FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people) - loss of consciousness (fainting, which may be preceded by feeling dizzy, lightheaded or confused) - acute renal insufficiency (kidney problems which can be recognised from fluid retention, swelling in legs, ankles or feet, drowsiness, shortness of breath or fatigue) - hypersensitivity and serious allergic reaction (symptoms including localised or diffuse skin itching, dizziness, difficulty breathing, chest pain, gastrointestinal symptoms such as nausea, vomiting, diarrhea or intestinal pain, swelling of the throat, face, lips or tongue)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - telf ta' koxjenza (ħass ħażin, li jista' jkun preċedut minn sturdament, tħoss kollox idur bik jew konfużjoni) - insuffiċjenza akuta tal-kliewi (problemi fil-kliewi li jistgħu jingħarfu minn żamma ta' fluwidu, nefħa fis-saqajn, għekiesi jew saqajn, ngħas, qtugħ ta' nifs jew għeja) - sensittività eċċessiva u reazzjoni allerġika serja (sintomi li jinkludu ħakk lokalizzat jew mifrux fil-ġilda, sturdament, diffikultà biex tieħu n-nifs, uġigħ fis-sider, sintomi gastrointestinali bħal dardir, rimettar, dijarea jew uġigħ intestinali, nefħa tal-gerżuma, wiċċ, xufftejn jew ilsien).
English: [95% CI] p-value p=0.406
Maltese: [CI ta' 95%] valur p p=0.406
English: Enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.
Maltese: Terapija ta' sostituzzjoni tal-enzimi għat-trattament ta' manifestazzjonijiet mhux newroloġiċi f'pazjenti b'alpha-mannosidosis ħafifa sa moderata.
English: The metabolic pathway of velmanase alfa is predicted to be similar to other natural occurring proteins that degrade into small peptides and finally into amino acids.
Maltese: Il-passaġġ metaboliku ta' velmanase alfa huwa mbassar li jkun simili għall-proteini oħra li jseħħu b'mod naturali li jiddegradaw f'peptidi żgħar u finalment f'aċidi amminiċi.
English: Patients with the most severe rapidly progressing phenotype (with a deterioration within one year and central nervous system involvement) were excluded.
Maltese: Pazjenti bl-aktar fenotip sever li għandu progressjoni mgħaġġla (b'deterjorament fi żmien sena u involviment tas-sistema nervuża ċentrali) kienu esklużi.
English: Patient's weight (44 kg) × dose (1 mg/kg) = Patient dose (44 mg) 44 mg divided by 10 mg/vial = 4.4 vials, therefore, 5 vials should be reconstituted.
Maltese: Piż tal-pazjent (44 kg) × doża (1 mg/kg) = Doża tal-pazjent (44 mg)
English: The infusion duration should be a minimum of 50 minutes.
Maltese: It-tul tal-infużjoni għandu jkun mill-inqas 50 minuta.
English: Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1.
Maltese: Reazzjoni allerġika severa għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1.
English: As expected for a protein of this size, the steady-state volume of distribution was low (0.27 L/kg), indicating distribution confined to plasma.
Maltese: Distribuzzjoni Kif mistenni għal proteina ta' dan id-daqs, il-volum ta' distribuzzjoni fi stat fiss kien baxx (0.27 L/kg),
English: The maximum infusion rate is 25 mL/hour.
Maltese: Ir-rata massima tal-infużjoni hija 25 mL/siegħa.
English: Adjusted mean difference
Maltese: Differenza medja aġġustata
English: Reflux gastritis
Maltese: Gastrite b'rifluss
English: The typical manifestations of the disease include distinctive facial features, mental retardation, difficulty in controlling movements, difficulties in hearing and speaking, frequent infections, skeletal problems, muscle pain and weakness.
Maltese: diffikultà biex jiġu kkontrollati l-movimenti, diffikultajiet fis-smigħ u d-diskors, infezzjonijiet frekwenti, problemi skeletriċi, uġigħ fil-muskoli u dgħufija.
English: Lamzede 10 mg powder for solution for infusion velmanase alfa
Maltese: TAL-PRODOTT MEDIĊINALI Lamzede 10 mg trab għal soluzzjoni għall-infużjoni velmanase alfa
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: There were no apparent pharmacokinetic gender differences in patients with alpha-mannosidosis disease.
Maltese: Ma kien hemm l-ebda differenza farmakokinetika apparenti bejn is-sessi f'pazjenti bil-marda ta' alpha-mannosidosis.
English: Eyelid oedema
Maltese: Ż-ŻGĦAR EWLENIN
English: Functional
Maltese: Funzjonali
English: At steady-state after weekly infusion administration of 1 mg/kg of velmanase alfa, the mean maximum plasma concentration was about 8 µg/mL and was reached at 1.8 hours after the start of administration corresponding to the mean infusion duration time.
Maltese: 1 mg/kg ta' velmanase alfa, il-medja tal-konċentrazzjoni massima fil-plażma kienet madwar 8 µg/mL u ntlaħqet wara 1.8 sigħat wara l-bidu tal-għoti li jikkorrispondi tat-tul ta' ħin medju tal-infużjoni.
English: Overall, 58% of patients (19 out of 33) with alpha-mannosidosis receiving velmanase alfa in clinical studies were aged 6 to 17 years at the start of the study.
Maltese: B'mod ġenerali, 58% tal-pazjenti (19 minn 33) b'alpha mannosidosis li kienu qed jirċievu velmanase alfa fl-istudji kliniċi kellhom età minn 6 sa 17-il sena fil-bidu tal-istudju.
English: In the phase 3 pivotal multi-centre, double-blind, randomised, placebo-controlled, parallel group study rhLAMAN-05, the efficacy and safety of repeated administrations of velmanase alfa over 52 weeks at a dose of 1 mg/kg given weekly as intravenous infusion were investigated.
Maltese: Fl-istudju ta' fażi 3 importanti ħafna rhLAMAN-05, b'aktar minn ċentru wieħed, double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bil-plaċebo u bi grupp parallel ġew investigati l-effikaċja u s-sigurtà ta' għoti ripetut ta' velmanase alfa fuq medda ta' 52 ġimgħa b'doża ta' 1 mg/kg mogħtija kull ġimgħa bħala infużjoni ġol-vini.
English: Confusional state
Maltese: Stat ta' konfużjoni
English: Pyrexia(1)
Maltese: Rimettar(1)
English: An integrated database was created by pooling cumulative databases from all studies with velmanase alfa.
Maltese: Ġiet maħluqa database integrata billi inġabru databases kumulattivi mill-istudji kollha b'velmanase alfa.
English: Chiesi Pharma AB Tlf: + 46 8 753 35 20
Maltese: Tlf: + 46 8 753 35 20
English: Use of velmanase alfa in the age group 6 to 17 years is supported by evidence from clinical studies in paediatric (19 out of 33 patients) and adult patients.
Maltese: L-użu ta' velmanase alfa fil-grupp ta' età minn 6 snin sa 17-il sena huwa appoġġjat minn evidenza minn studji kliniċi f'pazjenti pedjatriċi (19 minn 33 pazjent) u adulti.
English: Administration of velmanase alfa may result in an IRR, including anaphylactoid reaction (see section 4.8).
Maltese: Reazzjoni relatata mal-infużjoni L-għoti ta' velmanase alfa jista' jwassal għal IRR, inkluż reazzjoni anafilattojda (ara sezzjoni 4.8).
English: Domain
Maltese: Dominju
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Maltese: Peress li din hi approvazzjoni taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tarRegolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li ġejjin:
English: Animal studies do not show evidence of impaired fertility.
Maltese: Studji fuq l-annimali ma jurux evidenza ta' fertilità indebolita.
English: Criterion
Maltese: Kriterju
English: The recommended dose of 1 mg/kg is determined using the following calculation: Patient's weight (kg) × dose (mg/kg) = Patient dose (in mg) Patient dose (in mg) divided by 10 mg/vial (content of one vial) = number of vials to reconstitute.
Maltese: Piż tal-pazjent (kg) × doża (mg/kg) = Doża tal-pazjent (f'mg) Doża tal-pazjent (f'mg) diviża b'10 mg/kunjett (kontenut ta' kunjett wieħed) = numru ta' kunjetti li għandhom jiġu rikostitwiti.
English: Lamzede 10 mg powder for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Lamzede 10 mg trab għal soluzzjoni għall-infużjoni
English: After the end of the infusion, velmanase alfa plasma concentrations fell in a biphasic fashion with a mean terminal elimination half-life of about 30 hours.
Maltese: Wara t-tmiem tal-infużjoni, il-konċentrazzjonijiet fil-plażma ta' velmanase alfa jonqsu b'mod bifażiku b'half-life medja ta' eliminazzjoni terminali ta' madwar 30 siegħa.
English: A 24 month multi-center, open label phase II trial investigating the safety and efficacy of repeated velmanase alfa (recombinant human alpha-mannosidase) treatment in paediatric patients <6 years of age with alpha-mannosidosis.
Maltese: II, ta' 24 xahar, b'aktar minn ċentru wieħed u open label li tinvestiga s-sigurtà u l-effikaċja ta' trattament ripetut b'velmanase alfa (alpha-mannosidase rikombinanti uman) f'pazjenti pedjatriċi b'età ta' <6 snin li jbatu minn alpha-mannosidosis.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: (1) For overall: adjusted mean change and adjusted mean difference estimated by ANCOVA model are presented (2) By age: unadjusted mean and SD are presented.
Maltese: (2) Skont l-età: huma ppreżentati medja u SD mhux aġġustati.
English: Lamzede contains the active substance velmanase alfa which belongs to a group of medicines known as enzyme replacement therapies.
Maltese: Lamzede fih is-sustanza attiva velmanase alfa li tagħmel parti minn grupp ta' mediċini magħrufa bħala terapiji ta' sostituzzjoni tal-enzimi.
English: The patient later experienced epileptic seizures that were considered not related.
Maltese: Aktar tard il-pazjent kellu attakki epilettiċi li kienu meqjusa bħala mhux relatati.
English: In the clinical studies, one patient experienced acute renal failure considered possibly related to the study treatment.
Maltese: Fl-istudji kliniċi, pazjent wieħed kellu insuffiċjenza akuta tal-kliewi kkunsidrata bħala possibbilment relatata mat-trattament tal-istudju.
English: Overall
Maltese: Totali
English: These reactions were non-serious and mild to moderate in intensity.
Maltese: Dawn ir-reazzjonijiet ma kinux serji u ħfief sa moderati fl-intensità.
English: Chiesi Pharma AB Sími: +46 8 753 35 20
Maltese: Sími: +46 8 753 35 20
English: nausea, vomiting - pain at the site the infusion is given, chills, feeling hot, malaise, tiredness (fatigue) - skin rashes (urticaria), increased sweating (hyperhidrosis) - nosebleed - joint pain, back pain, joint stiffness, muscle pain, pain in extremity (hands, feet) - eye irritation, eyelid swelling (eyelid oedema), eye redness - increased appetite
Maltese: - stat konfuż, ħass ħażin, rogħda, sturdament, uġigħ ta' ras - uġigħ intestinali (fl-addome), irritazzjoni fl-istonku kkawżata minn aċidi diġestivi (gastrite b'rifluss), dardir, rimettar
English: If not used immediately, the reconstituted solution may be stored up to 24 hours at 2°C to 8°C.
Maltese: is-soluzzjoni rikostitwita tista' tinħażen sa 24 siegħa f'temperatura ta' 2°C sa 8°C.
English: Statistically significant improvements were detected in serum oligosaccharide levels, 3MSCT, pulmonary function, serum IgG
Maltese: Kien osservat titjib statistikament sinifikanti fil-livelli ta' oligosakkaridi fis-serum, 3MSCT, fil-funzjoni pulmonari, fl-IgG fis-serum u f'EQ-5D-5L (euro quality of life-5 dimensions) maż-żmien, sal-aħħar osservazzjoni
English: Velmanase alfa is intended to supplement or replace natural alpha-mannosidase, an enzyme that catalyses the sequential degradation of hybrid and complex high-mannose oligosaccharides in the lysosome, reducing the amount of accumulated mannose-rich oligosaccharides.
Maltese: Velmanase alfa huwa maħsub biex jissupplimenta jew jissostitwixxi alpha-mannosidase naturali, enzima li tikkatalizza d-degradazzjoni sekwenzjali ta' oligosakkaridi b'ħafna mannose ibridi u kumplessi fil-lisosomi, u b'hekk inaqqas l-ammont ta' oligosakkaridi b'ħafna mannose akkumulati.
English: Chiesi Pharma AB Tel: +46 8 753 35 20
Maltese: Tel: +46 8 753 35 20
English: Pharmacodynamic
Maltese: MEDIĊINALI
English: Final Study report:
Maltese: Rapport Finali talistudju:
English: The IRRs observed in clinical studies of velmanase alfa were characterised by a rapid onset of symptoms and were of mild to moderate severity.
Maltese: L-IRRs osservati fi studji kliniċi ta' velmanase alfa kienu kkaratterizzati minn bidu mgħaġġel ta' sintomi u kienu ta' severità ħafifa sa moderata.
English: It should be considered by the treating physician that the administration of velmanase alfa does not affect the irreversible complications (i.e. skeletal deformities, disostosis multiplex, neurological manifestations and impaired cognitive function).
Maltese: Għandu jiġi kkunsidrat mit-tabib kuranti li l-għoti ta' velmanase alfa ma jaffettwax il-kumplikazzjonijiet irriversibbli (jiġifieri deformazzjonijiet skeletriċi, disostosis multiplex, manifestazzjonijiet newroloġiċi u funzjoni konoxxittiva indebolita).
English: Velmanase alfa exhibited a linear (i.e. first-order) pharmacokinetic profile, and Cmax and AUC increased proportionally to the dose with doses ranging from 0.8 to 3.2 mg/kg (corresponding to 25 and 100 units/kg).
Maltese: żdiedu b'mod proporzjonali mad-doża, b'dożi li jvarjaw minn 0.8 sa 3.2 mg/kg (li jikkorrispondu għal
English: The adverse reactions reflecting exposure of 33 patients treated with velmanase alfa in clinical studies are listed in the table 1 below.
Maltese: Ir-reazzjonijiet avversi li jirriflettu l-esponiment ta' 33 pazjent ittrattati b'velmanase alfa fi studji kliniċi huma elenkati fit-tabella 1 hawn taħt.
English: Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required.
Maltese: Trattament minn qabel b'antistamini u/jew kortikosterojdi jista' jipprevjeni reazzjonijiet sussegwenti f'dawk il każijiet fejn kien meħtieġ trattament sintomatiku.
English: Hypersensitivity reactions have been reported in patients in clinical studies.
Maltese: Reazzjonijiet ta' sensittività eċċessiva kienu rrappurtati f'pazjenti fi studji kliniċi.
English: Once it has been made up, the medicine will be given by infusion pump (drip) into a vein over a period of at least 50 minutes under your doctor's supervision.
Maltese: Ladarba jkun ġie ppreparat, il-mediċina se tingħata permezz ta' pompa tal-infużjoni (dripp) ġol-vini fuq perjodu ta' mill-inqas 50 minuta taħt is-superviżjoni tat-tabib tiegħek.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment
English: Antibodies may play a role in treatment-related reactions observed with the use of velmanase alfa.
Maltese: Antikorpi jista' jkollhom rwol fir-reazzjonijiet relatati mat-trattament osservati bl-użu ta' velmanase alfa.
English: Baseline actual value Mean (SD)
Maltese: Medja talvalur attwali fillinja bażi (SD)
English: One vial contains 10 mg of velmanase alfa*.
Maltese: Kunjett wieħed fih 10 mg ta' velmanase alfa*.
English: From the total reconstituted volume, only 22 mL (corresponding to 44 mg) should be administered.
Maltese: Mill-volum totali rikostitwit, għandu jingħata 22 mL biss (li jikkorrispondu għal 44 mg).
English: Store and transport refrigerated (2°C - 8°C).
Maltese: Żommu kiesaħ waqt il-ħażna u l-ġarr (2°C - 8°C).
English: Abdominal pain upper
Maltese: Reazzjoni avversa
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: The total volume of infusion is determined by the patient's weight and should be administrated over a minimum of 50 minutes.
Maltese: Il-volum totali tal-infużjoni huwa determinat mill-piż tal-pazjent u għandu jingħata fuq minimu ta' 50 minuta.
English: Common side effects (may affect up to 1 in 10 people) - low heart beat (bradycardia) - psychotic behaviour (mental illness with hallucinations, difficulty in thinking clearly and understanding reality, anxiety), initial difficulty in sleeping - confused state, fainting, tremor, dizziness, headache - intestinal (abdominal) pain, irritation of the stomach caused by digestive acids (reflux gastritis),
Maltese: - imġiba psikotika (mard mentali b'alluċinazzjonijiet, diffikultà biex taħseb b'mod ċar u biex tifhem ir-realtà, ansjetà), diffikultà inizjali biex torqod
English: In order to obtain long-term data on effectiveness and safety of treatment with Lamzede and to characterize the entire alpha-mannosidosis population, including variability of clinical manifestation, progression and natural history, the MAH is requested to submit the results of a study based on adequate source of data deriving from a registry of patients with alpha-mannosidosis.
Maltese: Sabiex tinkiseb data fit-tul dwar l-effikaċja u s-sigurtà ta' trattament b'Lamzede u biex tiġi kkaratterizzata l-popolazzjoni kollha ta' alphamannosidosis, inklużi varjabilità tal-manifestazzjoni klinika, il-progressjoni u l-istorja naturali, l-MAH huwa mitlub jissottometti r-riżultati ta' studju bbażat fuq sors adegwat ta' data li ġejja minn reġistru ta' pazjenti b'alpha mannosidosis.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Lamzede in one or more subsets of the paediatric population in the treatment of alpha-mannosidosis disease (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Lamzede f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fit-trattament tal-marda ta' alpha mannosidosis (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: A slower infusion rate may be prescribed when clinically appropriate according to the physician's judgment, for example at the beginning of the treatment or in case of previous infusion-related reactions (IRRs).
Maltese: pereżempju fil-bidu tat-trattament jew f'każ ta' reazzjonijiet relatati mal-infużjoni (IRRs infusion-related reactions) preċedenti.
English: Name and address of the manufacturer of the biological active substance
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U
English: Lamzede may be given to children and adolescents at the same dose and frequency as in adults.
Maltese: Lamzede jista' jingħata lil tfal u adolexxenti bl-istess doża u frekwenza bħal fl-adulti.
English: Tremor
Maltese: TIKKETTAR
English: Forcefully ejecting the water for injections from the syringe onto the powder should be avoided to minimise foaming.
Maltese: Tfigħ bil-qawwa tal ilma għall-injezzjonijiet mis-siringa fuq it-trab għandu jiġi evitat biex tiġi minimizzata rragħwa.
English: Cardiac disorders
Maltese: Artralġja
English: Dosage
Maltese: Lamzede
English: Most side effects occur during the infusion or shortly after (“infusion-related reaction”, see section 2 Warnings and precautions).
Maltese: Il-biċċa l-kbira tal-effetti sekondarji jseħħu waqt l-infużjoni jew ftit wara (“reazzjoni relatata mal-infużjoni”, ara sezzjoni 2 Twissijiet u prekawzjonijiet).
English: Table 3: Change of clinical endpoints from baseline to the last observation in rhLAMAN-10 study (source data: rhLAMAN-10)
Maltese: Tabella 3: Bidla fil-punti finali kliniċi mil-linja bażi għall-aħħar osservazzjoni fl-istudju rhLAMAN-10
English: IRRs include hypersensitivity in 3 patients and anaphylactoid reaction in 1 patient.
Maltese: IRRs jinkludu sensittività eċċessiva fi 3 pazjenti u reazzjoni anafilattojda f'pazjent wieħed.
English: Lamzede 12 months
Maltese: Lamzede 12-il xahar
English: These medicines may include medicines used to treat allergies (antihistamines), medicines used to treat fever (antipyretics) and medicines to control inflammation (corticosteroids).
Maltese: Dawn il-mediċini jistgħu jinkludu mediċini użati biex jittrattaw allerġiji (antistamini), mediċini użati biex jittrattaw id-deni (sustanzi kontra d-deni) u mediċini biex jikkontrollaw l-infjammazzjoni (kortikosterojdi).
English: Nausea(1)
Maltese: Deni(1)
English: 10 mL vial (Type I glass) with a bromobutyl rubber stopper, an aluminium seal and a polypropylene flip off cap.
Maltese: Kunjett ta' 10 mL (ħġieġ Tip I) b'tapp tal-lastku bromobutyl, siġill tal-aluminium u għatu tal polypropylene li jitneħħa b'daqqa ta' saba'.
English: For infusion rate see section “Method of administration”.
Maltese: Għar-rata tal-infużjoni ara s-sezzjoni “Metodu ta' kif għandu jingħata”.
English: Each mL of reconstituted solution contains 2 mg of velmanase alfa.
Maltese: Kull mL ta' soluzzjoni rikostitwita fih 2 mg ta' velmanase alfa.
English: Ocular hyperaemia
Maltese: Il-Ġermanja
English: All patients who experienced IRRs recovered.
Maltese: Il-pazjenti kollha li kellhom IRRs irkupraw.
English: The reconstituted solution of Lamzede should be administered using an infusion set equipped with a pump and an in-line low protein-binding 0.22 µm filter.
Maltese: It-tul tal-infużjoni għandu jiġi kkalkulat b'mod individwali b'rata massima tal-infużjoni kkunsidrata bħala 25 mL/siegħa biex jiġi kkontrollat l-ammont tal-proteini.
English: EU number
Maltese: Numru ta' Proċedura ta' l-EU
English: Invented name
Maltese: Isem ivvintat
English: Ref.: EMEA/CHMP/643056/2009 EMEA/H/C/805
Maltese: EMEA/CHMP/643042/2009 EMEA/H/C/805
English: ranolazine EPAR summary for the public
Maltese: ranolazine Sommarju tal-EPAR għall-pubbliku
English: Ranexa is a medicine that contains the active substance ranolazine.
Maltese: Ranexa huwa mediċina li fiha s-sustanza attiva ranolazine.
English: This summary was last updated in 09-2009.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 09-2009.
English: The marketing authorisation holder is Menarini International Operations Luxembourg S.A.
Maltese: Iddetentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Menarini International Operations Luxembourg S.A.
English: 1 Previously known as Latixa.
Maltese: 1 Preċedentement magħruf bħala Latixa.
English: Two doses of Ranexa (750 and 1000 mg twice a day) were compared with placebo (a dummy treatment) as an add-on to commonly used medicines for angina pectoris (atenolol, amlodipine or diltiazem).
Maltese: Żewġ dożi ta' Ranexa (750 u 1000 mg darbtejn kuljum) tqabblu ma' plaċebo (trattament finta) bħala trattament addizzjonali flimkien ma' mediċini użati b'mod komuni għal anġina pectoris (atenolol, amlodipina jew diltiazem).
English: It is available as oval prolongedrelease tablets (blue: 375 mg; orange: 500 mg; green: 750 mg).
Maltese: Huwa disponibbli bħala pilloli ovali li jerħu l-mediċina bil-mod (blu: 375 mg; oranġjo: 500 mg; ħodor: 750 mg). ‘Li jerħu l-mediċina bilmod' ifisser li ranolazine jintreħa bil-mod mill-pillola fuq perjodu ta' ftit sigħat.
English: After 12 weeks, this increased by an average of 1 minute 56 seconds in the patients adding either dose of Ranexa, and by an average of 1 minute 32 seconds in those adding placebo.
Maltese: Wara 12-il ġimgħa dan żdied b'medja ta' 1 minuta u 56 sekonda f'pazjenti li jżidu jew id-doża ta' Ranexa u b'medja ta' 1 minuta u 32 sekonda f'dawk li jżidu l-plaċebo.
English: Ranexa has been studied in one main study including a total of 823 patients with an average age of 64 years who had had angina pectoris for at least three months.
Maltese: Ranexa ġie studjat fi studju prinċipali li kien jinkludi total ta' 823 pazjent ta' età medja ta' 64 sena li kellhom l-anġina pectoris għal mill-anqas tliet xhur.
English: The maximum dose is 750 mg twice a day.
Maltese: Id-doża massima hija ta' 750 mg darbtejn kuljum.
English: The name of the medicine was changed to Ranexa on 11 August 2008.
Maltese: Isem il-mediċina nbidel għal Ranexa fil-11 ta' Awwissu 2008.
English: What is Ranexa?
Maltese: X'inhu Ranexa?