FrancophonIA/ELRC3.0 huggingface dataset:
English: The characteristics of the patient population included in Phase 3 clinical trials were as follows: mean age of 43.9 years [range 18 - 87 years with 5.3% ≥ 65 years of age], 90.1% female.
Maltese: Il-karatteristiċi tal-popolazzjoni tal-pazjenti inklużi fil-provi kliniċi ta' Fażi 3 kienu kif ġej: età medja ta' 43.9 sena [medda 18-87 sena b'5.3% li kellhom ≥65 sena], 90.1% nisa.
English: The capsule should be taken at least 30 minutes before a meal (see section 4.5).
Maltese: Il-kapsula għandha preferibbilment tittieħed mill-anqas 30 minuta qabel ikla (ara sezzjoni 4.5).
English: The efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception (see the prescribing information of the oral contraceptive).
Maltese: L-effikaċja ta' kontraċettivi orali tista' titnaqqas u l-użu ta' metodu kontraċettiv addizzjonali huwa rrakkomandat sabiex jiġi impedut in-nuqqas ta' suċċess ta' kontraċezzjoni orali (ara l-informazzjoni tal-preskrizzjoni tal-kontraċettiv orali).
English: Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
Maltese: Constella hu indikat għall-kura sintomatika ta' sindrome tal-imsaren irritabbli moderat sa sever bi stitikezza (IBS-C) fl-adulti.
English: Linaclotide has been given orally to 1,166 patients with IBS-C in controlled clinical studies.
Maltese: Linaclotide ġie mogħti b'mod orali lil 1,166 pazjent b'IBS-C fi studji kliniċi kkontrollati.
English: Date of first authorisation: 26 November 2012 Date of latest renewal: 28 August 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26 Novembru 2012
English: In one clinical study (study 1), 804 patients were treated with Constella 290 micrograms or placebo once daily for 26 weeks.
Maltese: Fi studju kliniku minnhom (studju 1), 802 pazjenti ngħataw Constella 290 mikrogramma jew plaċebo darba kuljum għal 26 ġimgħa.
English: 28 capsules.
Maltese: U KONTENUT Kapsula iebsa. 28 kapsula.
English: EU/1/12/801/001 10 capsules EU/1/12/801/002 28 capsules EU/1/12/801/004 90 capsules
Maltese: EU/1/12/801/001 10 kapsuli EU/1/12/801/002 28 kapsula EU/1/12/801/004 90 kapsula
English: Bloating (11-point NRS)
Maltese: Nefħa (NRS ta' 11-il punt) 6.5
English: Orthostatic hypotension
Maltese: Potassium hydroxide
English: Flatulence Abdominal distension
Maltese: Gass fl-istonku Distensjoni addominali
English: Pack sizes: 10, 28 or 90 capsules and multipacks containing 112 (4 packs of 28) capsules.
Maltese: Daqsijiet tal-pakkett: 10, 28 jew 90 kapsula, u pakketti multipli li fihom 112-il kapsula (4 pakketti ta' 28).
English: When 2,897 micrograms was administered on day 8, following a 7-day course of 290 micrograms/day, linaclotide was detectable in only 2 of 18 subjects at concentrations just above the lower limit of quantification of 0.2 ng/ml (concentrations ranged from 0.212 to 0.735 ng/ml).
Maltese: Meta ngħataw 2,897 mikrogramma f'jum 8, wara kors ta' 7 ijiem ta' 290 mikrogramma/kuljum, linaclotide instab fi 2 biss minn 18-il persuna f'konċentrazzjonijiet ftit ogħla mil-limitu ta' taħt tal-kwantifikazzjoni ta' 0.2 ng/ml (il-konċentrazzjonijiet kienu jvarjaw minn 0.212 sa 0.735 ng/ml).
English: Clinically meaningful response in overall IBS-QoL (> 14 points difference) was achieved in 54% of linaclotide treated patients vs. 39% in placebo treated patients.
Maltese: Inkiseb rispons klinikament sinifikanti fl-IBS-QoL globali (>14-il punt differenza) f'54% tal-pazjenti li ngħataw linaclotide vs.
English: Elderly (>65 years), hypertensive and diabetic patients reported diarrhoea more frequently as compared to the overall IBS-C population included in the clinical trials.
Maltese: Pazjenti anzjani (>65 sena), bi pressjoni għolja u dijabetiċi rrappurtaw dijarea b'mod iżjed frekwenti meta mqabbla mal-popolazzjoni IBS-C globali inkluża fil-provi kliniċi.
English: Following a single oral dose of 2,897 micrograms linaclotide on day 8, after a 7-day course of 290 micrograms/day in 18 healthy volunteers, approximately 3 to 5% of the dose was recovered in the faeces, virtually all of it as the des-tyrosine active metabolite.
Maltese: Wara doża orali waħda ta' 2,897 mikrogramma ta' linaclotide f'jum 8, wara kors ta' 7 ijiem ta' 290 mikrogramma/kuljum fi 18-il voluntier b'saħħithom, madwar 3 sa 5% tad-doża ġiet irkuprata fl-ippurgar, tista' tgħid kollha kemm hi fil-metabolit attiv des-tyrosine.
English: Treatment with linaclotide also resulted in significant improvements in validated and disease-specific Quality of Life measure (IBS-QoL; p<0.0001), and EuroQoL (p = 0.001).
Maltese: Il-kura b'linaclotide rriżultat ukoll f'titjib sinifikanti fil-kejl tal-Kwalità tal-Ħajja validat u speċifiku għall-marda (IBS-QoL; p<0.0001), u l-EuroQoL (p = 0.001).
English: Linaclotide is a Guanylate Cyclase-C receptor agonist (GCCA) with visceral analgesic and secretory activities.
Maltese: Linaclotide huwa agonist tat-tip tar-riċettur Guanylate Cyclase-C (GC-C) b'attivitajiet analġesiċi vixxerali u ta' tnixxija.
English: Linaclotide is metabolised locally within the gastrointestinal tract to its active primary metabolite, destyrosine.
Maltese: Linaclotide jiġi metabolizzat lokalment fil-passaġġ gastrointestinali għall-metabolit attiv primarju tiegħu, des-tyrosine.
English: During the 2-weeks pre-treatment baseline period, patients had a mean abdominal pain score of 5.6 (0-10 scale) with 2.2% of abdominal pain-free days, a mean bloating score of 6.6 (0-10 scale), and an average of 1.8 spontaneous bowel movements (SBM)/week.
Maltese: Matul il-perjodu fil-linja bażi ta' ġimagħtejn ta' qabel il-kura, il-pazjenti kellhom punteġġ medju ta' 5.6 (skala minn 0 sa 10) ta' uġigħ addominali bi 2.2% ta' ġranet mingħajr uġigħ addominali, punteġġ medju ta' 6.6 (skala minn 0 sa 10) għal nefħa, u medja ta' 1.8 ippurgar spontanju (SBM - spontaneous bowel movements)/ġimgħa.
English: Capsule ink
Maltese: Qoxra tal-kapsula
English: Both linaclotide and des-tyrosine active metabolite are reduced and enzymatically proteolyzed within the gastrointestinal tract to smaller peptides and naturally occurring amino acids.
Maltese: Kemm linaclotide kif ukoll il-metabolit attiv des-tyrosine jiġu mnaqqsa u proteolizzati b'mod enzimatiku fl-apparat gastrointestinali għal peptides iżgħar u amino acids li jinsabu b'mod naturali.
English: Capsule shell Titanium dioxide (E 171) Gelatin
Maltese: Titanium dioxide (E171)
English: Constella 290 micrograms hard capsules linaclotide
Maltese: Constella 290 mikrogramma kapsuli ibsin linaclotide
English: EU/1/12/801/001 10 capsules
Maltese: EU/1/12/801/001 10 kapsuli
English: Very common Common Uncommon
Maltese: Komuni ħafna
English: There are limited data in elderly patients (see section 5.1).
Maltese: Hemm dejta limitata dwar pazjenti anzjani (ara sezzjoni 5.1).
English: Linaclotide is rarely detectable in plasma following administration of the recommended clinical doses and in vitro studies have shown that linaclotide is neither a substrate nor an inhibitor/inducer of the cytochrome P450 enzyme system and does not interact with a series of common efflux and uptake transporters (see section 5.2).
Maltese: Ma twettaq l-ebda studju ta' interazzjoni. Linaclotide rari jinstab fil-plażma wara l-għoti tad-dożi kliniċi rakkomandati u studji in vitro wrew li linaclotide la huwa substrat u lanqas inibitur/induttur tas-sistema taċ-ċitokrom P450 u ma jinteraġġix ma' sensiela ta' trasportaturi komuni tal-effluss u tat-teħid (ara sezzjoni 5.2).
English: EU/1/12/801/004 90 capsules
Maltese: EU/1/12/801/004 90 kapsula
English: In a study in healthy volunteers receiving a single dose of 2,897 micrograms (up to 10-fold the recommended therapeutic dose) the safety profile in these subjects was consistent with that in the overall population, with diarrhoea being the most commonly reported adverse event.
Maltese: Fi studju fuq voluntiera b'saħħithom li rċevew doża waħda ta' 2,897 mikrogramma (sa għaxar darbiet id-doża terapewtika rakkomandata), il-profil tas-sigurtà f'dawn il-persuni kien konsistenti ma' dak fil-popolazzjoni ġenerali, bid-dijarea tkun l-aktar avveniment avvers irrappurtat b'mod komuni.
English: Marketing Authorisation Holder Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Allergan Pharmaceuticals International Limited Clonshaugh Business & Technology Park Dublin 17, D17 E400
English: In the two pivotal phase 3 studies in which patients were dosed with 290 micrograms of linaclotide once daily, linaclotide was only detected in 2 out of 162 patients approximately 2 h following the initial linaclotide dose (concentrations were 0.241 ng/ml to 0.239 ng/ml) and in none of the 162 patients after 4 weeks of treatment.
Maltese: Fiż-żewġ studji importanti ħafna ta' fażi 3 li fihom il-pazjenti ngħataw 290 mikrogramma ta' linaclotide darba kuljum, linaclotide instab biss fi 2 minn 162 pazjent madwar sagħtejn wara d-doża inizjali ta' linaclotide (il-konċentrazzjonijiet kienu 0.241 ng/ml sa 0.239 ng/ml) u fl-ebda wieħed mill-162 pazjent wara 4 ġimgħat ta' kura.
English: - Medicines that need careful and exact dosing, such as levothyroxine (a hormone to treat reduced function of the thyroid gland).
Maltese: - Mediċini li jeħtieġu attenzjoni u dożaġġ eżatt, bħal levothyroxine (ormon sabiex jikkura funzjoni mnaqqsa tal-glandola tat-tirojde).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/801/005 Multipack: 112 (4 packs of 28) capsules 13.
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/801/005 Pakkett multiplu: 112-il (4 pakketti ta' 28) kapsula 13.
English: EU/1/12/801/002 28 capsules
Maltese: EU/1/12/801/002 28 kapsula
English: What Constella contains - The active substance is linaclotide.
Maltese: - Is-sustanza attiva hi linaclotide.
English: Pharmacotherapeutic group: Drugs for constipation, other drugs for constipation, ATC Code: A06AX04
Maltese: Mediċini għall-istitikezza, mediċini oħrajn kontra l-istitikezza, Kodiċi ATC:
English: All patients met Rome II criteria for IBS-C and were required to report a mean abdominal pain score of ≥ 3 on a 0-to-10-point numeric rating scale (criteria that correspond to a moderate to severe IBS population), < 3 complete spontaneous bowel movements and ≤ 5 SBMs per week during a 2-week baseline period.
Maltese: Il-pazjenti kollha laħqu l-kriterji Rome II għall-IBS-C u kienu meħtieġa li jirrappurtaw punteġġ medju ta' ≥3 għall-uġigħ addominali fuq skala ta' gradazzjoni numerika minn 0 sa 10 (kriterji li jikkorrespondu għal popolazzjoni ta' IBS moderata għal severa), <3 ippurgar sħiħ u ≤5 SBMs fil-ġimgħa matul perjodu fil-linja bażi ta' ġimagħtejn.
English: For the 26 weeks data, study 1 shows that 37% and 54% of the patients treated with linaclotide compared with 17% and 36% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and abdominal pain/discomfort (p<0.0001) respectively.
Maltese: Għad-dejta ta' 26 ġimgħa, studju 1 wera li 37% u 54% tal-pazjenti li ngħataw linaclotide meta mqabbla ma' 17% u 36% tal-pazjenti li ngħataw il-plaċebo wrew rispons għall-grad ta' solliev mill-IBS (p<0.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON CONTAINING 4 x 28 CAPSULE BOTTLES (MULTIPACK) WITH BLUE BOX
Maltese: B'4 X 28 KAPSULA (PAKKETT MULTIPLU) BIL-KAXXA BLU
English: Constella is available in packs containing 10, 28 or 90 capsules and in multipacks of 112 capsules comprising 4 cartons, each containing 28 capsules.
Maltese: Constella hu disponibbli f'pakketti li fihom 10, 28 jew 90 kapsula u f'pakketti multipli ta' 112-il kapsula li jikkonsistu minn 4 kaxxi tal-kartun, li kull waħda jkun fiha 28 kapsula.
English: The efficacy of linaclotide has been established in double-blind placebo-controlled studies for up to 6 months.
Maltese: L-effikaċja ta' linaclotide ġiet stabbilita fi studji double-blind ikkontrollati bi plaċebo għal perjodi sa 6 xhur.
English: In general, linaclotide is minimally detectable in plasma following therapeutic oral doses and therefore standard pharmacokinetic parameters cannot be calculated.
Maltese: B'mod ġenerali, linaclotide jinstab b'mod minimu fil-plażma wara dożi terapewtiċi orali u għalhekk il-parametri farmakokinetiċi standard ma jistgħux jiġu kkalkulati.
English: IBS is a common gut disorder.
Maltese: L-IBS huwa disturb komuni tal-imsaren.
English: Each capsule contains 290 micrograms of linaclotide.
Maltese: Kull kapsula fiha 290 mikrogramma ta' linaclotide.
English: Intracellular cGMP causes secretion of chloride and bicarbonate into the intestinal lumen, through activation of the cystic fibrosis transmembrane conductance regulator (CFTR), which results in increased intestinal fluid and accelerated transit.
Maltese: Is-cGMP intraċellulari jikkawża t-tnixxija ta' chloride u ta' bicarbonate għal ġol-lumen intestinali, permezz tal-attivazzjoni regolatorja ta' konduttanza transmembranja ta'fibrozi ċistika (CFTR), li jwassal għal żieda fil-fluwidu intestinali u passaġġ aċċellerat.
English: • infrequent, hard, small or pellet-like stools (faeces).
Maltese: • ippurgar mhux frekwenti, iebes, żgħir jew qisu pritkuni (boċċi żgħar)
English: Study 2 shows that 37% of the patients treated with linaclotide compared with 19% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and 55% of the patients treated with linaclotide compared with 42% of the patients treated with placebo showed response to abdominal pain/discomfort (p=0.0002).
Maltese: 0001) u 55% tal-pazjenti li ngħataw linaclotide meta mqabbel ma' 42% tal-pazjenti li ngħataw il-plaċebo wrew rispons għall-uġigħ/skumdità addominali (p=0.0002).
English: Pregnancy and breast-feeding Limited information is available on the effects of Constella in pregnant and breast-feeding women.
Maltese: Tqala u treddigħ Hemm informazzjoni limitata dwar l-effetti ta' Constella f'nisa tqal u li qegħdin ireddgħu.
English: Multipack : 112 (4 packs of 28) capsules METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children OTHER SPECIAL WARNING(S), IF NECESSARY
Maltese: Pakkett multiplu: 112-il (4 pakketti ta' 28) kapsula MOD TA' KIF U MNEJN JINGĦATA Aqra l-fuljett ta' tagħrif qabel l-użu.
English: Tel: + 385 1 6646 563
Maltese: Ewopharma d.o.o. Tel: + 385 1 6646 563
English: 2% of treated patients experienced severe diarrhoea and 5% of patients discontinued treatment due to diarrhoea in clinical studies.
Maltese: Id-dijarea hija l-aktar reazzjoni avversa komuni u hija konsistenti mal-azzjoni farmakoloġika tas-sustanza attiva. 2% tal-pazjenti kkurati esperjenzaw dijarea severa u 5% tal-pazjenti waqqfu l-kura minħabba dijarea fi studji kliniċi.
English: Tel: + 48 22 256 37 00
Maltese: Allergan Sp. z o.o. Tel: + 48 22 256 37 00
English: How to store Constella
Maltese: X'fih Constella
English: The safety and efficacy of Constella in children aged 0 to18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Constella fit-tfal ta' bejn 0 u 18-il sena għadhom ma ġewx determinati s'issa.
English: Activation of GC-C results in an increase in concentrations of cyclic guanosine monophosphate (cGMP), both extracellularly and intracellularly.
Maltese: L-attivazzjoni t' GC-C twassal għal żieda fil-konċentrazzjonijiet ta' cyclic guanosine monophosphate (cGMP), kemm b'mod extraċellulari kif ukoll b'mod intraċellulari.
English: Of these patients, 892 patients received linaclotide at the recommended dose of 290 micrograms per day.
Maltese: Minn dawn il-pazjenti, 892 pazjent irċevew Linaclotide fid-doża rakkomandata ta' 290 mikrogramma kuljum.
English: Dizziness
Maltese: Tqala
English: Special populations Patients with renal or hepatic impairment
Maltese: Popolazzjonijiet speċjali Pazjenti b'indeboliment renali jew epatiku
English: An IBS degree of relief responder was a patient that was considerably or completely relieved for at least 50% of the treatment period; an abdominal pain/discomfort responder was a patient that had an improvement of 30% or more for at least 50% of the treatment period.
Maltese: Il-grad ta' solliev għall-IBS ta' persuna li rrispondiet kien pazjent li kellu solliev konsiderevoli jew komplet tas-sintomi għal mill-anqas 50% tal-perjodu tal-kura; persuna li rrispondiet għall-uġigħ/skumdità addominali kienet pazjent li kellu titjib ta' 30% jew aktar għal mill-anqas 50% tal-perjodu tal-kura.
English: • feeling bloated
Maltese: • Sensazzjoni ta' nefħa
English: Total exposure in the clinical development plan exceeded 1,500 patient-years.
Maltese: L-esponiment totali fil-pjan ta' żvilupp kliniku kien jaqbeż l-1,500 sena tal-pazjent.
English: Results of these studies showed that linaclotide and des-tyrosine metabolite are not inhibitors or inducers of the cytochrome P450 enzyme system.
Maltese: Ir-riżultati ta' dawn l-istudji wrew li linaclotide u l-metabolit destyrosine mhumiex inibituri jew indutturi tas-sistema tal-enzimi taċ-ċitokrom P450.
English: It is expected that linaclotide is negligibly or not systemically distributed.
Maltese: Huwa mistenni li linaclotide jiġi distribwit b'mod negliġibbli jew b'mod mhux sistematiku.
English: • feeling dizzy
Maltese: Pazjenti anzjani
English: For the 12 weeks data, study 1 shows that 39% of the patients treated with linaclotide compared with 17% of the patients treated with placebo showed response to IBS degree of relief (p<0.0001) and 54% of the patients treated with linaclotide compared with 39% of the patients treated with placebo showed response to abdominal pain/discomfort (p<0.0001).
Maltese: 0001) u 54% tal-pazjenti li ngħataw linaclotide meta mqabbel ma' 39% tal-pazjenti li ngħataw il-plaċebo wrew rispons għall-uġigħ/skumdità addominali (p<0.0001).
English: The efficacy of linaclotide was established in two randomised, double-blind, placebo-controlled Phase 3 clinical studies in patients with IBS-C.
Maltese: L-effikaċja ta' linaclotide ġiet stabbilita f'żewġ studji kliniċi li fihom il-pazjenti ntgħażlu b'mod każwali, double-blind, ikkontrollati bil-plaċebo, ta' Fażi 3 f'pazjenti b'IBS-C.
English: GENERAL CLASSIFICATION FOR SUPPLY 15.
Maltese: TA' KIF JINGĦATA 15.
English: In rare and more severe cases, this may - as a consequence - lead to the occurrence of dehydration, hypokalaemia, blood bicarbonate decrease, dizziness, and orthostatic hypotension.
Maltese: F'każijiet rari u aktar severi, dan jista' - bħala konsegwenza - jwassal għal okkorrenza ta' deidratazzjoni, ipokalemija, tnaqqis tal-bikarbonati fid-demm, sturdament u pressjoni ortostatika baxxa.
English: Faecal incontinence Defecation urgency Lower gastrointestinal haemorrhage including haemorrhoidal haemorrhage and rectal haemorrhage Nausea
Maltese: Inkontinenza tal-ippurgar Ħtieġa urġenti biex tmur tipporga
English: Side effects with frequency not known (frequency cannot be estimated from the available data):
Maltese: Effetti sekondarji bi frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli):
English: The most frequently reported adverse reaction associated with Constella therapy was diarrhoea, mainly mild to moderate in intensity, occurring in less than 20% of patients.
Maltese: L-aktar reazzjoni avversa assoċjata mat-terapija b'Constella li ġiet irrappurtata b'mod frekwenti kienet dijarea, prinċipalment ħafifa għal moderata, li seħħet f'inqas minn 20% tal-pazjenti.
English: The main symptoms of IBS with constipation include:
Maltese: Is-sintomi prinċipali tal-IBS bi stitikezza jinkludu:
English: Constella should be used after organic diseases have been ruled out and a diagnosis of moderate to severe IBS-C (see section 5.1) is established.
Maltese: M'hemmx bżonn ta' aġġustamenti fid-doża għal pazjenti b'indeboliment tal-fwied jew tal-kliewi (ara sezzjoni 5.2).
English: Each capsule contains 290 micrograms of linaclotide
Maltese: Kull kapsula fiha 290 mikrogramma ta' linaclotide LISTA
English: It is used to treat the symptoms of moderate to severe irritable bowel syndrome (often just called “IBS”) with constipation in adult patients.
Maltese: Jintuża biex jikkura s-sintomi tas-sindrome tal-imsaren irritabbli (ħafna drabi msejjaħ biss “IBS”) moderat għal sever bi stitikezza f'pazjenti adulti.
English: Change from baseline Mean
Maltese: Differenz a medja LS
English: Hypersensitivity to linaclotide or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal linaclotide jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: MANIFATTUR(I) RESPONSABBLI
English: Constella acts locally in your gut, helping you to feel less pain and less bloated, and to restore the normal functioning of your bowels.
Maltese: Constella jaġixxi lokalment fl-imsaren tiegħek u jgħinek tħoss inqas uġigħ u inqas nefħa, u biex treġġa' lura l-funzjonament normali tal-imsaren tiegħek.
English: 10 capsules 28 capsules 90 capsules METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children OTHER SPECIAL WARNING(S), IF NECESSARY
Maltese: U KONTENUT Kapsula iebsa. 10 kapsuli 28 kapsula 90 kapsula MOD TA' KIF U MNEJN JINGĦATA Aqra l-fuljett ta' tagħrif qabel l-użu.
English: NAME OF THE MEDICINAL PRODUCT Constella 290 micrograms hard capsules linaclotide
Maltese: IL-PRODOTT MEDIĊINALI Constella 290 mikrogramma kapsuli iebsin.
English: A risk to the newborns/infants cannot be excluded.
Maltese: Ir-riskju gћat-trabi tattwelid mhux eskluż.
English: Other signs and symptoms of IBS-C including bloating, complete spontaneous bowel movement (CSBM) frequency, straining, stool consistency, were improved in linaclotide treated patients vs. placebo (p<0.0001) as shown in the following table.
Maltese: Sinjali u sintomi oħra ta' IBS-C fosthom nefħa, il-frekwenza ta' ippurgar sħiħ (CSBM), it-tqanżiħ, il-konsistenza tal-ippurgar, marru għall-aħjar fil-pazjenti li ngħataw linaclotide vs. il-plaċebo (p<0.
English: Additional caution should be exercised in patients who are prone to a disturbance of water or electrolyte balance (e.g. elderly, patients with cardiovascular (CV) diseases, diabetes, hypertension), and electrolyte control should be considered.
Maltese: Għandha ssir attenzjoni addizzjonali f'pazjenti li huma suxxettibbli għal disturb fil-bilanċ tal-ilma u l-elettroliti (eż. l-anzjani, pazjenti b'mard kardjovaskulari (CV - cardiovascular), dijabete, pressjoni għolja), u għandu jiġi kkunsidrat il-kontroll tal-elettroliti.
English: Lactation
Maltese: Dijarea
English: Take special care if you are older than 65 years, as there is a higher risk you experience diarrhoea.
Maltese: Jekk għandek aktar minn 65 sena, oqgħod attent/a aktar, minħabba li hemm riskju akbar li tesperjenza dijarea.
English: - Medicines to treat pain and inflammation called NSAIDs.
Maltese: - Mediċini li jikkuraw uġigħ u infjammazzjoni msejħin NSAIDs. - Lassattivi
English: The recommended dose is one capsule (i.e. 290 micrograms of linaclotide) taken orally once a day.
Maltese: Id-doża rakkomandata hija kapsula waħda (i.e. 290 mikrogramma ta' linaclotide) meħuda mill-ħalq darba kuljum.
English: It is not absorbed into the body, but attaches to receptor called guanylate cyclase C on the surface of your gut.
Maltese: Ma jiġix assorbit fil-ġisem, iżda jeħel ma' riċettur jismu guanylate cyclase C fuq is-superfiċje tal-imsaren tiegħek.
English: Taking Constella in the fed condition produced more frequent and looser stools, as well as more gastrointestinal adverse events, than when taking it under fasting conditions (see section 5.1).
Maltese: It-teħid ta' Constella wara l-ikel ipproduċa ppurgar aktar frekwenti u aktar maħlul, kif ukoll aktar avvenimenti gastrointestinali avversi milli meta ttieħed fuq stonku vojt (ara sezzjoni 5.1).