FrancophonIA/ELRC3.0 huggingface dataset:
English: • pimozide (used to treat mental illness);
Maltese: • pimozide (użat fil-kura ta' mard mentali);
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emend on 11 November 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Emend fil-11 ta' Novembru 2003.
English: This is a summary of the European public assessment report (EPAR) for Emend.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Emend.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku aprepitant
English: In children between 6 months and 12 years of age, Emend oral suspension is given together with a 5HT3 antagonist.
Maltese: Fi tfal li għandhom bejn 6 xhur u 12-il sena, Emend suspensjoni orali jingħata flimkien ma' 5-HT3 antagonist.
English: It is used with chemotherapy that is a moderate or high trigger of nausea and vomiting such as cisplatin, cyclophosphamide, doxorubicin or epirubicin.
Maltese: Jintuża flimkien ma' kimoterapija bi tqanqil moderat jew qawwi ta' nawsja u rimettar bħal cisplatin, cyclophosphamide, doxorubicin jew epirubicin.
English: • cisapride (used to relieve certain stomach problems).
Maltese: • cisapride (użat biex inaqqas ċerti problemi tal-istonku).
English: It is available as capsules (40, 80, 125 and 165 mg) and as a powder to be made up into an oral (by mouth) suspension (125 mg).
Maltese: Jiġi bħala kapsuli (40, 80, 125 u 165 mg) u bħala trab biex isir suspensjoni orali (mill-ħalq [125 mg]).
English: • terfenadine, astemizole (commonly used to treat allergy symptoms - these medicines may be available without a prescription);
Maltese: • terfenadine, astemizole (użati komunement għall-kura ta' sintomi allerġiċi - dawn il-mediċini jistgħu jkunu disponibbli mingħajr riċetta ta' tabib);
English: Emend 40 mg capsules are used to prevent postoperative nausea and vomiting (PONV) in adults.
Maltese: Il-kapsuli ta' Emend 40 mg jintużaw għall-prevenzjoni tan-nawsja u r-rimettar wara operazzjoni (PONV) fl-adulti.
English: In PONV, Emend was as effective as ondansetron.
Maltese: Fil-PONV, Emend kien effikaċi daqs ondansetron.
English: Emend 80, 125 and 165 mg capsules are used in adults; children from 12 years of age may be given the 80- or 125-mg capsules and children between 6 months and 12 years of age are given the oral suspension.
Maltese: Il-kapsuli ta' Emend 80, 125 u 165 mg jintużaw fl-adulti; it-tfal minn 12-il sena jistgħu jingħataw ilkapsuli ta' 80 jew 125 mg u t-tfal li għandhom bejn 6 xhur u 12-il sena jingħataw is-suspensjoni orali.
English: In the study in children, around 51% (77 out of 152) of children given Emend with ondansetron had a complete response 25 to 120 hours after beginning chemotherapy, compared with 26% (39 out of 150) of children given ondansetron alone.
Maltese: Fl-istudji fit-tfal, madwar 51% (77 minn 152) tat-tfal li ngħataw Emend ma' ondansetron kellhom rispons komplet 25 sa 120 siegħa wara li nbdiet il-kimoterapija, meta mqabbla ma' 26% (39 minn 150) tat-tfal li ngħataw ondansetron waħdu.
English: It must be given with other medicines that also prevent nausea and vomiting, including a corticosteroid (such as dexamethasone) and a ‘5-HT3 antagonist' (such as ondansetron).
Maltese: Emend għandu jingħata flimkien ma' mediċini oħra li wkoll jipprevjenu n-nawsja u r-rimettar, inkluż kortikosterojde (bħal dexamethasone) u ‘5-HT3 antagonist' (bħal ondansetron).
English: The first two studies involved a total of 1,094 adults receiving chemotherapy including cisplatin, and the third involved 866 adults with breast cancer who were receiving cyclophosphamide, with or without doxorubicin or epirubicin.
Maltese: L-ewwel żewġ studji involvew total ta' 1,094 adult ikkurati bil-kimoterapija li inkludiet cisplatin, u t-tielet wieħed involva 866 pazjent li jbatu minn kanċer tas-sider ikkurati b'cyclophosphamide, b'doxorubicin jew epirubicin jew mingħajrhom.
English: A fourth study has been carried out with Emend (125 mg capsules or 125 mg oral solution) in 307 children from 6 months to 17 years of age, where Emend, taken with ondansetron (with or without dexamethasone), was compared with ondansetron alone (with or without dexamethasone).
Maltese: Ir-raba' studju twettaq b'Emend (kapsuli ta' 125 mg jew soluzzjoni orali ta' 125 mg) f'307 tifel u tifla minn 6 xhur sa 17-il sena, fejn Emend, meħud ma' ondansetron (flimkien ma' dexamethasone jew mingħajru), tqabbel ma' ondansetron waħdu (flimkien ma' dexamethasone jew waħdu).
English: At a dose of 80, 125 and 165 mg, the other side effects seen in between 1 and 10 patients in 100 are headache, hiccups, constipation, dyspepsia (indigestion), loss of appetite, and fatigue (tiredness).
Maltese: B'doża ta' 80, 125 u 165 mg, l-effetti sekondarji l-oħra li dehru f'bejn pazjent 1 u 10 minn kull 100 kienu wġigħ ta' ras, sulluzzu, stitikezza, dispepsija (indiġestjoni), telf ta' aptit u għeja.
English: How has Emend been studied?
Maltese: Kif ġie studjat Emend?
English: In chemotherapy, three main studies have been carried out for Emend 80 and 125 mg capsules.
Maltese: Fil-kimoterapija, twettqu tliet studji ewlenin għall-kapsuli ta' Emend 80 u 125 mg.
English: What is Emend?
Maltese: X'inhu Emend?
English: Looking at the results of both studies together, 55% of the patients (298 out of 541) taking Emend capsules at a dose of 40 mg had a complete response, compared with 49% of the patients who received ondansetron (258 out of 526).
Maltese: Meta jitqiesu r-riżultati taż-żewġ studji flimkien, 55% tal-pazjenti (298 minn 541) li ħadu l-kapsuli ta' Emend b'doża ta' 40 mg kellhom rispons komplet, meta mqabbla ma' 49% tal-pazjent li rċevew ondansetron (258 minn 526).
English: In PONV, the usual dose is one 40 mg capsule given to adults within the three hours before the patient is anaesthetised (‘put to sleep').
Maltese: Fil-PONV, id-doża tas-soltu hija kapsula waħda ta' 40 mg li tingħata lill-adulti fit-3 sigħat qabel ma lpazjent jiġi anestetizzat (‘imraqqad').
English: Tests were performed to determine that Emend 165 mg produces the same amount of aprepitant in the body as a single dose of 150 mg Ivemend.
Maltese: Twettqu testijiet biex jiġi stabbilit li Emend 165 mg jipproduċi l-istess ammont ta' aprepitant fil-ġisem daqs doża unika ta' Ivemend 150 mg.
English: Looking at the results of the two cisplatin studies taken together, 68% of the patients taking Emend had no nausea or vomiting over five days (352 out of 520), compared with 48% of the patients who did not take it (250 out of 523).
Maltese: Meta jitqiesu r-riżultati taż-żewġ studji ta' cisplatin f'daqqa, 68% tal-pazjenti li kienu qegħdin jieħdu Emend la kellhom nawsja u lanqas rimettar tul ħamest ijiem (352 minn 520), meta mqabbla ma' 48% tal-pazjenti li ma ħaduhx (250 minn 523).
English: A risk management plan has been developed to ensure that Emend is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jassigura li Emend jintuża bl-aktar mod sigur possibbli.
English: In the study of chemotherapy that is a moderate trigger of nausea and vomiting, 51% of the patients taking Emend had no nausea or vomiting (220 out of 433), compared with 43% of the patients who did not take it (180 out of 424).
Maltese: Fl-istudju tal-kimoterapija bi tqanqil moderat ta' nawsja u rimettar, 51% tal-pazjenti kkurati b'Emend la kellhom nawsja u lanqas rimettar (220 minn 433), meta mqabbla ma' 43% tal-pazjenti li ma ġewx ikkurati bih (180 minn 424).
English: In the chemotherapy studies in adults, adding Emend to the standard combination was more effective than the standard combination alone.
Maltese: Fl-istudji waqt il-kimoterapija, iż-żieda ta' Emend mal-kombinazzjoni standard kienet iktar effikaċi millkombinazzjoni standard waħedha.
English: Why has Emend been approved?
Maltese: Għaliex ġie approvat Emend?
English: The most common side effect of Emend at all doses in adults (seen in between 1 and 10 patients in 100) is increased liver enzymes.
Maltese: L-effett sekondarju l-aktar komuni b'Emend fid-dożi kollha (li deher f'bejn pazjent 1 u 10 minn kull 100) kien żieda fl-enzimi tal-fwied.
English: Emend is an antiemetic, a medicine that prevents nausea (feeling sick) and vomiting.
Maltese: Emend huwa antiemetiku, mediċina għall-prevenzjoni tan-nawsja (tħossok ma tiflaħx) u rimettar.
English: Emend is used with other medicines to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer).
Maltese: Emend jintuża flimkien ma' mediċini oħra sabiex jipprevjeni nawsja u rimettar li huma kkawżati millkimoterapija (mediċina użata fil-kura tal-kanċer).
English: What is the risk associated with Emend?
Maltese: X'inhu r-riskju assoċjat ma' Emend?
English: This is nausea and vomiting that a patient can experience after surgery.
Maltese: Dawn huma nawsja u rimettar li pazjent jista' jesperjenza wara operazzjoni kirurġika.
English: It is only given on the first day of the chemotherapy and is followed by treatment involving a corticosteroid and a 5HT3 antagonist.
Maltese: Jingħata biss flewwel jum tal-kimoterapija u jiġi segwit minn kura li tinvolvi kortikosterojde u 5-HT3 antagonist.
English: The main measure of effectiveness was based on how many patients had a ‘complete response', which was defined as no vomiting, retching or dry heaves and no need for any other medication to control nausea and vomiting 25 to 120 hours after the start of chemotherapy (delayed phase).The study also looked at how many patients achieved a complete response in the first 24 hours after chemotherapy (acute phase).
Maltese: Il-kejl ewlieni tal-effikaċja kien ibbażat fuq l-ammont ta' pazjenti li kellhom 'rispons komplet', li kien iddefinit bħala ebda rimettar, tqalligħ jew heaves niexef u l-ebda bżonn għal xi medikazzjoni oħra biex tiġi kkontrollata n-nawsja u r-rimettar 25 sa 120 siegħa wara l-bidu tal-kimoterapija (fażi mdewma).
English: How does Emend work?
Maltese: Għalxiex jintuża Emend?
English: All three studies compared the effectiveness of Emend, taken in combination with dexamethasone and ondansetron, with that of the standard combination of dexamethasone and ondansetron.
Maltese: It-tliet studji kollha qabblu l-effikaċja ta' Emend, meħud flimkien ma' dexamethasone u ondansetron, ma' dik tal-kombinazzjoni standard ta' dexamethasone u ondansetron.
English: Emend 165 mg capsules were shown to be bioequivalent to Ivemend 150 mg, which means that like Ivemend it can also be used to prevent nausea and vomiting caused by chemotherapy.
Maltese: Il-kapsuli ta' Emend 165 mg wrew li huma bijoekwivalenti għal Ivemend 150 mg, li jfisser li bħal Ivemend, jista' jintuża wkoll għall-prevenzjoni ta' nawsja u rimettar ikkawżati bil-kimoterapija.
English: In chemotherapy, the usual dose of Emend in adults and children from 12 years of age is one 125 mg capsule by mouth one hour before the start of chemotherapy.
Maltese: Matul il-kimoterapija, id-doża tas-soltu ta' Emend fl-adulti u t-tfal minn 12-il sena hija kapsula waħda ta' 125 mg meħuda mill-ħalq siegħa qabel il-bidu tal-kimoterapija.
English: In children, the most common side effects are hiccups and flushing.
Maltese: Fit-tfal, l-effetti sekondarji l-iktar komuni huma sulluzzu u fwawar.
English: Two doses of Emend (40 and 125 mg as capsules) were compared with ondansetron given as an injection.
Maltese: Tqabblu żewġ dożi ta' Emend (40 u 125 mg) ma' ondansetron mogħti permezz ta' injezzjoni.
English: What benefit has Emend shown during the studies?
Maltese: Liema benefiċċju wera Emend matul l-istudji?
English: The CHMP decided that Emend's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Emend huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: For the full list of restrictions with Emend, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet b'Emend, ara l-fuljett ta' tagħrif.
English: For the full list of all side effects reported with Emend, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Emend, ara l-fuljett ta' tagħrif.
English: EU/1/17/1232/001 Miglustat Gen.Orph
Maltese: EU/1/17/1232/001 Miglustat Gen.Orph 100 mg Kapsula, iebsa
English: Blister (OPA/alu/PVC) 84 capsules
Maltese: Użu orali folja (OPA/alu/PVC)
English: 100 mg Capsule, hard
Maltese: 84 kapsula
English: MA (EU) number (Invented) name
Maltese: Numru ta' l-EU (MA)
English: 19 April 2012
Maltese: 19 ta' April 2012
English: Pralatrexate is an ‘antimetabolite' medicine.
Maltese: Il-pralatreksat hija mediċina ‘antimetabolita'.
English: What is Folotyn?
Maltese: X'inhu Folotyn?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Folotyn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għal Prodotti Mediċinali Orfni għal Folotyn jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Refusal of the marketing authorisation for Folotyn (pralatrexate) EMA/CHMP/255106/2012
Maltese: Ċaħda tal-awtorizzazzjoni għat-tqegħid fis-suq għal Folotyn (pralatreksat) EMA/CHMP/255106/2012
English: Folotyn is a medicine that contains the active substance pralatrexate.
Maltese: Folotyn huwa mediċina li fiha s-sustanza attiva pralatreksat.
English: Folotyn was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 13 April 2007 for the treatment of peripheral T-cell lymphoma.
Maltese: Folotyn ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-13 ta' April 2007 għallkura tal-linfoma periferika taċ-ċelloli T.
English: In the body, it is expected to take the place of folic acid and attach to an enzyme called dihydrofolate reductase (DHFR).
Maltese: Fil-ġisem din mistennija tieħu post l-aċidu foliku u taqbad ma' enzima msejħa didrofolat reduttażi (DHFR).
English: The company presented the results of one main study involving a total of 115 adults with peripheral Tcell lymphoma which kept coming back or did not respond to previous treatments.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju ewlieni fuq total ta' 115-il adult bil-linfoma periferika taċċelloli T li baqgħet terġa' tfeġġ jew li ma kinitx irrispondiet għall-kuri preċedenti.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 April 2012.
Maltese: Wara li qies ir-raġunijiet għal din it-talba, is-CHMP reġa' analizza l-opinjoni inizjali u fid-19 ta' April 2012 ikkonferma ċ-ċaħda tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: What was Folotyn expected to be used for?
Maltese: Għal xiex kien mistenni jintuża Folotyn?
English: It was to be available as a solution for infusion (drip into a vein).
Maltese: Kellu jitqiegħed fis-suq f'soluzzjoni għal infużjoni (dripp ġol-vina).
English: Patients were given Folotyn together with vitamin B12 and folic acid supplements (to compensate for the deficiency in these vitamins that may occur during Folotyn treatment).
Maltese: B12 u tal-aċidu foliku (bħala kumpens għan-nuqqas f'dawn il-vitamini li jista' jiżviluppa matul il-kura b'Folotyn).
English: Refusal of the marketing authorisation for Folotyn (pralatrexate)
Maltese: Ċaħda tal-awtorizzazzjoni għat-tqegħid fis-suq għal Folotyn (pralatreksat)
English: Folotyn was expected to be used to treat adults with peripheral T-cell lymphoma, which is a cancer of a type of white blood cell called T-cells.
Maltese: mistennija timblokka l-attività tal-enzima, u b'hekk tipprevjeni l-qsim taċ-ċelloli tal-kanċer u mażżmien toqtolhom.
English: On 19 January 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Folotyn, intended for the treatment of peripheral T-cell lymphoma.
Maltese: Fid-19 ta' Jannar 2012 il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva li fiha rrakkomanda ċ-ċaħda tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Folotyn, maħsub għall-kura tal-linfoma periferika taċ-ċelloli T. Il-kumpanija li applikat għallawtorizzazzjoni hija Allos Therapeutics Limited.
English: By attaching to DHFR, pralatrexate is
Maltese: Xi pppreżentat il-kumpanija biex issostni l-applikazzjoni tagħha?
English: During the re-examination in April 2012, the CHMP's concerns were not resolved.
Maltese: Matul l-analiżi mill-ġdid li saret f'April 2012, ma ġiex eliminat it-tħassib tas-CHMP.
English: The effects of Folotyn were first tested in experimental models before being studied in humans.
Maltese: Qabelxejn l-effetti ta' Folotyn ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fil-bniedem.
English: This summary was last updated in 04-2009.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi: 04-2009.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) MODIGRAF EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) MODIGRAF Sommarju tal-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the European Union for Modigraf to Astellas Pharma Europe B.V. on 15 May 2009.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Modigraf lil Astellas Pharma Europe B.V. fil-15 ta' Mejju 2009.
English: Tacrolimus, the active substance in Modigraf, is an immunosuppressive agent.
Maltese: Tacrolimus, is-sustanza attiva f'Modigraf, huwa mediċina immunosoppressiva.
English: In the first study, 79% of patients given Modigraf (22 out of 28) did not have organ rejection.
Maltese: Flewwel studju, 79% tal-pazjenti ttrattati b'Modigraf (22 minn 28) ma kellhomx rifjut tal-organu.
English: Modigraf is a medicine that contains the active substance tacrolimus.
Maltese: Modigraf huwa mediċina li fiha s-sustanza attiva tacrolimus.
English: The most common side effects with Modigraf (seen in more than 1 patient in 10) are diabetes, hyperglycaemia (high blood glucose), hyperkalaemia (high blood potassium), insomnia (difficulty sleeping), headache, tremor (shaking), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), abnormal liver function test (abnormal level of liver enzymes), and kidney problems.
Maltese: L-effetti sekondarji l-aktar komuni b'Modigraf (li dehru f'iktar minn pazjent 1 minn 10) huma dijabete, ipergliċemija (livelli għoljin taz-zokkor fid-demm), iperkaljemija (livelli għoljin tal-potassju fiddemm), insonnja (diffikultà biex torqod), uġigħ ta' ras, rogħda, ipertensjoni (pressjoni għolja taddemm), dijarrea, nawżea (dardir), testijiet fuq il-funzjonijiet epatiċi (tal-fwied) anomali (livelli anomali tal-enzimi epatiċi) u problemi bil-kliewi.
English: The second study involved 185 children who were given either Modigraf with corticosteroids (a group of immunosuppressant medicine) or a combination of other immunosuppressant medicines (cicosporin, azathioprine and corticosteroids) for one year.
Maltese: Ittieni studju involva 185 tifel u tifla ttrattati b'Modigraf flimkien mal-kortikosterojdi (grupp ta' mediċina immunosoppressiva) jew b'kombinazzjoni ta' mediċini immunosoppressivi (ċiklosporina, azathioprine and kortikosterojdi) għal sena.
English: Modigraf is similar to another tacrolimus-containing medicine, Prograf or Prograft, which is available as capsules.
Maltese: Modigraf huwa simili għal mediċina oħra li fiha tacrolimus, Prograf jew Prograft, disponibbli f'kapsuli.
English: In the second study, the difference between the total number of rejections for the two medicine combinations was not considered to be relevant.
Maltese: Fittieni studju, id-differenza bejn in-numru totali ta' rifjuti għaż-żewġ kombinazzjonijiet ta' mediċini ma tqisitx rilevanti.
English: It is available as sachets (0.2 mg and 1 mg) containing granules that are made up into an oral suspension.
Maltese: Huwa disponibbli f'sachets (0.2 mg u 1 mg) li jkun fihom granuli li jitħalltu biex jiffurmaw sospensjoni orali.
English: Tacrolimus acts on some special cells in the immune system called T-cells that are primarily responsible for attacking the transplanted organ (organ rejection).
Maltese: Tacrolimus jaġixxi fuq ċelloli speċjali tas-sistema immunitarja, imsejħin ċelloli T, li huma primarjament responsabbli għall-attakk fuq lorganu trapjantat (rifjut tal-organu).
English: Modigraf is taken twice a day, usually in the morning and evening.
Maltese: Modigraf jittieħed darbtejn kuljum, normalment filgħodu u filgħaxija.
English: However, the Modigraf combination was more effective than the other combination at preventing organ rejections that could not be treated by corticosteroids.
Maltese: Madankollu, il-kombinazzjoni b'Modigraf kienet iktar effikaċi mill-kombinazzjoni loħra fil-prevenzjoni tar-rifjuti tal-organu li jistgħu jiġu ttrattati bil-kortikosterojdi.
English: Tacrolimus has been available in the European Union (EU) for preventing organ rejection since the mid-1990's.
Maltese: Tacromilus ilu disponibbli fl-Unjoni Ewropea (UE) min-nofs is-snin disgħin għall-prevenzjoni tarrifjut tal-organu.
English: What is Modigraf?
Maltese: Għal xiex jintuża Modigraf?
English: The CHMP decided that Modigraf's benefits are greater than its risks for prophylaxis of transplant rejection in kidney, liver and heart recipients, and in the treatment of rejection resistant to treatment with other immunosuppressive medicinal products.
Maltese: Is-CHMP ddeċieda li l-benefiċċji ta' Modigraf huma ogħla mir-riskji tiegħu għall-profilassi tar-rifjut ta' trapjant f'pazjenti sottoposti għal trapjant ta' kilwa, tal-fwied u tal-qalb, u fit-trattament tar-rifjut reżistenti għat-trattament bi prodotti mediċinali immunosoppressivi oħra.
English: One study involved 28 children who were given the medicine for up to one year.
Maltese: Studju wieħed involva 28 tifel u tifla ttrattati bil-mediċina sa sena.
English: The starting daily dose for heart transplant patients is 0.075 mg/kg for adults and 0.3 mg/kg for children.
Maltese: Għall-pazjenti sottoposti għal trapjant tal-qalb, iddoża inizjali ta' kuljum hija 0.075 mg/kg għall-adulti u 0.3 mg/kg għat-tfal.
English: The Committee for Medicinal Products for Human Use (CHMP) was of the opinion that in terms of effectiveness and safety, Modigraf was similar to other tacrolimus medicines available as capsules.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) kien tal-fehma li f'termini ta' effikaċja u ta' sigurtà, Modigraf kien simili għal mediċini oħra li fihom tacrolimus disponibbli f'kapsuli.
English: Modigraf should not be used in people who may be hypersensitive (allergic) to tacrolimus or any of the other ingredients or to other macrolides (medicines with a similar structure to tacrolimus).
Maltese: Modigraf ma għandux jintuża f'persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal tacrolimus jew għal kwalunkwe sustanza oħra jew għal makrolidi oħra (mediċini bi struttura simili għal tacrolimus).
English: In liver transplant patients, the starting daily dose is 0.1 to 0.2 mg/kg for adults and 0.3 mg/kg for children.
Maltese: Għall-pazjenti sottoposti għal trapjant tal-fwied, id-doża inizjali hija 0.1 sa 0.2 mg/kg għall-adulti u 0.3 mg/kg għat-tfal.
English: For heart transplants the dose is 0.15 mg/kg/day for adults and 0.2 to 0.3 mg/kg for children.
Maltese: Għat-trapjanti tal-qalb, id-doża hija 0.15 mg/kg/ġurnata għall-adulti u 0.2 sa 0.3 mg/kg għat-tfal.
English: What is the risk associated with Modigraf?
Maltese: X'inhu r-risku assoċjat ma' Modigraf?
English: Other information about Modigraf:
Maltese: Aktar tagħrif dwar Modigraf:
English: Doctors should monitor the levels of tacrolimus in the blood to check that they stay within predefined ranges.
Maltese: It-tabib għandu jimmonitorja l-livelli ta' tacrolimus fid-demm biex jikkontrolla jekk jibqgħu fi ħdan il-limiti predefiniti.
English: The full EPAR for Modigraf can be found here.
Maltese: Għaliex ġie approvat Modigraf?