FrancophonIA/ELRC3.0 huggingface dataset:
English: In this trial, 2 cohorts (one using subcutaneous formulation in vial and one using subcutaneous formulation in administration system) were investigated using a 2-arm, cross-over design with 488 patients being randomized to one of two different three-weekly Trastuzumab treatment sequences (intravenous [Cycles 1-4]→ subcutaneous [Cycles 5-8], or subcutaneous [Cycles 1-4]→ intravenous [Cycles 5-8]).
Maltese: F'din il-prova, 2 koorti (wieħed fejn intużat ilformulazzjoni għall-għoti taħt il-ġilda f'kunjett u ieħor fejn intużat il-formulazzjoni għall-għoti taħt ilġilda f'sistema ta' għoti) kienu investigati permezz ta' mudell cross-over b'żewġ gruppi fejn 488 pazjent kienu randomised għal waħda minn żewġ sekwenzi differenti ta' kura bi Trastuzumab kull tliet ġimgħat ([Ċikli 1-4] fil-vini → [Ċikli 5-8] taħt il-ġilda, jew [Ċikli 1-4] taħt il-ġilda → [Ċikli 5-8] filvini).
English: Patients assigned to receive trastuzumab were given an initial loading dose of 8 mg/kg, followed by 6 mg/kg every three weeks for either one or two years.
Maltese: Pazjenti assenjati biex jirċievu trastuzumab ingħataw doża ogħla talbidu ta' 8 mg/kg, segwita minn 6 mg/kg kull tliet ġimgħat għal sena jew għal sentejn.
English: Ecchymosis
Maltese: Ekwivoku
English: Other medicines and Ogivri
Maltese: Kif taħżen Ogivri
English: L-histidine
Maltese: +Ipoxja
English: which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 3060 minutes repeated every 3 weeks for a total of six cycles.
Maltese: It-tnejn ingħataw ma': cisplatin - 80 mg/m² kull 3 ġimgħat għal 6 ċikli fl-ewwel ġurnata ta' kull ċiklu.
English: Study MO16419
Maltese: 3 Studju BO15935 4 Studju MO16419
English: Experience of concurrent administration of trastuzumab with low dose anthracycline regimens is currently limited to the trial MO16432.
Maltese: Esperjenza ta' għoti fl-istess waqt ta' trastuzumab ma' korsijiet b'doża baxxa ta' antharacycline bħalissa hija limitata għall-prova MO16432.
English: In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50 % of tumour cells.
Maltese: B'mod ġenerali, CISH huwa kkunsidrat pożittiv jekk ikun hemm aktar minn 5 kopji tal-ġene HER2 f'kull nukleu f'aktar minn 50% taċ-ċelluli tat-tumur.
English: Each carton contains 1 vial of powder.
Maltese: Kura kombinata bi Trastuzumab u anastrozole
English: • heartburn (dyspepsia)
Maltese: Tul medjan tarrispons (xhur) (firxa)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Ogivri 150 mg powder for concentrate for solution for infusion One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures.
Maltese: U KWANTITATTIVA Ogivri 150 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett wieħed fih 150 mg ta' trastuzumab, antikorp monoklonali
English: Ogivri should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
Maltese: Ogivri għandu jintuża biss f'pazjenti b'kanċer metastatiku tal-istonku (MGC - metastatic gastric cancer) li t-tumuri tagħhom jagħmlu ammont eċċessiv ta' HER2 kif definit b'IHC2+ u b'riżultat SISH jew FISH li jikkonferma, jew b'riżultat IHC 3+.
English: White to pale yellow lyophilised powder.
Maltese: Kull kartuna fiha kunjett wieħed bit-trab.
English: Immune thrombocytopenia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: - Doxorubicin 60 mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles,
Maltese: Kunjett ta' 150 mg + 7.2 mL
English: When trastuzumab was administered after completion of adjuvant chemotherapy NYHA Class III - IV heart failure was observed in 0.6 % of patients in the one-year arm after a median follow-up of 12 months.
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali 4 snin.
English: As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during trastuzumab therapy and for 7 months after the last dose.
Maltese: Peress li IgG1 uman jitneħħa fil-ħalib tas-sider tal-bniedem, u l-potenzjal ta' ħsara għat-tarbija mhux magħruf, nisa m'għandhomx ireddgħu waqt terapija bi trastuzumab u sa 7 xhur wara l-aħħar doża.
English: After a median follow-up of 12 months, the hazard ratio (HR) for disease free survival (DFS) was 0.54 (95 % CI 0.44, 0.67) which translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8 % versus 78.2 %) in favour of the trastuzumab arm.
Maltese: Wara segwitu medjan ta' 12-il xahar, il-proporzjon ta' periklu (HR - hazard ratio) għas-sopravivenza mingħajr ilmarda (DFS - disease free survival) kien ta' 0.54 (CI ta' 95% 0.44, 0.67) li huwa definit bħala benefiċċju assolut, f'termini ta' rata ta' sopravivenza mingħajr il-marda ta' sentejn, ta' 7.6 punti perċentwali (85.
English: Mylan EPD bvba/sprl
Maltese: Suomi/Finland Mylan Finland OY Puh/Tel:
English: or - intravenous paclitaxel - 175 mg/ m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
Maltese: jew paclitaxel fil-vini - 175 mg/m² bħala infużjoni kontinwa fil-vini, mogħti kull 3 ġimgħat għal 4 ċikli (l-ewwel ġurnata ta' kull ċiklu).
English: The pre-planned final analysis of OS from the joint analysis of studies NSABP B-31 and NCCTG N9831 was performed when 707 deaths had occurred (median follow-up 8.3 years in the AC→P H group).
Maltese: L-analiżi finali ppjanata minn qabel ta' OS mill-analiżi konġunta tal-istudji NSABP B-31 u NCCTG N9831 kienet imwettqa meta seħħew 707 imwiet (segwitu medjan ta' 8.3 snin fil-grupp ta' AC→PH).
English: Monotherapy Combination Therapy Trastuzumab1
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata.
English: Study H0648g: IHC3+ patient subset
Maltese: 41-0.81) fil-grupp ta' IHC 3+/FISH+.
English: The difference was not statistically significant, however more than half of the patients in the anastrozole alone arm crossed over to a trastuzumab containing regimen after progression of disease.
Maltese: Iddifferenza ma kinitx statistikament sinifikanti, iżda aktar minn nofs il-pazjenti fil-grupp ta' anastrozole waħdu inqalbu għall-kors li kien fih trastuzumab wara progressjoni tal-marda.
English: Neoplasms benign, malignant and unspecified (incl.
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: Amongst the most serious and/or common adverse reactions reported in trastuzumab usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Maltese: Fost l-aktar reazzjonijiet avversi serji u/jew komuni rrappurtati sal-lum waqt l-użu ta' trastuzumab (formulazzjonijiet għall-għoti fil-vini u għall-għoti taħt il-ġilda) hemm disfunzjoni kardijaka, reazzjonijiet relatati mal-infużjoni, tossiċità ematoloġika (b'mod partikolari newtropenija), infezzjonijiet u reazzjonijiet pulmonari avversi.
English: ATC vet code: QI07AD08.
Maltese: QI07AD08.
English: Canine parainfluenza Type 2 virus
Maltese: Canine parainfluenza virus Tip 2
English: Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15
Maltese: Canine parainfluenza virus Tip 2, strejn CPiV-2-Bio 15
English: Overdose(symptoms, emergency procedures, antidotes):
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti):
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/168/001
Maltese: FIS-SUQ EU/2/14/168/001
English: First dose: Versican Plus Pi from 8-9 weeks of age.
Maltese: L-ewwel doża: Versican Plus Pi minn età ta' 8-9 ġimgħat.
English: However, in field studies 10% of seronegative dogs did not show seroconversion (>0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies.
Maltese: Mandankollu, f'field studies 10% ta' klieb sero-negattivi ma wrewx serokonverżjoni (> 0.1 IU/ml) 3-4 ġimgħat wara tilqima primarja waħda kontra r-rabbja.
English: Onset of immunity: 3 weeks after completion of the primary course.
Maltese: Bidu tal-immunità: 3 ġimgħat wara l-kors primarju.
English: Type 1 glass vial containing 1 ml of solvent closed with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-ħġieġ Tip I li fih 1 ml solvent magħluq b'tapp tal-chlorobutyl rubber u kappa tal-aluminju.
English: Rabies:
Maltese: Solvent:
English: Lyophilisate: Trometamol Edetic acid Sucrose Dextran 70
Maltese: DIKJARAZZJONI TAS-SUSTANZI ATTIVI
English: If protection against Leptospira is required, dogs can be vaccinated with two doses of Versican Plus Pi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus Pi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Maltese: Jekk hemm bżonn ta' protezzjoni kontra l-Leptospira, il-klieb jistgħu jitlaqqmu b'żewġ dożi ta' Versican Plus Pi imħallta ma' Versican Plus L4 3-4 ġimgħat minn xulxin minn età ta' 6 ġimgħat.
English: − to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus.
Maltese: - biex tilqa' għas-sinjali kliniċi (tnixxija mill-imnieħer u l-għajnejn) u tnaqqas it-tixrid virali kkważati mill-canine parainfluenza virus.
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Lijofiliżat:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi lyophilisate and solvent for suspension for injection for dogs
Maltese: VETERINARJU Versican Plus Pi lijofiliżat u solvent għal sospensjoni ħall-injezzjoni għall-klieb
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against disease caused by canine parainfluenza virus.
Maltese: It-tilqima hija intenzjonata għall-immunizzazzjoni attiva fi ġriewi f'saħħithom u klieb kontra mard ikkawżat mill-virus tal-canine parainfluenza.
English: First dose: Versican Plus Pi from 8-9 weeks of age Second dose: Versican Plus Pi mixed with Versiguard Rabies 3-4 weeks later, but not before 12 weeks of age.
Maltese: It-tieni doża: Versican Plus Pi mħalta ma' Versiguard Rabies 3-4 ġimgħat wara imma mhux qabel l-età ta' 12-il ġimgħa.
English: Lyophilisate and solvent for suspension for injection.
Maltese: Lijofiliżat u solvent għal sospensjoni għall-injezzjoni.
English: The contents of a single vial of Versican Plus Pi should be reconstituted with the contents of a single vial of Versiguard Rabies (instead of the solvent).
Maltese: Il-kontenut ta' kunjett wieħed ta' Versican Plus Pi għandu jiġi rikostitwit mal-kontenut ta' kunjett wieħed ta' Versiguard Rabies (minnflok is-solvent).
English: Lyophilisate: spongy matter of white colour.
Maltese: Lijofiliżat: materjal bħal sponża ta' lewn bajdani Solvent: likwidu ċar bla kulur.
English: Active immunisation of dogs from 6 weeks of age:
Maltese: Tilqim attiv għall-klieb minn età ta' 6 ġimgħat:
English: In case of travelling to risk areas or outside the EU, veterinary surgeons may wish to give additional rabies vaccinations after 12 weeks of age to ensure that the vaccinated dogs have an antibody titre of ≥ 0.5 IU/ml, which is generally regarded as sufficiently protective and that they meet the travel test requirements (antibody titres ≥ 0.5 IU/ml).
Maltese: F'każ ta' vjaġġar lejn żoni ta' riskju jew barra mill-UE, veterinarji jistgħu jagħżlu li jagħtu aktar tilqimiet tar-rabbja wara l-età ta' 12-il ġimgħa biex ikun żgurat li l-klieb imlaqqma ikollhom livelli ta' antikorpi ≥ 0.5
English: Although the efficacy of the rabies fraction has been demonstrated following administration at 12 weeks, at the discretion of the veterinary surgeon, in case of need, dogs younger than 8 weeks can be vaccinated with Versican Plus Pi mixed with Versiguard Rabies as the safety of this association has been demonstrated in 6 week old dogs.
Maltese: Għalkemm l-effikaċja tal-frazzjoni tar-rabbja ġiet murija wara amministrazzjoni fit-12-il ġimgħa, fiddiskrezzjoni tal-veterinarju, f'każ ta' bżonn, klieb ta' anqas minn 8 ġimgħat jistgħu jiġu mlaqqma b'Versican Plus Pi imħallat ma' Versiguard Rabies billi s-sigurtà ta' din l-assoċjazzjoni ġiet stabbilita fi klieb ta' 6 ġimgħat.
English: Primary vaccination scheme: Two doses of Versican Plus Pi 3-4 weeks apart from 6 weeks of age.
Maltese: Żewġ dożi ta' Versican Plus Pi 3-4 ġimgħat minn xulxin minn età ta' 6 ġimgħat.
English: Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versiguard Rabies and Versican Plus L4.
Maltese: M'hemmx informazzjoni dwar is-sigurtà u l-effikaċja ta' dan il-vaċċin jekk jintuża flimkien ma' kwalunkwe prodott mediċinali veterinarju ieħor ħlief Versiguard Rabies u Versican Plus L4 .
English: PACKAGE LEAFLET: Versican Plus Pi lyophilisate and solvent for suspension for injection for dogs
Maltese: Versican Plus Pi lijofiliżat u solvent għal sospensjoni għall-injezzjoni għall-klieb
English: Invented name
Maltese: Id-data li ġiet
English: Baycox 2,5 %
Maltese: Paġna 2/2
English: Energieweg 1
Maltese: INFORMAZZJONI TA' SFOND
English: Animal species
Maltese: VETERINARJI AWTORIZZATI
English: Conclusions and recommendations
Maltese: European Medicines Agency Veterinary Medicines and Inspections
English: Questions to the CVMP:
Maltese: GĦALL-UŻU VETERINARJU (CVMP)
English: Bayer Austria Ges.m.b.H Herbststraße 6-10
Maltese: Il-konklużjonijiet xjentifiċi huma pprovduti fl-Anness
English: 2794-003 Carnaxide
Maltese: EMEA/402698/2008-MT
English: Bayer HealthCare AG 51368 Leverkusen Germany
Maltese: OPINJONI WARA RIFERIMENT TAĦT L-ARTIKOLU 351 GĦALL-PRODOTTI MEDIĊINALI
English: The input parameters were those agreed in the CVMP guideline (Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)) with the exception of bodyweight, which for broilers and turkeys was age specific, and nitrogen production per place per year, which for broilers (0.34 kg N/place/year) and turkeys (1.23 kg N/place/year) was higher than the value in the guideline as it was agreed that birds with coccidiosis would have a lower feed conversion efficiency and excrete more nitrogen than healthy birds.
Maltese: Matul il-laqgħa tiegħu ta' Lulju 2008, is-CVMP, fid-dawl tad-data ġenerali sottomessa u taddiskussjoni xjentifika fi ħdan il-Kumitat, adotta opinjoni b'kunsens li tikkonkludi li l-valutazzjoni tarriskji ppreżentati minn toltrazuril u l-metabolit maġġuri tiegħu, toltrazuril sulfone, għal pjanti terrestri u għall-ilma ta' taħt l-art uriet li l-użu ta' prodotti li fihom toltrazuril huwa aċċettabbli.
English: Following the introduction of the Water Framework Directive (2000/60/EC) the Groundwater Directive (80/68/EEC) will be repealed by 2013.
Maltese: Artikolu 35 tad-Direttiva 2001/82/KE, kif emendata.
English: In both chickens and turkeys, toltrazuril is administered orally in the drinking water at a dose of 7 mg/kg bodyweight per day for two consecutive days.
Maltese: Id-doża rakkomandata u t-tul tal-kura għal tiġieġ u dundjani hija 7 mg/kg piż tal-ġisem kuljum għal jumejn konsekuttivi.
English: The assessment of the risk presented by toltrazuril sulfone to terrestrial plants and to groundwater demonstrated that the use of products containing toltrazuril is acceptable and the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i.e. a dose of 7 mg/kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.
Maltese: Madankollu, ġie nnotat li l-indikazzjonijiet, l-ispeċi u l-pożoloġija fl-SPCs ta' uħud mill-prodotti awtorizzati kienu differenti u għaldaqstant, dawn ħtieġu li jiġu emendati sabiex jinġiebu konformi ma' l-indikazzjonijiet u r-reġimi ta' dożaġġ użati fil-valutazzjoni tar-riskji ambjentali.
English: Baycox 2,5 % w/v oral solution Bayer d.o.o., Bravničarjeva 13,
Maltese: Fil-31 ta' Awwissu 2007, inbeda riferiment Komunitarju skont l-Artikolu 35 tad-Direttiva 2001/82/KE, kif emendata, mill-Ġermanja għall-prodott awtorizzat fuq livell nazzjonali, Baycox 2.5% (soluzzjoni għat-tjur).
English: Oral solution 25 mg/ml Prevention and treatment of coccidiosis
Maltese: KUMITAT GĦALL-PRODOTTI MEDIĊINALI
English: Baycox 2,5 % oral solution Bayer Portugal S.A Rua Da Quinta do Pinheiro, N.º 5
Maltese: Ir-Relatur u l-KoRelatur maħturin kienu s-Sinjura R. Kearsley u s-Sur G. J. Schefferlie rispettivament.
English: Litvinovska 609/3 190 21 Praha 9
Maltese: Londra, 26 ta' Settembru 2008 EMEA/402698/2008
English: Toltrazuril sulfone (Ponazuril) the major metabolite of toltrazuril, may reach groundwater after spreading of Baycox 2.5 % contaminated poultry manure on agricultural land (PECgroundwater >0.1 µg/l).
Maltese: Fl-10 ta' Ottubru 2007, il-Kummissjoni Ewropea ddeċidiet li l-ambitu tar-riferiment għandu jinkludi lprodotti mediċinali veterinarji awtorizzati kollha li fihom toltrazuril (jiġifieri il-prodott ta' riferiment u l-ġeneriċi tiegħu) u maħsubin għall-użu fi speċi ta' tjur.
English: Belgium Baycox 2,5 % orale oplossing Bayer SA-NV Health Care
Maltese: Matul il-laqgħa tiegħu tal-11-13 ta' Diċembru 2007, is-CVMP qabel fuq estensjoni ta' xahrejn għaddata għas-sottomissjoni tat-tweġibiet għal-lista ta' mistoqsijiet fuq talba ta' Bayer HealthCare.
English: Package size micrograms/0.5 ml
Maltese: Daqs talpakkett microgrammi/ 0.5ml
English: Cartridge in a prefilled pen (250 micrograms/ 0.5 ml)
Maltese: Skartoċċ f'pinna mimlija għal-lest (250 microgrammi/ 0.5ml)
English: 1 pre-filled pen + 1 needle
Maltese: 1 pinna mimlija għal-lest + 1 labra
English: Solution for injection Subcutaneous use pre-filled syringe (glass)
Maltese: Soluzzjoni għal injezzjoni
English: EMA/599498/2014 EMEA/H/C/002819
Maltese: EMEA/H/C/002819
English: The full EPAR and risk management plan summary for Rezolsta 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: Darunavir is a protease inhibitor.
Maltese: Darunavir huwa impeditur tal-proteażi.
English: Other information about Rezolsta
Maltese: Informazzjoni oħra dwar Rezolsta
English: Rezolsta is available as tablets that contain 800 mg of darunavir and 150 mg of cobicistat.
Maltese: Rezolsta huwa disponibbli bħala pilloli li fihom 800 mg ta' darunavir u 150 mg ta' cobicistat.
English: This is a summary of the European public assessment report (EPAR) for Rezolsta.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rezolsta.
English: Overall, 258 patients (82%) achieved this response after 24 weeks of treatment, and 253 patients (81%) at 48 weeks, which was comparable to results previously seen with darunavir plus ritonavir.
Maltese: B'mod globali, 258 pazjent (82%) kisbu din ir-rispons wara 24 ġimgħa ta' kura, u 253 pazjent (81%) fi 48 ġimgħa, li kien komparabbli ma' riżultati li dehru qabel b'darunavir flimkien ma' ritonavir.
English: What are the risks associated with Rezolsta?
Maltese: X'inhuma r-riskji assoċjati ma' Rezolsta?
English: The most serious side effects were rash, diabetes, hypersensitivity (allergic) reactions, vomiting, and ‘immune reconstitution syndrome'.
Maltese: L-iktar effetti sekondarji serji kienu raxx, dijabete, reazzjonijiet ta' ipersensittività (allerġiċi), rimettar, u ‘sindromu tar-rikostituzzjoni immuni'.
English: Rezolsta contains the active substances darunavir and cobicistat.
Maltese: Rezolsta fih is-sustanzi attivi darunavir u cobicistat.
English: Rezolsta is an antiviral medicine used, in combination with other medicines, to treat adults with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Rezolsta huwa mediċina antivirali li tintuża, flimkien ma' mediċini oħrajn, għall-kura ta' adulti bil-virus tal-immunodefiċjenza umana ta' tip 1 (HIV-1), virus li jikkawża s-sindromu tal-immunodefiċenzja akkwiżita (AIDS).
English: Darunavir is currently authorised as Prezista and cobicistat as Tybost.
Maltese: Darunavir huwa attwalment awtorizzat bħala Prezista u cobicistat bħala Tybost.
English: Because darunavir and cobicistat have both previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Rezolsta produced similar effects and levels of darunavir in the blood to the two active substances given separately, and to darunavir given with a different booster medicine, ritonavir (an established combination).
Maltese: Minħabba li darunavir u cobicistat it-tnejn diġà ntwerew li huma effettivi u huma awtorizzati għall-użu fil-kura ta' infezzjonijiet tal-HIV, twettqu studji primarjament biex jintwera li Rezolsta pproduċa effetti u livelli simili ta' darunavir fid-demm għal meta ż-żewġ sustanzi ngħataw separatament, u għal darunavir mogħti ma' mediċina ta' rinforz differenti, ritonavir (kombinazzjoni stabbilita).
English: Effectiveness was measured by a reduction in viral load (the amount of HIV-1 virus in the blood) to less than 50 copies/ml.
Maltese: L-effikaċja tkejlet bi tnaqqis fittagħbija virali (l-ammont ta' virus tal-HIV-1 fid-demm) għal inqas minn 50 kopja/ml.
English: This summary was last updated in 11-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 11-2014.
English: Why is Rezolsta approved?
Maltese: Għaliex ġie approvat Rezolsta?
English: In addition there was no evidence of unexpected safety concerns.
Maltese: Barra minn hekk ma kien hemm ebda evidenza ta' tħassib mhux mistenni dwar sigurtà.
English: In addition, one main study was carried out to examine the safety and effectiveness of darunavir and cobicistat given with other HIV medicines, in 313 adult patients with HIV who had not been previously treated or who had been previously treated and whose infection was not expected to be resistant to darunavir.
Maltese: Barra minn hekk, twettaq studju ewlieni wieħed biex jiġu eżaminati s-sigurtà u l-effikaċja ta' darunavir u cobicistat mogħtija ma' mediċini oħrajn tal-HIV, fi 313-il pazjent adult b'HIV li diġà ġew ikkurati u li lmarda tagħhom mhijiex mistennija li tkun reżistenti għal darunavir.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rezolsta on 19/11/2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rezolsta fid-19/11/2014.
English: Rezolsta contains two active substances.
Maltese: Rezolsta fih żewġ sustanzi attivi.
English: The most common side effects with Rezolsta (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), and rash.
Maltese: L-effetti sekondarji l-aktar komuni b'Rezolsta (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma dijarea, dardir (tħossok ma tiflaħx) u raxx.
English: Both active substances have already been shown to be effective, and combining them into a single tablet was considered to be more convenient than taking them separately, reducing the risk of errors.
Maltese: Iż-żewġ sustanzi attivi diġà ntwerew li huma effettivi, u l-fatt li jiġu kkombinati f'pillola waħda kien ikkunsidrat bħala iktar konvenjenti milli jittieħdu separatament, u jnaqqas ir-riskju ta' żbalji.
English: Rezolsta must not be taken by patients who have severely reduced liver function.
Maltese: Rezolsta m'għandux jittieħed minn pazjenti li għandhom il-funzjoni tal-fwied imnaqqsa severament.
English: Rezolsta does not cure HIV infection or AIDS, but it can delay or reverse the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Ma jikkurax infezzjonijiet tal-HIV jew AIDS, iżda jista' jdawwem jew ireġġa' lura ħsara lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.