FrancophonIA/ELRC3.0 huggingface dataset:
English: values similar to those seen in adult renal transplant patients receiving mycophenolate mofetil at a dose of 1°g BID in the early and late post-transplant period.
Maltese: kienu ġeneralment simili għal dawk osservati f'pazjenti adulti li ngħataw 1 g mycophenolate mofetil darbtejn kuljum.
English: Myfenax should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients listed in section 6.1.
Maltese: Myfenax m'għandux jingħata lil f'pazjenti b'sensittività eċċessiva għal mycophenolate mofetil, mycophenolic acid jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: • feeling restless, abnormalities of thought, perception and levels of awareness, depression, feeling anxious, abnormal thinking, difficulty in sleeping
Maltese: • irrekwitezza, anormalitajiet fil-ħsieb, fil-perċezzjoni u l-livelli ta' koxjenza, depressjoni, tħossok ansjuż, ħsibijiet mhux normali, diffikultà biex torqod
English: • Before you start taking Myfenax
Maltese: • Qabel ma tibda tieħu Myfenax
English: There have also been isolated reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal (see section 4.8).
Maltese: Kien hemm ukoll rapporti iżolati ta' mard interstizjali tal-pulmun u fibrożi pulmonari, li uħud minnhom kienu fatali (ara sezzjoni 4.8).
English: Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Maltese: Myfenax hu indikat flimkien ma' ciclosporin u corticosteroids għall-profilassi ta' riġezzjoni akuta ta' trapjanti f'pazjenti li jirċievu trapjanti renali, kardijaċi jew epatiċi alloġeniċi.
English: Delayed renal graft function
Maltese: Pazjenti b'funzjoni mdewwma tal-graft
English: In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5 g taken twice a day [BID], morning and evening) were administered to hepatic transplant patients taking tacrolimus.
Maltese: B'kuntrast, kien hemm żjieda ta' madwar 20 % fl-AUC ta' tacrolimus meta dożi multipli ta' mycophenolate mofetil (1.5 g [BID], filgħodu u filgħaxija) ingħataw lil pazjenti li kellhom trapjant tal-fwied li kienu qed jieħdu tacrolimus.
English: Mogilska 80 Str.
Maltese: 20 mg/kg/day.
English: Myfenax is used in children and adolescents (aged 2 to 18) to prevent a body rejecting a transplanted kidney.
Maltese: Myfenax jintuża fi tfal u adoloxxenti (b'età minn 2 sa 18-il sena) biex jipprevjeni r-riġessjoni milġisem ta kilwa trapjantata
English: Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed)).Your baby may be affected by one or more of these.
Maltese: Difetti tat-twelid li kienu rrappurtati jinkludu anomaliji tal widnejn, tal-għajnejn, tal-wiċċ (xoffa/palat mixquq), tal-iżvilupp tas-swaba, tal-qalb, tal-esofagu (tubu li jgħaqqad il-gerżuma mal-istonku), tal-kliewi u tas-sistema nervuża (per eżempju spina bifida (fejn lgħadam tas-sinsla tad-dahar ma jkunux żviluppati sew)).
English: Myfenax 500 mg film-coated tablets Mycophenolate mofetil
Maltese: Kull pillola fiha 500 mg mycophenolate mofetil
English: Myfenax should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
Maltese: Myfenax m'għandux jintuża waqt it-tqala ħlief jekk ma jkunx disponibbli trattament alternattiv xieraq biex jiġi evitat rifjut tat-trapjant (ara sezzjoni 4.6).
English: Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, Myfenax is contraindicated in breast-feeding mothers (see section 4.3).
Maltese: Minħabba fir-riskju potenzjali għarreazzjonijiet avversi serji għal mycophenolate mofetil fi trabi li jkunu mredda', Myfenax huwa kontraindikat f'ommijiet li jkunu qegħdin ireddgħu (ara sezzjoni 4.3).
English: A negligible amount of substance is excreted as MPA (<°1% of dose) in the urine.
Maltese: Ammont negliġibbli ta' sustanza hija merħija bħala MPA (< 1% tad-doża) fl-awrina.
English: Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18°years) given 600°mg/m2 mycophenolate mofetil orally twice daily.
Maltese: 18-il sena) li ngħataw 600 mg/m2 mycophenalate mofetil oralment darbtejn kuljum.
English: There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate mofetil, some of which have been fatal.
Maltese: Kien hemm rapporti ta' anemija aplastika u depressjoni tal-mudullun f' pazjenti ttrattati b'mycophenolate mofetil, li xi ftit minnhom kienu fatali.
English: Before starting Myfenax treatment, women of childbearing potential must have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL in order to exclude unintended exposure of the embryo to mycophenolate.
Maltese: Qabel ma jinbeda trattament b'Myfenax, nisa li jistgħu joħorġu tqal għandu jkollhom żewġ testijiet tat-tqala tas-serum jew tal-awrina negattivi b'sensittività ta' mill-inqas 25 mIU/mL negattivi sabiex jiġi eskluż esponiment mhux intenzjonat tal-embriju għal mycophenolate.
English: Skin cancer, benign neoplasm of skin
Maltese: Kanser tal-ġilda, neoplażmu beninn tal-ġilda
English: The patient information pack should contain:
Maltese: Il-Pakkett ta' informazzjoni għall-pazjent:
English: Based on the results of a single dose administration study of recommended doses of oral mycophenolate mofetil and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate mofetil (see section 4.2) and ganciclovir, it is anticipated that coadministration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Maltese: Ibbażat fuq ir-riżultati ta' stħarriġ b'għoti ta' doża ewlenija tad-dożi rakkomandati ta' mycophenolate mofetil b'mod orali u ganciclovir intravenuż u l-effetti magħrufa dwar l-indeboliment tal-kliewi fuq ilfarmakokinetiċi ta' mycophenolate mofetil (ara sezzjoni 4.2) u ganciclovir, huwa antiċipat li l-għoti konkomittanti ta' dawn iż-żewġ mediċini (li jikkompetu għall-mekaniżmi ta' tnixxija mit-tubuli talkliewi) tirriżulta f'żidiet fil-konċentrazzjonijiet ta' MPAG u ganciclovir.
English: Serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Maltese: Infezzjonijiet serji li jipperikolaw il-ħajja jinkludu meninġite, endokardite, tuberkulożi u infezzjonijiet b'mikobatterja atipika.
English: Body: caramel opaque, printed ‘250' axially in black ink.
Maltese: Il-korp: lewn il-karamelli opak, li fuqu hemm stampat ‘250' b'mod assjali b'linka sewda
English: Elderly patients receiving Myfenax as part of a combination immunosuppressive regimen may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger individuals.
Maltese: Pazjenti anzjani li qegħdin jingħataw Myfenax bħala parti minn reġimen immunosoppressiv kkombinat jistgħu jkunu f'riskju akbar ta' ċertu infezzjonijiet (li jinkludu mard ta' invażjoni tat-tessuti minn cytomegalovirus) u possibilment t'emorraġija gastrointestinali u edema pulmonarja, meta mqabblin ma' individwi aktar żgħar.
English: The mean single dose MPAG AUC was 3-6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Maltese: Madankollu, il-MPAG AUC medju ta' doża ewlenija kien minn 3-6 darbiet ogħla f'suġġetti b'indeboliment kroniku tal-kliewi sever milli f'suġġetti b'indeboliment tal-kliewi ħafif jew suġġetti normali u f'saħħithom, konsistenti mat-tneħħija millkliewi ta' MPAG kif magħrufa.
English: The following malformations were most frequently reported:
Maltese: Il-malformazzjonijiet li ġejjin kienu rrappurtati l-aktar frekwenti:
English: Female patients of childbearing potential should be made aware of the risks and follow the recommendations provided in section 4.6 (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with mycophenolate.
Maltese: Pazjenti nisa li jistgħu joħorġu tqal għandhom jingħataw parir dwar ir-riskji u għandhom isegwu r-rakkomandazzjonijiet ipprovduti fis sezzjoni 4.6 (eż. metodi ta' kontraċezzjoni, ittestjar għat-tqala) qabel, matul u wara terapija b'mycophenolate.
English: Influenza vaccination may be of value.
Maltese: Il-vaċċin kontra l-influwenza jista' jkun ta' siwi.
English: Drugs which interfere with MPA's enterohepatic cycle (e.g. cholestyramine, antibiotics) should be used with caution due to their potential to reduce the plasma level and efficacy of mycophenolate mofetil (see also section 4.5).
Maltese: Mediċini li jfixklu ċ-ċiklu enterepatiku ta' MPA (eż. cholestyramine, antibijotiċi) għandhom jintużaw b'attenzjoni minħabba l-potenzjal tagħhom li jnaqqsu l-livelli fil-plażma u l-effikaċja ta' mycophenolate mofetil (ara wkoll sezzjoni 4.5).
English: In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively unaffected by hepatic parenchymal disease.
Maltese: F'voluntieri b'ċirrożi alkoħolika, proċessi ta' glukorinazzjoni ta' MPA epatiċi kienu relativament mhux effettwati minn mard epatiku parenkimali.
English: The systemic exposure at this dose was approximately 0.5°times the clinical exposure at the recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3°times the clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients.
Maltese: L-espożizzjoni sistemika f'din id-doża kienet bejn wieħed u ieħor ta' 0.5 darbiet l-espożizzjoni klinika fid-doża klinika rakkomandata ta' 2 g/kuljum għall-pazjenti bi trapjanti tal-kliewi u bejn wieħed u ieħor 0.3 darbiet l-espożizzjoni klinika fid-doża klinika rakkomandata ta' 3 g/kuljum f'pazjenti bi trapjanti tal-qalb.
English: Men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate.
Maltese: 90 jum wara t-twaqqif ta' mycophenolate.
English: Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day.
Maltese: Mycophenolate mofetil ma kellu l-ebda effett fuq il-fertilità ta' firien irġiel f'dożi orali sa 20 mg/kg/
English: How to store Myfenax
Maltese: X'fih Myfenax
English: Paediatric population < 2 years
Maltese: Popolazzjoni pedjatrika (< Sentejn)
English: Because MPAG plasma concentrations are increased in the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e.g. valaciclovir, to compete for tubular secretion and further increases in concentrations of both substances may occur.
Maltese: Peress li konċentrazzjonijiet fil-plażma ta' MPAG jiżdiedu filpreżenza ta' indeboliment tal-kliewi, kif jiġri lill-konċentrazzjonijiet ta' aciclovir, jeżisti l-potenzjal għal mycophenolate mofetil u aciclovir, jew il-prodrugs tiegħu, eż. valaciclovir, li jikkompetu għattnixxija tubulari u jista' jkun hemm aktar żidiet fil-konċentrazzjonijiet taż-żewġ sustanzi.
English: In patients with delayed renal graft function post-transplant, mean MPA AUC (0-12°h) was comparable to that seen in post-transplant patients without delayed graft function.
Maltese: F'pazjenti b'funzjoni mdewwma tal-graft tal-kilwa wara t-trapjant, l-MPA AUC (0-12-il siegħa) medju kien komparabbli ma dak li jidher f'pazjenti wara t-trapjant li ma kellhomx dewmien fil funzjoni tal-graft.
English: • Are you taking any medicines containing: o azathioprine or other immunosuppressive agents (which are sometimes given to patients after a transplant operation), o cholestyramine (used to treat patients with high blood cholesterol), o rifampicin (antibiotic), o antacids or proton pump inhibitors (used for acid problem in your stomach such as indigestion), o phosphate binders (used in patients with chronic kidney failure to reduce the absorption of phosphate), o antibiotics (used to treat bacterial infections), o isavuconazole (used to treat fungal infections), o telmisartan (used to treat high blood pressure) o or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
Maltese: o antibijotiċi - użati biex jittrattaw infezzjonijiet batteriċi o isavuconazole - użat biex jittratta infezzjonijiet mill-moffa o telmisartan - użat biex jittratta l-pressjoni għolja o jew xi mediċini oħra (inkluż dawk li tista' tixtri mingħajr riċetta) li t-tabib tiegħek ma jafx dwarhom?
English: Mycophenolate mofetil is not measurable systemically in plasma following oral administration.
Maltese: Mycophenolate mofetil mhuwiex imkejjel sistemikament fil-plażma wara t-teħid orali.
English: • infection of the digestive tract
Maltese: • infjammazzjoni tal-apparat diġestiv • infezzjoni
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil (see section 4.4).
Maltese: F'pazjenti ttrattati b'mycophenolate mofetil flimkien ma' sustanzi immunosoppressivi kienu rrapportati każijiet ta' aplasija pura taċ-ċelluli ħomor (PRCA) (ara sezzjoni 4.4).
English: In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25°mL/min/1.73°m2) were 28-75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Maltese: kienet 28 - 75% aktar għolja relattivament mal-medji osservati f'suġġetti normali u f'saħħithom jew suġġetti bi gradi anqas ta' indeboliment tal-kliewi.
English: However, at high MPAG plasma concentrations (>°100 µg/mL), small amounts of MPAG are removed.
Maltese: Madankollu, f'konċentrazzjonijiet ta' MPAG fil-plażma għoljin (> 100 µg/mL), ammonti żgħar ta' MPAG huma mneħħijin.
English: In hepatic transplant patients initiated on mycophenolate mofetil and tacrolimus, the AUC and Cmax of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by coadministration with tacrolimus.
Maltese: Kif muri mis-soppressjoni ta' riġett akut wara trapjant tal-kliewi, l-attività immunosoppressanti ta' mycophenolate mofetil hija korrelata mal-konċentrazzjoni ta' MPA.
English: The recommended dose is 600°mg/m2 taken twice a day.
Maltese: Id-doża rakkomandata hija ta' 600 mg/m2 li tingħata mill-ħalq darbtejn kuljum.
English: The capsule cap is light blue opaque printed ‘M' axially in black ink.
Maltese: Jekk kapsula tkun infetħet b'mod aċċidentali, laħlaħ it-trab minn mal-ġilda bis-sapun u l-ilma.
English: Sevelamer
Maltese: Anzjani
English: • if you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.
Maltese: • jekk ikollok xi evidenza ta' infezzjoni (e.g. deni, griżmejk juġawk), tbenġil mhux mistenni u/jew fsada
English: Therefore Myfenax is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection.
Maltese: Għalhekk Myfenax huwa kontraindikat waqt it-tqala ħlief jekk ma jkunux disponibbli trattamenti alternattivi xierqa biex jiġi evitat rifjut tat-trapjant.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola miksija b'rita, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: In healthy volunteers, no significant interaction was observed when mycophenolate mofetil was concomitantly administered with norfloxacin or metronidazole separately.
Maltese: Norfloxacin u metronidazole F'voluntiera f'saħħithom, ma kienet osservata l-ebda interazzjoni sinifikanti meta mycophenolate mofetil ingħata flimkien ma' norfloxacin jew metronidazole separatament.
English: Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation.
Maltese: Mycophenolate mofetil ġie assoċjat ma' inċidenza akbar ta' reazzjonijiet avversi tas-sistema diġestiva, inkluż każi mhux tas-soltu ta' ulċerazzjoni tat-tubi gastrointestinali, emorraġija u perforazzjoni, Myfenax għandu jiġi mgħoti b'kawtela 'l pazjenti b'mard attiv serju tas-sistema diġestiva.
English: The systemic exposure at these levels is approximately equivalent to or less than 0.5°times the clinical exposure at the recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3°times the clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients (see section 4.6).
Maltese: 0.3 darbiet l-esponiżizzjoni klinika fid-doża klinika rakkomandata ta' 3 g/kuljum f'pazjenti bi trapjanti tal-qalb (ara sezzjoni 4.6).
English: Norfloxacin and metronidazole
Maltese: toraċiċi u medjastinali
English: The most common opportunistic infections in patients receiving mycophenolate mofetil (2°g or 3°g daily) with other immunosuppressants in controlled clinical trials in renal (2°g data), cardiac and hepatic transplant patients followed for at least 1°year were candida mucocutaneous, cytomegalovirus (CMV) viraemia/syndrome and Herpes simplex.
Maltese: mediċini immunosoppressivi oħrajn fi provi kliniċi kkontrollati fuq pazjenti bi trapjanti tal-kliewi (2 g kuljum), tal-qalb u tal-fwied, li kienu seġwiti għal tal-anqas sena.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Maltese: malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
English: Film-coated tablet (tablet)
Maltese: Pilloli miksija b'rita (pillola)
English: • infection of the urinary tract
Maltese: • infezzjoni tal-apparat tal-awrina
English: Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia,
Maltese: Emorraġija gastro-intestinali, peritonite, ileus, kolite,
English: No pharmacokinetic data are available during hepatic transplant rejection.
Maltese: interazzjoni farmakokinetika bejn mediċina u oħra.
English: System organ class Frequency Adverse drug reactions hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia Psychiatric disorders Very commonCommon
Maltese: iperlipidimja, ipofosfatimja, iperurikimja, gotta, anoressija
English: Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience.
Maltese: Waslu rapporti ta' dożi eċċessivi b'mycophenolate mofetil minn provi kliniċi u mill-esperjenza ta' wara t-tqegħid fis-suq.
English: These data support extrapolation of this finding to all antacids because the reduction in exposure when mycophenolate mofetil was co- administered with magnesium and aluminium hydroxides is considerably less than when mycophenolate mofetil was co-administered with PPIs.
Maltese: Ħtieġa ta' kontraċezzjoni għall-pazjenti li jista' jkollhom it-tfal qabel, matul u wara trattament b'mycophenolate mofetil.
English: Additional adverse reactions reported during post-marketing are described below with the frequencies reported within brackets if known.
Maltese: Reazzjonijiet avversi addizzjonali rrapportati fil-proċess ta' waqt it-tqegħid fis-suq huma mfissrin hawn taħt bil-frekwenzi rrapportati fil-parentesi jekk ikunu magħrufin.
English: Intravenous use vial (glass) 1 ml
Maltese: 1 ml kunjett 1
English: Concentrate for solution for infusion
Maltese: Konċentrat għal soluzzjoni għal infużjoni
English: 1 vial
Maltese: t x
English: Rivium Westlaan 142 2909 LD Capelle a/d Ijssel Nederlands
Maltese: Westlaan 142 2909 LD Capelle a/d Ijssel Nederlands
English: S.M.B
Maltese: M.B
English: de Europa, 20 B. Parque Empresarial La Moraleja; Alcobendas; 28108 Madrid
Maltese: Parque Empresarial La Moraleja; Alcobendas; 28108 Madrid
English: 176, rue de l'Arbrisseau 59000 Lille
Maltese: 176, rue de l'Arbrisseau 59000
English: BioPhausia AB, Blasieholmsgatan 2 111 48 Stockholm Sweden
Maltese: AB, Blasieholmsgatan 2 111 48 Stockholm Sweden
English: 25, rue des Peupliers ZAC Les Hautes Pâtures Parc d'Activités des Peupliers 92000 Nanterre France
Maltese: 25, rue des Peupliers ZAC Les Hautes Pâtures Parc d'Activités des Peupliers 92000
English: Expanpharm International 6, rue de la Rochefoucauld 16000 Angoulême France
Maltese: Expanpharm International 6, rue de la Rochefoucauld 16000
English: 185 Giannou Kranidioti Avenue CY-2235
Maltese: 185 Giannou Kranidioti Avenue
English: Medochemie LTD Medochemie Building 1-10 Constantinoupoleos Str., 3011 Limassol, Cyprus
Maltese: Medochemie LTD Medochemie Building 1-10 Constantinoupoleos
English: For a single dose of dextropropoxyphene 65 mg in postoperative pain the number needed to treat to benefit for at least 50% pain relief was 7.7 (95% confidence interval 4.6 to 22) when compared with placebo over 4-6 hours.
Maltese: Għal doża unika ta' dextropropoxyphene 65 mg għall-uġigħ ta' wara operazzjoni, in-numru ta' pazjenti li kellhom jiġu kkurati biex jibbenefikaw minn tnaqqis tal-uġigħ ta' mill-inqas 50% kien ta' 7.7 (intervall ta' kunfidenza ta' 95% bejn 4.6 u 22) meta mqabbel mal-plaċebo fuq perijodu ta' 4-6 sigħat.
English: On the basis of evidence of harm from reports of fatal overdose, of divergent safety reviews and previous regulatory action taken in several Member States, the European Commission initiated a referral under Article 31(2) of Directive 2001/83/EC, as amended, to address this public health issue for medicinal products containing dextropropoxyphene and paracetamol, and therefore referred the matter to the CHMP on 30 November 2007.
Maltese: Fuq il-bażi ta' evidenza ta' danni minn rapporti ta' doża eċċessiva fatali, ta' reviżjonijiet diverġenti dwar is-sigurtà u ta' azzjoni regolatorja preċedenti meħuda f'bosta Stati Membri, il-Kummissjoni Ewropea tat bidu għal riferiment skont l-Artikolu 31(2) tad-Direttiva 2001/83/KE, kif emendata, sabiex tindirizza din il-kwistjoni ta' saħħa pubblika għall-prodotti mediċinali li fihom dextropropoxyphene u paracetamol, u għalhekk irreferiet il-kwistjoni lis-CHMP fit-30 ta' Novembru 2007.
English: Labo Concept Pharm 26, boulevard Paul Vaillant Couturier 94200 Ivry Sur Seine France
Maltese: Labo Concept Pharm 26, boulevard Paul Vaillant Couturier 94200
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended for medicinal products containing dextropropoxyphene;
Maltese: - Il-Kumitat ikkunsidra r-riferiment magħmul skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata għal prodotti mediċinali li fihom dextropropoxyphene;
English: The most frequently reported adverse reactions with fatal outcome involved hepatobiliary disorders, skin disorders, general disorders, blood and lymphatic disorders, nervous system disorders, gastrointestinal disorders and cardiac disorders.
Maltese: Ir-reazzjonijiet avversi li l-aktar li ġew irrapportati b'eżitu fatali involvew disturbi fil-kliewi u fis-sistema urinarja, disturbi tal-ġilda, disturbi ġenerali, disturbi tad-demm u tas-sistema limfatika, disturbi fis-sistema nervuża, disturbi gastro-intestinali u disturbi fil-qalb..
English: For the equivalent dose of dextropropoxyphene combined with paracetamol 650 mg the NNT was 4.4 (3.5 to 5.6) when compared with placebo, indicating higher efficacy.
Maltese: Għad-doża ekwivalenti ta' dextropropoxyphene flimkien ma' paracetamol 650 mg, l-NNT (in-numru ta' pazjenti li kellhom jiġu kkurati - number needed to treat) kien ta' 4.4 (3.5 sa 5.6) meta mqabbel mal-plaċebo, u dan jindika effikaċja ogħla.
English: Qualimed (Lyon) 117 Allée des Parcs 69800 Saint Priest France
Maltese: Qualimed (Lyon) 117 Allée des Parcs 69800
English: Parke Davis, S.L.
Maltese: Parke Davis, S.L. Avda. de Europa, 20 B.
English: Pharmacie Generiques 11-15 Quai de Dion Bouton 92800 Puteaux France
Maltese: Quai de Dion Bouton 92800 Puteaux France