FrancophonIA/ELRC3.0 huggingface dataset:
English: In four patients <1 year of age, the overall safety profile of a higher dose (2 mg/kg/week) did not differ in a clinically meaningful manner from that of the recommended 1 mg/kg/week dose, and was consistent with the safety profile of Naglazyme in older children.
Maltese: F'erba' pazjenti b'età ta' <1 sena, il-profil ta' sigurtà globali ta' doża ogħla (2 mg/kg/ġimgħa) ma kienx differenti b'mod klinikament sinifikanti minn dak tad-doża rrakkomandata ta' 1 mg/kg/ġimgħa, u kien konsistenti mal-profil ta' sigurtà ta' Naglazyme fi tfal akbar.
English: 53/54 patients (98%) were positive for IgG antibodies to galsulfase.
Maltese: IgG. 53 pazjent minn 54 (98%) kienu pożittivi għall-antikorpi
English: 1Reactions reported more frequently in the active arm of the placebo-controlled study than the placebo arm; frequency determined from 39 patients of the blinded Phase 3 study.
Maltese: 1Reazzjonijiet rrappurtati aktar ta' spiss fil-grupp attiv tal-istudju kkontrollat bil-plaċebo milli fil-grupp tal-plaċebo; frekwenza determinata minn 39 pazjent tal-istudju blinded ta' Fażi 3.
English: • Bulging belly button
Maltese: • Żokra bbuzzata 'l barra
English: A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA' L-AWTORIZZAZZJONI TALMANIFATTURA RESPONSABBLI
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilMediċini http://www.ema.europa.eu/.
English: Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23C - 27C).
Maltese: Stabbilità kimika u fiżika waqt l-użu kienet demostrata sa 4 tijiem f'temperatura tal-kamra (23°C - 27°C).
English: Pain1, chest pain1, rigors1, malaise1, pyrexia
Maltese: Uġigħ addominali1, ftuq miż-żokra1, rimettar, tqalligħ
English: Very common adverse reactions are those with a frequency of 1/10.
Maltese: Reazzjonijiet avversi komuni ħafna huma dawk bi frekwenza ta' 1/10.
English: Patients who could walk more than 5 meters (m) but less than 250 m in 6 minutes of a 12 Minute Walk test or less than 400 m at the 12 minute time point at baseline were enrolled in the study.
Maltese: Pazjenti li setgħu jimxu aktar minn 5 metri (m) iżda anqas minn 250 m f'6 minuti ta' eżami ta' Mixja ta' 12-il Minuta jew anqas minn 400 m fi 12-il minuta fil-linja bażi ddaħħlu fl-istudju.
English: ▼This medicinal product is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Urinary GAG levels decreased by more than 70%, consistent with results in older patients.
Maltese: Livelli ta' GAG fl-awrina naqsu b'aktar minn 70%, konsistenti mar-riżultati f'pazjenti akbar.
English: The primary efficacy endpoint was the numbers of meters walked in 12 minutes at Week 24 compared to the number of meters walked at baseline.
Maltese: Il-mira prinċipali ta' l-effikaċja kienet in-numru ta' metri li mxew fi 12-il minuta fl-24 Ġimgħa mqabbla mannumru ta' metri li mxew fil-linja bażi.
English: Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAGs).
Maltese: Disturbi fil-ħażna ta' mukopolisakkarajd huwa kkawżat minn defiċjenza ta' enzimi liżosomali speċifiċi li huma meħtieġa għall-kataboliżmu ta' glycosaminoglycans (GAGs).
English: The cause of clinical relevance of the hepatic toxicity (bile duct hyperplasia / periportal inflammation) seen at clinically relevant doses in the repeated dose monkey toxicity study is not known.
Maltese: Il-kawża ta' rilevanza klinika tat-tossiċità epatika (iperplasija tal-kanal biljari / infjammazzjoni periportali) li deheret f'dożi ta' rilevanza klinika fl-istudju ta' dożi ripetuti fix-xadini mhix magħrufa.
English: The pharmacokinetics of galsulfase were evaluated in 13 patients with MPS VI who received 1 mg/kg of galsulfase as a 4 hour infusion.
Maltese: Il-farmakokinetiċi ta' galsulfase kienu evalwati fi 13-il pazjent b‘MPS VI li rċevew 1 mg/kg ta' galsulfase bħala infużjoni fuq medda ta' 4 sigħat.
English: • Itching
Maltese: • Xokk
English: All patients treated with NAGLAZYME (59/59) reported at least one AE.
Maltese: Il-pazjenti kollha kkurati b'NAGLAZYME (59/59) irrappurtaw mill-inqas AE wieħed.
English: • Low blood-oxygen
Maltese: • Ossiġnu baxx fid-demm
English: Spinal/cervical cord compression (SCC) with resultant myelopathy is a known and serious complication that can be due to MPS VI.
Maltese: Kompressjoni tas-Sinsla tad-dahar/ċervikali (spinal/cervical cord compression - SCC) li twassal għal mjelopatija hija kumplikazzjoni magħrufa u serja li tista' tkun ikkawżata minn MPS VI.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/324/001
Maltese: FIS-SUQ EU/1/05/324/001 kunjett 1
English: Subjects enrolled in the program will have urinary glycosaminoglycan and samples for total antibodies routinely collected as specified in the Schedule of Activities.
Maltese: Individwi li se jieħdu sehem fil-programm se jkollhom il-glycosaminoglycan fl-awrina u kampjuni għall-antikorpi totali miġbura b'mod regolari kif speċifikat fl-Iskeda ta' l-Attivitajiet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg galsulfase.
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni fih 1 mg galsulfase.
English: Final CSP Study Report: 31 July activities.
Maltese: Rapport Finali ta' l-Istudju tas-CSP : 31 ta' Lulju 2020
English: This medicine may improve the symptoms of MPS VI.
Maltese: Din il-mediċina tista' ittejjeb is-sintomi ta' MPS VI.
English: In case of a recurrent moderate IAR or re-challenge after a single severe IAR, pre-treatment should be considered (antihistamines and paracetamol and/or corticosteroids) and a reduction of the infusion rate to 50% - 25% of the rate at which the previous reaction occurred.
Maltese: IAR severa waħda, kura minn qabel għandha tkun ikkunsidrata (antistamini u paracetamol u/jew kortikosterojdi) u tnaqqis fir-rata tal-infużjoni għal 50% - 25% tar-rata li fiha tkun seħħet ir-reazzjoni ta' qabel.
English: • Skin paleness
Maltese: • Ġilda pallida
English: Other measures (urinary GAG, antibodies) are assessed more frequently.
Maltese: Miżuri oħra (GAG fl-awrina, antikorpi) jiġu stmati aktar ta' spiss.
English: Preparation of the Naglazyme Infusion (Use Aseptic Technique)
Maltese: Preparazzjoni tal-Infużjoni ta' Naglazyme (teknika asettika li għandha tintuża)
English: A volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion is to be withdrawn and discarded from a 250 ml infusion bag equal to the total volume of Naglazyme to be added.
Maltese: Volum ta' soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%) ugwali għall-volum totali ta' Naglazyme li jrid jiġi miżjud, għandu jittiħed mill-borża ta' l-infużjoni ta' 250 ml u jintrema.
English: Out of the 59 patients treated with Naglazyme in the clinical studies, 54 were tested for IgG antibodies.
Maltese: Minn 59 pazjent ikkurat b'Naglazyme fl-istudji kliniċi, 54 kienu ttestjati għall-antikorpi
English: Samples for total antibody will be collected at specific intervals.
Maltese: Kampjuni għall-antikorpi totali se jinġabru f'intervalli speċifiċi.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and must normally not be longer than 24 hours at 2C - 8C followed by up to 24 hours at room temperature (23C - 27C) during administration.
Maltese: Jekk ma jintużax immedjatament, il-ħin u l-kondizzjonijiet ta' ħażna waqt l-użu huma r-responsabbiltà ta' minn qed juża' l-prodott, u normalment m'għandhomx ikunu itwal minn 24 siegħa f'temperatura ta' 2 C - 8 C, segwit minn massimu ta' 24 siegħa f'temperatura tal-kamra (23 C - 27 C) waqt l-amministrazzjoni.
English: Dyspnoea1, nasal congestion1
Maltese: Konġuntivite1, korneja opaka1
English: The three clinical studies performed with Naglazyme focused on assessing the systemic manifestations of MPS VI such as endurance, joint mobility, joint pain and stiffness, upper airway obstruction, manual dexterity and visual acuity.
Maltese: It-tliet studji kliniċi li saru b'Naglazyme iffukaw fuq il-valutazzjoni tal-manifestazzjonijiet sistemiċi ta' MPS VI bħal reżistenza, mobilità tal-ġogi, uġigħ fil-ġogi u ebusija, ostruzzjoni tal-passaġġ respiratorju ta' fuq, ħeffa manwali u akutezza fil-vista.
English: Infusion reactions, defined as adverse reactions occurring during Naglazyme infusions or until the end of the infusion day, were observed in 33 (56%) of the 59 patients treated with Naglazyme across five clinical studies.
Maltese: Reazzjonijiet għall-infużjoni, definiti bħala reazzjonijiet avversi li seħħew waqt l-infużjonijiet b'Naglazyme jew sat-tmiem tal-ġurnata tal-infużjoni, kienu osservati fi 33 (56%) minn 59 pazjent ikkurati b'Naglazyme waqt ħames studji kliniċi.
English: NAME OF THE MEDICINAL PRODUCT Naglazyme 1 mg/ml concentrate for solution for infusion Galsulfase
Maltese: Naglazyme 1 mg/ml konċentrat għal soluzzjoni għall-infużjoni Galsulfase
English: Treatment has been shown to improve walking and stairclimbing ability, and to reduce the levels of glycosaminoglycans in the body.
Maltese: Intwera li l-kura ttejjeb l-kapaċità li wieħed jimxi u jitla' t-taraġ, u tnaqqas il-livelli ta' glycosaminoglycans fil-ġisem.
English: - The other ingredients are: sodium chloride, sodium phosphate monobasic, monohydrate, sodium phosphate dibasic, heptahydrate, polysorbate 80, water for injections.
Maltese: Galsulfase huwa forma rikombinanti ta' Nacetylgalactosamine 4-sulfatase uman magħmul permezz ta' inġinerija ġenetika minn ċelluli talOvarju tal-Hamster Ċiniż (CHO). - Is-sustanzi l-oħra huma: sodium chloride, sodium phosphate monobasic, monohydrate, sodium phosphate dibasic, heptahydrate, polysorbate 80, ilma għall-injezzjoni.
English: Due to the low number of patients in clinical trials, adverse event (AE) data from all Naglazyme studies have been pooled and reviewed in a single, clinical trial safety analysis.
Maltese: Minħabba n-numru żgħir ta' pazjenti fil-provi kliniċi, dejta ta' avvenimenti avversi (AE) mill-istudji kollha b'Naglazyme ġew miġbura u riveduti, f'analiżi waħda dwar is-sigurtà tal-provi kliniċi.
English: Reduced or absent N-acetylgalactosamine 4-sulfatase activity results in the accumulation of dermatan sulfate in many cell types and tissues.
Maltese: Attività ta' N-acetyl galactosamine 4-sulfatase imnaqqsa jew assenti tirriżulta fl-akkumulazzjoni ta' dermatan sulfate f'diversi tipi ta' ċelluli u tessuti.
English: • Poor reflexes
Maltese: • Riflessi ħżiena
English: • Pain (including ear, abdominal, joint, chest pain)
Maltese: • Uġigħ (inkluż uġigħ fil-widnejn, fiż-żaqq,
English: In an additional Phase 4, randomised, two-dose level study, four MPS VI patients <1 year of age were treated at 1 or 2 mg/kg/week for 53 to 153 weeks.
Maltese: Fi studju addizzjonali ta' Fażi 4, randomised, b'livell ta' żewġ dożi, erba' pazjenti b'MPS VI b'età <sena kienu kkurati b'1 jew 2 mg/kg/ġimgħa għal minn 53 sa 153 ġimgħa.
English: Areflexia1, headache
Maltese: Anafilassi, xokk
English: BioMarin Pharmaceutical Inc.
Maltese: Ilma għall-injezzjoni.
English: The infusion can be restarted with a reduction of the infusion rate to 50% - 25% of the rate at which the reaction occurred.
Maltese: L-infużjoni tista' terġa tinbeda bi tnaqqis firrata tal-infużjoni għal 50% - 25% tar-rata li fiha tkun seħħet ir-reazzjoni.
English: Marketing Authorization Holder BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
Maltese: BioMarin International Limited Shanbally, Ringaskiddy
English: BioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298 Ireland
Maltese: Shanbally, Ringaskiddy, P43 R298
English: Patients should be monitored for signs and symptoms of spinal/cervical cord compression (including back pain, paralysis of limbs below the level of compression, urinary and faecal incontinence) and given appropriate clinical care.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' kompressjoni tas-Sinsla tad-dahar/ċervikali (inkluż uġigħ fiddahar, paraliżi tar-riġlejn u d-dirgħajn taħt il-livell ta' kompressjoni, inkontinenza urinarja u talippurgar), u għandhom jingħataw attenzjoni klinika adattata.
English: With administration of Naglazyme it is recommended that patients be administered pre-treatment medicinal products (antihistamines with or without antipyretics) approximately 30-60 minutes prior to the start of the infusion, to minimise the potential occurrence of IARs.
Maltese: Biex jitnaqqas il-potenzjal li jseħħu IARs, huwa rakkomandat li meta jkun se jingħata Naglazyme pazjenti jingħataw prodotti mediċinali minn qabel (antistamini flimkien ma', jew mingħajr sustanzi kontra d-deni), madwar 30-60 minuta qabel il-bidu ta' l-infużjoni, biex titnaqqas il-posibbilta ta' IARs.
English: The majority (42/59; 71%) of patients experienced at least one Adverse Drug Reaction.
Maltese: Il-maġġoranza (42/59; 71%) tal-pazjenti kellhom esperjenza ta' mill-inqas Reazzjoni Avversa tal-Mediċina waħda.
English: • Wheezing • Skin redness
Maltese: • Imnieħer miżdud
English: This medicine contains Sodium
Maltese: Din il-mediċina fiha Sodium
English: Unopened vials:
Maltese: Soluzzjonijiet dilwiti:
English: Vial (type I glass) with a stopper (siliconized chlorobutyl rubber) and a seal (aluminium) with a flipoff cap (polypropylene).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett (ħġieġ tat-tip I) b'tapp (lasktu siliconized tal-chlorobutyl) u siġill (aluminju) u għatu li jinfetaħ b'daqqa ta' saba' (polypropylene).
English: The volume of Naglazyme is to be slowly added to the sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Il-volum ta' Naglazyme għandu jiġi miżjud bil-mod mas-soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%).
English: ▼This medicine is subject to additional monitoring.
Maltese: Tossiċità ta' waqt u wara t-twelid ma ġietx investigata.
English: The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Maltese: Il-konċentrat għal soluzzjoni għallinfużjoni jrid jiġi dilwit b'soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%) permezz ta' teknika asettika.
English: For information on pre-treatment see section 4.4 and for further instructions see section 6.6.
Maltese: Għall-informazzjoni dwar x'għandu jsir qabel il-kura ara sezzjoni 4.4 u għall-aktar struzzjonijiet ara sezzjoni 6.6.
English: The most serious side effects were swollen face and fever (very common); longer than normal gaps between breaths, difficulty breathing, asthma and hives (common); and swelling of the tongue and throat, and serious allergic reaction to this medicine (unknown frequency).
Maltese: L-aktar effetti sekondarji serji kienu nefħa fil-wiċċ u deni (komuni ħafna); pawżi itwal min-normal bejn nifs u ieħor, diffikultà biex tieħu nifs, ażżma u ħorriqija (komuni); u nefħa fl-ilsien u l-griżmejn, u reazzjoni allerġika serja għal din il-mediċina (frekwenza mhux magħrufa).
English: Patients received either 1 mg/kg of galsulfase or placebo every week for a total of 24 weeks.
Maltese: Il-pazjenti rċevew 1 mg/kg ta' galsulfase jew plaċebo kull ġimgħa għal total ta' 24 ġimgħa.
English: Likewise, antibody development is not predictive of decreased efficacy although subjects with limited response in endurance parameters or urinary glycosaminoglycans (GAGs) tended to have higher peak anti-galsulfase titres than those with good response.
Maltese: Bl-istess mod, l-iżvilupp ta' antikorpi ma tindikax effikaċja imnaqqsa għalkemm individwi b'rispons limitat fil-parametri ta' reżistenza jew glycosaminoglycans (GAGs) fl-awrina kellhom tendenza li jkollhom titri l-aktar għolja kontra galsulfase ogħla minn dawk b'rispons tajjeb.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity, repeated-dose toxicity or on general reproductive performance or embryo-foetal development in rats or rabbits.
Maltese: Informazzjoni li mhix klinika, ma' turi l-ebda periklu speċjali għall-bnedmin ibbażata fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn doża waħda, effett tossiku minn dożi ripetuti, jew fuq il-funzjoni riproduttiva ġenerali, jew l-iżvilupp ta' l-embriju/fetu fil-firien jew filfniek.
English: What is in this leaflet:
Maltese: Kunjetti mhux miftuħa:
English: It is recommended that the diluted Naglazyme solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
Maltese: Huwa rakkomandat li s-soluzzjoni dilwita ta' Naglazyme tingħata lill-pazjenti permezz ta' sett ta' l-infużjoni mgħammar b'filter in-line ta' 0.2 µm.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of galsulfase in a clinically significant way.
Maltese: Konsegwentament, funzjoni tal-fwied indebbolita mhix mistennija li taffettwa lfarmakokinetiċi ta' galsulfase b'mod sinifikanti klinikament.
English: This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Maltese: Dan ifisser li minħabba li l-marda hija rari ma kienx possibbli li tinkiseb informazzjoni kompleta dwar dan il-prodott mediċinali.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Fi żmien 60 jumminn meta jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskju);
English: A comprehensive antibody analysis based on data from three clinical studies has been carried out in 48 patients.
Maltese: Analiżi komprensiva ta' antikorpi bbażata fuq dejta minn tliet studji kliniċi saret fuq 48 pazjent.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 002 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq jimpenja ruħu li jwettaq l-istudji u lattivitajiet addizzjonali ta' farmakovigilanza kif inhu deskritt fil-Pjan ta' Farmakoviġilanza, kif inhu deciż f'verżjoni 002 tal-pjan ta' l-Immaniġġar tar-Riskju (RMP) ippreżentata f'Modulu 1.8.2. tal-Applikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq u aġġornamenti sussegwenti tal-RMP kif deciż mill-Kumitat għall-Prodotti Mediċinali għall-Użu Uman ta' lAġenzija Ewropeja dwar il-Mediċini (CHMP).
English: This medicine has been authorised under “exceptional circumstances”.
Maltese: Dan il-prodott mediċinali kien awtorizzata taħt "Ċirkustanzi ta' Eċċezzjoni".
English: Samples from those subjects who have a consistent increase in urinary GAG values together with high antibody levels will have their antibody samples assessed for evidence of neutralizing activities.
Maltese: Diversi miżuri se jiġu mplimentati biex tiġi stmata d-doża ta' Naglazyme.
English: People with MPS VI disease have either a low level, or no level, of an enzyme called N-acetylgalactosamine 4-sulfatase, which breaks down specific substances (glycosaminoglycans) in the body.
Maltese: Persuni bil-marda MPS VI jkollhom livell baxx, jew l-ebda livell, ta' enzima msejħa N-acetylgalactosamine 4-sulfatase, li tkisser sustanzi speċifiċi (glycosaminoglycans) fil-ġisem.
English: Other reactions with known frequency were reported from 59 patients treated with Naglazyme from all five clinical trials.
Maltese: Reazzjonijiet oħra bi frekwenza magħrufa kienu rrappurtati minn 59 pazjent ikkurati b'Naglazyme mill-ħames provi kliniċi kollha.
English: The most common adverse reactions were pyrexia, rash, pruritus, urticaria, chills/rigors, nausea, headache, abdominal pain, vomiting and dypsnoea.
Maltese: Laktar reazzjonijiet avversi komuni kienu deni, raxx, ħakk, urtikarja, tkexkix ta' bard/tertir, tqalligħ, uġigħ ta' ras, uġigħ addominali, rimettar u qtugħ ta' nifs.
English: It did not prevent the progression of skeletal dysplasia and development of hernias and did not prevent the progression of corneal clouding.
Maltese: Hija ma impedixxitx il-progressjoni ta' displasja skeletrali u żvilupp ta' ftuq u ma impedixxitx il-progressjoni ta' ċpar filkorneja.
English: Reproduction studies have been performed in rats and rabbits at doses up to 3 mg/kg/day and have revealed no evidence of impaired fertility or harm to the embryo or foetus due to Naglazyme.
Maltese: Studji dwar ir-riproduzzjoni saru fuq firien u fniek b'dożi sa 3 mg/kg/kuljum u ma wrew l-ebda evidenza ta' indeboliment fuq il-fertilità jew ħsara lill-embriju jew fetu ikkawżata minn Naglazyme.
English: Pallor
Maltese: Pożoloġija
English: • Low blood pressure
Maltese: • Pressjoni baxxa
English: Hypertension1
Maltese: ANNESS II
English: 100 ml infusion bags should be considered for patients who are susceptible to fluid volume overload and weigh less than 20 kg; in this case the infusion rate (ml/min) should be decreased so that the total duration remains no less than 4 hours.
Maltese: Boroż tal-infużjoni ta' 100 ml għandhom jiġu kkunsidrati għall-pazjenti li huma suxxettibbli għal volum żejjed ta' fluwidu u jiżnu inqas minn 20 kg; f'dan il-każ ir-rata ta' infużjoni (ml/min) għandha tiġi mnaqqsa sabiex it-tul totali jibqa' mhux inqas minn 4 sigħat.
English: Infusion reactions began as early as Week 1 and as late as Week 146 of Naglazyme treatment, and occurred during multiple infusions though not always in consecutive weeks.
Maltese: Reazzjonijiet għall-infużjoni bdew minn Ġimgħa 1 u kienu osservati l-aktar tard f'Ġimgħa 146 tal-kura b'Naglazyme, u seħħew waqt infużjonijiet multipli għalkemm mhux dejjem f'ġimgħat konsekuttivi.
English: Ear pain1, hearing impaired1
Maltese: Qtugħ ta' nifs1, konġestjoni flimnieħer1
English: Tremor
Maltese: Tqala
English: To be taken into consideration by patients on a controlled sodium diet.
Maltese: Għandu jittieħed f'konsiderazzjoni minn pazjenti fuq dieta ta' sodium ikkontrollat.
English: Other medicines and Naglazyme
Maltese: Mediċini oħra u Naglazyme
English: The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to hydrolyze the accumulated substrate and to prevent further accumulation.
Maltese: Ir-raġuni tat-terapija ta' sostituzzjoni ta' enzimi hija biex jerġa jinkiseb livell ta' attività enzimatika għoli biżżejjed biex ikun idrolizzat is-substrat akkumulat u tipprevjeni aktar akkumulazzjoni.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq jimpenja ruħu li jwettaq l-istudji u lattivitajiet addizzjonali ta' farmakovigilanza dettaljati fil-Pjan ta' Farmakoviġilanza.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation , is in place and functioning before and whilst the product is on the market.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq għandu jiżgura li s-sistema ta' farmakoviġilanza, ippreżentata f'Modulu 1.8.1 tal-Awtorizzazzjoni għat-Tqegħid fis-suq tkun fis-seħħ u tiffunzjona qabel u waqt li l-prodott ikun fuq is-suq.
English: Pharmacokinetic parameters in Phase 1 patients have remained stable over the long term (through at least 194 weeks).
Maltese: Il-parametri farmakokinetiċi fil-pazjenti ta' Fażi 1 baqgħu stabbli għal tul ta' żmien twil (ta' millanqas 194 ġimgħa).
English: EMA/13030/2016 EMEA/H/C/003925
Maltese: EU/1/15/1017/003
English: Taxespira is used with cisplatin and 5-fluorouracil.
Maltese: Cisplatin u 5-fluorouracil
English: Taxespira docetaxel
Maltese: Kif taħżen Taxespira
English: Previously known as Docetaxel Hospira UK Limited.
Maltese: Hospira UK Limited Horizon,
English: EPAR summary for the public
Maltese: Reazzjonijiet Avversi komuni