FrancophonIA/ELRC3.0 huggingface dataset:
English: The task force of the American Society for Bone and Mineral Research (ASBMR) on atypical subtrochanteric and diaphyseal femoral fractures have defined major and minor features of atypical femoral fracture (Shane et al, 20103) and recommend that for a case to be considered an atypical femoral fracture all major features need to be present, whereas the minor features have commonly been described in cases of atypical femoral fractures, but are not present in all patients.
Maltese: Il-grupp ta' ħidma tas-Soċjetà Amerikana għar-Riċerka dwar l-Għadam u l-Minerali (ASBMR) dwar ilfratturi atipiċi subtrokanteriċi u dijafisejali tal-femur iddefinixxa l-karatteristiċi maġġuri u minuri ta' frattura atipika femorali (Shane et al, 20103) u rrakkomanda li biex każ jiġi kkunsidrat bħala frattura atipika femorali, il-karatteristiċi maġġuri kollha jridu jkunu preżenti, filwaqt li l-karatteristiċi minuri ġew normalment deskritti f'każijiet ta' fratturi femorali atipiċi , iżda mhumiex preżenti fil-pazjenti kollha.
English: The number of post-marketing reports of possible atypical femur fracture suspected to be associated with bisphosphonates has increased since the 2008 PhVWP review.
Maltese: In-numru ta' rapporti ta' wara t-tqegħid fis-suq dwar fratturi femorali atipiċi possibbli li huma suspettati li huma marbuta mal-bisfosfonati żdiedu sa mir-reviżjoni tal-PhVWP tal-2008.
English: Concomitant treatment with other anti-resorptive drugs such as hormone replacement therapy and raloxifene have also been proposed as possible risk factors.
Maltese: Kura konkomittanti b'mediċini kontra lassorbiment mill-ġdid bħal terapija ta' sostituzzjoni tal-ormoni u raloxifene ġiet proposta wkoll bħala fattur ta' riskju possibbli.
English: Overall summary of the scientific evaluation of Bisphosphonate-containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika tal-prodotti mediċinali li fihom il-Bisfosfonat (ara Anness I)
English: The lack of reports with the remaining bisphosphonates, clodronic acid, neridronic acid and tiludronic acid may be related to the lower exposure of these medicinal products compared with other bisphosphonates and a lack of an association can not be excluded.
Maltese: In-nuqqas ta' rapporti bil-bisfosfonati li fadal, aċidu klodroniku, aċidu neridroniku u aċidu tiludroniku jistgħu jkunu relatati mal-espożizzjoni aktar baxxa ta' dawn il-prodotti mediċinali meta mqabbla mal-bisfosfonati loħra u nuqqas ta' assoċjazzjoni ma jistax jiġi eskluż.
English: Other studies with radiographic evidence have also reported an increased incidence of atypical femoral fractures in patients treated with bisphosphonates compared to non-exposed patients, which may increase with duration of bisphosphonate treatment (Dell et al, 201013, Schilcher et al, 200914).
Maltese: Studji oħra li għandhom evidenza radjografika rrapportaw ukoll żieda fl-inċidenza ta' fratturi femorali atipiċi f'pazjenti li rċevew kura bilbisfosfonati meta mqabbla ma' dawk il-pazjenti li ma kinux esposti, li dan jista' jiżdied mat-tul tal-kura bil-bisfosfonat (Dell et al, 201013, Schilcher et al, 200914).
English: Other than osteoporosis the most prevalent co-morbid conditions in patients with atypical femur fracture were found to be chronic obstructive pulmonary disease or asthma, rheumatoid arthritis and diabetes.
Maltese: Minbarra l-osteoporożi, l-aktar kundizzjonijiet ko-morbidi prevalenti filpazjenti bi fratturi femorali atipiċi nstabu li kienu l-mard pulmonari kroniku ostruttiv jew l-ażżma, lartrite rewmatika u d-dijabete.
English: Bisphosphonates are medicinal products that are used to treat and prevent bone disorders including hypercalcaemia and the prevention of bone problems in patients with cancer, the treatment of osteoporosis and Paget's disease.
Maltese: Il-bisfosfonati huma prodotti mediċinali li jintużaw fil-kura u fil-prevenzjoni tal-mard tal-għadam inkluż l-iyperkalkemija u l-prevenzjoni ta' problemi fl-għadam fil-pazjenti bil-kanċer, fil-kura tal-osteoporożi u fil-marda ta' Paget.
English: Following a Pharmacovigilance Working Party (PhVWP) review in 2008, it was concluded that a warning about atypical stress fractures of the proximal femoral shaft would be added to the product information for alendronic acid containing medicinal products across Europe.
Maltese: Wara reviżjoni tal-Grupp ta' Ħidma ta' Farmakoviġilanza (PhVWP) fl-2008, ġie konkluż li fl-Ewropa kollha sejra tiżdied twissija dwar il-fratturi atipiċi minħabba stress tax-xaft femorali prossimali mattagħrif dwar il-prodott għall-prodotti mediċinali li fihom l-aċidu alendroniku.
English: • On the basis of the available evidence, mainly from epidemiological studies and post-marketing reports, the Committee concluded that use of bisphosphonates may be associated with the risk of atypical femoral fractures.
Maltese: • Fuq bażi tal-evidenza disponibbli, primarjament minn studji epidemjoloġiċi u minn rapporti ta' wara t-tqegħid fis-suq, il-Kumitat ikkonkluda li l-użu tal-bisfosfonati jista' jiġi assoċjat mar-riskju ta' fratturi femorali atipiċi.
English: At the present time there is little evidence from literature and spontaneous reports to support an association between bisphosphonates and atypical fracture at sites other than the femur.
Maltese: Fil-preżent, ftit hemm evidenza minn dokumentazzjoni u minn rapporti spontanji li tappoġġa rabta bejn il-bisfosfonati u l-fratturi atipiċi f'siti oħra għajr il-femur.
English: 100 capsules 300 capsules 100 x 1 capsules
Maltese: 100 kapsula 300 kapsula 100x1 kapsula
English: 50 tablets 150 tablets 50 x 1 tablets
Maltese: 50 pillola 150 pillola 50x1 pillola
English: EU/1/07/438/001 (100 capsules) EU/1/07/438/002 (300 capsules) EU/1/07/438/006 (100 x 1 capsules)
Maltese: EU/1/07/438/001 (100 kapsula) EU/1/07/438/002 (300 kapsula) EU/1/07/438/006 (100x1 kapsula)
English: 2031GA Haarlem Netherlands
Maltese: 2031GA Haarlem L-Olanda
English: EU/1/07/438/003 (50 tablets) EU/1/07/438/004 (150 tablets) EU/1/07/438/005 (50 x 1 tablets)
Maltese: EU/1/07/439/003 (50 pillola) EU/1/07/439/004 (150 pillola) EU/1/07/439/005 (50x1 pillola)
English: Medicinal products that interfere with enterohepatic circulation (e.g. cholestyramine, ciclosporin A, antibiotics)
Maltese: Prodotti mediċinali li jinterferixxu maċ-ċirkolazzjoni enteroepatika (eż. cholestyramine, ciclosporin A, antibijotiċi)
English: • Congenital choroid plexus cyst;
Maltese: • ċesta konġenitali fil-choroid plexus;
English: Myfenax is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Maltese: Myfenax huwa impeditur ta' inosine monophosphate dehydrogenase (IMPDH).
English: Teva Operations Poland Sp. Z.o.o.
Maltese: Teva Operations Poland Sp. Z.o.o. Mogilska 80
English: It is important not to take too many capsules.
Maltese: Huwa importanti li ma tieħux aktar kapsuli milli suppost.
English: The proportion of patients with CMV viraemia/syndrome was 13.5%.
Maltese: Il-proporzjon ta' pazjenti b'viremja/sindromu CMV kien ta' 13.5%.
English: Potential interaction
Maltese: Interazzjonijiet potenzjali
English: Very common Sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster
Maltese: Komuni ħafna Sepsis, kandidjasi gastrointestinali, infezzjoni tal-passaġġ urinarju, herpes simplex, herpes zoster
English: Capsule content Pregelatinised starch (maize) Povidone K-30
Maltese: X'tikkonsisti l-kapsula Pregelatinised maize starch Povidone K-30
English: Children and adolescents (aged 2 to 18)
Maltese: Tfal u adoloxxenti (b'età minn 2 sa 18-il sena)
English: • proliferation of the lymphatic tissue, including malignant tumours
Maltese: • proliferazzjoni tat-tessut linfatiku, li jinkludi tumuri malinni
English: Microcrystalline cellulose Povidone K-30
Maltese: Il-qalba tal-pillola Microcrystalline cellulose Povidone K-30
English: Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA).
Maltese: Mycophenolate mofetil huwa l-2-morpholinoethyl ester ta' mycophenolic acid (MPA).
English: Myfenax contains sodium
Maltese: Myfenax fih sodium
English: • changes in different laboratory parameters
Maltese: • bidliet f'parametri differenti tal-laboratorju
English: Skin hypertrophy, rash, acne, alopecia
Maltese: Ipertrofija tal-ġilda, raxx, akne, alopeċja
English: System organ class Frequency Adverse drug reactions
Maltese: Sistema tal-klassifikazzjoni tal-organi
English: Note: 501 (2°g mycophenolate mofetil daily), 289 (3°g mycophenolate mofetil daily) and 277 (2°g intravenous/3°g oral mycophenolate mofetil daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
Maltese: Nota: 501 (2 g mycophenolate mofetil kuljum), 289 (3 g mycophenolate mofetil kuljum) u 277 (2 g intravenużi/3 g mycophenolate mofetil orali kuljum) pazjenti ġew ittrattati fi studji ta' Fażi
English: Pancytopenia, leukocytosis
Maltese: Panċitopenija, lewkoċitożi
English: Myfenax 250 mg Capsules
Maltese: Myfenax 250 mg Kapsuli
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 non-transplant women (not taking other immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of mycophenolate mofetil on the ovulation suppressing action of the oral contraceptives.
Maltese: Pazjenti li jieħdu kontraċettivi orali Studju dwar l-għoti konġunt ta' mycophenolate mofetil (1 g BID) u kontraċettivi orali kkombinati li jkun 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 to 0.10 mg) magħmul fi 18-il mara li ma kellhomx trapjant (mhux qegħdin jieħdu immunosoppressanti oħrajn) fuq 3 ċiċkli menstruwali konsekuttivi ma wrew l-ebda influwenza klinikament relevanti ta' mycophenolate mofetil fuq l-azzjoni ta' trażżin tal-ovulazzjoni tal-kontraċettivi orali.
English: Serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH) and progesterone were not significantly affected.
Maltese: Livelli fis-sirum tal-ormon lewtanizzanti (LH), ormon li jistimula l-follikuli (FSH) u progesterone ma kinux sinifikattivament effettwati.
English: • Septum pellucidum agenesis;
Maltese: • aġenesi tas-septum pellucidum;
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: pancreatitis (≥1/100 to <1/10) and intestinal villous atrophy.
Maltese: <1/10), (common), pankreatite (≥1/100 to <1/10) u atrofija tal-villi intestinali.
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 twassal għal espressjoni u attività ta' UGT1A9 imsaħħa.
English: Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA.
Maltese: Wara teħid orali, mycophenolate mofetil iġarrab assorbiment rapidu u estensiv u metaboliżmu komplut presistematiku għall-metabolit attiv, MPA.
English: MPA at clinically relevant concentrations is 97% bound to plasma albumin.
Maltese: MPA huwa 97% maqgħud mal-albumina tal-plażma.
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-espożizzjoni għal MPA kien osservat meta antaċidi, bħal magnesium u aluminium hydroxides, u PPIs, inkluż lansoprazol u pantoprazol, ingħataw flimkien ma' mycophenolate mofetil.
English: Pharmacotherapeutic group: immunosuppressive agents ATC code: LO4A A06
Maltese: Kategorija farmakoterapewtika: mediċini immunosoppressanti, Kodiċi ATC:
English: • serious disease of the central nervous system (JC virus associated progressive multifocal leucoencephalopathy)
Maltese: • marda serja tas-sistema nervuża ċentrali (lewkoenċefalopatija multifokali progressiva assoċjata mal-virus JC)
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali wrew tossiċità reproduttiva (ara sezzjoni 5.3).
English: Pharmacokinetic behaviour of mycophenolate mofetil in the elderly (≥°65 years) has not been formally evaluated.
Maltese: L-imġieba farmakokinetika ta' mycophenolate mofetil fl-anzjani (≥ 65 sena) ma ġietx formalment evalwata.
English: Hypotension, hypertension, vasodilatation
Maltese: Ipotensjoni, ipertensjoni, vażodilazzjoni
English: • The active substance is mycophenolate mofetil.
Maltese: • Is-sustanza attiva hi mycophenolate mofetil.
English: Transparent PVC/PVdC - aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.
Maltese: Pakketti trasparenti tal-PVC/PVdC - folji tal-aluminju li fihom 100, 300 jew 100x1 kapsula f'kull kartuna.
English: The pharmacodynamic profile and the reported adverse reactions indicate that an effect is unlikely.
Maltese: Il-profil farmakodinamiku u r-reazzjonijiet avversi rraportati jindikaw li effett mhux probabbli li jseħħ.
English: • bacterial infections usually resulting in a serious lung disorder (tuberculosis, atypical mycobacterial infection)
Maltese: • infezzjonijiet batteriċi li ġeneralment iwasslu għal disturb serju fil-pulmun (tuberkulożi, infezzjoni atipika kkawżata minn mikobatterja)
English: Adverse reactions, probably or possibly related to mycophenolate mofetil, reported in ≥1/10 and in ≥1/100 to <1/10 of patients treated with mycophenolate mofetil in the controlled clinical trials of renal (2°g data), cardiac and hepatic transplant patients are listed in the following table.
Maltese: Reazzjonijiet avversi, li probabilment jew possibilment huma relatati ma' mycophenolate mofetil, irraportati f'≥ 1/10 u f'≥1/100 sa <1/10 ta' pazjenti trattati b'mycophenolate mofetil fil-provi kliniċi kkontrollati ta' pazjenti bi trapjanti renali (dejta ta' 2 g), kardijaċi e epatiċi huma elenkati fit-tabella li ġejja.
English: Hypersensitivity reactions to Myfenax have been observed (see section 4.8).
Maltese: Kienu osservati reazzjonijiet ta' sensittività eċċessiva għal Myfenax (ara sezzjoni 4.8).
English: Date of first authorisation: 21 February 2008 Date of first renewal: 19 November 2012
Maltese: Data tal-ewwel tiġdid: 19 Novembru 2012
English: Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide.
Maltese: Il-linka sewda tikkonsisti minn: shellac, black iron oxide (E172), propylene glycol u potassium hydroxide.
English: • fungal infections (e.g. of the respiratory tract, skin and vagina)
Maltese: • infezzjonijiet fungali (eż. tal-apparat respiratorju, tal-ġilda u l-vaġina)
English: MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.
Maltese: MPA huwa impeditur potenti, silettiv, mhux kompettitiv u impeditur reversibbli ta' inosine monophosphate dehydrogenase, u għalhekk jimpedixxi l-passaġġ de novo tas-sintesi ta' guanosine nucleotide mingħajr ma jinkorporah fid-DNA.
English: Gingival hyperplasia (≥1/100 to <1/10), colitis including cytomegalovirus colitis (≥1/100 to <1/10),
Maltese: Iperplasja tal-ħanek (≥1/100 sa <1/10), kolite li tinkludi kolite minn ċitomegalovajrus(≥1/100 to
English: Spontaneous abortion (rate of 45% to 49%) and congenital malformations (estimated rate of 23% to 27%) have been reported following MMF exposure during pregnancy.
Maltese: Wara esponiment għal MMF waqt it-tqala kienu rrappurtati abort spontanju (rata ta' 45% sa 49%) u malformazzjonijiet konġenitali (rata stmata ta' 23% sa 27%).
English: Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide
Maltese: Il-linka sewda tikkonsisti minn: shellac, black iron oxide (E172), propylene glycol u potassium hydroxide
English: AcMPAG is pharmacologically active and is suspected to be responsible for some of MMF´s side effects (diarrhoea, leucopenia).
Maltese: AcMPAG huwa farmakoloġikament attiv u hemm suspett li huwa responsabbli għal xi wħud milleffetti sekondarji ta' MMF (dijarea, lewkopenija).
English: Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Maltese: Għalhekk, għandu jiġi evitat f'pazjenti li għandhom defiċjenza ereditarja rari ta' hypoxanthine-guanine phosphoribosyltransferase (HGPRT) bħal ma' huma s-sindromi Lesch-Nyhan u Kelley-Seegmiller.
English: • Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3% of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil).
Maltese: • Abbażi ta' rapporti mil-letteratura, malformazzjonijiet seħħew fi 23 sa 27% ta' twelid ħaj f'nisa esposti għal mycophenolate mofetil waqt it-tqala (imqabbla ma' 2 sa 3% ta' twelid ħaj fil popolazzjoni ġenerali u madwar 4 sa 5% ta' twelid ħaj f'riċevituri ta' trapjant ta' organi solidi kkurati b'immunosoppressanti minbarra mycophenolate mofetil).
English: Transparent PVC/PVdC-aluminium blisters in pack sizes of 50 or 150 or 50 x 1 tablets per carton.
Maltese: Pakketti tal-folji trasparenti ta' PVC/PVdC ta' folji ta' 50, 150 jew 50x1 pillola f'kull kartuna.
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leucoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Myfenax.
Maltese: Każijiet ta' newropatija assoċjata mal-virus BK, kif ukoll każijiet ta' lewkoenċefalopatija multifokali progressiva (PML) assoċjata mal-virus JC, kienu rrapportati f'pazjenti kkurati b'immunosoppressanti, inkluż Myfenax.
English: Teva UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG, UK
Maltese: Teva UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG, Ir-Renju Unit
English: Antibiotics eliminating β-glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA enterohepatic recirculation thus leading to reduced systemic MPA exposure.
Maltese: Antibijotiċi li jeliminaw il-batterji li jipproduċu β-glucuronidase fl-imsaren (eż. aminoglycoside, cephalosporin, fluoroquinolone, u klassijiet ta' penicillin ta' antibijotiċi) jistgħu jinterferixxu mar riċirkolazzjoni enteroepatika ta' MPAG/MPA li b'hekk jista' jwassal għal esponiment sistemikumnaqqas għal MPA.
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom
Maltese: TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG Ir-Renju Unit
English: Patients treated with immunosuppressants, including Myfenax, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Maltese: Pazjenti trattati b'immunosoppressanti, inkluż Myfenax, huma f'riskju akbar għall-infezzjonijiet opportunistiċi (mill-batterja, moffa, virus u protożoa), infezzjonijiet fatali u sepsis (ara sezzjoni 4.8).
English: The recommended daily dose is 8 capsules (2°g of the active ingredient) taken as 2 separate doses.
Maltese: Id-doża rakkomandata ta' kuljum hi ta' 8 kapsuli (2 g tas-sustanza attiva) meħuda f'żewġ dożi separati.
English: Very common Leukopenia, thrombocytopenia, anaemia Common
Maltese: Komuni ħafna Lewkopenija, tromboċitopenija, anemija
English: This means taking 6°capsules in the morning then 6°capsules in the evening.
Maltese: Dan ifisser li għandhom jittieħdu 6 kapsuli filgħodu imbagħad 6 kapsuli filgħaxija.
English: Myfenax 250 mg hard capsules are available in PVC/PVdC-aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.
Maltese: Myfenax 250 mg kapsuli iebsin jiġu f'pakketti tal-folji tal-PVC/PVdC-aluminju f'daqsijiet ta' 100, 300 jew 100x1 kapsula f'kull kartuna
English: Following single dose administration of 1.5°g of mycophenolate mofetil to normal healthy subjects pre-treated with 4°g three times a day (TID) of cholestyramine for 4°days, there was a 40% reduction in the AUC of MPA (see section 4.4 and section 5.2).
Maltese: Cholestyramine Wara l-għoti ta' doża waħda ta' 1.5 g ta' mycophenolate mofetil lil individwi normali f'saħħithom li kienu trattati minn qabel b'4 g tliet darbiet kuljum (TID) ta' cholestyramine għal 4 ijiem, kien hemm tnaqqis ta' 40% fl-AUC ta' MPA (ara sezzjoni 4.4 u sezzjoni 5.2).
English: Ciprofloxacin or amoxicillin plus clavulanic acid
Maltese: ciprofloxacin jew amoxicillin flimkien ma' clavulanic acid orali.
English: Each capsule contains 250 mg mycophenolate mofetil.
Maltese: Kull kapsula fiha 250 mg mycophenolate mofetil.
English: Trimethoprim/sulfamethoxazole No effect on the bioavailability of MPA was observed.
Maltese: Trimethoprim/sulphamethoxazole Ma ġie osservat l-ebda effett fuq il-bijodisponibiltà ta' MPA.
English: All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4).
Maltese: Il-pazjenti kollha li għandhom trapjant għandhom riskju akbar ta' infezzjonijiet opportunistiċi; irriskju jikber aktar ma tikber it-tagħbija immunosoppressiva totali (ara sezzjoni 4.4).
English: Contraception in men taking Myfenax
Maltese: Mediċini oħra u Myfenax
English: Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Maltese: Fi ħdan is-sistema ta' kategoriji tas-sistema ta' organi, l-effetti mhux mixtieqa huma elenkati taħt intestaturi ta' frekwenza bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (≤1/10,000),
English: Hypromellose (HPMC 2910) Titanium dioxide (E171)
Maltese: Hypromellose (HPMC 2910)
English: • infection of the lung, flu, infection of the respiratory tract
Maltese: • infezzjoni tal-pulmun, influwenza, infezzjoni tal-apparat respiratorju
English: In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg/kg/day (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg/kg/day (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
Maltese: Fl-istudji teratoloġiċi fil-firien u fil-fniek, risorbiment tal-fetu u malformazzjonijiet seħħew fil-firien f'6 mg/kg/day (li jinkludu anoftalmja, agnatija u idrokefali) u fil-fniek f'90 mg/kg/day (li jinkludu anomaliji kardjovaskularu u tal-kliewi, bħal ma huma ektopia kordis u kliewi ektopiċi, u ftuq dijafragmatiku u umbilikali), fl-assenza ta' tossicità materna.