FrancophonIA/ELRC3.0 huggingface dataset:
English: Somnolence Tremor Dysgeusia
Maltese: Ngħas Rogħda Dysgeusia
English: For Tavanic 500 mg, the tablets are provided in pack sizes of 1, 5, 7, 10, 50, 200 and 500 tablets.
Maltese: Għal Tavanic 500 mg, il-pilloli jiġu f'daksijiet ta' pakketti ta': 1, 5, 7, 10, 50, 200 u 500 pillola.
English: For Tavanic 250 mg, the tablets are provided in pack sizes of 1, 3, 5, 7, 10, 50 and 200 tablets.
Maltese: Għal Tavanic 250 mg, il-pilloli jiġu f'daksijiet ta' pakketti ta' : 1, 3, 5, 7, 10, 50 u 200 pillola.
English: Tendinitis and tendon rupture, sometimes bilateral, may occur within 48 hours of starting treatment with levofloxacin and have been reported up to several months after discontinuation of treatment.
Maltese: Tendinite u tiċrit tat-tendini, kultant bilaterali, jistgħu jseħħu fi żmien 48 siegħa minn meta tinbeda l-kura b'levofloxacin u ġew irrapurtati sa xi xhur wara li l-kura tkun twaqqfet.
English: 1 film-coated tablet 5 film-coated tablets 7 film-coated tablets 10 film-coated tablets 50 film-coated tablets 200 film-coated tablets 500 film-coated tablets
Maltese: Għall-pillola ta' 500 mg : Pillola 1 miksija b'rita 5 pilloli miksijin b'rita 7 pilloli miksijin b'rita 10 pilloli miksijin b'rita 50 pillola miksija b'rita 200 pillola miksija b'rita 500 pillola miksija b'rita
English: Transient vision loss (see section 4.4)
Maltese: Telf temporanju tal-vista (ara sezzjoni 4.4)
English: • Corticosteroids, sometimes called steroids - used for inflammation.
Maltese: • Kortikosterojdi, kultant imsejħa sterojdi - użati għall-infjammazzjoni.
English: Adults and the elderly
Maltese: Adulti u anzjani
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuni)
English: Following oral and intravenous administration of levofloxacin, it is eliminated relatively slowly from the plasma (t½ : 6 - 8 h).
Maltese: Wara li levofloxacin jingħata b'mod orali u minn ġol-vina, huwa eliminat relattivament bil-mod millplażma (t½: 6 - 8 sigħat).
English: As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA-DNA-gyrase complex and topoisomerase IV.
Maltese: Bħala fluoroquinolone b'azzjoni antibatterjali, levofloxacin jaħdem fuq il-kumpless DNA-DNAgyrase u topoisomerase IV.
English: Ear and Labyrinth disorders
Maltese: Disturbi fissistema labirintika talwidnejn
English: Superinfection
Maltese: Superinfezzjoni
English: The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience.
Maltese: L-informazzjoni mogħtija hawn taħt hija msejsa fuq dejta minn studji kliniċi magħmula fuq aktar minn 8300 pazjent u minn esperjenza estensiva wara t-tqegħid tal-prodott fis-suq.
English: Each film-coated tablet contains 250 mg of levofloxacin as levofloxacin hemihydrate Each film-coated tablet contains 500 mg of levofloxacin as levofloxacin hemihydrate
Maltese: Is-sustanza attiva hija levofloxacin.Kull pillola ta' 250 mg fiha 250 mg ta' levofloxacin u kull pillola ta' Tavanic 500 mg fiha 500 mg ta' levofloxacin
English: Dyspnoea
Maltese: Disgliċemija
English: No adjustment of dose is required in the elderly, other than that imposed by consideration of renal function (see section 4.4 “Tendinitis and tendon rupture” and “QT interval prolongation”).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża fl-anzjani, ħlief aġġustament li jrid isir minħabba l-funzjoni renali (ara sezzjoni 4.4 “Tendinite u tiċrit tat-tendini” u “l-intervall QT imtawwal”).
English: Enterococcus faecium # Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin.
Maltese: S. aureus li hu reżistenti għal methicillin x'aktarx li jkollu wkoll reżistenza għal fluoroquinolones, inkluż levofloxacin.
English: According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdose of Tavanic tablets are central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures, increases in QT interval as well as gastro-intestinal reactions such as nausea and mucosal erosions.
Maltese: Skont studji ta' tossiċità fl-annimali jew studji kliniċi farmakoloġiċi li saru b'dożi supra-terapewtiċi, issinjali l-aktar importanti li huma mistennija li jiġru wara dożaġġ eċċessiv bil-pilloli Tavanic huma sintomi tas-sistema nervuża ċentrali bħal konfużjoni, sturdament, indeboliment tas-sensi, u aċċessjonijiet konvulsivi, żidiet fl-intervall QT kif ukoll reazzjonijiet gastro-intestinali bħad-dardir u ulċeri superfiċjali fil-mukoża.
English: As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g., glibenclamide) or with insulin.
Maltese: Bħal quinolones oħra, ġew irrapportati disturbi fiz-zokkor fid-demm, u dan jinkludi kemm lipogliċemija u anke ipergliċemija, normalment f'pazjenti dijabetiċi li jirċievu kura konkomittanti ma' xi mediċina ipogliċemika orali (eż. glibenclamide) jew mal-insulina.
English: LIST OF EXCIPIENTS
Maltese: Providencia stuartii
English: Cross-resistance between levofloxacin and other fluoroquinolones is observed.
Maltese: Ġiet osservata reżistenza għall-antibijotiċi komuni bejn levofloxacin u fluoroquinolones oħra.
English: Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.
Maltese: Fluoroquinolones, inkluż levofloxacin, jistgħu jikkaġunaw imblukkar newromuskolari u jistgħu jaggravaw dgħufija fil-muskoli f'pazjenti b'myasthenia gravis.
English: Acinetobacter baumannii Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Providencia stuartii Pseudomonas aeruginosa Serratia marcescens
Maltese: Enterobacter aerogenes Enterobacter cloacae Escherichia coli
English: Bacillus anthracis
Maltese: Popolazzjoni anzjana
English: • Sinuses
Maltese: • tas-Sinusis
English: PVC/ALUMINIUM FOIL / BLISTER
Maltese: Folji tal-PVC/ Aluminju li fihom il-pilloli miksijin b'rita.
English: You may be more likely to get the side effects of ciclosporin
Maltese: Hemm ċans akbar li jkollok l-effetti sekondarji ta' ciclosporin
English: Separate analysis for male and female subjects showed small to marginal gender differences in levofloxacin pharmacokinetics.
Maltese: Analiżi separata fuq irġiel u nisa wriet differenzi fil-farmakokinetika ta' levofloxacin li kienu minn żgħar sa marġinali.
English: 1 film-coated tablet 3 film-coated tablets 5 film-coated tablets 7 film-coated tablets 10 film-coated tablets 50 film-coated tablets 200 film-coated tablets
Maltese: Għall-pillola ta' 250 mg : Pillola 1 miksija b'rita 3 pilloli miksijin b'rita 5 pilloli miksijin b'rita 7 pilloli miksijin b'rita 10 pilloli miksijin b'rita 50 pillola miksija b'rita 200 pillola miksija b'rita
English: Hypersensitivity reactions
Maltese: Reazzjonijiet ta' sensitività eċċessiva
English: • Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
Maltese: • Tħossok mdejjaq, problemi mentali, tkun bla sabar (aġitazzjoni), ħolm mhux tas-soltu jew inkubi
English: In common with other fluoroquinolones, levofloxacin showed effects on cartilage (blistering and cavities) in rats and dogs.
Maltese: B'mod simili ma' fluoroquinolones oħra, levofloxacin wera effetti fuq il-qarquċa (bżieżaq u toqob) filfirien u l-klieb.
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna)
English: • in children or growing adolescents,
Maltese: • fit-tfal u fl-adolexxenti,
English: • Temporary loss of consciousness or posture (syncope)
Maltese: • Telf temporanju tas-sensi jew qagħda tal-ġisem (sinkope)
English: • One or two tablets of Tavanic 250 mg, each day
Maltese: • Żewġ pilloli ta' Tavanic 250 mg, darba kuljum
English: Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example: - congenital long QT syndrome - concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) - uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia) - cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).
Maltese: IA u III, antidepressanti triċikliċi, macrolides, antipsikotiċi). - żbilanċ fl-elettroliti li għadu mhux irranġat (eż. ipokalimja, ipomagneżimja) - anzjani - mard tal-qalb (eż. insuffiċjenza tal-qalb, infart mijokardijaku, bradikardja) Nisa u pazjenti anzjani jistgħu jkunu iżjed sensittivi għall-medikazzjonijiet li jtawlu l-QTc.
English: Pack sizes for 250 mg tablets: 1, 3, 5, 7, 10, 50 and 200 as commercially available.
Maltese: Daqsijiet tal-pakketti għall-pilloli ta' 250 mg: 1, 3, 5, 7, 10, 50 u 200 huma disponibbli biex ikunu fissuq.
English: Peripheral sensory neuropathy and peripheral sensory motor neuropathy have been reported in patients receiving fluoroquinolones, including levofloxacin, which can be rapid in its onset (see section 4.8).
Maltese: Ġew irrapportati newropatija sensorjali periferali u newropatija sensorjali periferali tas-sistema lokomottiva f'pazjenti li qed jieħdu fluoroquinolones, inkluż levofloxacin, li jistgħu jseħħu malajr ħafna meta jibdew (ara sezzjoni 4.8).
English: Uncomplicated cystitis (see section 4.4)
Maltese: Ipergliċemija Koma ipogliċemika (ara sezzjoni 4.4)
English: • Shortness of breath (dyspnoea)
Maltese: • Qtugħ ta' nifs (dispneja)
English: Anaerobic bacteria
Maltese: Batterji li huma anaerobiċi Bacteroides fragilis
English: Cases of hepatic necrosis up to fatal hepatic failure have been reported with levofloxacin, primarily in patients with severe underlying diseases, e.g. sepsis (see section 4.8).
Maltese: Ġew irrapportati każijiet ta' nekrożi fil-fwied sa insuffiċjenza tal-fwied li tista' tkun fatali ma' levofloxacin, primarjament f'pazjenti morda b'mard serju, eż. sepsis (ara sezzjoni 4.8).
English: Levofloxacin did not show any genotoxic potential in a photomutagenicity assay, and it reduced tumour development in a photocarcinogenity study.
Maltese: Levofloxacin ma wera l-ebda potenzjal ġenotossiku f'analiżi fotomutaġeniku, u naqqas l-iżvilupp tattumur fi studju photokarsinoġenetiku.
English: Tavanic is contraindicated in children and growing adolescents (see section 4.3).
Maltese: Tavanic huwa kontra-indikat fit-tfal u fl-adolexxenti (ara sezzjoni 4.3).
English: NAME OF THE MEDICINAL PRODUCT Tavanic 250 mg film-coated tablets Tavanic 500 mg film-coated tablets levofloxacin
Maltese: TAVANIC 250 mg pilloli miksijin b'rita TAVANIC 500 mg pilloli miksijin b'rita levofloxacin
English: Score line pale yellowish-white to reddish-white film-coated tablets.
Maltese: Dawn is-sejbiet kienu aktar notevoli fil-frieħ tal-annimali.
English: • Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopenia)
Maltese: • Numru baxx ta' ċelluli bojod tad-demm (newtropenija)
English: Aerobic Gram-positive bacteria
Maltese: Batterji li huma aerobiċi u Gram-positive Bacillus anthracis
English: CNS effects including confusional state, convulsion, hallucination, and tremor have been observed in post marketing experience.
Maltese: Effetti tas-CNS inkluż stat ta' konfużjoni, aċċessjoni, alluċinazzjoni, u rogħda ġew osservati wara ttqegħid tal-prodott fis-suq.
English: Infection of skin and underneath the skin, including muscles
Maltese: Infezzjoni tal-ġilda u taħt il-ġilda, inkluż il-muskoli
English: Hyperglycaemia Hypoglycaemic coma (see section 4.4)
Maltese: Anoreksja Ipogliċemija speċjalment f'pazjenti dijabetiċi (ara sezzjoni 4.4)
English: Mycoplasma pneumoniae Mycoplasma hominis Ureaplasma urealyticum
Maltese: Il-pilloli levofloxacin m'għandhomx jintużaw:
English: BATCH NUMBER Batch
Maltese: Pressjoni baxxa
English: Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin (and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate).
Maltese: Għalhekk levofloxacin mhux rakkomandat għal kura ta' infezzjonijiet bl-MRSA magħrufa jew suspettati sakemm ir-riżultati tal-laboratorju jikkonfermaw li l-mikrobu huwa sensittiv għal levofloxacin (u antibijotiċi li huma normalment rakkomandati għal kura tal-infezzjonijiet blMRSA mhumiex ikkunsidrati xierqa).
English: • Attacks of porphyria in people who already have porphyria (a very rare metabolic disease) • Persistent headache with or without blurred vision (benign intracranial hypertension)
Maltese: • L-attakki ta' porfirija f'persuni li diġà għandhom porfirija (marda metabolika rari ħafna)
English: • Inflammation of the tissue inside the mouth (stomatitis)
Maltese: • Infjammazzjoni tat-tessut tal-ħalq (stomatite)
English: Resistance to levofloxacin is acquired through a stepwise process by target site mutations in both type II topoisomerases, DNA gyrase and topoisomerase IV. Other resistance mechanisms such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may also affect susceptibility to levofloxacin.
Maltese: Dawn l-effetti jistgħu jiġu attribwiti għall-inibizzjoni ta' topoisomerase II. Testijiet in vivo (micronucleus, sister chromatid exchange, sinteżi tad-DNA mhux skedat, testijiet letali dominanti) ma wrew l-ebda potenzjal ġenotossiku.
English: Daily dose regimen (according to severity)
Maltese: Żmien totali tal-kura (skont is-severità)
English: • Skin and underneath the skin, including muscles.
Maltese: • Ġilda u taħt il-ġilda, inkluż il-muskoli.
English: Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents.
Maltese: Pazjenti li għandhom xi difetti moħbija jew attwali fl-attività ta' glucose-6-phosphate dehydrogenase jistgħu jkunu suxxettibli għal reazzjonijiet emolitiċi meta kkurati b'aġenti antibatteriċi tal-klassi quinolone.
English: Rash
Maltese: OĦRAJN
English: The breakpoints for levofloxacin relate to high dose therapy.
Maltese: Il-breakpoints għal levofloxacin huma assoċjati ma' terapija b'doża għolja.
English: • Difficulty breathing or wheezing (bronchospasm)
Maltese: • Diffikultà biex tieħu n-nifs jew tħarħir (bronkospażmu)
English: • Iron tablets (for anemia), zinc supplements, magnesium or aluminum-containing antacids (for acid or heartburn), didanosine, or sucralfate (for stomach ulcers).
Maltese: • Pilloli tal-ħadid (għall-anemija), vitamini taż-żingu, sustanzi kontra l-aċtu li fihom il-manjesju jew l-aluminju (għall-aċtu jew ħruq ta' stonku), didanosine, jew sucralfate (għall-ulċeri flistonku).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet of Tavanic 250 mg contains 250 mg of levofloxacin as levofloxacin hemihydrate.
Maltese: Kull pillola miksija b'rita ta' Tavanic 250 mg fiha 250 mg ta' levofloxacin bħala levofloxacin hemihydrate
English: Aerobic Gram- negative bacteria
Maltese: Batterji li huma aerobiċi u Gram-negative Eikenella corrodens
English: Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body.
Maltese: Emodijalisi, inkluż dijalisi peritoneali u CAPD, mhumiex effettivi fit-tneħħija tallevofloxacin mill-ġisem.
English: Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin).
Maltese: Żieda fit-testijiet tal-koagulazzjoni (PT/INR) u /jew tnixxija tad-demm, li jistgħu jkunu severi, kienu rrapportati f'pazjenti kkurati b'levofloxacin flimkien ma' antagonista tal-vitamina K (eż. warfarin).
English: Levofloxacin caused no impairment of fertility or reproductive performance in rats and its only effect on fetuses was delayed maturation as a result of maternal toxicity.
Maltese: Levofloxacin ma kkawża l-ebda indeboliment fil-fertilità jew l-andament riproduttiv fil-firien u luniku effett tiegħu fuq il-feti kien maturazzjoni ttardjata minħabba tossiċità materna.
English: Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists (see section 4.4).
Maltese: Għalhekk, testijiet tal-koagulazzjoni għandhom jiġu mmonitorjati f'pazjenti li qed jieħdu kura b'antagonisti tal-vitamina K (ara sezzjoni 4.4)
English: Pyrexia
Maltese: Pnewmonja
English: With decreasing renal function renal elimination and clearance are decreased, and elimination half-lives increased as shown in the table below:
Maltese: Meta l-funzjoni renali tibda tonqos, l-eliminazzjoni renali u t-tneħħija renali jiġu wkoll mnaqqsa, u l-half lives taleliminazzjoni died kif m i fit jiż u ur tabella hawn taħt:
English: Visual disturbances such as blurred vision (see section 4.4)
Maltese: Disturbi tal-vista bħal per eżempju vista mċajpra (ara sezzjoni 4.4)
English: Levofloxacin concentrations were about 13% higher in the presence of fenbufen than when administered alone.
Maltese: Il-konċentrazzjonijiet ta' levofloxacin kienu xi 13% ogħla fil-preżenza ta' fenbufen milli meta kien mogħti waħdu.
English: Very rare (may affect up to 1 in 10,000 people)
Maltese: Rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna)
English: Other medicines and Tavanic
Maltese: Effett tal-mediċini oħra fuq Tavanic
English: then: 125 mg/48 h then: 125 mg/24 h then: 125 mg/24 h
Maltese: imbagħad: 125 mg/48 h imbagħad: 125 mg/24 h imbagħad: 125 mg/24 h 1M'hemmx bżonn ta' dożi oħra wara emodijalisi jew dijalisi peritoneali kontinwa ambulatorja (CAPD).
English: The degree of the bactericidal activity of levofloxacin depends on the ratio of the maximum concentration in serum (Cmax) or the area under the curve (AUC) and the minimal inhibitory concentration (MIC).
Maltese: Il-livell tal-attività batteriċidjali ta' levofloxacin jiddependi fuq il-proporzjon tal-konċentrazzjoni massima fis-serum (Cmax) jew l-erja taħt il-kurva (AUC) u l-konċentrazzjoni minima inibitorja (MIC).
English: Tavanic 250 mg film-coated tablets contain the following excipients for a weight of 315 mg: Tavanic 500 mg film-coated tablets contain the following excipients for a weight of 630 mg:
Maltese: Tavanic 250 mg pilloli miksijin b'rita fihom dawn l-eċċipjenti li ġejjin li jagħtu piż ta' 315 mg: Tavanic 500 mg pilloli miksijin b'rita fihom dawn l-eċċipjenti li ġejjin li jagħtu piż ta' 630 mg:
English: • Or, one tablet of Tavanic 500 mg, once each day
Maltese: • Jew, pillola waħda ta' Tavanic 500 mg, darba kuljum
English: Blood bilirubin increased
Maltese: INFORMAZZJONI BIL-BRAILLE
English: OTHER
Maltese: III
English: Insomnia Anxiety Confusional state
Maltese: Insomnja Ansjetà Stat ta' konfużjoni,
English: See section 3 “If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate” below.
Maltese: Ara sezzjoni 3 “Jekk diġà qed/a tieħu pilloli tal-ħadid, vitamini taż-żingu, sustanzi kontra l-aċtu, didanosine jew sucralfate” aktar 'l isfel
English: Acute bacterial sinusitis
Maltese: Sinusite akuta kkawżata millbatterji
English: Effect of Tavanic on other medicinal products
Maltese: Effett ta' Tavanic fuq prodotti mediċinali oħra
English: Vision disorders
Maltese: Disturbi fil-vista
English: • Headache, feeling dizzy
Maltese: • Indeboliment jew telf ta' smigħ
English: • You have ever had heart problems: caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia'), have a weak heart (heart failure),
Maltese: • Il-pazjent jista' jara jew jisma' affarijiet li mhumiex hemm (alluċinazzjonijiet, paranojja), tibdil fl-opinjoni tiegħek u ħsibijiet (reazzjonijiet psikotiċi) b'riskju li jkollok ħsibijiet jew azzjonijiet ta' suwiċidju
English: Special populations
Maltese: Reżistenti
English: There are no significant differences in levofloxacin pharmacokinetics between young and elderly subjects, except those associated with differences in creatinine clearance.
Maltese: M'hemmx differenzi sinifikanti fil-farmakokinetiċi ta' levofloxacin bejn individwi ta' età żgħira u lanzjani, ħlief dawk assoċjati ma' differenzi fit-tneħħija tal-kreatinina.
English: Levofloxacin is contraindicated in patients with a history of epilepsy (see section 4.3) and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures or concomitant treatment with active substances that lower the cerebral seizure threshold, such as theophylline (see section 4.5).
Maltese: Levofloxacin huwa kontra-indikat f'pazjenti li għandhom storja ta' epilessija (ara sezzjoni 4.3) u, bħal fil-każ ta' quinolones oħra, għandu jintuża b'kawtela kbira f'pazjenti li huma predisposti għallaċċessjonijiet jew jekk ikun hemm kura eżistenti b'mediċini oħra li jbaxxu l-limitu ċerebrali li jkun hemm xi aċċessjoni, bħal per eżempju theophylline (ara sezzjoni 4.5).
English: • Two tablets of Tavanic 250 mg, once each day
Maltese: • Żewġ pilloli ta' Tavanic 250 mg, darba jew darbtejn kuljum
English: • Itching and skin rash, severe itching or hives (urticaria), sweating too much (hyperhidrosis)
Maltese: • Ħakk u raxx tal-ġilda, ħakk sever jew ħorriqija (urtikarja), ħafna għaraq (iperidrożi)
English: No specific antidote exists.
Maltese: Ebda antidotu speċifiku ma jeżisti.
English: • Muscle weakness.
Maltese: • Ikollok reazzjoni allerġika.
English: Jaundice and severe liver injury, including cases with fatal acute liver failure, primarily in patients with severe underlying diseases (see section 4.4) Hepatitis
Maltese: Suffejra u ħsara severa filfwied inkluż każijiet b'insuffiċjenza akuta fatali tal-fwied, primarjament f'pazjenti morda b'mard ieħor serju (ara sezzjoni 4.4) Epatite
English: How to store Tavanic tablets 6.
Maltese: L-isem tal-mediċina tiegħek hija pilloli Tavanic.
English: 24 March 2017 EMA/192276/2017 EMEA/H/C/004193
Maltese: EMA/192276/2017 EMEA/H/C/004193
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom organi bħall-milsa, u jġiegħluhom jikbru.
English: Withdrawal of the marketing authorisation application for Enpaxiq (pacritinib) EMA/192276/2017
Maltese: (pacritinib) EMA/192276/2017
English: Enpaxiq is a medicine that contains the active substance pacritinib.
Maltese: Enpaxiq huwa mediċina li fiha s-sustanza attiva pacritinib.
English: What is Enpaxiq?
Maltese: Kif jaħdem Enpaxiq?
English: How does Enpaxiq work?
Maltese: 'inhu Enpaxiq?
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP kien evalwa d-dokumentazzjoni inizjali pprovduta millkumpanija u fformula lista ta
English: Questions and answers
Maltese: -numru
English: The study compared Enpaxiq with ‘best available therapy', which included treatments that do not act on JAK proteins such as hydroxyurea or supportive care.
Maltese: -"aqwa terapija disponibbi", li inkludiet kuri li ma jaġixxux fuq il-proteini JAK bħal pereżempju hydroxyurea jew il-kura ta
English: What was Enpaxiq expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Enpaxiq?
English: Withdrawal of the marketing authorisation application for Enpaxiq (pacritinib)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Enpaxiq (pacritinib)
English: At the time of the withdrawal of application, the CHMP was of the provisional opinion that Enpaxiq could not have been approved for myelofibrosis.
Maltese: Fiż-żmien tal-irtirar tal-applikazzjoni, is-CHMP kien tal-fehma provviżorja li Enpaxiq ma setax jiġi approvat għall-mjelofibrożi.