FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products associated with bleeding risk: There is an increased risk of bleeding due to the potential additive effect.
Maltese: Hemm żieda fir-riskju ta' fsada minħabba l-potenzjal ta' effett addizzjonali.
English: In patients with atrial fibrillation, clopidogrel should be given as a single daily dose of 75 mg. ASA (75-100 mg daily) should be initiated and continued in combination with clopidogrel (see section
Maltese: F'pazjenti b'fibrillazzjoni atrijali, clopidogrel għandu jingħata bħala doża waħda kuljum ta' 75 mg. ASA (75-100 mg) għandu jinbeda u jitkompla jittieħed flimkien ma' clopidogrel (ara sezzjoni 5.1)
English: SSRIs: since SSRIs affect platelet activation and increase the risk of bleeding, the concomitant administration of SSRIs with clopidogrel should be undertaken with caution.
Maltese: SSRIs: peress li l-SSRIs jaffettwaw l-attivazzjoni tal-plejtlits u jżidu r-riskju ta' fsada, it-teħid flimkien ta' SSRIs ma' clopidogrel għandu jsir b'kawtela.
English: TOPIC and TROPICAL-ACS were designed to study how to mitigate the bleeding events while maintaining efficacy.
Maltese: TOPIC u TROPICAL-ACS ġew magħmula biex jiġi studjat kif jitnaqsu dawn l-avvenimenti ta' fsada waqt li tinżamm l-effikaċja.
English: Tablet core:
Maltese: Farmakoġenetika:
English: TOPIC (Timing Of Platelet Inhibition after acute Coronary syndrome) This randomized, open-label trial included ACS patients requiring PCI.
Maltese: TOPIC (L-Aħjar Żmien għall-Inibizzjoni tal-Plejtlits wara sindromu Koronarju akut- Timing Of Platelet Inhibition after acute Coronary syndrome)
English: Packaging Content Package size
Maltese: Ippakkjar Kontenut Dacqs tal pakkett
English: Target species Route of administration
Maltese: Speċi li fuqhom għandu jintuża il-prodott
English: EU Number
Maltese: Numru ta' l-UE Isem kummerċjali
English: Withdrawal period
Maltese: Perjodu ta' Tiżmim
English: EMA Number
Maltese: Numru tal-UE
English: 29 May 2013 EMA/313994/2013
Maltese: 29 ta' Mejju 2013 EMA/313994/2013
English: The review of oral almitrine-containing medicines was initiated in December 2012 at the request of France, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni tal-mediċini li fihom almitrine nbdiet f'Diċembru 2012 fuq talba minn Franza, skont lArtikolu 31 tad-Direttiva 2001/83/KE.
English: Almitrine is a respiratory stimulant, a medicine that stimulates the part of the brain responsible for the breathing reflex.
Maltese: Almitrine huwa stimulant respiratorju, mediċina li tistimula l-parti tal-moħħ responsabbli għar-rifless tan-nifs.
English: • The safety review confirmed a clear association of oral almitrine therapy with significant weight loss and peripheral neuropathy (which can be long-lasting and possibly irreversible).
Maltese: • Ir-reviżjoni tas-sigurtà kkonfermat assoċjazzjoni ċara tat-terapija b'almitrine orali ma' telf sinifikanti fil-piż u newtroterapija periferali (li tista' tkun fit-tul u possibbilment irreversibbli).
English: In 489 cases, neuropathy was indicated to have been irreversible, or to have led to sequelae.
Maltese: F'489 każ, innewtroterapija kienet indikata bħala irreversibbli, jew li wasslet għal konsegwenzi negattivi.
English: In the EU, it is authorised in France, Poland and Portugal as 50-mg tablets (Vectarion, Armanor) for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood).
Maltese: Fl-UE, huwa awtorizzat fi Franza, il-Polonja u l-Portugall bħala pilloli ta' 50 mg (Vectarion, Armanor) għall-kura ta' insuffiċjenza respiratorja kronika (l-inabbiltà tal-pulmuni li jieħdu l-ossiġenu u jeħilsu mid-dijossidu tal-karbonju sew), li huwa assoċjat ma' hypoxaemia (livelli ta' ossiġnu fid-demm anqas min-normal).
English: The company marketing almitrine identified 795 spontaneously reported cases of weight loss and 2,304 cases of peripheral neuropathy over the 30-year period that the medicine has been marketed (representing several million patient months of treatment).
Maltese: Il-kumpanija li tikkumerċjalizza almitrine identifikat 795 każ irrappurtat b'mod spontanju ta' telf fil-piż u 2 304 każijiet ta' newtroterapija periferali matul il-perjodu ta' 30 sena li l-mediċina kienet qiegħda fis-suq (dan jirrappreżenta xhur fejn ġew ikkurati diversi miljuni ta' pazjenti).
English: Almitrine is a stimulant of the part of the brain responsible for the breathing reflex.
Maltese: Almitrine huwa stimulant tal-parti tal-moħħ responsabbli għar-rifless tan-nifs.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: Is-CMDh, korp li jirrappreżenta l-Istati Membri tal-UE, huwa responsabbli għall-iżgurar ta' standards armonizzati għas-sigurtà tal-mediċini awtorizzati permezz tal-proċeduri nazzjonali madwar l-UE kollha.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: Il-Kumitat Konsultattiv dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) wettaq l-ewwel reviżjoni ta' din id-dejta.
English: PRAC recommendation will be directly implemented following CMDh consensus
Maltese: Ir-rakkomandazzjonijiet tal-PRAC se jiġu implimentanti direttament wara lkunsens tas-CMDh
English: Of the spontaneous reports, 7 cases of weight loss and 20 of peripheral neuropathy had been reported since September 2003 when all these measures were in operation.
Maltese: Mir-rapporti spontanji, 7 każijiet ta' telf fil-piż u 20 ta' newroterapija periferali ġew irrappurtati minn Settembru 2003 meta dawn il-miżuri kollha kienu fis-seħħ.
English: The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), a medicines regulatory body representing the EU Member States, has endorsed the recommendation by the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC), that permission to market oral medicines containing almitrine should be withdrawn across the European Union (EU).
Maltese: Il-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh), korp regolatorju tal-mediċini li jirrappreżenta l-Istati Membri tal-UE, approva rrakkomandazzjoni mill-Kumitat Konsultattiv għall-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) tal-EMA, li l-permess għat-tqegħid fis-suq tal-mediċini orali li fihom almitrine għandu jiġi rtirat madwar l-Unjoni Ewropea (UE) kollha.
English: • Prescribers and pharmacists will be sent a letter giving them further information on the withdrawal of oral almitrine.
Maltese: • It-tobba li jippreskrivu u l-ispiżjara se tintbagħtilhom ittra li tagħtihom aktar informazzjoni dwar lirtirar ta' almitrine orali.
English: In the EU, it is authorised in France, Poland and Portugal to be taken orally for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood).
Maltese: Fl-UE, huwa awtorizzat fi Franza, il-Polonja u l-Portugall biex jittieħed mill-ħalq għall-kura ta' insuffiċjenza respiratorja kronika (linabbiltà tal-pulmuni li jieħdu l-ossiġenu u jeħilsu mid-dijossidu tal-karbonju sew), li huwa assoċjat ma' hypoxaemia (livelli ta' ossiġnu fid-demm inqas min-normali).
English: • The PRAC noted that cases of weight loss and peripheral neuropathy have continued to be reported, despite the introduction of a number of risk minimisation measures, including sequential administration (two months treatment followed by a one-month break), dose reduction and appropriate warnings in the product information.
Maltese: • Il-PRAC innota li l-każijiet ta' telf fil-piż u newroterapija periferali baqgħu jiġu rrappurtati, minkejja l-introduzzjoni ta' għadd ta' miżuri għat-tnaqqis tar-riskju, inkluż għoti sekwenzali (kura ta' xahrejn segwita minn waqfien temporanju ta' xahar), tnaqqis fid-doża u twissijiet xierqa fl-informazzjoni dwar il-prodott.
English: Almitrine is not one of the treatments currently recommended in international guidelines for COPD management (GOLD), and the available evidence does not support a clinical benefit for long-term oral treatment with the medicine.
Maltese: Almitrine mhuwiex wieħed mill-kuri rrakkomandati bħalissa fil-linji gwida internazzjonali għall-ġestjoni tas-COPD (GOLD), u l-evidenza disponibbli ma tappoġġjax il-benefiċċju kliniku għall-kura orali għal żmien twil bil-mediċina.
English: The safety review of oral almitrine was requested by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), because of concerns about side effects and a view that the available evidence did not support the use of the medicine in the current management of COPD.
Maltese: Ir-reviżjoni tas-sigurtà ta' almitrine orali kienet mitluba mill-aġenzija Franċiża tal-mediċini, l-Aġenzija Nazzjonali għas-Sigurtà tal-Mediċini u l-Prodotti tas-Saħħa (ANSM), minħabba tħassib dwar l-effetti sekondarji u opinjoni li l-evidenza disponibbli ma kinitx tappoġġja l-użu tal-mediċina fil-ġestjoni attwali tas-COPD.
English: • Oral almitrine-containing products should no longer be prescribed or dispensed to patients.
Maltese: • Il-prodotti orali li fihom almitrine ma għandhomx jiġu preskritti jew mogħtija lill-pazjenti.
English: In view of the potentially serious adverse effects and the lack of an established role in the current management of hypoxaemic pulmonary disease, the benefit-risk of oral almitrine is no longer considered favourable.
Maltese: Fid-dawl tal-effetti ħżiena potenzjalment serji u n-nuqqas ta' rwol stabbilit fil-ġestjoni attwali ta' mard pulmonari ipossjemiku, il-benefiċċju u r-riskju ta' almitrine orali ma għadux jitqies favorevoli.
English: The PRAC concluded that there is a clear association between oral almitrine treatment and potentially serious and long-lasting peripheral neuropathy (damage to the nerves in the hands and feet) and significant weight loss that further weakens patients.
Maltese: Il-PRAC ikkonkluda li hemm assoċjazzjoni ċara bejn il-kura b'almitrine orali u newropatija periferali potenzjalment serja u fit-tul (ħsara lin-nervituri tal-idejn u s-saqajn) u telf sinifikanti fil-piż li jdgħajjef ulterjorment lill-pazjenti.
English: As the CMDh position was adopted by consensus, it will be directly implemented by the Member States where oral almitrine-containing medicines are authorised.
Maltese: Peress l-pożizzjoni tas-CMDh ġiet adottata b'kunsens, din ġiet implimentata b'mod dirett mill-Istati Membri fejn huma awtorizzati l-mediċini orali li fihom almitrine.
English: As almitrine-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Maltese: Peress li l-mediċini li fihom almitrine huma kollha awtorizzati fuq livelli nazzjonali, ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għal Proċedura tarRikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem, li adotta pożizzjoni finali.
English: • Because almitrine has been shown to carry a risk of damage to the nerves in the hands and feet as well as weight loss, and because a number of alternative treatments are now available, it will be withdrawn across the EU.
Maltese: • Peress li ntwera li amitrine għandu riskju ta' ħsara fin-nervituri tal-idejn u s-saqajn kif ukoll ta' telf fil-piż, u peress li huma disponibbli għadd ta' kuri alternattivi, se jiġi rtirat madwar l-UE kollha.
English: • The understanding of COPD and the therapeutic options for its management have changed considerably since the original authorisation of oral almitrine.
Maltese: • Il-fehim tas-COPD u l-għażliet terapewitiċi għall-ġestjoni tagħha raw tibdil konsiderevoli minn mindu ngħatat l-awtorizzazzjoni oriġinali ta' almitrine orali.
English: The Agency's recommendations are based on an EU-wide safety review.
Maltese: Ir-rakkomandazzjonjiet tal-Aġenzija huma bbażati fuq reviżjoni tas-sigurtà għall-Ewropa kollha.
English: Furthermore, oral almitrine is no longer included as a recommended therapy in international treatment guidelines for the management of COPD.
Maltese: Barra minn hekk, amitrine orali ma għadux inkluż bħala terapija rrakkomandata fil-linji gwida internazzjonali ta' kura għall-ġestjoni tasCOPD.
English: In three of the latter cases, patients were rechallenged with almitrine and this led to a recurrence of neuropathic symptoms, including sequelae in two.
Maltese: Fi tlieta minn dawn ilkażijiet li għadhom kif issemmew, il-pazjenti ġew ikkurati mill-ġdid b'almitrine u dan wassal għal rikorrenza tas-sintomi newropatiċi, inkluż konsegwenzi negattivi f'tnejn minnhom.
English: As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented directly by the Member States where oral almitrine is authorised, according to an agreed timetable which should be completed by 25 July 2013.
Maltese: Peress li r-rakkomandazzjoni tal-PRAC ġiet approvata b'kunsens mis-CMDh, issa se tiġi implimentata direttament mill-Istati Membri fejn huwa awtorizzat almitrine orali, skont l-iskedi ta' żmien miftehma li għandhom ikunu lesti sal-25 ta' Lulju 2013.
English: Store below 30 °C.
Maltese: Aħżen f'temperatura taħt 30 °C.
English: Κηφισίας 120 & Φλοίας 10 151 25 Μαρούσι, Αθήνα - Ελλάδα
Maltese: Φλοίας 10 151 25 Μαρούσι, Αθήνα - Ελλάδα
English: ISANGEN PHARMA CYPRUS LTD Guricon House, Ηνωμένων Εθνών 48, 2ος & 3ος όροφος
Maltese: ISANGEN PHARMA CYPRUS LTD Guricon House, Ηνωμένων Εθνών 48, 2ος &
English: Contraception (see section 4.6)
Maltese: Kontraċezzjoni (ara sezzjoni 4.6)
English: Norfloxacin and metronidazole
Maltese: Norfloxacin u metronidazole
English: • Nervous system malformations such as spina bifida;
Maltese: • Malformazzjonijiet fis-sistema nervuża bħal spina bifida;
English: Date of latest renewal: 27 May 2015
Maltese: Data tal-aħħar tiġdid: 27 ta' Mejju 2015
English: • sinus problems.
Maltese: • problemi tas-sinus.
English: Gastrointestinal
Maltese: Gastrointestinali
English: Teratogenic effects
Maltese: Effetti teratoġeniċi
English: • Ciclosporin and corticosteroids.
Maltese: • Ciclosporin u Kortikosterojdi.
English: Capsule shells Gelatine
Maltese: Il-qxur tal-kapsula Gelatine
English: • congenital choroid plexus cyst;
Maltese: • ċesta konġenitali fil-choroid plexus;
English: Children aged 2 to 18 years
Maltese: Tfal b'età minn 2 sa 18-il sena
English: Gastro-intestinal
Maltese: Gastro-intestinali
English: EU/1/10/647/004 (300 hard capsules)
Maltese: EU/1/10/647/004 (300 kapsula iebsa)
English: Capsule shells: gelatine, titanium dioxide (E 171)
Maltese: Qalba tal-kapsula: Gelatine, titanium, titanium dioxide (E 171)
English: • pneumonia, bronchitis
Maltese: • pnewmonja, bronkite,
English: 300 hard capsules
Maltese: 300 kapsula ibsin
English: MPA's disposition depends on several transporters.
Maltese: Id-dispożizzjoni ta' MPA tiddependi fuq diversi trasportaturi.
English: Paediatric population < 2 years
Maltese: Popolazzjoni pedjatrika < 2 sentejn
English: For contraception advice for men see section 4.6.
Maltese: Għal parir dwar il-kontraċezzjoni għall-irġiel ara sezzjoni 4.6.
English: • using a sunscreen with a high protection factor.
Maltese: • tuża' sunscreen b'fattur protettiv għoli.
English: INFORMATION IN BRAILLE Myclausen 250 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Myclausen 250 mg
English: MPA at clinically relevant concentrations is 97 % bound to plasma albumin.
Maltese: F'konċentrazzjonijiet li huma klinikament rilevanti MPA huwa 97 % maqgħud mal-albumina talplażma.
English: INFORMATION IN BRAILLE Myclausen 500 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Myclausen 500 mg
English: The pharmacodynamic profile and the reported adverse reactions indicate that an effect is unlikely.
Maltese: Il-profil farmakodinamiku u r-rapporti ta' reazzjonijiet avversi, jindikaw li effett mhux probabbli.
English: This leaflet was last revised in {MM/YYYY}
Maltese: DATA TA' META ĠIET RIVEDUTA
English: Trimethoprim/sulfamethoxazole No effect on the bioavailability of MPA was observed.
Maltese: Trimethoprim /sulphamethoxazole Ma ġie osservat l-ebda effett fuq il-biodisponibiltà ta' MPA.
English: The proportion of patients with CMV viraemia/syndrome was 13.5 %.
Maltese: Il-proporzjon ta' pazjenti b'viremija/sindrome b'CMV kien ta' 13.5 %.
English: Mycophenolate mofetil is an IMPDH (inosine monophosphate dehydrogenase) inhibitor.
Maltese: Mycophenolic mofetil huwa inibitur ta' IMPDH (inosine monophosphate dehydrogenase).
English: • rifampicin (an antibiotic used to prevent and treat infections such as tuberculosis)
Maltese: • rifampicin (antibijotiku użat għall-prevenzjoni u l-kura ta' infezzjonijiet bħat-tuberkulożi (TB))
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletrali u tat-tessut konnettiv
English: A minor acylglucuronide (AcMPAG) is also formed.
Maltese: Jiġi ffurmat ukoll acylglucuronide minuri (AcMPAG).
English: • septum pellucidum agenesis;
Maltese: • aġenesi tas-septum pellucidum;
English: • Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ transplant patients treated with immunosuppressants other than mycophenolate mofetil.
Maltese: • Aborti spontanji kienu irrappurtati f'45 sa 49% ta' nisa tqal esposti għal mycophenolate mofetil, imqabbel ma' rata rappurtata ta' bejn 12 u 33% f'pazjenti bi trapjant ta' organi solidi ttrattati b'immunosoppressanti oħra minbarra mycophenolate mofetil.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 7 ta' Ottubru 2010
English: A study of the co-administration of mycophenolate mofetil (1 g bid) and combined oral contraceptives containing ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) or gestodene (0.05 mg to 0.10 mg) conducted in 18 nontransplant women (not taking other immunosupressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of mycophenolate mofetil on the ovulation suppressing action of the oral contraceptives.
Maltese: Studju tal-għotja ta' mycophenolate mofetil (1 g bid) flimkien ma' kontraċettivi orali kombinati li fihom ethinylestradiol (0.02 mg sa 0.04 mg) u levonorgestrel (0.05 mg sa 0.15 mg), desogestrel (0.15 mg) jew gestodene (0.05 mg sa 0.10 mg) li sar fuq 18-il mara mingħajr trapjant (u li ma kienux qed jieħdu immunosoppressanti oħrajn) fuq medda ta' 3 ċikli menstruwali konsekuttivi ma wera l-ebda influwenza klinikament rilevanti ta' mycophenolate mofetil fuq l-azzjoni ta' soppressjoni tal-ovulazzjoni tal-kontraċettivi orali.
English: Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA.
Maltese: Mycophenolate mofetil huwa l-ester 2-morpholinoethyl ta' MPA.
English: Pharmacotherapeutic group: immunosuppressants, selective immunosuppressants, ATC code L04AA06
Maltese: Kategorija farmakoterapewtika: immunosoppresanti, immunosoppressanti selettivi, Kodiċi ATC:
English: Antacids and proton pump inhibitors (PPIs)
Maltese: Antaċidi u inibituri tal-pompa tal-protoni (PPIs)
English: Organic anion-transporting polypeptides (OATPs) and multidrug resistance-associated protein 2 (MRP2) are involved in MPA's disposition; OATP isoforms, MRP2 and breast cancer resistance protein (BCRP) are transporters associated with the glucuronides' biliary excretion.
Maltese: Polipeptidi organiċi li jittrasportaw lanjoni (OATPs - organic anion-transporting polypeptides) u proteina 2 assoċjata ma' reżistenza għal ħafna mediċini (MRP2 - multidrug resistance-associated protein 2) huma involuti fid-dispożizzjoni ta' MPA; isoformi ta' OATP, MRP2 u proteina ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein) huma trasportaturi assoċjati mat-tneħħija biljari ta' glucuronides.
English: Common Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Maltese: Emorraġija gastrointestinali, peritonite, ileus, kolite, ulċera gastrika, ulċera fid-duwodenu, gastrite, osofaġite, stomatite, stitikezza, dispepsja, gass, tifwiq
English: Telmisartan changes MPA's elimination by enhancing PPAR gamma (peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced UGT1A9 expression and activity.
Maltese: Telmisartan ibiddel l-eliminazzjoni ta' MPA billi jtejjeb l-espressjoni ta' PPAR gamma (peroxisome proliferator-activated receptor gamma), li mbagħad iwassal għal titjib flespressjoni u l-attività ta' UGT1A9.
English: Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with mycophenolate mofetil.
Maltese: Tnaqqis fl- esponiment għal MPA kien osservat meta antaċidi, bħal magnesium u aluminium hydroxides, u PPIs, inkluż lansoprazol u pantoprazol, ingħataw flimkien ma' mycophenolate mofetil.
English: • Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the orbits;
Maltese: • Malformazzjonijiet fil-wiċċ bħal xoffa mixquqa, palat mixquq, mikrognatija u iperteloriżmu tal orbiti;
English: Do not take Myclausen
Maltese: Tiħux Myclausen
English: PHARMACEUTICAL FORM AND CONTENTS 100 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 100 kapsula ibsin
English: Serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Maltese: Infezzjonijiet serji li jipperikolaw il-ħajja inkluż meninġite, endokardite, tuberkulożi, u infezzjonijiet atipiċi kkawżati minn mycobacteria.
English: Tel.: 0049 (0)30 744 60 12 Fax: 0049 (0)30 744 60 41
Maltese: 12 Fax: 0049 (0)30 744 60
English: Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Maltese: Għalhekk għandu jiġi evitat f'pazjenti b'nuqqas ereditarju, rari ta' hypoxanthine-guanine phosphoribosyltransferase (HGPRT) bħas- sindrome Lesch-Nyhan u Kelley-Seegmiller.
English: Sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster Common Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
Maltese: Pnewmonja, influwenza,infezzjoni fl-apparat respiratorju, monolijażi respiratorja, infezzjoni gastrointestinali, kandidajażi, gastroenterite, infezzjoni, bronkite, farinġite, sinożite, infezzjoni tal-ġilda mill-moffa, kandida talġilda, kandidajażi tal-vaġina, rinite
English: MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive phenolic glucuronide of MPA (MPAG).
Maltese: MPA huwa metabolizzat l-aktar minn glucuronyl transferase (isoforma UGT1A9) biex jifforma ilglucuronide fenoliku mhux attiv ta' MPA (MPAG).
English: • Abnormalities of the eye (e.g. coloboma);
Maltese: • Anormalitajiet tal-għajnejn (eż. koloboma);
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Mediċini http://www.ema.europa.eu.
English: • Tracheo-Oesophageal malformations (e.g. oesophageal atresia);
Maltese: • Malformazzjonijiet tat-trakea u tal-esofagu (eż. atreżja tal-esofagu);
English: Gingival hyperplasia (≥ 1/100 to < 1/10), colitis including cytomegalovirus colitis, (≥ 1/100 to < 1/10), pancreatitis, (≥ 1/100 to < 1/10) and intestinal villous atrophy.
Maltese: Iperplasija tal-ħanek (≥ 1/100 sa < 1/10), kolite (inkluż kolite b'cytomegalovirus), (≥ 1/100 sa < 1/10), pankreatite, (≥ 1/100 sa < 1/10) u atrofija tal-villi fl-imsaren.
English: Common Skin hypertrophy, rash, acne, alopecia
Maltese: Ipertrofija tal-ġilda, raxx, akne, alopeċja