FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical practice, miglustat-induced gastrointestinal events have been observed to respond to individualised diet modification (for example reduction of sucrose, lactose and other carbohydrate intake), to taking miglustat between meals, and/or to anti-diarrhoeal medicinal products such as loperamide.
Maltese: Fil-prattika klinika, avvenimenti gastro-intestinali indotti minn miglustat kienu osservati li jirrispondu għall-modifikazzjoni fid-dieta (per eżempju tnaqqis f'sucrose, lactose u fit-teħid ta' karboidrati oħra), għat-teħid ta' miglustat bejn likliet, u/jew għal prodotti mediċinali kontra d-dijarea bħal loperamide.
English: Dosage in Niemann-Pick type C disease
Maltese: Dożaġġ fil-marda ta' Niemann-Pick ta' tip Ċ
English: Use in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended (see sections 4.4 and 5.2).
Maltese: L-użu f'pazjenti b'indeboliment serju tal-kliewi (tneħħija tal-krejatinina ta' <30 ml/min/1.73 m2) mhuwiex irrakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: Renal Impairment
Maltese: Doża rrakkomandata
English: Niemann-Pick type C disease is a very rare, invariably progressive and eventually fatal neurodegenerative disorder characterised by impaired intracellular lipid trafficking.
Maltese: Il-marda ta' Niemann-Pick ta' tip Ċ hija disturb newrodeġenerattiv rari ħafna, progressiv b'mod kostanti u eventwalment fatali, ikkaratterizzat minn traffikar indebolit tal-lipidi fiċ-ċelluli.
English: Clinical benefit has been assessed at 24 and 36 months in 13 patients.
Maltese: Il-benefiċċju kliniku kien eżaminat wara 24 u 36 xahar fi 13-il pazjent.
English: In some cases the doctor may prescribe anti-diarrhoeal medicines such as loperamide.
Maltese: F'ċertu każijiet it-tabib jista' jippreskrivilek mediċini kontra d-dijarea bħal loperamide.
English: Limited data suggest that co-administration of miglustat and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions of 22% in Cmax and 14% in AUC were observed in a small parallel-group study).
Maltese: Tagħrif limitat jissuġġerrixxi li l-użu ta' miglustat flimkien ma' sostituzzjoni ta' enżimi b'imiglucerase f'pazjenti bil-marda ta' Gaucher ta' tip 1 jista' jirriżulta fi tnaqqis tal-espożizzjoni għal miglustat (tnaqqis ta' madwar 22% fis- Cmax u tnaqqis ta' madwar 14% fl-AUC kien osservat fi studju żgħir ta' gruppi paralleli).
English: Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Maltese: Effetti komuni - jistgħu jaffettwa sa 1 minn kull 10 persuni Effetti sekondarji komuni tal-kura jinkludu uġigħ ta' ras, sturdament, parasteżija (tnemmin jew tirżiħ), koordinazzjoni mhux normali, ipoestesija (sensazzjoni tal-mess imnaqqsa), dispepsja (ħruq ta' stonku), tqalligħ (tħossok imdardar), stitikezza u rimettar, nefħa jew skomdu fl-addome (stonku) u tromboċitopenja (livelli mnaqqsa ta' plejtlits tad-demm).
English: Based on mg/kg/day and corrected for differences in faecal excretion, the doses corresponded to 8, 16 and 33/19 times the highest recommended human dose (200 mg t.i.d.).
Maltese: Ibbażat fuq mg/kg/kuljum u kkoreġut għad-differenzi fit-tneħħija fl-ippurgar, id-dożi kkorrispondew għal 8, 16 u 33/19 darba l-ogħla doża rrakkomandata għall-bniedem (200 mg t.i.d.).
English: Dosing in children at 200 mg t.i.d.
Maltese: 200 mg tliet darbiet kuljum200 mg darbtejn kuljum
English: Leukopenia and neutropenia have also been observed in a similar group of patients receiving 800 mg/day or higher dose.
Maltese: Lewkopenja u newtropenja kienu osservati wkoll fi grupp simili ta' pazjenti li ngħataw doża ta' 800 mg/kuljum jew iktar.
English: While the numbers of subjects with mild and moderate renal impairment were very small, the data suggest an approximate decrease in CL/F of 40% and 60% respectively, in mild and moderate renal impairment (see section 4.2).
Maltese: Waqt li n-numru ta' individwi b'indeboliment tal-kliewi minn ħafif sa moderat kien żgħir ħafna, t-tagħrif jindika tnaqqis fis-CL/F ta' madwar 40% u 60%, rispettivament, f'indeboliment tal-kliewi minn ħafif sa moderat (ara sezzjoni 4.2).
English: Pharmacokinetic parameters of miglustat were assessed in healthy subjects, in a small number of patients with type 1 Gaucher disease, Fabry disease, HIV-infected patients, and in adults, adolescents and children with Niemann-Pick type C disease or type 3 Gaucher disease.
Maltese: Il-parametri farmakokinetiċi ta' miglustat kienu evalwati f'individwi b'saħħithom, fi grupp żgħir ta' pazjenti li kellhom il-marda ta' Gaucher ta' tip 1, il-marda ta' Fabry, pazjenti infetti bl-HIV, u f'adulti adoloxxenti u tfal bil-marda ta' Niemann-Pick ta' tip Ċ jew il-marda ta' Gaucher ta' tip 3.
English: • Yargesa is used to treat mild to moderate type 1 Gaucher disease in adults.
Maltese: • Yargesa huwa wżat għall-kura tal-marda ta' Gaucher ta' tip 1 ħafifa sa moderata fl-adulti.
English: Over the range of data available, no significant relationships or trends were noted between miglustat pharmacokinetic parameters and demographic variables (age, BMI, gender or race).
Maltese: Mill-medda ta' tagħrif disponibbli, ma kienu osservati l-ebda relazzjonijiet jew tendenzi sinifikanti bejn il-parametri farmakokinetiċi ta' Miglustat u l-varjanti demografiċi (età, BMI, sess jew razza).
English: Pharmacokinetic data were obtained in paediatric patients with type 3 Gaucher disease aged 3 to 15 years, and patients with Niemann-Pick type C disease aged 5-16 years.
Maltese: Tagħrif farmakokinetiku kien miksub minn pazjenti pedjatriċi bil-marda ta' Gaucher ta' tip 3 b'età minn 3 snin sa 15-il sena u minn pazjenti bil-marda ta' Niemann-Pick ta' tip Ċ b'età minn 5 snin sa 16-il sena.
English: Thrombocytopenia Metabolism and nutrition disorders Very common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna
English: An open-label, non-comparative, 2-year study enrolled 42 patients with type 1 Gaucher disease, who had received a minimum of 3 years of ERT and who fulfilled criteria of stable disease for at least 2 years.
Maltese: Studju open-label, mhux komparattiv ta' sentejn kien jinvolvi 42 pazjenti bil-marda ta' Gaucher ta' tip 1, li kienu rċevew mill-inqas 3 snin ta' ERT u li ssodisfaw b'mod sħiħ il-kriterji ta' marda stabbli għal mill-inqas sentejn.
English: In addition, inhibitory action on a non-lysosomal glycosylceramidase has been demonstrated experimentally in vitro.
Maltese: Barra dan, kienet dimostrata azzjoni inibitorja fuq glycosylceramidase mhux lisożomali b'mod sperimentali in vitro.
English: Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of miglustat having an efficacy or safety advantage over ERT. ERT is the standard of care for patients who require treatment for type 1 Gaucher disease (see section 5.1).
Maltese: Għalkemm ma saru l-ebda paraguni diretti ma' Terapija tas-Sostituzzjoni tal-Enzimi (Enzyme Replacement Therapy - ERT) f'pazjenti bil-marda ta' Gaucher ta' tip 1 li qatt ma ġew ikkurati qabel, m'hemmx evidenza li miglustat għandu vantaġġ ta' effikaċja jew ta' sigurtà fuq ERT. ERT hi l-kura standard għall-pazjenti li jeħtieġu kura għall-marda ta' Gaucher ta' tip 1 (ara sezzjoni 5.1).
English: Studies in the rat have shown that miglustat adversely affects sperm parameters (motility and morphology) thereby reducing fertility (see sections 4.4 and 5.3).
Maltese: Studji fuq il-far urew li miglustat jaffettwa b'mod negattiv il-parametri tal-isperma (motilità u morfoloġija) u b'hekk inaqqas il-fertilità (ara sezzjonijiet 4.4 u 5.3).
English: Several metabolites were identified in urine and faeces.
Maltese: Bosta metaboliti kienu identifikati fl-awrina u flippurgar.
English: Patients with chronic diarrhoea or other persistent gastrointestinal events that do not respond to these interventions should be investigated according to clinical practice.
Maltese: Pazjenti b'dijarea kronika jew b'episodji gastro-intestinali persistenti li ma jirrispondux għal dawn l-interventi għandhom jiġu nvestigati skond il-prattika klinika.
English: • Yargesa is also used to treat progressive neurological symptoms in Niemann-Pick type C disease in adults and in children.
Maltese: • Yargesa huwa wżat ukoll għall-kura ta' sintomi newroloġiċi progressive fil-marda ta' Niemann-Pick ta' tip Ċ fl-adulti u t-tfal.
English: NAME OF THE MEDICINAL PRODUCT Yargesa 100 mg hard capsules
Maltese: Informazzjoni għall-utent Yargesa 100 mg kapsuli iebsin
English: The inhibitory action on glucosylceramide synthase forms the rationale for substrate reduction therapy in Gaucher disease.
Maltese: L-azzjoni ta' inibizzjoni fuq glucosylceramide synthase hi r-raġuni għat-terapija tat-tnaqqis tas-sottostrat (substrate reduction therapy) fil-marda ta' Gaucher.
English: • For type 1 Gaucher disease: For adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening).
Maltese: • Għall-marda ta' Gaucher ta' tip 1: Għall-adulti, id-doża tas-soltu hija kapsula (100 mg) tliet darbiet kuljum (filgħodu, wara nofsinhar u filgħaxija).
English: The hard capsule consists of an opaque white cap and body with “708” printed in black on the body.
Maltese: Il-kapsula iebsa tikkonsisti minn għatu u korp opaki u bojod b'“708” miktuba bl-iswed fuq il-korp.
English: How to store Yargesa
Maltese: Kif taħżen Yargesa
English: Management
Maltese: LISTA
English: In type 1 Gaucher disease, a substance called glucosylceramide is not removed from your body.
Maltese: Fil-marda ta' Gaucher ta' tip 1, sustanza msejħa glucosylceramide ma titneħħiex minn ġismek.
English: Bone manifestations of type 1 Gaucher disease were evaluated in 3 open-label clinical studies in patients treated with miglustat 100 mg t.i.d.
Maltese: Manifestazzjonijiet fl-għadam tal-marda ta' Gaucher tat-tip 1 kienu evalwati fi 3 studji kliniċi openlabel f'pazjenti kkurati b'miglustat 100 mg t.i.d. għal perijodu sa sentejn (n = 72).
English: In patients with an adjusted creatinine clearance of 50-70 ml/min/1.73 m2, administration should commence at a dose of 100 mg twice daily in patients with type 1 Gaucher disease and at a dose of 200 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
Maltese: F'pazjenti li l-krejatinina tagħhom titneħħa b'rata aġġustata ta' 50-70 ml/min/1.73 m2, l-għoti għandu jinbeda b'doża ta' 100 mg darbtejn kuljum f'pazjenti bil-marda ta' Gaucher ta' tip 1, u b'doża ta' 200 mg darbtejn kuljum (aġġustata għal erja tas-superfiċje tal-ġisem f'pazjenti taħt l-età ta' 12-il sena) f'pazjenti bil-marda ta' Niemann-Pick ta' tip Ċ.
English: NAME OF THE MEDICINAL PRODUCT Yargesa 100 mg hard capsules miglustat
Maltese: Yargesa 100 mg kapsuli iebsa miglustat
English: Both data sets included paediatric, adolescent and adult patients with an age range of 1 year to 43 years.
Maltese: Iż-żewġ settijiet ta' tagħrif kienu jinkludu pazjenti pedjatriċi, adoloxxenti u adulti ta' età li varjat minn sena sa 43 sena.
English: For the full list of excipients, see section 6.1.
Maltese: Kull kapsula iebsa fiha 100mg ta' miglustat Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Other possible side effects are muscular spasms or weakness, fatigue, chills and malaise, depression, difficulty sleeping, forgetfulness and reduced libido.
Maltese: Effetti sekondarji possibli oħrajn huma spażmi jew dgħjufija fil-muskoli, għeja, sirdat u tħossok ma tiflaħx, depressjoni, diffikultà biex torqod, tinsa u tnaqqis fil-libido.
English: Use of Yargesa in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Maltese: L-użu ta' Yargesa f'pazjenti b'indeboliment kbir tal-kliewi (b'rata ta' tneħħija tal-krejatinina ta' < 30 ml/min/1.73 m2) mhux irrakkomandat.
English: The efficacy of Yargesa in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Maltese: L-effikaċja ta' Yargesa fi tfal u adoloxxenti b'età minn 0-17-il sena bil-marda ta' Gaucher tat-tip 1 ma ġietx determinata.
English: Your doctor can give you more information.
Maltese: Sorsi oħra ta' informazzjoni
English: Peripheral neuropathy seems to be more common in patients with type 1 Gaucher disease compared to the general population.
Maltese: Newropatija periferali tidher li hija aktar komuni f'pazjenti bil-marda ta' Gaucher ta' tip 1 meta mqabbla mal-popolazzjoni ġenerali.
English: The usual treatment for type 1 Gaucher disease is enzyme replacement therapy.
Maltese: Il-kura normali għal marda ta' Gaucher ta' tip 1 hi t-terapija tat-tibdil ta' l-enzimi.
English: Other studies revealed changes in sperm parameters (motility and morphology) consistent with an observed reduction in fertility.
Maltese: Studji oħrajn urew bidliet fil-parametri tal-isperma (moviment u morfoloġija) li kienu konsistenti mat-tnaqqis fil-fertilità osservata.
English: The most common adverse reactions reported in clinical studies with miglustat were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4).
Maltese: L-aktar reazzjonijiet avversi komuni rrappurtati fi studji kliniċi b'miglustat kienu dijarea, gass flistonku, uġigħ addominali, telf ta' piż u rogħda (ara sezzjoni 4.4).
English: Yargesa is a white hard capsule that consists of an opaque white cap and body with “708” printed in black on the body.
Maltese: Yargesa huwa kapsula iebsa bajda li tikkonsisti minn għatu u korp opaki u bojod b'“708” stampat bliswed fuq il-korp.
English: The terminal half-life of radioactivity in plasma was 150 h suggesting the presence of one or more metabolites with very long half-life.
Maltese: Il-half-life terminali tar-radjuattività fil-plażma kienet 150 h li tissuġġerixxi l-preżenza ta' metabolit wieħed jew aktar b'half-life twila ħafna.
English: In patients with an adjusted creatinine clearance of 30-50 ml/min/1.73 m2, administration should commence at a dose of 100 mg once daily in patients with type 1 Gaucher disease and at a dose of 100 mg twice daily (adjusted for body surface area in patients below the age of 12) in patients with Niemann-Pick type C disease.
Maltese: F'pazjenti li l-krejatinina tagħhom titneħħa b'rata aġġustata ta' 30-50 ml/min/1.73 m2, l-għoti għandu jinbeda b'doża ta' kapsula ta' 100 mg darba kuljum f'pazjenti bil-marda ta' Gaucher ta' tip 1 u b'doża ta' 100 mg darbtejn kuljum (aġġustata għal erja tas-superfiċje tal-ġisem f'pazjenti taħt l-età ta' 12-il sena) f'pazjenti bil-marda ta' Niemann-Pick ta' tip Ċ.
English: Limited data in patients with Fabry disease and impaired renal function showed that CL/F decreases with decreasing renal function.
Maltese: Tagħrif limitat dwar pazjenti li jbatu bil-marda ta' Fabry u b'indeboliment tal-funzjoni tal-kliewi wera li s-CL/F tonqos iktar ma tonqos il-funzjoni tal-kliewi.
English: Elderly There is no experience with the use of Yargesa in patients over the age of 70.
Maltese: M'hemmx esperjenza bl-użu ta' Yargesa f'pazjenti b'età 'l fuq minn 70 sena.
English: Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Yargesa (see section 4).
Maltese: It-tabib tiegħek jista' jnaqqas id-doża tiegħek, eż., għall-kapsula waħda (100 mg) darba jew darbtejn kuljum, jekk inti ssofri minn dijarea meta tieħu Yargesa (ara sezzjoni 4).
English: In addition 12 paediatric patients were enrolled in an uncontrolled substudy for an overall average duration of 3.1 years and up to 4.4 years.
Maltese: Barra dan, 12-il pazjent pedjatriku oħra ħadu sehem f'sottostudju mhux ikkontrollat għal medja ta' tul totali ta' 3.1 snin u sa 4.4 snin.
English: There is a close relationship between renal function and clearance of miglustat, and exposure to miglustat is markedly increased in patients with severe renal impairment (see section 5.2).
Maltese: Hemm relazzjoni mill-qrib bejn il-funzjoni tal-kliewi u t-tneħħija ta' miglustat, u l-espożizzjoni għal miglustat tiżdied ħafna f'pazjenti b'indeboliment serju tal-kliewi (ara sezzjoni 5.2).
English: BN
Maltese: OĦRAJN
English: This means a daily maximum of six capsules (600 mg).
Maltese: Dan ifisser massimu ta' sitt kapsuli kuljum(600 mg).
English: Blood and lymphatic system disorders
Maltese: Disturbi muskolo-skeltrali u tal-connective-tissue
English: Separate at perforations
Maltese: Issepara fil-perforazzjonijiet
English: A second open, controlled study of miglustat randomised 36 patients who had received a minimum of 2 years of treatment with ERT, into three treatment groups: continuation with imiglucerase, imiglucerase in combination with miglustat, or switch to miglustat.
Maltese: Sar studju ieħor tat-tip open, controlled u randomised ta' miglustat fejn 36 pazjent u li kienu rċivew kura bl-ERT għal mill-inqas sentejn, inqasmu fi tliet gruppi ta' kura: grupp li kompla l-kura bl-użu ta' imiglucerase, grupp ieħor li ngħata imiglucerase flimkien ma' miglustat, u l-aħħar grupp li fih ilpazjenti qalbu l-kura għal miglustat.
English: Muscle spasms, muscle weakness General disorders and administration site reactions Common
Maltese: Spażmi fil-muskoli, debbulizza fil-muskoli Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni
English: Further effects seen in animals at doses that result in exposure levels similar to or moderately higher than the clinical exposure level were: changes in lymphoid organs in all species tested, transaminase changes, vacuolation of thyroid and pancreas, cataracts, nephropathy and myocardial changes in rats.
Maltese: Effetti oħrajn li dehru fl-annimali b'dożi li jirriżultaw f'livelli ta' espożizzjoni simili għal jew moderatament ogħla mil-livelli ta' espożizzjoni kliniċi kienu: bidliet fl-organi tal-limfojde fl-ispeċi kollha ttestjati, bidliet fit-transaminase, formazzjoni ta' spazji żgħar mimlijin bl-arja fit-tirojde u fil-frixa, katarretti, nefropatija u bidliet mijokardijaċi fil-firien.
English: The benefit to the patient of treatment with Yargesa should be evaluated on a regular basis (see section 4.4).
Maltese: Il-benefiċċju tal-kura b'Yargesa għall-pazjent għandu jiġi vvalutat fuq bażi regolari (ara sezzjoni 4.4).
English: The survey included a case series of 66 patients treated with Yargesa outside of the clinical trial for a mean duration of 1.5 years.
Maltese: Is-servej kien jinkludi serje ta' każijiet ta' 66 pazjent ikkurati b'Yargesa barra mill-prova klinika għal medja ta' tul ta' żmien ta' 1.5 snin.
English: • For Niemann-Pick type C disease: For adults and adolescents (over 12 years old), the usual dose is two capsules (200 mg) three times a day (morning, afternoon and evening).
Maltese: Għall-adulti u adoloxxenti ('l fuq minn 12-il sena), id-doża tas-soltu hija żewġ kapsuli (200 mg) tliet darbiet kuljum (filgħodu, wara nofsinhar u filgħaxija).
English: Your doctor will perform some tests before and during treatment with Yargesa to assess this (see section 2).
Maltese: It-tabib tiegħek se jagħmel xi testijiet qabel u waqt kura b'Yargesa sabiex jivvaluta dan (ara sezzjoni 2).
English: This can result in disturbances in neurological functions such as slow eye movements, balance, swallowing, and memory, and in seizures.
Maltese: Dan jista' jwassal għal disturbi fil-funzjoni newroloġika bħal moviment bil-mod ta' lgħajnejn, disturbi fil-bilanċ, biex tibla', u fil-memorja, u aċċessjonijiet.
English: Of these patients, 132 had type 1 Gaucher disease, and 40 had Niemann-Pick type C disease.
Maltese: Minn dawn il-pazjenti, 132 kellhom il-marda ta' Gaucher ta' tip 1, u 40 kellhom il-marda ta' Niemann-Pick ta' tip Ċ.
English: Miglustat did not show any potential for mutagenic or clastogenic effects in the standard battery of genotoxicity tests.
Maltese: Miglustat ma wera l-ebda potenzjal għal effetti mutaġeniċi jew klastoġeniċi fit-testijiet stàndard ta' ġenotossiċità.
English: Regular monitoring of vitamin B12 level is recommended because of the high prevalence of vitamin B12 deficiency in patients with type 1 Gaucher disease.
Maltese: B12 minħabba l-prevalenza għolja ta' nuqqas ta' vitamina
English: Miglustat has been studied in indications where certain events reported as adverse reactions, such as neurological and neuropsychological symptoms/signs, cognitive dysfunction and thrombocytopenia could also be due to the underlying conditions.
Maltese: Il-Miglustat kien studjat f'indikazzjonijiet fejn ċertu avvenimenti rrapportati bħala reazzjonijiet avversi, bħal sintomi/sinjali newroloġiċi u newropsikoloġiċi, disfunzjoni konoxxittiva u tromboċitopenja jista' jkunu kkawżata wkoll mill-marda li ġa hemm.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, ATC Code: A16AX06
Maltese: • Meta l-Aġenzija Ewropea għall-Mediċini titlob din l-informazzjoni;
English: The benefit of treatment with Yargesa for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be reappraised after at least 1 year of treatment with Yargesa, (see section 4.4).
Maltese: Il-benefiċċju ta' kura b'Yargesa għall-manifestazzjonijiet newroloġiċi f'pazjenti bil-marda ta' Niemann-Pick ta' tip Ċ għandu jiġi evalwat fuq bażi regolari, eż. kull 6 xhur; jekk għandhiex titkompla it-terapija għandu jiġi ivvalutat mill-ġdid wara mill-inqas sena ta' kura b'Yargesa, (ara sezzjoni 4.4).
English: Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Maltese: Yargesa jista' jintuża biss għall-kura ta' dawk il-pazjenti fejn itterapija ta' sostituzzjoni tal-enzimi mhijiex adattata (ara sezzjonijiet 4.4 u 5.1).
English: Data in severe renal impairment are limited to two patients with creatinine clearance in the range 18 - 29 ml/min and cannot be extrapolated below this range.
Maltese: Tagħrif dwar indeboliment sever tal-kliewi hu limitat għal żewg pazjenti bir-rata ta' tneħħija tal-krejatinina ta' 1829 ml/min, u dan ma jistax ikun estrapolat taħt din il-medda.
English: The main effects common to all species were weight loss and diarrhoea, and, at higher doses, damage to the gastrointestinal mucosa (erosions and ulceration).
Maltese: L-effetti prinċipali li dehru fl-ispeċi kollha kienu tnaqqis fil-piż tal-ġisem u dijarea u, bl-użu ta' dożi ogħla, ħsara tal-mukosa gastro-intestinali (tgħawwir u ulċeri).
English: In some patients, temporary dose reduction may be necessary.
Maltese: F'xi pazjenti, jista' jkun neċessarju tnaqqis temporanju fid-doża.
English: The mechanism is most likely inhibition of intestinal disaccharidases such as sucrase-isomaltase in the gastrointestinal tract leading to reduced absorption of dietary disaccharides.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Oral use
Maltese: Użu orali
English: If you stop taking Yargesa
Maltese: Mediċini oħra u Yargesa
English: Male patients should maintain reliable contraceptive methods while taking Yargesa (see sections 4.4 and 5.3).
Maltese: Pazjenti rġiel għandhom jibqgħu jużaw metodu affidabbli ta' kontraċezzjoni waqt it-teħid ta' Yargesa (ara sezzjonijiet 4.4 u
English: Bottle (HDPE) with measuring syringe (LDPE)
Maltese: flixkun talpolyethylene ta' densità għolja + b'siringa waħda talkejl.
English: Target species
Maltese: Kunjett wieħed
English: Pack size
Maltese: 4 kunjetti
English: 1 ml (180 µg/ml) 1 vial
Maltese: Il-pakkett li jmiss malprodott kunjett wieħed
English: Route of Administration
Maltese: Soluzzjoni għallinjezzjoni
English: 1 ml (180 µg/ml) 4 vials
Maltese: 90 µg
English: • Irritation
Maltese: • Irritazzjoni
English: - The active substance is bimatoprost.
Maltese: - Is-sustanza attiva hi Bimatoprost.
English: System Organ class
Maltese: Sistema tal-Klassifika talOrgani