natgillin/translations-raw huggingface dataset:
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.
Ostali znakovi i simptomi IBS-C-a uključujući nadutost, učestalost potpunog spontanog pražnjenja crijeva, naprezanje i konzistenciju stolice su se poboljšali u bolesnika liječenih linaklotidom u usporedbi s placebom (p< 0,0001) kao što je prikazano u sljedećoj tablici.
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).
Nakon primjene jednokratnih doza do 966 mikrograma i višestrukih doza do 290 mikrograma linaklotida, nisu utvrđene razine ishodišnog lijeka ili aktivnog metabolita (des-tirozin) koje bi bilo moguće detektirati u plazmi.
Activation of GC-C results in an increase in concentrations of cyclic guanosine monophosphate (cGMP), both extracellularly and intracellularly.
Aktiviranje GC-C rezultira povećanjem koncentracija cikličkog gvanozin-monofosfata (cGMP), kako izvanstanično tako i unutarstanično.
White to off-white-orange opaque capsule (18 mm x 6.35 mm) marked “290” with grey ink.
Neprozirna kapsula bijele do bjelkasto-narančaste boje (18 mm x 6,35 mm) s oznakom „290“ otisnutom sivom tintom.
IBS is a common gut disorder.
IBS je čest poremećaj crijeva.
Pregnancy and breast-feeding Limited information is available on the effects of Constella in pregnant and breast-feeding women.
Na raspolaganju su ograničene informacije o utjecajima Constelle u trudnica i dojilja.
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).
Linaklotid se rijetko otkriva u plazmi nakon davanja preporučenih kliničkih doza, a in vitro ispitivanja su pokazala da linaklotid nije ni supstrat, niti inhibitor/induktor enzimskog sustava citokroma P450 te da nema interakcija s nizom uobičajenih transportera izbacivanja i unosa u stanici (vidjeti dio 5.2).
Constella acts locally in your gut, helping you to feel less pain and less bloated, and to restore the normal functioning of your bowels.
Constella djeluje lokalno u Vašim crijevima, pomažući u smanjenju osjećaja boli i nadutosti i ponovno uspostavlja normalni rad crijeva.
Linaclotide is a Guanylate Cyclase-C receptor agonist (GCCA) with visceral analgesic and secretory activities.
Linaklotid je agonist receptora gvanilat ciklaze-C (GCCA) s visceralnom analgetičkom i sekretornom aktivnošću.
Both linaclotide and des-tyrosine active metabolite are reduced and enzymatically proteolyzed within the gastrointestinal tract to smaller peptides and naturally occurring amino acids.
Linaklotid i aktivni metabolit des-tirozin se reduciraju i enzimatski proteoliziraju unutar gastrointestinalnog trakta na manje peptide i aminokiseline koje se prirodno pojavljuju.
Should prolonged (e.g. more than 1 week) or severe diarrhoea occur, medical advice should be sought and temporary discontinuation of linaclotide until diarrhoea episode is resolved may be considered.
Ako se dogode slučajevi produljenog (npr. dulje od tjedan dana) ili teškog proljeva, mora se potražiti savjet liječnika i razmotriti privremeni prekid uzimanja linaklotida za vrijeme trajanja proljeva.
In those patients in whom diarrhoea led to discontinuation, it resolved after a few days of discontinuing treatment.
U bolesnika koji su prekinuli liječenje radi proljeva, nekoliko dana nakon prekida liječenja proljev je prestao.
• low level of potassium in your blood
• niska razina kalija u krvi
If you experience severe or prolonged diarrhoea (passing of frequent watery stools for 7 days or more), stop taking Constella and contact your doctor (see section 4).
Ako imate teški ili produljeni proljev (česta vodenasta stolica u trajanju od 7 dana ili dulje), molimo prekinite primjenu Constelle i kontaktirajte Vašeg liječnika (vidjeti dio 4).
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.
Unutarstanični cGMP uzrokuje lučenje klorida i bikarbonata u lumen crijeva aktivacijom transmembranskog regulatora provodljivosti u cističnoj fibrozi (CFTR), što rezultira povećanjem intestinalne tekućine i ubrzanim prolazom.
Talk to your doctor if you suffer from inflammatory diseases of the guts such as Crohn's disease or ulcerative colitis as Constella is not recommended in these patients.
Obratite se svom liječniku ako bolujete od upalnih bolesti crijeva kao što su Crohnova bolest ili ulcerozni kolitis, budući da primjena Constelle nije preporučena u tih bolesnika.
In general, linaclotide is minimally detectable in plasma following therapeutic oral doses and therefore standard pharmacokinetic parameters cannot be calculated.
Općenito, linaklotid se u plazmi detektira u minimalnim količinama pri oralnim terapijskim dozama te se prema tome standardni farmakokinetički parametri ne mogu izmjeriti.
The efficacy of linaclotide was established in two randomised, double-blind, placebo-controlled Phase 3 clinical studies in patients with IBS-C.
Djelotvornost linaklotida je utvrđena u dva randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja faze III u bolesnika sa sindromom iritabilnih crijeva s konstipacijom (IBS-C).
Extracellular cGMP decreases pain-fiber activity, resulting in reduced visceral pain in animal models.
Izvanstanični cGMP smanjuje aktivnost vlakana osjetljivih na bol te rezultira smanjenjem visceralne boli u životinjskih modela.
Do not store above 30C Keep the bottle tightly closed in order to protect from moisture
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30°C Bocu čuvati čvrsto zatvorenu radi zaštite od vlage
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).
Kad je 2897 mikrograma primijenjeno 8. dan, nakon sedmodnevne primjene 290 mikrograma dnevno, linaklotid je otkriven u samo 2 od 18 ispitanika u koncentracijama tek malo iznad donje granice kvantifikacije od 0,2 ng/ml (koncentracije su se kretale od 0,212 do 0,735 ng/ml).
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.
Za vrijeme 2 tjedna početnog razdoblja prije liječenja, bolesnici su imali prosječan intenzitet boli u abdomenu od 5,6 (na ljestvici 0-10) s 2,2% dana bez boli u abdomenu, dok je prosječan intenzitet nadutosti bio 6,6 (na ljestvici 0-10), a spontano pražnjenje crijeva iznosilo je prosječno 1,8 puta tjedno.
In a cross-over food interaction study, 18 healthy subjects were administered Constella 290 micrograms for 7 days both in the fasting and fed state.
U ukriženom ispitivanju interakcije hrane, 18 zdravih ispitanika je primalo Constella 290 mikrograma tijekom 7 dana natašte i nakon obroka.
Flatulence Abdominal distension
Bol u abdomenu Flatulencija Distenzija abdomena
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.
Potencijalna inhibitorska aktivnost linaklotida i njegovog aktivnog primarnog metabolita MM-419447 na transportere izbacivanja u ljudi BCRP, MRP2, MRP3 i MRP4 i transportere unosa u ljudi OATP1B1,
A food interaction clinical study in healthy subjects showed that linaclotide was not detectable in plasma either in fed or in fasted conditions at the therapeutic doses.
Kliničko ispitivanje interakcije s hranom na zdravim ispitanicima pokazalo je da se linaklotid u terapijskim dozama ne može otkriti u plazmi niti nakon obroka niti natašte.
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.
Kao bolesnik s odgovorom s obzirom na stupanj olakšanja IBS-a se smatrao onaj koji je značajno ili u potpunosti oslobođen boli u trajanju od najmanje 50% provedenog vremena liječenja; kod bolova/nelagode u abdomenu bolesnik s odgovorom je bio onaj koji je imao 30%-tno poboljšanje ili više u trajanju od najmanje 50% provedenog vremena liječenja.
Bloating (11-point NRS)
Nadutost (numerička ljestvica od 11 bodova)
Constella is indicated for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
Constella je indicirana za simptomatsko liječenje umjerenog do teškog oblika sindroma iritabilnog crijeva s konstipacijom (IBS-C) u odraslih osoba.
Of these patients, 892 patients received linaclotide at the recommended dose of 290 micrograms per day.
892 bolesnika od 1166 je primilo linaklotid u preporučenoj dozi od 290 mikrograma dnevno.
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.
Nakon primjene jedne oralne doze od 2897 mikrograma linaklotida 8. dan, koja je uslijedila nakon 7 dana primjene 290 mikrograma dnevno u 18 zdravih dobrovoljaca, približno 3 do 5% doze je otkriveno u fecesu i to gotovo u potpunosti u obliku aktivnog metabolita des-tirozina.
No dose adjustments are required for patients with hepatic or renal impairment (see section 5.2).
Nije potrebno prilagođavanje doza za bolesnike s oštećenjem funkcije bubrega ili jetre (vidjeti dio 5.2).
Constella is available in packs containing 10, 28 or 90 capsules and in multipacks of 112 capsules comprising 4 cartons, each containing 28 capsules.
Constella je dostupna u pakiranjima od 10, 28 ili 90 kapsula, te u višestrukom pakiranju od 112 kapsula koje sadrži 4 kutije, a svaka sadrži 28 kapsula.
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.
U dva glavna ispitivanja faze III u kojima je bolesnicima davana doza od 290 mikrograma linaklotida jedanput dnevno, linaklotid je detektiran u samo 2 od 162 bolesnika približno 2 sata nakon početne doze linaklotida (koncentracije su se kretale od 0,241 do 0,239 ng/ml), a nije detektiran niti u jednog od 162 bolesnika nakon 4 tjedna liječenja.
Straining (5-point ordinal scale) *p<0.0001, linaclotide vs placebo.
*p< 0,0001, linaklotid naspram placeba.
Linaclotide has not been studied in patients with chronic inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis; therefore it is not recommended to use Constella in these patients.
Linaklotid nije ispitivan u bolesnika s kroničnim upalnim stanjima intestinalnog trakta kao što su Crohnova bolest i ulcerozni kolitis te se, prema tome, ne preporučuje primjena Constelle u takvih bolesnika.
What Constella is used for
Za što se Constella koristi
- Medicines to treat pain and inflammation called NSAIDs.
- Lijekovi namijenjeni liječenju boli i upale pod nazivom nesteroidni protuupalni lijekovi.
Faecal incontinence Defecation urgency Lower gastrointestinal haemorrhage including haemorrhoidal haemorrhage and rectal haemorrhage Nausea
Fekalna inkontinencija Urgencija defekacije Krvarenje iz donjeg gastrointestinalnog trakta, uključujući hemoroidalno krvarenje i krvarenje iz rektuma
Through its action at GC-C, linaclotide has been shown to reduce visceral pain and increase GI transit in animal models and increase colonic transit in humans.
Pokazalo se da linaklotid svojim djelovanjem na GC-C, smanjuje visceralnu bol, povećava gastrointestinalni prolazak u životinjskim modelima i povećava prolazak kroz kolon u ljudi.
Caution should be exercised when prescribing medicinal products absorbed in the intestinal tract with a narrow therapeutic index such as levothyroxine as their efficacy may be reduced.
Pri propisivanju lijekova s uskim terapijskim indeksom koji se apsorbiraju u intestinalnom traktu, kao što je levotiroksin, mora se primijeniti oprez, jer njihova djelotvornost može biti smanjena.
The European Medicines Agency has deferred the obligation to submit the results of clinical studies with Constella in one or more subsets of the paediatric population in functional constipation (see section 4.2 for information on paediatric use).
Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja Constelle u jednoj ili više podskupina pedijatrijske populacije s funkcionalnim zatvorom.
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.
Constellu se smije uzeti nakon što su isključene organske bolesti te je dijagnosticiran umjereni do teški oblik IBS-C-a (vidjeti dio 5.1).
• infrequent, hard, small or pellet-like stools (faeces).
• neučestala, tvrda, mala količina stolice ili stolica u obliku kuglice.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING SINGLE BOTTLE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA KOJA SADRŽI JEDNU BOCU
Unopened bottle for 28, 90 and multipack containing 112 (4 packs of 28) capsules: 3 years.
Neotvorena boca s 28, 90 i višestruko pakiranje sa 112 (4 pakiranja od 28) kapsula: 3 godine.
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).
Uzimanje Constelle nakon obroka rezultiralo je češćim i mekšim stolicama kao i sa više štetnih gastrointestinalnih događaja, nego kad se uzimala natašte (vidjeti dio 5.1).
Hypokalaemia Dehydration Decreased appetite
Hipokalemija Dehidracija Smanjenje teka
Linaclotide is rarely detectable in plasma, therefore, renal impairment would not be expected to affect clearance of the parent compound or its metabolite.
Linaklotid se rijetko detektira u plazmi, stoga se ne očekuje da oštećenje bubrega utiče na klirens ishodišne tvari ili njegovih metabolita.
Each capsule contains 290 micrograms of linaclotide.
Svaka kapsula sadrži 290 mikrograma linaklotida.
Both linaclotide and its active metabolite bind to the GC-C receptor, on the luminal surface of the intestinal epithelium.
Linaklotid i njegov aktivni metabolit se vežu za receptor gvanilat ciklaze-C (GC-C), na luminalnoj površini intestinalnog epitela.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOCA
Constella contains the active substance linaclotide.
Constella sadrži djelatnu tvar linaklotid.
Once opened, use within 18 weeks.
Nakon otvaranja, upotrijebiti u roku od 18 tjedana.
Warning: The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry.
Upozorenje: Boca sadrži jedan ili više zatvorenih spremnika koji sadrže silikagel radi zaštite kapsula od vlage.
LS: Least Square CSBM: Complete Spontaneous Bowel Movement
LS: Metoda najmanjih kvadrata (Least Square)
White high density polyethylene (HDPE) bottle with a tamper evident seal and a child-resistant closure, together with one or more desiccant canisters containing silica gel.
Bijela boca od polietilena visoke gustoće (HDPE) sa zaštitnom folijom s evidencijom otvaranja i sigurnosnim zatvaračem za djecu, zajedno s jednim ili više spremnika sa sredstvom za sušenje koji sadrže silikagel.
• bicarbonate decrease in your blood
• smanjenje bikarbonata u krvi
Constella has not been studied in patients who have hepatic impairment.
Constella nije ispitivana na bolesnicima s oštećenjem jetre.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON CONTAINING 4 x 28 CAPSULE BOTTLES (MULTIPACK) WITH BLUE BOX
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA KOJA SADRŽI 4 BOCE PO 28 KAPSULA (VIŠESTRUKO PAKIRANJE) S PLAVIM OKVIROM
What Constella looks like and contents of the pack The capsules are white to off-white-orange opaque hard capsules marked “290” with grey ink.
Kapsule su tvrde, neprozirne, bijele do bjelkasto-narančaste boje s oznakom „290“ otisnutom sivom tintom.
They are packaged in a white, high density polyethylene (HDPE) bottle with a tamper evident seal and a child-resistant screw cap, together with one or more desiccant canisters containing silica gel.
Pakirane su u bijele boce od polietilena visoke gustoće (HDPE) sa zaštitnom folijom s evidencijom otvaranja i sigurnosnim zatvaračem za djecu, zajedno s jednim ili više spremnika sa sredstvom za sušenje koji sadrže silikagel.
The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry.
Boca sadrži jedan ili više zatvorenih spremnika koji sadrže silikagel radi zaštite kapsula od vlage.
Capsule shell: red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatin.
Ovojnica kapsule: crveni željezov oksid (E172), titanijev dioksid (E171), žuti željezov oksid (E172) i želatina.
Stool consistency (BSFS Score)
Konzistencija stolice (BSFS rezultat) Naprezanje (Ordinalna ljestvica s 5 bodova)
Diarrhoea is normally short lived; however, if you experience severe or prolonged diarrhoea (passing frequent or watery stools for 7 days or more) and feel lightheaded, dizzy or faint, stop taking Constella and contact your doctor.
Međutim, ako iskusite teški ili produljeni proljev (česta ili vodenasta stolica u trajanju od 7 dana ili dulje) te se osjećate ošamućeni, imate omaglicu ili nesvjesticu, prestanite uzimati Constellu i obratite se svom liječniku.
The co-primary endpoints in both clinical studies were 12-week IBS degree of relief responder rate and 12 week abdominal pain/discomfort responder rate.
Zajednička primarna mjera ishoda u oba klinička ispitivanja je stopa bolesnika s odgovorom s obzirom na stupanj olakšanja IBS-a i stopa bolesnika s odgovorom s obzirom na bolove/nelagodu u abdomenu u trajanju od 12 tjedana.
Pack sizes: 10, 28 or 90 capsules and multipacks containing 112 (4 packs of 28) capsules.
Veličina pakiranja: 10, 28, ili 90 kapsula, te višestruko pakiranje koje sadrži 112 (4 pakiranja s 28) kapsula.
EU/1/12/801/005 Multipack: 112 (4 packs of28) capsules
EU/1/12/801/005 Višestruko pakiranje: 112 (4 pakiranja s 28) kapsula
Constella has not been studied in patients who have renal impairment.
Constella nije ispitivana na bolesnicima s oštećenjem bubrega.
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.
Iz podataka prikupljenih u periodu od 26 tjedana, ispitivanje 1 je pokazalo da je 37% i 54% bolesnika liječenih linaklotidom u usporedbi sa 17% i 36% bolesnika liječenih placebom pokazalo odgovor s obzirom na stupanj olakšanja IBS-a (p< 0,0001) odnosno s obzirom na bol/nelagodu u trbuhu (p< 0,0001).
Constella 290 micrograms hard capsules linaclotide
Constella 290 mikrograma tvrde kapsule linaklotid
• urgency to pass stools
• hitnost pražnjenja stolice
The recommended dose is one capsule (i.e. 290 micrograms of linaclotide) taken orally once a day.
Preporučena doza je jedna kapsula (tj. 290 mikrograma linaklotida) jedanput na dan kroz usta.
EU/1/12/801/001 10 capsules EU/1/12/801/002 28 capsules EU/1/12/801/004 90 capsules
EU/1/12/801/001 10 kapsula EU/1/12/801/002 28 kapsula EU/1/12/801/004 90 kapsula
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON CONTAINING SINGLE 28 CAPSULE BOTTLES (MULTIPACK) WITHOUT BLUE BOX
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA KOJA SADRŽI JEDNU BOCU S 28 KAPSULA (VIŠESTRUKO PAKIRANJE)
Very common side effects (may affect more than 1 in 10 people):
Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba):
Fig 2.
PRILOG II.
• stomach or abdominal pain,
• bol u želucu ili trbuhu,
It is preferable to discuss stopping treatment with your doctor before actually doing so.
Preporučuje se razgovarati sa svojim liječnikom u slučaju da želite prekinuti liječenje.
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).
je pokazalo da je 37% bolesnika liječenih linaklotidom u usporedbi s 19% bolesnika liječenih placebom pokazalo odgovor s obzirom na stupanj olakšanja IBS-a (p< 0,0001), dok je 55% bolesnika liječenih linaklotidom u usporedbi s 42% bolesnika liječenih placebom pokazalo odgovor s obzirom na bolove/nelagodu u abdomenu (p= 0,0002).
Printing ink: shellac, propylene glycol, concentrated ammonia solution, potassium hydroxide, titanium dioxide (E171) and black iron oxide (E172).
Tinta za označavanje: šelak, propilenglikol, koncentrirana otopina amonijaka, kalijev hidroksid, titanijev dioksid (E171) i crni željezov oksid (E172).
2% of treated patients experienced severe diarrhoea and 5% of patients discontinued treatment due to diarrhoea in clinical studies.
U kliničkim ispitivanjima, 2% liječenih bolesnika je imalo teški oblik proljeva, a 5% bolesnika je prekinulo liječenje zbog proljeva.
• feeling bloated,
• osjećaj nadutosti,
• feeling bloated
• osjećaj omaglice
MARKETING AUTHORISATION NUMBER(S) EU/1/12/801/005 Multipack: 112 (4 packs of 28) capsules 13.
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/801/005 Višestruko pakiranje: 112 (4 pakiranja s 28) kapsula 13. BROJ SERIJE
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).
Iz podataka prikupljenih u periodu od 12 tjedana, ispitivanje 1 je pokazalo da je 39% bolesnika liječenih linaklotidom u usporedbi sa 17% bolesnika liječenih placebom pokazalo odgovor s obzirom na stupanj olakšanja IBS-a (p< 0,0001), dok je 54% bolesnika liječenih linaklotidom u usporedbi s 39% bolesnika liječenih placebom pokazalo odgovor s obzirom na bolove/nelagodu u abdomenu (p< 0,0001).
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
Višestruko pakiranje: 112 (4 pakiranja s 28) kapsula NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
Red iron oxide (E172) Yellow iron oxide (E172)
željezov oksid, crni (E172)
Rare side effects (may affect up to 1 in 1,000 people):
Rijetke nuspojave (mogu se javiti kod do 1 na 1000 osoba):
Five percent of patients discontinued treatment due to diarrhoea in clinical studies.
U kliničkim ispitivanjima, 5% bolesnika je prekinulo liječenje radi proljeva.
NAME OF THE MEDICINAL PRODUCT Constella 290 micrograms hard capsules linaclotide
NAZIV LIJEKA Constella 290 mikrograma tvrde kapsule
EU/1/12/801/004 90 capsules
EU/1/12/801/004 90 kapsula
How to take Constella
Kako uzimati Constellu