FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/11/716/001 3 film-coated tablets EU/1/11/716/002 6 film-coated tablets EU/1/11/716/003 9 film-coated tablets EU/1/11/716/004 12 film-coated tablets
Maltese: EU/1/11/716/002 6 pilloli miksija b'rita EU/1/11/716/003 9 pilloli miksija b'rita
English: In patients mean (CV%) Cmax and AUC0-24 (observed after the first dose of Eurartesim) were 179 (62%) ng/ml and 1,679 (47%) ng/ml*h, respectively.
Maltese: Fil-pazjenti, il-medja (CV%) tas- Cmax u l-AUC0-24 (osservata wara l-ewwel doża ta' Eurartesim) kienu 179 (62%) ng/ml u 1,679 (47%) ng/ml*h, rispettivament.
English: These medicines include: mefloquine, halofantrine, lumefantrine, chloroquine or quinine
Maltese: Dawn il-mediċini jinkludu: mefloquine, halofantrine, lumefantrine, chloroquine jew quinine.
English: artenimol is eliminated by metabolism (mainly glucuroconjugation).
Maltese: Artenimol jiġi eliminat permezz tal-metaboliżmu (prinċipalment minn glukurokonjugazzjoni).
English: • Interference with mitochondrial electron transport
Maltese: • Interferenza fit-trasport tal-elettroni mitokondrijali.
English: 6 tablets
Maltese: 6 pilloli
English: Before the third dose of Eurartesim, in one of the two Phase III studies 3/767 patients (0.4%) were reported to have a QTcF value of >500 ms versus none in the comparator group.
Maltese: III, ġie rrappurtat li 3/767 pazjent (0.4%) kellhom valur ta' QTcF ta' >500 ms kontra xejn fil-grupp komparatur.
English: • Disruption of parasite mitochondrial function
Maltese: • Interruzzjoni tal-funzjoni mitokondrijali tal-parassiti.
English: In patients, mean Cmax (CV%) and AUCINF of artenimol (observed after the first dose of Eurartesim) were 752 (47%) ng/ml and 2,002 (45 %) ng/ml*h, respectively.
Maltese: Fil-pazjenti, il-medja tas-Cmax (CV%) u tal-AUCINF ta' artenimol (osservati wara l-ewwel doża ta' Eurartesim) kienu 752 (47%) ng/ml u 2,002 (45%) ng/ml*h, rispettivament.
English: White oblong biconvex film-coated tablet (dimension 11.5x5.5mm / thickness 4.4mm) with a break-line and marked on one side with the letters “S” and “T”.
Maltese: Pillola miksija b'rita, bajda, oblunga (daqs ta' 11.5x5.5mm/ħxuna 4.4mm) u mżaqqa fiż-żewġ naħat u mmarkata fuq naħa waħda bl-ittri “S” u “T”.
English: The mean oral clearance for adult patients with malaria was 2.09 l/h/kg, while in paediatric patients was 2.43 l/h/kg.
Maltese: Il-medja tat-tneħħija orali għal pazjenti adulti bil-malarja kienet ta' 2.09 l/siegħa/kg, filwaqt li f'pazjenti pedjatriċi kienet ta' 2.43 l/siegħa/kg.
English: Alfasigma Belgium sprl/bvba Tel: +32 (0)2 420 93 16 eurartesim.be@alfasigma.com
Maltese: Tel: +32 (0)2 420 93 16 eurartesim.be@alfasigma.com
English: The following ADRs were observed at an incidence of ≥5.0%: Cough (32%), Pyrexia (22.4%), Influenza (16.0%), P. falciparum infection (14.1%), Diarrhoea (9.4%), Vomiting (5.5%) and Anorexia (5.2%).
Maltese: Fit-tieni prova, li fiha l-parteċipanti ntgħażlu b'mod każwali, 1,038 tifel u tifla li kellhom bejn 6 xhur u 5 snin kienu esposti għal Eurartesim u 71% kienu ġġudikati li kellhom ADR. L-ADRs li ġejjin kienu osservati f'inċidenza ta' ≥5.0%: Sogħla (32%), Deni (22.4%), Influwenza (16.0%), infezzjoni b'P. falciparum (14.1%), Dijarea (9.4%), Rimettar (5.5%) u Anoreksja (5.2%).
English: - Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia.
Maltese: - Disturbi fl-elettroliti, partikularment ipokalemija, ipokalċemija jew ipomanjesemija.
English: The elimination half-life of piperaquine is around 22 days for adult patients and around 20 days for paediatric patients.
Maltese: Il-half-life tal-eliminazzjoni ta' piperaquine hi ta' madwar 22 jum għal pazjenti adulti u madwar 20 jum għal pazjenti pedjatriċi.
English: EU/1/11/716/005 3 film-coated tablets
Maltese: EU/1/11/716/001 3 pilloli miksija b'rita
English: • Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive medicinal products.
Maltese: • Newroleptiċi (eż. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol,
English: In vitro metabolism studies demonstrated that piperaquine is metabolised by human hepatocytes (approximately 85% of piperaquine remained after 2 hours incubation at 37°C).
Maltese: Studji in-vitro dwar il-metaboliżmu wrew li piperaquine hu mmetabolizzat minn epatoċiti tal-bniedem (kien baqa' madwar 85% ta' piperaquine wara sagħtejn ta' inkubazzjoni f'temperatura ta' 37°C).
English: Piperaquine has the potential to increase the rate of metabolism for CYP2E1 substrates resulting in a decrease in the plasma concentrations of substrates such as paracetamol or theophylline, and the anaesthetic gases enflurane, halothane and isoflurane.
Maltese: Piperaquine għandu l-potenzjal li jżid ir-rata ta' metaboliżmu għal substrati ta' CYP2E1 li tirriżulta fi tnaqqis fil-konċentrazzjonijiet fil-plażma ta' substrati bħal paracetamol jew theophylline, u l-gassijiet anestetiċi enflurane, halothane u isoflurane.
English: White oblong biconvex film-coated tablet (dimension 16x8mm / thickness 5.5mm) with a break-line and marked on one side with two “σ” letters.
Maltese: Pillola miksija b'rita, bajda, oblunga (daqs ta' 16x8mm/ħxuna 5.5mm) u mżaqqa fiż-żewġ naħat u mmarkata fuq naħa waħda b'żewġ ittri “σ”.
English: 1 x 160 mg / 20 mg tablet
Maltese: 1 x 160 mg / 20 mg pillola
English: Respiratory tract infection Ear infection
Maltese: Infezzjoni tal-apparat respiratorju
English: 2 x 320 mg / 40 mg tablets
Maltese: 2 x 320 mg / 40 mg pilloli
English: • Interference with parasite transport proteins
Maltese: • Interferenza fil-proteini tat-trasport tal-parassiti.
English: • That Eurartesim is contraindicated in patients with severe malaria according to WHO definition and in patients with a history of clinical conditions that may lead to QTc interval prolongation, and in patients taking drugs that are known to prolong the QTc interval.
Maltese: • Li Eurartesim hu kontraindikat f'pazjenti b'malarja severa skont id-definizzjoni tal-WHO u f'pazjenti bi storja medika ta' kundizzjonijiet kliniċi li jistgħu jwasslu għal titwil tal-intervall tal-QTc, u f'pazjenti li jkunu qed jieħdu mediċini li huma magħrufa li jtawlu l-intervall QTc.
English: General toxicity
Maltese: Tossiċità Ġenerali
English: >2 to ≤5 years
Maltese: >sentejn sa ≤5 snin
English: Cardiac conduction disorders Sinus arrhythmias Bradycardia
Maltese: Arritmiji tas-sinus Bradikardija
English: The primary end-point was PCR-corrected cure rate at Day 28.
Maltese: Il-punt aħħari primarju kien rata ta' kura kkoreġuta għal PCR f'Jum 28.
English: In a paediatric pharmacokinetic study, and based on very limited sampling, minor differences were observed for artenimol pharmacokinetics between the paediatric and adult populations.
Maltese: Fi studju farmakokinetiku pedjatriku u bbażat fuq ammont limitat ħafna ta' kampjuni, kienu osservati differenzi żgħar għal farmakokinetika ta' artenimol bejn il-popolazzjonijiet pedjatriċi u adulti.
English: Piperaquine is also a substrate of CYP3A4.
Maltese: Piperaquine hu wkoll sottostrat ta' CYP3A4.
English: In clinical trials with Eurartesim limited ECGs were obtained during treatment.
Maltese: Fil-provi kliniċi b'Eurartesim, inkisbu ECGs limitati matul il-kura.
English: Pharmacokinetic profiles of artenimol and piperaquine have been investigated in animal models and in different human populations (healthy volunteers, adult patients and paediatric patients).
Maltese: Il-profili farmakokinetiċi ta' artenimol u piperaquine ġew investigati f'mudelli ta' annimali u f'popolazzjonijiet differenti ta' bnedmin (voluntiera b'saħħithom, pazjenti adulti u pazjenti pedjatriċi).
English: Concomitant Medication checklist
Maltese: TAL-PRODOTT MEDIĊINALI
English: However, the apparent clearance was faster (1.30 versus 1.14 l/h/kg) and the apparent total volume of distribution was lower in the paediatric population (623 versus 730 l/kg).
Maltese: Madankollu, ittneħħija apparenti kienet iktar mgħaġla (1.30 kontra 1.14 l/siegħa/kg) u volum totali apparenti tad distribuzzjoni kien iktar baxx fil-popolazzjoni pedjatrika (623 kontra 730 l/kg).
English: Eurartesim is indicated for the treatment of uncomplicated Plasmodium falciparum malaria in adults, adolescents, children and infants 6 months and over and weighing 5 kg or more.
Maltese: Eurartesim hu indikat għall-kura ta' malarja mhux ikkumplikata minħabba Plasmodium falciparum f'persuni adulti, fl-adolexxenti, fit-tfal u trabi ta' 6 xhur u aktar u li jiżnu 5 kg jew iżjed.
English: The extent of interactions in the paediatric population is not known.
Maltese: Il-grad ta' interazzjonijiet fil-popolazzjoni pedjatrika mhuwiex magħruf.
English: When co-administered to healthy women, Eurartesim exerted only a minimum effect on an estrogen/progestinic combination oral contraceptive treatment increasing the ethynilestradiol rate of absorption (expressed by geometric mean Cmax) of about 28% but not significantly changing the exposure to ethynilestradiol and levonorgestrel and not influencing contraception activity as demonstrated by the similar plasma concentrations of follicle stimulating hormone (FSH), luteinizing hormone (LH) and progesterone observed after oral contraceptive treatment with or without concomitant Eurartesim administration.
Maltese: Meta ngħata lil nisa b'saħħithom, Eurartesim eżerċita biss effett minimu fuq kura b'kombinazzjoni ta' kontraċettivi orali ta' estroġenu/proġestinika, li żiedet ir-rata ta' assorbiment ta' ethynilestradiol (espressa permezz tal-medja ġeometrika tas-Cmax) b'madwar 28%, iżda ma bidilx b'mod sinifikanti l-esponiment għal ethynilestradiol u levonorgestrel, u ma influwenzax l-attività ta' kontraċezzjoni kif muri mill-konċentrazzjonijiet simili fil-plażma tal-ormon li jistimula l-follikuli (FSH), l-ormon luteinizing (LH) u progesterone, osservati wara l-kura b'kontraċettivi orali bi jew mingħajr l-għoti fl-istess ħin ta' Eurartesim.
English: Since piperaquine is present in the skin (about 9% in the non-pigmented rat and only 3% in the pigmented rat), slight phototoxic reactions (swelling and erythema) were observed 24 hours after oral treatment in mice exposed to UV radiation.
Maltese: Billi piperaquine jinsab fil-ġilda (madwar 9% f'firien mhux ippigmentati u 3% f'firien ippigmentati), reazzjonijiet fototossiċi żgħar (nefħa u eritema) kienu osservati 24 siegħa wara l-kura orali fi ġrieden esposti għal radjazzjoni UV.
English: The 320 mg/40 mg tablets have two 'σ' letters on one side and come in blisters containing 3, 6, 9 or 12
Maltese: Il-pilloli ta' 320 mg/40 mg fihom żewġ ittri ‘σ' fuq naħa waħda u jiġu fornuti f'folji li jkun fihom 3, 6, 9 jew 12-il pillola.
English: Pruritis
Maltese: Pożoloġija
English: In vitro drug-drug interaction studies revealed that artenimol is an inhibitor of CYP1A2; therefore, there is the potential for artenimol to increase plasma concentrations of CYP1A2 substrates (see section 4.5).
Maltese: Studji formali in vitro dwar l-interazzjonijiet ta' mediċina fuq oħra żvelaw li artenimol hu inibitur ta' CYP1A2, u għalhekk hemm il-potenzjal għal artenimol li jżid il-konċentrazzjonijiet fil-plażma ta' substrati ta' CYP1A2 (ara sezzjoni 4.5).
English: Studies in human liver microsomes showed that artenimol was metabolised by the UDP-glucuronosyltransferase (UGT1A9 and UGT2B7) to α- artenimol-G with no cytochrome P450-mediated metabolism.
Maltese: glucuronosyltransferase (UGT1A9 u UGT2B7) għal α-artenimol-G mingħajr l-ebda metaboliżmu medjat minn ċitokrom P450.
English: Studies in human liver microsomes showed that artenimol was metabolised by the UDP-glucuronosyltransferase (UGT1A9 and UGT2B7) to α-artenimol-G with no cytochrome P450-mediated metabolism.
Maltese: Studji li saru f'mikrosomi tal-fwied tal-bniedem urew li artenimol ġie mmetabolizzat mill-UDPglucuronosyltransferase (UGT1A9 u UGT2B7) għal α-artenimol-G mingħajr l-ebda metaboliżmu medjat minn ċitokrom P450.
English: In human studies, piperaquine was found to be a mild inhibitor of CYP3A4 enzyme while potent inhibitors of CYP3A4 activity caused mild inhibition of piperaquine metabolism (see section 4.5).
Maltese: Fi studji fuq il-bnedmin, instab li piperaquine kien inibitur ħafif tal-enzima ta' CYP3A4 filwaqt li inibituri qawwija tal-attività ta' CYP3A4 ikkawżaw inibizzjoni ħafifa tal-metaboliżmu ta' piperaquine
English: QTc intervals of more than 500 ms are associated with a pronounced risk for potentially life-threatening ventricular tachyarrhythmias.
Maltese: Intervalli tal-QTc ta' iktar minn 500 ms huma assoċjati ma' riskju notevoli għal takiarritmiji ventrikulari li potenzjalment jistgħu jkunu ta' periklu għall-ħajja.
English: Hypromellose (E464) Croscarmellose sodium Magnesium stearate (E572)
Maltese: Magnesium stearate (E572).
English: nitrendipine, verapamil, felodipine, amlodipine); - some medicines used to treat HIV (antiretroviral medicinese): protease inhibitors (such as amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine); - some medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone); - medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam,
Maltese: - xi mediċini li jintużaw għal kura ta' kolesterol għoli fid-demm (bħal atorvastatin, cerivastatin, lovastatin, simvastatin); - mediċini li jintużaw għal kura ta' pressjoni għolja u problemi tal-qalb (bħal diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine); - xi mediċini li jintużaw għal kura ta' HIV (mediċini antiretrovirali): inibituri tal-protease (bħal amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), inibituri non-nucleoside reverse transcriptase (bħal efavirenz, nevirapine); - xi mediċini li jintużaw għal kura ta' infezzjonijiet mikrobjali (bħal telithromycin, rifampicin,
English: The concurrent administration of oral Eurartesim with 7.5 mg oral midazolam, a CYP3A4 probe substrate, led to a modest increase (≤2-fold) in midazolam and its metabolites exposures in healthy adult subjects.
Maltese: Eurartesim orali ma' 7.5 mg midazolam orali, test b'sottostrat ta' CYP3A4, wassal għal żieda modesta
English: 1 x 320 mg / 40 mg tablet
Maltese: 1 x 320 mg / 40 mg pillola
English: Piperaquine is a mild inhibitor of CYP3A4.
Maltese: Piperaquine hu inibitur ħafif ta' CYP3A4.
English: From in vitro data, piperaquine undergoes a low level of metabolism by CYP2C19, and is also an inhibitor of this enzyme.
Maltese: Minn dejta in vitro, piperaquine jgħaddi minn livell baxx ta' metaboliżmu minn CYP2C19 u hu wkoll inibitur ta' din l-enzima.
English: • That Eurartesim has a potential to prolong the QTc interval that may lead to potentially lethal arrhythmias.
Maltese: • Li Eurartesim għandu l-potenzjal li jtawwal l-intervall tal-QTc u li dan jista' jwassal għal arritmiji potenzjalment letali.
English: Reactions such as cough, pyrexia, headache, P. falciparum infection, anaemia, asthenia, anorexia and the observed changes in blood cell parameters are consistent with those expected in patients with acute malaria.
Maltese: Reazzjonijiet bħal sogħla, deni, uġigħ ta' ras, infezzjoni b'P. falciparum, anemija, astenja, anoreksja u t-tibdil osservat fil-parametri taċ-ċelluli tad-demm huma konsistenti ma' dak mistenni f'pazjenti b'malarja akuta.
English: Frequency of ADRs in adult patients participating in clinical studies with Eurartesim:
Maltese: Frekwenza ta' ADRs f'pazjenti adulti li pparteċipaw fi studji kliniċi b'Eurartesim:
English: • The ECG monitoring recommendations.
Maltese: • Ir-rakkomandazzjonijiet dwar il-monitoraġġ permezz ta' ECG.
English: Compared to placebo, the maximum mean increases in QTcF on Day 3 of dosing with Eurartesim were 45.2, 35.5 and 21.0 msec under respective dosing conditions.
Maltese: Meta mqabbel mal-plaċebo, iż-żidiet medji massimi fil-QTcF f'Jum 3 tad-dożaġġ b'Eurartesim kienu 45.2, 35.5 u 21.0 msek, taħt kundizzjonijiet tad-dożaġġ rispettivi.
English: The mean clearance (1.45 l/h/kg) was slightly faster in the paediatric patients than in the adult patients (1.34 l/h/kg), while the mean volume of distribution in the paediatric patients (0.705 l/kg) was lower than in the adults (0.801 l/kg).
Maltese: (0.705 l/kg) kienet iktar baxxa milli f'pazjenti adulti (0.801 l/kg).
English: Film-coated tablet 3 tablets
Maltese: Pillola miksija b'rita 3 pilloli
English: Piperaquine was found to be an inhibitor of CYP3A4 (also in a time-dependent way) and to a lesser extent of CYP2C19, while it stimulated the activity of CYP2E1.
Maltese: (b'mod li kien jiddependi fuq il-ħin ukoll) u fi grad anqas ta' CYP2C19, filwaqt li stimula l-attività ta' CYP2E1.
English: 12 tablets
Maltese: 12-il pillola
English: In the absence of carcinogenicity study data, and due to lack of clinical experience with repeated courses of treatment in humans, no more than two courses of Eurartesim should be given in a 12-month period (see sections 4.2 and 5.3).
Maltese: Fl-assenza ta' dejta minn studji dwar il-karċinoġeneċità, u minħabba n-nuqqas ta' esperjenza klinika b'korsijiet ripetuti ta' kura fil-bnedmin, m'għandhomx jingħataw iktar minn żewġ korsijiet ta' Eurartesim f'perjodu ta' 12-il xahar (ara sezzjonijiet 4.2 u 5.3).
English: Due to the lack of multiple dose PK data for piperaquine, administration of any strong CYP3A4-inhibitors should be discouraged after initiation (i.e. the first dose) of Eurartesim (see sections 4.5 and 5.2).
Maltese: Minħabba n-nuqqas ta' dejta PK dwar dożi multipli għal piperaquine, l-għoti ta' kwalunkwe inibituri qawwija ta' CYP3A4 għandu jiġi skoraġġit wara li jibda jingħata (i.e. l-ewwel doża) Eurartesim (ara sezzjonijiet 4.5 u 5.2).
English: A total of 15 (1.5%) subjects had serious ADRs in the study.
Maltese: Total ta' 15 (1.5%) tal-individwi kellhom ADRs serji fl-istudju.
English: Eurartesim 160 mg/20 mg film-coated tablets.
Maltese: Eurartesim 160 mg/20 mg pilloli miksija b'rita.
English: Eurartesim is contraindicated in patients already taking other medicinal products that are known to prolong the QTc interval due to the risk of a pharmacodynamic interaction leading to an additive effect on the QTc interval (see section 4.3 and 4.4).
Maltese: Eurartesim hu kontraindikat f'pazjenti li jkunu diġà qed jieħdu prodotti mediċinali oħrajn li huma magħrufa li jtawlu l-intervall tal-QTc minħabba r-riskju ta' interazzjoni farmakodinamika li twassal għal effett addittiv fuq l-intervall tal-QTc (ara sezzjonijiet 4.3 u 4.4).
English: • has a malaria infection caused by a parasite other than Plasmodium falciparum;
Maltese: • għandkom infezzjoni bil-malarja kkawżata minn parassita, li mhix Plasmodium falciparum;
English: Eurartesim contains the active substances piperaquine tetraphosphate and artenimol.
Maltese: Eurartesim fih is-sustanzi attivi piperaquine tetraphosphate u artenimol.
English: >1 to ≤ 2 years >2 to ≤5 years
Maltese: ≤5 snin >5 sa ≤12-il sena
English: Package leaflet: information for the user Eurartesim 160 mg/20 mg film-coated tablets
Maltese: Informazzjoni għall-utent Eurartesim 160 mg/20 mg pilloli miksija b'rita
English: The 160 mg/20 mg tablets have the letters ‘S' and ‘T' on one side and come in blisters containing 3 tablets.
Maltese: Il-pilloli ta' 160 mg/20 mg għandhom l-ittri ‘S' u ‘T' fuq naħa waħda u jiġu fornuti f'folji li jkun fihom 3 pilloli.
English: Eurartesim 320 mg/40 mg tablets piperaquine tetraphosphate / artenimol
Maltese: Eurartesim 320 mg / 40 mg Pilloli piperaquine tetraphosphate/artenimol
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: No single type of ADR occurred at an incidence of ≥5%.
Maltese: L-ebda tip wieħed ta' ADR ma seħħet f'inċidenza ta' ≥5%.
English: Eurartesim 160 mg/20 mg tablets piperaquine tetraphosphate/artenimol
Maltese: Eurartesim 160 mg / 20 mg Pilloli piperaquine tetraphosphate/artenimol
English: progesterone, estradiol), testosterone; - glucocorticoids (hydrocortisone, dexamethasone); - omeprazole (used to treat diseases related to gastric acid production); - paracetamol (used to treat pain and fever); - theophylline (used to improve bronchial air flow); - nefazodone (used to treat depression); - aprepitant (used to treat nausea); - some gases (such as enflurane, halothane and isoflurane) used to give a general anaesthetic.
Maltese: - glukokortikojdi (hydrocortisone, dexamethasone); - omeprazole (jintuża għal kura ta' mard relatat mal-produzzjoni ta' aċidu gastriku); - paracetamol (jintuża biex jikkura wġigħ u deni);
English: The safety and efficacy of Eurartesim in infants aged less than 6 months and in children weighing less than 5 kg has not been established.
Maltese: Is-sigurtà u effikaċja ta' Eurartesim fit-trabi minn età ta' inqas minn 6 xhur u fi tfal li jiżnu inqas minn 5 kg ma ġewx determinati s'issa.
English: These adverse reactions were seen in animals at exposure levels similar to clinical exposure levels, and with possible relevance to clinical use.
Maltese: Dawn l-effetti mhux mixtieqa dehru f'annimali f'livelli ta' esponiment simili għal-livelli ta' esponiment kliniku u b'rilevanza possibbli għall-użu kliniku.
English: Respiratory infections, ear infection, anaemia, abnormalities in various types of blood cells (white blood cells and platelets), poor appetite or loss of appetite, eye infection, heart rhythm disturbances (change as in adults, ECG changes), abdominal pain, vomiting, diarrhoea, skin inflammation, rash, general weakness.
Maltese: Infezzjoni respiratorja, infezzjoni fil-widnejn, anemija, anormalitajiet f'diversi tipi ta' ċelluli taddemm (ċelluli tad-demm bojod u plejtlits), aptit batut jew telf ta' aptit, infezzjoni fl-għajnejn, disturbi fir-ritmu tal-qalb (tibdil bħal dak fl-adulti, tibdil fl-ECG), uġigħ ta' żaqq, rimettar, dijarea, infjammazzjoni tal-ġilda, raxx, dgħufija ġenerali.
English: • is allergic to the active substances, piperaquine tetraphosphate or artenimol, or to any of the other ingredients of this medicine (listed in section 6);
Maltese: • intom allerġiċi għas-sustanzi attivi, piperaquine tetraphosphate jew artenimol, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6);
English: Convulsion Dizziness
Maltese: Rimettar Dijarea
English: Eurartesim 320 mg/40 mg film-coated tablets.
Maltese: Eurartesim 320 mg/40 mg pilloli miksija b'rita.
English: The efficacy and safety of Eurartesim have been assessed in two large randomised, open-label clinical trials:
Maltese: Is-sigurtà ta' Eurartesim ġiet evalwata f'żewġ studji open-label ta' fażi
English: The bulky bisquinolone structure may be important for activity against chloroquine-resistant strains, and may act through the following mechanisms:
Maltese: L-istruttura goffa ta' bisquinolone tista' tkun importanti għall-attività kontra razez reżistenti għal chloroquine u tista' taġixxi permezz tal-mekkaniżmi li ġejjin:
English: Caution is recommended when co-administering Eurartesim with medicinal products exhibiting variable patterns of inhibition, induction or competition for CYP3A4 as the therapeutic and/or toxic effects of some co-administered medicinal products could be altered.
Maltese: Il-kawtela hi rakkomandata meta Eurartesim jingħata flimkien ma' prodotti mediċinali li juru ritmi varjabbli ta' inibizzjoni, induzzjoni jew kompetizzjoni għal CYP3A4, għax l-effetti terapewtiċi u/jew tossiċi ta' xi wħud mill-prodotti mediċinali mogħtija flimkien jistgħu jinbidlu
English: Piperaquine pharmacokinetic parameters were found to be similar in healthy volunteers of Asian and Caucasian origin.
Maltese: Instab li l-parametri farmakokinetiċi ta' piperaquine kienu simili f'voluntiera b'saħħithom ta' oriġini Asjatika u Kawkasa.