FrancophonIA/ELRC3.0 huggingface dataset:
English: The company provided data from studies with the reference medicine Suboxone and from the published literature showing the benefits of buprenorphine and naloxone in the treatment of opioid dependence.
Maltese: Il-kumpanija pprovdiet data minn studji bil-mediċina ta' referenza Suboxone u mil-letteratura ppubblikata li turi l-benefiċċji tal-buprenorfina u n-nalossina fil-kura ta' dipendenza fuq l-opjojdi.
English: Zubsolv contains two active substances: buprenorphine, a partial opioid agonist (it acts like an opioid drug but less powerfully), and naloxone, an opioid antagonist (it counteracts the effects of opioid drugs).
Maltese: Zubsolv fih żewġ sustanzi attivi: il-buprenorfina, li hija agonista tal-oppjojdi parzjali (jiġifieri taġixxi bħal mediċina opjojde iżda b'inqas saħħa) u n-nalossina, antagonista tal-opjojdi (sustanza li tiġġieled leffetti ta' mediċini opjojdi).
English: Zubsolv must not be used in patients with severe respiratory insufficiency (inability to breathe properly), severe liver problems, acute alcoholism (excessive alcohol consumption) or delirium tremens (a condition caused by alcohol withdrawal).
Maltese: Zubsolv m'għandux jintuża f'pazjenti b'insuffiċjenza respiratorja severa (ma tkunx tista' tieħu n-nifs), problemi severi fil-fwied, alkoħoliżmu akut (konsum eċċessiv ta' alkoħol) jew delirium tremens (kundizzjoni kkawżata minn meta wieħed jieqaf jieħu l-alkoħol).
English: Combining buprenorphine and naloxone is an established strategy for managing opioid dependence which prevents misuse of the medicine.
Maltese: Il-kombinazzjoni tal-buprenorfina u n-nalossina hi strateġija stabbilita biex tiġi mmaniġġjata ddipendenza fuq l-opjojdi li tipprevjeni l-użu ħażin tal-mediċina.
English: Serious side effects include seizures (fits), vomiting, diarrhoea and abnormal results of blood tests for liver function.
Maltese: Effetti sekondarji serji jinkludu konvulżjonijiet (aċċessjonijiet), rimettar, dijarea u riżultati mhux normali tattestijiet tad-demm għall-funzjoni tal-fwied.
English: On the first day of treatment, the recommended daily dose is one or two tablets of Zubsolv 1.4 mg/0.36 mg or 2.9 mg/0.71 mg. During the next days, the doctor may increase the dose depending on the patient's response, but the daily dose should not be higher than 17.2 mg buprenorphine.
Maltese: 18 mg, 1.4 mg/0.36 mg, 2.9 mg/0.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Zubsolv contains these at different strengths.
Maltese: Dan ifisser li huwa simili għal “mediċina ta' referenza” li fiha l-istess sustanzi attivi, iżda Zubsolv fih dawn is-sustanzi f'qawwa differenti.
English: Zubsolv is used in individuals who are also receiving medical, social and psychological support and who have agreed to be treated for their addiction.
Maltese: Zubsolc jintuża f'individwi li jkunu qed jirċievu wkoll appoġġ mediku, soċjali u psikoloġiku u li qablu li jiġu kkurati għad-dipendenza tagħhom.
English: For the full list of side effects reported with Zubsolv, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zubsolv, ara l-fuljett ta' tagħrif.
English: The most common side effects with Zubsolv (which may affect more than 1 in 10 people) are constipation and symptoms of drug withdrawal such as insomnia (difficulty sleeping), headache, nausea (feeling sick), hyperhidrosis (excessive sweating) and pain.
Maltese: L-effetti sekondarji l-iktar komuni b'Zubsolv (li jistgħu jaffettwaw iktar minn persuna 1 minn kull 10) huma stitikezza u sintomi ta' meta tieqaf tieħu l-mediċina bħal pereżempju nuqqas ta' rqad (diffikultà biex torqod), uġigħ ta' ras, dardir (tħossok ma tiflaħx), iperidrożi (għaraq eċċessiv) u wġigħ.
English: How is Zubsolv used?
Maltese: Kif jintuża Zubsolv?
English: What measures are being taken to ensure the safe and effective use of Zubsolv?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Zubsolv?
English: A study involving 125 healthy volunteers showed that some strengths of the Zubsolv tablets produced a lower level of the active substances in the body than the reference product and therefore the two medicines cannot be used interchangeably.
Maltese: Studju li jinvolvi 125 voluntier/a b'saħħithom wera li xi qawwiet tal-pilloli Zubsolv ipproduċew livell iktar baxx tas-sustanzi attivi fil-ġisem mill-prodott ta' referenza u għalhekk, iż-żewġ mediċini ma jistgħux jintużaw waħda minflok l-oħra.
English: Since Zubsolv does not produce the same amounts of buprenorphine and naloxone in the blood as the reference medicine, the medicines cannot be used interchangeably.
Maltese: nalossina fid-demm bħall-mediċina ta' referenza, il-mediċini ma jistgħux jintużaw waħda minflok loħra.
English: MA (EU) Number
Maltese: Numru MA (UE)
English: Annex A_en
Maltese: Annex A_mt
English: 90 capsules blister (PVC/Aclar/alu)
Maltese: 90 kapsula folja (PVC/Aclar/alu) 90 (9x10) kapsula
English: bene-Arzneimittel GmbH
Maltese: 300 (3x100) kapsula bene-Arzneimittel GmbH
English: Immediate Packaging Pack size
Maltese: Immediate Packaging
English: MA (EU) number
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 17 February 2011 EMA/121971/2011 EMEA/H/C/002091
Maltese: EMA/121971/2011 EMEA/H/C/002091
English: It contains the active substance topotecan.
Maltese: Huwa fih issustanza attiva topotecan.
English: What is Topotecan SUN?
Maltese: X'inhu Topotecan SUN?
English: How far into the evaluation was the application when it was withdrawn?
Maltese: Sa fejn kienet waslet l-evalwazzjoni qabel ma din ġiet irtirata?
English: The active substance in Topotecan SUN, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Maltese: Is-sustanza attiva f'Topotecan SUN, topotecan, hija mediċina kontra l-kanċer li tagħmel parti millgrupp ‘inibituri tat-topoisomerażi'.
English: The company provided data from the published literature on topotecan.
Maltese: Il-kumpanija pprovdiet dejta mid-dokumentazzjoni ppubblikata dwar topotecan.
English: On 3 January 2011, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Topotecan SUN for the treatment metastatic cancer of the ovary, small cell lung cancer and cervical cancer.
Maltese: Fit-3 ta' Jannar 2011, Sun Pharmaceutical Industries Europe B.V. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Topotecan SUN għall-kura tal-kanċer metastatiku tal-ovarju, tal-kanċer tal-pulmun b'ċelloli żgħar u tal-kanċer ċervikali.
English: Topotecan SUN was developed as a ‘generic medicine'.
Maltese: Topotecan SUN kien żviluppat bħala ‘mediċina ġenerika'.
English: This means that Topotecan SUN was intended to be similar to a ‘reference medicine' already authorised in the European Union called Hycamtin.
Maltese: Dan ifisser li Topotecan SUN kien maħsub li huwa simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea msejħa Hycamtin.
English: Withdrawal of the marketing authorisation application for Topotecan SUN (topotecan)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Topotecan SUN (topotecan)
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar mediċini ġeneriċi, ara d-dokument ta' mistoqsija u tweġiba hawn.
English: Topotecan SUN was to be used on its own to treat patients with:
Maltese: Topotecan SUN kellu jintuża waħdu fil-kura ta' pazjenti bi:
English: How is Topotecan SUN expected to work?
Maltese: Għalxiex kien mistenni li jintuża Topotecan SUN?
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Maltese: L-ittra mill-kumpanija li tgħarraf lill-Aġenzija bl-irtirar tal-applikazzjoni hija disponibbli taħt it-tab ‘Dokumenti kollha'.
English: It was also to be used together with cisplatin (another anticancer medicine) to treat women with cervical cancer (cancer of the cervix), when the cancer had come back after radiotherapy, or when the disease was at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Maltese: Kellu jintuża wkoll flimkien ma' cisplatin (mediċina oħra kontra l-kanċer) fil-kura ta' nisa bil-kanċer ċervikali (kanċer taċ-ċerviċi), meta l-kanċer kien reġa' ġie lura wara r-radjoterapija, jew meta l-marda kienet fi stadju avvanzat (stadju IVB: il-kanċer ikun infirex 'l hinn miċ-ċerviċi).
English: • metastatic cancer of the ovary (when the cancer has spread to other parts of the body) after at least one other treatment has failed;
Maltese: • kanċer metastatiku tal-ovarju (meta l-kanċer ikun infirex lejn partijiet oħra tal-ġisem) wara li mill inqas kura waħda oħra ma tkunx irnexxiet;
English: This means that the CHMP was still evaluating the initial documentation provided by the company.
Maltese: Dan ifisser li s-CHMP kien għadu qed jevalwa ddokumentazzjoni inizjali pprovduta mill-kumpanija.
English: No additional studies were needed as Topotecan SUN is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Maltese: L-ebda studju addizzjonali ma kien meħtieġ minħabba li Topotecan SUN huwa mediċina ġenerika li tingħata permezz ta' infużjoni u li fiha l-istess sustanza attiva bħal tal-mediċina ta' referenza, Hycamtin.
English: When the enzyme is blocked, the DNA strands break.
Maltese: Din timblokka enzima li tissejjaħ topoisomerażi I, li hija nvoluta fiddiviżjoni tad-DNA.
English: Topotecan SUN is a powder to be made up into a solution for infusion (drip into a vein).
Maltese: Topotecan SUN huwa trab li jkun magħmul f'soluzzjoni għal infużjoni (dripp fil-vina).
English: Topotecan SUN also affects non-cancer cells, which causes side effects.
Maltese: Topotecan SUN jaffettwa wkoll liċ-ċelloli mhux tal-kanċer, u dan jikkawża effetti sekondarji.
English: It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Maltese: Meta l-enzima tiġi mblukkata, il-filamenti tad-DNA jinqatgħu.
English: EMA/CVMP/768405/2010 EMEA/V/C/000158
Maltese: EMA/CVMP/768405/2010
English: This increase can sometimes be higher (up to 1.6º C in adult cows and up to 2.2º C in calves).
Maltese: Xi minn daqqiet din iż-żieda tista' tkun ogħla (sa 1.6º C fil-baqar adulti u sa 2.2º C flgħoġġiela).
English: Live vaccine against infectious bovine rhinotracheitis (IBR)
Maltese: Vaċċin ħaj kontra r-rinotrakeite tal-bovini li tittieħed (IBR)
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CVMP, aqra dDiskussjoni Xjentifika (parti mill-EPAR ukoll).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Hiprabovis IBR Marker Live exceed the risks for the active immunisation of cattle from three months of age against Bovine Herpes Virus type 1 to reduce the clinical signs of infectious bovine IBR and field virus excretion and recommended that Hiprabovis IBR Marker Live be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) kkonkluda li l-benefiċċji ta' Hiprabovis IBR Marker Live jiżbqu lir-riskji f'dak li għandu x'jaqsam mat-tilqim attiv tal-għoġġiela minn tliet xhur 'il fuq kontra l-Vajrus Erpetiku tal-Bovini tat-tip 1 biex jitnaqqsu s-sinjali kliniċi tar-rinotrakeite talbovini li tittieħed u l-eskrezzjoni tal-vajrus fuq il-post, u għaldaqstant irrakkomanda li Hiprabovis IBR Marker Live jingħata l-awtorizzazzjoni biex jitqiegħed fis-suq.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Hiprabovis IBR Marker Live to Laboratorios Hipra S.A. on 27 January 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Hiprabovis IBR Marker Live lil Laboratorios Hipra S.A. fid-data tal-27/01/2011.
English: Animals can also show a temporary inflammation at the site of injection in the 72 hours after-vaccination.
Maltese: L-annimali jistgħu jġarrbu wkoll infjammazzjoni temporanja fis-sit tattitqiba matul it-72 siegħa ta' wara t-tilqima.
English: Hiprabovis IBR Marker Live is a vaccine.
Maltese: Hiprabovis IBR Marker Live huwa vaċċin.
English: Hiprabovis IBR Marker Live is used to vaccinate cattle (cows and calves) against the respiratory infections caused by IBR.
Maltese: Hiprabovis IBR Marker Live jintuża biex jingħataw vaċċini lill-bhejjem (baqar u għoġġiela) kontra infezzjonijiet respiratorji li jkunu kkaġunati mill-IBR.
English: This vaccine is a marker vaccine and can enable a differential testing of vaccinated and naturally infected cattle, which is a useful tool in eradication campaigns.
Maltese: Dan il-vaċċin huwa vaċċin markatur u jista' jintuża f'testijiet differenzjali ta' għoġġiela mlaqqma u infettati b'mod naturali, li huwa għodda utli fil-kampanji tal-qerda tal-vajrus.
English: After vaccination, animals may show a slight increase in body temperature up to 1° C, in the four days following vaccination.
Maltese: Wara t-tilqim u fl-erbat ijiem ta' wara l-annimali jistgħu jġarrbu żieda żgħira fit-temperatura tal-ġisem sa 1° C.
English: The safety of Hiprabovis IBR Marker Live was investigated in a number of laboratory studies and in one field trial that included dairy cows and fattening cattle.
Maltese: Is-sikurezza ta' Hiprabovis IBR Marker Live ġiet mistħarrġa f'laboratorju waqt għadd ta' studji u fi prova fuq il-post li inkludiet baqar tal-ħalib u għoġġiela tas-simna.
English: The vaccine is used to reduce the clinical signs of IBR and the excretion (shedding) of the virus by the infected animals.
Maltese: Il-vaċċin jintuża biex inaqqas is-sinjali kliniċi talIBR u tal-eskrezzjoni (tixrid) tal-vajrus mill-annimali infettati.
English: Why has Hiprabovis IBR Marker Live been approved?
Maltese: Għaliex ġie approvat Hiprabovis IBR Marker Live?
English: What is Hiprabovis IBR Marker Live?
Maltese: X'inhu Hiprabovis IBR Marker Live?
English: Hiprabovis IBR Marker Live is a vaccine that contains an IBR virus that has been genetically modified to delete two genes so that the virus is less ‘pathogenic' (less able to cause a disease).
Maltese: Hiprabovis IBR Marker Live huwa vaċċin li fih vajrus IBR li jkun immodifikat b'mod ġenetiku biex iħassar żewġ ġeni partikulari ħalli l-vajrus isir inqas ‘patoġeniku' (inqas kapaċi jikkawżaw mard).
English: It is a powder for suspension for injection that contains a modified live infectious bovine rhinotracheitis (IBR) virus (also known as Bovine Herpes Virus type 1).
Maltese: Dan huwa trab għas-sospensjoni għat-titqib li fih vajrus immodifikat ħaj tar-rinotrakeite tal-bovini li tittieħed (IBR) li huwa magħruf ukoll bħala Vajrus Erpetiku tal-Bovini tat-tip 1.
English: 23 April 2009
Maltese: 23 ta' April 2009
English: Ref. EMEA/CHMP/499991/2009 EMEA/H/A-29/1061
Maltese: EMEA/495511/2009 EMEA/H/A-29/1061
English: Dr van Zwieten-Boot (Netherlands)
Maltese: Dott. van Zwieten-Boot (Olanda)
English: Prof Pirożynski (Poland)
Maltese: Pirożynski (Polonja)
English: 1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Maltese: 1 Artikolu 29 tad-Direttiva 2001/83/KE kif emendata, referenza abbażi ta' riskju potenzjali gravi għas-saħħa pubblika
English: London, 16 July 2009 Doc.
Maltese: Londra, 16 ta' Lulju 2009 Dok. ta' ref.
English: Prokanazol can be used against a range of fungi and yeasts, including Candida, Aspergillus and Cryptococcus.
Maltese: Prokanazol jista' jintuża kontra għadd ta' fungi u ħmejjer, fosthom Candida, Aspergillus u Cryptococcus.
English: What is Prokanazol?
Maltese: X'inhu Prokanazol?
English: The review was carried out under an ‘Article 29' referral1.
Maltese: Ir-reviżjoni saret skont referenza ‘tal-Artikolu 29'1.
English: The active substance in Prokanazol, itraconazole, is an antifungal substance that belongs to the group ‘triazoles'.
Maltese: Is-sustanza attiva fi Prokanazol, itraconazole, hija mediċina antifungali li tappartjeni għall-grupp tal‘trijazoli' (triazoles).
English: The company PRO.MED.CS Praha a. s. submitted Prokanazol for mutual recognition on the basis of the initial authorisation granted by the Czech Republic on 30 July 2003.
Maltese: Il-kumpanija PRO.MED.CS Praha a. s. ippreżentat il-mediċina Prokanazol għar-rikonoxximent reċiproku abbażi tal-awtorizzazzjoni inizjali mogħtija mir-Repubblika Ċeka fit-30 ta' Lulju 2003.
English: Questions and answers on the referral for Prokanazol capsules containing itraconazole 100 mg
Maltese: Mistoqsija u tweġiba dwar ir-referenza għal Prokanazol kapsuli li fihom itraconazole 100 mg
English: The company wanted the authorisation to be recognised in Latvia, Lithuania, Poland, Slovakia and Slovenia (the ‘concerned Member States').
Maltese: Ilkumpanija riedet li l-awtorizzazzjoni tkun rikonoxxuta fil-Latvja, fil-Litwanja, fil-Polonja, fisSlovakkja u fis-Slovenja (l-‘Istati Membri kkonċernati').
English: Prokanazol is a generic medicine that is based on a reference medicine authorised in the Czech Republic (Sporanox 100 mg capsules).
Maltese: Prokanazol huwa mediċina ġenerika bbażata fuq mediċina ta' referenza awtorizzata fir-Repubblika Ċeka (Sporanox 100 mg kapsuli) Prokanazol huwa kkummerċjalizzat ukoll bl-isem Prokanaz.
English: The grounds for the referral were that one of the concerned Member States, Poland, did not agree that enough evidence had been presented to show that Prokanazol was ‘bioequivalent' to the reference medicine.
Maltese: Ir-raġunijiet għar-referenza kienu li wieħed mill-Istati Membri kkonċernati, il-Polonja, ma qabilx li ġew ippreżentati provi suffiċjenti biex juru li Prokanazol kien ‘bijoekwivalenti' għall-mediċina ta' referenza.
English: Company responses provided on: 15 December 2008 Opinion date:
Maltese: Tweġibiet tal-kumpanija pprovduti fi: 15 ta' Diċembru 2008
English: Why was Prokanazol reviewed?
Maltese: Għaliex ġie rivedut Prokanazol?
English: It can also be used in systemic infections (infections that affect the whole body), including tropical infections.
Maltese: Jista' jintuża wkoll f'infezzjonijiet sistemiċi (infezzjonijiet li jolqtu l-ġisem kollu), fosthom infezzjonijiet tropikali.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Prokanazol.
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMEA) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-mediċina Prokanazol.
English: Co-rapporteur:
Maltese: Korelatur(i):
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Maltese: Din taħdem billi tipprevjeni l-formazzjoni ta' ergosterol li huwa parti importanti mill-ħitan taċ-ċelloli tal-fungi.
English: However, because the concerned Member States were not able to reach an agreement, the Czech medicines regulatory agency referred the matter to the CHMP for arbitration on 31 July 2008.
Maltese: Madankollu, billi l-Istati Membri ma setgħux jaslu għal qbil, fit-30 ta' Lulju 2008 l-aġenzija ta' regolamentazzjoni tal-mediċini Ċeka rreferiet ilkwistjoni lis-CHMP għall-arbitraġġ.
English: Fiasp (insulin aspart)
Maltese: Fiasp (insulina aspart)
English: Further information on Fiasp can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/fiasp.
Maltese: ema.europa.eu/medicines/human/EPAR/fiasp.
English: Fiasp received a marketing authorisation valid throughout the EU on 9 January 2017.
Maltese: Fiasp irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-9 ta' Jannar 2017.
English: Other information about Fiasp
Maltese: Informazzjoni oħra dwar Fiasp
English: In the second study involving 689 adults with type 2 diabetes, the fall after 6 months of treatment (from a starting value of 7.96% and 7.89% respectively) was 1.38 points with Fiasp and 1.36 points with the comparator.
Maltese: Fit-tieni studju li involva 689 pazjent bid-dijabete tat-tip 2, it-tnaqqis wara 6 xhur ta' kura (minn valur tal-bidu ta' 7.96 % u 7.89 % rispettivament) kien ta' 1.38 punt bi Fiasp u ta' 1.36 punt bil-komparatur.
English: What are the risks associated with Fiasp?
Maltese: X'inhuma r-riskji assoċjati ma' Fiasp?
English: It contains the active substance insulin aspart, a rapid-acting insulin.
Maltese: Dan fih issustanza attiva insulin aspart, insulina li taħdem malajr.
English: Compared with the already authorised insulin aspart medicine NovoRapid, the lowering of blood glucose develops earlier in adults given Fiasp, although the total extent of the lowering effect is similar.
Maltese: Meta mqabbel mal-mediċina NovoRapid tal-insulina aspart li diġà hija awtorizzata, it-tnaqqis talglukożju fid-demm jiżviluppa aktar kmieni f'adulti li jingħataw Fiasp, għalkemm il-firxa totali tal-effett tat-tnaqqis hija simili.
English: One study involving 1,143 adults with type 1 diabetes whose starting HbA1c was around 7.6% found that after 6 months of treatment HbA1c fell by 0.32 percentage points with a mealtime dose of Fiasp, compared with 0.17 points with the other insulin.
Maltese: Studju wieħed li involva 1,143 pazent bid-dijabete tat-tip 1 li l-HbA1c tal-bidu tagħhom kien ta' madwar 7.6 % sab li wara 6 xhur ta' kura, l-HbA1c naqas b'0.32 punt perċentwali b'doża waqt il-ħin tal-ikel ta' Fiasp, meta mqabbel ma' 0.17-il punt bl-insulina l-oħra.
English: In two studies Fiasp was at least as effective as another insulin, NovoRapid.
Maltese: Fiasp intwera li kien tal-inqas effettiv daqs insulina oħra, NovoRapid.
English: A fourth study in 777 adolescents and children from 2 years of age with type 1 diabetes and a starting HbA1c of around 7.6% compared Fiasp (given at mealtime or 20 minutes after the start of the meal) with NovoRapid (given at mealtime).
Maltese: Ir-raba' studju f'777 adoloxxent u tifel u tifla mill-età ta' sentejn bid-dijabete tat-tip 1 u HbA1c tal-bidu ta' madwar 7.6 % qabbel Fiasp (mogħti fil-ħin tal-ikel jew 20 minuta wara l-bidu tal-ikel) ma' NovoRapid (mogħti fil-ħin tal-ikel).
English: In this study, Fiasp was at least as effective as the comparator: there was almost no change in HbA1c in patients given Fiasp at mealtime (0.05 percentage points) and a similar slight increase in those given Fiasp after a meal or NovoRapid at mealtime (0.35 and 0.23 percentage points respectively).
Maltese: F'dan l-istudju, Fiasp kien tal-inqas effettiv daqs il-komparatur: ma kien hemm kważi l-ebda bidla fl-HbA1c fil-pazjenti li ngħataw Fiasp fil-ħin tal-ikla (0.05 punti perċentwali) u żieda żgħira simili f'dawk li ngħataw Fiasp wara ikla jew NovoRapid fil-ħin tal-ikla (0.35 u 0.23 punt perċentwali rispettivament).
English: (There was no direct comparison between Fiasp and another mealtime insulin in this study.)
Maltese: (Ma kien hemm l-ebda tqabbil dirett bejn Fiasp u insulina oħra waqt il-ħin tal-ikel f'dan l-istudju.)
English: A clinically relevant benefit in lowering blood glucose has been shown in studies with Fiasp.
Maltese: Intwera benefiċċju klinikament rilevanti fit-tnaqqis tal-glukożju fid-demm fi studji bi Fiasp.
English: Fiasp can also be used in a pump system for continuous insulin infusion under the skin or alternatively, it can be injected into a vein but only by a doctor or a nurse.
Maltese: Fiasp jista' jintuża wkoll f'sistema ta' pompa għal infużjoni tal-insulina kontinwa taħt il-ġilda jew bħala alternattiva, jista' jiġi injettat ġo vina iżda minn tabib jew infermier biss.
English: As for all medicines, data on the use of Fiasp are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Fiasp hija ssorveljata kontinwament.