FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies, serious adverse reactions occurring within 12 weeks following infusion were reported in 29 % of ZINPLAVA-treated patients and 33 % in patients receiving placebo.
Maltese: Fi studji kliniċi, reazzjonijiet avversi serji li seħħew fi żmien 12-il ġimgħa mill-infużjoni ġew irrappurtati f'29 % tal-pazjenti ttrattati b'ZINPLAVA u 33 % tal-pazjenti li kienu qed jirċievu plaċebo.
English: Bezlotoxumab is a human monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Maltese: Mill-aspett mikrobijoloġiku, il-prodott mediċinali għandu jintuża immedjatament.
English: p-value n = Number of patients in the analysis population meeting the criteria for endpoint N = Number of patients included in the analysis population Full Analysis Set = a subset of all randomised patients with exclusions for: (i) did not receive infusion of study medication, (ii) did not have a positive local stool test for toxigenic C. difficile; (iii) did not receive protocol defined standard of care therapy within a 1 day window of the infusion; (iiii) GCP non-compliance SoC = Standard of Care antibacterial (metronidazole or vancomycin or fidaxomicin) One sided p-value based on the Miettinen and Nurminen method stratified by protocol (MODIFY I and MODIFY II), SoC antibacterial (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)
Maltese: SoC = Antibatteriku tal-Kura Standard (metronidazole jew vancomycin jew fidaxomicin) Valur p one sided abbażi tal-metodu Miettinen u Nurminen stratifikat skont il-protokoll (MODIFY I u MODIFY II), antibatteriku SoC (metronidazole vs. vancomycin vs. fidaxomicin) u l-istat ta' rikoverar l-isptar (pazjent rikoverat l-isptar vs. outpatient)
English: ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1).
Maltese: ZINPLAVA għandu jingħata waqt il-kors ta' terapija antibatterika għal CDI (ara sezzjonijiet 4.4 u
English: Bezlotoxumab prevents CDI recurrence by providing passive immunity against toxin produced by the outgrowth of persistent or newly-acquired C. difficile spores.
Maltese: Bezlotoxumab jevita r-rikorrenza ta' CDI billi jipprovdi immunità passiva kontra t-tossina magħmula mit-tkabbir ta' spori persistenti jew miksuba ġodda ta' C. difficile.
English: The effect of hepatic impairment on the pharmacokinetics of bezlotoxumab was evaluated in patients with hepatic impairment (defined as having two or more of the following: [1] albumin ≤ 3.1 g/dL; [2] ALT ≥ 2X ULN; [3] total bilirubin ≥ 1.3X ULN; or [4] mild, moderate or severe liver disease as reported by the Charlson Co-morbidity Index), as compared to patients with normal hepatic function.
Maltese: [3] bilirubina totali ≥ 1.3X ULN; jew [4] mard tal-fwied ħafif, moderat jew sever kif irrappurtat mill-Indiċi Charlson għal Kondizzjonijiet Mediċi Oħra fl-Istess Waqt ), mqabbel ma' pazjenti b'funzjoni normali tal-fwied.
English: • feeling sick (nausea)
Maltese: • dardir (nawsja)
English: Following treatment with ZINPLAVA in MODIFY I and MODIFY II, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.
Maltese: Wara trattament b'ZINPLAVA f'MODIFY I u MODIFY II, l-ebda wieħed mis-710 pazjenti li setgħu jiġu evalwati ma kellu riżultat pożittiv għal antikorpi kontra bezlotoxumab li fiġġu minħabba ttrattament.
English: No formal interactions studies with other medicinal products were conducted.
Maltese: Ma saru l-ebda studji formali ta' interazzjoni ma' prodotti mediċinali oħra.
English: Overall, 10 % of subjects in the ZINPLAVA group experienced one or more infusion specific adverse reactions on the day of, or the day after, the infusion compared to 8 % in the placebo group.
Maltese: Globalment, 10 % tal-individwi fil-grupp ta' ZINPLAVA kellhom reazzjoni avversa speċifika waħda jew aktar għall-infużjoni fil-jum tal-infużjoni jew fil-jum ta' wara, meta mqabbla ma' 8 % fil-grupp ta' plaċebo.
English: The safety profile of ZINPLAVA was assessed in two Phase 3 clinical studies.
Maltese: Il-profil ta' sigurtà ta' ZINPLAVA ġie evalwat f'żewġ studji kliniċi ta' Fażi 3.
English: In the studies, the clinical cure rates of the presenting CDI episode were comparable between the treatment arms.
Maltese: Fl-istudji kliniċi, ir-rati ta' fejqan kliniku tal-episodju attwali ta' CDI kienu kumparabbli bejn ilfergħat ta' trattament.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 24 hours at 2°C - 8°C or 16 hours at room temperature (at or below 25°C).
Maltese: Jekk ma jintużax immedjatament il-ħinijiet u l-kondizzjonijiet tal-ħażna qabel u waqt l-użu huma r-responsabbiltà ta' min ikun qed jużah u m'għandhomx ikunu aktar minn total ta' 24 siegħa f'temperatura ta' 2°C - 8°C jew 16-il siegħa f'temperatura ambjentali (f'temperatura ta' 25°C jew anqas).
English: In clinical trials, healthy subjects received up to 20 mg/kg, which was generally well tolerated.
Maltese: Fi provi kliniċi, individwi f'saħħithom irċivew sa 20 mg/kg, li b'mod ġenerali kien ittollerat tajjeb.
English: Bezlotoxumab is eliminated from the body primarily by protein degradation.
Maltese: Bezlotoxumab jiġi eliminat mill-ġisem l-aktar permezz ta' degradazzjoni tal-proteina.
English: All patients received concomitant standard of care antibacterial therapy for CDI.
Maltese: ZINPLAVA jingħata mat-terapija tal-antibijotiku li qed tieħu għal CDI.
English: ≥ 90 mL/min/1.73 m2) renal function.
Maltese: [1] albumina ≤ 3.1 g/dL; [2] ALT ≥ 2X ULN;
English: No clinically meaningful differences in the exposure of bezlotoxumab were found between patients with renal impairment and patients with normal renal function.
Maltese: Ma nstabu l-ebda differenzi li kellhom sinifikat kliniku fl-esponiment għal bezlotoxumab bejn pazjenti b'indeboliment tal-kliewi u pazjenti b'funzjoni normali tal-kliewi.
English: Hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustment fid-doża għal pazjenti b'indeboliment tal-kliewi (ara sezzjoni 5.2).
English: Children and adolescents ZINPLAVA should not be used in children and adolescents below 18 years of age.
Maltese: Is-sigurtà u l-effikaċja ta' ZINPLAVA f'pazjenti ta' età inqas minn18-il sena għadhom ma ġewx determinati s'issa.
English: Concentrate for solution for infusion.
Maltese: Konċentrat għal soluzzjoni għall-infużjoni.
English: Infected with 027 ribotype n = Number of patients within subgroup that met the criteria for endpoint m = Number of patients within subgroup
Maltese: n = Numru ta' pazjenti fis-sottogrupp li ssodisfaw il-kriterji għall-iskop finali m = Numru ta' pazjenti fis-sottogrupp
English: • The diluted solution can be infused via a central line or peripheral catheter.
Maltese: • Is-soluzzjoni dilwita tista' tiġi infuża permezz ta' pajp ċentrali jew kateter periferali.
English: Placebo with SoC Percent (n/N)
Maltese: Plaċebo ma' SoC
English: ZINPLAVA contains the active substance bezlotoxumab.
Maltese: Inti tista' tgħin billi tirrapporta kwalunkwe effett sekondarju li jista' jkollok.
English: 7 May 2015
Maltese: 7 ta' Mejju 2015
English: EMA/55773/2016 EMEA/V/C/003786
Maltese: EMEA/V/C/003786
English: Refusal of the marketing authorisation for Lodipressin (amlodipine besilate)
Maltese: Lodipressin (amlodipine besilate)
English: Lodipressin is a veterinary medicine that contains the active substance amlodipine besilate.
Maltese: Lodipressin huwa mediċina veterinarja li fiha s-sustanza attiva amlodipine besilate.
English: On 15 January 2015, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lodipressin, intended for the treatment of systemic arterial hypertension in cats.
Maltese: Fil-15 ta' Jannar 2015, il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Lodipressin, maħsub għall-kura ta' pressjoni għolja arterjali sistemika fil-qtates.
English: What is Lodipressin?
Maltese: X'inhu Lodipressin?
English: After considering the grounds for this request, the CVMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 7 May 2015.
Maltese: Wara li kkunsidra r-raġunijet għal din ittalba, is-CVMP reġa' eżamina l-opinjoni inizjali u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fissuq fis-7 ta' Mejju 2015.
English: In the second part, 23 cats received Lodipressin for 16 weeks with no placebo group.
Maltese: Fittieni parti, 23 qattus irċevew Lodipressin għal 16-il ġimgħa mingħajr grupp ta' plaċebo.
English: Lodipressin was expected to be used to treat cats with systemic arterial hypertension (high blood pressure).
Maltese: Lodipressin huwa mistenni li jintuża biex jikkura qtates bi pressjoni għolja arterjali sistemika (pressjoni għolja tad-demm).
English: The company that applied for authorisation is Le Vet Beheer B.V.
Maltese: Il-kumpanija li applikat għal awtorizzazzjoni hija Le Vet Beheer B.V.
English: During the re-examination, the CVMP considered advice from an expert group in feline medicine.
Maltese: Waqt l-eżaminazzjoni mill-ġdid, is-CVMP ikkunsidra pariri minn grupp espert fil-mediċina tal-qtates.
English: What was Lodipressin expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Lodipressin?
English: The study had two parts, an initial part with 19 cats, 11 of which were treated with Lodipressin and 8 of which received placebo (a dummy treatment) for two weeks.
Maltese: L-istudju kellu żewġ partijiet, il-parti inizjali bi 19-il qattus, 11 li kienu kkurati b'Lodipressin u 8 li rċevew plaċebo (kura finta) għal ġimagħtejn.
English: The expert group advised that although the field study showed some evidence of a reduction in blood pressure, the many shortcomings in the study did not allow to conclude that the benefits of Lodipressin in the treatment of high blood pressure in cats outweigh the risks.
Maltese: Ilgrupp espert spjega li minkejja li l-istudju li twettaq fil-kamp wera xi evidenza ta' tnaqqis fil-pressjoni tad-demm, il-ħafna nuqqasijiet fl-istudju ma ppermettewx li jiġi konkluż li l-benefiċċji ta' Lodipressin fil-kura ta' pressjoni għolja tad-demm fil-qtates huma akbar mir-riskji.
English: This meant that whilst there is some evidence that Lodipressin is effective in lowering blood pressure, no firm conclusions could be drawn on its effectiveness for treatment of high blood pressure in cats.
Maltese: Dan ifisser li filwaqt li hemm xi evidenza li Lodipressin huwa effettiv fit-tnaqqis tal-pressjoni tad-demm, ma tista' tinstilet lebda konklużjoni soda dwar l-effettività tiegħu għall-kura ta' pressjoni għolja tad-demm fil-qtates.
English: This means that it blocks channels on the surface of cells through which calcium normally enters the cell.
Maltese: Dan ifisser li timblokka l-kanali preżenti fuq il-wiċċ taċ-ċelluli li minnhom normalment il-kalċju jidħol fiċ-ċelluli.
English: Invented name
Maltese: Numru ta' Proċedura ta' l-EU Isem inventat
English: * see section 5.1
Maltese: * ara sezzjoni 5.1
English: Magyarország, Malta, Norge, Österreich, Polska, România, Slovenija, Slovenská republika,
Maltese: България, Česká republika, Danmark, Eesti, Hrvatska, Ireland, Ísland, Latvija, Lietuva, Magyarország, Malta, Norge, Österreich, Polska, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige, UK.
English: Central nervous system (CNS) toxicity
Maltese: Tossiċità tas-sistema nervuża ċentrali (CNS)
English: 36 to <75
Maltese: 36 sa <75
English: − and also pentamidine and saquinavir.
Maltese: − u wkoll pentamidine u saquinavir.
English: Pre-gelatinised starch Dextrin
Maltese: Pre-gelatinised starch,
English: Dermatitis Rash
Maltese: Dermatite Raxx
English: Via Ragazzi del '99, n. 5 40133 Bologna Italy
Maltese: Via Ragazzi del '99, n. 5
English: • Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide.
Maltese: • Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkalojdi, arsenic trioxide.
English: Side effects in adults
Maltese: Effetti sekondarji fl-adulti
English: 5 to <7
Maltese: 5 sa <7
English: 24 to <36
Maltese: 24 sa <36
English: 30.400 00071 Pomezia (Rome) Italy
Maltese: 00071 Pomezia (Ruma)
English: Date of first authorisation: 27 October 2011 Date of latest renewal: 09 September 2016
Maltese: Data tal-aħħar tiġdid: 09 ta'settembru, 2016
English: 95 % two-sided CI on the treatment difference (EurartesimComparator); p-value
Maltese: 95% two-sided CI fuq id-differenza tal-kura (EurartesimKomparatur); valur p
English: Eurartesim kills the Plasmodium falciparum parasite.
Maltese: Eurartesim joqtol il-parassita Plasmodium falciparum.
English: 7 to <13
Maltese: 7 sa <13
English: 1.5 tablet
Maltese: 1.5 pillola
English: Influenza P. falciparum infection
Maltese: Infezzjoni b'P. falciparum
English: 13 to <24
Maltese: 13 sa <24
English: • Inhibition of falciparum sarcoplasmic-endoplasmic reticulum calcium ATPase,
Maltese: • Inibizzjoni ta' falciparum reticulum calcium ATPase sarkoplażmiku-endoplażmiku.
English: Film coating: hypromellose, titanium dioxide (E171), macrogol 400.
Maltese: Kisja tar-rita: hypromellose, titanium dioxide (E171), macrogol 400.
English: Enzyme inducing medicinal products such as rifampicin, carbamazepine, phenytoin, phenobarbital, St. John's wort (Hypericum perforatum) are likely to lead to reduced piperaquine plasma concentrations.
Maltese: Prodotti mediċinali li jinduċu l-enzimi bħal rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort (Hypericum perforatum), x'aktarx li se jwasslu għal tnaqqis fil-konċentrazzjonijiet ta' piperaquine fil-plażma.
English: P. falciparum infection
Maltese: P. falciparum.
English: - History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
Maltese: - Storja medika ta' arritmiji kardijaċi sintomatiċi jew bi bradikardija klinikament rilevanti.
English: Other medicines and Eurartesim
Maltese: Mediċini oħra u Eurartesim
English: In the hERG test, the IC50 was 0.15 µmol for piperaquine and 7.7 µmol forartenimol.
Maltese: Fit-test hERG, l-IC50 kien ta' 0.15 µmol għal piperaquine u 7.7 µmol għal artenimol.
English: Artenimolwas observed to have a small volume of distribution in humans (0.8 l/kg; CV 35.5%).
Maltese: Artenimol kien osservat li għandu volum żgħir ta' distribuzzjoni fil-bnedmin (0.8 l/kg; CV 35.5%).
English: PCR-corrected cure rate (m-ITT) Eurartesim AS + MQ A + L
Maltese: Eurartesim AS + MQ A + L
English: The most frequent ADRs observed at an incidence ≥1.0% were: Headache (3.9%), Electrocardiogram QTc Prolonged (3.4%), P. falciparum infection (3.0%), Anaemia (2.8%), Eosinophilia (1.7%), Haemoglobin decreased (1.7%), Sinus tachycardia (1.7%), Asthenia (1.6%), Haematocrit [decreased] (1.6%), Pyrexia (1.5%), Red Blood Cell Count decreased (1.4%).
Maltese: Uġigħ ta' Ras (3.9%), Titwil fil-QTc fl-elettrokardjogramm (3.4%), Infezzjoni b'P. falciparum (3.0%), Anemija (2.8%), Esinofilja (1.7%), Tnaqqis fl-emoglobina (1.7%), Takikardija tas-sinus (1.7%), Astenja (1.6%), [tnaqqis] fl-ematokrit (1.6%), Deni (1.5%), Tnaqqis fl-Għadd taċ-Ċelluli tad-Demm Ħomor (1.4%).
English: Daily dose (mg)
Maltese: Doża ta' kuljum (mg)
English: − imidazole and triazole antifungal medicinal products,
Maltese: - imidazole u triazole t-tnejn huma prodotti mediċinali antifungali
English: In healthy male volunteers under fasting conditions, mean Cmax and AUCINF of artenimol ranged between 180-252 ng/ml and 516-684 ng/ml*h, respectively.
Maltese: F'voluntiera rġiel b'saħħithom f'kundizzjonijiet ta' stat sajjem, il-medja tas-Cmax u tal-AUCINF ta' artenimol varjat bejn 180-252 ng/ml u 516-684 ng/ml*h, rispettivament.
English: • Certain non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine).
Maltese: • Ċerti antistamini mhux sedattivi (eż. terfenadine, astemizole, mizolastine).
English: • is taking certain other medicines which could cause possible metabolic interactions.
Maltese: • qed tieħdu ċerti mediċini oħrajn li jistgħu jikkawżaw interazzjonijiet metaboliċi possibbli.
English: Tablet core: pre-gelatinised starch, dextrin, hypromellose (E464), croscarmellose sodium, magnesium stearate (E572).
Maltese: Il-qalba tal-pillola: pre-gelatinised starch, dextrin, hypromellose (E464), croscarmellose sodium,
English: Via Pontina Km 30.400 IT-00071 Pomezia (RM) Italy
Maltese: IT-00071 Pomezia (RM) L-Italja
English: (ADR).
Maltese: (kg)
English: Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3, 6, 9 or 12 tablets.
Maltese: Il-pilloli Eurartesim huma ppakkjati f'folji tal-PVC/PVDC/aluminju li fihom 3, 6, 9 jew 12 il-pillola.
English: The piperaquine major metabolites were a carboxyl acid cleavage product, and a mono-N-oxidated product.
Maltese: Il-metaboliti maġġuri ta' peraquine kienu prodott magħmul minn carboxyl acid u prodott mono-N-oxidated.
English: Piperaquine was mainly metabolised by CYP3A4 and to a lesser extent by CYP2C9 and CYP2C19.
Maltese: Piperaquine kien prinċipalment immetabolizzat minn CYP3A4 u fi grad anqas minn CYP2C9 u CYP2C19.
English: In the European Safety Registry 25 patients weighing ≥ 100 kg (range 100 -121 kg) were treated with 4 tablets 320/40 mg PQP/artenimol for 3 days.
Maltese: Fir-Reġistru Ewropew dwar is-Sigurtà, 25 pazjent li jiżnu ≥ 100 kg (firxa ta' 100 - 121 kg) kienu ttrattati b'4 pilloli ta' 320/40 mg PQP/artenimol għal 3 ijiem.
English: Effect of co-administered medicinal products on Eurartesim Piperaquine is metabolised by CYP3A4 in vitro.
Maltese: Effetti ta' prodotti mediċinali mogħtija fl-istess ħin fuq Eurartesim Piperaquine jiġi mmetabolizzat minn CYP3A4 in vitro.
English: Artenimol is principally converted to α-artenimol-β-glucuronide (α-artenimol-G).
Maltese: Artenimol jiġi prinċipalment mibdul għal α-artenimol-β-glucuronide (α-artenimol-G).
English: 9 tablets
Maltese: 9 pilloli
English: Film coating Hypromellose (E464) Titanium dioxide (E171) Macrogol 400
Maltese: Hypromellose (E464) Titanium dioxide (E171)
English: Special populations
Maltese: Popolazzjoni specjali
English: The safety of Eurartesim has been evaluated in two phase III open-label studies involving 1,239 paediatric patients up to 18 years and 566 adult patients >18 years treated with Eurartesim.
Maltese: 1,239 pazjent pedjatriku li kellhom sa 18-il sena u 566 pazjent adult li kellhom >18 sena kkurati b'Eurartesim.
English: Both piperaquine and artenimol are highly bound to human plasma proteins: the protein binding observed in in vitro studies was 44-93% for artenimol and >99% for piperaquine.
Maltese: Distribuzzjoni Kemm piperaquine kif ukoll artenimol jeħlu ħafna mal-proteini tal-plażma tal-bniedem: it-twaħħil mal-proteini osservat fi studji in vitro kien ta' 44-93% għal artenimol u >99% għal piperaquine.
English: 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).
Maltese: 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), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Eurartesim tablets are packaged in PVC/PVDC/aluminium blisters containing 3 tablets.
Maltese: Il-pilloli Eurartesim huma ppakkjati f'folji tal-PVC/PVDC/aluminju li fihom 3 pilloli.
English: Delayed Haemolytic Anaemia
Maltese: Anemija Emolitika Ttardjata
English: Pharmacokinetic parameters observed for piperaquine in humans indicate that this active substance has a large volume of distribution (730 l/kg; CV 37.5%).
Maltese: Il-parametri farmakokinetiċi osservati għal piperaquine fil-bnedmin jindikaw li din is-sustanza attiva għandha volum kbir ta' distribuzzjoni (730 l/kg; CV 37.5%).
English: • Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
Maltese: • Antiarritimiċi (eż. amiodarone, disopyramide, dofetilide, ibutilide, procainamide,
English: България, Česká republika, Danmark, Eesti, Hrvatska, Ireland, Ísland, Latvija, Lietuva,
Maltese: Италия, Olaszország, Itàlie, Italja, Italien, Italia, Itaalia, Włochy, Italija, Ítalía, taliansko, Itālija
English: Cardiac conduction disorders
Maltese: Disturbi fil-konduzzjoni kardijaka
English: • 31-60 minutes, half the dose must be taken again.
Maltese: • 31-60 minuta, nofs id-doża trid tittieħed mill-ġdid.
English: Eurartesim treatment was compared with Artemether + Lumefantrine (A + L).
Maltese: Il-kura b'Eurartesim tqabblet ma' Artemeter + Lumefantrine (A + L).
English: Cardiovascular toxicity
Maltese: Tossiċità Kardjovaskulari
English: progesterone, estradiol), testosterone; - glucocorticoids (hydrocortisone, dexamethasone);
Maltese: progesterone, estradiol), testosterone;
English: The most important nonclinical safety findings after repeated dosing were the infiltration of macrophages with intracytoplasmic basophilic granular material consistent with phospholipidosis and degenerative lesions in numerous organs and tissues.
Maltese: L-iktar riżultat importanti dwar is-sigurtà mhux klinika wara dożaġġ ripetut kienet l-infiltrazzjoni ta' makrofaġi b'materjal granulari basofiliku intraċitoplażmiku li hu konsistenti ma' fosfolipidosi u leżjonijiet deġenerattivi f'organi u tessut numerużi.
English: 3 x 320 mg / 40 mg tablets 4 x 320 mg / 40 mg tablets
Maltese: 3 x 320 mg / 40 mg pilloli 4 x 320 mg / 40 mg pilloli
English: Do not take this medicine after the expiry date which is stated on the package after ‘EXP'.
Maltese: Tiħux din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-pakkett wara ‘EXP'.
English: The majority of paediatric experience is derived from African children aged 6 months to 5 years.
Maltese: Il-maġġoranza tal-esperjenza pedjatrika nkisbet minn tfal Afrikani li kellhom bejn 6 xhur u 5 snin.
English: Eurartesim treatment was compared with Artesunate + Mefloquine (AS + MQ).
Maltese: Il-kura b'Eurartesim tqabblet ma' Artesunate + Mefloquine (AS + MQ).
English: Piperaquine is a bisquinoline, and this class has shown good antimalarial activity against chloroquineresistant Plasmodium strains in vitro.
Maltese: Piperaquine hu bisquinoline u din il-klassi wriet attività tajba kontra l-malarja kontra razez ta' Plasmodium in vitro reżistenti għal chloroquine.
English: Study DM040010 was conducted in Asian adult and paediatric patients with uncomplicated P. falciparum malaria.
Maltese: Studju DM040010 twettaq fuq pazjenti adulti u pedjatriċi Asjatiċi b'malarja mhux ikkumplikata minħabba P. falciparum.
English: >12 to ≤18 years >18 to ≤64 years DM04011 (n=1524) ≤1 year >1 to ≤2 years
Maltese: ≤5 snin >5 sa ≤12-il sena >12 sa ≤18-il sena >18 sa ≤64 sena
English: Delayed haemolytic anaemia has been observed up to one month following use of IV artesunate and oral artemisinin-based combination treatment (ACT) including reports involving Eurartesim.
Maltese: Anemija emolitika ttardjata ġiet osservata sa xahar wara l-użu ta' artesunate ġol-vini u trattament ikkombinat ibbażat fuq artemisinin mill-ħalq (ACT, artemisinin-based combination treatment) inklużi rapporti li jinvolvu Eurartesim.
English: The number of subjects with QTcF greater than 480 msec after dosing with low fat meals was 3/64, while 10/64 had QTcF values over this threshold after dosing with high fat meals.
Maltese: In-numru ta' individwi bi QTcF ta' iktar minn 480 msek wara dożaġġ ma' ikel b'ammont baxx ta' xaħam kien ta' 3/64, filwaqt li 10/64 kellhom valuri tal-QTcF fuq dan il-limitu wara d-dożaġġ ma' ikel b'ammont għoli ta' xaħam.
English: A moderate increase of piperaquine plasma concentrations (<2-fold) was observed when co-administered with strong CYP3A4 inhibitors, resulting in a potential exacerbation of the effect on QTc prolongation (see section 4.5).
Maltese: Żieda moderata fil-konċentrazzjonijiet ta' piperaquine fil-plażma (< darbtejn) ġiet osservata meta ngħata ma' inibituri qawwija ta' CYP3A4, li rriżultat f'aggravament potenzjali tal-effett fuq it-titwil tal-QTc (ara sezzjoni 4.5).
English: ½ x 160 mg / 20 mg tablet
Maltese: ½ x 160 mg/20 mg pillola