FrancophonIA/ELRC3.0 huggingface dataset:
English: Aseptically transfer this volume (mL)c of reconstituted Caspofungin Accord to an IV bag
Maltese: Ittrasferixxi b'mod asettiku dan il-volum (mL)c ta' Caspofungin Accord rikostitwit għal borża (jew flixkun)
English: c. Caspofungin Accord is formulated to provide the full labelled vial dose (70 mg) when 10 mL is withdrawn from the vial.
Maltese: ċ Caspofungin Accord huwa fformulat sabiex jipprovdi d-doża ttikkettata kollha tal-kunjett (70 mg) meta jinġibdu 10 ml mill-kunjett.
English: In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Maltese: B'mod ġenerali, itterapija antifungali għandha tissokta għal mill-anqas 14-il jum wara l-aħħar kultura pożittiva.
English: 2 years
Maltese: 2 sentejn
English: Caspofungin was negative in in vitro assays for potential genotoxicity as well as in the in vivo mouse bone marrow chromosomal test. No long-term studies in animals have been performed to evaluate the carcinogenic potential.
Maltese: Ġiet innotata wkoll żieda fl-inċidenza tal-kustilji ċervikali. Caspofungin kien negattiv f'assaġġi in vitro għallġenotossiċità potenzjali kif ukoll fit-test kromosomali in vivo fuq il-mudullun tal-ġurdien.
English: Caspofungin Accord can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride solution for infusion or Lactated Ringers solution for infusion, not to exceed a final concentration of 0.5 mg/mL.
Maltese: Caspofungin Accord rikostitwit jista' jiġi miżjud ma' volum imnaqqas ta' 0.9 %, 0.45 %, jew 0.225 % soluzzjoni għal infużjoni ta' Klorur tas-Sodju jew soluzzjoni għal infużjoni Lactated ta' Ringers, li m'għandhiex taqbeż konċentrazzjoni finali ta' 0.5 mg/ml.
English: Repeated dose toxicity studies in rats and monkeys using doses up to 7-8 mg/kg given intravenously showed injection site reactions in rats and monkeys, signs of histamine release in rats, and evidence of adverse effects directed at the liver in monkeys.
Maltese: Studji dwar l-effett tossiku minn dożi ripetuti fil-firien u x-xadini bl-użu ta' dożi sa 7-8 mg/kg mogħtija ġol-vini wrew reazzjonijiet fis-sit tal-injezzjoni fil-firien u x-xadini, sinjali ta' rilaxx talistamina fil-firien, u evidenza ta' effetti avversi diretti fil-fwied tax-xadini.
English: When caspofungin is co-administered to paediatric patients (12 months to 17 years of age) with these same inducers of metabolic enzymes (see section 4.5), a caspofungin dose of 70-mg/m2 daily (not to exceed an actual daily dose of 70 mg)
Maltese: Meta caspofungin jingħata lil pazjenti pedjatriċi (12-il xahar sa 17-il sena) fl-istess ħin ma' dawn l-istess indutturi ta' enzimi metaboliċi (ara sezzjoni 4.5), għandha tiġi kkunsidrata doża ta' caspofungin ta' 70-mg/m2 kuljum (li m'għandhiex taqbeż doża attwali ta' 70 mg kuljum).
English: Each vial of Caspofungin Accord contains 50 mg or 70 mg of caspofungin (as acetate).
Maltese: Kull kunjett ta' Caspofungin Accord fih 50 mg jew 70 mg ta' caspofungin (bħala acetate).
English: c. Caspofungin Accord is formulated to provide the full labeled vial dose (50 mg) when 10 mL is withdrawn from the vial.
Maltese: ċ Caspofungin Accord huwa fformulat sabiex jipprovdi d-doża ttikkettjata kollha tal-kunjett (50 mg) meta jinġibdu 10 ml mill-kunjett.
English: Aseptically transfer this volume (mL)c of reconstituted Caspofungin
Maltese: Ittrasferixxi b'mod asettiku dan il-volum (mL)c ta' Caspofungin Accord rikostitwit għal borża
English: In children (ages 2 to 11 years) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr after multiple doses was comparable to that seen in adults receiving caspofungin at 50 mg/day.
Maltese: 70 mg kuljum), l-AUC0-24hr ta' caspofungin fil-plażma wara dożi multipli kienet komparabbli ma' dik li dehret f'persuni adulti li rċevew caspofungin f'doża ta' 50 mg/kuljum.
English: Preparation of the 50 mg/m2 infusion for paediatric patients > 3 months of age (using a 70-mg vial)
Maltese: Preparazzjoni tal-infużjoni ta' 50 mg/m2 għal pazjenti pedjatriċi minn 3 xhur 'il fuq (billi jintuża kunjett ta' 70 mg)
English: Preparation of the 70 mg/m2 infusion for paediatric patients >3 months of age (using a 50-mg vial)
Maltese: Preparazzjoni tal-infużjoni ta' 70 mg/m2 għal pazjenti pedjatriċi minn 3 xhur 'il fuq (billi jintuża kunjett ta' 50 mg)
English: Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial.
Maltese: Neħħi mill-kunjett il-volum ta' prodott mediċinali ugwali għal-loading dose kkalkulata (Pass 1).
English: After signs and symptoms of invasive candidiasis have improved and cultures have become negative, a switch to oral antifungal therapy may be considered.
Maltese: Wara li s-sinjali u s-sintomi ta' kandidjasi invażiva jitjiebu u l-kulturi jkunu saru negattivi, tista' tiġi kkunsidrata bidla għal terapija antifungali orali.
English: DO NOT MIX OR CO-INFUSE CASPOFUNGIN ACCORD WITH ANY OTHER MEDICINES, as there are no data available on the compatibility of Caspofungin Accord with other intravenous substances, additives, or medicinal products.
Maltese: Caspofungin Accord M'GĦANDUX JIĠI MĦALLAT JEW INFUŻ MA' MEDIĊINI OĦRA, billi ma hemmx informazzjoni disponibbli dwar il-kompatibilità ta' Caspofungin Accordma' sustanzi, addittivi, jew prodotti mediċinali oħra għal ġol-vini.
English: • by slow injection into a vein (intravenous infusion)
Maltese: • permezz ta' injezzjoni bil-mod fil-vina (infużjoni fil-vina)
English: Preparation of the 50 mg/m2 infusion for paediatric patients >3 months of age (using a 50-mg vial)
Maltese: Preparazzjoni tal-infużjoni ta' 50 mg/m2 għal pazjenti pedjatriċi minn 3 xhur 'il fuq (billi jintuża kunjett ta' 50 mg)
English: Vascular disorders phlebitis thrombophlebitis, flushing, hot flush, hypertension, hypotension
Maltese: Disturbi vaskulari flebite tromboflebite, fwawar, fwawar tassħana, pressjoni għolja, pressjoni baxxa
English: Preparation of the 70 mg/m2 infusion for paediatric patients > 3 months of age (using a 70-mg vial)
Maltese: Preparazzjoni tal-infużjoni ta' 70 mg/m2 għal pazjenti pedjatriċi minn 3 xhur 'il fuq (billi jintuża kunjett ta' 70 mg)
English: In the studies involving patients with documented Candida infections, the majority of the patients with invasive Candida infections had serious underlying medical conditions (e.g., haematologic or other malignancy, recent major surgery, HIV) requiring multiple concomitant medications.
Maltese: Fl-istudji li kienu jinvolvu pazjenti b'infezzjonijiet Candida dokumentati, ilmaġġoranza tal-pazjenti b'infezzjonijiet Candida invażivi kellhom kundizzjonijiet mediċi sottostanti (eż. tumuri tad-demm jew oħrajn, operazzjoni maġġuri riċenti, HIV) li kienu jeħtieġu diversi medikazzjonijiet konkomitanti.
English: On Day 1, C1 hr was comparable and C24 hr modestly elevated (36 %) in these neonates and infants relative to adults.
Maltese: F'Jum 1, il-C1 hr kienet komparabbli u l-C24 hr daqsxejn għolja (36 %) f'dawn it-trabi għadhom jitwieldu u ttrabi żgħar meta mqabbel mal-adulti.
English: NAME OF THE MEDICINAL PRODUCT Caspofungin Accord 50 mg powder for concentrate for solution for infusion caspofungin
Maltese: U KWANTITATTIVA Caspofungin Accord 50 mg trab għal konċentrat għal soluzzjoni għal infużjoni
English: Read the package leaflet before use.
Maltese: Jiġi f'pakketti ta' kunjett wieħed.
English: Caspofungin Accord 70 mg powder for concentrate for solution for infusion Each vial contains 70 mg caspofungin (as acetate).
Maltese: Caspofungin Accord 70 mg trab għal konċentrat għal soluzzjoni għal infużjoni Kull kunjett fih 70 mg caspofungin (bħala aċetat).
English: Gastrointestinal disorders nausea, diarrhoea, vomiting abdominal pain, abdominal pain upper, dry mouth, dyspepsia, stomach discomfort, abdominal distension, ascites, constipation, dysphagia, flatulence
Maltese: Disturbi gastrointestinali dardir, dijarea, rimettar uġigħ addominali, uġigħ addominali fil-parti ta' fuq, ħalq xott, dispepsja, skumdità fl-istonku, distensjoni addominali, axxite, stitikezza, disfaġja, gass
English: INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (Caspofungin Accord 50 mg)
Maltese: STRUZZJONIJIET GĦALL-UŻU F'PAZJENTI PEDJATRIĊI (Caspofungin Accord 50 mg)
English: Psychiatric anxiety, disorientation, insomnia disorders
Maltese: Disturbi psikjatriċi ansjetà, diżorjentament, diffikultà flirqad
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Distribution plays the prominent role in caspofungin plasma pharmacokinetics and is the rate-controlling step in both the alpha- and beta-disposition phases.
Maltese: Iddistribuzzjoni tilgħab rwol prominenti fil-farmakokinetiċi ta' caspofungin fil-plażma u hija l-pass li jikkontrolla r-rata fil-fażijiet ta' dispożizzjoni kemm alpha kif ukoll beta.
English: Alternatively, the volume (mL)c of reconstituted
Maltese: Inkella, il-volum (ml)c ta'
English: • Loss of kidney function, sudden loss of kidney function
Maltese: • Telf tal-funzjoni tal-kliewi, telf f'daqqa tal-funzjoni tal-kliewi
English: A reduction of the daily dose to 35 mg is recommended for adults with moderate hepatic impairment.
Maltese: Huwa rakkomandat tnaqqis fid-doża ta' kuljum għal 35 mg għall-adulti li jkollhom indeboliment moderat tal-fwied.
English: Instructions of how to reconstitute and dilute Caspofungin Accord:
Maltese: Inti se tingħata Caspofungin Accord:
English: bag (or bottle) containing 250 mL of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride solution for infusion or Lactated Ringers solution for infusion.
Maltese: IV li fiha 250 mL ta' 0.9%, 0.45 %, jew 0.225 % soluzzjoni għal infużjoni ta' Klorur tas-Sodju, jew soluzzjoni għal infużjoni Lactated ta' Ringers.
English: Also reported in patients with invasive aspergillosis were pulmonary oedema, adult respiratory distress syndrome (ARDS), and radiographic infiltrates.
Maltese: Edima fil-pulmun, sindrome ta' distress respiratorju fl-adulti (ARDS), u infiltrati radjografiċi wkoll kienu rrappurtati f'pazjenti b'asperġillożi invażiva.
English: (or bottle) containing 250 mL of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride solution for infusion or Lactated Ringers solution for infusion.
Maltese: (jew flixkun) IV li fiha 250 mL ta' 0.9%, 0.45 %, jew 0.225 % soluzzjoni għal infuzjoni ta' Klorur tas-Sodju, jew soluzzjoni għal infużjoni Lactated ta' Ringers.
English: Patients were to be treated until up to 72 hours after resolution of neutropaenia, with a maximum duration of 28 days.
Maltese: Il-pazjenti kellhom jiġu kkurati sa 72 siegħa wara li titlaq in-newtropenija, b'dewmien massimu ta' 28 ġurnata.
English: In a retrospective study of 40 patients treated during marketed use with caspofungin and cyclosporin for 1 to 290 days (median 17.5 days), no serious hepatic adverse reactions were noted.
Maltese: Fi studju retrospettiv ta' 40 pazjent ittrattati waqt l-użu kummerċjalizzat b'caspofungin u cyclosporin għal 1 sa 290 ġurnata (medjan 17.5 ġurnata), ma ġew innotati l-ebda reazzjonijiet avversi serji fil-fwied.
English: Caspofungin Accord 50 mg powder for concentrate caspofungin
Maltese: Kull kunjett fih 50 mg caspofungin (bħala aċetat).
English: Blood and lymphatic system disorders eosinophil count increased
Maltese: Disturbi tad-demm u tas-sistema limfatika żieda fl-għadd ta' eosinofili
English: 50 mg at reduced volume
Maltese: 50 mg f'volum imnaqqas
English: Caspofungin Accord 70 mg powder for concentrate caspofungin
Maltese: STRUZZJONIJIET GĦALL-UŻU F'PAZJENTI PEDJATRIĊI (Caspofungin Accord 70 mg)
English: The mean duration of intravenous therapy was 11.9 days, with a range of 1 to 28 days.
Maltese: It-tul medju tatterapija fil-vini kien ta' 11.9 ġranet, b'medda ta' 1 sa 28 ġurnata.
English: No dosage adjustment is necessary based on renal impairment (see section 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża minħabba indeboliment tal-kliewi (ara sezzjoni 5.2).
English: Hepatic impairment
Maltese: Twissijiet u prekawzjonijiet
English: Oxervate contains the active substance cenegermin.
Maltese: Oxervate fih is-sustanza attiva cenegermin.
English: The full EPAR for Oxervate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Oxervate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Oxervate jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In the second study, figures were 70% (16 out of 23) with Oxervate and 29% (7 out of 24) with the dummy treatment.
Maltese: Fit-tieni studju, il-figuri kienu ta' 70 % (16 minn 23) b'Oxervate u 29 % (7 minn 24) bil-kura finta.
English: This is a summary of the European public assessment report (EPAR) for Oxervate.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Oxervate.
English: In the first study, 74% (37 out of 50) of patients treated with Oxervate for 8 weeks achieved complete healing of the eye's surface compared with 43% (22 out of 51) of patients treated with a dummy treatment containing the same eye drop formula but no active substance.
Maltese: Fl-ewwel studju, 74 % (37 minn 50) tal-pazjenti kkurati b'Oxervate għal 8 ġimgħat kisbu fejqan sħiħ tal-wiċċ tal-għajn meta mqabbel ma' 43 % (22 minn 51) tal-pazjenti kkurati b'kura finta li fiha l-istess formula ta' qtar tal-għajnejn iżda lebda sustanza attiva.
English: Why is Oxervate approved?
Maltese: Għaliex ġie approvat Oxervate?
English: Because the number of patients with neurotrophic keratitis is low, the disease is considered ‘rare', and Oxervate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 December
Maltese: Peress li n-numru ta' pazjenti li jbatu minn kerarite newrotrofika huwa baxx, il-marda hija kkunsidrata ‘rari', u Oxervate ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fl14 ta' Diċembru 2015.
English: What are the risks associated with Oxervate?
Maltese: X'inhuma r-riskji assoċjati ma' Oxervate?
English: The most common side effects with Oxervate (which may affect more than 1 in 100 people) are eye pain and inflammation, increased lacrimation (watery eyes), pain in the eyelid and sensation of a foreign body in the eye.
Maltese: L-effetti sekondarji l-aktar komuni b'Oxervate (li jistgħu jaffettwaw aktar minn 1 minn kull 100) huma uġigħ u infjammazzjoni fl-għajnejn, lakrimazzjoni miżjuda (għajnejn imdemmgħin), uġigħ fil-kappell tal-għajn u sensazzjoni ta' korp barrani fl-għajn.
English: Other information about Oxervate
Maltese: Informazzjoni oħra dwar Oxervate
English: Oxervate has been shown to increase by around 30-40% the number of patients who achieve complete healing of the eye's surface when compared with eye drops containing no active substance.
Maltese: Oxervate ntwera li jżid b'madwar 30-40 % in-numru ta' pazjenti li jiksbu fejqan sħiħ tal-wiċċ tal-għajn meta mqabbel ma' qtar tal-għajnejn li ma fihom l-ebda sustanza attiva.
English: The recommended dose is 1 drop in the affected eye every 2 hours, 6 times per day.
Maltese: Id-doża rakkomandata hija qatra 1 fl-għajn affettwata kull sagħtejn, 6 darbiet kuljum.
English: Oxervate is a medicine used to treat neurotrophic keratitis, an eye condition in which damage to the trigeminal nerve supplying the surface of the eye causes loss of sensation and defects that do not heal naturally.
Maltese: Oxervate hija mediċina li tintuża beix tikkura kerarite newrotrofika, kondizzjoni tal-għajnejn li fiha ħsara fin-nerv triġeminali li jforni l-wiċċ tal-għajn tikkawża telf ta' sensazjoni u difetti li ma jfiqux b'mod naturali.
English: Oxervate has been shown to help heal damage to the eye's surface in 2 main studies involving a total of 204 adults with moderate or severe neurotrophic keratitis.
Maltese: F'2 studji ewlwenin li involvew total ta' 204 adult b'kerarite newrotrofika moderata jew severa, Oxervate intwera li jgħin biex ifejjaq il-ħsara lill-wiċċ tal-għajn.
English: Patients with neurotrophic keratitis have lower than normal levels of substances including growth factors that are normally supplied by the trigeminal nerve and which play an important role in the growth and survival of the cells of the eye's surface.
Maltese: Il-pazjenti b'kerarite newtrotrofika għandhom livelli aktar baxxi min-normal ta' sustanzi inkluż fatturi ta' tkabbir li normalment jiġu fornuti min-nerv triġeminali u li għandhom rwol importanti fit-tkabbir u fis-sopravivenza taċ-ċelluli tal-wiċċ tal-għajn.
English: The medicine is only used in adults with moderate or severe disease.
Maltese: Il-mediċina tintuża biss fl-adulti b'marda moderata jew severa.
English: How does Oxervate work?
Maltese: Kif jintuża Oxervate ?
English: For the full list of all side effects and restrictions with Oxervate, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b᾿ Oxervate, ara l-fuljett ta' tagħrif.
English: How is Oxervate used?
Maltese: Kif jaħdem Oxervate?
English: Side effects with Oxervate are mainly related to the eye, are mild or moderate in severity and resolve over time.
Maltese: L-effetti sekondarji b'Oxervate huma prinċipalment relatati mal-għajn, huma ħfief jew moderati fis-severità u jmorru maż-żmien.
English: The active substance in Oxervate, cenegermin, is a copy of a human growth factor called nerve growth factor.
Maltese: Is-sustanza attiva f'Oxervate, cenegermin, hija kopja ta' fattur ta' tkabbir tal-bniedem li jissejjaħ fattur ta' tkabbir tan-nerv.
English: Placebo (N =797)
Maltese: Plaċebo (N =797)
English: LS: Least Square CSBM: Complete Spontaneous Bowel Movement
Maltese: Least Square CSBM: Complete Spontaneous Bowel Movement - Ippurgar spontanju komplet
English: For age related information, please see sections 4.2., 4.4., and 4.8.
Maltese: Għal informazzjoni relatata mal-età, jekk jogħġbok ara s-sezzjonijiet 4.2., 4.4., u 4.8.
English: INFORMATION IN BRAILLE constella 290 mcg
Maltese: INFORMAZZJONI BIL-BRAILLE constella 290 mcg
English: Straining (5-point ordinal scale) *p<0.0001, linaclotide vs placebo.
Maltese: 5 punti) *p<0.0001, linaclotide vs placebo.
English: Microcrystalline cellulose Hypromellose 4-6 mPa's - substitution type 2910 Calcium chloride dihydrate Leucine
Maltese: Microcrystalline cellulose Hypromellose 4-6 mPa's -sostituzzjoni tip 2910 Calcium chloride dihydrate Leucine
English: Abdominal pain/discomfort responder
Maltese: Abdominal pain/discomfort Re sponder
English: Unopened bottle for 10 capsules: 2 years.
Maltese: Flixkun mhux miftuħ għal 10 kapsuli: 2 snin.
English: Gastroenteritis viral
Maltese: Gastroenterite virali
English: Linaclotide is a 14-amino acid synthetic peptide structurally related to the endogenous guanylin peptide family.
Maltese: Linaclotide huwa peptide sintetiku ta' 14-amino acid strutturalment relatat mal-familja endoġena tal-peptide guanylin.
English: Capsule content: microcrystalline cellulose, hypromellose, calcium chloride dihydrate and leucine.
Maltese: Kontenut tal-kapsula: microcrystalline cellulose, hypromellose, calcium chloride dihydrate u leucine.
English: The potential inhibitory activity of linaclotide and its active primary metabolite MM-419447 on the human efflux transporters BCRP, MRP2, MRP3, and MRP4 and the human uptake transporters OATP1B1, OATP1B3, OATP2B1, PEPT1 and OCTN1 was investigated in vitro.
Maltese: L-attività inibitorja potenzjali ta' linaclotide u tal-metabolit attiv primarju tiegħu MM-419447 fuq it-trasportaturi tal-effluss uman BCRP, MRP2, MRP3, u MRP4 u t-trasportaturi tat-teħid uman OATP1B1, OATP1B3, OATP2B1, PEPT1 u OCTN1 ġiet investigata in vitro.
English: Tabulated list of adverse reactions
Maltese: Tabella elenkata ta' reazzjonijiet avversi
English: Age and gender
Maltese: Età u Sess tal-Persuna
English: • stomach flu (viral gastroenteritis)
Maltese: • Influwenza fl-istonku (gastroenterite virali)
English: White to off-white-orange opaque capsule (18 mm x 6.35 mm) marked “290” with grey ink.
Maltese: Kapsula opaka bajda għal offwajt-oranġjo (18 mm x 6.35 mm) immarkata “290” b'linka griża.
English: Capsule shell: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatin.
Maltese: Qoxra tal-kapsula: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) u gelatin.
English: Printing ink: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, titanium dioxide (E171) and black iron oxide (E172).
Maltese: Linka tal-istampar: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, titanium dioxide (E171) u black iron oxide (E172).
English: The following adverse reactions were reported in controlled clinical studies at the recommended dose of 290 micrograms per day with frequencies corresponding to: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to < 1/1,000) and very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrappurtati fi studji kliniċi kkontrollati bid-doża rakkomandata ta' 290 mikrogramma kuljum bi frekwenzi li jikkorrispondu għal: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000) u rari ħafna (≤1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: How to take Constella
Maltese: Tiħux Constella
English: The effect of linaclotide and its metabolites to inhibit the common intestinal enzymes (CYP2C9 and CYP3A4) and liver enzymes (CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4) or to induce liver enzymes (CYP1A2, 2B6, and 3A4/5) was investigated in vitro.
Maltese: L-effett ta' linaclotide u tal-metaboliti tiegħu biex jinibixxi l-enzimi intestinali komuni (CYP2C9 u CYP3A4) u l-enzimi tal-fwied (CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 u 3A4) jew biex jinduċi l-enzimi tal-fwied (CYP1A2, 2B6, u 3A4/5) ġie investigat in vitro.
English: Constella contains the active substance linaclotide.
Maltese: Constella fih is-sustanza attiva linaclotide.
English: MedDRA system organ class
Maltese: Sistema tal-klassifika tal-organi fid-database MedDRA
English: The capsule should be taken at least 30 minutes before a meal.
Maltese: Il-kapsula għandha tittieħed mill-anqas 30 minuta qabel ikla.
English: CSBM/week
Maltese: CSBM/ġimgħa
English: Stool consistency (BSFS Score)
Maltese: Konsistenza tal-ippurgar (Punteġġ BSFS)
English: The majority of reported cases of diarrhoea were mild (43%) to moderate (47%); 2% of treated patients experienced severe diarrhoea.
Maltese: Il-maġġoranza tal-każijiet irrappurtati ta' dijarea kienu ħfief (43%) sa moderati (47%); 2% tal-pazjenti kkurati kellhom dijarea severa.
English: Red iron oxide (E172) Yellow iron oxide (E172)
Maltese: Red iron oxide (E172)
English: EU/1/12/801/005 Multipack: 112 (4 packs of28) capsules
Maltese: EU/1/12/801/005 Pakkett multiplu: 112-il (4 pakketti ta' 28) kapsula
English: Following single doses of up to 966 micrograms and multiple doses up to 290 micrograms of linaclotide, there were no detectable plasma levels of parent compound or the active metabolite (des-tyrosine).
Maltese: Wara dożi singoli sa 966 mikrogramma u dożi multipli sa 290 mikrogramma ta' linaclotide, ma kienx hemm livelli identifikabbli tal-kompost prinċipali jew tal-metabolit attiv fil-plażma (des-tyrosine).
English: • lack of control over passing stools (faecal incontinence)
Maltese: • nuqqas ta' kontroll fuq l-ippurgar (inkontinenza tal-ippurgar)
English: • feeling bloated,
Maltese: • sensazzjoni ta' nefħa,