FrancophonIA/ELRC3.0 huggingface dataset:
English: Pomalidomide dose reduction∞ Dose level
Maltese: GĦAMLA KWALITATTIVA
English: Uncommon Muscle spasms
Maltese: Mhux komuni Spażmi tal-muskoli
English: Patients in the Pom+LD-Dex arm were administered 4 mg pomalidomide orally on days 1 to 21 of each 28-day cycle.
Maltese: Pazjenti fil-parti tal-istudju dwar POM + LD-Dex ingħataw 4 mg ta' pomalidomide mill-ħalq f'jiem 1 sa 21 ta' kull ċiklu ta' 28 jum.
English: • The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132) and yellow iron oxide (E172) and white and black ink.
Maltese: • Il-qoxra tal-kapsula fiha: gelatin, titanium dioxide (E171), indigotine (E132) u yellow iron oxide (E172) u linka bajda u sewda.
English: Common Bone pain Muscle spasms
Maltese: Uġigħ fl-għadam Spażmi tal-muskoli
English: A total of 455 patients were enrolled in the study: 302 in the Pom+LD-Dex arm and 153 in the HD-Dex arm.
Maltese: 302 fil-parti tal-istudju dwar POM + LD-Dex u 153 fil-parti tal-istudju dwar HD-Dex.
English: Imnovid 3 mg hard capsules pomalidomide
Maltese: Imnovid 3 mg kapsuli ibsin pomalidomide
English: Dark blue opaque cap and orange opaque body, imprinted “POML 2 mg” in white ink, size 2 gelatin hard capsule.
Maltese: Għatu opak blu skur u korp opak oranġjo, stampat b'“POML 2 mg” b'linka bajda, kapsula iebsa talġelatina daqs 2.
English: Cycle 9 onwards
Maltese: Minn Ċiklu 9 'il quddiem
English: The adverse reactions observed in patients treated with pomalidomide in combination with bortezomib and dexamethasone are listed in Table 7 by system organ class (SOC) and frequency for all adverse reactions and for Grade 3 or 4 adverse reactions.
Maltese: Ir-reazzjonijiet avversi osservati f'pazjenti kkurati b'pomalidomide flimkien ma' bortezomib u dexamethasone huma elenkati f'Tabella 7 skont il-klassi tas-sistemi u tal-organi (SOC) u l-frekwenza għar-reazzjonijiet avversi kollha u għal reazzjonijiet avversi ta Grad 3 jew 4.
English: Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink, size 2 gelatin hard capsule.
Maltese: Għatu opak blu skur u korp opak blu, stampat b'“POML 4 mg” b'linka bajda, kapsula iebsa talġelatina daqs 2.
English: • Infections of the nose, sinuses and throat, caused by bacteria or viruses.
Maltese: • Infezzjonijiet fl-imnieħer, sinusis u fil-gerżuma, ikkawżati minn batterji jew viruses.
English: What Imnovid looks like and contents of the pack Imnovid 1 mg hard capsules: Dark blue opaque cap and yellow opaque body, with “POML 1 mg” written on them.
Maltese: Imnovid 1 mg kapsuli ibsin: Għatu opak blu skur u korp opak isfar bil-kliem “POML 1 mg” miktubin fuqha.
English: Very Common Dyspnoea Cough
Maltese: Komuni Ħafna Dispneja Sogħla
English: Minimal or mild bile duct proliferation with associated increases in ALP and GGT were also observed at 1 mg/kg/day.
Maltese: Proliferazzjoni ta' kanali tal-bila minima jew ħafifa b'żidiet assoċjati f'ALP u GGT ġiet osservata wkoll f'doża ta' 1 mg/kg/jum.
English: Based on Cox proportional hazards model.
Maltese: Ibbażati fuq mudell tal-perikli proporzjonali Cox.
English: • Description of the PPP and categorisation of patients based on sex and childbearing potential o Algorithm for implementation of PPP o Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure
Maltese: • Deskrizzjoni tal-PPP u l-kategorizzazzjoni ta' pazjenti bbażata fuq is-sess u l-potenzjal li jistgħu joħorġu tqal o Algorithm għall-implimentazzjoni tal-PPP o Definizzjoni ta' nisa li jista' jkollhom tfal (WCBP, Women of ChildBearing Potential) u azzjonijiet li t-tabib għandu jieħu jekk ma jkunx ċert
English: Muscle weakness ≥ Grade 2
Maltese: Dgħufija fil-muskoli ≥ Grad 2
English: For patients > 75 years of age, the starting dose of dexamethasone is:
Maltese: Età > 75 sena Doża (Ċiklu 1-8:
English: • Requirements in the event of pregnancy o Instructions to stop pomalidomide immediately upon suspicion of pregnancy if female patients o Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice o Local contact details for reporting of any suspected pregnancy o Pregnancy reporting form
Maltese: • Pariri rilevanti dwar is-sigurtà lill-pazjenti kollha o Deskrizzjoni u mmaniġġjar ta' tromboċitopenja li tinkludi rati ta' inċidenzi minn studji kliniċi o Deskrizzjoni u mmaniġġjar ta' insuffiċjenza kardijaka o Rimi ta' mediċina mhux meħtieġa o Arranġamenti lokali speċifiċi għall-pajjiż għal riċetta biex jingħata pomalidomide
English: As per an interim analysis for Overall Survival (OS), using a cut-off of 15 September 2018 (median follow-up period of 26.2 months), median OS time from Kaplan-Meier estimates was 40.5 months for the Pom + Btz + LD-Dex arm and 30.5 months for the Btz + LD-Dex arm; HR = 0.91, 95% CI: 0.70, 1.18, with an overall event rate of 43.3%.
Maltese: Skont analiżi interim għal Sopravivenza Globali (OS, Overall Survival), bl-użu tad-data tal-15 ta' Settembru 2018 bħala l-limitu ta' meta nġabret id-data (perjodu ta' segwitu medjan ta' 26.2 xhur), iżżmien OS medjan mill-istimi Kaplan-Meier kien 40.5 xhur għall-grupp ta' Pom + Btz + LD-Dex u 30.5 xhur għall-grupp ta' Btz + LD-Dex;
English: Kaplan-Meier curve for PFS for the ITT population is provided in Figure 2.
Maltese: Sopravivenza totali qed tintwera fil-qosor f'Tabella 12 għall-popolazzjoni ITT.
English: Pom+Btz+LD-Dex (N = 281)
Maltese: Sommarju tad-dejta globali dwar l-effikaċja Pom+Btz+LD-Dex (N = 281)
English: EU/1/13/850/006 (Pack size of 14 hard capsules) EU/1/13/850/002 (Pack size of 21 hard capsules)
Maltese: EU/1/13/850/006 (Daqs tal-pakkett ta' 14-il kapsula iebsa) EU/1/13/850/002 (Daqs tal-pakkett ta' 21 kapsula iebsa)
English: These immunosuppressive effects resulted in early euthanasia of 4 monkeys due to poor health condition (watery stool, inappetence, reduced food intake, and weight loss); histopathologic evaluation of these animals showed chronic inflammation of the large intestine and villous atrophy of the small intestine.
Maltese: Dawn l-effetti immunosoppressivi rriżultaw f'ewtanasja bikrija ta' 4 xadini minħabba l-kundizzjoni ta' saħħa batuta (ippurgar maħlul, nuqqas ta' aptit, tnaqqis fit-teħid tal-ikel, u telf ta' piż); evalwazzjoni istopatoloġika ta' dawn l-annimali wriet infjammazzjoni kronika tal-musrana l-kbira u atrofija tal-villi tal-musrana żżgħira.
English: Progression Free Survival (weeks)
Maltese: Sopravivenza Mingħajr Progressjoni (ġimgħat)
English: Common Febrile neutropenia Leucopenia Lymphopenia
Maltese: Newtropenija bid-deni Lewkopenija Limfopenija
English: • Pomalidomide in combination with bortezomib and dexamethasone The efficacy and safety of pomalidomide in combination with bortezomib and low -dose dexamethasone (Pom+Btz+LD-Dex) was compared with bortezomib and low-dose dexamethasone (Btz+LD-Dex) in a Phase III multi-centre, randomised, open-label study (CC-4047-MM-007), in previously treated adult patients with multiple myeloma, who had received at least one prior regimen, including lenalidomide and have demonstrated disease progression on or after the last therapy.
Maltese: • Pomalidomide flimkien ma' bortezomib u dexamethasone L-effikaċja u s-sigurtà ta' pomalidomide flimkien ma' bortezomib u doża baxxa ta' dexamethasone (Pom+Btz+LD-Dex) ġew imqabbla ma' bortezomib u doża baxxa ta' dexamethasone (Btz+LD-Dex) fi studju b'ħafna ċentri, randomizzat u open-label ta' Fażi
English: EU/1/13/850/008 (Pack size of 14 hard capsules) EU/1/13/850/004 (Pack size of 21 hard capsules)
Maltese: EU/1/13/850/008 (Daqs tal-pakkett ta' 14-il kapsula iebsa) EU/1/13/850/004 (Daqs tal-pakkett ta' 21 kapsula iebsa)
English: There is no relevant use of pomalidomide in children aged 0-17 years for the indication of multiple myeloma.
Maltese: M'hemm l-ebda użu rilevanti ta' pomalidomide fit-tfal minn età ta' 0 sa 17-il sena għal indikazzjoni ta' majeloma multipla.
English: For information on bortezomib given in combination with Imnovid, refer to the respective current SmPC.
Maltese: Għal informazzjoni dwar bortezomib li jingħata flimkien ma' Imnovid, irreferi għall-SmPC attwali rispettiv.
English: Imnovid 3 mg hard capsules: Dark blue opaque cap and green opaque body, with “POML 3 mg” written on them.
Maltese: Imnovid 3 mg kapsuli ibsin: Għatu opak blu skur u korp opak aħdar bil-kliem “POML 3 mg” miktubin fuqha.
English: Pomalidomide has direct anti-myeloma tumoricidal activity, immunomodulatory activities and inhibits stromal cell support for multiple myeloma tumour cell growth.
Maltese: Pomalidomide għandu attività tumoriċidjali diretta kontra l-majeloma, attivitajiet immunomodulatorji u jinibixxi l-appoġġ taċ-ċelluli stromali għal tkabbir taċ-ċelluli tat-tumur ta' majeloma multipla.
English: • Chest pain, chest infection.
Maltese: • Uġigħ fis-sider, infezzjoni fis-sider.
English: • The recommended starting dose of Imnovid is 4 mg per day.
Maltese: • Id-doża tal-bidu rakkomandata ta' Imnovid hi ta' 4 mg kuljum.
English: Common Deep vein thrombosis
Maltese: Komuni Newtropenija bid-deni
English: EU/1/13/850/007 (Pack size of 14 hard capsules) EU/1/13/850/003 (Pack size of 21 hard capsules)
Maltese: EU/1/13/850/007 (Daqs tal-pakkett ta' 14-il kapsula iebsa) EU/1/13/850/003 (Daqs tal-pakkett ta' 21 kapsula iebsa)
English: Fatigue, depressed level of consciousness, confusion, and dizziness have been reported with the use of pomalidomide.
Maltese: Għeja kbira, livell imnaqqas ta' koxjenza, konfużjoni, u sturdament kienu irrappurtati bl-użu ta' pomalidomide.
English: EU/1/13/850/005 (Pack size of 14 hard capsules) EU/1/13/850/001 (Pack size of 21 hard capsules)
Maltese: EU/1/13/850/005 (Daqs tal-pakkett ta' 14-il kapsula iebsa) EU/1/13/850/001 (Daqs tal-pakkett ta' 21 kapsula iebsa)
English: • you have or have ever had hepatitis B infection.
Maltese: • għandek jew qatt kellek infezzjoni tal-epatite B.
English: Mean normalised AUC exposure to pomalidomide was 98.2% with a 90% confidence interval [77.4% to 120.6%] in moderate renal impairment patients (eGFR ≥30 to ≤45 mL/minute/1.73 m2) compared to patients with normal renal function.
Maltese: 6%] f'pazjenti b'indeboliment moderat tal-kliewi (eGFR < 30 sa ≤ 45 mL/minuta/1.73 m2) meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi.
English: • Pomalidomide in combination with bortezomib and dexamethasone Patients with ongoing peripheral neuropathy ≥ Grade 2 with pain within 14 days prior to randomisation were excluded from clinical trials.
Maltese: • Pomalidomide flimkien ma' bortezomib u dexamethasone Pazjenti b'newropatija periferali ta' ≥ Grad 2 li baqgħet għaddejja b'uġigħ fi żmien 14-il jum qabel irrandomizzazzjoni ġew esklużi mill-provi kliniċi.
English: Appropriate caution should be exercised when considering the treatment of such patients with pomalidomide, including periodic monitoring for signs or symptoms of cardiac events.
Maltese: Għandu jkun hemm kawtela adattata meta tiġi kkunsidrata l-kura ta' dawn il-pazjenti b'pomalidomide, li jinkludu monitoraġġ perjodiku għal sinjali u sintomi ta' avvenimenti kardijaċi.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tattessuti k onnettivi
English: Peripheral sensorimotor neuropathy Paraesthesia
Maltese: Newropatija sensimotorja periferali
English: • Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
Maltese: • Pilloli li jinibixxu l-ovulazzjoni (i.e. desogestrel), li jkun fihom il-progesterone biss
English: The pharmacokinetic parameters were modestly changed in hepatically impaired patients (defined by Child-Pugh criteria) compared to healthy subjects.
Maltese: Il-parametri farmakokinetiċi nbidlu b'mod moderat f'pazjenti b'indeboliment tal-fwied (definiti millkriterji ta' Child-Pugh) meta mqabbla ma' individwi f'saħħithom.
English: • Pomalidomide in combination with dexamethasone The recommended starting dose of Imnovid is 4 mg orally once daily on Days 1 to 21 of repeated 28-day cycles.
Maltese: Id-doża tal-bidu rakkomandata ta' Imnovid hi 4 mg mill-ħalq darba kuljum f'Jiem 1 sa 21 ta' ċikli ta' 28 jum ripetuti.
English: Common Hyperkalaemia Hyponatraemia
Maltese: Newtropenija bid-deni Limfopenija
English: **ANC - Absolute Neutrophil Count; ***CBC - Complete Blood Count.
Maltese: *F'każ ta' newtropenija, it-tabib għandu jikkunsidra l-użu ta' fatturi tat-tkabbir. **ANC - Għadd Assolut tan-Newtrofili; ***CBC - Għadd Sħiħ tad-Demm.
English: Upper respiratory tract infection Respiratory tract infection Lower respiratory tract infection Lung infection
Maltese: Infezzjoni fl-apparat respiratorju Infezzjoni fin-naħa ta' fuq talapparat respiratorju Nażofarinġite
English: • one other medicine - called ‘dexamethasone' in people whose myeloma has become worse, despite having at least two other treatments - including lenalidomide and bortezomib.
Maltese: • mediċina oħra - imsejħa ‘dexamethasone' f'persuni li l-majeloma tagħhom tkun marret għallagħar, minkejja li jkunu ħadu mill-inqas żewġ kuri oħrajn - inklużi lenalidomide u bortezomib.
English: The CHMP reviewed the data submitted by the marketing authorisation holder, taking into account the provisions of Article 14(11) of Regulation (EC) No 726/2004, and considers that the new therapeutic indication brings significant clinical benefit in comparison with existing therapies as further explained in the European Public Assessment Report.
Maltese: • sena waħda ta' protezzjoni tal-kummerċjalizzazzjoni Is-CHMP irreveda d-data sottomessa mid-Detentur ta' Awtorizzazzjoni għat-Tqegħid fis-Suq, filwaqt li kkunsidra d-dispożizzjonijiet tal-Artikolu 14(11) tar-Regolament (KE) Nru 726/2004, u jqis li lindikazzjonijiet terapewtiċi jġibu magħhom benefiċċju kliniku sinifikanti meta mqabbla ma' terapiji eżistenti, kif spjegat aktar fir-Rapport Pubbliku Ewropew ta' Valutazzjoni.
English: Common Intracranial haemorrhage
Maltese: Komuni Emorraġija intrakranjali
English: A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Maltese: Sistema ta' distribuzzjoni nazzjonali kkontrollata ġiet implimentata b'kollaborazzjoni ma' kull Awtorità Kompetenti Nazzjonali
English: Instructions on dose interruptions or reductions for pomalidomide related adverse reactions are outlined in the Table 2 and dose levels are defined in Table 3 below:
Maltese: Istruzzjonijiet dwar interruzzjonijiet jew tnaqqis fid-doża għal reazzjonijiet avversi relatati ma' pomalidomide qed jintwerew fil-qosor fit-Tabella 2 u l-livelli tad-doża huma ddefiniti fit-Tabella 3 hawn taħt:
English: Upper respiratory tract infection Viral upper respiratory tract infection
Maltese: Infezzjoni fin-naħa ta' fuq tal-apparat respiratorju
English: Common Pelvic pain
Maltese: Komuni Uġigħ pelviku
English: Uncommon Bone pain
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Common Depressed level of consciousness
Maltese: Komuni Depressjoni Nuqqas ta' rqad
English: Second primary malignancies, such as non-melanoma skin cancer, have been reported in patients receiving pomalidomide (see section 4.8).
Maltese: Tieni tumuri malinni primarji, bħal kanċer fil-ġilda li mhux melanoma, ġew irrappurtati f'pazjenti li kienu qed jirċievu pomalidomide (ara sezzjoni 4.8).
English: Neutrophil count decreased White blood cell count decreased Platelet count decreased Alanine aminotransferase increased
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Abdominal pain Abdominal pain upper Stomatitis
Maltese: Trombożi tal-vini profondi Pressjoni baxxa Pressjoni għolja
English: Recommended dosing scheme for Imnovid in combination with bortezomib and dexamethasone
Maltese: L-iskeda tad-dożaġġ rakkomandata għal Imnovid flimkien ma' bortezomib u dexamethasone
English: 90 (3 x 30) tablets (multipack)
Maltese: Daqs tal-pakkett flixkun (HDPE) 30 pillola flixkun (HDPE) 90 (3 × 30) kapsuli (pakkett multiplu)
English: Ref. EMEA/409402/2009 EMEA/H/C/995
Maltese: Londra, 25 ta' Ġunju 2009 Dok. ta' ref.: EMEA/455041/2009 EMEA/H/C/995
English: What is Factive?
Maltese: X'inhu Factive?
English: The active substance in Factive, gemifloxacin, is an antibiotic belonging to the class ‘fluoroquinolones'.
Maltese: Is-sustanza attiva f'Factive, gemifloxacin, hija antibijotiku li tappartjeni għall-klassi tal‘fluworokinoloni' (fluoroquinolones).
English: Factive is a medicine that contains the active substance gemifloxacin.
Maltese: Factive huwa mediċina li fiha s-sustanza attiva gemifloxacin.
English: • acute exacerbation (flare-up) of chronic bronchitis (inflammation of the airways in the lungs).
Maltese: • taħrix akut ta' bronkite kronika (infjammazzjoni tal-passaġġi tal-arja fil-pulmuni).
English: In four main studies, 1,874 adults with mild to moderate community-acquired pneumonia were treated for at least seven days with Factive or other antibiotics.
Maltese: F'erba' studji ewlenin, 1,874 adult li jbatu minn pulmonite minn ħafifa għal moderata akkwiżita f'komunità ġew ittrattati għal tal-anqas sebat ijiem b'Factive u antibijotiċi oħra.
English: On 17 June 2009, Menarini International Operations Luxembourg S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Factive, for the treatment of the bacterial infections, communityacquired pneumonia and acute exacerbation of chronic bronchitis.
Maltese: Fis-17 ta' Ġunju 2009, Menarini International Operations Luxembourg S.A. għarrfet uffiċjalment lillKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira lapplikazzjoni tagħha għal awtorizzazzjoni għat-tqegħid fis-suq għal Factive, għat-trattament ta' infezzjonijiet batteriċi, pulmonite akkwiżita f'komunità u taħrix akut ta' bronkite kronika.
English: How is Factive expected to work?
Maltese: Kif kien mistenni li jaħdem Factive?
English: In three other main studies, 1,652 adults with acute exacerbation of chronic bronchitis were treated with Factive for five days or with other antibiotics.
Maltese: Fi tliet studji ewlenin oħra, 1,652 adult li jbatu minn taħrix akut ta' bronkite kronika ġew ittrattati b'Factive għal ħamest ijiem jew b'antibijotiċi oħra.
English: The seven-day treatment was not considered acceptable because of the risk of side effects.
Maltese: Ittrattament ta' sebat ijiem ma tqiesx aċċettabbli minħabba r-riskju ta' effetti sekondarji.
English: Questions and answers on the withdrawal of the marketing authorisation application for Factive gemifloxacin
Maltese: Mistoqsija u tweġiba dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Factive gemifloxacin
English: In another study of patients with communityacquired pneumonia, 510 adults were given Factive either as a five- or seven-day treatment.
Maltese: Fi studju ieħor fuq pazjenti li jbatu minn pulmonite akkwiżita f'komunità, 510 adulti ġew ittrattati b'Factive fi trattament fuq perjodu ta' ħamest ijiem jew ta' sebat ijiem.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Factive could not have been approved for the treatment of community acquired pneumonia and acute exacerbation of chronic bronchitis caused by bacterial infection.
Maltese: Skont l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u kellu opinjoni provviżorja li Factive ma setax jiġi approvat għattrattament tal-pulmonite akkwiżita f'komunità u tal-bronkite kronika kkawżati minn infezzjoni batterika.
English: • mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital);
Maltese: • pulmonite ħafifa jew moderata akkwiżita f'komunità (infezzjoni tal-pulmuni li tittieħed barra minn sptar);
English: Factive was expected to be used to treat the following bacterial infections in adults:
Maltese: Factive kien mistenni li jintuża għat-trattament ta' dawn l-infezzjonijiet batteriċi fl-adulti li ġejjin:
English: The effects of Factive were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Factive għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati filbniedem.
English: The application was at day 196 when the company withdrew.
Maltese: L-applikazzjoni kienet waslet f'jum 196 meta l-kumpanija rtiratha.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Factive in the treatment of community-acquired pneumonia and acute exacerbation of chronic bronchitis caused by bacterial infection did not outweigh its risks.
Maltese: Tħassib ieħor tal-Kumitat irrigwarda l-insuffiċjenza ta' provi ta' effikaċja ta' Factive fil-pazjenti li jbatu minn pulmonite moderata akkwiżita f'komunità meta mogħtija trattament ta' ħamest ijiem.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to issue a decision on this opinion.
Maltese: Wara l-opinjoni tas-CHMP, il-Kummissjoni Ewropea normalment iddum madwar xahrejn sakemm toħroġ deċiżjoni dwar l-opinjoni.
English: It is expected to work by blocking the action of two bacterial enzymes called DNA gyrase and topoisomerase IV, which are needed to make and repair bacterial DNA.
Maltese: Din mistennija taħdem billi timblokka l-azzjoni ta' żewġ enzimi batteriċi bl-isem DNA ġirażi (gyrase) u topoisomerażi (topoisomerase) IV, meħtieġa għall-produzzjoni u t-tiswija tad-DNA batteriku.
English: The recommended dose is 1 mg per kilogram bodyweight.
Maltese: Id-doża rakkomandata hija 1 mg għal kull kilogramm tal-ġisem.
English: The active substance in Naglazyme, galsulfase, is a copy of the human enzyme N-acetylgalactosamine 4-sulfatase.
Maltese: Is-sustanza attiva f'Naglazyme, galsulfase, hija kopja tal-enzima umana Nacetylgalactosamine 4-sulfatase.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Nagalzyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni dwar Nagalzyme huwa disponibbli fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Naglazyme is a solution for infusion (drip into a vein) that contains the active substance galsulfase (1 mg/ml).
Maltese: Naglazyme huwa soluzzjoni għal infużjoni (dripp fil-vina) li fih is-sustanza attiva galsulfase (1 mg/ml).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Naglazyme to BioMarin Europe Limited on 24 January 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Naglazyme lil BioMarin Europe Limited fl-24 ta' Jannar 2006.
English: The full EPAR for Naglazyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Nagalzyme jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Naglazyme is an enzyme replacement therapy.
Maltese: Naglazyme hu terapija enzimatika sostituttiva.
English: Naglazyme is used to treat patients who have mucopolysaccharidosis VI (MPS VI or Maroteaux-Lamy syndrome).
Maltese: Naglazyme jintuża fit-trattament ta' pazjenti li għandhom mukopolisakkaridożi VI (MPS VI jew is sindromu ta' Maroteaux-Lamy).
English: After 24 weeks, the average distance walked over 12 minutes increased by 109 metres in the patients treated with Naglazyme and by 18 metres in those receiving placebo.
Maltese: Wara 24 ġimgħa, id-distanza medja li setgħu jimxu lpazjenti fi 12-il minuta żdiedet għal 109 metri f'dawk ittrattati b'Naglazyme u 18-il metru f'dawk ittrattati bi plaċebo.
English: Galsulfase is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce the enzyme.
Maltese: Galsulfase tiġi prodotta b'metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': l-enzima tiġi prodotta minn ċellula li tkun ingħatat ġene (DNA), li jagħmel il-produzzjoni tal-enzima possibbli.