FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product, the European Commission therefore notified the CHMP/European Medicines Agency on 14 October 2015 of a referral under Article 30 of Directive 2001/83/EC for Vepesid and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise the product information across the EU.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti meħudin mill-Istati Membri fir-rigward talawtorizzazzjoni tal-prodott imsemmi hawn fuq, għalhekk fl-14 ta' Ottubru 2015, il-Kummissjoni Ewropea, innotifikat lis-CHMP/Aġenzija Ewropea għall-Mediċini dwar riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE għal Vepesid u l-ismijiet assoċjati sabiex jiġu riżolti diverġenzi fost linformazzjoni dwar il-prodott awtorizzata fuq livell nazzjonali u b'hekk tiġi armonizzata linformazzjoni dwar il-prodott madwar l-UE kollha.
English: The adult dosing section contains details on monotherapy, combination therapy, an alternative dosing schedule, and dosing adjustments for a low neutrophil count.
Maltese: Is-sezzjoni tad-dożaġġ għall-adulti fiha dettalji dwar il-monoterapija, it-terapija kombinata, skeda tad-dożaġġ alternattiv, u aġġustamenti fid-dożaġġ għal għadd ta' newtrofili baxx.
English: In section 4.3 of the SmPC Contraindications, the inclusions of hypersensitivity and concomitant use of live vaccines have been agreed as these are in line with the SmPC guidelines.
Maltese: Fis-sezzjoni 4.3 tal-SmPC Kontraindikazzjonijiiet, sar qbil fuq l-inklużjonijiet ta' sensittività eċċessiva u l-użu konkomitanti ta' vaċċini ħajjin peress li dawn huma konformi mal-linji gwida talSmPC.
English: With regards to lactation, etoposide is excreted in the milk (Medications and Mothers' Milk: Thomas W. Hale) and it has been included as a contraindication.
Maltese: Thomas W. Hale) u ġie inkluż bħala kontraindikazzjoni.
English: With regards to fertility, pregnancy and lactation, section 4.6 of the SmPC, information addressed to women of childbearing potential with regards to contraception in males and females was included.
Maltese: Fir-rigward tal-fertilità, it-tqala u t-treddigħ, is-sezzjoni 4.6 tal-SmPC, ġiet inkluża informazzjoni indirizzata lil nisa li jistgħu joħorġu tqal fir-rigward tal-kontraċezzjoni fl-irġiel u fin-nisa.
English: It contains the active substance degarelix.
Maltese: Fih is-sustanza attiva degarelix.
English: Other information about Firmagon:
Maltese: Informazzjoni oħra dwar Firmagon:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FIRMAGON EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) FIRMAGON Sommarju tal-EPAR għall-pubbliku
English: The active substance in Firmagon, degarelix, is a gonadotrophin-releasing hormone antagonist, which means that it blocks the effects of a natural hormone called gonadotrophin-releasing hormone (GnRH).
Maltese: Is-sustanza attiva f'Firmagon, degarelix, hija antagonista tal-ormon li jirrilaxxa l-gonadotrofina, jiġifieri jimblokka l-effetti ta' ormon naturali msejjaħ ormon li jirrilaxxa l-gonadotrofina (gonadotrophin-releasing hormone - GnRH).
English: Treatment starts with two 120-mg injections, followed by single 80-mg injections every month.
Maltese: It-trattament jibda b'żewġ injezzjonijiet ta' 120 mg, segwiti minn injezzjonijiet singoli ta' 80 mg kull xahar.
English: This was compared with 96% of patients receiving leuprorelin.
Maltese: Dan tqabbel ma' 96% ta' pazjenti li kienu qed jirċievu leuprorelin.
English: Firmagon was as effective as leuprorelin at reducing testosterone levels.
Maltese: Firmagon kien effettiv daqs leuprorelin fit-tnaqqis tal-livelli tat-testosteron.
English: This document is a summary of the European Public Assessment Report (EPAR).
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubblika Ewropew ta' Valutazzjoni (EPAR).
English: GnRH normally stimulates the pituitary gland at the base of the brain to produce two hormones which cause the testes to produce testosterone.
Maltese: Il-GnRH normalment jistimola l-glandola pitwitarja fil-bażi tal-moħħ biex tipproduċi żewġ ormoni li jġiegħlu lit-testikoli jipproduċu t-testosteron.
English: What is Firmagon?
Maltese: Kif jintuża Firmagon?
English: Therefore, the CHMP decided that Firmagon's benefits are greater than its risks for the treatment of adult male patients with advanced hormone-dependent prostate cancer.
Maltese: Għaldaqstant, is-CHMP ddeċieda li l-benefiċċji ta' Firmagon huma akbar mir-riskji tiegħu fil-kura ta' pazjenti rġiel adulti b'kanċer tal-prostata fi stat avvanzat dipendenti fuq l-ormoni.
English: During the first year, 97% of the patients receiving Firmagon at the approved dose of 80 mg once a month dose had testosterone levels below the required level.
Maltese: Matul l-ewwel sena, 97% tal-pazjenti li kienu qed jirċievu Firmagon fid-doża approvata ta' 80 mg darba fix-xahar kellhom livelli ta' testosteron inqas mil-livell meħtieġ.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Firmagon to Ferring Pharmaceuticals A/S on 17 February 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq madwar l-Unjoni Ewropea, għal Firmagon lil Ferring Pharmaceuticals A/S fi 17 ta' Frar 2009.
English: How has Firmagon been studied?
Maltese: Kif ġie studjat Firmagon?
English: PSA is a protein that is produced by the prostate gland and is often found at high levels in men with prostate cancer.
Maltese: PSA huwa proteina li tiġi prodotta mill-glandola tal-prostata u spiss tinstab f'livelli għoljin f'irġiel li jkollhom kanċer tal-prostata.
English: The Committee also noted that treatment with Firmagon does not trigger the temporary sharp rise in testosterone levels seen with ‘GnRH agonists' (other medicines for prostate cancer that stimulate the production of GnRH).
Maltese: Il-Kumitat innota wkoll li t-trattament b'Firmagon ma jagħtix bidu għal żieda f'daqqa temporanja fillivelli tat-testosteron li jidhru b'‘antagonisti GnRH' (mediċini oħrajn għall-kanċer tal-prostata li jistimulaw il-produzzjoni ta' GnRH).
English: What is the risk associated with Firmagon?
Maltese: X'inhu r-riskju assoċjat ma' Firmagon?
English: The Committee for Medicinal Products for Human Use (CHMP) noted that Firmagon was as effective as leuprorelin in the main study.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) innota li Firmagon kien effettiv daqs leuprorelin fl-istudju ewlieni.
English: Why has Firmagon been approved?
Maltese: Għaliex ġie approvat Firmagon?
English: Testosterone can make prostate cancer cells grow.
Maltese: It-testosteron jista' jkabbar iċ-ċelloli tal-kanċer tal-prostata.
English: What benefit has Firmagon shown during the studies?
Maltese: Liema benefiċċju wera Firmagon waqt l-istudji mwettqa?
English: Doctors should monitor the effectiveness of Firmagon treatment by looking at blood levels of testosterone and prostate-specific antigen (PSA).
Maltese: It-tobba għandhom jimmonitorjaw l-effikaċja tal-kura b'Firmagon billi josservaw il-livelli tad-demm tat-testosteron u tal-antiġen speċifiku tal-prostata (prostate-specific antigen - PSA).
English: ‘Advanced' means that the cancer has spread beyond the gland to some lymph nodes, but not to other organs.
Maltese: ‘Avvanzat' tfisser li l-kanċer infirex barra l-glandola għal xi nodi limfatiċi, iżda mhux għal organi oħra.
English: Firmagon can be used if the cancer is ‘hormone-dependent', which means that it responds to treatments that reduce the levels of the hormone testosterone.
Maltese: Firmagon jista' jintuża jekk il-kanċer huwa ‘dipendenti fuq l-ormoni', li jfisser li jwieġeb għal trattamenti li jnaqqsu l-livelli tal-ormon testosteron.
English: The company that makes Firmagon will make sure that educational materials are provided to all doctors in all Member States who will prescribe the medicine.
Maltese: Il-kumpanija li tipproduċi Firmagon ser tiżgura li materjal edukattiv jingħata lit-tobba kollha fl-Istati Membri kollha li ser jippreskrivu din il-mediċina.
English: Similar results were seen in patients receiving Firmagon at the higher dose of 160 mg once a month.
Maltese: Riżultati simili dehru f'pazjenti li kienu qed jirċievu Firmagon fid-doża ogħla ta' 160 mg darba fix-xahar.
English: The effects of Firmagon were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Firmagon l-ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbnedmin.
English: The most common side effects with Firmagon (seen in more than 1 patient in 10) are hot flushes and problems at the injection site such as pain and redness.
Maltese: L-iktar effetti sekondarji komuni b'Firmagon (li dehru f'iktar minn pazjent 1 minn kull 10) huma fwawar u problemi fil-post tal-injezzjoni bħalma huma uġigħ u ħmura.
English: Firmagon is used to treat patients with advanced prostate cancer.
Maltese: Firmagon jintuża għall-kura ta' pazjenti b'kanċer tal-prostata fi stat avvanzat.
English: For the full list of all side effects reported with Firmagon, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrapportati b'Firmagon, ara l-Fuljett ta' Tagħrif.
English: This summary was last updated in 01-2009.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Jannar 2009.
English: Firmagon is a powder and solvent that are made up into a solution for injection.
Maltese: Firmagon huwa trab u solvent li meta jitħalltu jsiru soluzzjoni għall-injezzjoni.
English: Two doses of Firmagon have been compared with leuprorelin in one main study involving 610 men with prostate cancer at all stages of the disease.
Maltese: Żewġ dożi ta' Firmagon tqabblu ma' leuprorelin fi studju wieħed ewlieni li kien jinvolvi 610 irġiel bilkanċer tal-prostata f'kull stadju tal-marda.
English: Further information on Rapamune can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni fuq Rapamune tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Rapamune is available as an oral solution (1 mg/ml) and tablets (0.5, 1 and 2 mg).
Maltese: Rapamune jiġi bħala soluzzjoni orali (1 mg/ml) u pilloli (0.5 mg, 1 u 2 mg).
English: The most common side effects with Rapamune (which may affect more than 1 in 10 people) are infections, fever, slow wound healing, low counts of various blood cells, blood tests showing altered levels of various substances (including low potassium and phosphate; raised fats, cholesterol, glucose and markers for tissue breakdown and for liver and kidney function), diabetes, lymphocele (collection of lymph fluid usually in the lower belly), pain in various parts of the body, rapid heartbeat, raised blood pressure, problems affecting the gut, proteinuria (protein in the urine), menstrual disorders, oedema (swelling because of fluid build-up), rash and acne.
Maltese: L-effetti sekondarji l-aktar komuni b'Rapamune (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjonijiet, deni, fejqan bil-mod tal-feriti, għadd baxx ta' diversi ċelloli tad-demm, testijiet tad-demm li juru livelli mibdula ta' diversi sustanzi (inkuż potassju u fosfat baxx; żieda fix-xaħam, filkolesterol, fil-glukożju u markaturi għat-tkissir tat-tessut u għall-funzjoni tal-fwied u tal-kliewi), dijabete, linfoċele (ġbir ta' fluwidi tal-limfi, normalment fil-parti t'isfel taż-żaqq), uġigħ f'diversi partijiet tal-ġisem, taħbit tal-qalb mgħaġġel, żieda fil-pressjoni tad-demm, problemi li jaffettwaw il-musrana, proteinurja (proteina fl-awrina), disturbi mestruwali, edema (nefħa minħabba akkumulazzjoni ta' fluwidu), raxx u akne.
English: Rapamune contains the active substance sirolimus.
Maltese: Rapamune fih is-sustanza attiva sirolimus.
English: Treatment of S-LAM
Maltese: Kura ta' S-LAM
English: Rapamune received a marketing authorisation valid throughout the EU on 14 March 2001.
Maltese: Rapamune rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-14 ta' Marzu 2001.
English: Other information about Rapamune
Maltese: Informazzjoni oħra dwar Rapamune
English: The active substance in Rapamune, sirolimus, is an immunosuppressant (a medicine that reduces the activity of the immune system).
Maltese: Is-sustanza attiva f'Rapamune, is-sirolimus, hija immunosoppressant (mediċina li tnaqqas l-attività tas-sistema immunitarja).
English: In the second study, treatment failed in 30% (68 out of 277) of the patients adding Rapamune, compared with 48% (62 out of 130) of those adding placebo.
Maltese: Fit-tieni studju, il-kura falliet fi 30 % (68 minn 277) tal-pazjenti li żiedu Rapamune, meta mqabbel ma' 48 % (62 minn 130) ta' dawk li żiedu plaċebo.
English: Rapamune was more effective than placebo (a dummy treatment) or azathioprine (another immunosuppressive medicine) in two main studies involving a total of 1,295 patients who were having a kidney transplant.
Maltese: Rapamune kien aktar effettiv minn plaċebo (kura finta) jew azathioprine (mediċina immunosoppressiva oħra) f'żewġ studji ewlenin li involvew total ta' 1,295 pazjent li kien qiegħed isirilhom trapjant talkliewi.
English: In the first study, treatment failed in 19% (53 out of 284) of the patients adding Rapamune after 6 months, compared with 32% (52 out of 161) of those adding azathioprine.
Maltese: Fl-ewwel studju, il-kura falliet fi 19 % (53 minn 284) talpazjenti li żiedu Rapamune wara 6 xhur, meta mqabbel ma' 32 % 52 minn 161) ta' dawk li żiedu azathioprine.
English: This complex then blocks another protein called ‘mammalian target of rapamycin' (mTOR).
Maltese: Dan il-kumpless imbagħad jimblokka proteina oħra msejħa "mira mammifera ta' rapamicin" (mTOR).
English: Two additional studies looked at Rapamune as continuing treatment for up to 5 years in 765 patients who were able to stop ciclosporin after 2 to 3 months.
Maltese: Żewġ studji addizzjonali ħarsu lejn Rapamune bħala kontinwazzjoni ta' kura sa 5 snin f'765 pazjent li setgħu jwaqqfu ċiklosporina wara xahrejn sa 3 xhur.
English: What are the risks associated with Rapamune?
Maltese: X'inhuma r-riskji assoċjati ma' Rapamune?
English: Since mTOR is involved in the multiplication of activated T-lymphocytes (white blood cells that are responsible for attacking the transplanted organ), Rapamune reduces the number of these cells, reducing the risk of organ rejection.
Maltese: Minħabba li mTOR hija involuta fil-multiplikazzjoni ta' linfoċiti-T attivati (ċelloli bojod tad-demm li huma responsabbli biex jattakkaw l-organu trapjantat), Rapamune jnaqqas innumru ta' dawn iċ-ċelloli, b'hekk jitnaqqas ir-riskju tar-rifjut tal-organu.
English: Rapamune was more effective than placebo in improving lung function in a study involving 81 patients with S-LAM.
Maltese: Rapamune kien aktar effettiv minn plaċebo fit-titjib tal-funzjoni tal-pulmun fi studju li involva 81 pazjent b'S-LAM.
English: As for all medicines, data on the use of Rapamune are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Rapamune hija ssorveljata kontinwament.
English: To treat patients with S-LAM, the dose of Rapamune is 2 mg daily and after 10 to 20 days the doctor will adjust the dose to achieve appropriate levels of sirolimus in the patient's blood.
Maltese: Biex jiġu kkurati pazjenti b'S-LAM, id-doża ta' Rapamune hija 2 mg kuljum u wara 10 sa 20 jum, ittabib ser jaġġusta d-doża sabiex jinkisbu l-livelli xierqa ta' sirolimus fid-demm tal-pazjent.
English: To prevent organ rejection, the first dose is usually 6 mg given soon after the transplantation followed by 2 mg once a day.
Maltese: Biex jiġi evitat ir-rifjut tal-organi, l-ewwel doża tkun normalment ta' 6 mg li tingħata ftit ħin wara ttrapjant segwita minn 2 mg darba kuljum.
English: How does Rapamune work?
Maltese: Kif jaħdem Rapamune?
English: Rapamune is also used for treating patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or worsening lung function.
Maltese: Rapamune jintuża wkoll biex jikkura pazjenti b'limfanġjolejomijomatożi sporadika (S-LAM) b'marda moderata tal-pulmun jew b'funzjoni tal-pulmun li qed tiggrava.
English: It is used in adults who are at a low to moderate risk of rejection.
Maltese: Dan jintuża fl-adulti li huma f'riskju ta' rifjut baxx għal moderat.
English: What measures are being taken to ensure the safe and effective use of Rapamune?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Rapamune?
English: For the full list of side effects and restrictions of Rapamune, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Rapamune, ara l-fuljett ta' tagħrif.
English: FEV1 improved by an average of 1 ml per month in patients treated with Rapamune compared with a worsening by 12 ml per month in patients receiving placebo.
Maltese: FEV1 tjieb b'medja ta' 1 ml fix-xahar f'pazjenti kkurati b'Rapamune meta mqabbel ma' aggravar bi 12-il ml fix-xahar f'pazjenti li rċivew plaċebo.
English: All patients were also treated with ciclosporin and corticosteroids and were at low to moderate risk of rejection.
Maltese: Il-pazjenti kollha ġew ikkurati wkoll b'ċiklosporina u b'kortikosterojdi u kienu f'riskju ta' rifjut baxx sa moderat.
English: It is recommended that Rapamune is used with ciclosporin and corticosteroids (other medicines to prevent organ rejection) for two to three months.
Maltese: Huwa rrakkomandat li Rapamune jintuża ma' ċiklosporina u kortikosterojdi (mediċini oħrajn biex jipprevjenu r-rifjut talorgani) għal xahrejn sa tliet xhur.
English: In the body, sirolimus attaches to a protein inside cells to make a ‘complex'.
Maltese: Fil-ġisem, is-sirolimus jeħel ma' proteina li tinsab fiċ-ċelloli biex tifforma "kumpless".
English: The Agency noted that no medicinal product has been approved for the treatment of S-LAM and Rapamune's effect on lung function is considered important.
Maltese: L-Aġenzija nnutat li l-ebda prodott mediċinali ma ġie approvat għall-kura ta' S-LAM u l-effett ta' Rapamune fuq il-funzjoni tal-pulmun jitqies importanti.
English: The Agency decided that Rapamune's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija ddeċidiet li l-benefiċċji ta' Rapamune huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: The European Medicines Agency considered that Rapamune is effective for the prevention of rejection of a transplanted kidney in patients at low to moderate risk of rejection.
Maltese: L-Aġenzija Ewropea għall-Mediċini qieset li Rapamune huwa effettiv għall-prevenzjoni tar-rifjut ta' kilwa trapjantata f'pazjenti b'riskju baxx sa moderat ta' rifjut.
English: The main measure of effectiveness was the number of treatment failures (rejection or loss of the new kidney, or death) after 6 months.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' fallimenti ta' kura (rifjut jew telf talkilwa l-ġdida, jew mewt) wara 6 xhur.
English: Tibolona Aristo
Maltese: Tibolona Aristo 2.5 mg
English: Germany
Maltese: Stat Membru
English: The full EPAR for Tesavel 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: Tesavel is a medicine that contains the active substance sitagliptin.
Maltese: Tesavel huwa mediċina li fiha s-sustanza attiva sitagliptina.
English: The active substance in Tesavel, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Maltese: Is-sustanza attiva f'Tesavel, is-sitagliptina, hija inibitur tad-dipeptidil-peptidażi-4 (DPP 4).
English: Serious side effects reported with Tesavel include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Maltese: L-effetti sekondarji serji li ġew irrapportarti bl-użu ta' Tesavel inkludew pankreatite (infjamazzjoni talfrixa) u ipersensittività (reazzjonijiet allerġiċi).
English: This is a summary of the European public assessment report (EPAR) for Tesavel.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Tesavel.
English: Tesavel is taken at a dose of 100 mg once a day.
Maltese: Tesavel jittieħed f'doża ta' 100 mg darba kuljum.
English: • three additional studies compared Tesavel with placebo when they were added to other antidiabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.
Maltese: • tliet studji oħra qabblu lil Tesavel ma' plaċebo meta żdiedu ma' mediċini oħrajn kontra d-dijabete: il-glimepiride (sulfonilurea oħra), bil-metformina jew mingħajrha, fuq 441 pazjent; it-taħlita talmetformina u r-rosiglitażonu (agonista PPAR gamma) fuq 278 pazjent; u doża stabbli ta' insulina, bil-metformina jew mingħajrha, fuq 641 pazjent.
English: Tesavel or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;
Maltese: Tesavel jew plaċebo ntużaw waħedhom f'żewġ studji fuq 1,262 pazjent, bħala żieda mal-metformina fi studju wieħed fuq 701 pazjent, u bħala żieda mal-pijoglitażonu (agonista PPAR-gamma) fi studju fuq 353 pazjent;
English: In patients taking Tesavel on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks.
Maltese: F'pazjenti li ngħataw Tesavel waħdu, il-livelli tal-HbA1c naqsu minn madwar 8.0% fil-bidu talistudji b'0.48% wara 18-il ġimgħa u b'0.61% wara 24 ġimgħa.
English: Finally, they were reduced by 0.59% in patients adding Tesavel to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Maltese: Fl-aħħar nett, tnaqqsu b'0.59% f'pazjenti li żiedu Tesavel mal-insulina (bil-metformina jew mingħajrha), apparagun ma' tnaqqis ta' 0.03% f'dawk li żiedu l-plaċebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tesavel on 10 January 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tesavel fl-10 ta' Jannar 2008.
English: HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Tesavel to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Maltese: Il-livelli tal-HbA1c tnaqqsu b'1.03% wara 18-il ġimgħa f'pazjenti li żiedu Tesavel malmetformina u r-rosiglitażonu, apparagun ma' tnaqqis ta' 0.31% f'dawk li żiedu l-plaċebo.
English: • four of the studies compared Tesavel with placebo (a dummy treatment).
Maltese: • erbgħa minn dawn l-istudji qabblu lil Tesavel ma' plaċebo (trattament finta).
English: One study compared Tesavel with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients.
Maltese: Studju minnhom qabbel lil Tesavel mal-glipiżide (sulfonilurea), meta ntużaw bħala żieda mal-metformina fuq 1,172 pazjent.
English: Adding Tesavel to metformin reduced HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Maltese: Biż-żieda ta' Tesavel mal-metformina, il-livelli talHbA1c tnaqqsu b'0.67% wara 24 ġimgħa, apparagun ma' tnaqqis ta' 0.02% f'pazjenti li żiedu l plaċebo.
English: Why has Tesavel been approved?
Maltese: Għaliex ġie approvat Tesavel?
English: When added to pioglitazone, Tesavel reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
Maltese: Meta żdied mal-pijoglitażonu, Tesavel naqqas il-livelli tal-HbA1c b'0.85% wara 24 ġimgħa, apparagun ma' tnaqqis ta' 0.15% f'pazjenti li żiedu l-plaċebo.
English: The other study compared Tesavel with metformin, used on their own, in 1,058 patients;
Maltese: L-istudju l-ieħor qabbel lil Tesavel mal-metformina, użati waħedhom, fuq 1,058 pazjent;
English: What is the risk associated with Tesavel?
Maltese: Għal xiex jintuża Tesavel?
English: What is Tesavel?
Maltese: X'inhu Tesavel?