FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on Pazenir can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pazenir.
Maltese: ema.europa.eu/medicines/human/EPAR/pazenir.
English: Pazenir received a marketing authorisation valid throughout the EU on 6 May 2019.
Maltese: Pazenir ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-6 ta' Mejju 2019.
English: Pazenir is given as an infusion into a vein over a period of 30 minutes.
Maltese: Pazenir jingħata bħala infużjoni ġo vina fuq perjodu ta' 30 minuta.
English: In non-small cell lung cancer, treatment is carried out in 3-week cycles with Pazenir given on days 1, 8 and 15 of each cycle and carboplatin given on day 1 immediately after Pazenir.
Maltese: Fil-kanċer tal-pulmun ta' ċellola mhux żgħira, il-kura tingħata f'ċikli ta' 3 ġimgħat b'Pazenir li jingħata fl-1 jum, fit-8 jum u fil-15-il jum ta' kull ċiklu u b'carboplatin li jingħata fl-1 jum eżatt wara Pazenir.
English: Paclitaxel has been available as a cancer medicine since 1993.
Maltese: Il-paklitaksel ilha disponibbli bħala mediċina kontra l-kanċer mill-1993.
English: The medicine is given once a day on days 1, 8 and 15 of each cycle.
Maltese: Il-mediċina tingħata darba kuljum fl-1 jum, fit-8 jum u fil-15-il jum ta' kull ċiklu.
English: In Pazenir, as in its reference medicine Abraxane, paclitaxel is attached to a human protein called albumin in tiny particles known as ‘nanoparticles'.
Maltese: F'Pazenir, bħal fil-każ talmediċina ta' referenza Abraxane, il-paklitaksel teħel mal-proteina umana msejħa albumina f'partikuli żgħar magħrufa bħala “nanopartikuli”.
English: Pazenir contains the active substance paclitaxel attached to a human protein called albumin and is a ‘generic medicine'.
Maltese: Pazenir fih is-sustanza attiva paklitaksel imwaħħla ma' proteina umana msejħa albumina u hija “mediċina ġenerika”.
English: • metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine;
Maltese: • adenokarċinoma metastatika tal-frixa, bħala l-ewwel kura flimkien ma' mediċina oħra kontra lkanċer, gemcitabine;
English: This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein.
Maltese: Dan jiffaċilita l-preparazzjoni ta' sospensjoni ta' paklitaksel, li tista' tiġi injettata ġo vina.
English: How has Pazenir been studied?
Maltese: Kif ġie studjat Pazenir?
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Abraxane, and do not need to be repeated for Pazenir.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użi awtorizzati bil-mediċina ta' referenza, Abraxane, u ma hemmx bżonn li jiġu ripetuti għal Pazenir.
English: What are the benefits and risks of Pazenir?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pazenir?
English: The medicine can only be obtained with a prescription.
Maltese: Ma għandux jiġi sostitwit b'mediċini oħra li fihom ilpaklitaksel.
English: Other information about Pazenir
Maltese: Informazzjoni oħra dwar Pazenir
English: Because Pazenir is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Pazenir huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: • non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin when the patient cannot have surgery or radiotherapy.
Maltese: • kanċer tal-pulmun ta' ċellola mhux żgħira (non-small cell lung cancer), bħala l-ewwel kura flimkien mal-mediċina kontra l-kanċer carboplatin meta l-pazjent ma jkunx jista' jiġi operat jew ma jkunx jista' jirċievi radjoterapija.
English: Immediately after giving Pazenir, gemcitabine should be given.
Maltese: Immedjatament wara l-għoti ta' Pazenir, għandha tingħata gemcitabine.
English: As for all medicines, data on the use of Pazenir are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Pazenir hija ssorveljata kontinwament.
English: What measures are being taken to ensure the safe and effective use of Pazenir?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Pazenir?
English: The active substance in Pazenir, paclitaxel, belongs to the group of cancer medicines known as the ‘taxanes'.
Maltese: Is-sustanza attiva f'Pazenir, il-paklitaksel, tappartjeni għall-grupp ta' mediċini kontra l-kanċer magħrufa bħala “tassani”.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar ilmediċini ġeneriċi, ara d-dokument bil-mistoqsijiet u t-tweġibiet hawnhekk.
English: Pazenir is used to treat the following cancers in adults:
Maltese: Pazenir jintuża f'adulti għall-kura tal-kanċers li ġejjin:
English: This means that Pazenir contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Abraxane.
Maltese: Dan ifisser li Pazenir fih l-istess sustanza attiva u jaħdem bl-istess mod bħal “mediċina ta' referenza” diġà awtorizzata fl-UE msejħa Abraxane.
English: Pazenir should only be given under the supervision of a cancer doctor in clinics that are specialised in giving ‘cytotoxic' (cell-killing) medicines.
Maltese: Id-doża rakkomandata tiddependi fuq it-tul u l-piż tal-pazjent.
English: This is because Pazenir is given by infusion into a vein and the nanoparticles it contains rapidly separate into its constituent parts in the same way as Abraxane's.
Maltese: Dan hu minħabba li Pazenir jingħata b'infużjoni ġol-vina u n-nanopartikuli li fih jisseparaw b'mod rapidu fil-partijiet kostitwenti tiegħu bl-istess mod bħal dawk f'Abraxane.
English: There was no need for ‘bioequivalence' studies to investigate whether Pazenir is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' “bijoekwivalenza” biex jiġi investigat jekk Pazenir jiġix assorbit b'mod simili għallmediċina ta' referenza biex jipproduċi l-istess livell tas-sustanza attiva fid-demm.
English: How is Pazenir used?
Maltese: Kif jaħdem Pazenir?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Pazenir has been shown to be comparable to Abraxane.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, f'konformità mar-rekwiżiti tal-UE, Pazenir intwera li huwa komparabbli ma' Abraxane.
English: In metastatic adenocarcinoma of the pancreas, Pazenir is given in 4-week treatment cycles.
Maltese: Informazzjoni dwar il-mediċina ta' referenza tinstab ukoll fis-sit web tal-Aġenzija.
English: • metastatic breast cancer, when the first treatment has stopped working and standard treatment including an anthracycline (another type of cancer medicine) is not suitable.
Maltese: • kanċer metastatiku tas-sider, meta l-ewwel kura ma tkunx baqgħet taħdem u kura standard li tinkludi antraċiklina (tip ta' mediċina oħra kontra l-kanċer) ma tkunx adattata. “Metastatiku” tfisser li l-kanċer ikun infirex lejn partijiet oħra tal-ġisem;
English: Pictures of rash according to different grades
Maltese: Ritratti tar-raxx skont gradi differenti
English: Rash and Severe Cutaneous Adverse Reactions safety data from Phases 2 and 3 Incidence of rash and severe cutaneous reactions Grading and management of rash and severe cutaneous reactions, particularly with respect to criteria for the continuation or discontinuation of telaprevir and the other
Maltese: Tagħrif dwar is-sigurtà rigward Raxx u Reazzjonijiet Qawwijin fil-Ġilda mill-Fażijiet 2 u 3
English: The Summary of Product Characteristics
Maltese: MILL-ISTATI
English: The Member States shall ensure that the MAH provides to all physicians who are expected to prescribe or use INCIVO a healthcare professional educational pack containing the following:
Maltese: L-Istati Membri għandhom jiżguraw li l-kundizzjonijiet jew restrizzjonijiet rigward l-użu sigur u effettiv tal-prodott mediċinali li ġejjin jiġu implimentati:
English: Invented name
Maltese: Isem inventat
English: 1 capsule
Maltese: 1 Kapsuli
English: Strength Pharmaceutical Form
Maltese: Għamla farmaċewtika
English: 1 vial
Maltese: 1 Fjala
English: Packaging Content (concentration) Package size
Maltese: Daqs tal-pakkett
English: Intravenous use vial (glass) 5 ml
Maltese: 5 ml
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 April 2018 EMA/258015/2018 EMEA/H/C/004150
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 ta' April 2018 EMA/258015/2018 EMEA/H/C/004150
English: What is Prohippur?
Maltese: X'inhu Prohippur?
English: Prohippur was designated an ‘orphan medicine' (a medicine to be used in rare diseases) for non-ketotic hyperglycinaemia on 11 September 2002 and for urea cycle disorders on 14 July 2016, 29 August 2016 and 18 November 2016.
Maltese: Prohippur kien imfassal bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) għal ipergliċinemija mhux ketotika fil-11 ta' Settembru 2002 u għal disturbi fiċ-ċiklu tal-urea fl-14 ta' Lulju 2016, fid-29 ta' Awwissu 2016 u fit-18 ta' Novembru 2016.
English: Prohippur is a medicine containing the active substance sodium benzoate.
Maltese: Prohippur huwa mediċina li fiha s-sustanza attiva benżoat tas-sodju.
English: It was to be available as granules.
Maltese: Dan kellu jkun disponibbli bħala granuli.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP kien evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fformula lista ta' mistoqsijiet.
English: What was Prohippur expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Prohippur?
English: Withdrawal of the marketing authorisation application for Prohippur (sodium benzoate) EMA/258015/2018
Maltese: EMA/258015/2018
English: Finally, the CHMP had questions about the high levels of a substance in Prohippur (butylated methacrylate copolymer), the method of administration and quality control of the medicine in general.
Maltese: Fl-aħħar nett, is-CHMP kellu mistoqsijiet dwar il-livelli għoljin ta' sustanza f'Prohippur (kopolimeru metakrilat butilat), il-metodu ta' amministrazzjoni u l-kontroll ta' kwalità tal-mediċina b'mod ġenerali.
English: On 3 April 2018, Lucane Pharma officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Prohippur, for the treatment of non-ketotic hyperglycinaemia and urea cycle disorders.
Maltese: Fit-3 ta' April 2018, Lucane Pharma għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li xtaqet tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għall-Prohippur, għall-kura ta' ipergliċinemija mhux ketotika u għad-disturbi fiċ-ċiklu tal-urea.
English: The CHMP noted that the published studies submitted by the company did not provide enough evidence of the effectiveness and safety of sodium benzoate in the various disorders.
Maltese: Is-CHMP innota li l-istudji ppubblikati sottomessi millkumpanija ma pprovdewx biżżejjed evidenza dwar l-effettività u s-sigurtà tal-benżoat tas-sodju fiddisturbi varji.
English: • urea cycle disorders, a group of conditions where abnormally high levels of nitrogen occur in the body in the form of ammonia.
Maltese: • disturbi fiċ-ċiklu tal-urea, grupp ta' kundizzjonijiet fejn livelli għoljin b'mod anormali ta' nitroġenu jimmanifestaw ruħhom fil-ġisem fil-forma ta' ammonja.
English: Furthermore, as Prohippur was not used in clinical trials, the company should have provided data to show that Prohippur granules worked in the same way as the sodium benzoate used in the published studies.
Maltese: Barra minn hekk, billi Prohippur ma ntużax fi provi kliniċi, il-kumpanija kellha tipprovdi data biex turi li l-granuli Prohippur ħadmu bl-istess mod bħall-benżoat tas-sodju fl-istudji ppubblikati.
English: The company presented data from published studies on the use of sodium benzoate in patients with non-ketotic hyperglycinaemia and urea cycle disorders.
Maltese: Il-kumpanija ppreżentat data minn studji ppubblikati dwar l-użu tal-benżoat tas-sodju fil-pazjenti b'ipergliċinemija mhux ketotika u b'disturbi fiċ-ċiklu tal-urea.
English: The active substance in Prohippur, sodium benzoate, helps reduce harmful levels of glycine by attaching to glycine and forming a substance that is more easily removed by the kidneys.
Maltese: Is-sustanza attiva f'Prohippur, il-benżoat tas-sodju, tgħin biex tnaqqas il-livelli tal-gliċina li huma ta' periklu billi teħel mal-gliċina biex tifforma sustanza li hija iktar faċli biex titneħħa mill-kliewi.
English: The company informed the CHMP that there are no ongoing clinical trials with Prohippur and that a compassionate use programme approved in France will continue as planned.
Maltese: Il-kumpanija infurmat lis-CHMP li ma kienx hemm provi kliniċi bi Prohippur għaddejjin u l-programm ta' użu b'kompassjoni approvat fi Franza se jitkompla kif ippjanat.
English: • non-ketotic hyperglycinaemia, where abnormally high levels of the amino acid glycine occur in the blood.
Maltese: • ipergliċinemija mhux ketotika, fejn fid-demm ikunu jinsabu livelli għoljin b'mod anormali tal-aċidu amminiku gliċina.
English: 5 years.
Maltese: 5 snin.
English: Date of first authorisation: 20 November 2002 Date of latest renewal: 20 November 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Novembru 2002 Data tal-aħħar tiġdid: 20 ta' Novembru 2012
English: INSTRUCTIONS ON USE 16.
Maltese: ISTRUZZJONIJIET DWAR L-UŻU 16.
English: Possible side effects
Maltese: Effetti sekondarji possibli
English: The active substance is miglustat 100 mg.
Maltese: Is-sustanza attiva hi miglustat 100 mg.
English: Capsule, hard 84 capsules
Maltese: Kapsula, iebsa 84 kapsula
English: Capsule shell Gelatin,
Maltese: Qoxra tal-kapsula Gelatin,
English: Black iron oxide (E172) Shellac.
Maltese: Linka tal-kitba Black iron oxide (E172), Shellac.
English: Small mean reductions in haemoglobin [0.95 g/dL (95% CI: -1.38, -0.53)] and platelet count [-44.1 × 109/L (95% CI: -57.6, -30.7)] were observed between baseline and end of study.
Maltese: Tnaqqis żgħir fil-medja tal-emoglobina [-0.95 g/dL (95% CI: -1.38, -0.53)] u l-għadd tal-plejtlits [-44.1 × 109/L (95% CI: -57.6, -30.7)]
English: Capsule contents Sodium starch glycollate, Povidone (K30), Magnesium stearate.
Maltese: Kontenut tal-kapsula Sodium starch glycollate, Povidone (K30), Magnesium stearate
English: Weight loss has been reported in 55% of patients.
Maltese: Tnaqqis fil-piż kien irrappurtat f'55% tal-pazjenti.
English: Musculoskeletal and connective tissue disorders Common
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue Komuni
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Mediċini: http://www.ema.europa.eu.
English: Zavesca 100 mg capsules
Maltese: Zavesca 100 mg kapsuli
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità, tqala u treddigħ Tqala
English: Niemann-Pick type C disease
Maltese: Niemann-Pick ta' tip Ċ.
English: Box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
Maltese: Kaxxa ta' 4 strixxi tal-folji, kull strixxa tal-folji fiha 21 kapsula għal total ta' 84 kapsula.
English: Depression, insomnia, libido decreased Nervous system disorders Very common
Maltese: Depressjoni, nuqqas ta' rqad, tnaqqis fil-libido Disturbi fis-sistema nervuża
English: Gastrointestinal disturbances
Maltese: Disturbi gastro-intestinali
English: Recommended dose 200 mg three times a day 200 mg twice a day 100 mg three times a day 100 mg twice a day 100 mg once a day
Maltese: 200 mg tliet darbiet kuljum 200 mg darbtejn kuljum 100 mg tliet darbiet kuljum 100 mg darbtejn kuljum 100 mg darba kuljum
English: Teл.
Maltese: xhur.
English: Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia, headache, dizziness
Maltese: Newropatija periferali, ataxja, amneżija, parasteżija, ipoestesija, uġigħ ta' ras, sturdament
English: Zavesca 100 mg capsules Miglustat
Maltese: Zavesca 100 mg kapsuli Miglustat
English: Data to support safety and efficacy of Zavesca in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Maltese: Tagħrif li jsostni s-sigurtà u l-effikaċja ta' Zavesca fil-marda ta' Niemann-Pick ta' tip Ċ ġej minn prova klinika open-label prospettiva u minn servej retrospettiv.
English: When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of Zavesca monotherapy (20 and 6 patients, respectively).
Maltese: Meta mqabbel mar-riżultati wara 6 xhur, il-kontroll tal-marda baqa' ma nbidilx wara 18 u 24 xahar ta' monoterapija ta' Zavesca (20 u 6 pazjent, rispettivament).
English: Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Maltese: Zavesca huwa indikat għall-kura ta' manifestazzjonijiet newroloġiċi progressivi f'pazjenti adulti u pazjenti pedjatriċi li għandhom il-marda Niemann-Pick ta' tip Ċ (ara sezzjonijiet 4.4, u 5.1).
English: In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements.
Maltese: F'analiżi miġbura ta' tagħrif mhux ikkontrollat, punteġġi Z tad-densità tal-minerali fl-għadam fl-ispina lombari u fl għonq femorali żdiedu b'aktar minn 0.1 unità mil-linja bażi f'27 (57%) u 28 (65%) tal-pazjenti b'qisien lonġitudinali tad-densità ta' l-għadam.
English: In 11 clinical trials in different indications 247 patients were treated with Zavesca at dosages of 50200 mg t.i.d.
Maltese: Fi 11-il prova klinika dwar indikazzjonijiet differenti, 247 pazjent kienu kkurati b'Zavesca b'dożaġġ ta' 50-200 mg t.i.d. għal tul medju ta' 2.1 sena.
English: In some cases the doctor may prescribe anti-diarrhoeal medicines such as loperamide.
Maltese: jippreskrivilek mediċini kontra d-dijarea bħal loperamide.
English: There was a mean increase of 22.2 × 109/l in platelet count, and a mean increase of 0.95 g/dl in haemoglobin concentration.
Maltese: Kien hemm żjieda medja ta' 22.2 × 109/l fl-għadd tal-plejtlets u żjieda medja ta' 0.95 g/dl fil-konċentrazzjoni ta' l-emoglobina.
English: 5.2 Pharmacokinetic properties
Maltese: .1 Proprjetajiet farmakodinamiċi
English: A mean increase in haemoglobin concentration of 0.26 g/dl and a mean platelet count increase of 8.29 × 109/l were observed.
Maltese: Żjieda medja filkonċentrazzjoni ta' l-emoglobina ta' 0.26 g/dl u żjieda medja fl-għadd tal-plejtlets ta' 8.29 × 109/l kienu osservati.
English: Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥1/1,000 to <1/100, rare: ≥1/10,000 to <1/1,000, very rare: <1/10,000).
Maltese: Reazzjonijiet avversi minn provi kliniċi u rappurtar spontanju li seħħew f'>1% tal-pazjenti, huma mniżżlin fit-tabella taħt skont is-sistema tal-klassifika tal-organi u skond il-frekwenza (komuni ħafna: ≥1/10, komuni: ≥1/100, <1/10,
English: At 12 months, there was a mean reduction in liver organ volume of 12.1% and a mean reduction in spleen volume of 19.0%.
Maltese: Wara 12-il xahar, kien hemm tnaqqis medju fil-volum ta' lorganu tal-fwied ta' 12.1% u tnaqqis medju fil-volum tal-milsa ta' 19.0%.
English: This leaflet was last revised in:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: The most common serious adverse reaction reported with Zavesca treatment in clinical studies was peripheral neuropathy (see section 4.4).
Maltese: L-aktar reazzjoni avversa komuni u serja rrappurtata b'kura ta' Zavesca fi studji kliniċi kienet newropatija periferali (ara sezzjoni 4.4).
English: Other medicines and Zavesca
Maltese: Mediċini oħra u Zavesca
English: BATCH NUMBER
Maltese: NUMRU TAL- LOTT
English: OTHER
Maltese: Meta
English: Approximately 37% of patients in clinical trials in type 1 Gaucher disease, and 58% of patients in a clinical trial in Niemann-Pick type C disease reported tremor on treatment.
Maltese: Madwar 37% tal-pazjenti fil-provi kliniċi bil-marda ta' Gaucher ta' tip 1, u 58% tal-pazjenti fi prova klinika bil-marda ta' Niemann-Pick ta' tip Ċ irrappurtaw li qabdithom rogħda meta ħadu l-kura.
English: At steady state, the concentration of miglustat in cerebrospinal fluid of six type 3 Gaucher disease patients was 31.4-67.2% of that in plasma.
Maltese: kienet 31.4-67.2% ta' dik fil-plażma.
English: Zavesca is a white 100 mg capsule with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Maltese: Zavesca huwa kapsula bajda ta' 100 mg b'“OGT 918” stampata bl-iswed fuq l-għatu u “100” stampata bl-iswed fuq il-korp tal-kapsula.
English: Most serious side effects:
Maltese: L-aktar effetti sekondarji serji:
English: Common effects - may affect up to 1 in 10 people Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Maltese: Effetti sekondarji possibli oħrajn huma spażmi jew dgħjufija fil-muskoli, għeja, sirdat u tħossok ma tiflaħx, depressjoni, diffikultà biex torqod, tinsa u tnaqqis fil-libido.
English: Dosage in Niemann-Pick type C disease
Maltese: Marda ta' Niemann-Pick ta' tip Ċ
English: An open-label, non comparative, 2-year study enrolled 42 patients with type 1 Gaucher disease, who had received a minimum of 3 years of ERT and who fulfilled criteria of stable disease for at least 2 years.
Maltese: Studju open-label, mhux komparattiv ta' sentejn kien jinvolvi 42 pazjenti bil-marda ta' Gaucher ta' tip 1, li kienu rċevew mill-inqas 3 snin ta' ERT u li ssodisfaw b'mod sħiħ il-kriterji ta' marda stabbli għal mill-inqas sentejn.
English: Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of Zavesca having an efficacy or safety advantage over ERT. ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1).
Maltese: Għalkemm ma saru l-ebda paraguni diretti ma' Terapija tas-Sostituzzjoni tal-Enzimi (Enzyme Replacement Therapy - ERT) f'pazjenti bil-marda ta' Gaucher ta' tip 1 li qatt ma ġew ikkurati qabel, m'hemmx evidenza li Zavesca għandu vantaġġ ta' effikaċja jew ta' sigurtà fuq ERT. ERT hi l-kura standard għall-pazjenti li jeħtieġu kura għall-marda ta' Gaucher ta' tip 1 (ara sezzjoni 5.1).
English: Several metabolites were identified in urine and faeces.
Maltese: Bosta metaboliti kienu identifikati fl-awrina u fl ippurgar.
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 web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà 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 lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Each capsule contains 100 mg miglustat
Maltese: Kull kapsula fiha 100 mg ta' miglustat