FrancophonIA/ELRC3.0 huggingface dataset:
English: Onset and duration of protection for the seronegative cattle form 2 weeks of age is 2 weeks and 6 months respectively after completion of the primary vaccination
Maltese: Il-bidu u t-tul tal-protezzjoni għall-frat seronegattivi mill-età ta' ġimagħtejn huma ġimagħtejn u 6 xhur rispettivament wara t-tlestija tat-tilqima primarja
English: In the past initially epidemiological information and then rapidly increasing pharmacovigilance data documented an increase of the frequency of this alloimmune reaction between the dam and the foetus and finally a close relationship between the occurrences of BNP and the repeated vaccination of dams with PregSure BVD was established.
Maltese: Fil-passat l-informazzjoni epidemjoloġika tal-bidu u wara d-data ta' farmakoviġilanza li dejjem tiżdied b'rata mgħaġġla ddokumentaw żieda fil-frekwenza ta' din ir-reazzjoni alloimmunitarja bejn lomm u l-fetu u finalment ġiet stabbilita relazzjoni mill-qrib bejn l-okkorrenzi tal-BNP u t-tilqim ripetut tal-ommijiet bi PregSure BVD.
English: The potential risk of recurrence of BNP linked to the use of this vaccine in pregnant cows has been addressed by the MAH; however Germany considered that the proposed handling of the risks was inadequate and that a large scale post authorisation study should be initiated by the MAH.
Maltese: Ir-riskju potenzjali ta' rikorrenza tal-BNP relatat mal-użu ta' dan il-vaċċin f'baqar tqal ġie indirizzat mill-MAH; madankollu il-Ġermanja kkunsidrat li l-ġestjoni proposta tar-riskji kienet inadegwata u li għandu jinbeda studju ta' wara l-awtorizzazzjoni fuq skala kbira mill-MAH.
English: • The marketing authorisation holder shall conduct a controlled laboratory study to confirm that hyperimmunisation of cattle with CattleMarker IBR Inactivated does not induce a significant alloantibody response to MHC-I and MDBK cells and also to assess if vaccination with other cattle vaccines produced on bovine cell lines and with high amount of ANAS followed by booster with CattleMarker IBR Inactivated leads to a significant increase in alloantibody titres against MHC-I and MDBK cells.
Maltese: • Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jwettaq studju biex jivvaluta l-booster potenzjali ta' CattleMarket IBR Inactivated fuq kwalunkwe MHC jew rispons ta' alloantikorpi opsonizzanti fi frat li kienu mlaqqma qabel bi PregSure BVD.
English: • The marketing authorisation holder shall include a new specification in the finished product of a maximum total protein content.
Maltese: • Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jinkludi speċifikazzjoni ġdida fil-prodott lest ta' kontenut ta' proteini totali massimu.
English: • The marketing authorisation holder shall implement a single risk management plan addressing the following risk mitigation and surveillance measures:
Maltese: • Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jimplimenta pjan uniku ta' ġestjoni tar-riskju li jindirizza l-miżuri ta' mitigazzjoni u sorveljanza tar-riskju li ġejjin:
English: − Provide a contingency plan in the unlikely circumstance that BNP reports occur that involve CattleMarker IBR Inactivated vaccinated dams.
Maltese: − Li jiġi pprovdut pjan ta' kontinġenza fiċ-ċirkustanza improbabbli li jseħħu rapporti ta' BNP li jinvolvu ommijiet frat imlaqqma b'CattleMarket IBR Inactivated.
English: • to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.
Maltese: • biex titnaqqas l-inċidenza tal-aborti assoċjati mal-infezzjonijiet tal-BoHV-1 kif intwera matul it-tieni trimestru tal-ġestazzjoni ta' wara l-isfida.
English: Evaluation of the overall benefit-risk balance
Maltese: Miżuri għall-ġestjoni tar-riskju
English: A large scale post-marketing prospective survey is deemed less effective to identify whether the level of BNP is acceptable when compared with the surveillance and monitoring strategy proposed, because the number of animals to be enrolled in such a study would exceed several thousands of animals (due to the estimated BNP frequency of around 0.01%) and the time span anticipated for BNP cases to occur consecutive to vaccination would not be shorter.
Maltese: Stħarriġ prospettiv ta' wara t-tqegħid fis-suq fuq skala kbira huwa meqjus inqas effettiv biex jidentifika jekk il-livell ta' BNP huwiex aċċettabbli meta mqabbel mal-istrateġija ta' sorveljanza u ta' monitoraġġ proposta, peress li n-numru ta' annimali li għandhom jiġu rreġistrati fi studju bħal dan se jaqbeż diversi eluf ta' annimali (minħabba l-frekwenza ta' BNP stmata ta' madwar 0.01%) u lperjodu ta' żmien antiċipat għall-każijiet ta' BNP li se jseħħ konsekuttiv għat-tilqim mhux se jkun iqsar.
English: Data have been provided to demonstrate the efficiency of the filtration step.
Maltese: Ġiet ipprovduta data biex turi l-effiċjenza tal-istadju tal-filtrazzjoni.
English: − Prior to launch of the vaccine on the market and annually thereafter, provide specific training to the bovine sales and technical teams on the CattleMarker IBR Inactivated product safety profile, BNP and pharmacovigilance obligations.
Maltese: − Qabel ma l-vaċċin jitqiegħed fis-suq u kull sena wara li jseħħ dan, jiġi pprovdut taħriġ speċifiku lit-timijiet tal-bejgħ tal-bovini u tekniċi dwar il-profil tas-sigurtà tal-prodott CattleMarket IBR Inactivated, il-BNP u l-obbligi ta' farmakoviġilanza.
English: CattleMarker IBR Inactivated fulfils the criteria for an effective IBR marker vaccine and provides the full therapeutic benefit.
Maltese: CattleMarket IBR Inactivated jissodisfa l-kriterji għal vaċċin markatur tal-IBR effettiv u jipprovdi benefiċċju terapewtiku sħiħ.
English: During the MRP Germany raised a concern about the immunological safety of CattleMarker IBR Inactivated, as the composition of this product is similar to PregSure BVD, a vaccine which has been shown to induce a long-lasting allogeneic antibody response which has been associated with Bovine Neonatal Pancytopenia (BNP), a neonatal alloimmune disease, in the progeny of vaccinated dams.
Maltese: CattleMarket IBR Inactivated għandu l-istess aġġuvant Procision-A bħal PregSure BVD u lproduzzjoni tal-virus tuża wkoll linja ta' ċelloli tal-kliewi derivata mill-bovini (MDBK). L-assoċjazzjoni bejn il-BNP u r-reazzjoni alloimmunitarja għal Antiġeni Mhux relatati mas-Sustanza Attiva (ANAS) (eż. linja ta' ċelloli tal-kliewi tal-bovini derivata minn antiġeni u s-sustanzi antiġeniċi kollha li jifdal millproċess ta' manifattura) hija aċċettata b'mod ġenerali.
English: BNP is a disease which can be fatal in neonatal calves and which has been experimentally reproduced by the intake of colostrum from dams which have alloantibodies.
Maltese: BNP hija marda li tista' tkun fatali f'għoġġiela tat-twelid u li ġiet riprodotta b'mod esperimentali millkonsum tal-kolostru mill-ommijiet li għandhom alloantikorpi.
English: CattleMarker IBR Inactivated could induce BNP is significantly lower than this for PregSure BVD;
Maltese: Inactivated jistgħu jikkaġunaw BNP huwa ferm iktar baxx minn dan fi PregSure BVD;
English: The product is indicated for active immunisation of seronegative cattle from 2 weeks of age to reduce the clinical signs (pyrexia and depression) of IBR and the duration of virus shedding caused by BoHV-1 infection.
Maltese: Dan il-prodott huwa indikat għat-tilqim attiv ta' frat seronegattivi mill-età ta' ġimagħtejn biex jitnaqqsu s-sinjali kliniċi (piressija u dipressjoni) tal-IBR u t-tul ta' żmien tat-tixrid tal-virus ikkawżat mill-infezzjoni BoHV-1.
English: In 2010, due to these concerns, a procedure under Article 78 of Directive 2001/82/EC was initiated in which the CVMP concluded that although the aetiology of BNP had yet to be determined there was evidence to suggest that PregSure BVD may be associated with BNP and that the benefit-risk balance for the product was unfavourable.
Maltese: Fl-2010, minħabba dan it-tħassib, inbdiet proċedura skont l-Artikolu 78 tad-Direttiva 2001/82/KE li fiha s-CVMP ikkonkluda li għalkemm l-etjoloġija tal-BNP kienet għadha trid tiġi ddeterminata kien hemm evidenza li tissuġġerixxi li PregSure BVD jista' jiġi assoċjat ma' BNP u li lbilanċ ta' benefiċċju-riskju għal dan il-prodott ma kienx favorevoli.
English: − In addition to the usual pharmacovigilance system for the monitoring of animals vaccinated with CattleMarker IBR Inactivated, to conduct thorough investigations for any unexplained mortality in the offspring of vaccinated animals following documented use of CattleMarker IBR Inactivated.
Maltese: − Minbarra s-sistema ta' farmakoviġilanza tas-soltu għall-monitoraġġ ta' annimali mlaqqma b'CattleMarker IBR Inactivated, li jitwettqu investigazzjonijiet bir-reqqa għal kwalunkwe mewta mhux spjegata fil-frieħ ta' annimali mlaqqma wara l-użu dokumentat ta' CattleMarket IBR
English: EMA/393112/2018 EMEA/H/C/004124
Maltese: EMA/393112/2018 EMA/H/C/004124
English: Further information on Tagrisso 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: Tagrisso is available as 40 and 80 mg tablets.
Maltese: Tagrisso jiġi bħala pilloli ta' 40 u 80 mg.
English: It contains the active substance osimertinib.
Maltese: Dan fih is-sustanza attiva osimertinib.
English: This was switched to a full marketing authorisation on 24 April 2017.
Maltese: Din inqelbet għal awtorizzazzjoni għat-tqegħid fis-suq sħiħa fl-24 ta' April 2017.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Maltese: Peress li l-kumpanija forniet l-informazzjoni addizzjonali meħtieġa, l-awtorizzazzjoni nqelbet minn kondizzjonali għal approvazzjoni sħiħa.
English: Tagrisso received a conditional marketing authorisation valid throughout the EU on on 2 February 2016.
Maltese: Tagrisso rċieva awtorizzazzjoni kondizzjonali għat-tqegħid fis-suq valida fl-UE kollha fit-2 ta' Frar 2016.
English: Other information about Tagrisso
Maltese: Informazzjoni oħra dwar Tagrisso
English: Finally, in a study of 556 patients with activating mutations, patients taking Tagrisso as a first treatment lived for 18.9 months without their disease getting worse compared with 10.2 months in patients receiving treatment with other medicines (either erlotinib or gefitinib).
Maltese: Fl-aħħar nett, fi studju ta' 556 pazjent b'mutazzjonijiet attivanti, il-pazjenti li ħadu Tagrisso bħala lewwel kura għexu għal 18.9 xhur mingħajr ma l-marda tagħhom aggravat meta mqabbel ma' 10.2 xhur f'pazjenti li rċivew kura b'mediċini oħrajn (jew erlotinib jew gefitinib).
English: The active substance in Tagrisso, osimertinib, is a type of cancer medicine called tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Tagrisso, l-osimertinib, hija tip ta' mediċina kontra l-kanċer msejħa inibitur ta' kinażi tat-tirożina.
English: The most common side effects with Tagrisso (which may affect more than 1 in 10 people) are diarrhoea, rash, dry skin, paronychia (nail bed infection), itching, stomatitis (inflammation of the lining of the mouth) and a decrease in the levels of white blood cells and platelets.
Maltese: L-effetti sekondarji l-aktar komuni ta' Tagrisso (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma dijarea, raxx, ġilda xotta, paronkija (infezzjoni fil-bażi tad-dwiefer), ħakk, stomatite (infjamazzjoni tal-kisja tal-ħalq) u tnaqqis fil-livelli ta' ċelluli bojod tad-demm u ta' pjastrini.
English: In patients with T790 mutation, the medicine may be given after other treatments.
Maltese: Fil-pazjenti bil-mutazzjoni T790, il-mediċina tista' tingħata wara kuri oħrajn.
English: What are the risks associated with Tagrisso?
Maltese: X'inhuma r-riskji assoċjati ma' Tagrisso?
English: As for all medicines, data on the use of Tagrisso are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Tagrisso hija ssorveljata kontinwament.
English: In two studies involving 411 previously treated patients who had T790 mutations, the overall response rates (the proportion of patients whose tumours shrank) with Tagrisso was 66% and the average length of time the response lasted was 12.5 months.
Maltese: F'żewġ studji li kienu jinvolvu 411-il pazjent li kellhom mutazzjonijiet T790 li ġew ikkurati qabel, ir-rati tar-rispons globali (il-proporzjon ta' pazjenti li t-tumuri tagħhom ċkienu) b'Tagrisso kien 66 % u t-tul medju taż-żmien li dam ir-rispons kien 12.5 xhur.
English: How is Tagrisso used?
Maltese: Tagrisso?
English: It blocks the activity of EGFR, which normally controls growth and division of cells.
Maltese: Din timblokka l-attività tal-EGFR, li normalment tikkontrolla t-tkabbir u d-diviżjoni taċ-ċelluli.
English: Tagrisso was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Maltese: Oriġinarjament, Tagrisso ngħata ‘approvazzjoni kondizzjonali' minħabba li kien għad hemm iktar evidenza x'tingħata dwar il-mediċina.
English: For the full list of restrictions and side effects with Tagrisso, see the package leaflet.
Maltese: Għal-lista sħiħa tar-restrizzjonijiet u tal-effetti sekondarji ta' Tagrisso, ara l-fuljett ta' tagħrif.
English: A third study in 419 previously treated patients with T790 mutations looked mainly at how effective Tagrisso was at preventing the cancer from worsening, comparing it with a platinum-based chemotherapy (the standard treatment for NSCLC).
Maltese: It-tielet studju f'419-il pazjent b'mutazzjonijiet T790 li ġew ikkurati qabel ħares prinċipalment lejn kemm kien effettiv Tagrisso fil-prevenzjoni milli l-kanċer ikompli jaggrava, fejn tqabbel ma' kimoterapija bbażata fuq il-platinu (il-kura standard għal NSCLC).
English: Tagrisso is medicine for treating a lung cancer called non-small cell lung cancer (NSCLC) when the cancer is advanced or has spread.
Maltese: Tagrisso huwa mediċina għall-kura ta' kanċer tal-pulmun imsejjaħ kanċer tal-pulmun b'ċelluli mhux żgħar (NSCLC, non-small-cell lung cancer) meta l-kanċer ikun avvanzat jew infirex.
English: Tagrisso must not be used together with St. John's wort (a herbal preparation used to treat depression).
Maltese: Tagrisso m'għandux jintuża flimkien ma' St John's wort (preparazzjoni erbali li tintuża fil-kura taddipressjoni).
English: Side effects reported with Tagrisso are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati ma' Tagrisso huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Regarding safety, the adverse effects with Tagrisso are similar to other medicines of the same class and are considered acceptable.
Maltese: Rigward issigurtà, l-effetti avversi b'Tagrisso huma simili għal mediċini oħrajn tal-istess klassi u huma kkunsidrati aċċettabbli.
English: Tagrisso has been shown to be effective at shrinking tumours in patients with NSCLC and at slowing down the worsening of the cancer.
Maltese: Tagrisso ntwera li huwa effettiv biex iċekken it-tumuri f'pazjenti b'NSCLC u biex inaqqas ir-ritmu talaggravar tal-kanċer.
English: Further information on Steglatro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Steglatro tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Steglatro is available as tablets (5 and 15mg).
Maltese: Steglatro jiġi bħala pilloli (5 u 15 mg).
English: Steglatro contains the active substance ertugliflozin.
Maltese: Steglatro fih is-sustanza attiva ertugliflozin.
English: Other information about Steglatro
Maltese: Informazzjoni oħra dwar Steglatro
English: A lower dose of ertugliflozin 5 mg was less effective.
Maltese: Doża aktar baxxa ta' ertugliflozin 5 mg kienet inqas effettiva.
English: HbA1c levels fell by 0.6 points with ertugliflozin and 0.7 points with glimepiride.
Maltese: Il-livelli ta' HbA1c naqsu b'0.6 punti bl-ertugliflozin u b'0.7 punti bi glimepiride.
English: • A sixth study found that adding the combination of ertugliflozin and sitagliptin to diet and exercise was much more effective than placebo, with HbA1c levels falling by between 1.6 and 1.7 points with the combination of ertugliflozin and sitagliptin compared with a fall of 0.4 points with placebo.
Maltese: • Is-sitt studju sab li ż-żieda tal-kombinazzjoni tal-ertugliflozin u sitagliptin mad-dieta u mależerċizzju kienet ħafna aktar effettiva mill-plaċebo, bil-livelli ta' HbA1c jonqsu bejn 1.6 u 1.7 punti bil-kombinazzjoni tal-ertugliflozin u sitagliptin meta mqabbel ma' tnaqqis ta' 0.4 punti bil-plaċebo.
English: HbA1c levels fell by between 0.8 and 0.9 points when ertugliflozin was added, compared with a fall of 0.1 with placebo.
Maltese: Il-livelli ta' HbA1c naqsu b'bejn 0.8 u 0.9 punti meta żdied ertugliflozin, meta mqabbel ma' tnaqqis ta' 0.1 bil-plaċebo.
English: • A third study found that a combination of ertugliflozin at a 15 mg dose with metformin was about as effective as a combination of metformin with another diabetes medicine, glimepiride.
Maltese: • It-tielet studju sab li kombinazzjoni tal-ertugliflozin b'doża ta' 15 mg mal-metformina kienet kważi effettiva daqs kombinazzjoni tal-metmorfina ma' mediċina tad-dijabete oħra, glimepiride.
English: What are the risks associated with Steglatro?
Maltese: X'inhuma r-riskji assoċjati ma' Steglatro?
English: • A study of ertugliflozin on its own, showed that levels of HbA1c (a measure of blood glucose) fell by between 0.8 points and 1 point in patients who took the medicine compared with a rise of 0.2 points in patients receiving placebo (a dummy treatment).
Maltese: • Studju tal-ertugliflozin waħdu, wera li l-livelli ta' HbA1c (kejl tal-glukożju fid-demm) naqsu b'bejn 0.8 punti u punt 1 f'pazjenti li ħadu l-mediċina meta mqabbel ma' żieda ta' 0.2 punti f'pazjenti li kienu qegħdin jirċievu l-plaċebo (kura finta).
English: It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.
Maltese: Din tagħmel dan billi timblokka proteina fil-kliewi (imsejħa SGLT2) li normalment tieħu l-glukożju lura fid-demm mill-kliewi.
English: • A second study found that in patients taking a combination of ertugliflozin and metformin, HbA1c levels fell by around 0.8 points, compared with reductions of 0.03 when placebo was added to metformin.
Maltese: • It-tieni studju sab li f'pazjenti li kienu qegħdin jieħdu kombinazzjoni tal-ertugliflozin u talmetformina, il-livelli ta' HbA1c naqsu b'madwar 0.8 punti, meta mqabbel ma' tnaqqis ta' 0.03 meta l-plaċebo żdied mal-metformina.
English: The most common side effects with Steglatro (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system.
Maltese: L-effetti sekondarji l-aktar komuni bi Steglatro (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjonijiet fungali tal-vaġina u infezzjonijiet oħra tas-sistema riproduttiva tal-mara.
English: At the start of the studies, patients' HbA1c was above 7 percentage points.
Maltese: Fil-bidu tal-istudju, HbA1c tal-pazjenti kienet 'il fuq minn 7 punti perċentwali.
English: As for all medicines, data on the use of Steglatro is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Steglatro hija ssorveljata kontinwament.
English: For the full list of side effects and restrictions with Steglatro, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet bi Steglatro, ara l-fuljett ta' tagħrif.
English: Steglatro is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes together with diet and exercise.
Maltese: Steglatro huwa mediċina li tintuża biex tikkontrolla l-livelli tal-glukożju (taz-zokkor) fid-demm f'adulti b'dijabete tat-tip 2 flimkien ma' dieta u eżerċizzju.
English: Rare cases of diabetic ketoacidosis, a serious condition where the patient has very high blood acid levels, may occur in up to 1 in 1,000 patients.
Maltese: Każijiet rari ta' ketoaċidożi dijabetika, kondizzjoni serja fejn il-pazjent ikollu livelli għoljin ħafna ta' aċidu fid-demm, jistgħu jseħħu f'sa pazjent 1 minn kull 1,000.
English: HbA1c levels fell by a further 0.5 points when both medicines were added to metformin.
Maltese: Il-livelli ta' HbA1c naqsu b'0.5 punti oħra meta ż-żewġ mediċini żdiedu mal-metmorfina.
English: • A seventh study showed that ertugliflozin was not more effective than placebo in patients with moderate kidney impairment.
Maltese: • Is-seba' studju wera li l-ertugliflozin ma kinitx aktar effettiv mill-plaċebo f'pazjenti b'indeboliment tal-kliewi moderat.
English: How is Steglatro used?
Maltese: Steglatro?
English: • A fifth study found that adding ertugliflozin to a combination of sitagliptin and metformin was more effective than placebo.
Maltese: • Il-ħames studju sab li ż-żieda tal-ertugliflozin ma' kombinazzjoni ta' sitagliptin u metformina kienet aktar effettiva mill-plaċebo.
English: Several studies in around 4,800 patients with type 2 diabetes have shown that ertugliflozin helps lower glucose levels on its own and in combination with other diabetes medicine.
Maltese: Diversi studji f'madwar 4,800 pazjent b'dijabete tat-tip 2 urew li l-ertugliflozin tgħin biex tbaxxi l-livelli tal-glukożju waħdu jew flimkien ma' mediċina tad-dijabete oħra.
English: • A fourth study found that, in patients taking metformin, adding ertugliflozin was as effective as adding sitagliptin, another diabetes medicine, with HbA1c levels falling by around 1 point with both treatments.
Maltese: • Ir-raba' studju sab li, f'pazjenti li kienu qegħdin jieħdu l-metmorfina, iż-żieda tal-ertugliflozin kienet kważi effettiva daqs iż-żieda ta' sitagliptin, mediċina tad-dijabete oħra, bil-livelli ta' HbA1c jonqsu b'madwar punt 1 biż-żewġ kuri.
English: The patient should start with one 5 mg tablet once a day in the morning.
Maltese: Il-pazjent għandu jibda b'pillola waħda ta' 5 mg darba kuljum filgħodu.
English: EMA/359552/2014 EMEA/H/C/000593
Maltese: EMEA/H/C/000593
English: Other information about Xyrem:
Maltese: Informazzjoni oħra dwar Xyrem:
English: The full EPAR for Xyrem 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: Xyrem is an oral solution that contains the active substance sodium oxybate (500 mg/ml).
Maltese: Xyrem huwa soluzzjoni orali li fiha s-sustanza attiva ossibat tas-sodju (500 mg/ml).
English: The active substance in Xyrem, sodium oxybate, is a central nervous system depressant.
Maltese: Is-sustanza attiva fi Xyrem, ossibat tas-sodju, hija dipressant tas-sistema nervuża ċentrali.
English: Xyrem sodium oxybate
Maltese: Xyrem ossibat tas-sodju
English: This document is a summary of the European Public Assessment Report (EPAR) for Xyrem.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Xyrem.
English: The effects of Xyrem in narcolepsy and cataplexy have been studied in 707 patients in four studies.
Maltese: L-effetti ta' Xyrem fin-narkolessija u l-katalessja ġew studjati f'707 pazjenti f'erba' studji.
English: In the first study, a daily dose of 9 g reduced the number of cataplexy attacks by 16.1 (from 23.5 to 8.7) per week, compared with a fall of 4.3 per week in the patients taking placebo.
Maltese: Fl-ewwel studju, doża ta' 9 g kuljum naqqset in-numru ta' attakki tal-katalessja b'16.1 (minn 23.5 sa 8.7) kull ġimgħa, waqt li fil-pazjenti li kienu qed jieħdu l-plaċebo kien hemm tnaqqis ta' 4.3 kull ġimgħa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xyrem on 13 October 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Xyrem valida fl-Unjoni Ewropea kollha fit-13 ta' Ottubru 2005.
English: What is Xyrem?
Maltese: X'inhu Xyrem?