FrancophonIA/ELRC3.0 huggingface dataset:
English: Otherwise, there were no effects on mating or fertility with darunavir treatment up to 1,000 mg/kg/day and exposure levels below (AUC-0.5 fold) of that in human at the clinically recommended dose.
Maltese: Mill'bqija, ma kienx hemm effetti fuq tgħammir u fertilità bi trattament ta' darunavir sa 1,000 mg/kg/ġurnata u b'livelli ta' esponiment anqas minn (AUC- 0.5 drabi) dawk filbnedmin fid-doża rakkomandata klinikament.
English: EU/1/16/1140/030 EU/1/16/1140/031 EU/1/16/1140/032 EU/1/16/1140/033 EU/1/16/1140/034 EU/1/16/1140/035 EU/1/16/1140/036 EU/1/16/1140/037 EU/1/16/1140/038
Maltese: EU/1/16/1140/035 EU/1/16/1140/036 EU/1/16/1140/037 EU/1/16/1140/038
English: Darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.
Maltese: Darunavir, mogħti flimkien ma' doża baxxa ta' ritonavir huwa indikat, flimkien ma' prodotti mediċinali antiretrovirali oħra, għall-kura ta' pazjenti b'infezzjoni bil-virus uman ta' limmunodefiċjenza (HIV-1).
English: Number of subjects with virologic failure and paired baseline/endpoint phenotypes, showing loss of susceptibility to PIs at endpoint compared to baseline, n/N PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir a TLOVR non-VF censored algorithm based on HIV-1 RNA < 50 copies/ml, except for TITAN (HIV-1 RNA <
Maltese: darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir a Algoritmu ċċensurat TLOVR mhux-VF ibbażat fuq HIV-1 RNA < 50 kopja/ml, minbarra għal TITAN (HIV-1 RNA
English: (-4.3; 12.2)d median CD4+ cell count change from baseline (x 10
Maltese: )b il-medjan ta' tibdil fl-għadd ta' ċelluli CD4+ mill-linja bażi (x
English: Atazanavir: comparison of atazanavir/ritonavir 300/100 mg once daily vs. atazanavir 300 mg once daily in combination with darunavir/ritonavir 400/100 mg twice daily.
Maltese: Atazanavir: tqabbil ta' atazanavir/ritonavir 300/100 mg darba kuljum ma' atazanavir 300 mg darba kuljum flimkien ma' darunavir/ritonavir 400/100 mg darbtejn kuljum
English: For clinical trial results in ART-naïve adult patients, refer to the Summary of Product Characteristics for darunavir 400 mg and 800 mg tablets.
Maltese: Għal riżultati minn provi kliniċi f'pazjenti adulti li qatt ma ħadu kura b'ART qabel, irreferi għasSommarju tal-Karatteristiċi tal-Prodott tal-pilloli darunavir ta' 400 mg u 800 mg.
English: HDPE bottle pack with a PP screw cap containing 480 tablets.
Maltese: Flixkun tal-HDPE b'tapp bil-kamini tal-PP li jkun fih 480 pillola.
English: Uncommon diabetes mellitus, hypertriglyceridaemia, hypercholesterolaemia, hyperlipidaemia gout, anorexia, decreased appetite, decreased weight, increased weight, hyperglycaemia, insulin resistance, decreased high density lipoprotein, increased appetite, polydipsia, increased blood lactate dehydrogenase
Maltese: Mhux komuni gotta, anoreksja, tnaqqis fl-aptit, tnaqqis fil-piż, żieda fil-piż, ipergliċemija, reżistenza għallinsulina, tnaqqis fil-lipoproteina ta' densità għolja, żieda fl-aptit, polidipsja, żieda fil-lactate dehydrogenase fid-demm
English: Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) The dose is either: - 600 milligram darunavir (2 tablets containing 300 milligram of darunavir or 1 tablet containing 600 milligram of darunavir) together with 100 milligram ritonavir twice daily.
Maltese: Id-doża hija jew: - 600 milligramma darunavir (2 pilloli li fihom 300 milligramma ta' darunavir jew pillola waħda1 li fiha 600 milligramma ta' darunavir) flimkien ma' 100 milligramma ritonavir darbtejn kuljum.
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with PIs.
Maltese: Kien hemm rapporti ta' żieda fil-fsada, inkluż ematomi spontanji fil-ġilda u emartrożi f'pazjenti blemofilja tat-tip A u B trattati bl-Impedituri ta' Protease.
English: Co-administration of boosted darunavir and alfuzosin is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' darunavir intensifikat u alfuzosin huwa kontraindikat (ara sezzjoni 4.3).
English: Treatment-naïve darunavir/cobicistat 800/150 mg once daily N=295
Maltese: Pazjenti li qatt ma kienu ħadu kura qabel darunavir/cobicistat 800/150 mg darba kuljum N=295
English: (↑ clarithromycin from CYP3A inhibition and possible P-gp inhibition)
Maltese: (↑ nevirapine minn impediment ta' CYP3A)
English: #darunavir AUC ↔ darunavir Cmin ↔ #darunavir Cmax ↔
Maltese: Darunavir mogħti flimkien ma' doża baxxa ta' ritonavir m'għandux jintuża flimkien ma' dawn ilmediċini.
English: For clinical trial results in ART-naïve paediatric patients aged 12 to 17 years, refer to the Summary of Product Characteristics for darunavir 400 mg and 800 mg tablets.
Maltese: Għar-riżultati mill-provi kliniċi f'pazjenti pedjatriċi bejn it-12 sa 17-il sena li ma ngħatawx kura b'ART, irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal darunavir pilloli ta' 400 mg u 800 mg.
English: 30 film-coated tablets 120 film-coated tablets
Maltese: 30 pillola miksija b'rita 120 pillola miksija b'rita
English: Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with boosted darunavir.
Maltese: Sorveljanza klinika tal-effetti terapewtiċi u avversi hija rrakkomandata meta dawn ilmediċini jingħataw flimkien ma' darunavir intensifikat.
English: toxic epidermal necrolysis*, acute generalised exanthematous pustulosis*
Maltese: Mhux magħruf nekroliżi tossika tal-epidermide*, reazzjoni akuta ta' bżieżaq b'materja mifruxa*
English: HIV PI darunavir amprenavir atazanavir indinavir lopinavir saquinavir tipranavir a Virogic failures were defined as: never suppressed: confirmed HIV-1 RNA < 1 log10 reduction from baseline and ≥ 50
Maltese: L-għażla in vitro tal-virus reżistenti għal darunavir minn tip ta' HIV-1 li jeżisti fin-natura ħadet fit-tul (> 3 snin).
English: EU/1/16/1140/010 EU/1/16/1140/011
Maltese: EU/1/16/1140/012 EU/1/16/1140/013 EU/1/16/1140/014
English: Darunavir/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk (see sections 4.4, 4.6 and 5.2).
Maltese: Darunavir/ritonavir għandu jintuża biss waqt it-tqala jekk il-benefiċċju li jista' jkun hemm jiġġustifika r-riskju li jista' jkun hemm (ara sezzjonijiet 4.4, 4.6 u 5.2).
English: Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of these compounds and consequently that of darunavir, leading to loss of therapeutic effect and possible development of resistance (see sections 4.3 and 4.4).
Maltese: Prodotti mediċinali li jinduċu l-attività ta' CYP3A ikunu mistennija jżidu t-tneħħija ta' darunavir u ritonavir, li jwassal għal tnaqqis filkonċentrazzjonijiet ta' dawn is-sustanzi fil-plażma u konsegwenza ta' dan dik ta' darunavir, li jwassal għal telf tal-effett terapewtiku u żvilupp possibbli ta' reżistenza (ara sezzjonijiet 4.3 u 4.4).
English: Treatment-experienced darunavir/cobicistat 800/150 mg once daily N=18 Number of subjects with virologic failurea and genotype data that develop mutationsb at endpoint, n/N
Maltese: It-trattament b'darunavir/cobicistat 800/150 mg darba kuljum waqt it-tqala jwassal għal esponiment baxx għal darunavir.
English: A once daily dose regimen of darunavir 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: • Għal adulti li jkunu diġà ħadu kura b'ART qabel mingħajr reżistenza għal darunavir assoċjata ma' mutazzjonijiet (DRV-RAMs)* u li għandhom < 100,000 kopja/ml ta' HIV-1 RNA u għadd ta' ċelluli CD4+ ≥ 100 ċelluli x 10
English: Pharmacokinetic enhancer and concomitant medications Darunavir has different interaction profiles depending on whether the compound is boosted with ritonavir or cobicistat: - Darunavir boosted with cobicistat is more sensitive for CYP3A induction: concomitant use of darunavir/cobicistat and strong CYP3A inducers is therefore contraindicated (see section 4.3), and concomitant use with weak to moderate CYP3A inducers is not recommended (see section 4.5).
Maltese: - Darunavir intensifikat b'cobicistat huwa aktar sensittiv għal induzzjoni minn CYP3A: għalhekk l-użu ta' darunavir/cobicistat flimkien ma' indutturi qawwija ta' CYP3A huwa kontraindikat (ara sezzjoni 4.3), u l-użu flimken ma' indutturi ħfief sa moderati ta' CYP3A mhuwiex irrakkomandat (ara sezzjoni 4.5).
English: Ciclosporin Sirolimus Tacrolimus Everolimus
Maltese: Għall-kura ta' anormalità erettili Avanafil Sildenafil Tadalafil Vardenafil
English: The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg twice daily (see section 4.4).
Maltese: L-effett ta' titjib farmakokinetiku totali permezz ta' ritonavir kien ta' żieda ta' bejn wieħed u ieħor 14-il darba flesponiment sistemiku ta' darunavir meta doża waħda ta' darunavir 600 mg ingħatat mill-ħalq flimkien ma' ritonavir f'doża ta' 100 mg darbtejn kuljum (ara sezzjoni 4.4).
English: For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Maltese: Mediċini kontra l-HIV jistgħu jġagħluk tħossok aħjar.
English: Postpartum (6-12 weeks) (n=12)
Maltese: Wara t-twelid (6 ġimgħat-12-il ġimgħ a) (n=12)
English: ART-naïve adult patients
Maltese: Istruzzjonijiet għall-adulti.
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 għandek tieħu darunavir kuljum u dejjem tieħdu flimkien ma' 150 milligramma ta' cobicistat jew 100 milligramma ta' ritonavir u mal-ikel.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is combined with boosted darunavir.
Maltese: Huwa rrakkomandat li l-proporzjon internazzjonali normalizzat (INR) jiġi mmonitorjat meta warfarin jingħata ma' darunavir intensifikat.
English: Darunavir Mylan 800 mg film-coated tablets
Maltese: Darunavir Mylan 800 mg pilloli miksijin b'rita
English: The pharmacokinetics of darunavir in combination with ritonavir taken once daily in 12 ART-naïve paediatric patients, aged 12 to < 18 years and weighing at least 40 kg, showed that darunavir/ritonavir 800/100 mg once daily results in darunavir exposure that was comparable to that achieved in adults receiving darunavir/ritonavir 800/100 mg once daily.
Maltese: Il-farmakokinetiċi ta' darunavir flimkien ma' ritonavir li ttieħed darba kuljum fi 12-il pazjent pedjatriku mhux ikkurati b'ART, ta' bejn 12 sa < 18-il sena u li kienu jiżnu li jiżnu tal-anqas 40 kg, urew li darunavir/ritonavir 800/100 mg darba kuljum irriżulta f'esponiment għal darunavir li kien komparabbli ma dak miksub f'adulti li rċevew darunavir/ritonavir 800/100 mg darba kuljum.
English: Darunavir with low dose ritonavir may increase the exposure to grazoprevir.
Maltese: Darunavir intensifikat u raltegravir jistgħu jintużaw mingħajr aġġustamenti fid-doża.
English: Rare asthenia, fatigue pyrexia, chest pain, peripheral oedema, malaise, feeling hot, irritability, pain chills, abnormal feeling, xerosis
Maltese: Mhux komuni deni, uġigħ fis-sider, edima periferali, telqa' mingħajr sinjali ta' mard, tħoss is-sħana, irritabbiltà, uġigħ, kserożi
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: Darunavir Mylan 300 mg film-coated tablets are white to off-white, oval shaped, with two curved sides, marked with M on one side and DV3 on the other side.
Maltese: Darunavir Mylan 300 mg pilloli miksija b'rita huma bojod għal offwajt, b'forma ovali, imbuzzati fuq iż-żewġ naħat, imnaqqxa b'M fuq naħa waħda u DV3 fuq in-naħa l-oħra.
English: Furthermore, AUC of the sum of active moieties of rifabutin (parent drug + 25-Odesacetyl metabolite) was increased 1.6-fold, while Cmax remained comparable.
Maltese: Barra minn hekk, l-AUC tat-total tan-nofsijiet attivi ta' rifabutin (mediċina oriġinali + il-metabolit 25-O-desacetyl) żdiedet b'1.6 drabi aktar, filwaqt li s-Cmax baqgħet kumparabbli.
English: Boosted darunavir with triazolam or oral midazolam is contraindicated (see section 4.3)
Maltese: It-taħlita ta' rifampicin u darunavir intensifikat hija kontraindikata (ara sezzjoni 4.3).
English: The evidence of efficacy of darunavir co-administered with ritonavir (600/100 mg twice daily) in ART-experienced patients is based on the 96 weeks analysis of the Phase III trial TITAN in ART-experienced lopinavir naïve patients, on the 48 week analysis of the Phase III trial ODIN in ART-experienced patients with no DRV-RAMs, and on the analyses of 96 weeks data from the Phase IIb trials POWER 1 and 2 in ART-experienced patients with high level of PI resistance.
Maltese: Dejta minn provi kliniċi minn pazjenti li diġà ħadu kura b'ART qabel (prova TITAN u l-analiżi miġbura minn POWER 1, 2 u 3 u l-provi DUET 1 u 2 ) urew li r-rispons viroloġiku għall-darunavir mogħti flimkien ma' doża baxxa ta' ritonavir tnaqqas meta 3 RAMs
English: - Tell your doctor if you notice any musculoskeletal problems.
Maltese: - Għid lit-tabib tiegħek jekk tinnota xi problemi muskolu-skeletrali.
English: The combination product lopinavir/ritonavir this anti-HIV medicine belongs to the same class as Darunavir Mylan
Maltese: Il-prodott li fih lopinavir/ritonavir f'daqqa din il-mediċina kontra l-HIV tagħmel parti millistess klassi ta' Darunavir Mylan
English: 10 x 1-ml suspension (10 doses) 20 x 1-ml suspension (20 doses) 50 x 1-ml suspension (50 doses)
Maltese: 10 x 1 ml suspensjoni (10 dożi) 20 x 1 ml suspensjoni (20 doża) 50 x 1 ml suspensjoni (50 doża)
English: Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections.
Maltese: Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Ilma għall-injezzjonijiet
English: Active substance
Maltese: Sustanza Attiva :
English: EU/2/00/019/005 10 doses: 1-ml suspension (10 bottles) EU/2/00/019/006 20 doses: 1-ml suspension (20 bottles) EU/2/00/019/007 50 doses: 1-ml suspension (50 bottles)
Maltese: EU/2/00/019/005 10 dożi: ml suspensjoni (10 flixken) EU/2/00/019/006 20 doża: ml suspensjoni (20 flixkun)
English: FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50
Maltese: FeLV vajrus rikombinant tal-Canarypox (vCP97)......> 10 7.2 CCID50
English: Date of first authorisation: 13/04/2000 Date of last renewal: 22/03/2010
Maltese: Data ta' l-aħħar tiġdid: 22/03/2010
English: Purevax FeLV Suspension for injection
Maltese: Purevax FeLV suspensjoni għal injezzjoni
English: Store and transport refrigerated (2°C - 8°C), Protect from light.
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C) Ipproteġi mid-dawl.
English: Under field conditions, only sub-group A is infective and immunisation against sub-group A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat.
Maltese: F'kundizzjonijiet ta' barra, is-sotto-grupp A huwa infettiv u l-immunizzazjoni kontra is-sotto-grupp A jipprovdi protezzjoni totali kontra A, B u C.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (European Medicines Agency) http://www.ema.europa.eu.
English: Plastic box containing 10, 20 or 50 bottles Not all pack sizes may be marketed.
Maltese: Kaxxa tal-plastik li fiha 10, 20 jew 50 flixkun.
English: Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.
Maltese: Immunizzazjoni attiva tal-qtates ta' tmien ġimgħat jew akbar kontra l-lewċemija fil-qattus biex tipprevjeni viraemja persistenti u sinjali kliniċi tal-marda relatata.
English: Plastic box containing 10, 20 or 50 type I glass bottle with a Butyl elastomer closure and sealed with an aluminium cap.
Maltese: Kaxxa tal-plastik li fiha 10,20 jew 50 flixkun tal-ħġieġ ta' l-Ewwel Tip. b'tapp tal-butyl elastomer u ssiġillat b'tapp tal-aluminju.
English: Purevax FeLV suspension for injection
Maltese: VETERINARJU Purevax FeLV suspensjoni għall-injezzjoni.
English: INDICATION(S)
Maltese: MANIFATTURA(I)
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini (European Medicines Agency) http://www.ema.europa.eu.
English: Each dose of 1ml contains:
Maltese: Tilqim mill-ġdid:
English: Subcutaneous use
Maltese: Mhux applikabbli
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Maltese: FIR-REĠISTRU TAL-KOMUNITA TA' PRODOTTI MEDIĊINALI
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components)
Maltese: Hemm informazzjoni dwar is-sigurta' u l-effiċjenza li turi li dan il-vaċċin jista jiġi mħallat u amministrat ma' serje ta' vaċċini mingħajr adjuvant tal-Merial (diversi għaqdiet ta' komponenti tar rinotrakeite virali tal-qtates, kaliċivirosi, panlewkopenja, u klamydjosi.).
English: Do not use after the expiry date stated on the label.
Maltese: Tużax wara d-data ta' skadenza fuq it-tikketta.
English: Duration of immunity:1 year after the last vaccination.
Maltese: Tul ta' l- immunità: sena wara l-aħħar tilqima.
English: SPECIAL WARNING(S)
Maltese: U SID(/S
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: ĦRUĠ TAL-LOTT Isem u indirizz tal-manufattur tas-sustanza(i) bioloġika(ċi) attiva(i)
English: Vaccine against feline leukaemia.
Maltese: Taħt il-ġilda.
English: ATC vet code: QI06AD
Maltese: TAL-PRODOTT FIL-QOSOR
English: Do not use in pregnant animals.
Maltese: Laqqam biss annimali f'saħħithom.
English: first injection: from 8 weeks of age, second injection: 3 to 5 weeks later.
Maltese: it-tieni injezzjoni : 3 sa' 5 ġimgħat wara.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components) and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Maltese: Hemm informazzjoni dwar is-sigurtà u l-effiċjenza li turi li dan il-vaċċin jista jiġi użat flimkien masserje ta- vaċċini mingħajr adjuvant tal-Merial (diversi għaqdiet tal-komponenti tar-rhinotrakeite virali fil-qtates, kaliċivirosis, panlewkopenja u klamydiosis) u/jew amministrat fl-istess ġurnata iżda mhux użat flimkien mal-vaċċin tal-Merial bl-adjuvant kontra r-rabbja.
English: As a consequence, the vaccine induces an immune status against feline leukaemia virus.
Maltese: Konsegwentement, il-vaċċin jinduċi stat ta' immunità kontra l-vajrus tal-lewċemija fil-qattus.
English: In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Maltese: F'ċirkostanzi eċċezzjonali, jista' jkun hemm reazzjoni ta' ipersensitività li tista' tirrikjedi kura sintomatika xierqa.
English: Suspension for injection
Maltese: Suspensjoni għal injezzjoni.
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: MANIFATTUR(I) TAS-SUSTANZA(I)
English: Vaccination of FeLV positive cats is of no benefit.
Maltese: It-tilqim ta' qtates positivi għal FeLV m'għandu l-ebda benefiċċju.
English: Name and address of the manufacturer of the biological active substance(s)
Maltese: TAS-SUSTANZA(I) BIOLOĠIKA(ĊI) ATTIVA(I)
English: ADVERSE REACTIONS
Maltese: KUNTRADIZZJONIJIET
English: The full EPAR for Yargesa 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: Yargesa is a ‘generic medicine'.
Maltese: Yargesa huwa "mediċina ġenerika".
English: This is a summary of the European public assessment report (EPAR) for Yargesa.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Yargesa.
English: Why is Yargesa approved?
Maltese: Għaliex ġie approvat Yargesa?
English: The active substance in Yargesa, miglustat, prevents an enzyme called glucosylceramide synthase from working.
Maltese: Is-sustanza attiva f'Yargesa, il-miglustat, tipprevjeni enzima msejħa sintażi tal-glukożilċeramid milli taħdem.
English: Other information about Yargesa
Maltese: Informazzjoni oħra dwar Yargesa
English: Because Yargesa is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Yargesa huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Yargesa is a medicine used to treat adults with mild to moderate type-1 Gaucher disease.
Maltese: Yargesa huwa mediċina li tintuża biex tikkura adulti bil-marda Gaucher tat-tip 1 minn ħafifa sa moderata.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Yargesa.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat bil-mediċina ta' referenza, Zavesca, u ma għandhomx għalfejn jiġu ripetuti għal Yargesa.
English: The Committee recommended that Yargesa be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Yargesa jkun approvat għallużu fl-UE.
English: This means that it contains the same active substance (miglustat) and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Zavesca.
Maltese: Dan ifisser li fih l-istess sustanza attiva (il-miglustat) u jaħdem blistess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Zavesca.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Yargesa has been shown to have comparable quality and to be bioequivalent to Zavesca.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, f'konformità mar-rekwiżiti tal-UE, intwera li Yargesa għandu kwalità komparabbli u li huwa bijoekwivalenti għal Zavesca.
English: By preventing the enzyme from working, miglustat can reduce the production of glucosylceramide in cells, thereby reducing the symptoms of type-1 Gaucher disease.
Maltese: Meta tipprevjeni lill-enzima milli taħdem, il-miglustat tista' tnaqqas il-produzzjoni tal-glukożilċeramid fiċ-ċelloli, b'hekk jitnaqqsu s-sintomi tal-marda Gaucher tat-tip 1.
English: How has Yargesa been studied?
Maltese: Kif ġie studjat Yargesa?
English: As a result, glucosylceramide builds up in different parts of the body, such as the spleen, liver and bones.
Maltese: B'riżultat ta' dan, il-glukożilċeramid jifforma f'partijiet differenti tal-ġisem, bħall-milsa, il-fwied u l-għadam.