FrancophonIA/ELRC3.0 huggingface dataset:
English: The metabolism of alfentanil is mediated via CYP3A, and may as such be inhibited by PREZISTA co-administered with low dose ritonavir.
Maltese: Il-metaboliżmu ta' alfentanil huwa medjat permezz ta' CYP3A, u fil-fatt jista' jiġi impedit minn PREZISTA mogħti flimkien ma' doża baxxa ta' ritonavir.
English: • For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.
Maltese: • Għall-kura tal-infezzjoni tal-HIV f'pazjenti adulti li diġà ħadu kura b'antiretrovirali (ART),
English: During the clinical development program of raltegravir in treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing PREZISTA/ritonavir + raltegravir compared to those containing PREZISTA/ritonavir without raltegravir or raltegravir without PREZISTA/ritonavir.
Maltese: Matul il-programm ta' żvilupp kliniku ta' raltegravir f'pazjenti li jkunu diġà ħadu kura qabel, raxx, irrispettivament mill-kawżalità, ġie osservat b'mod iktar komuni b'korsijiet li kien fihom PREZISTA/ritonavir + raltegravir meta mqabbla ma' dawk li kien fihom PREZISTA/ritonavir mingħajr raltegravir jew raltegravir mingħajr PREZISTA/ritonavir.
English: The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with PREZISTA should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
Maltese: Il-lista t'hawn taħt ta' eżempji ta' interazzjonijiet bejn mediċina u oħra mhijiex komprensiva u għalhekk it-tikketta ta' kull mediċina li tittieħed flimkien ma' PREZISTA għandha tiġi kkonsultata għal informazzjoni marbuta mar-rotta ta' metaboliżmu, is-sensiela ta' reazzjonijiet ta' interazzjoni, riskji possibbli, u azzjonijiet speċifiċi li għandhom jittieħdu dwar l-għoti tagħhom flimkien.
English: In deciding to initiate treatment with PREZISTA in such ART-experienced patients, genotypic testing should guide the use of PREZISTA (see sections 4.2, 4.3, 4.4 and 5.1).
Maltese: Meta wieħed jiddeċiedi li jibda kura bi PREZISTA f'pazjenti bħal dawn li jkunu diġà ħadu kura b'ARTqabel ittestjar ġenotipiku għandu jservi ta' gwida għall-użu ta' PREZISTA (ara sezzjonijiet 4.2, 4.3, 4.4, u 5.1).
English: Psychiatric disorders common insomnia uncommon depression, disorientation, anxiety, sleep disorder, abnormal dreams, nightmare, decreased libido rare confusional state, altered mood, restlessness
Maltese: Disturbi psikjatriċi komuni insomnja mhux komuni rari depressjoni, diżorjentament, ansjetà, disturb flirqad, ħolm mhux normali, ħmar il-lejl, tnaqqis fil-libido,
English: Rash occurred more commonly in treatment-experienced patients receiving regimens containing PREZISTA/ritonavir + raltegravir compared to patients receiving PREZISTA/ritonavir without raltegravir or raltegravir without PREZISTA (see section 4.8).
Maltese: Ir-raxx osservat flistudji kliniċi kien minn ħafif sa moderat fis-severità u ma rriżultax fit-twaqqif tat-terapija (ara sezzjoni 4.4).
English: PREZISTA 400 mg film-coated tablets Tablet core
Maltese: PREZISTA 400 mg pilloli miksijin b'rita Qalba tal-pillola
English: PREZISTA is also available as 75 milligram, 150 milligram, 300 milligram, 400 milligram and 800 milligram film-coated tablets and 100 milligram per milliliter oral suspension.
Maltese: PREZISTA huwa disponibbli wkoll bħala pilloli miksija b'rita ta' 75 milligramma, 150 milligramma, 300 milligramma, 400 milligramma u 800 milligramma u 100 milligramma/millilitru suspensjoni orali.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is combined with boosted PREZISTA.
Maltese: Huwa rrakkomandat li l-proporzjon internazzjonali normalizzat (INR) jiġi mmonitorjat meta warfarin jingħata ma' PREZISTA intensifikat.
English: PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:
Maltese: Il-pilloli PREZISTA 400 mg u 800 mg jistgħu jintużaw biex jipprovdu skedi ta' għoti ta' dożi xierqa għat-trattament ta' infezzjoni ta' HIV-1 f'pazjenti adulti u pedjatriċi minn età ta' 3 snin u b'tal-anqas 40 kg ta' piż tal-ġisem li :
English: No pharmacokinetic data are available in patients with severe hepatic impairment.
Maltese: L-ebda dejta farmakokinetika ma hija disponibbli f'pazjenti b'indeboliment epatiku serju.
English: Each film-coated tablet contains 400 mg darunavir (as ethanolate).
Maltese: Kull pillola miksija b'rita fiha 400 mg darunavir (bħala ethanolate).
English: zoldipem (sedative agents) - Perphenazine, risperidone, thioridazine (to treat psychiatric conditions) - Metformin (to treat type 2 diabetes).
Maltese: - Glecaprevir/pibrentasvir, simeprevir (biex titratta infezzjoni tal-epatite C) - Fentanyl, oxycodone, tramadol (biex jittrattaw l-uġigħ)
English: Tell your doctor if you take: - Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.
Maltese: Għid lit-tabib tiegħek jekk inti tieħu: - Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol,
English: If concomitant use of PREZISTA co-administered with low dose ritonavir with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.
Maltese: Jekk ikun indikat l-użu konkomitanti ta' PREZISTA intensifikat flimkien ma' sildenafil, vardenafil, jew tadalafil hija rrakommandata doża waħda ta' sildenafil li ma' taqbiżx 25 mg f'48 siegħa, doża waħda ta' vardenafil li ma taqbiżx 2.5 mg f' 72 siegħa jew doża waħda ta' tadalafil li ma' taqbiżx 10 mg f'72 siegħa.
English: Each tablet contains 600 milligram of darunavir (as ethanolate).
Maltese: Kull pillola fiha 600 milligramma ta' darunavir bħala ethanolate.
English: PREZISTA is also available as 75 mg, 150 mg, 300 mg, 400 mg, 600 mg and 800 mg film-coated tablets.
Maltese: PREZISTA hu disponibbli wkoll bħala pilloli miksija b'rita ta' 75 mg, 150 mg, 300 mg, 400 mg, 600 mg u 800 mg.
English: PREZISTA must always be given orally with cobicistat or low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products.
Maltese: PREZISTA għandu dejjem jingħata mill-ħalq flimkien ma' cobicistat jew doża baxxa ta' ritonavir li jservi ta' intensifikatur farmakokinetiku u flimkien ma' prodotti mediċinali antiretrovirali oħra.
English: • In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen is described in the Summary of Product Characteristics for PREZISTA 100 mg/ml oral suspension,75 mg, 150 mg, 300 mg and 600 mg tablets.
Maltese: ● Fil-pazjenti kollha l-oħra li għandhom esperjenza ta' ART jew kemm-il darba testijiet talġenotip HIV-1 mhumiex disponibbli, l-iskeda tad-doża rakkomandata tinsab fis-Sommarju tal-Karatteristiċi tal-Prodott ta' PREZISTA 100 mg/ml suspensjoni orali, u l-pillola ta' 75 mg, 150 mg, 300 mg u 600 mg. * DRV-RAMs:
English: not known toxic epidermal necrolysis*, acute generalised exanthematous pustulosis*
Maltese: mhux magħruf nekroliżi tossika tal-epidermide*, reazzjoni akuta ta' bżieżaq b'materja mifruxa*
English: If parenteral midazolam is co-administered with PREZISTA with low dose ritonavir, it should be done in an intensive care unit (ICU) or similar setting, which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Maltese: Jekk midazolam parenterali jingħata flimkien ma' PREZISTA intensifikat, dan għandu jsir f'qasam tal-kura intensiva (ICUintensive care unit) jew post jixbhu, li jiżgura sorveljanza klinika mill-qrib u immaniġġar mediku xieraq f'każ ta' depressjoni respiratorja u/jew sedazzjoni fit-tul.
English: A once daily dose regimen of PREZISTA taken with ritonavir taken with food may be used in patients with prior exposure to antiretroviral medicinal products but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Maltese: Skeda ta' kura b'doża darba kuljum ta' PREZISTA li jittieħed ma' ritonavir u mal-ikel tista' tintuża f'pazjenti li diġà kellhom esponiment għal prodotti mediċinali antiretrovirali iżda li m'għandhomx mutazzjonijiet assoċjati ma' reżistenza għal darunavir (DRV-RAMs)* u li fil-plażma għandhom < 100,000 kopja/ml ta' RNA ta' HIV-1 (HIV-1 RNA) u għadd ta'  100 ċellula x 10
English: The pharmacokinetic enhancing effect of cobicistat on darunavir was evaluated in a Phase I study in healthy subjects that were administered darunavir 800 mg with either cobicistat at 150 mg or ritonavir at 100 mg once daily.
Maltese: Inti trid tieħu PREZISTA kuljum u dejjem flimkien ma' 150 milligramma ta' cobicistat jew 100 milligramma ta' ritonavir u mal-ikel.
English: Each tablet contains 300 milligram of darunavir (as ethanolate).
Maltese: Kull pillola fiha 300 milligramma ta' darunavir bħala ethanolate.
English: The PREZISTA 400 milligram tablet is used to treat adults and children (3 years of age and above, at least 40 kilograms body weight) who are infected by HIV and - who have not used antiretroviral medicines before.
Maltese: Il-pillola PREZISTA 400 milligramma tintuża għat-trattament ta' adulti u tfal (3 snin u aktar, tal-anqas b'piż tal-ġisem ta' 40 kilogramma) li huma infettati bl-HIV u - li qatt ma kienu użaw mediċini antiretrovirali qabel.
English: prezista 600 mg (this is only applicable to the outer pack)
Maltese: prezista 600 mg (din tapplika biss għall-pakkett ta' barra)
English: Concomitant use of bosentan and boosted PREZISTA may increase plasma concentrations of bosentan.
Maltese: L-użu komkomitanti ta' bosentan u PREZISTA intensifikat jista' jżid il-konċentrazzjonijiet ta' bosentan filplażma.
English: - In the evening, take one 600 milligram PREZISTA tablet together with 100 milligram ritonavir.
Maltese: - Filgħodu, ħu pillola waħda ta' 600 milligramma PREZISTA flimkien ma' 100 milligramma ritonavir.
English: Therefore, PREZISTA must not be used in patients with severe hepatic impairment (Child-Pugh Class C) (see sections 4.3, 4.4 and 5.2).
Maltese: Għalhekk, PREZISTA m'għandux jintuża f'pazjenti b'indeboliment epatiku serju (Child-Pugh Klassi Ċ) (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: The combination product lopinavir/ritonavir this anti-HIV medicine belongs to the same class as PREZISTA
Maltese: Il-prodott li fih lopinavir/ritonavir f'daqqa din il-mediċina kontra l-HIV tagħmel parti millistess klassi ta' PREZISTA
English: The full EPAR for Riprazo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Riprazo jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (150 and
Maltese: Jiġi bħala pilloli (150 u 300 mg).
English: The recommended dose of Riprazo is 150 mg once a day.
Maltese: Id-doża rrakkomandatata ta' Riprazo hi 150 mg darba kuljum.
English: When the results of the five studies comparing Riprazo taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Riprazo, from an average of 99.4 mmHg at the start of the study.
Maltese: Meta r-riżultati tal-ħames studji li qabblu Riprazo meħud waħdu ma' plaċebo ġew studjati flimkien, il-pazjenti li kellhom inqas minn 65 sena kellhom tnaqqis medju fil-pressjoni dijastolika ta' 9.0 mmHg wara tmien ġimgħat jieħdu 150 mg Riprazo, minn medja ta' 99.4 mmHg fil-bidu tattrattament.
English: The active substance in Riprazo, aliskiren, is a renin inhibitor.
Maltese: Is-sustanza attiva f'Riprazo, aliskiren, hi inibitur tar-renina.
English: Combination studies looked at Riprazo used with an ACE inhibitor (ramipril), an ARB (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Maltese: L-istudji tat-tqabbil eżaminaw l-effett ta' Riprazo użat flimkien ma' inibitur tal-ACE (ramipril), ma' ARB (valsartan), ma' beta-blocker (atenolol), u ma' sustanza li timblokka l-kanali tal-kalċju (amlodipina) u sustanza djuretika (idroklorotijażide).
English: This is a summary of the European public assessment report (EPAR) for Riprazo.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Riprazo.
English: Riprazo is a medicine that contains the active substance aliskiren.
Maltese: Riprazo hu mediċina li fiha s-sustanza attiva aliskiren.
English: This was compared with a fall of 5.8 mmHg from 99.3 mmHg in the patients
Maltese: Min-naħa l-oħra kien hemm tnaqqis ta' 5.8 mmHg minn 99.3 mmHg fil-pazjenti li kienu qed jieħdu l-plaċebo.
English: The most common side effects with Riprazo (seen in between 1 and 10 patients in 100) are dizziness, diarrhoea, arthralgia (joint pain) and hyperkalaemia (high blood potassium levels).
Maltese: L-effetti sekondarji l-aktar komuni ta' Riprazo (li dehru f'bejn pazjent wieħed u 10 minn kull 100) huma sturdament, dijarrea, artralġija (uġigħ fil-ġogi) u iperkalemija (livelli għoljin ta' potassju fid-demm).
English: What is the risk associated with Riprazo?
Maltese: X'inhu r-riskju assoċjat ma' Riprazo?
English: Riprazo has been studied in 14 main studies involving over 10,000 patients with essential hypertension.
Maltese: Riprazo ġie studjat f'14-il studju ewlieni li fihom ħadu sehem iktar minn 10,000 pazjent b'ipertensjoni essenzjali.
English: How does Riprazo work?
Maltese: Għal xiex jintuża Riprazo?
English: Riprazo must also not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Maltese: Riprazo m'għandux jittieħed ma' ciclosporin, itraconazole jew mediċini oħra magħrufa bħala ‘inibituri qawwija ta' P-glycoprotein' (bħal quinidine).
English: However, in February 2012, following the review of a study called ALTITUDE, the CHMP recommended that Riprazo should not be used together with an ACE inhibitor or ARB in patients with diabetes or with moderate or severe kidney impairment because of an increase in the risk of cardiovascular and kidney problems.
Maltese: Madanakollu, fi Frar 2012, wara rreviżjoni ta' studju msejjaħ ALTITUDE, is-CHMP irrakkomanda li Riprazo ma għandux jintuża flimkien ma' inibitur ta' ACE jew ma' ARB f'pazjenti bid-dijabete jew b'indeboliment renali moderat jew sever minħabba żieda fir-riskju ta' problemi kardjovaskulari u renali.
English: For the full list of all side effects reported with Riprazo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati ma' Riprazo, ara l-fuljett ta' tagħrif.
English: Riprazo may be taken alone or in combination with other medicines for hypertension, with the exception of ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) in patients with diabetes, or moderate or severe kidney impairment.
Maltese: Riprazo jista' jittieħed waħdu jew flimkien ma' mediċini oħra għall-ipertensjoni bl-eċċezzjoni ta' ‘inibituri ta' enzimi li jikkonvertu anġjotensini' (ACE) jew ‘imblukkaturi tar-riċetturi tal-anġjotensini' (ARBs) f'pazjenti bid-dijabete, jew b'indeboliment renali moderat jew sever.
English: Riprazo, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Maltese: Riprazo waħdu kien iktar effikaċi mill-plaċebo u kien effikaċi daqs it-trattamenti komparattivi fit-tnaqqis tal-pressjoni.
English: Why has Riprazo been approved?
Maltese: Għaliex ġie approvat Riprazo?
English: This summary was last updated in 09-2008.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi: 09-2008.
English: Filgrastim is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim.
Maltese: Filgrastim huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': hija magħmula minn batterju li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi filgrastim.
English: The active substance in Tevagrastim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Tevagrastim, filgrastim hija simili ħafna għal proteina umana msejjħa stimulazzjoni tal-kolownja granuloċijto (G-CSF).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TEVAGRASTIM EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) TEVAGRASTIM
English: Tevagrastim is a ‘biosimilar' medicine.
Maltese: Tevagrastim hija mediċina ‘bijosimili'.
English: Tevagrastim was studied to show that it is comparable to the reference medicine, Neupogen.
Maltese: Tevagrastim ġie studjat biex jiġi muri li huwa komparabbli mal-mediċina ta' referenza, Neupogen.
English: During the first 21-day chemotherapy cycle, patients treated with either Tevagrastim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Maltese: Matul l-ewwel 21 jum ta' ċiklu kemoterapewtiku, pazjenti trattati b'kemm Tevagrastim jew Neupogen kellhom newtropenija severa għal medja ta' 1.1 jum, kumparat ma' 3.8 jum f'dak li jirċievu placebo.
English: The European Commission granted a marketing authorisation valid throughout the EU for Tevagrastim to Teva Generics GmbH on 15 September 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tevagrastim lil Teva Generics GmbH fil-15 ta' Settembru 2008.
English: The reference medicine for Tevagrastim is Neupogen.
Maltese: Il-mediċina ta' referenza għal Tevagrastim hija Neupogen.
English: Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal Neupogen, ilbenefiċċji jegħlbu r-riskji identifikati.
English: What is Tevagrastim?
Maltese: X'inhu Tevagrastim?
English: Treatment with Tevagrastim and Neupogen brought about similar reductions in duration of severe neutropenia.
Maltese: Trattament bir-Tevagrastim u n-Neupogen ġab tnaqqis simili fiż-żmien ta' newtropenija severa.
English: Why has Tevagrastim been approved?
Maltese: Għaliex ġie approvat Tevagrastim?
English: To study the safety of Tevagrastim, two further studies were carried out in patients with lung cancer and with non-Hodgkin's lymphoma.
Maltese: Sabiex tiġi studjata s-sigurtà ta' Tevagrastim, saru żewġ studju oħrajn fuq pazjenti bil-kanċer talpulmun u limfoma non-Hodgkin.
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Maltese: • Iżid il-livelli ta' newtrofili u jnaqqas ir-riskju ta' infezzjonijiet f'pazjenti bin-newtropenija li għandhom storja ta' infezzjonijiet severi u repetuti;
English: This means that Tevagrastim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Maltese: Dan ifisser li Tevagrastim huwa simili għal mediċina bijoloġika li hija diġà awtorizzata fl-Unjoni Ewropea (UE) u li tinkludi fiha l-istess sustanza attiva (magħrufa bħala ‘mediċina ta' referenza').
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy
Maltese: • Inaqqas iż-żmien ta' newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm) u lkaż li jkun hemm newtropenija febbrili (newtropenija fil-fwied) f'pazjenti li jirċievu lkemoterapija (trattament tal-kanċer) li huwa ċitotossiku (joqtol iċ-ċelloli);
English: Other information about Tevagrastim:
Maltese: Tagħrif ieħor dwar Tevagrastim:
English: Tevagrastim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Maltese: Tevagrastim normalment jingħata f'ċentru ta' trattament speċjalizzat, minkejja li pazjenti li jirċievuh b'injezzjoni taħt il-ġilda jistgħu jinjettaw rwieħhom ladarba jiġu mħarrġa sabiex jagħmlu dan.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara d-dokument ta' ‘mistoqsija u tweġiba' hawn.
English: What is the risk associated with Tevagrastim?
Maltese: X'inhu r-riskju assoċjat ma' Tevagrastim?
English: Tevagrastim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Maltese: Tevagrastim ġie kumparat ma' Neupogen u ma' placebo (trattament fint) fi studju prinċipali li kien jinvolvi
English: For the full list of all side effects reported with Tevagrastim, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji kollha rrappurtata b'Tevagrastim, ara l-Fuljett ta' Tagħrif.
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;
Maltese: • Inaqqas iż-żmien ta' newtropenija f'pazjenti li għaddejjin bi trattament li jkisser iċ-ċelloli talmudullum qabel ma' l-mudullum jiġi trapjantat (bħal f'xi pazjenti bil-lewkimja) jekk ikunu f'riskju ta' newtropenija severa fuq żmien twil;
English: Tevagrastim is used to stimulate the production of white blood cells in the following situations:
Maltese: Tevagrastim huwa wżat sabiex jistimula l-produzzjoni ta' ċelloli bojod fid-demm fis-sitwazzjonijiet li ġejjin:
English: The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Tevagrastim has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkunsidra li, b'mod konformi mal-ħtiġijiet ta' l-Unjoni Ewropea, Tevagrastim wera li għandu kwalità, sigurtà u effikaċja komparabbli ma' dawk ta' Neupogen.
English: How has Tevagrastim been studied?
Maltese: Kif ġie studjat Tevagrastim?
English: The most common side effect with Tevagrastim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Maltese: (li deher f'iktar minn pazjent wieħed minn kull għaxra) hu uġiegħ muskoloskeletali (uġigħ fil-muskoli u fl-għadam).
English: Further information on Tremfya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After 16 weeks, about 71% of patients (588 out of 825) receiving Tremfya had a reduction of at least 90% in PASI scores, compared with 48% (282 out of 582) of those receiving adalimumab and under 3% (11 out of 422) receiving placebo.
Maltese: Wara 16-il ġimgħa, madwar 71 % tal-pazjenti (588 minn 825) li kienu qed jirċievu Tremfya kellhom tnaqqis ta' mill-inqas 90 % fil-punteġġi PASI, meta mqabbel ma' 48 % (282 minn 582) ta' dawk li kienu qed jirċievu adalimumab u inqas minn 3 % (11 minn 422) ta' dawk li kienu qed jirċievu l-plaċebo.
English: Tremfya received a marketing authorisation valid throughout the EU on 10 November 2017.
Maltese: Tremfya ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-10 ta' Novembru 2017.
English: Tremfya contains the active substance guselkumab.
Maltese: Tremfya fih is-sustanza attiva guselkumab.