sacubitril u 51.4 mg valsartan (bħala kumpless ta' melħ tassodju sacubitril valsartan).
English: At steady state, sacubitril and valsartan do not accumulate significantly, while LBQ657 accumulates 1.6-fold.
Maltese: Fi stat stabbli, sacubitril u valsartan ma jakkumulawx b'mod sinjifikanti, filwaqt li LBQ657 jakkumula b'1.6 darbiet.
English: Pale yellow ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L1” on the other side.
Maltese: Pillola miksija b'rita ta' għamla mżaqqa u ovali u ta' lewn isfar pallidu bi ġnub tasturati, mingħajr sinjali dritti, imnaqqxa b'“NVR” fuq naħa waħda u “L1” fuq in-naħa l-oħra.
English: There is very limited clinical experience in patients with severe renal impairment (estimated GFR <30 ml/min/1.73m2) and these patients may be at greatest risk of hypotension (see section 4.2).
Maltese: Teżisti esperjenza klinika limitata ħafna f'pazjenti b'indeboliment tal-kliewi gravi (GFR stmata ta' <30 ml/min/1.73m2) u dawn il-pazjenti jistgħu jkunu f'riskju akbar ta' pressjoni baxxa (ara sezzjoni 4.2).
English: Use of Neparvis may be associated with an increased risk of hyperkalaemia, although hypokalaemia may also occur (see section 4.8).
Maltese: L-użu ta' Neparvis jista' jiġi assoċjat ma' żieda fir-riskju ta' iperkalemija, għalkemm jista' jkun hemm ukoll ipokalemija (ara sezzjoni 4.8).
English: Light pink ovaloid biconvex film-coated tablet with bevelled edges, unscored, debossed with “NVR” on one side and “L11” on the other side.
Maltese: Pillola miksija b'rita ta' għamla mżaqqa u ovali u ta' lewn roża ċar bi ġnub tasturati, mingħajr sinjali dritti, imnaqqxa b'“NVR” fuq naħa waħda u “L11” fuq in-naħa l-oħra.
English: Non-clinical data (including studies with sacubitril and valsartan components and/or Neparvis) reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and fertility.
Maltese: Tagħrif mhux kliniku (inklużi studji b'komponenti ta' sacubitril u valsartan u/jew Neparvis) ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer u l-fertilità, ma juri l-ebda periklu speċjali għall-bnedmin.
English: 1) Limits for NDMA and NDEA outlined below should be implemented for a transitional period of 2 years:
Maltese: 1) Il-limiti għall-NDMA u l-NDEA deskritti hawn taħt għandhom jiġu implimentati għal perjodu tranżitorju ta' sentejn:
English: 20 film-coated tablets
Maltese: 20 pillola miksija b'rita
English: Time to occurrence of CV death in PARADIGM-HF
Maltese: Żmien sal-okkorrenza ta' mewt CV f'PARADIGM-HF
English: In vitro data indicate that sacubitril inhibits OATP1B1 and OATP1B3 transporters.
Maltese: Id-dejta in vitro tindika li sacubitril jinibixxi t-trasportaturi OATP1B1 u OATP1B3. Għalhekk, Neparvis jista' jżid l-espożizzjoni sistemika ta' sottostrati OATP1B1 u OATP1B3 bħal statini.
English: Do not take Neparvis with ACE inhibitors.
Maltese: Għaldaqstant, din ilkombinazzjoni mhijiex irrakkomandata.
English: Each film-coated tablet contains 97.2 mg sacubitril and 102.8 mg valsartan (as sacubitril valsartan sodium salt complex).
Maltese: Kull pillola miksija b'rita fiha 97.2 mg sacubitril u 102.8 mg valsartan (bħala kumpless ta' melħ tassodju sacubitril valsartan).
English: Administration of Neparvis 194 mg sacubitril/206 mg valsartan once daily for two weeks to healthy subjects was associated with an increase in CSF Aβ1-38 compared to placebo; there were no changes in concentrations of CSF Aβ1-40 and 1-42.
Maltese: L-għoti ta' Neparvis 194 mg sacubitril/206 mg valsartan darba kuljum għal ġimgħatejn lil individwi f'saħħithom kien assoċjat ma' żieda fis-CSF Aβ1-38 meta mqabbel mal-plaċebo; ma kien hemm ebda bidla fil-konċentrazzjonijiet tas-CSF
English: Interactions requiring precautions
Maltese: Interazzjonijiet li jeħtieġu prekawzjonijiet
English: • low blood pressure (dizziness, light-headedness)
Maltese: • pressjoni tad-demm baxxa (sturdament, mejt)
English: • some medicines known as statins that are used to lower high cholesterol levels (for example atorvastatin).
Maltese: • xi mediċini magħrufa bħala statini li jintużaw biex ibaxxu l-livelli għolja ta' kolesterol (pereżempju; atorvastatin).
English: Cough
Maltese: FOLJI
English: Exposure to ARBs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Maltese: Esponiment għal terapija b'ARBs waqt it-tieni u t-tielet trimestri huwa magħruf li jinduċi fetotossiċità fil-bniedem (tnaqqis fil-funzjoni tal-kliewi, tnaqqis tal-fluwidu amnjotiku, ossifikazzjoni tal-kranju ittardjata) u tossiċità neonatali (insuffiċjenza tal-kliewi, pressjoni baxxa, iperkalimja).
English: Patients with mild and moderate renal impairment are more at risk of developing hypotension (see section 4.2).
Maltese: Pazjenti b'indeboliment tal-kliewi minn ħafif sa moderat huma aktar f'riskju li jiżviluppaw pressjoni baxxa (ara sezzjoni 4.2).
English: There is limited experience in patients not currently taking an ACE inhibitor or an ARB or taking low doses of these medicinal products, therefore a starting dose of 24 mg/26 mg twice daily and slow dose titration (doubling every 3-4 weeks) are recommended in these patients (see “Titration” in section 5.1).
Maltese: Teżisti esperjenza limitata f'pazjenti li bħalissa mhux qed jieħdu inibitur ta' ACE jew ARB jew li qed jieħdu dożi baxxi ta' dawn il-prodotti mediċinali, għalhekk doża inizjali ta' 24 mg/26 mg darbtejn kuljum u titrazzjoni tad-doża bil-mod (irduppjar kull 3-4 ġimgħa) huma rakkomandati f'dawn il-pazjenti (ara “TITRAZZJONI” f'sezzjoni 5.1).
English: However, LBQ657 and valsartan are highly bound to plasma protein and therefore unlikely to be effectively removed by dialysis.
Maltese: Madankollu, LBQ657 u valsartan huma marbuta ħafna mal-proteini filplażma u, għalhekk, mhux probabbli li dawn jitneħħew b'mod effettiv permezz ta' dijaliżi.
English: If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Maltese: Jekk jintwera li l-kombinazzjoni hija neċessarja, huwa rrakkomandat li jsir monitoraġġ bir-reqqa tal-livelli ta' lithium fis-serum.
English: Angioedema associated with laryngeal oedema may be fatal.
Maltese: Anġjoedima assoċjata ma' edima larinġali tista' tkun fatali.
English: In the PARADIGM-HF study, Neparvis decreased plasma NT-proBNP and increased plasma BNP and urine cGMP compared with enalapril.
Maltese: NT-proBNP u żied il-plażma BNP u l-awrina cGMP, meta mqabbel ma' enalapril.
English: Symptomatic hypotension is more likely to occur if the patient has been volume-depleted, e.g. by diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Maltese: Pressjoni baxxa sintomatika hija aktar probabbli jekk il-pazjent ikun naqqas mill-volum, eż. permezz ta' terapija dijuretika, restrizzjoni tal-melħ għal skop ta' dieta, dijarrea jew remettar.
English: o Each 24 mg/26 mg film-coated tablet contains 24.3 mg sacubitril and 25.7 mg valsartan (as sacubitril valsartan sodium salt complex).
Maltese: Kull pillola ta' 24 mg/26 mg fiha 24.3 mg sacubitril u 25.
English: EMA/142918/2019 EMEA/H/C/001110
Maltese: EMA/142918/2019 EMA/H/C/001110
English: ITP in adults
Maltese: ITP fl-adulti
English: Further information on Revolade can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Revolade.
Maltese: ema.europa.eu/medicines/human/EPAR/Revolade.
English: Severe aplastic anaemia
Maltese: Anemija aplastika severa
English: Other information about Revolade
Maltese: Informazzjoni oħra dwar Revolade
English: Revolade received a marketing authorisation valid throughout the EU on 11 March 2010.
Maltese: Revolade rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-11 ta' Marzu 2010.
English: This overview was last updated in 03-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'03-2019.
English: Revolade contains the active substance eltrombopag.
Maltese: Revolade fih is-sustanza attiva eltrombopag.
English: Revolade is available as tablets (12.5, 25, 50 and 75 mg) and as a powder (25 mg) to prepare a suspension (a liquid) to be taken by mouth.
Maltese: Revolade jiġi bħala pilloli (12.5, 25, 50 u 75 mg) u bħala trab (25 mg) sabiex tiġi ppreparata sospensjoni (likwidu) li għandha tittieħed mill-ħalq.
English: For the treatment of thrombocytopenia associated with hepatitis C, two main studies involving a total of 1,441 adults were carried out.
Maltese: Għall-kura tat-tromboċitopenja assoċjata mal-epatite Ċ, saru żewġ studji ewlenin li involvew total ta' 1,441 adult.
English: Important serious side effects are liver problems and thromboembolic complications.
Maltese: Effetti sekondarji importanti huma problemi fil-fwied u komplikazzjonijiet tromboemboliċi.
English: What are the risks associated with Revolade?
Maltese: X'inhuma r-riskji assoċjati ma' Revolade?
English: Revolade was more effective than placebo: in the first study, 59% of the patients who took Revolade (43 out of 73) achieved a platelet count of at least 50,000 per microlitre (which is considered adequate to prevent bleeding complications) after 6 weeks of treatment, compared with 16% of those who took placebo (6 out of 37).
Maltese: Revolade kien aktar effettiv mill-plaċebo: fl-ewwel studju, 59 % tal-pazjenti li ħadu Revolade (43 minn 73) kisbu għadd ta' pjastrini ta' milll-inqas 50,000 għal kull mikrolitru (li hu meqjus adegwat sabiex jipprevjeni kumplikazzjonijiet ta' fsada) wara sitt ġimgħat ta' kura, meta mqabbla ma' 16 % ta' dawk li ħadu l-plaċebo (6 minn 37).
English: How is Revolade used?
Maltese: Revolade?
English: • thrombocytopenia in adults with chronic (long-term) hepatitis C, a liver disease caused by the hepatitis C virus.
Maltese: • tromboċitopenija f'adulti b'epatite Ċ kronika (fit-tul), marda tal-fwied ikkawżata mill-virus talepatite Ċ.
English: In patients with thrombocytopenia and advanced chronic hepatitis C who are treated with interferon and Revolade, the most common side effects include headache, anaemia (low red blood cell counts), decreased appetite, cough, nausea, diarrhoea, high levels of bilirubin in the blood, hair loss, itching, muscle pain, fever, tiredness, flu-like illness, weakness, chills and swelling (because of build-up of water in the body).
Maltese: F'pazjenti bi tromboċitopenija u b'epatite Ċ kronika avvanzata li huma kkurati b'interferon u b'Revolade, l-effetti sekondarji l-aktar komuni jinkludu wġigħ ta' ras, anemija (għadd baxx ta' ċelloli ħomor tad-demm), tnaqqis fl-aptit, sogħla, nawżja, dijarea, livelli għoljin ta' bilirubina fid-demm, telf ta' xagħar, ħakk, uġigħ fil-muskoli, deni, għeja, marda li tixbah lill-influwenza, dgħufija, tertir u nefħa (minħabba l-akkumulazzjoni tal-ilma fil-ġisem).
English: In these two studies, a higher proportion of patients who took Revolade tested negative for hepatitis C, compared with those who took placebo (23% versus 14% in the first study, and 19% versus 13% in the second study).
Maltese: F'dawn iż-żewġ studji, proporzjon ogħla ta' pazjenti li ħadu Revolade rriżultalhom test negattiv għallepatite Ċ meta mqabbla ma' dawk li ħadu l-plaċebo (23 % kontra 14 % fl-ewwel studju, u 19 % kontra 13 % fit-tieni studju).
English: An extension of the study found that Revolade was effective at maintaining adequate levels of platelets in the long term.
Maltese: Estensjoni tal-istudju sabet li Revolade kien effettiv fiż-żamma ta' livelli adegwati ta' pjastrini fit-tul.
English: This occurred in around 40% of those taking Revolade (25 out of 63) compared with around 3% (1 out of 29) of those who took placebo.
Maltese: Dan seħħ f'madwar 40 % ta' dawk li ħadu Revolade (25 minn 63) meta mqabbla ma' madwar 3 % (1 minn 29) ta' dawk li ħadu l-plaċebo.
English: For the treatment of severe aplastic anaemia, Revolade was studied in 43 patients and it was not compared with any other medicine.
Maltese: Għall-kura ta' anemija aplastika severa, Revolade ġie studjat fi 43 pazjent u ma tqabbel ma' ebda mediċina oħra.
English: In children with ITP, Revolade was more effective than placebo in one main study involving 92 children between 1 and 17 years of age who had previously been treated for ITP.
Maltese: Fit-tfal bl-ITP, Revolade kien aktar effettiv mill-plaċebo fi studju ewlieni wieħed li involva total ta' 92 tifel u tifla li kellhom bejn sena u 17-il sena li kienu ġew ikkurati preċedentement għall-ITP.
English: Thrombocytopenia associated with hepatitis C
Maltese: Tromboċitopenija assoċjata mal-epatite Ċ
English: In adults with severe aplastic anaemia the most common side effects include headache, dizziness, cough, pain in the belly or in the mouth and throat, nausea, diarrhoea, joint pain, pain in limbs, tiredness, fever and abnormal blood levels of certain liver enzymes.
Maltese: Fl-adulti b'anemija aplastika severa, l-effetti sekondarji l-aktar komuni jinkludu wġigħ ta' ras, sturdament, sogħla, uġigħ fiż-żaqq jew fil-ħalq u fil-griżmejn, nawżja, dijarea, uġigħ fil-ġogi, uġigħ fiddirgħajn u fir-riġlejn, għeja, deni u livelli tad-demm anormali ta' ċerti enzimi tal-fwied.
English: • primary immune thrombocytopenia (ITP), a disease in which the patient's immune system destroys platelets (components in the blood that help it to clot).
Maltese: • tromboċitopenija immunitarja primarja, (primary immune thrombocytopenia - ITP) , marda li fiha s-sistema immunitarja tal-pazjent tkisser il-pjastrini (komponenti fid-demm li jgħinuh jagħqad).
English: Revolade is used when the thrombocytopenia is too severe to allow interferonbased therapy (type of treatment for hepatitis C );
Maltese: Revolade jintuża meta t-tromboċitopenija tkun severa wisq biex tippermetti terapija bbażata fuq interferon (tip ta' kura għall-epatite Ċ);
English: The most important serious side effects are liver problems and thromboembolic complications (problems with clots in blood vessels).
Maltese: L-effetti sekondarji l-aktar importanti huma problemi fil-fwied u komplikazzjonijiet tromboemboliċi (problemi b'emboli fil-vażijiet).
English: As for all medicines, data on the use of Revolade are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Revolade hija ssorveljata kontinwament.
English: The active substance in Revolade, eltrombopag, also attaches to and stimulates the thrombopoietin receptors.
Maltese: Is-sustanza attiva f'Revolade, l-eltrombopag, teħel ma' u tistimula wkoll irriċetturi ta' trombopojetin.
English: Revolade is used in adult patients whose disease is not controlled by immunosuppressive therapy (medicines that lower the body's immune defences) and cannot receive haematopoietic stem cell transplantation (where the patient's bone marrow is replaced by stem cells from a donor to form new bone marrow).
Maltese: Revolade jintuża f'pazjenti adulti li l-marda tagħhom ma tkunx ikkontrollata minn terapija immunosoppressiva (mediċini li jbaxxu d-difiżi immunitarji tal-ġisem) u ma jistgħux jirċievu trapjant taċ-ċelloli staminali ematopojetiċi (fejn il-mudullun tal-pazjent jinbidel b'ċelloli staminali minn donatur biex jifforma mudullun ġdid).
English: For the treatment of ITP in adults, Revolade was compared with placebo (a dummy treatment) in two main studies involving a total of 311 patients who had previously been treated, but the treatments had not worked or the disease had come back.
Maltese: Għall-kura tal-ITP fl-adulti, Revolade tqabbel mal-plaċebo (kura finta) f'żewġ studji ewlenin li involvew total ta' 311-il pazjent li ġew ikkurati preċedentement, iżda li l-kuri fuqhom ma ħadmux jew inkella li lmarda reġgħet tfaċċat.
English: The most important serious side effects are febrile neutropenia (low white blood cell counts with fever) and infection.
Maltese: L-effetti sekondarji l-aktar importanti huma newtropenija febrili (għadd baxx ta' ċelloli bojod tad-demm biddeni) u infezzjoni.
English: In this study, 40% of patients (17 out of 43) responded to treatment after 12 weeks, and in 65% of them (11 out of 17) the platelet count either increased by at least 20,000 per microliter or it was stable without a need for blood transfusions.
Maltese: F'dan l-istudju, 40 % tal-pazjenti (17 minn 43) irrispondew għall-kura wara 12-il ġimgħa, u f'65 % minnhom (11 minn 17) l-għadd ta' pjastrini jew żdied b'mill-inqas 20,000 għal kull mikrolitru jew inkella kien stabbli mingħajr bżonn ta' trasfużjonijiet tad-demm.
English: Preliminary data from a supportive study are consistent with the result of the main study, with 46% of patients responding to treatment after 12 weeks.
Maltese: Data preliminari minn studju ta' appoġġ hija konsistenti mar-riżultat tal-istudju ewlieni, b'46 % tal-pazjenti li rrispondew għall-kura wara 12-il ġimgħa.
English: In the second study, patients taking Revolade were around 8 times more likely than those taking placebo to reach the target platelet count of between 50,000 and 400,000 per microlitre during the 6 months of treatment.
Maltese: Fit-tieni studju, il-pazjenti li ħadu Revolade kellhom probabbiltà ta' madwar tmien darbiet iktar minn dawk li ħadu l-plaċebo li jilħqu għadd ta' pjastrini fil-mira ta' bejn 50,000 u 400,000 għal kull mikrolitru matul is-sitt xhur ta' kura.
English: For the full list of restrictions and side effects of Revolade, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet u l-effetti sekondarji ta' Revolade, ara l-fuljett ta' tagħrif.