FrancophonIA/ELRC3.0 huggingface dataset:
English: - Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Maltese: Pioglitazone huwa indikat ukoll għall-użu flimkien ma' insulina f'pazjenti adulti b'dijabete mellitus tat-tip 2 b'kontroll gliċemiku insuffiċjenti bl-insulina u li għalihom metformin mhux adattat minħabba kontra-indikazzjonijiet jew intolleranza (ara sezzjoni 4.4).
English: After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Maltese: Wara lesklużjoni ta' pazjenti fejn l-espożizzjoni għall-mediċina tal-istudju kien ta' inqas minn sena fiż-żmien id-dijanjosi tal-kanċer tal-bużżieqa tal-awrina, kien hemm 7 każijiet (0.06%) fuq pioglitazone u 2 każijiet (0.02%) fil-gruppi ikkontrollati.
English: Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Maltese: Pazjenti li rċevew pioglitazone kellhom tnaqqis medju f'HbA1c ta' 0.45% meta mqabbel ma' dawk li komplew fuq l-insulina biss, u fil-grupp ikkurat b'pioglitazone kien hemm tnaqqis fid-doża talinsulina.
English: Read all of this leaflet carefully before you start taking this medicine.
Maltese: F'pazjenti li juru nuqqas ta' rispons suffiċjenti, pioglitazone għandu jitwaqqaf.
English: Monotherapy with metformin with sulphonylurea with metformin and sulphonylurea with insulin
Maltese: Ma' metformin u sulphonylurea
English: NAME OF THE MEDICINAL PRODUCT Sepioglin 15 mg tablets Pioglitazone
Maltese: Pilloli Sepioglin 15 mg Pioglitazone
English: As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral therapy with a sulphonylurea or in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea or insulin may be necessary.
Maltese: Bħala konsegwenza ta' żieda fis-sensittività għall-insulina, pazjenti li qed jirċievu pioglitazone f'terapija mill-ħalq doppja jew trippla ma' mediċina tat-tip sulphonylurea jew f'terapija doppja malinsulina jistgħu jkunu f'riskju ta' ipogliċemija relatat mad-doża, u tista' tkun neċessarja tnaqqis fiddoża tal-mediċina tat-tip sulphonylurea jew tal-insulina.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni:
English: A possible risk after short term treatment cannot be excluded.
Maltese: Riskju possibbli wara trattament ta' perijodu qasir ma jistax jiġi eskluż.
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, to be agreed in the Risk Management Plan to be submitted and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Maltese: Id-detentur tal-awtorizazzjoni għat-tqegħid fis-suq għandu jwettaq l-attivitajiet ta' farmakoviġilanza li għandu jsir ftehim dwarhom fil-Pjan ta' Ġestjoni tar-Riskju li għandu jiġi ppreżentat u kull aġġornament sussegwenti tal-RMP miftiehem mill-Kumitat għall-Prodotti Mediċinali għall-Użu millBniedem (CHMP) .
English: Renal and urinary disorders haematuria glycosuria uncommon proteinuria uncommon
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Sepioglin Dan il-mediċina fiha lactose monohydrate.
English: NAME OF THE MEDICINAL PRODUCT Sepioglin 30 mg tablets Pioglitazone
Maltese: Pilloli Sepioglin 30 mg Pioglitazone
English: The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per 100 patient years of use.
Maltese: Iż-żieda osservata fir-riskju ta' fratturi għan-nisa f'dan id-dataset fuq pioglitazone għalhekk huwa ta' 0.8 ratturi kull 100 sena ta' pazjent ta' użu.
English: When Sepioglin is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Maltese: Meta Sepioglin tittieħed flimkien ma' mediċini oħra wżati għall-kura tad-dijabete (bħal insulina, chlorpropamide, glibenclamide, gliclazide, tolbutamide), it-tabib tiegħek jgħidlek jekk għandekx bżonn tieħu doża inqas tal-mediċini tiegħek.
English: Take Sepioglin daily as prescribed.
Maltese: Mhemmx dejta disponibbli.
English: 4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised,
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: Sepioglin may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control in blood sugar .
Maltese: Sepioglin jista jintuża waħdu f'pazjenti li ma jistgħux jieħdu metformin, u fejn trattament ma' dieta u eżercizzju naqas milli jikkontrolla z-zokkor fid-demm jew jista' jittieħed flimkien ma'terapiji oħra (bħal metformin, sulphonylurea jew insulina) li naqsu milli jipprovdu kontroll biżżejjed taz-zokkor fid-demm.
English: Monotherapy with metformin with sulphonylurea with metformin and sulphonylurea with insulin increased increased lactic dehydro-genase uncommon
Maltese: Madwar terz talpazjenti kienu qed jirċievu l-insulina flimkien ma' metformin u jew mediċina tat-tip sulphonylurea.
English: In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Maltese: Fi studji kliniċi, pazjenti ħadu pioglitazone f'doża aktar mill-ogħla doża rakkomandata ta' 45 mg kuljum.
English: Take special care with Sepioglin
Maltese: Oqgħod attent ħafna b'Sepioglin
English: Roundworms and hookworms
Maltese: Roundworms u hookworms
English: Further information on Simparica Trio can be found on the Agency's website: ema.europa.eu/Find medicines/veterinary/EPAR/simparica-trio.
Maltese: ema.europa.eu/Find medicines/veterinary/EPAR/simparica-trio.
English: Sarolaner acts as an ‘ectoparasiticide'.
Maltese: Is-sarolaner taġixxi bħala “ektoparassitiċida”.
English: Simparica Trio (sarolaner / moxidectin / pyrantel)
Maltese: Simparica Trio (sarolaner / mossidektin / pirantel)
English: Simparica Trio received a marketing authorisation valid throughout the EU on 17 September 2019.
Maltese: Simparica Trio rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fi 17/09/2019.
English: Other information about Simparica Trio
Maltese: Informazzjoni oħra dwar Simparica Trio
English: In a field study in dogs infested with at least 5 live fleas, 297 dogs were treated with Simparica Trio and 164 dogs with afoxolaner and milbemycin oxime (an authorised treatment for fleas and ticks).
Maltese: Fi studju fuq il-post fuq klieb infestati b'minn tal-inqas 5 briegħed ħajjin, 297 kelb kienu kkurati b'Simparica Trio u 164 kelb b'afoxolaner u milbemycin oxime (kura awtorizzata għall-briegħed u lqurdien).
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey signals between nerves (neurotransmitters).
Maltese: Din timblokka l-moviment normali tal partikoli ċċarġjati tal-klorur (joni) ġewwa u barra ċ-ċelloli tan-nervituri, speċjalment dawk assoċjati mal-aċidu gamma-aminobutirriku (GABA) u l-glutamat, żewġ sustanzi li jgħaddu l-messaġġi bejn innervituri (newrotrażmettituri).
English: Simparica Trio contains the active substances sarolaner, moxidectin and pyrantel.
Maltese: Simparica Trio fih is-sustanzi attivi sarolaner, mossidektin u pirantel.
English: Moxidectin kills parasites present inside the body of animals, such as roundworms, hookworms, lungworm and heartworm.
Maltese: Il-mossidektin toqtol il-parassiti preżenti fil-ġisem tal-annimali, bħar-roundworms, il-hookworms, illungworm u l-heartworm.
English: The study showed Simparica Trio to be comparable to the comparator medicine as measured by flea counts on day 14 and 30 after treatment.
Maltese: L-istudju were li Simparia Trio huwa komparabbli mal-mediċina komparatur kif imkejjel millgħadd tal-briegħed fil-jiem 14 u 30 wara l-kura.
English: What are the risks associated with Simparica Trio?
Maltese: X'inhuma r-riskji assoċjati ma' Simparica Trio?
English: This overview was last updated in July 2019.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Lulju 2019.
English: In a US study of 410 dogs in an area affected by heartworm disease, dogs treated with Simparica Trio every 30 days until day 300 showed 100% effectiveness based on blood tests at days 120, 240 and 330 after first treatment.
Maltese: Fi studju fl-Istati Uniti fuq 410 iklieb f'żona infettata bil-marda talheartworm, il-klieb ikkurati b'Simparica Trio kull 30 jum sal-jum 300 wrew effikaċja ta' 100 % abbażi tat-testijiet tad-demm fil-jiem 120, 240 u 330 wara l-ewwel kura.
English: Ticks
Maltese: Qurdien
English: Pyrantel also kills roundworms and hookworms present in the gut but acts differently to moxidectin.
Maltese: Il-pirantel toqtol ukoll ir-roundworms u l-hookworms preżenti fl-imsaren iżda taġixxi b'mod differenti mill-mossidektin.
English: In a field study involving dogs infected with roundworms or hookworms, 194 dogs were treated with Simparica Trio and 97 dogs with afoxolaner and milbemycin oxime.
Maltese: Fi studju fuq il-post li kien jinvolvi klieb infettati bir-roundworms jew bil-hookworms, 194 kelb ġew ikkurati b'Simparica Trio u 97 kelb b'afoxolaner u milbemycin oxime.
English: Simparica contains three active substances: sarolaner, moxidectin and pyrantel.
Maltese: Simparica Trio fih tliet sustanzi attivi: is-sarolaner, il-mossidektin u l-pirantel.
English: The study showed Simparica Trio to be comparable to the comparator medicine as measured by the percentage reduction in live tick counts on day 7, 14, 21 and 30 after treatment.
Maltese: L-istudju wera li Simparica Trio huma komparabbli mal-mediċina komparatur kif imkejjel mit-tnaqqis fil-perċentwal tal-għadd tal-qurdien ħajjin fil-jiem 7, 14, 21 u 30 wara l-kura.
English: Further flea or tick treatment should be continued using a different veterinary medicine with a narrower range of action.
Maltese: Kura ulterjuri tal-briegħed jew talqurdien għanda titkompla bl-użu ta' mediċina veterinarja differenti b'firxa aktar limitata ta' azzjoni.
English: In a field study involving 622 dogs in an area of Denmark and Italy known to be affected by lungworm disease, dogs treated with Simparica Trio every 30 days until day 270 did not test positive for lungworm until day 300 after first treatment and therefore the effectiveness was 100% with some dogs testing positive in the control group which was given a dummy treatment.
Maltese: Fi studju fuq il-post li kien jinvolvi 622 kelb f'żona tad-Danimarka u f'żona tal-Italja magħrufin li huma infettati mill-marda tal-lungworm, il-klieb ikkurati b'Simparica Trio kull 30 jum sal-jum 270 ma ttestjawx pożittiv għal-lungworm sal-jum 300 wara l-ewwel kura u għaldaqstant l-effikaċja kienet ta' 100 % b'xi klieb li ttestjaw pożittiv fil-grupp ta' kontroll li ngħataw kura finta.
English: In a further field study in dogs infested with at least 3 live ticks, 189 dogs were treated with Simparica Trio and 91 dogs with afoxolaner and milbemycin oxime.
Maltese: Fi studju ieħor fuq il-post fuq klieb infestati b'minn tal-inqas 3 qurdien ħajjin, 189 kelb ġew ikkurati b'Simparica Trio u 91 kelb b'afoxolaner u milbemycin oxime.
English: Why is Simparica Trio authorised in the EU?
Maltese: Għalfejn Simparica Trio huwa awtorizzat fl-UE?
English: How does Simparica Trio work?
Maltese: Kif jintuża Simparica Trio?
English: Simparica Trio is a veterinary medicine used to treat dogs with flea or tick infestations and roundworm or hookworm infections in the gut.
Maltese: Simparica Trio huwa mediċina veterinarja li tintuża biex tikkura l-klieb b'infestazzjonijiet tal-briegħed u tal-qurdien u b'infezzjonijiet tar-roundworm jew tal-hookworm fl-imsaren.
English: Moxidectin causes paralysis and death of these parasites by interfering in a different way to sarolaner with the flow of chloride ions in nerve cells associated with GABA and glutamate.
Maltese: Il-mossidektin tikkawża l-paraliżi u l-mewt ta' dawn il-parassiti billi tinterferixxi b'mod differenti mis-sarolaner bil-fluss tal-joni tal-klorur fiċ-ċelloli tan-nervituri assoċjati ma' GABA u l-glutamat.
English: Two studies conducted in Australia and one in Japan that followed a similar design to the US study also showed 100% effectiveness against naturally occurring heartworm infection.
Maltese: Żewġ studji li twettqu fl-Awstralja u wieħed fil-Ġappun li segwew tfassil simili għall-istudju fl-Istati Uniti, ukoll urew effikaċja ta' 100 % kontra l-infezzjoni tal-heartworm li sseħħ b'mod naturali.
English: It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites).
Maltese: Dan jista' jintuża wkoll bħala parti minn kura għal dermatite allerġika għall-briegħed (reazzjoni allerġika għall-gdim tal-briegħed).
English: It acts by blocking signals, normally associated with the neurotransmitter acetylcholine, from their nerves to their muscles, causing sudden contraction followed by paralysis and death.
Maltese: Din taġixxi billi timblokka s-sinjali, normalment assoċjati mal-aċetilkolina tannewrotrażmettitur, min-nervituri tagħhom għall-muskoli tagħhom, u b'hekk tikkawża kontrazzjoni f'daqqa segwita minn paraliżi u mewt.
English: For flea or tick infestations, one treatment with Simparica Trio is effective for up to 5 weeks.
Maltese: Għall-infestazzjonijiet tal-briegħed jew talqurdien, kura waħda b'Simparica Trio tibqa' effettiva sa 5 ġimgħat.
English: Tolura is a ‘generic medicine'.
Maltese: Tolura huwa ‘mediċina ġenerika'.
English: EPAR summary for the public telmisartan
Maltese: Sommarju tal-EPAR għall-pubbliku telmisartan
English: It is available as white tablets (round: 20 mg; oval: 40 mg; capsule-shaped: 80 mg).
Maltese: Huwa disponibbli f'pilloli bojod (tondi: 20 mg; ovali: 40 mg; forma ta' kapsuli: 80 mg).
English: The full EPAR for Tolura can be found on the Agency's website: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: Tolura is a medicine that contains the active substance telmisartan.
Maltese: Tolura huwa mediċina li fiha s-sustanza attiva telmisartan.
English: This document is a summary of the European Public Assessment Report (EPAR) for Tolura.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Tolura.
English: The active substance in Tolura, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Tolura, it-telmisartan, hija ‘antagonist tar-riċettur ta' anġjotensin II', li tfisser li timblokka l-azzjoni ta' ormon fil-ġisem magħruf bħala anġjotensin II. L-Anġjotensina
English: The European Commission granted a marketing authorisation valid throughout the EU for Tolura to Krka, d.d., Novo mesto on 4 June 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tolura lil Krka, d.d., Novo mesto fl-4 ta' Ġunju 2010.
English: Because Tolura is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Maltese: Peress li Tolura huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet li jistabbilixxu lbijoekwivalenza tiegħu mal-mediċina ta' referenza, Micardis.
English: This means that Tolura is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
Maltese: Dan ifisser li Tolura huwa simili għall-“mediċina ta' referenza” diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Micardis.
English: What is Tolura?
Maltese: X'inhu Tolura?
English: What are the benefit and risk of Tolura?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Tolura?
English: dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Maltese: Jekk il-pressjoni tad-demm mixtieqa ma tintlaħaqx, id-doża tista' tiżdied għal 80 mg, jew inkella tista' tiżdied mediċina oħra għall-ipertensjoni, bħal idroklorotijażide (hydrochlorothiazide).
English: For the treatment of essential hypertension, the recommended dose of Tolura is 40 mg once a day, but some patients may benefit from using a 20-mg dose.
Maltese: Għall-kura tal-ipertensjoni essenzjali, id-doża rakkomandata ta' Tolura hija 40 mg darba kuljum, iżda xi pazjenti jistgħu jibbenefikaw mill-użu ta' doża ta' 20 mg.
English: Why has Tolura been approved?
Maltese: Għaliex ġie approvat Tolura?
English: The CHMP concluded that, in accordance with EU requirements, Tolura has been shown to have comparable quality and to be bioequivalent to Micardis.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Tolura intwera li għandu kwalità li tixbaħ lil dik ta' Micardis u li huwa bijoekwivalenti.
English: Other information about Tolura:
Maltese: Tagħrif ieħor dwar Tolura:
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Maltese: Billi jimblokka r-riċetturi li magħhom lanġjotensina II normalment teħel, it-telmisartan iwaqqaf l-ormon milli jkollu effett, b'hekk iħalli larterji u l-vini jitwessgħu.
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Maltese: Dan jippermetti wkoll lill-qalb sabiex tippompja d-demm b'mod aktar faċli, sistema li tista' tgħin biex tnaqqas ir-riskju ta' problemi kardjovaskolari fil-futur.
English: Because Tolura is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Maltese: Minħabba li Tolura huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċju u r-riskju tiegħu huma meqjusa li huma analogi għal dawk tal-mediċina ta' referenza.
English: How has Tolura been studied?
Maltese: Kif ġie studjat Tolura?
English: Tolura is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks.
Maltese: Tolura jintuża wkoll għall-prevenzjoni ta' problemi kardjovaskulari (problemi relatati mal-qalb u larterji u l-vini) bħalma huma l-attakki tal-qalb u l-puplesija.
English: Therefore, the CHMP's view was that, as for Micardis, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Miardis, ilbenefiċċji huma akbar mir-riskji identifikati.
English: Daklinza is available as 30, 60, and 90 mg tablets.
Maltese: Daklinza jiġi bħala pilloli ta' 30, 60 u 90 mg.
English: Around 99% of patients with genotype 1 infection (125 out of 126), 96% of patients with genotype 2 infection (25 out of 26) and 89% of patients with genotype 3 infection (16 out of 18) did not show any sign of the virus in their blood 12 weeks after the end of their planned treatment.
Maltese: Madwar 99% tal-pazjenti b'infezzjoni ta' ġenotip 1 (125 minn 126), 96% tal-pazjenti b'infezzjoni ta' ġenotip 2 (25 minn 26) u 89% tal-pazjenti b'infezzjoni ta' ġenotip 3 (16 minn 18) ma wrew l-ebda sinjal tal-virus f'demmhom 12-il ġimgħa wara t-tmiem tal-kura ppjanata tagħhom.
English: What are the risks associated with Daklinza?
Maltese: X'inhuma r-riskji assoċjati ma' Daklinza?
English: The full EPAR and risk management plan summary for Daklinza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Daklinza jistgħu jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Daklinza.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Daklinza.
English: Other information about Daklinza
Maltese: Informazzjoni oħra dwar Daklinza
English: By blocking this protein, the medicine stops the hepatitis C virus from multiplying.
Maltese: Billi timblokka din il-proteina, ilmediċina twaqqaf lill-virus tal-epatite Ċ milli jimmultiplika.
English: How does Daklinza work?
Maltese: Kif jaħdem Daklinza?
English: Daklinza must be used in combination with other medicines for chronic hepatitis C, such as sofosbuvir, peginterferon alfa and ribavirin.
Maltese: Daklinza għandu jintuża flimkien ma' mediċini oħrajn għal epatite Ċ kronika, bħal sofosbuvir, peginterferon alfa u ribavirin.
English: The active substance in Daklinza, daclatasvir, blocks the action of a protein in the hepatitis C virus called ‘NS5A', which is essential for the virus to multiply.
Maltese: Is-sustanza attiva f'Daklinza, id-daclatasvir, timblokka l-azzjoni ta' proteina fil-virus tal-epatite Ċ imsejħa ‘NS5A', li hija essenzjali sabiex il-virus jimmultiplika ruħu.
English: Most patients had not previously been treated for hepatitis C, though some had genotype 1 infection that was resistant to standard medicines (consisting of either telaprevir or boceprevir - the so-called NS3/4A inhibitors - in combination with peginterferon alfa and ribavirin).
Maltese: Il-biċċa l-kbira tal-pazjenti ma kinux ġew ikkurati qabel għal epatite Ċ, għalkemm xi wħud kellhom infezzjoni ta' ġenotip 1 li kienet reżistenti għal mediċini standard (li jikkonsistu minn telaprevir jew boceprevir - l-hekk imsejħa inibituri NS3/4A - flimkien ma' peginterferon alfa u ribavirin).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Daklinza on 22 August 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Daklinza fit-22 ta' Awwissu 2014.
English: Several varieties (genotypes) of hepatitis C virus exist and Daklinza is recommended for use in patients with virus of genotypes 1, 3 and 4.
Maltese: Jeżistu diversi varjetajiet (ġenotipi) tal-epatite Ċ u Daklinza huwa rrakkomandat għall-użu f'pazjenti bil-virus tal-ġenotipi 1, 3 u 4.
English: Additional studies involving patients with genotypes 4 indicate that Daklinza is also as effective against genotype 4 as it is against genotype 1.
Maltese: Studji addizzjonali li involvew pazjenti b'ġenotip 4 indikaw li Daklinza huwa wkoll effettiv kontra ġenotip 4 daqs kemm huwa kontra ġenotip 1.
English: The usual dose is 60 mg once a day for 12 or 24 weeks.
Maltese: Id-doża regolari hija 60 mg darba kuljum għal 12 jew 24 ġimgħa.
English: Daklinza is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
Maltese: Daklinza hija mediċina antivirali li tintuża flimkien ma' mediċini oħrajn biex tikkura epatite Ċ kronika (fit-tul), marda infettiva tal-fwied ikkawżata mill-virus tal-epatite Ċ.
English: Daklinza used in combination with sofosbuvir (with or without ribavirin) was effective at clearing the hepatitis C virus from the blood in a main study involving 211 adults.
Maltese: Daklinza użat flimkien ma' sofosbuvir (bir-ribavirin jew mingħajru) intwera li huwa effettiv fit-tneħħija tal-virus tal-epatite Ċ mid-demm fi studju ewlieni li involva 211-il adult.
English: The European Medicines Agency noted that Daklinza used in combination with other medicines was shown to be effective against hepatitis C virus, including in patients with genotype 1 resistant to previous treatment.
Maltese: L-Aġenzija Ewropea għall-Mediċini nnotat li Daklinza użat flimkien ma' mediċini oħrajn intwera li huwa effettiv kontra l-virus tal-epatite Ċ, inkluż f'pazjenti b'ġenotip 1 reżistenti għal kura preċedenti.