FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of telmisartan in children and adolescents aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' telmisartan fi tfal u adolexxenti li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: General disorders and administration site conditions Uncommon:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
English: In some of the investigated patients the doses used were higher than those recommended in the treatment of hypertension in the adult population, reaching a daily dose comparable to160 mg, which was tested in adults.
Maltese: F'xi wħud mill-pazjenti investigati, iddożi użati kienu ogħla minn dawk rakkomandati fil-kura ta' pressjoni għolja fil-popolazzjoni adulta, u laħqu doża ta' kuljum komparabbli għal 160 mg, li ġiet ittestjata fl-adulti.
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Maltese: Sepsis* (ta' spiss imsejħa “avvelenament tad-demm”, hi infezzjoni severa b'rispons infjammatorju talġisem kollu), nefħa mgħaġġla tal-ġilda u l-mukuża (anġjoedema); dawn l-effetti sekondarji huma rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000) iżda huma estremament serji u l-pazjenti għandhom jieqfu jieħdu l-mediċina u jaraw lit-tabib tagħhom immedjatament.
English: Sepsis including fatal outcome
Maltese: Sepsis li jista' jwassal għal tmiem fatali
English: These clinical data do not allow to make conclusions on the efficacy and safety of telmisartan in hypertensive paediatric population.
Maltese: Din id-dejta klinika ma tippermettix li jsiru konklużjonijiet fuq l-effikaċja u s-sigurtà ta' telmisartan fil-popolazzjoni pedjatrika bi pressjoni għolja.
English: Tolura should be used only with caution in patients with mild to moderate hepatic impairment.
Maltese: Tolura għandha tintuża biss b'attenzjoni f'pazjenti li għandhom indeboliment epatiku minn ħafif sa moderat.
English: Ear and labyrinth disorders Uncommon:
Maltese: Disturbi fil-widnejn u fis-sistema labirintika:
English: Each blister contains 7 or 10 tablets.
Maltese: Kull folja fiha 7 jew 10 pilloli
English: Dyspnoea, cough Interstitial lung disease
Maltese: Mard interstizjali tal-pulmun
English: In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
Maltese: Fi studji dwar is-sigurtà ta' qabel l-użu kliniku, id-dożi li pproduċew esponiment li kien komparabbli għal dak fil-medda terapewtika klinika, ikkawżaw tnaqqis fil-parametri taċ-ċelluli ħomor tad-demm (eritroċiti, emoglobina, ematokrit), u bidliet fl-emodinamiċi renali (żieda fin-nitrogen tal-urea u l-kreatinina fid-demm), kif ukoll żieda tal-potassju fis-serum f'annimali normotensivi.
English: The effect of Tolura may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Maltese: L-effetti ta' Tolura jistgħu jitnaqqsu meta tieħu NSAIDs (mediċini ta' kontra l-infjammazzjoni mhux sterojdi) eż. aspirina jew ibuprofen) jew kortikosterojdi.
English: Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see sections 4.3 and 4.4).
Maltese: Trabi li ommijiethom ikunu ħadu antagonisti tar-riċetturi ta' angiotensin II, għandhom ikunu taħt osservazzjoni mill-qrib għal pressjoni baxxa (ara sezzjonijiet 4.3 u 4.4).
English: Gastric mucosal injury (erosion, ulcers or inflammation) also was noted in rats and dogs.
Maltese: Ħsara fil-mukuża gastrika (tgħawwir, ulċeri jew infjammazzjoni) kienu wkoll osservati fil-firien u fil-klieb.
English: Ref. EMEA/166909/2008
Maltese: EMEA/166896/2008
English: London, 21 February 2008 Doc.
Maltese: Londra, 21 ta' Frar 2008 Doc.
English: International non-proprietary name (INN): somatropin
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): somatropin
English: The active ingredient in NutropinAq, somatropin, is identical to the human growth hormone.
Maltese: Is-sustanza attiva f'NutropinAq, somatropin, hija identika għall-ormon tat-tkabbir uman.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by a bacterium that has received a gene (DNA) that makes it able to produce human growth hormone.
Maltese: Hija prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': l-ormon isir b'batterju li jkun irċieva ġene (DNA) li jagħmilha possibbli li jipproduċi l-ormon tat-tkabbir uman.
English: The CHMP was concerned that only a modest benefit of NutropinAq in severe idiopathic short stature had been demonstrated, with an average gain in final adult height of around 6 to 7 cm in the main study.
Maltese: Is-CHMP kien imħasseb li kien intwera biss benefiċċju modest ta' NutropinAq fi statura żgħira idjopatika gravi, b'żieda medja fit-tul adult finali ta' madwar 6 sa 7 ċentimetri fl-istudju prinċipali.
English: The evaluation had finished and the CHMP had given a negative opinion.
Maltese: L-evalwazzjoni waslet fi tmiemha u s-CHMP kien ħareġ opinjoni negattiva.
English: This must be confirmed by chromosome analysis (DNA testing);
Maltese: Dan irid jiġi kkonfermat b'analiżi kromosomika (ittestjar tad-DNA);
English: On 24 January 2008, Ipsen Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for NutropinAq, for the long-term treatment of children with severe idiopathic short stature.
Maltese: Fl-24 ta' Jannar 2008, Ipsen Ltd għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għal indikazzjoni ġdida għal NutropinAq, għat-trattament ta' tfal bi statura żgħira idjopatika gravi.
English: What is happening for NutropinAq for treatment of failure to grow due to growth hormone deficiency, Turner syndrome or chronic renal insufficiency?
Maltese: X'jiġri b'NutropinAq għat-trattament tan-nuqqas ta' tkabbir minħabba defiċjenza ta' l-ormon tat-tkabbir, is-sindromu ta' Turner jew insuffiċjenza renali kronika?
English: The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment begins.
Maltese: Id-defiċjenza tista' tkun bdiet fit-tfulija jew f'età adulta, u trid tiġi kkonfermata b'testijiet qabel jinbeda t-trattament.
English: • before puberty, when they fail to grow because of longstanding kidney disease (chronic renal insufficiency).
Maltese: • qabel il-pubertà, meta ma jikbrux minħabba mard tal-kliewi li jkun ilu preżenti (insuffiċjenza renali kronika).
English: NutropinAq is a solution for injection in a cartridge, which contains the active substance somatropin.
Maltese: NutropinAq huwa soluzzjoni għal injezzjoni fi skartoċċ, li fih s-sustanza attiva somatropin.
English: • if they are short because of Turner syndrome (a rare genetic disorder affecting girls).
Maltese: • jekk ikunu qosra minħabba s-sindromu ta' Turner (disturb ġenetiku rari li jolqot il-bniet).
English: • when they fail to grow because of a lack of growth hormone;
Maltese: • meta ma jikbrux minħabba nuqqas ta' l-ormon tat-tkabbir;
English: In the new indication, NutropinAq was expected to be used to treat children with ‘severe idiopathic short stature' (severe growth impairment with no identifiable cause).
Maltese: Fl-indikazzjoni l-ġdida, NutropinAq kien mistenni li jintuża biex jiġu kkurati tfal bi ‘statura żgħira idjopatika gravi' (indeboliment gravi tat-tkabbir mingħajr ebda kawża identifikabbli).
English: Based on the review of the data and the company's response to the CHMP's list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend the approval of NutropinAq for the long-term treatment of children with severe idiopathic short stature.
Maltese: Abbażi ta' l-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tas-CHMP fi żmien l-irtirar, is-CHMP kien ta opinjoni negattiva u ma rrakkomandax l-approvazzjoni ta' NutropinAq għat-trattament fuq perjodu fit-tul ta' tfal bi statura żgħira idjopatika gravi.
English: NutropinAq is also used to treat adults with growth hormone deficiency, as replacement therapy.
Maltese: NutropinAq jintuża wkoll għat-trattament ta' adulti b'defiċjenza ta' l-ormon tat-tkabbir, bħala terapija sostituttiva.
English: The main measure of effectiveness was the increase in adult height.
Maltese: Il-kejl prinċipali ta' l-effikaċja kien iż-żieda fit-tul ta' l-adulti.
English: What was NutropinAq expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża NutropinAq?
English: It promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and carbohydrates.
Maltese: Huwa jippromwovi t-tkabbir matul it-tfulija u l-adoloxxenza, u jaġixxi wkoll fuq il-mod kif il-ġisem jimmetabolizza l-proteini, ix-xaħam u l-karboidrati.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes in Europe with NutropinAq in this indication.
Maltese: Il-kumpanija għarrfet lis-CHMP li ma kienu għaddejjin ebda provi kliniċi jew programmi ta' użu b'kumpassjoni fl-Ewropa b'NutropinAq f'din l-indikazzjoni.
English: This was based on the
Maltese: trattament.
English: ATC code: A16AB15.
Maltese: A16AB15.
English: Patients n=33
Maltese: Pazjenti n=33
English: 6MWT (metres)
Maltese: 6MWT (metri)
English: (1) MCID: minimal clinically important difference
Maltese: (1) MCID: differenza minima klinikament importanti Popolazzjoni pedjatrika
English: Velmanase alfa vs. placebo
Maltese: Velmanase alfa vs. plaċebo
English: Linearity/(Non)linearity
Maltese: Linearità/nuqqas ta' linearità
English: There is a potential for immunogenicity.
Maltese: Hemm potenzjal ta' immunoġeniċità.
English: - The active substance is velmanase alfa.
Maltese: - Is-sustanza attiva hi velmanase alfa.
English: rhLAMAN-10 study n=33
Maltese: Studju rhLAMAN-10 n=33
English: Velmanase alfa, the active substance of Lamzede, is a recombinant form of human alpha-mannosidase.
Maltese: Velmanase alfa, is-sustanza attiva ta' Lamzede, huwa forma rikombinanti ta' alpha-mannosidase uman.
English: Renal failure acute(2)
Maltese: Insuffiċjenza renali akuta(2)
English: Chiesi España, S.A.U.
Maltese: Chiesi España, S.
English: See sections 4.4 and 5.1.
Maltese: Ara sezzjonijiet 4.4 u 5
English: Combined
Maltese: Ikkombinat
English: p-value [95% CI]
Maltese: valur p [CI ta' 95%]
English: Lamzede contains sodium
Maltese: Lamzede fih sodium
English: Dose (mL)
Maltese: (mL)
English: Paediatric Study rhLAMAN-08.
Maltese: Studju Pedjatriku rhLAMAN-08.
English: QoL Domain
Maltese: Dominju QoL
English: 5 vials
Maltese: 5 kunjetti.
English: November 2020
Maltese: Novembru
English: *Velmanase alfa is produced in mammalian Chinese Hamster Ovary (CHO) cells using recombinant DNA technology.
Maltese: *Velmanase alfa huwa magħmul fiċ-ċelluli mammiferi tal-Ovarju tal-Ħamster Ċiniż (CHO - Chinese Hamster Ovary) permezz ta' teknoloġija ta' DNA rikombinanti.
English: 3MSCT (steps/min)
Maltese: 3MSCT (tarġa/min)
English: Adverse reactions are classified by system organ class and preferred term according to the MedDRA frequency convention.
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont issistema tal-klassifika tal-organi u t-terminu ppreferut skont il-konvenzjoni tal-frekwenza MedDRA.
English: Serum oligosaccharide concentration (µmol/L)
Maltese: oligosakkaridi fis-serum (µmol/L)
English: - The other ingredients are: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, mannitol and glycine.
Maltese: - Is-sustanzi mhux attivi l-oħra huma: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, mannitol u glycine.
English: Date of first authorisation: 23/03/2018
Maltese: Data tal-ewwel awtorizzazzjoni: 23/03/2018
English: Maximum infusion rate (mL/h)
Maltese: Rata massima tal infużjoni (mL/siegħa)
English: f) When the last syringe is empty, the dosage syringe is replaced with a 20 mL syringe filled with sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: f) Meta l-aħħar siringa tkun vojta, is-siringa tad-dożaġġ tiġi sostitwita b'siringa ta' 20 mL mimlija b'soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: Initial insomnia
Maltese: Insomnja inizjali
English: Urticaria(1)
Maltese: Urtikarja(1)
English: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
Maltese: (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000) jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: For further instructions, see section 4.4.
Maltese: Għal aktar istruzzjonijiet, ara sezzjoni 4.4.
English: In total 15 patients (7 paediatrics and 8 adults) received active treatment and 10 patients received placebo (5 paediatrics and 5 adults).
Maltese: B'kollox 15-il pazjent (7 pedjatriċi u 8 adulti) irċevew trattament attiv u 10 pazjenti rċevew plaċebo (5 pedjatriċi u 5 adulti).
English: <18 years(2) ≥18 years(2) 6MWT (metres) Overall(1)
Maltese: < 18-il sena(2) ≥ 18-il sena(2) 6MWT (metri) Totali(1)
English: The results (serum oligosaccharide concentration, 3MSCT, 6MWT and FVC%) are presented in table 2.
Maltese: oligosakkaridi fis-serum, 3MSCT, 6MWT u FVC%) huma ppreżentati fit-tabella 2.
English: After reconstitution, one mL of the solution contains 2 mg of velmanase alfa (10 mg / 5 mL).
Maltese: Wara r-rikostituzzjoni, mL wieħed ta' soluzzjoni fih 2 mg ta' velmanase alfa (10 mg/5 mL).
English: Each carton contains 1, 5 or 10 vials.
Maltese: Kull kartuna fiha 1, 5 jew 10 kunjetti.
English: Psychotic behaviour
Maltese: Imġiba psikotika
English: No treatment was administered.
Maltese: Ma ngħata l-ebda trattament.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
Maltese: Stabbiltà kimika u fiżika waqt l-użu intweriet għal 24 siegħa f'temperatura ta' 2°C - 8°C .
English: Velmanase alfa is a protein and is predicted to be metabolically degraded into amino acids.
Maltese: Velmanase alfa huwa proteina u huwa mbassar li jkun degradat metabolikament f'aċidi amminiċi.
English: Overall effects of treatment were evaluated in the domains of pharmacodynamics (reduction of serum oligosaccharides), functional (three-minute stair climbing test (3MSCT), six-minute walking test (6MWT), and forced vital capacity (FVC) % predicted) and quality of life (childhood health assessment questionnaire (CHAQ) disability index (DI) and CHAQ VAS pain (visual analogue scale)).
Maltese: L-effetti globali tat-trattament kienu evalwati fid-dominji tal-farmakodinamika (tnaqqis ta' oligosakkaridi fis-serum), funzjonali (test ta' tliet minuti ta' tlugħ ta' taraġ (3MSCT - three-minute stair climbing test), test ta' sitt minuti ta' mixi (6MWT - six-minute walking test), u l-kapaċità vitali sfurzata (FVC% - forced vital capacity) % imbassra) u l-kwalità tal-ħajja (indiċi ta' diżabilità (DIdisability index) tal-kwestjonarju tal-valutazzjoni tas-saħħa fit-tfal (CHAQ - childhood health assessment questionnaire) u wġigħ CHAQ VAS (skala analoga viżiva)).
English: For the management of adverse reactions, see sections 4.4 and 4.8.
Maltese: Għall-immanniġġjar ta' reazzjonijiet avversi, ara sezzjonijiet 4.4 u 4.8.
English: FVC (% of predicted) Overall
Maltese: FVC (% ta' dak imbassar) Totali
English: Patient weight (kg)
Maltese: Piż tal pazjent (kg)
English: Pack sizes of 1, 5 or 10 vials per carton.
Maltese: Daqsijiet tal-pakkett ta' 1, 5 jew 10 kunjetti f'kull kartuna.
English: Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 88471 Laupheim Germany
Maltese: Erwin-Rentschler-Strasse 21
English: A total of 25 patients were enrolled, including 12 paediatric subjects (age range: 6 to 17 years; mean: 10.9 years) and 13 adult subjects (age range: 18 to 35 years; mean: 24.6).
Maltese: 9 snin) u 13-il individwu adult (firxa ta' età: 18 sa 35 sena; medja: 24.6).
English: <18 years(2) ≥18 years(2)
Maltese: < 18-il sena(2) ≥ 18-il sena(2)
English: In the clinical studies at any time under treatment, 8 patients out of 33 (24%) developed IgG-class antibodies to velmanase alfa.
Maltese: Fl-istudji kliniċi fi kwalunkwe żmien waqt it-trattament, 8 pazjent minn 33 (24%) żviluppaw antikorpi tal-klassi IgG għal velmanase alfa.
English: Treatment with velmanase alfa for 12 months (n=15)
Maltese: Trattament b'velmanase alfa għal 12-il xahar (n=15)
English: Responders Rates rhLAMAN-05 study n=25
Maltese: Rati ta' Persuni li Rrispondew Studju rhLAMAN-05 n=25
English: <18 years(2) ≥18 years(2) 3MSCT (steps/min) Overall(1)
Maltese: < 18-il sena(2) ≥ 18-il sena(2) 3MSCT (tarġa/min) Totali(1)
English: The most common adverse reactions observed were weight increase (18%), IRRs (9%), diarrhoea (12%), headache (9%), arthralgia (9%), increased appetite (6%) and pain in extremity (6%).
Maltese: uġigħ ta' ras (9%), artralġja (9%), żieda fl-aptit (6%) u wġigħ fl-estremitajiet (6%).
English: No clinical data are available in children below the age of 6 years.
Maltese: M'hemmx dejta klinika disponibbli dwar tfal taħt l-età ta' 6 snin.
English: The amino acid sequence of the monomeric protein is identical to the naturally occurring human enzyme, alpha-mannosidase.
Maltese: Is-sekwenza ta' aċidi amminiċi tal-proteina monomerika hija identika għall-enzima umana alpha-mannosidase, li sseħħ b'mod naturali.
English: Proteins larger than 50,000 Da, such as velmanase alfa, are not eliminated renally.
Maltese: Proteini akbar minn 50,000 Da, bħal velmanase alfa, mhumiex eliminati mill-kliewi.
English: Other medicines and Lamzede
Maltese: Mediċini oħra u Lamzede
English: Table 4: Multiparametric responder analysis: MCID(1) Responders Rates by Endpoints and Domains (source data: rhLAMAN-05; rhLAMAN-10)
Maltese: Rrispondew skont il-Punti Finali u d-Dominji (sors ta' data: rhLAMAN-05; rhLAMAN-10)
English: Overall response
Maltese: Rispons globali
English: In patients over 18 years old a stabilisation has been demonstrated.
Maltese: F'pazjenti ta' età 'l fuq minn 18-il sena ġiet murija stabilizzazzjoni.
English: The maximum infusion rate is 25 mL/hour (see section 4.2).
Maltese: Ir-rata massima tal-infużjoni hija 25 mL/siegħa (ara sezzjoni 4.2).
English: The vials should reach ambient temperature (between 15°C and 25°C) prior to reconstitution.
Maltese: Il-kunjetti għandhom jilħqu temperatura ambjentali (bejn 15°C u 25°C) qabel ir-rikostituzzjoni.
English: Aseptic technique is to be used during preparation.
Maltese: Għandha tintuża teknika asettika waqt il-preparazzjoni.
English: IRRs (including hypersensitivity, nausea, vomiting, pyrexia, chills, feeling hot, malaise, urticaria, anaphylactoid reaction and hyperhidrosis) were reported in 9% of the patients (3 out of 33 patients) in clinical studies.
Maltese: IRRs (inklużi sensittività eċċessiva, dardir, rimettar, deni, kesħa, tħossok taħraq, telqa mingħajr sinjali jew sintomi ta' mard, urtikarja, reazzjoni anafilattojda u għaraq eċċessiv) kienu rrappurtati f'9% tal pazjenti (3 minn 33 pazjent) fl-istudji kliniċi.
English: The safety profile of velmanase alfa in clinical studies involving children and adolescents was similar to that observed in adult patients.
Maltese: Il-profil tas-sigurtà ta' velmanase alfa fi studji kliniċi li nvolvew tfal u adolexxenti kien simili għal dak osservat f'pazjenti adulti.
English: The maximum dose of velmanase alfa in clinical studies was a single administration of 100 units/kg (approximately corresponding to 3.2 mg/kg).
Maltese: Id-doża massima ta' velmanase alfa fi studji kliniċi kienet għoti waħda ta' 100 unità/kg (li tikkorrispondi għal madwar 3.2 mg/kg).
English: Hypersensitivity(1)
Maltese: Sensittività eċċessiva(1)
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Maltese: Prodotti oħrajn tal-passaġġ tal-ikel u tal-metaboliżmu, enzimi.
English: Treatment with placebo for 12 months (n=10)
Maltese: Trattament bi plaċebo għal 12-il xahar (n=10)
English: A total of 33 patients (20 males and 13 females, ranging in age from 6 to 35 years) were exposed to velmanase alfa in five clinical studies.
Maltese: Total ta' 33 pazjent (20 raġel u 13-il mara, b'età li varjat minn 6 snin sa 35 sena) kienu esposti għal velmanase alfa f'ħames studji kliniċi.
English: Metabolism and nutrition disorders Increased appetite
Maltese: Disturbi fil-metaboliżmu u n nutrizzjoni
English: The clearance of velmanase alfa from plasma (mean 6.7 mL/h/kg) is consistent with a rapid cellular uptake of velmanase alfa via mannose receptors.
Maltese: It-tneħħija ta' velmanase alfa mill-plażma (medja 6.7 mL/siegħa/kg) hija konsistenti ma' assorbiment ċellulari mgħaġġel ta' velmanase alfa permezz ta' riċetturi ta' mannose.
English: The effects of velmanase alfa were more evident in patients younger than 18 years.
Maltese: L-effetti ta' velmanase alfa kienu aktar evidenti f'pazjenti iżgħar minn 18-il sena.
English: A post-hoc multiparametric responders analysis supports the benefit of longer treatment with velmanase alfa in 87.9% of responders in at least 2 domains at last observation (table 4).
Maltese: Analiżi post-hoc multiparametriku ta' persuni li rrispondew tappoġġja l-benefiċċju ta' trattament itwal b'velmanase alfa f'87.9% tal-persuni li rrispondew f'mill-inqas żewġ dominji fl-aħħar osservazzjoni (tabella 4).
English: Oligosaccharides 20.0% 100% 91.0%
Maltese: Dominju wieħed 30.0% 13.3% 9.1% L-ebda dominju 40.0% 0
English: There are no clinical data on the effects of velmanase alfa on fertility.
Maltese: M'hemmx dejta klinika dwar l-effetti ta' velmanase alfa fuq il-fertilità.
English: Patients were diagnosed based on alpha-mannosidase activity <10% of normal activity in blood leukocytes.
Maltese: alpha mannosidosis < 10% tal-attività normali fil-lewkoċiti tad-demm.
English: The long-term efficacy and safety of velmanase alfa was investigated in the uncontrolled, open label, phase 3 clinical study rhLAMAN-10 in 33 subjects (19 paediatrics and 14 adults, from 6 to 35 years at treatment initiation) who previously participated in velmanase alfa studies.
Maltese: L-effikaċja u s-sigurtà ta' velmanase alfa fit-tul kienu investigati fl-istudju kliniku rhLAMAN-10, ta' fażi 3, mhux ikkontrollat, open label fi 33 individwu (19 pedjatriċi u 14 adulti, ta' età minn 6 snin sa 35 sena fil-bidu tat-trattament) li pparteċipaw qabel fl-istudji b'velmanase alfa.
English: Table 1: Adverse reactions reported in clinical studies in patients with alpha-mannosidosis treated with velmanase alfa
Maltese: Tabella 1: Reazzjonijiet avversi rrappurtati fl-istudji kliniċi f'pazjenti b'alpha-mannosidosis ittrattati b'velmanase alfa Sistema tal-klassifika tal-organi
English: Pharmacodynamic Domain Response
Maltese: Rispons tad-Dominju Farmakodinamiku
English: [95% CI] p-value p=0.692
Maltese: [CI ta' 95%] valur p p=0.692
English: Serum oligosaccharide concentration (μmol/l) Overall(1)
Maltese: Konċentrazzjoni ta' oligosakkaridi fis-serum (μmol/l)
English: Table 2: Results from placebo-controlled clinical study rhLAMAN-05 (source data: rhLAMAN-05)
Maltese: Tabella 2: Riżultati minn studju kliniku kkontrollat bi plaċebo rhLAMAN-05
English: [95% CI] p-value p<0.001
Maltese: [CI ta' 95%] valur p p < 0.001
English: [95% CI] p-value p=0.278
Maltese: [CI ta' 95%] valur p p=0.278
English: Do not use this medicine after the expiry date which is stated on the label and the carton after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara ‘EXP'.