FrancophonIA/ELRC3.0 huggingface dataset:
English: Aflibercept should be discontinued in patients that develop PRES (see section 4.2).
Maltese: Aflibercept għandu jitwaqqaf f'pazjenti li jiżviluppaw PRES (ara sezzjoni 4.2).
English: Patients with Grade 3 DVT should be treated with anticoagulation as clinically indicated, and aflibercept therapy should be continued.
Maltese: Pazjenti bi Grad 3 DVT għandhom jiġu ttrattati b'terapija kontra l-koagulazzjoni kif indikat klinikament, u l-kura b'aflibercept għandha titkompla.
English: Grade 3-4 fistula occurred in 0.2 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Maltese: Kien hemm formazzjoni ta' fistula tal-grad 3-4 f'0.2 % tal-pazjenti kkurati b'ZALTRAP u f'0.1 % tal-pazjenti kkurati bi plaċebo (ara sezzjoni 4.4).
English: Urinary tract infection
Maltese: Infezzjoni fl-apparat urinarju
English: Musculoskeletal and connective tissue disorders Uncommon
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: In the pivotal study for MCRC, compromised wound healing was reported in 3 patients (0.5 %) treated with the ZALTRAP/FOLFIRI regimen and 5 patients (0.8 %) treated with the placebo/FOLFIRI regimen.
Maltese: Fl-istudju prinċipali ta' MCRC, fejqan tal-feriti mhux komplet kien irrappurtat fi 3 pazjenti (0.5 %) ikkurati bil-kors ZALTRAP/FOLFIRI u f'5 pazjenti (0.8 %) ikkurati bil-kors plaċebo/FOLFIRI.
English: Reproductive and developmental toxicology
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: In the pivotal study of MCRC patients, severe hypersensitivity reactions have been reported in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
Maltese: Fl-istudju prinċipali ta' pazjenti b'MCRC, reazzjonijiet severi ta' sensittività eċċessiva kienu rrappurtati f'pazjenti kkurati bil-kors ZALTRAP/FOLFIRI (ara sezzjoni 4.8).
English: PRES may present with altered mental status, seizure, nausea, vomiting, headache, or visual disturbances.
Maltese: PRES jista' jippreżenta bi stat mentali mibdul, aċċessjoni, dardir, rimettar, uġigħ ta' ras, jew disturbi fil-vista.
English: • 8 ml of concentrate in a 10 ml clear borosilicate glass vial (type I), sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Maltese: • 8 ml ta' konċentrat f'kunjett tal-10 ml tal-ħġieġ ċar magħmul mil-borosilicate (tip I), issiġillat permezz ta' tapp bi flanġ bl-għatu flip-off u diska laminata li tissiġilla mdaħħla fuq ġewwa.
English: ZALTRAP 25 mg/ml concentrate for solution for infusion
Maltese: ZALTRAP 25 mg/ml prodott ikkonċentrat għal soluzzjoni għall-infużjoni
English: Aflibercept increased blood pressure in normotensive rodents.
Maltese: Aflibercept żied l-pressjoni tad-demm fl-annimali gerriema normotensivi.
English: In other studies, PRES was reported in patients treated with monotherapy ZALTRAP (0.5 %) and in combination with other chemotherapies (see section 4.4).
Maltese: Fi studji oħra, PRES kien irrappurtat f'pazjenti kkurati b'monoterapija ZALTRAP (0.5%) u flimkien ma' kimoterapiji oħra (ara sezzjoni 4.4).
English: Posterior reversible encephalopathy syndrome (PRES) PRES was not reported in the pivotal Phase III study of MCRC patients.
Maltese: PRES ma kienx irrappurtat fl-istudju prinċipali tal-Fażi III tal-pazjenti b'MCRC.
English: Consistent with target-mediated drug disposition, free aflibercept exhibits a faster (non-linear) clearance at doses below 2 mg/kg, likely due to the high affinity binding of aflibercept to endogenous VEGF.
Maltese: B'mod konsistenti mad-dispożizzjoni tal-mediċina li hi target-mediated, aflibercept ħieles juri tneħħija aktar mgħaġġla (mhux lineari) f'dożi anqas minn 2 mg/kg, x'aktarx minħabba l-affinità għolja tal-irbit ta' aflibercept għall-VEGF endoġenu.
English: The pharmacokinetic properties described below have to a large extent been derived from a population pharmacokinetic analysis with data from 1,507 patients with various types of advanced malignancies.
Maltese: .2 Tagħrif farmakokinetiku Il-proprjetajiet farmakokinetiċi deskritti hawn taħt sa ċertu punt ġew derivati minn analiżi farmakokinetika tal-popolazzjoni bid-data minn 1507 pazjenti tipi varji ta 'tumuri malinni avanzati.
English: Febrile neutropenia or neutropenic sepsis
Maltese: Newtropenja bid-deni jew sepsis newtropenika
English: ZALTRAP contains the active substance aflibercept, a protein that works by blocking the growth of new blood vessels within the tumour.
Maltese: ZALTRAP fih aflibercept bħala sustanza attiva, proteina li taħdem billi timblokka l-iżvilupp ta' vini u arterji ġodda fit-tumur.
English: In the event of a severe hypersensitivity reaction (including bronchospasm, dyspnoea, angioedema, and anaphylaxis), aflibercept should be discontinued and appropriate medical measures should be administered (see section 4.2).
Maltese: Fil-każ ta' reazzjoni severa ta' sensittività eċċessiva (inkluż bronkospażmu, qtugħ ta' nifs, anġjoedema, u anafilassi), aflibercept għandu jitwaqqaf u jinbdew miżuri mediċi xierqa (ara sezzjoni 4.2).
English: Intensity of the adverse reactions is graded according to NCI CTC version 3.0 (grade ≥ 3 = G ≥ 3).
Maltese: (grad ≥ 3 = G ≥ 3).
English: EXP
Maltese: PFSb
English: As with other large proteins, both free and bound aflibercept, are expected to be cleared, more slowly, by other biological mechanisms, such as proteolytic catabolism.
Maltese: huma mistennija li jitneħħew aktar bil-mod, permezz ta' mekkaniżmi bijoloġiċi oħra, bħall kataboliżmu proteolitiku.
English: Fistula formation
Maltese: Stomatite veżikulari
English: Signs of allergic reaction may include rash or itching, skin redness, feeling dizzy or faint, being short of breath, tight chest or throat, or swelling of the face.
Maltese: Sinjali ta' reazzjoni allerġika jistgħu jinkludu raxx jew ħakk, ħmura tal-ġilda, tħossok sturdut jew mintix f'sikktek, qtugħ ta' nifs, għoqla fis-sider jew fil-gerżuma, jew nefħa tal-wiċċ.
English: Abdominal pain Abdominal pain upper
Maltese: Minħabba l-iperosmolalità
English: There was no observed impact on the pharmacokinetic profile of aflibercept in patients who were positive in the immunogenicity assays.
Maltese: Ma kien hemm l-ebda impatt fuq il-profil farmakokinetiku ta' aflibercept f'pazjenti li kienu pożittivi fl-analiżi tal-immunoġeniċità.
English: ZALTRAP is a medicine used to treat advanced cancers of the colon or rectum (parts of the large intestine) in adults.
Maltese: ZALTRAP huwa mediċina li tintuża għal kura ta' kanċer avvanzat tal-kolon jew rektum (partijiet millmusrana l-kbira) fl-adulti.
English: Single-dose vial.
Maltese: bidla fid-doża.
English: Aflibercept treatment should be discontinued in patients who experience GI perforation (see section 4.2).
Maltese: It-trattament b'aflibercept għandu jitwaqqaf f'pazjenti li jiżviluppaw fistula (ara sezzjoni 4.2).
English: Grade 3 hypertension (requiring adjustment in existing anti-hypertensive therapy or treatment with more than one medicinal product) was reported in 1.5 % of patients treated with the placebo/FOLFIRI regimen and 19.1 % of patients treated with the ZALTRAP/FOLFIRI regimen.
Maltese: Pressjoni għolja tal-grad 3 (li teħtieġ aġġustament fit-terapija kurrenti kontra l-pressjoni jew kura b'aktar minn prodott mediċinali wieħed) kienet irrappurtata f'1.5 % tal-pazjenti kkurati bil-kors plaċebo/FOLFIRI u f'19.1 % tal-pazjenti kkurati bil-kors ZALTRAP/FOLFIRI.
English: • Pain in the mouth, teeth and/or jaw, swelling or non-healing sores in the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth: Uncommon (may affect up to 1 in 100 people) - These symptoms could be signs of bone damage in the jaw (osteonecrosis).
Maltese: • Konnessjonijiet jew passaġġi fil-ġisem bejn l-organi interni u l-ġilda jew tessuti oħra (imsejħa wkoll "fistula"): Komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni) - dawn ilkonnessjonijiet jew passaġġi anormali jistgħu jiffurmaw per eżempju, bejn l-imsaren u l-ġilda tiegħek.
English: Weight had an effect on free aflibercept clearance and volume of distribution resulting with a 29 % increase in aflibercept exposure in patients weighing ≥ 100 kg.
Maltese: Il-piż kellu effett fuq it-tneħħija ta' aflibercept ħieles u l-volum tad-distribuzzjoni u dan irriżulta f'żieda ta' 29% fl-espożizzjoni ta' aflibercept f'pazjenti li jiżnu ≥ 100 kg.
English: Treatment with corticosteroids and/or antihistamines can be used as clinically indicated.
Maltese: Kura bil-kortikosterojdi u/jew anti-istaminiċi tista' tinbeda kif indikat klinikament.
English: Aflibercept should be suspended for at least 4 weeks prior to elective surgery.
Maltese: Aflibercept għandu jiġi sospiż għal mill-inqas 4 ġimgħat qabel il-kirurġija elettiva.
English: Pregnancy
Maltese: Aflibercept
English: In case of recurrent medically significant or severe hypertension, despite optimal treatment, ZALTRAP should be suspended until the hypertension is controlled and the dose reduced to 2 mg / kg for subsequent cycles.
Maltese: F'każ ta' ipertensjoni li mil-lat mediku tkun sinifikanti jew severa u li sseħħ b'mod ripetut minkejja l-aħjar kura possibbli, Zaltrap għandu jiġi mwaqqaf sakemm l ipertensjoni tkun ikkontrollata u d-doża tiġi mnaqqsa għal 2 mg/kg fiċ-ċikli sussegwenti.
English: One patient treated with the ZALTRAP/FOLFIRI regimen presenting with proteinuria and hypertension was diagnosed with thrombotic microangiopathy (TMA).
Maltese: Pazjent wieħed ikkurat bil-kors ZALTRAP/FOLFIRI u li kellu protejnurja u pressjoni għolja, instab li kellu mikroanġjopatija trombotika (TMA).
English: Dysphonia Oropharyngeal pain
Maltese: Aġġustament fid-doża
English: • PVC containing DEHP infusion bags or polyolefin infusion bags should be used.
Maltese: • Boroż tal-infużjoni tal-PVC li fihom DEHP jew boroż ta' infużjoni ta' polyolefin għandhom jintużaw.
English: Administration of the ZALTRAP/FOLFIRI should be delayed until platelet count is 75 x 10
Maltese: L-amministrazzjoni ta' ZALTRAP/FOLFIRI għandha tiġi ttardjata sakemm l-għadd ta' plejtlits ikun ≥75 x 109/L (ara sezzjoni
English: Venous thromboembolic events
Maltese: Newtropenja jew tromboċitopenja
English: PlGF is also linked to pathological neovascularisation and recruitment of inflammatory cells into tumours.
Maltese: PlGF huwa marbut ukoll man-neovaskularizzazzjoni patoloġika u r-reklutaġġ ta' ċelluli infjammatorji għal ġot-tumuri.
English: Asthenic conditions
Maltese: Immunoġeniċità
English: • during treatment with ZALTRAP and
Maltese: • waqt it-trattament b'ZALTRAP u
English: The hazard ratio (95 % CI) of overall survival was 0.77 (0.64 to 0.93) for ECOG performance status 0 and 0.87 (0.71 to 1.06) for ECOG
Maltese: 77 (0.64 sa 0.93) għall ECOG performance status 0 u 0.
English: In case of recurrent medically significant or severe hypertension, despite optimal treatment, aflibercept should be suspended until the hypertension is controlled and the aflibercept dose should be reduced to 2 mg/kg for subsequent cycles.
Maltese: F'każ ta' ipertensjoni li mil-lat mediku tkun sinifikanti jew severa u li sseħħ b'mod ripetut minkejja l-aħjar kura possibbli, aflibercept għandu jiġi mwaqqaf sakemm l ipertensjoni tkun ikkontrollata u d-doża ta' aflibercept għandha titnaqqas għal 2 mg/kg fiċ-ċikli sussegwenti..
English: • you have illnesses where your gut is inflamed, such as an infected section of the bowel wall (also called ‘diverticulitis'), stomach ulcers or colitis.
Maltese: • għandek mard fejn l-imsaren tiegħek huwa fjammati, bħal taqsima infettata tal-ħajt tal-musrana (imsejħa wkoll "divertikulite"), ulċeri fl-istonku jew kolite.
English: ZALTRAP should be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Maltese: ZALTRAP għandu jingħata taħt is-superviżjoni ta' tabib b'esperjenza fl-użu ta' prodotti mediċinali antineoplastiċi.
English: GI perforation including fatal GI perforation has been reported in patients treated with aflibercept (see section 4.8).
Maltese: Perforazzjoni gastro-intestinali inkluż perforazzjoni gastro-intestinali fatali kienet rrapportata f'pazjenti kkurati b'aflibercept (ara sezzjoni 4.8).
English: • you have kidney problems (protein in the urine), since your doctor will monitor your kidney function and may need to adjust your dose of ZALTRAP.
Maltese: • għandek problemi fil-kliewi (proteina fl-awrina), peress li t-tabib tiegħek ser jimmonitorja lfunzjoni tal-kliewi tiegħek u jista' jkollu bżonn jaġġusta d-doża tiegħek' ta' ZALTRAP.
English: Not known
Maltese: Qtugħ ta' nifs
English: • Cardiac failure and ejection fraction decreased
Maltese: • Insuffiċjenza kardijaka u tnaqqis fil-frazzjoni tad-demm li tiġi mitfugħa
English: High molecular weight proteins are not cleared by the renal route, therefore renal elimination of aflibercept is expected to be minimal.
Maltese: Proteini b'piż molekulari għoli mhumiex imneħħija mis-sistema renali, għalhekk l-eliminazzjoni renali ta' aflibercept hija mistennija li tkun minima.
English: Module 5 - Clinical
Maltese: Modulu 5 - Kliniku
English: Common reactions have a frequency of 1/100 to <1/10.
Maltese: Reazzjonijiet komuni għandhom frekwenza ta' 1/100 sa <1/10.
English: Pack sizes: 1 and 6 vials.
Maltese: Daqsijiet tal-pakkett: 1 u 6 kunjett.
English: Date of latest renewal: 26 January 2011
Maltese: Data tal-aħħar tiġdid: 26 ta' Jannar 2011
English: - The active substance is galsulfase.
Maltese: - Is-sustanza attiva hija galsulfase.
English: • Gastroenteritis
Maltese: • Gastroenterite
English: Pharyngitis1, gastroenteritis1
Maltese: Farinġite1, gastroenterite1
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 January 2006
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 24 ta' Jannar 2006
English: Apnoea1, cough, respiratory distress, asthma, bronchospasm
Maltese: Apnea1, sogħla, distress respiratorju, ażżma, bronkospażmu
English: Each 5 ml vial contains 0.8 mmol (18.4 mg) of sodium.
Maltese: Kull kunjett ta' 5 ml fih 0.8 mmol (18.4 mg) ta' sodium.
English: Galsulfase is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Maltese: Galsulfase huwa proteina u huwa mistenni li jiġi degradat metabolikament permezz ta' idrolisi ta' peptide.
English: Bradycardia, tachycardia, cyanosis
Maltese: Bradikardija, takikardija, ċjanożi
English: The molecule contains 6 N-linked oligosaccharide modification sites.
Maltese: Il-molekola fiha 6 siti ta' modifikazzjoni ta' N-linked oligosaccharide.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: 46 Galli Drive, Novato, CA 94949 United States of America
Maltese: BioMarin Pharmaceutical Inc., 46 Galli Drive, Novato, CA 94949
English: One vial of 5 ml contains 5 mg galsulfase.
Maltese: Kunjett wieħed ta' 5 ml fih 5 mg galsulfase.
English: MedDRA Preferred Term
Maltese: Terminu Ppreferut MedDRA Frekwenza
English: The mean ( SD) volume of distribution (Vz) was 316 ( 752) ml/kg and the mean ( SD) plasma clearance (CL) was 7.9 ( 14.7) ml/min/kg.
Maltese: Il-volum ta' distribuzzjoni medju fil-plażma (Vz) ( SD) kien 316 ( 752) ml/kg u l-medja tat-tneħħija mill-plażma (CL) ( SD) kienet 7.9 ( 14.7) ml/min/kg.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mg/5 ml
Maltese: INDIVIDWALI 5 mg/5 ml
English: BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298 Ireland
Maltese: BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298 L-Irlanda
English: The mean ( SD) elimination half-life (t1/2) was 22.8 ( 10.7) minutes at Week 24.
Maltese: Ilhalf-life (t1/2) ta' eliminazzjoni medja ( SD) kienet 22.8 ( 10.7) minuti fl-24 ġimgħa.
English: Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1).
Maltese: Naglazyme huwa ndikat għal terapija ta' sostituzzjoni ta' enzima fit-tul f'pazjenti b'dijanjosi kkonfermata ta' Mukoplisakkaridosi VI (MPS VI; defiċjenza ta' N-acetylgalactosamine 4-sulfatase; sindromu Maroteaux-Lamy) (ara sezzjoni 5.1).
English: Following 24 weeks of therapy, Naglazyme-treated patients experienced a 92 ± 40 m improvement in the distance walked in 12 minutes relative to placebo-treated patients (p = 0.025).
Maltese: Wara 24 ġimgħa ta' terapija, pazjenti kkurati b'Naglazyme esperjenzaw titjib ta' 92 ± 40 m fiddistanza li mxew fi 12-il minuta meta mqabbla mal-pazjenti kkurati bil-plaċebo (p = 0.025).
English: Adverse reactions reported during the Post Marketing period are included at a frequency category of “unknown”.
Maltese: Reazzjonijiet avversi rrappurtati waqt il-perijodu ta' wara t-tqegħid fis-suq huma inklużi fil-kategorija ta' frekwenza “mhux magħrufa”.
English: The safety and efficacy of Naglazyme was assessed in a randomised, double blind, placebo controlled, Phase 3 study of 39 MPS VI patients, ranging in age from 5 to 29 years.
Maltese: Is-sigurtà u l-effikaċja ta' Naglazyme kienu vvalutati fi studju randomised, double blind, u kkontrollat bil-plaċebo, ta' Fażi 3 ta' 39 pazjent bi MPS VI, b'età minn 5 sa 29 sena.
English: Information will also be collected on clinical status, adverse events, assessments of immunogenicity and potential effects on antibody formation.
Maltese: Se tinġabar ukoll informazzjoni dwar l-istat kliniku, avvenimenti avversi, stimi ta' l-immunoġeniċità u effetti potenzjali fuq il-formazzjoni ta' antikorpi.
English: Higher antibody levels (≥ 65610 Dilution Fraction) will be compared with the subject's urinary GAG values with a view to assess potential impacts on efficacy.
Maltese: Livelli ta' antikorpi ogħla (≥ 65610 Frazzjoni ta' Dilwazzjoni) se jiġu mqabbla mal-valuri ta' GAG fl-awrina ta' lindividwu bi ħsieb li jiġu stmati l-impatti potenzjali fuq l-effikaċja.
English: Purified galsulfase, a recombinant form of human N-acetylgalactosamine 4-sulfatase, is a glycoprotein with a molecular weight of approximately 56 kD. Galsulfase is comprised of 495 amino acids after cleavage of the N-terminus.
Maltese: Galsulfase ppurifikat, forma rikombinanti ta' N-acetylgalactosamine 4-sulfatase uman, huwa glikoproteina b'piż molekulari ta' madwar 56 kD. Galsulfase jikkonsisti minn 495 aċidu amminiku wara l-qtuħ ta' N-terminus.
English: Other side effects with an unknown frequency:
Maltese: Effetti sekondarji oħra bi frekwenza mhux magħrufa:
English: After 24 weeks of treatment the mean ( Standard Deviation [SD]) maximum plasma concentration (Cmax) was 2,357 (± 1,560) ng/ml and the mean ( SD) area under the plasma concentration-time curve (AUC0-t) was 5,860 ( 4,184) h  ng/ml.
Maltese: Wara 24 ġimgħa ta' kura l-medja ( Devjazzjoni Stàndard [SD]) ta' konċentrazzjoni massima fil-plazma (Cmax) kienet ta' 2,357 (± 1,560) ng/ml u lmedja ta' l-erja ( SD) taħt il-kurva ta' konċentrazzjoni fil-plażma-ħin (AUC 0-t) kienet 5,860 ( 4,184) h  ng/ml.
English: MM/YYYY
Maltese: L-KITBA MM/YYYY
English: EU/1/05/324/001 1 vial EU/1/05/324/002 6 vials
Maltese: EU/1/05/324/002 6 kunjetti
English: MPS VI is a heterogeneous and multisystemic disorder characterized by the deficiency of N-acetylgalactoasamine 4-sulfatase, a lysosomal hydrolase which catalyses the hydrolysis of sulfate moiety of the glycosaminoglycan, dermatan sulfate.
Maltese: MPS VI hija marda eteroġena li tidher f'diversi sistemi tal-ġisem, ikkaratterizzata minn defiċjenza ta' Nacetylgalactoasamine 4-sulfatase, hydrolase liżosomali li tikkatalizza l-idroliżi tal-porzjon ta' sulfate ta' glycosaminoglycan, dermatan sulfate.
English: Treated patients also experienced a mean decrease in urinary glycosaminoglycan excretion of 238 ± 17.8 μg/mg creatinine ( Standard Error [SE]) following 24 weeks of treatment relative to placebo-treated patients.
Maltese: Pazjenti kkurati esperjenzaw ukoll tnaqqis medju fit-tneħħija ta' glycosaminoglycan fl-awrina ta' 238 ± 17.8 μg/mg krejatinina ( Standard Error [SE]) wara 24 ġimgħa ta' kura meta mqabbla mal-pazjenti kkurati bil-plaċebo.
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of concentrate for solution for infusion 6 vials of concentrate for solution for infusion 5 mg/5 ml
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT kunjett ta' konċentrat għal soluzzjoni għall-infużjoni 6 kunjett ta' konċentrat għal soluzzjoni għall-infużjoni 5 mg/5 ml
English: Renal elimination of galsulfase is considered a minor pathway for clearance (see section 4.2).
Maltese: L-eliminazzjoni renali ta' galsulfase hija kkunsidrata bħala passaġġ minuri għat-tneħħija (ara sezzjoni 4.2).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB08
Maltese: Prodotti tal-metaboliżmu u tal-kanal alimentari oħra, enzimi, Kodiċi ATC:
English: The reactions are listed following the MedDRA frequency convention.
Maltese: Ir-reazzjonijiet huma mniżżla skond il-konvenzjoni ta' frekwenza MedDRA.
English: Common symptoms of infusion reactions were pruritus, vomiting, abdominal pain, nausea, hypertension, headache, chest pain, erythema, cough, hypotension, angioedema, respiratory distress, tremor, conjunctivitis, malaise, bronchospasm and arthralgia.
Maltese: Sintomi komuni ta' reazzjonijiet għall-infużjoni kienu ħakk, rimettar, uġigħ addominali, tqalligħ, pressjoni għolja, uġigħ ta' ras, uġigħ fis-sider, eritema, sogħla, pressjoni baxxa, anġjoedima, distress respiratorju, rogħda, konġuntivite, tħossok ma tiflaħx, bronkospażmu u artralġija.
English: This medicine contains a recombinant enzyme called galsulfase.
Maltese: Din il-mediċina fiha enzima rikombinanti msejħa galsulfase.
English: Table 1: Frequency of adverse drug reactions with Naglazyme
Maltese: Tabella 1: Frekwenza ta' reazzjonijiet avversi tal-mediċina b'Naglazyme Sistema tal-Klassifika tal-Organi
English: Serious adverse reactions included laryngeal edema, apnoea, pyrexia, urticaria, respiratory distress, angioedema, asthma and anaphylactoid reaction.
Maltese: Reazzjonijiet avversi serji kienu jinkludu edima fil-larinġi, apnea, deni, urtikarja, distress respiratorju, anġjoedima, ażżma u reazzjoni anafilattojda.
English: This medicinal product contains 0.8 mmol (18.4 mg) sodium per vial and is administered in sodium chloride 9 mg/ml solution for injection (see section 6.6).
Maltese: Dan il-prodott mediċinali fih 0.8 mmol (18.4 mg) ta' sodium f'kull kunjett u jingħata f'soluzzjoni għall-injezzjoni ta' sodium chloride ta' 9 mg/ml (ara sezzjoni 6.6).
English: Musculoskeletal and Connective Tissue Disorders
Maltese: Disturbi muskolu-skeletriċi u tattessuti konnettivi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution contains 1 mg galsulfase.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull ml ta' soluzzjoni fih 1 mg galsulfase.
English: Adverse reactions are listed in Table 1 by System Organ Class.
Maltese: Reazzjonijiet avversi huma elenkati f'Tabella 1 skont is-Sistema tal-Klassifika tal-Organi.
English: Galsulfase is a recombinant form of human N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Maltese: Galsulfase huwa forma rikombinanti ta' N-acetylgalactosamine 4-sulfatase uman u huwa magħmul b'teknoloġija ta' DNA rikombinanti permezz ta' koltura ta' ċelluli mammiferi tal-Ovarju ta' Ħamster Ċiniż (CHO).
English: Naglazyme is used to treat patients with MPS VI disease (Mucopolysaccharidosis VI).
Maltese: Naglazyme jintuża għall-kura ta' pazjenti bil-marda MPS VI (Mucopolisakkaridożi VI).
English: Treated patients experienced a 5.7 stair per minute improvement in the 3 Minute Stair Climb relative to placebo-treated patients.
Maltese: Pazjenti kkurati wrew titjib ta' 5.7 tarġiet kull minuta fil-prova ta' Tlugħ ta' Taraġ ta' 3 Minuti, meta mqabbla mal-pazjenti kkurati bil-plaċebo.
English: Angioeodema1, rash1, urticaria, pruritus Very Common Erythema
Maltese: Anġjoedima1, raxx1, urtikarja, ħakk Komuni ħafna Eritema
English: Diluted solutions: Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23C - 27C).
Maltese: Soluzzjonijiet dilwiti: Stabbiltà kimika u fiżika waqt l-użu kienet demostrata sa 4 ijiem f'temperatura tal-kamra (23C - 27C).
English: • Tingling
Maltese: • Tqalligħ