FrancophonIA/ELRC3.0 huggingface dataset:
English: a: FLU/ITZ (1899); FLU (316).
Maltese: a: FLU/ITZ (1899); FLU (316). b: f'1899 dan kien il-perijodu minn meta kienu randomized sa l-aħħar doża tal-prodott mediċinali li qed jiġi studjat u
English: After administration of 14C-posaconazole, radioactivity was predominantly recovered in the faeces (77 % of the radiolabelled dose) with the major component being parent compound (66 % of the radiolabelled dose).
Maltese: Wara li jingħata 14C-posaconazole, ir-radjuattività inġabret fil-parti l-kbira mill-ippurgar (77 % tad doża radjutikkettata) bl-akbar komponent ikun il-mediċina oriġinali (66 % tad-doża radjutikkettata).
English: Both doses of posaconazole increased Cmax and AUC of oral midazolam (2 mg single oral dose) by 2.2 and 4.5-fold, respectively.
Maltese: Iż-żewġ dożi ta' pozaconazole it-tnejn li huma żiedu s-Cmax u l-AUC ta' midazolam mill-ħalq (2 mg doża waħda mill-ħalq) b'2.2 u 4.5-il darba, rispettivament.
English: acute renal failure, renal failure, blood creatinine increased renal tubular acidosis, interstitial nephritis
Maltese: insuffiċjenza renali akuta, insuffiċjenza renali, krejatinina fid-demm jiżdied aċidożi tat-tubi renali ż-żgħar, nefrite fl-interstizzju
English: Following co-administration of oral posaconazole (400 mg twice daily) with atazanavir and ritonavir (300/100 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 1.5-fold and 2.5-fold (range 0.9 to 4.1-fold), respectively.
Maltese: Wara l-għotja fl-istess ħin ta' posaconazole mill-ħalq (400 mg darbtejn kuljum) ma' azatanavir u ritonavir (300/100 mg darba kuljum) għal 7 ijiem f'individwi b'saħħithom is-Cmax u l-AUC ta' atazanavir żdiedu b'medja ta' 1.5-il darba u 2.5-il darba (medda 0.9 sa 4.1-il darba), rispettivament.
English: In addition, oral posaconazole (200 mg or 400 mg) prolonged the mean terminal half-life of midazolam from approximately 3-4 hours to 810 hours during co-administration.
Maltese: Minbarra hekk, posaconazole mill-ħalq (200 mg jew 400 mg) tawwal il-medja tal-half-life terminali ta' midazolam minn madwar 3-4 sigħat għal 8-10 sigħat meta ngħataw flimkien.
English: Oral posaconazole 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a non-comparative salvage therapy trial.
Maltese: Posaconazole orali 800 mg/jum mogħti f'dożi maqsuma kien evalwata għall-kura ta' asperġillożi invażiva f'pazjenti b'mard li kien refrattarju għal amphotericin B (inklużi formulazzjonijiet liposomali) jew itraconazole jew f'pazjenti li kienu intolleranti għal dawn il-prodotti mediċinali fi prova mhux kumparattiva b'terapija ta' salvataġġ.
English: liver function tests raised (ALT increased, AST increased, bilirubin increased, alkaline phosphatase increased, GGT increased) hepatocellular damage*, hepatitis, jaundice, hepatomegaly hepatic failure, hepatitis cholestatic, cholestasis,
Maltese: testijiet tal-funzjoni tal-fwied jiġu għoljin (ALT jiżdied, AST jiżdied, bilirubin jiżdied, alkaline phosphatase jiżdied, GGT jiżdied) ħsara epatoċellulari*, epatite, suffejra, epatomegalija insuffiċjenza epatika, epatite kolestatika, kolestażi, epatosplenomegalija, tenerezza tal-fwied, asteriksis
English: • Some medicines used to treat or prevent fits, such as phenytoin, carbamazepine, phenobarbital,
Maltese: • Xi mediċini li jintużaw biex jevitaw aċċessjonijiet, bħal phenytoin, carbamazepine, phenobarbital,
English: PHARMACEUTICAL FORM AND CONTENTS One bottle of 105 ml of oral suspension Measuring spoon
Maltese: U KONTENUT Flixkun ta' 105 ml ta' suspensjoni orali Magħrfa tal-kejl
English: Important information about some of the ingredients of Posaconazole SP Posaconazole SP contains approximately 1.75 g of glucose per 5 ml of suspension.
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Posaconazole SP Posaconazole SP fih madwar 1.75 g ta' glucose għal kull 5 ml ta' suspensjoni.
English: • Any problem with amounts of potassium, magnesium or calcium in your blood.
Maltese: • Kwalunkwe problema fl-ammonti ta' potassium, magnesium jew calcium fid-demm tiegħek.
English: Coccidioidomycosis: 11 of 16 patients were successfully treated (at the end of treatment complete or partial resolution of signs and symptoms present at baseline) with posaconazole 800 mg/day in divided doses for a median of 296 days and up to 460 days.
Maltese: Kokkidajojdomikożi:11 mis-16-il pazjent kienu kkurati b'suċċess (fi tmiem il-kura kellhom fejqan komplet jew parzjali mis-sinjali u s-sintomi li kien hemm mal-linja bażi) b'posaconazole 800 mg/jum b'dożi maqsuma għal medjan ta' 296 jum u sa 460 jum.
English: Excretion
Maltese: Manifattur
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of oral suspension contains 40 mg of posaconazole.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull ml tas-suspensjoni orali fiha 40 mg ta' posaconazole.
English: Use in renal impairment: An effect of renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended (see section 5.2).
Maltese: Mhux mistenni li jkun hemm effett minn indeboliment renali fuq ilfarmakokinetiċi ta' posaconazole u mhux rakkomandat li tinbidel id-doża (ara sezzjoni 5.2).
English: Posaconazole SP may increase (possibly increasing the risk of side effects) the blood levels of some other medicines.
Maltese: Posaconazole SP jista' jżid (possibilment jżid ir-riskju ta' effetti sekondarji) fil-livelli ta' mediċini oħrajn fid-demm.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral suspension contains 40 mg of posaconazole.
Maltese: U KWANTITATTIVA Kull ml ta' suspensjoni orali fih 40 mg ta' posaconazole.
English: Cases of elevated ciclosporin levels resulting in serious adverse events, including nephrotoxicity and one fatal case of leukoencephalopathy, were reported in clinical efficacy studies.
Maltese: Każijiet ta' żiediet fil-livelli ta' ciclosporin li wasslu għal każijiet avversi severi, inkluża nefrotossiċità u każ fatali ta' lewko-enċefalopatija, kienu rrappurtati fi studji dwar l-effikaċja klinika.
English: • Sulfonylureas such as glipizide (used to treat high blood sugar).
Maltese: • Sulfonylureas bħal glipizide (jintużaw għal kura ta' zokkor għoli fid-demm).
English: hearing impaired
Maltese: Insuffiċjenza epatika
English: H2 receptor antagonists and proton pump inhibitors: Posaconazole plasma concentrations (Cmax and AUC) were reduced by 39 % when posaconazole was administered with cimetidine (400 mg twice a day) due to reduced absorption possibly secondary to a decrease in gastric acid production.
Maltese: Il-konċentrazzjonijiet fil-plażma ta' posaconazole (Cmax u AUC) kienu mnaqqsa b'39% meta posaconazole ingħata ma' cimetidine (400 mg darbtejn kuljum) minħabba tnaqqis fl-assorbiment li jista' jkun effett sekondarju għal tnaqqis ta' l-aċidu gastriku.
English: Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;
Maltese: Kromoblastomikożi u miċetoma f'pazjenti b'mard li hu refrattarju għal itraconazole jew f'pazjenti intolleranti għal itraconazole;
English: Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 1.4-fold and 4.6-fold greater, respectively, than those achieved with therapeutic doses.
Maltese: Żiediet fil-pressjonijiet sistoliċi u arterjali (sa 29 mm-Hg) dehru f'firien u xadini b'esponimenti sistemiċi 1.4-il darba u 4.6-il darba ogħla rispettivament, minn dawk li jinkisbu b'dożi terapewtiċi.
English: Results from clinical studies in prophylaxis of Invasive Fungal Infections.
Maltese: Riżultati mill-istudji kliniċi fil-profilassi ta' Infezzjonijiet Invażivi bil-Fungu.
English: Allergic reaction
Maltese: Rispons globali
English: Posaconazole SP is a white, cherry flavoured, 105 ml oral suspension packaged in amber glass bottles.
Maltese: Posaconazole SP huwa suspensjoni bajda, b'togħma taċ-ċirasa, 105 ml ta' suspensjoni orali impakkettati fi fliexken tal-ħġieġ kannella jagħtu fl-oranġjo.
English: There are limited pharmacokinetic data in patients with severe gastrointestinal dysfunction (such as severe diarrhoea).
Maltese: Hemm tagħrif farmakokinetiku limitat f'pazjenti b'funzjoni ħażina b'mod sever gastro-intestinali (bħal dijarea severa).
English: Therefore posaconazole is not recommended for use in patients below 18 years of age (see sections 5.1 and 5.2).
Maltese: Għalhekk posaconazole mhux rakkomandat għall-użu f'pazjenti taħt it-18-il sena (ara sezzjonijiet 5.1 u 5.2).
English: paresthesia, dizziness, somnolence, headache convulsion, neuropathy, hypoaesthesia, tremor cerebrovascular accident, encephalopathy, peripheral neuropathy, syncope
Maltese: parasteżija, sturdament, ngħas, uġigħ ta' ras aċċessjonijiet, newropatija, ipoesteżija, tregħid inċident ċerebrovaskulari, enċefalopatija, newropatija periferali, sinkope
English: Fungal Infections
Maltese: Disturbi gastro-intestinali
English: Of the circulating metabolites, the majority are glucuronide conjugates of posaconazole with only minor amounts of oxidative (CYP450 mediated) metabolites observed.
Maltese: Mill-metaboli li jkunu qed jiċċirkulaw, ilmaġġoranza huma konjugati ta' glukuronajd ta' posaconazole u jidhru ammonti żgħar ta' metaboli ossidattivi (medjati b'CYP450).
English: Multiple, time-matched ECGs collected over a 12 hour period were obtained before and during administration of posaconazole (400 mg twice daily with high fat meals) from 173 healthy male and female volunteers aged 18 to 85 years.
Maltese: Ħafna ECG's imqabbla bil-ħin li nġabru fuq perijodu ta' 12-il siegħa inkisbu qabel u wara li ngħata posaconazole (400 mg darbtejn kuljum ma' ikel b'ħafna xaħam) minn 173 irġiel u nisa b'saħħithom ta' etajiet bejn 18 u 85 sena.
English: Therefore trough concentrations that fall in the upper part of the usual therapeutic range should be targetted and careful attention should be paid to clinical signs and symptoms, laboratory parameters and tissue biopsies.
Maltese: Għalhekk konċentrazzjonijiet baxxi li jaqgħu fil-parti ta' fuq tal-medda terapewtika tas-soltu għandhom jiġu mmirati u għandha tingħata attenzjoni bir-reqqa għal sinjali u sintomi kliniċi, parametri tal-laboratorju u bijopsiji tat-tessuti.
English: The most frequently reported serious related adverse events included nausea, vomiting, diarrhoea, pyrexia, and increased bilirubin.
Maltese: L-aktar każijiet avversi li kienu rrappurtati ta' spiss kienu jinkludu dardir, remettar, dijarea, deni u żieda fil-bilirubin.
English: Medicines that can decrease blood levels of posaconazole include:
Maltese: Mediċini li jistgħu jnaqqsu il-livelli ta' posaconazole fid-demm jinkludu:
English: The primary efficacy endpoint was the incidence of proven/probable IFIs at 16 weeks post-randomization as determined by an independent, blinded external expert panel.
Maltese: L-endpoint ewlieni ta' l-effikaċja kien l-inċidenza ta' IFI's li probabbli/ġew pruvati li seħħew wara 16-il ġimgħa li tkun seħħet ir-randomisation, hekk kif ikun deċiż minn pannell estern ta' esperti indipendenti blinded.
English: Mouth ulcers
Maltese: Vista mċajpra
English: Pharmacotherapeutic group: Antimycotics for systemic use-triazole derivatives, ATC code: J02A C04.
Maltese: Mediċini kontra l-fungu għall-użu sistemiku - derivati triazole,
English: Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin).
Maltese: L-imaniġġar tal-pazjenti għandu jinkludi evalwazzjoni permezz ta' laboratorju tal-funzjoni epatika (l-aktar testijiet tal-funzjoni tal-fwied u bilirubin).
English: In healthy volunteers under fasting conditions, dividing the total daily dose (800 mg) into 200 mg four times daily compared to 400 mg twice daily, was shown to increase posaconazole exposure by 58 % over 48 hours.
Maltese: F'voluntiera b'saħħithom fl-istat sajjem, meta d-doża tal-jum (800 mg) kienet maqsuma f'200 mg erba' darbiet kuljum imqabbel ma' 400 mg darbtejn kuljum, intwera li l-esponiment ta' posconazole żdied b'58 % fuq 48 siegħa.
English: Sleepiness
Maltese: Studju
English: Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), efavirenz and cimetidine: Posaconazole concentrations may be significantly lowered in combination; therefore, concomitant use with posaconazole should be avoided unless the benefit to the patient outweighs the risk (see section 4.5).
Maltese: Antibatteriċi ta' rifamycin (rifampicin, rifabutin), ċerti mediċini kontra l-aċċessjonijiet (phenytoin, carbamazepine, phenobarbital, primidone), efavirenz u cimetidine:
English: pyrexia (fever), asthenia, fatigue oedema, pain, chills, malaise tongue oedema, face oedema
Maltese: deni (ssir taħraq), astenja, għeja edima, uġigħ, degħxiet, tħossok ma tiflaħx edima ta' l-ilsien, edima tal-wiċċ
English: hypertension, hypotension pulmonary embolism, deep vein thrombosis
Maltese: pressjoni għolja, pressjoni baxxa emboliżmu pulmonari, trombożi fil-vini fondi
English: Sixteen patients 8-17 years of age were treated with 800 mg/day in a study for invasive fungal infections.
Maltese: Sittax il-pazjent f'etajiet ta' bejn 8-17-il sena kienu kkurati b'800 mg/jum fi studju dwar infezzjonijiet invażivi tal-fungu.
English: No pharmacokinetic data are available from paediatric patients less than 8 years of age.
Maltese: Ma kienx hemm tagħrif farmakokinetiku għal pazjenti taħt it-8 snin.
English: As observed with other azole antifungal agents, effects related to inhibition of steroid hormone synthesis were seen in repeated-dose toxicity studies with posaconazole.
Maltese: Kif deher b'aġenti kontra l-fungu oħrajn, l-effetti relatati ma' l-impediment tas-sintesi ta' l-ormon sterojdali dehru fi studji dwar it-tossiċità b'dożi ripetuti b'posaconazole.
English: If you are taking simvastatin, lovastatin, atorvastatin and some similar medicines (called HMGCoA reductase inhibitors or statins) that are used to treat high cholesterol levels in the blood.
Maltese: - Jekk qed tieħu simvastatin, lovastatin, atorvastatin u xi mediċini simili (li jissejħu impedituri ta' HMG-CoA reductase jew statini) li jintużaw għall-kura ta' livelli għoljin ta' kolesterol fid-demm.
English: • Digoxin (used to treat heart failure)
Maltese: • Digoxin (jintuża għal kura ta' insuffiċjenza tal-qalb)
English: The effect of other H2 receptor antagonists (e.g. famotidine, ranitidine) and proton pump inhibitors (e.g. omeprazole) that may suppress gastric acidity for several hours on plasma levels of posaconazole has not been studied but a reduction in bioavailability may occur so that coadministration should be avoided if possible.
Maltese: L-effett ta' antagonisti oħrajn tar-riċettur H2 (eż. famotidine, ranitidine) u impedituri tal-pompa tal-protoni (eż. omeprazole) li jistgħu jikkawżaw soppressjoni ta' laċidità gastrika għal bosta sigħat fuq il-livelli fil-plażma ta' posaconazole ma ġiex studjat iżda tnaqqis fil-biodisponibilità jista' jseħħ u għalhekk l-użu fl-istess ħin għandu jkun evitat jekk ikun possibli.
English: In this leaflet:
Maltese: Alkalojdi vinka:
English: Posaconazole SP belongs to a group of medicines called triazole antifungal agents.
Maltese: Posaconazole SP jgħamel parti minn grupp ta' mediċini li jissejjħu aġenti triazole kontra l-fungu.
English: It is particularly important to try to ensure that maximal plasma levels are achieved in patients infected with Aspergillus (see sections 4.2 and 5.2 on recommended dose regimens and the effects of food on absorption).
Maltese: Huwa importanti b'mod partikolari li tipprova taċċerta ruħek li jinkisbu l-ogħla livelli fil-plażma f'pazjenti infettati b'Aspergillus (ara sezzjonijiet 4.2 u 5.2 dwar il-korsijiet tad-dożi rakkomandati u leffetti ta' l-ikel fuq l-assorbiment).
English: Overall Response Success by Species All mycologically confirmed Aspergillus spp.1
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna
English: Take 400 mg (two 5 ml spoonfuls) of the suspension twice a day with food or with a nutritional supplement if you are unable to tolerate food.
Maltese: Ħu 400 mg (żewġ kuċċarini ta' 5 ml) tas-suspensjoni darbtejn kuljum ma' l-ikel jew ma' suppliment nutrizzjonali jekk ma tistax iżżomm ikel.
English: Hypersensitivity: There is no information regarding cross-sensitivity between posaconazole and other azole antifungal agents.
Maltese: M'hemmx tagħrif dwar cross-sensitivity bejn posaconazole u sustanzi oħrajn azole kontra l-fungu.
English: Fixed-time period c
Maltese: Perijodu b'ħin-fiss c d
English: • Medicines used to decrease stomach acid such as cimetidine and ranitidine or omeprazole and similar medicines that are called proton pump inhibitors.
Maltese: • Mediċini li jintużaw biex inaqqsu l-aċidu fl-istonku bħal cimetidine u ranitidine jew omeprazole u mediċini simili li jissejħu impedituri tal-pompi tal-protoni.
English: The safety of posaconazole has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience.
Maltese: Is-sigurtà ta' posaconazole ġiet stmata f' > 2,400 pazjent u voluntiera b'saħħithom li ddaħħlu fi provi kliniċi u minn esperjenza ta' wara t-tqegħid fis-suq.
English: How to store Posaconazole SP 6.
Maltese: Kif taħżen Posaconazole SP 6.
English: : 11 of 24 patients who had proven or probable fusariosis were successfully treated with posaconazole 800 mg/day in divided doses for a median of 124 days and up to 212 days.
Maltese: Fusarium spp.: 11 minn 24 pazjent li wrew li probabbli kellhom fusarjożi kienu ikkurati b'suċċess b'posaconazole 800 mg/jum b'dożi maqsumin għal medjan ta' 124 jum u sa 212 jum.
English: Study
Maltese: JIS
English: For patients with acute myelogenous leukemia or myelodysplastic syndromes, prophylaxis with Posaconazole SP should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm
Maltese: Għal pazjenti b'sindromi ta' lewkimja majeloġenuża jew majelodisplastika, profilassi b'Posaconazole SP għandha tibda ħafna ġranet qabel ma tkun mistennija li tfeġġ in-newtropenja u titkompla għal 7 ijiem wara li l-għadd tan-newtrofili jitla' fuq il-500 ċellula kull mm3.
English: QTc prolongation: Some azoles have been associated with prolongation of the QTc interval.
Maltese: Xi azoles kienu assoċjati ma' titwil ta' l-intervall QTc.
English: Frequent monitoring for adverse events and toxicity related to antiretroviral agents that are substrates of CYP3A4 is recommended during co-administration with
Maltese: Monitoraġġ frekwenti ta' każijiet avversi u tossiċità relatata ma' aġenti kontra r-retrovajrus li huma sottostrati ta' CYP3A4 huwa rakkomandat meta jingħataw flimkien ma' posaconazole.
English: Caution is advised during coadministration of posaconazole with CYP3A4 substrates administered intravenously and the dose of the CYP3A4 substrate may need to be reduced.
Maltese: Impedituri ta' HMG-CoA reductase metabolizzati permezz ta' CYP3A4
English: Common side effects (occurring in at least 1 in 100 patients) are:
Maltese: Effetti sekondarji komuni (jseħħu mill-anqas f'1 minn kull 100 pazjent) huma:
English: Co-administration of posaconazole with CYP3A4 substrates may result in large increases in exposure to CYP3A4 substrates as exemplified by the effects on tacrolimus, sirolimus, atazanavir and midazolam below.
Maltese: L-għotja fl-istess ħin ta' posaconazole ma' sottostrati ta' CYP3A4 jista'jwassal għal żidiet kbar fl-esponiment għas-sottostrati ta' CYP3A4 hekk kif qed jiġi spjegat b'eżempji għall-effetti fuq tacrolimus, sirolimus, atazanavir u midazolam hawn taħt.
English: • Any heart rhythm disturbance
Maltese: • Kwalunkwe disturb fir-ritmu tal-qalb
English: Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;
Maltese: Pazjenti li qed jirċievu kimoterapija ta' remissjoni-induzzjoni għall-lewkimja majeloġenuża (AML) jew għal sindromi majelodisplastiċi (MDS) li jkunu mistennija li jikkawżaw newtropenja u li jkollhom riskju għoli li jiżviluppaw infezzjonijiet tal-fungu invażivi;
English: EXP
Maltese: Eskrezzjoni
English: Hair loss, itching
Maltese: UŻATI JEW SKART MINN DAWN
English: There was a slight decrease (16 %) in the AUC and Cmax of posaconazole in Black subjects relative to Caucasian subjects.
Maltese: Kien hemm tnaqqis żgħir (16 %) fl-AUC u s-Cmax ta' posaconazole f'individwi Suwed relattivi ma' individwi
English: Control a
Maltese: Kontroll ª
English: The addition of posaconazole to therapy with atazanavir or with atazanavir plus ritonavir was associated with increases in plasma bilirubin levels.
Maltese: Iż-żieda ta' posaconazole matterapija b'atazanavir jew b'atazanavir ma' ritonavir kienet assoċjata ma' żiediet fil-livelli ta' bilirubin fil-plażma.
English: Following co-administration of oral posaconazole (400 mg twice daily) with atazanavir (300 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 2.6-fold and 3.7-fold (range 1.2 to 26fold), respectively.
Maltese: Posaconazole 400 mg darbtejn kuljum għal 7 ijiem żied is-Cmax u l-AUC ta' midazolam mogħti minn ġol-vina b'1.6 u 6.2-il darba (medda 1.6 sa 7.6-il darba), rispettivament.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER SP Europe
Maltese: Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq SP Europe
English: Do not take Posaconazole SP
Maltese: X'fih Posaconazole SP
English: Monitoring of hepatic function: Patients who develop abnormal liver function tests during Posaconazole SP therapy must be routinely monitored for the development of more severe hepatic injury.
Maltese: Testijiet għoljin tal-funzjoni tal-fwied kienu fil-parti l-kbira riversibbli malli twaqqfet it-terapija u f'xi każijiet it-testijiet reġgħu lura għan-normal mingħajr ma twaqqfet it-terapija.
English: Breast pain
Maltese: Kullha kkurati
English: Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Maltese: Tkun definita refrattarja meta l-infezzjoni tavvanza jew ma titjiebx wara mill-anqas 7 ijiem ta' dożi terapewtiċi b'terapija effettiva kontra l-fungu li jkunu ngħataw qabel.
English: Take 200 mg (one 5 ml spoonful) three times a day with food or nutritional supplement if you are unable to tolerate food.
Maltese: Ħu 200 mg (kuċċarina waħda ta' 5 ml) tliet darbiet kuljum ma' l-ikel jew ma' suppliment nutrizzjonali jekk ma tistax iżomm ikel.
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
Maltese: DETENTUR TA' L-AWTORIZZAZZJONI TALMANIFATTURA RESPONSABBLI
English: Accidental overdose was noted in one patient who took 1,200 mg twice a day for 3 days.
Maltese: Doża eċċessiva bi żball kienet rappurtata f'pazjent wieħed li ħa 1,200 mg darbtejn kuljum għal 3 ijiem.
English: Vall de Bianya 17813 (Girona) SPAIN
Maltese: Vall de Bianya 17813 (Girona) SPANJA
English: ATCvet code: QA04AD90.
Maltese: QA04AD90
English: Date of last renewal: 29/09/2011.
Maltese: Data tal-aħħar tiġdid: 29/09/2011
English: Maropitant is effective against vomiting.
Maltese: Maropitant huwa effettiv kontra remettar.
English: Cerenia Tablets:
Maltese: Cerenia pilloli:
English: Estimates for the oral bioavailability of maropitant were 23.7% at 2 mg/kg and 37.0% at 8 mg/kg.
Maltese: Estimi għall-bijodisponibilità orali ta' maropitant kienu 23.7% b'2 mg/kg u 37.0% b'8 mg/kg.
English: 29 route des Industries 37530 Pocé-sur-Cisse FRANCE
Maltese: 37530 Pocé-sur-Cisse FRANZA
English: Pale orange tablet
Maltese: Pillola oranġjo ċar.
English: Metacresol (as preservative)
Maltese: Metacresol (bħala preservattiv)
English: Sulphobutyl ether β-cyclodextrin (SBECD) Metacresol
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Sulphobutyl ether β-cyclodextrin (SBECD)
English: One ml of solution contains:
Maltese: U KWANTITATTIVA 1 ml ta' soluzzjoni fih:
English: Each tablet contains 0.075% w/w Sunset Yellow (E110) as a colorant.
Maltese: Kull pillola fiha 0.075% w/w Sunset Yellow (E110) bħala kolorant